The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted March 23, 2010 and the Health Care and Education Reconciliation Act of 2010, Public Law 111-152 was enacted March 30, 2010 (these Acts collectively known as the “Affordable Care Act” or “ACA”). The Affordable Care Act reorganizes, amends and supplements the provisions of Part A of Title XXVII of the Public Health Service Act (PHS Act) relating to group health insurance plans and health insurance issuers in the group and individual markets.
Pursuant to Section 2719A of the PHS Act, as amended by the Affordable Care Act and incorporated into ERISA and the Code, if a non-grandfathered group health plan or an issuer of health insurance that offers non-grandfathered group or individual health insurance coverage provides benefits in relation thereto for emergency services in In a hospital emergency department, the plan or issuer must cover emergency services without requiring prior authorization from the individual or healthcare provider (including where the emergency services are provided off-grid) and regardless of whether the healthcare provider providing the emergency services is in is an in-network provider in relation to the Services. The emergency services must be provided without regard to any other term or condition of the plan or health insurance coverage other than the exclusion or coordination of benefits, membership or qualifying period permitted under the Code, ERISA, and the PHS Act, or applicable cost-sharing requirements. For a plan or health insurance coverage with a network of providers providing emergency services benefits, the plan or issuer may not impose administrative requirements or restrictions for off-network emergency services benefits that are more restrictive than the requirements or restrictions applicable to on-network emergency services . In addition, airlines offering FEHB plans must comply with the requirements described in Section 2719A of the PHS Act in the same manner as they apply to a plan or issuer.
For purposes of the requirements under Section 2719A of the PHS Act, ambulance services in relation to a medical emergency means (1) a medical screening (as required under Section 1867 of the Social Security Act) capable of providing a hospital emergency department, including emergency services, which are routinely available to the emergency department to assess such a medical emergency, and (2) which is within the ability of the hospital staff and facilities to provide such further medical evaluation and treatment as required under Section 1867 of the Social Security Act to stabilize the patient.
The regulations implementing Section 2719A of the PHS Act include this consumer protection.
The No Surprises Act added Section 9816 of the Code, Section 716 of ERISA and Section 2799A-1 of the PHS Act which extend patient protections in relation to ambulance services under Section 2719A of the PHS Act in part by providing additional consumer protections related to balance settlement .
In addition, the No Surprises Act re-codified patient protections in relation to the election of healthcare professionals from Section 2719A (a), (c) and (d) of the PHS Act in new Section 9822 of the Code, Section 722 of ERISA and Section 2799A-7 of the PHS Act. Where a plan or issuer requires or contemplates designation by a participant, beneficiary, or participant of a participating primary care provider, these provisions permit individuals to designate any participating primary care providers available to accept them, including pediatricians, and the plan or issuer to prohibit not requiring a permit or referral for obstetric or gynecologic care.
Most group health plans and health plans that offer group or individual health insurance have a network of providers and healthcare organizations (participating providers or preferred providers) who contractually agree to accept a certain amount for their services.
A balance calculation can come as a surprise to the individual. An unexpected medical bill is an unexpected bill from a healthcare provider or facility that occurs when an insured person receives medical services from a provider or facility that, usually unknown to the participant, beneficiary or enroller, is a non-participating provider or facility individual coverage. Surprise billing occurs for both emergency care and non-emergency care. In an emergency, a person will usually go (or be taken by emergency transport) to a nearby emergency room. Even if they go to a participating hospital or facility for emergency care, they may receive care from nonparticipating providers working at that facility. For non-emergency care, an individual may choose a participating facility (and possibly even a participating provider) without knowing that at least one provider involved in their care (e.g., an anesthetist or a radiologist) is a non participating provider. In either case, the individual may not be able to select the provider or ensure that the provider is a participating provider. Therefore, in addition to being billed for their co-payment amount, which tends to be higher for off-network services, the individual may receive a compensation bill from the non-participating provider or facility. This scenario also often plays out in air ambulance services, where individuals generally do not have the ability to select an air ambulance service provider and therefore have little or no control over whether the provider is on the network with their plan or coverage.
When individuals are unable to avoid nonparticipating providers, it increases healthcare costs and puts patients at financial risk.
Another study using claim data from a major commercial issuer for the period 2010-2016 found that over 39 percent of on-network hospital emergency room visits resulted in an off-network bill, and the 32.3 percent incidence in 2010 increased 42.8 percent in 2016. The average potential amount of surprise medical bills also increased from $220 in 2010 to $628 in 2016. During the same period, 37 percent of inpatient admissions at hospitals within the network resulted in at least one off-network bill, which increased from 26.3 percent in 2010 to 42 percent in 2016, and the average potential medical bill for surprises increased from $804 to $2,040.
Although some states have enacted legislation to reduce or eliminate balance sheet accounting, these efforts have resulted in a patchwork of consumer protection measures. Even within a state that has such protections in place, those protections typically only apply to individuals enrolled in individual and group health insurance, such as ERISA generally
Surprise medical bills can lead to medical debt for people struggling to pay their bills. The impact will be felt most clearly by communities affected by poverty and other social risk factors, as unexpected medical bills and medical debt can negatively impact an individual's ability to eliminate debt and create wealth, and ultimately affect a family for generations.
Communications between providers, plans, consumers, communities and consumer advocates must be consistent with and reinforce all relevant consumer protections related to surprise bills. Such communication must be accessible, linguistically tailored and at an appropriate level of literacy. This includes meeting the requirements for providing effective communications for people with disabilities under the Americans with Disabilities Act of 1990,
Am 20. Januar 2021 erließ Präsident Biden die Executive Order 13985 „On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government“.
On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA), which included the No Surprises Act, came into effect. The No Surprises Act provides federal protection against surprise billing and limits off-net cost sharing in many of the circumstances where surprise bills most commonly occur.
The CAA added provisions applicable to group health insurance plans and issuers of health insurance in the group and individual markets in a new Part D of Title XXVII of the PHS Act, and also added new provisions to Part 7 of ERISA and Subchapter B of Chapter 100 of the Code . Section 102 of the No Surprises Act added Section 9816 of the Code, Section 716 of ERISA and Section 2799A-1 of the PHS Act which contain limitations on cost sharing and requirements for initial payments for emergency services and for non-emergency services provided by
The CAA regulations that apply to healthcare providers and facilities and providers of air ambulance services, such as: B. Cost-sharing requirements, prohibitions on balance accounting for certain items and services, and disclosure requirements to protect balance accounting, have been added to Title XXVII of the PHS Act in a new Part E.
Departments are enacting regulations implementing the provisions of Title I (No Surprises Act) and Title II (Transparency) of Division BB of the CAA in phases. Later this year, the divisions plan to issue regulations on the federal IDR process (sections 103 and 105 of Division BB), patient protection through transparency and the patient-provider dispute resolution process (section 112), and price comparison tools (section 114). . The Ministries also intend to issue regulations this year to propose the form and manner in which plans, issuers and providers of air ambulance services would report information on air ambulance services (Section 106). In addition, HHS intends to issue regulations to implement requirements for health insurance issuers that offer individual health insurance coverage or short-term limited-duration health insurance to disclose and report information about direct or indirect compensation to agents and brokers (Section 202(c) ) and provisions in the Related to HHS enforcement of requirements for issuers, non-state group health insurers, providers, facilities and air ambulance service providers.
The CAA also includes provisions on transparency in plan and insurance statements (Section 107), continuity of care (Section 113), accuracy of provider network directories (Section 116), and prohibition of gag clauses (Section 201) applicable to plan fiscal years commencing on or after January 1, 2022; and reporting of pharmacy services and drug costs (Section 204), which is required by December 27, 2021. The Departments intend to issue regulations to fully implement these provisions, but regulations on some of these provisions may not be issued until after January 1, 2022. The Departments advise that any such rulemaking to fully implement these provisions will include an expected effective date that allows a reasonable amount of time for schemes, issuers, providers and institutions, as applicable, to comply with new or clarified requirements. Until rulemaking to fully implement these provisions is complete and effective, plans and issuers are expected to implement the requirements in good faith and fair interpretation of the law. The Ministries intend to issue guidance in the near future on their expectations for good faith compliance with these provisions.
The No Surprises Act also amended the FEHBA, 5 U.S.C. 8901
OPM is charged with administering the FEHB program and retains supervisory and enforcement authority with respect to FEHB health benefit plans, which are federal government plans. Generally under 5 U.S.C. 8902(p), each FEHB contract must require an airline to comply with certain PHS Act, ERISA and Code requirements in the same manner as they apply to a group health plan or health insurance issuer.
These interim final rules implement provisions of the No Surprises Act that: (1) apply to group health insurance plans, health insurance issuers offering group or individual health insurance coverage, and carriers in the FEHB program to protect against balance billing and out-of-network cost-sharing with respect to emergency services, non-emergency services provided by non-participating providers at certain participating healthcare facilities, and air ambulance services provided by non-participating air ambulance service providers; (2) Prohibit nonparticipating providers, health care facilities and air ambulance service providers in certain situations from accounting for participants, beneficiaries and enrollers and allow those providers and facilities to offset individuals' bills where certain notification and consent requirements are set forth in the No Surprises Act satisfied; (3) require certain healthcare facilities and providers to provide federal and state patient protection disclosures against balance sheet accounting; (4) recodify certain patient safeguards originally appearing in the ACA and that the No Surprises Act applies to grandfathering plans; and (5) establish grievance procedures relating to breaches of off-network chargeback and cost-sharing protections under the No Surprises Act.
These interim final rules protect individuals, in certain circumstances, from unexpected medical bills for emergency services, air ambulance services provided by non-participating providers, and non-emergency-related services provided by non-participating providers at participating facilities. These interim final regulations require, among other things, that emergency services be covered without prior approval, regardless of whether the healthcare provider providing the emergency services is a participating provider or emergency facility with respect to the Services, and without regard to any other provision or Condition of plan or coverage other than exclusion or coordination of benefits or eligible membership or qualifying period. In addition, emergency services include certain services in a hospital emergency department or an independent free-standing emergency department and, in certain cases, post-stabilization services.
With respect to emergency services, air ambulance services provided by non-participating providers and non-
These Interim Final Rules provide that co-payment amounts for such services provided by non-participating emergency care facilities and non-participating providers at participating facilities must be calculated based on one of the following amounts: (1) An amount determined by an applicable All -Payer model agreement established pursuant to Section 1115A of the Social Security Act; (2) if there is no such applicable all-payer model agreement, an amount to be determined by a particular state statute; or (3) if there is no such applicable all-payer model agreement or a particular state law, the lesser of the billed fee or the plan's or issuer's median contract rate that constitutes the Qualifying Payment Amount , QPA). Cost sharing amounts for air ambulance services provided by non-participating providers must be calculated using the lesser of the billed fee or the QPA and the cost sharing requirement that would apply if such services were provided by a participating provider.
Under these Interim Final Rules, balance billing for services covered by the Rules is generally prohibited, and the total amount payable to the Provider or Facility, including any co-payment, is based on: (1) an amount determined by an applicable All -Payer Model Agreement under Section 1115A of the Social Security Act; (2) if there is no such applicable all-payer model agreement, an amount to be determined by a particular state statute; (3) if there is no such applicable all-payer model agreement or specific state law, an amount agreed between the plan or issuer and the provider or entity; or (4) if none of these three conditions are met, an amount determined by an IDR agency.
In general, under the No Surprises Act and these Interim Final Rules, the safeguards limiting cost-sharing and prohibiting balance sheet accounting do not apply to certain post-stabilization services or to certain non-emergency services performed by non-participating providers at participating healthcare facilities when the provider or facility notifies the participant, beneficiary or registrant and obtains the individual's consent to waive the protection of the balance of accounts. However, in certain circumstances where surprise bills are likely, providers and establishments may not make such notices or obtain consent from individuals, e.g. In such circumstances, offsetting is prohibited and the other safeguards of the No Surprises Act, such as B. Network cost sharing requirements continue to apply.
Neither the No Surprises Act nor these interim final rules protect individuals generally from every large or unexpected medical bill. For example, an individual may be enrolled in a group health plan or health insurance coverage that provides little or no coverage for their particular medical condition or the items and services needed to treat that condition. In addition, balance billing is still permitted in circumstances where these Interim Final Rules do not apply, except where prohibited by state law or treaty, e.g. Nursing Facility in this Interim Final Rule. Nonetheless, the No Surprises Act and these interim final rules provide relief in some of the more common scenarios in which a participant, beneficiary or enroller might otherwise face large and unexpected medical expenses.
These interim final rules establish a complaints procedure for receiving and resolving complaints related to these new balance settlement protections.
These interim final rules also implement the requirement of the No Surprises Act that certain healthcare providers and facilities make publicly available, post on a public website, and provide a unilateral notice to individuals regarding: (1) the requirements and prohibitions that apply to the provider or entity referred to in Sections 2799B-1 and 2799B-2 of the PHS Act and its implementing regulations; (2) any applicable state accounting requirements; and (3) how to contact appropriate state and federal authorities if the individual believes that the provider or facility has failed to comply with the requirements described in the notice.
Section 116 of the No Surprises Act also added Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c) of the PHS Act which contain similar disclosure requirements for plans and issuers. Generally, under these provisions, plans and issuers must make publicly available, post on a public website of the plan or issuer, and include in any statement of benefits for an item or service with respect to which the requirements of Section 9816 of the Code are met, Section 716 of ERISA and Section 2799A-1 of the PHS Act apply, information on the requirements applicable under those sections above, if any; the requirements and prohibitions under Sections 2799B-1 and 2799B-2 of the PHS Act; to other applicable state laws governing the settlement of off-grid balances; and in contacting appropriate state and federal authorities if any person believes that such provider or entity has violated the accounting prohibition. These disclosure requirements apply to plan years beginning on or after January 1, 2022. At the same time, to reduce the burden and facilitate compliance with these disclosure requirements, the departments are issuing a model disclosure notice that healthcare providers, institutions, group health insurance companies and healthcare issuers may, but do not have to, use to meet the disclosure requirements related to settlement billing protection to fulfill. The Departments consider the use of the model notice in accordance with the attached instructions to be good faith compliance with the disclosure requirements of Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c). of the PHS Act when all other applicable requirements are met. In addition, HHS will consider use of the sample notice in accordance with the attached instructions as good faith compliance with the disclosure requirements of Section 2799B-3 of the PHS Act and 45 CFR 149.430 when all other applicable requirements of the PHS Act are met. Departments may address the requirements under Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c) of the PHS Act, as added by the No Surprises Act, in more detail in future guidance or rulemaking. Pending the release of further guidance, plans and issuers are expected to implement the requirements of Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c) of the PHS Act in good faith, reasonably legal interpretation. Departments shall consider the effective date of the law and the timeframe for implementation in determining compliance with the law in good faith.
These interim final rules generally apply to group health plans and health insurance issuers that offer group or individual health insurance coverage (including existing health insurance plans) with respect to plan years (in the individual market, policy years) beginning on or after January 1, 2022. as
In OPM's Interim Final Rules incorporated in this rulemaking, OPM incorporates all provisions of the Divisions' Interim Final Rules relating to those sections of the Code, ERISA and the PHS Act referred to in 5 U.S.C. 8902(p). In the OPM Interim Final Rules, OPM defines specific terms for the FEHB program, modifies some of the divisions' rules as necessary to properly integrate them into the existing regulatory and contractual structure of the FEHB program, and sets out the circumstances under which OPM enforces these rules FEHB airlines and sets out the types of legal proceedings related to the FEHB program that may be brought against OPM in relation to the No Surprises Act.
Upon compliance with 5 U.S.C. 8902(p), FEHB contract terms relating to the nature, provision, or scope of insurance coverage or benefits (including payments with respect to benefits) supersede and supersede state or local law or any regulations made thereunder that relate to obtain health insurance or plans.
The provisions of the Code, ERISA and the PHS Act added by the No Surprises Act, as well as these Interim Final Rules, contain defined terms specific to the requirements and implementation of the Act. Definitions of these key terms are described in this preamble. These terms help define the scope of protection for the remainder billing and how co-payment amounts and payment levels are determined.
The Departments note that these interim final regulations define the term “physician or healthcare provider” to mean a physician or other healthcare provider acting in the exercise of that provider’s license or certification under applicable state law, but the definition specifically excluding providers of air ambulance services. The Departments recognize that the No Surprises Act, while not defining 'provider', uses the term in a way that includes providers of air ambulance services in some provisions. For example, the No Surprises Act added Section 2799B-4 of the PHS Act, which specifically includes providers of air ambulance services when referring to providers. However, certain other provisions of the No Surprises Act apply only to air ambulance service providers or to health care providers generally, but by virtue of their provisions are not applicable to air ambulance service providers. As an example of the latter, the No Surprises Act added Section 2799B-2 of the PHS Act, which generally prohibits remainder billing by non-participating healthcare providers who provide non-emergency services at participating healthcare facilities. Although this provision does not specifically exclude air ambulance service providers, air ambulance service providers would not provide non-emergency services at participating healthcare facilities. Therefore, the provision does not apply to providers of air ambulance services (however, such providers are prohibited from making balance sheet accounts under Section 2799B-5 of the PHS Act). Similarly, Section 2799B-3 of the PHS Act, which requires a healthcare provider to notify individuals of the requirements and prohibitions for such healthcare provider in Sections 2799B-1 and 2799B-2 of the PHS Act (neither of which apply to providers of air rescue services), according to its provisions, does not apply to providers of air rescue services. Therefore, these Interim Final Rules define “physician or healthcare provider” to exclude air ambulance service providers to clarify which provisions of the No Surprises Act and Interim Final Rules apply to air ambulance service providers. Where provisions of the No Surprises Act, as implemented in these interim final regulations, apply to air ambulance service providers, the provisions expressly relate to air ambulance service providers. If, on the other hand, providers of air ambulance services are not expressly mentioned, the provisions do not apply.
Departments seek comments on the terms defined in these interim final rules, including the adequacy and usability of the definitions and whether additional terms should be defined in future rulemaking.
Subject to Section 9816(a) of the Code, Section 716(a) of ERISA and Section 2799A-1(a) of the PHS Act and these Interim Final Rules if it is a group health plan or a health insurance provider offering a group or more individual Health Insurance Coverage provides or covers benefits in respect of hospital emergency room services or in respect of emergency services in an independent stand-alone emergency room, the plan or issuer must cover the emergency services defined in these interim final provisions and such coverage must be in accordance with those interim final provisions final regulations will be provided.
A plan or issuer that covers emergency services must do so without requiring prior authorization from the individual or healthcare provider (including where the emergency services are provided off-network) and regardless of whether the healthcare provider providing the emergency services is a participating Provider or a participating emergency facility with respect to the Services. The emergency services must be provided without regard to any other term or condition of the plan or coverage, except for the exclusion or coordination of benefits (to the extent not inconsistent with emergency medical benefits as defined in these interim final provisions), affiliation, or Waiting period as required by the Code, ERISA, or the PHS Act or applicable cost-sharing requirements. For a plan or health insurance coverage with a network of providers that provides emergency services benefits, the plan or issuer may not impose administrative requirements or restrictions on coverage for emergency services from nonparticipating providers or nonparticipating emergency care facilities that are more restrictive than the requirements or Restrictions Applicable to Emergency Services Obtained from Participating Providers or Participating Emergency Facilities. In addition, such plan or health insurance coverage must meet the requirements described elsewhere in this preamble related to cost sharing, payment amounts, and procedures for resolving billing disputes.
The terms "medical emergency," "emergency services," and "for stabilization" generally have the meanings given to them in the Emergency Medical Treatment and Labor Act (EMTALA), Section 1867 of the Social Security Act.
Under Section 2719A of the PHS Act, emergency services have been defined to include: (1) A screening medical examination (as required under Section 1867 of the Social Security Act) that is within the capabilities of a hospital's emergency department, including additional services routinely provided for the emergency room available to assess such medical emergency; and (2) such other medical evaluation and treatment as may be required by Section 1867 of the Social Security Act to stabilize the patient, to the extent of the hospital's staff and facilities. HHS has previously interpreted hospitals' obligations under EMTALA to provide medical assessment and stabilization services to end when a patient is officially admitted in good faith.
Section 102 of the No Surprises Act further expands the definition of emergency services to include emergency services provided in an independent, free standing emergency department. An independent, standalone emergency department is a healthcare facility (not limited to those described in the definition of healthcare facility in Section 9816(b)(2)(A)(ii) of the Code, Section 716(b)(2)) . (A)(ii) of ERISA and Section 2799A-1(b)(2)(A)(ii) of the PHS Act, if applicable) that provides emergency services and is geographically distinct and separate from a hospital, and separate as those licensed by a state. The definition of "independent, stand-alone emergency department" is intended to include any healthcare facility that is geographically distinct and separate from a hospital and that is licensed by a state to provide emergency services, even if the facility does not fall under the term "independent, stand-alone emergency department."
Regulation of healthcare facilities varies by state. In particular, government regulation of emergency care centers varies significantly and is evolving as these types of centers become more common.
The term "medical emergency" means a medical condition manifested by acute symptoms of sufficient severity (including severe pain) that a prudent layman of average knowledge of health and medicine could reasonably expect that prompt medical attention would not be available occurs leading to a condition described in EMTALA, including (1) serious harm to the health of the person (or, in relation to a pregnant woman, the health of the woman or her unborn child), (2) serious impairment of bodily functions, or ( 3) severe dysfunction of a body organ or part.
Departments are aware that some plans and issuers are currently denying coverage for certain services provided in a hospital's emergency department by determining whether an episode of care involves a medical emergency based solely on definitive diagnostic codes, such as: B. The International Classification of Diseases, Tenth Revision, Clinical Modification Codes (ICD-10-CM) . In addition, some tariffs and issuers may automatically deny coverage based on a list of definitive diagnostic codes, without regard to the person's symptoms or additional screening. After an initial rejection, plans and issuers may then provide for a full review of the claim and apply the prudent lay standard only as part of an appeals process if the participant, beneficiary, or claimant files an appeal. These practices are inconsistent with the emergency service requirements of the No Surprises Act and the ACA.
These Interim Final Provisions clarify that if a group health plan or a health insurance company offering group or individual health insurance coverage provides benefits with respect to hospital emergency department services or with respect to emergency services in an independent, stand-alone emergency department, the plan or issuer must Cover emergency services without limiting what constitutes a medical emergency (as defined in these Interim Final Rules) based solely on diagnostic codes. If a plan or issuer refuses to provide coverage, in whole or in part, for a claim for payment of a service provided in a hospital emergency department or an independent free-standing emergency department, including services during observation or surgical services, the prudent determination is whether the lay standard must be based on all relevant documentation and focus on the symptoms present (rather than just the definitive diagnosis). This provision must take into account the legal norm
Departments are also aware that some plans and issuers that generally cover emergency services have nevertheless denied benefits for such services due to other general plan exclusions. For example, departments are aware of some plans and issuers that deny entitlements to emergency services for dependent pregnant women based on a general plan exclusion for dependent maternity care. As previously explained, both the scope of the emergency services regulations enacted pursuant to Section 2719A of the PHS Act and the new emergency services requirements contained in these interim final regulations provide in part for a plan or issuer to provide or cover benefits related to Emergency services in a hospital emergency department (or, according to these interim final rules, in an independent, stand-alone emergency department), emergency services must be provided “without regard to any other term or condition of the plan or coverage (other than exclusion or coordination of benefits). . . )” The Departments clarify that this provision does not permit plans and issuers to exclude benefits for items and services that would otherwise constitute medical emergency benefits for the purposes of these interim final regulations. This provision does not permit plans and issuers that cover emergency services to deny service to a participant, beneficiary or insured with a medical emergency who is receiving emergency services based on a general plan exclusion that would apply to items and services other than emergency services.
Pursuant to Section 9816(a)(3)(C)(ii) of the Code, Section 716(a)(3)(C)(ii) of ERISA and Section 2799A-1(a)(3)(C)(ii). ) of the PHS Act, emergency services include any additional items and services covered by a plan or coverage and provided by a nonparticipating provider or emergency facility (regardless of the department of the hospital where those items and services are provided will). ) following stabilization of a participant, beneficiary or enroller and in the context of an outpatient observation or inpatient or outpatient stay in relation to the visit during which the other emergency services will be provided. Such ancillary items and services (referred to in this preamble as post-stabilization services) shall be considered emergency services subject to surprise billing protection, except as provided in Section 9816(a)(3)(C)(ii)(II)(aa )-(cc) of the Code, Section 716(a)(3)(C)(ii)(II)(aa)-(cc) of ERISA or Section 2799A-1(a)(3)(C)(ii )(II)(aa)-(cc) of the PHS Act, if applicable, and any other conditions specified by the Divisions under paragraph (dd) of the relevant sections. Therefore, these Interim Final Rules provide that post-stabilization services are emergency services unless all of the following conditions are met.
First, the treating EMS physician or treating provider must determine that the participant, beneficiary or registrant is able to travel by non-medical transportation or non-emergency medical transportation to an available participating provider or facility within a reasonable distance, while providing medical care of the person is a condition. HHS Interim Final Rules codify this requirement under 45 CFR 149.410(b)(1). For this purpose, a treating provider is a doctor or healthcare provider who has examined the individual. It is generally expected that a treating provider with medical training and experience pertaining to the individual's specific medical condition will determine whether the individual is able to travel by non-medical or non-emergency medical transportation to an available Participating Provider or Facility to travel within reasonable distance. This determination is based on all relevant facts and circumstances and the individual should be involved in the decision-making process whenever possible. The determination of the treating emergency physician or treating service provider is binding for the facility within the meaning of this requirement. This requirement is based on the Ministries' perception that such a provider is best placed to make this decision.
For persons receiving service in or near the coverage area of their plan or issuer, as well as persons with coverage that utilizes a national network of providers and facilities, the statutory criterion would generally be sufficient to ensure that a person may choose, based on their coverage area and health status, to receive post-stabilization services at a participating facility or provider. The additional requirement in these Interim Final Rules that the individual be able to travel to an available participating provider or facility at a reasonable distance, taking into account the individual's medical condition, is necessary and reasonable to enable the provision of No Surprises to be carried out Act because the requirement is intended to address the common situations in which an individual has sought emergency services in a geographic region remote from the locations of participating providers or facilities. In cases where the person is unable to travel by non-medical transport or non-emergency medical transport, or in cases where there are no participating facilities or participating providers within a reasonable distance, the departments shall, taking into account the health status of the person the who believe that this is the case are unable to give their consent voluntarily and therefore the protection of balance settlement still applies.
In addition, Ministries recognize that an individual's transportation options may vary based on location, social risk and other risk factors. In cases of underserved and geographically isolated communities and those with social risk factors related to income and transportation, individuals may face additional barriers to receiving post-stabilization services without disruption of care. For example, individuals may not be able to pay for a taxi, may not have access to a car, may not be able to safely use public transportation due to medical conditions, or may not have access to public transportation. In these cases, the net effect would be the same: the person would be faced with unreasonable travel expenses that could prevent them from voluntarily agreeing to waive the otherwise applicable accounting safeguards. The authorities expect that the treating emergency doctor or treating doctor takes such factors into account if necessary
Unlike situations where a Participant, Beneficiary, or Enroller is able to travel on non-medical transportation or non-emergency medical transportation after stabilization, in the event that the individual requires medical transportation, including transportation by ground or air ambulance, the individual is unable to receive notification or provide consent. Therefore, protection from surprise bills will continue to apply to postal stabilization services provided in connection with the visit for which the individual received emergency services.
Second, the provider or facility providing post-stabilization services must meet the reporting and consent criteria of Section 2799B-2(d) of the PHS Act with respect to such items and services (required in the interim final regulations only for HHS under 45 CFR 149.410(b)(2) and incorporating criteria for notice and consent into 45 CFR 149.420(c) through (g)).
Third, the person (or the person's authorized representative) must be able to obtain the information in the notice provided for in Section 2799B-2 of the PHS Act (which is also implemented in 45 CFR 149.410(b)(3)) described, and subject to applicable state law, to provide informed consent in accordance with this Section. A person's ability to receive the information in the Notice will be determined by the treating physician or provider using reasonable medical judgment. A treating physician or treating provider with medical training and experience related to the individual's specific medical condition is generally expected to make this decision based on all relevant facts and circumstances. In addition to applying any requirements under state law, these healthcare professionals should apply the same principles used in determining whether a patient is capable of giving informed consent to treatment.
The consent must be given voluntarily, i. H. the person must be able to freely consent without undue influence, fraud or coercion. When post-stabilization services need to be provided quickly after the emergency services are provided, it may be difficult for the individual or their authorized representative to have sufficient time to make a clear decision about consent. Consent obtained through the threat of restraint or the immediacy of the need for treatment is not voluntary. In addition, the emergency physician or treating provider should assess whether the person has reasonable options regarding post-stabilization services, transportation, or service providers or facilities. Departments believe that post-stabilization notification and consent procedures should generally be used in limited circumstances where the person knowingly and intentionally seeks care from a non-participating provider or facility (e.g., or facility with which the person is familiar or familiar), and that the process should not be allowed to circumvent consumer protections in the No Surprises Act.
Fourth, the provider or facility must comply with any additional requirements or prohibitions that may be imposed under applicable state law. These interim final rules include this criterion, which recognizes that some state laws do not allow exceptions to the protection of state financial statements, such as As such, states may impose stricter standards exempting post-stabilization services from protection against surprise billing under these interim final rules, or states may not allow exemptions at all. This requirement is codified in the HHS Interim Final Rules at 45 CFR 149.410(b)(5).
The No Surprises Act empowers departments to set additional conditions that must be met for post-stabilization services to be exempt from the No Surprises Act definition of emergency services. The departments solicit comments on the terms previously described in this section. The departments are also seeking comment on whether there are additional terms that would be appropriate for designation under the definition of emergency services, such as: B. Conditions related to the coordination of care transitions to participating providers and facilities. The departments are also asking for comments
Section 9816(b) of the Code, Section 716(b) of ERISA, Section 2799A-1(b) of the PHS Act and these Interim Final Rules provide protection against surprise billing in the case of non-emergency services provided by non-participating service providers during a visit by a Participant, Beneficiary or Enroller to a Participating Healthcare Facility, unless the reporting and consent requirements set forth in these Interim Final Rules have been met.
Specifically, where a group health plan or health insurance issuer that offers group or individual health insurance coverage provides or covers benefits related to items and services (other than emergency services, for which Section 9816(a) of the Code, Section 716(a) of ERISA or Section 2799A-1(a) of the PHS Act applies), the plan or issuer must cover such items and services provided by a non-participating provider to a participant, beneficiary or eligible enroller of the plan or coverage to a visit to a participating healthcare facility in accordance with these Interim Final Rules, including the requirements relating to cost sharing, payment amounts and procedures for resolving billing disputes described elsewhere in this preamble.
These interim final rules comply with Section 9816(b)(2)(A) of the Code, Section 716(b)(2)(A) of ERISA, and Section 2799A-1(b)(2)(A) of the PHS -Act define a participating healthcare facility in the context of non-emergency services as a healthcare facility that has, directly or indirectly, a contractual relationship with a group health plan or health insurance issuer that offers group or individual health insurance coverage, specifying the terms and conditions to which a relevant article or Service provided to a Subscriber, Beneficiary or Registrant under the Plan or Coverage. These Interim Final Rules also establish that a case-by-case agreement between a healthcare facility and a plan or issuer, used to address unique situations where a participant, beneficiary or participant requires services that are typically provided off-network, constitutes a contractual relationship for the purposes of this definition and is limited to the contracting parties in relation to the relevant data subject. That is, where non-emergency services are being provided by a non-participating provider at a healthcare facility that has a case-by-case agreement with respect to the individual being treated, as opposed to an agreement or contract that would apply to all plans or issuers, participants, beneficiaries, or registrants , these non-emergency services would be subject to the protections described in 26 CFR 54.9816-5T, 29 CFR 2590.716-5, and 45 CFR 149.120 and the corresponding provider requirements at 45 CFR 149.420. The Divisions believe that it is reasonable for an individual to expect that items and services provided in a healthcare facility that has a case-by-case agreement relating to the individual's care to be provided on an intra-network basis. Therefore, in these circumstances, these Interim Final Rules apply the same protections as would apply to healthcare organizations participating in the Issuer's plan or network.
For these purposes, a healthcare facility as described in the Act is any of the following in the context of non-emergency services: (1) a hospital (as defined in Section 1861(e) of the Social Security Act); (2) a hospital outpatient department; (3) a critical access hospital (as defined in Section 1861(mm)(1) of the Social Security Act); or (4) an ambulatory surgical center as defined in Section 1833(i)(1)(A) of the Social Security Act.
In addition, Section 9816(b)(2)(A)(ii)(V) of the Code, Section 716(b)(2)(A)(ii)(V) of ERISA and Section 2799A-1(b) (2)(A)(ii)(V) of the PHS Act empowers departments to designate additional facilities as health facilities. Ministries are soliciting comments on other facilities that would qualify to be designated as healthcare facilities. Ministries are interested in comments that identify types of facilities that often generate unexpected bills, and are particularly interested in comments on whether emergency care centers or retail clinics should be designated as healthcare facilities for the purposes of these interim final regulations.
Departments recognize that state regulation of emergency care centers varies widely, as does the types of services that state law allows them to provide. Under these Interim Final Rules, emergency services provided in emergency care centers that are licensed in a manner that brings them within the definition of an independent, freestanding emergency department would be subject to, among other things, cost-sharing and compensation billing protections. However, due to significant variation in state law definitions, emergency care centers are not included in the definition of healthcare facilities in the context of non-emergency services. Therefore, in cases where non-emergency related services are provided in participating emergency care centers by non-participating providers, those services would not receive the protection under these Interim Final Rules. However, the departments believe that it is possible for individuals to use emergency care centers (regardless of how licensed) in a manner similar to independent, free-standing emergency departments, in which case it may be appropriate to designate emergency centers as healthcare facilities. The departments are seeking comment on the extent to which individuals may be using emergency care centers in a manner similar to independent, standalone emergency departments. The departments are asking for data on how often surprising bills arise in connection with emergency care centers. The divisions are also seeking comment on whether plans and issuers generally contract separately with emergency care centers and the providers operating at the centers, and how often contracting practices result in nonparticipating providers providing services at participating emergency care centers. The departments are also inviting comments on possible definitions of the term emergency care center.
In addition to the items and services provided by a provider at the facility, a “visit” at a participating healthcare facility includes the provision of equipment and devices, telemedicine services, imaging services, laboratory services, and preoperative and
The No Surprises Act and these Interim Final Rules provide exceptions to the remainder billing prohibitions and cost-sharing requirements where the participant, beneficiary or enroller receives compliant written notice agreeing to receive such services from a non-participating provider at a participating health care facility. However, these exceptions do not apply to certain ancillary services (related to non-emergency services) and other services under certain conditions, as discussed later in this preamble.
Section 105 of the No Surprises Act added Section 9817 of the Code, Section 717 of ERISA and Section 2799A-2 of the PHS Act to deal with surprise air ambulance bills. These provisions apply in the case of a participant, beneficiary or enroller receiving services from a non-participating air ambulance service provider, d , as defined in 42 CFR 414.605. These interim final rules apply these provisions when a plan or coverage generally has a network of participating providers and provides or covers air ambulance services benefits, even if the plan or coverage does not have air ambulance service providers in its network. With respect to air ambulance services provided by non-participating providers (including inter-facility transportation), plans and issuers must comply with the requirements related to cost sharing, payment amounts, and billing dispute resolution procedures described elsewhere in this preamble, provided such case would be covered if provided by a participating provider in relation to such plan or coverage.
Pursuant to Section 9816(a) of the Code, Section 716(a) of ERISA, Section 2799A-1(a) of the PHS Act and these Interim Final Rules, if a plan or issuer provides or covers benefits relating to services in an emergency room of a hospital or in relation to emergency services in an independent, stand-alone emergency department, the cost-sharing requirement for such services provided by a non-participating provider or emergency department shall not exceed the requirement that would apply to such services provided by a participating Provider or a participating emergency facility. In addition, when a plan or issuer provides or covers benefits for non-urgent items and services provided by a nonparticipating provider in relation to a visit to a participating healthcare facility, unless the provider has specific notification and consent criteria in relation thereto fulfills items and services, the plan or issuer may not impose a cost sharing requirement for such items and services that is higher than the cost sharing requirement that would apply if those items or services were provided by a participating provider. Similarly, if a plan or issuer provides or covers benefits for air ambulance services, the plan or issuer must cover such services from a non-participating provider in a manner that the cost-sharing requirement with respect to such services must be the same requirement as would apply if such Services were provided by a participating provider. For example, if a plan or issuer requires a 20 percent coinsurance rate for emergency services from participating providers or participating emergency facilities, the plan or issuer may not impose a coinsurance rate for emergency services from nonparticipating providers or facilities that exceeds 20 percent. Stakeholders have reported that network participation rates are low among air ambulance service providers. In cases where a plan or issuer does not have an established cost sharing requirement that applies specifically to participating providers, the plan or issuer must calculate the cost sharing amount using the generally applicable cost sharing requirement for the applicable item or service under the plan or coverage.
Subject to Sections 9816(a) and (b) and 9817(a) of the Code, Sections 716(a) and (b) and 717(a) of ERISA, Sections 2799A-1(a) and (b) and 2799A-2(a) of the PHS Act and these Interim Final Rules, all cost-sharing payments for emergency services, non-emergency related services provided by a nonparticipating provider at a participating healthcare facility, and air ambulance services provided by a nonparticipating provider, shall count towards any applicable network deductibles or deductible caps (and such in-network deductibles and deductible caps must be applied) under the plan or coverage (including the annual cost sharing limit under Section 2707(b) of the PHS Act) (if applicable). ) in the same manner as if such cost-sharing payments were made in respect of Services those provided by a participating vendor or entity.
Section 9816(a)(1)(C)(iii) of the Code, Section 716(a)(1)(C)(iii) of ERISA, Section 2799A-1(a)(1)(C)(iii) . ) of the PHS Act, and these interim final rules also state that for emergency services provided by a nonparticipating emergency facility and for non-emergency services provided by nonparticipating providers at a participating healthcare facility, cost sharing generally applies calculated as if the total cost would be calculated The amount that would have been billed by a participating emergency facility or provider for the services equaled the recognized amount for such services within the meaning of the Act and these Interim Final Provisions.
The “Acceptable Amount” is: (1) an amount determined by an applicable All-Payer Model Agreement under Section 1115A of the Social Security Act; (2) if there is no applicable All-Payer Model Agreement, an amount determined by a particular state statute; or (3) if there is no applicable All-Payer Model Agreement or specific governmental law, the lesser amount charged by Provider or Institution or QPA which, under these Interim Final Rules, is generally the median of the contracted Agreed rates of plan or issuer for the item or service in the geographic region.
By requiring plans and issuers to calculate the cost sharing amount using the recognized amount instead of the
Departments recognize that there may be some instances where a non-participating healthcare provider or facility could bill a plan or issuer for an item or service that is subject to this surprise billing protection at a lesser amount than the QPA . This can be relatively common, for example, for items whose patent expires after 2019, if the QPA is based on the median of the 2019 contracted rates. In these cases, it is understood that the plan or issuer would pay no more than the fee charged, the calculation of cost sharing based on the QPA would require a participant, beneficiary or registrant to pay a higher percentage of cost sharing than if the items or services were provided by a participating vendor. Section 9816(a)(1)(C)(ii) of the Code, Section 716(a)(1)(C)(ii) of ERISA and Section 2799A-1(a)(1)(C )(ii) of the PHS Act specifically prohibit plans and issuers from applying a cost-sharing requirement that is greater than the requirement that would apply if such services were provided by a participating provider or emergency facility. Therefore, under these interim final rules, in circumstances where a particular state law or all-payer model agreement does not apply to determine the cost sharing amount, the cost sharing must be based on the QPA or the amount billed by the provider, whichever is the case is lower for the item or service. The various methods used to determine the amount recognized are explained in separate sections of this Section III.B.2 of this preamble.
For air ambulance services provided by non-participating providers, the approved amount will not be used to determine co-payment. Rather, the law states that the cost-sharing requirement with respect to such services must be the same requirement that would apply if such services were provided by a participating provider, and any co-insurance or deductible must be based on rates that would apply to such services if provided by a participating provider. These interim final rules require plans and issuers to base any co-insurance and deductible for air ambulance services provided by a nonparticipating provider on the lower of the QPA or the amount billed. The Ministries have concluded that this policy is consistent with the general intention of the statute to protect participants, beneficiaries and enrollers from excessive bills and to keep individuals as far as possible away from disputes between plans and issuers and providers of air ambulance services. Additionally, using the QPA is a method of ensuring that any co-insurance or deductible is based on rates that would apply to the Services if provided by a participating provider, as the QPA is generally based on contracted average rates, as opposed to rates charged by non-participating providers and is a basis for determining the level of co-payments related to emergency services and items and services provided by non-participating providers at participating healthcare facilities.
As discussed in this preamble, the Airline Deregulation Act of 1978 (ADA) largely pre-empts state laws relating to air ambulance providers, and Departments are not aware of any instances where an all-payer model agreement or specific state law might apply . Because an all-payer model agreement or specific state law would not need to take an approach based on rates that would apply to such services if provided by a participating provider (e.g., Medicare rates could be used instead) . , the department believes that Congress did not intend to apply the concept of recognized amount to nonparticipating air ambulance service providers. The departments are seeking comments on possible alternative approaches to calculating the co-payment amount for air ambulance services provided by non-participating air ambulance service providers.
In addition to the cost-sharing requirements, the No Surprises Act and these Interim Final Regulations also establish requirements relating to the aggregate amount paid by a scheme or issuer for items and services subject to these Regulations that are considered out- of- network tariff. The plan or issuer must make an aggregate payment equal to one of the following amounts, less any cost contribution by the participant, beneficiary, or registrant: (1) An amount determined by an applicable all-payer model agreement under Section 1115A of the Social Security Act and Security Act; (2) if there is no such applicable all-payer model agreement, an amount to be determined by a particular state statute; (3) in the absence of an applicable all-payer model agreement or particular state law, if the plan or issuer and the provider or facility have agreed on a payment amount, the agreed amount; or (4) if none of these three conditions apply and the parties enter the IDR process and do not agree on a payment amount as determined by the IDR Agency prior to the date on which the IDR Agency makes a determination of the amount Amount. These four approaches to determining the off-net rate are discussed in more detail later in this preamble.
The co-payment and off-grid rate requirements apply when a group health plan or coverage provides or covers benefits for services subject to these Rules. The Departments interpret this as meaning that the requirements apply when a plan or issuer provides cover for such items and services under the terms of the plan or cover, even in cases where a person has failed to meet their deductible.
Although such a payment would generally cause a high-deductible health plan to lose its status as a high-deductible health plan, the No Surprises Act added Section 223(c)(2)(F) to the Code to specify that a Plan shall not fail as a result of provision of medical care benefits under Section 9816 or 9817 of the Code, Section 716 or 717 of ERISA, or Section 2799A-1 or 2799A-2 of the PHS Act (the provisions made by the No Surprises Act in reference to surprise medical and ambulance bills), or any state law that provides similar protections for individuals from meeting the deductible.
Under Section 9816(a)(3)(I) of the Code, Section 716(a)(3)(I) of ERISA, Section 2799A-1(a)(3)(I) of the PHS Act and these Interim Final Rules , a particular state law is a state law that provides a method for determining the total amount to be paid under a group medical plan or group or individual health insurance, to the extent state law applies. This includes instances where the departments have interpreted that term to include state statutes where state law applies because the state has allowed a plan not otherwise governed by applicable state law to elect for to enroll in a program established under state law Section 514 of ERISA, for an item or service provided by a nonparticipating provider or emergency facility. In cases where a particular state law applies, the eligible amount (the amount on which cost sharing is based) and off-line rates for emergency and non-emergency services subject to surprise billing protection will be based on that particular law charged by state law.
In order for a state law to determine the amount recognized or off-grid rate, such law must apply to: (1) the affected plan, issuer, or cover, even if a state law applies because the state has a plan that not otherwise subject to applicable state law, an opportunity to participate, subject to Section 514 of ERISA; (2) the participating non-participating provider or emergency facility (and in the case of state off-network rate laws, the non-participating provider of participating air ambulance services); and (3) the applicable item or service. In cases where a state law does not meet all of these criteria, the state law will not apply in determining the allowable amount or off-grid rate. For example, if a particular state law on surprise billing that governs the recognized amount and off-grid rate applies to a particular plan or coverage but does not apply to nonparticipating neonatologists who receive a particular supplemental service under Section 2799B-2( b)(2) of the PHS Act, consumer protection under federal law would determine the allowable amount and off-network rate with respect to neonatology services, while state law would apply with respect to other provider specialties covered by that state law. Similarly, if a state's surprise billing laws apply only to Health Maintenance Organizations (HMOs), federal protections against surprise bills would apply with respect to other types of coverage, while state protections would apply to HMOs for purposes of determining the amount and cost recognized . the network tariff.
The same definition of "off-grid rate" - including reference to certain state laws - applies to air ambulance services as it applies to other services. However, the ministries note that the ADA states in the relevant part: “. . . No State, political subdivision of a State, or political authority of at least 2 States shall make or enforce any law, regulation or other provision having the force and effect of law with respect to any fare, route or service of any air carrier subsection.”
The departments are also seeking advice on whether health insurance issuers, health care providers, or health care institutions, where they are not otherwise subject to a specific state law that provides a method for determining the total amount payable under a group health insurance plan, or group or individual health insurance, should for purposes of these Interim Final Rules, have the opportunity to opt-in to a program established under state law with respect to an item or service provided by a Nonparticipating Provider or Emergency Response Facility. The departments are seeking comments on whether this approach would allow more flexibility for the application of state laws, for example where they apply, according to their terms, to the health insurance issuer and the item and service in question, but not to the provider; whether an issuer, provider or entity would still be subject to certain governmental laws in their “home state” if they elect to enter a program established under the laws of another state; and whether an issuer, offeror or entity should be allowed to register episodically. Departments are concerned that allowing providers and facilities to participate in a program established under state law could increase health care costs if providers and facilities selectively choose state programs that favor providers and facilities off-network when determining the tariff. Departments are seeking input on the potential impact on providers and institutions of expanding the ability to opt into a government program. Departments specifically solicit comments from health insurance issuers, health care providers, or health care facilities located within or in services
Pursuant to the general pre-emption clause of Section 514(a) of ERISA, state law takes precedence to the extent that it “refers” to employee benefit plans under Title I of ERISA. However, there are a number of exceptions to this broad pre-emption rule. Section 514(b)(2)(A), referred to as the “Savings Clause”, provides in a relevant part that “Nothing in this title (Title I of ERISA) shall be construed as implying that it is a person of any state that regulates insurance exempts or exempts from a law. . . .” In addition, the preemption provisions of Section 731 of ERISA (implemented by 29 CFR 2590.731(a)) apply, so the requirements of Part 7 of ERISA “should not be construed to supersede any provision of state law that was implemented, implemented or indeed continues any standard or requirement that relates solely to issuers related to group health insurance coverage, unless such standard or requirement prevents the application of a “requirement” of a federal standard. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Conference Proceedings, which applies this preemption standard to state statutes in relation to its Health Insurance Reform provisions in Title I, indicates that this preemption is intended to be the "closest" preemption laws of the states .
While section 514(b)(2)(A) of state ERISA preemption statutes does not regulate insurance, section 514(b)(2)(B) of ERISA, referred to as the "Deemer clause," provides that a state statute "purports to regulate insurance" generally cannot treat an employee benefit plan as an insurance company (or engaged in the insurance business) to regulate such a plan because an insurance company (Section 514(b)(6)(A) creates a partial exemption from the Deemer Clause for employee benefit plans, which are also multiple Employer Welfare Arrangements (MEWAs)). To the extent that any state statute has a “reference to” or improper association with ERISA plans (e.g., statutes governing payment of benefits), those statutes are anticipated to the extent that they apply to self-insured plans sponsored by private employers.
The following examples illustrate how state laws may or may not apply. In each example, assume that there is no applicable all-payer model agreement that would determine the approved amount or off-grid rate.
(ii) Conclusion. In this example 1, the law of State A would apply to determine the allowable amount and the off-grid rate.
(ii) Conclusion. In this example 2, State A law would not apply in determining the allowable amount and off-grid rate. Instead, the lower of Invoice Amount or QPA would be used to determine the Acknowledged Amount, and either an amount established by agreement between the Provider and the Issuer or an amount established by an IDR entity would be used to determine the Off-Net Rate.
(ii) Conclusion. In this Example 3, State A's right to determine the cost sharing amount and the off-network rate for the emergency services would apply under State A's laws. State A
(ii) Conclusion. In this example 4, the law of State A would apply to determine the allowable amount and the off-grid rate.
The Departments believe that it would be unusual for the laws of more than one state to apply to the same issuer of health insurance and to the same provider for a particular item or service. Therefore, the Departments do not provide for many instances where there might be a question as to which state law applies to determine the allowable amount or the off-grid rate. In such unusual scenarios, however, one approach could be for the states involved to make this decision. Another approach could be that the law of the state where the service is provided would apply. Yet another approach would be for the QPA to request determination of the approved amount and either a negotiated amount or an amount determined by an IDR entity to request determination of the off-grid rate. The departments are asking for comments on these and other approaches to solving this choice of law issue. Departments are also asking for comments on how states handled such issues prior to passage of the No Surprises Act, should these types of conflicts exist.
The Departments believe that Congress intended that where state law provides a method for determining the total amount payable under a plan or coverage, the state statute governing the remainder shall govern and not the alternative method of determining the amount Off-grid amount interest rate under the No Surprises Act. The Departments interpret broadly the legal expression "a statute of state that provides a method of determining the total amount payable under such plan, coverage or issuer" and does not refer solely to statutes of state that use a mathematical Set formula to determine out-of-network tariff, or set a predetermined amount for an out-of-network item or service. Rather, departments interpret this language to include, for example, state law that requires or permits a plan or issuer and provider or facility to negotiate and then engage in state arbitration to determine the off-grid fee . Such state statutes provide a procedure for determining the total amount payable, and in such cases the timeframes and procedures under such state statute would apply with respect to negotiations and arbitrations, as opposed to the timeframes and IDR procedure under the No Surprises Act.
In addition, the Departments believe that Congress did not intend for the No Surprises Act to pre-empt provisions in state balance sheet accounting statutes that address issues beyond the calculation of the cost sharing amount and off-network tariff. To the extent that state law does not prevent the application of a state accounting requirement or prohibition, the Departments believe that such state law would be consistent with the legal framework of the No Surprises Act and would not be anticipated.
As previously described, in cases where an all-payer model agreement is applicable, the eligible amount (the amount on which cost sharing is based in relation to items and services provided by non-participating emergency facilities and non-participating providers of non- emergency items and services provided at the Participating Facilities) and the off-grid rate will be determined by the amount approved by the State under the All-Payer Model Agreement for such items or services.
An all-payer model agreement is an agreement between the Centers for Medicare & Medicaid Services (CMS) and a state to test and operate all-payer payment reform systems for medical care provided to residents of the state, pursuant to those granted pursuant to Section Power 1115A of the Social Security Act. Subject to the provisions of Section 1115A of the Social Security Act, such agreements may be subject to certain provisions of Titles XI and XVIII and Sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii ) and 1934 (excluding subsections (b)(1)(A) and (c)(5) of this section) to the extent necessary solely for the purpose of testing the model. All-payer model agreements can vary significantly by state, including using different approaches to authorizing payment amounts for items or services covered by the agreements. Departments believe it is important to maximize states' ability to test all-payer payments reform through these agreements, including their ability to do so using different approaches to setting payment amounts. These interim final rules leave the state free to determine the circumstances under which and how it will approve an amount for an item or service under a payment system established through a model all-payer agreement. Participation in an All-Payer Model subject to an All-Payer Model Agreement may be optional or mandatory for a given payer; the system of all-payer payment reform can be applied nationwide or only in certain regions, e.g. g. rural areas; and payments under the All-Payer Payments Reform scheme may apply only to certain vendors or facilities and certain items and services.
Under these Interim Final Rules, an All-Payer Model Agreement will be treated as applicable to a specific provider or facility and plan or issuer if the terms of the agreement or arrangements described in this Agreement apply to the provider, facility or plan are binding , or issuers, which can be done through various mechanisms. For example, under the All-Payer Model Agreement for the Maryland Total Cost of Care Model and under the All-Payer Law of the State of Maryland, all payers (including group health insurance plans and health insurance issuers that offer group or individual health insurance coverage) pay the amount required under the Agreement be established in relation to hospital services covered by the Agreement.
Although Maryland plans and issuers do not have discretion under state law whether to participate in the all-payer rate-setting system under the Maryland Total Cost of Care Model, participation in other state models is governed by All-Payer Model Agreements , voluntarily . For example, participation by providers, facilities, group health insurance plans, and health insurance issuers is voluntary under the All-Payer Model Agreement for the Vermont All-Payer Accountable Care Organization (ACO) model.
The No Surprises Act directs government departments to establish, through rulemaking, the methodology that a group health plan or health insurance issuer offering group or individual health insurance coverage must use to determine the Qualifying Payment Amount (QPA). As previously discussed in this preamble, the No Surprises Act and these interim final regulations require co-payment requirements imposed by plans and issuers in connection with emergency services provided by, or in connection with, performed by a nonparticipating emergency facility or provider Non-emergency services from non-participating providers at certain participating facilities on the basis of the lower of the billed fees or QPA where an all-payer model agreement under Section 1115A of the Social Security Act or a particular state law does not apply. In addition, IDR agencies are required by law to consider the QPA when choosing between the offer submitted by a plan or issuer and the offer submitted by a facility or provider to determine the total payment for emergency services provided by a nonparticipating emergency facility provided or non-participating provider or non-emergency related services performed by non-participating providers at certain participating facilities and are items and services subject to the IDR process.
Generally, pursuant to Section 9816(a)(3)(E) of the Code, Section 716(a)(3)(E) of ERISA and Section 2799A-1(a)(3)(E) of the PHS Act, the QPA is for a particular item or service, the median of the contracted rates recognized by the plan or issuer as of January 31, 2019 for the same or similar item or service provided by a provider in the same or similar specialty and provided in a geographic region where the item or service is provided plus inflation. The median contract rate is determined with respect to all of the plan sponsor's group health insurance plans, or all group or individual health insurance coverages offered by the health insurance issuer and offered in the same insurance market, in accordance with the methodology established by the divisions.
The No Surprises Act establishes an alternative method of determining the QPA in cases where a plan or issuer has insufficient information to calculate a contracted media rate for an item or service. However, the law stipulates that these alternative methods, such as B. the use of a third-party database, may only be used in limited circumstances where the plan or issuer cannot rely on its contracted rates as a reflection of market dynamics in a geographic region. Consistent with this statutory objective, these interim final regulations are generally intended to ensure that plans and issuers can meet the standard of sufficient information in determining the QPA and that the use of alternative methods is minimized where possible.
The departments seek comments on all aspects of the established methodology
These interim final rules establish the methodology that plans and issuers must use to calculate the median of contracted interest rates. The plan or issuer then generally applies an inflation adjustment to determine the QPA for items and services rendered in that year.
In general, the median contracted rate for an item or service is calculated by arranging, in order from lowest to highest, the contracted rates of all plans of the plan sponsor (or management entity, as the case may be) or all coverages offered by the issuer for the same insurance market for the same or similar item or service offered by a vendor in the same or similar specialty or establishment of the same or similar type of establishment and in the geographic region where the item or service is provided, and select the middle number . These interim final rules define each of the relevant terms, as discussed in more detail in this section of the preamble.
In determining the contracted median approach, the negotiated amount under each contract is treated as a separate amount. Suppose the contracted rates for all of a sponsor's plans in the same insurance market for a specific item or service provided by a provider in the same or a similar specialty in a specific geographic region are $475, $490, and $510 . The average contract price for this service is $490. If there is an even number of contract rates, the median contract rate is the average of the two median contract rates. In the previous example, if there were a fourth contracted interest rate of $515, the median contracted interest rate would be the average of the two middle amounts ($490 and $510) or $500 (($490 + $510)2) . If the same amount is paid under two or more separate contracts, each contract is counted separately. So, in the previous example, if there were a fifth contracted rate also of $515, the median contracted rate would be $510 since there are two contracted rates below that amount ($475 and $490) and two contracted rates above this amount ($515 and $515).
The Interim Final Rules define a "contracted rate" as the total amount (including cost-sharing) that a group health plan or health insurance issuer has contracted to pay to a participating provider, facility, or provider of air ambulance services for covered items and services, whether direct or indirectly, including through a third party administrator or pharmacy benefits administrator.
The No Surprises Act provides that each contract price for a specific item or service is treated as a single data point when calculating an average contract price. Therefore, where a plan or issuer has a contract with a provider group or entity, the rate negotiated with that provider group or entity under the contract is treated as a single contracted rate if the same rate applies to all providers of that provider group or entity in the framework of the single contract. Likewise, the rate negotiated under a contract constitutes a single contracted rate, regardless of the number of claims paid at that contracted rate. However, if a plan or issuer has a multivendor contract with separately negotiated rates with each individual vendor for a particular item or service, each individual contracted rate constitutes a single contracted rate for purposes of determining the median contracted rate.
The Departments understand that some plans or issuers may lease provider networks or otherwise contract with third parties to manage provider networks. In these situations, contracted rates between providers and the entity responsible for managing the provider network on behalf of a plan or issuer would be treated as the contracted rates of the plan or issuer for purposes of calculating QPA. The ministries are asking for advice on whether additional guidance or special rules for the definition of a contract are required in this situation.
The Departments also understand that plans and issuers sometimes enter into special agreements with providers and entities that are generally not otherwise contractually required to participate in any of the plan's or issuer's networks. For example, a plan or issuer may negotiate an ad hoc agreement with a nonparticipating provider or entity to supplement the plan's network or coverage for a particular participant, beneficiary, or registrant in specific circumstances. These Interim Final Rules provide that a case by case agreement, letter of understanding or other similar agreement between a plan or issuer and a provider, facility or provider of air ambulance services solely for purposes of defining the contracted rate does not constitute a contract, and the Any rate paid under such an arrangement should not be counted towards the contractual rates of the plan or the issuer. The term "contracted rate" refers only to the rate negotiated with providers and entities that are contractually required to participate in any of the plan's or issuer's networks under the generally applicable terms of the plan or coverage and excludes rates negotiated with other providers and institutions. The departments believe this definition is most consistent with the legal intent to ensure that the QPA reflects market rates in typical contract negotiations.
When calculating the average contract price for a specific item or service, the plan
With respect to self-insured group health insurance plans, these Interim Final Rules define the term "insurance market" to mean all self-insured group health insurance plans (excluding account-based plans and plans consisting solely of optional benefits) of the plan sponsor, or at the plan sponsor's option, all self-insured Group health insurance plans administered by the same entity (including a third party administrator appointed by the plan), to the extent permitted by law, that is responsible for calculating the QPA on behalf of the plan. The departments understand that many self-insured group health insurance plans are administered by entities other than the plan sponsor (e.g., a third-party administrator appointed by the plan) who would be responsible for calculating the QPA on the sponsor's behalf. To relieve the burden of self-insured group health plans, these interim final rules allow sponsors of self-insured group health plans to allow their external administrators to determine the QPA for the sponsor by calculating the contracted median approach using contract rates shared by all self-insured Recognize group health insurance plans administered by the third party administrator (not just those of the individual plan sponsor). With this approach, Departments anticipate there will be fewer instances where a self-insured group health insurance sponsor does not have sufficient information to calculate an average contracted price for an item or service.
The departments are seeking comment on the definition of the insurance market related to self-insured group health insurance plans and whether contractual or other issues a company, such as a third-party administrator, from using contracted rates from the various self-insured plans It administers the QPA for a specific self-insured group health plan. DOL is also seeking comment on the ability of self-insured group health insurance trustees to oversee the calculation of QPA by administrative units to ensure compliance with applicable requirements (e.g. by ensuring that units are using the correct contracted rates).
Ministries have noted that the inclusion of tariffs negotiated under other more limited forms of coverage, such as Other types of coverage, such as optional benefits, short-term, time-limited insurance, and account-based plans, including health insurance arrangements, could distort the calculation of the median contracted rate, and these forms of coverage should not be included in the definition of the applicable insurance market. In addition, the definition of "qualifying payment amount" in Section 2799A-1(a)(3)(E)(i)(I) of the PHS Act refers to individual health insurance coverage and the notion of individual health insurance coverage as defined under Section 2791( b)(5) of the PHS Act, excludes short term limited duration insurance.
The Departments also clarify that any plan or coverage that is not a "group health plan" or "group or individual health insurance coverage" offered by a "health insurer", as those terms are defined in the Code, ERISA and the PHS Act, such as a Medicare Advantage or Medicaid Managed Care Organization plan, also may not be included in an insurance market for purposes of determining the QPA. This approach is consistent with the legal requirement that the median contract rate be determined with respect to all of the sponsor's "group health insurance plans" or all "group or individual health insurance coverages" offered by a health insurer in the same insurance market.
Section 9816(a)(3)(E) of the Code, Section 716(a)(3)(E) of ERISA, Section 2799A-1(a)(3)(E) of the PHS Act and these interim The final rules provide that a plan or issuer must calculate the median contract price for an item or service using contract prices for the same or a similar item or service. Under the Interim Final Rules, the term “same or similar item or service” means a healthcare item or service billed under the same service code or a comparable code under a different procedure code system. Service Code means the code that describes an item or service, including a Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), or Diagnosis-Related Group (DRG) code. A service code is a unique identifier, typically a string of numeric digits or alphanumeric characters, and conforms to a standardized description in use
These Interim Final Rules contain specific requirements to account for Modifiers (if applicable), which are codes applied to the Service Code, which provide a more accurate description of the item or service provided and which adjust the payment rate or the Processing or payment may affect the code billed. Examples of modifiers include hospital revenue codes, which indicate the department or location in the hospital where a procedure or treatment is performed, and codes that indicate whether services or procedures were performed by specific types of providers, such as physician assistants or nurse practitioners, certified anesthesiologists or assistant surgeons. In addition, modifiers can be used to indicate that the work required to provide a service in a particular case was significantly more - or significantly less - than the service would normally require. The departments believe it is important that the QPA methodology accounts for modifiers that affect payment rates under contracts with participating providers and facilities.
Under the methodology set forth in these Interim Final Rules, plans and issuers are required to calculate separate median contract rates for CPT Code modifiers that distinguish the Professional Services component (“26”) from the Technical component (“TC”). This results in separate median contract rates being calculated for services when billed by an establishment versus a provider. In addition, where the contracted fees of a plan or issuer otherwise vary as a result of the application of a modifier code, the plan or issuer must calculate a separate median contracted fee for each such service code modifier combination. Modifiers that do not cause a change in contract prices may not be taken into account when calculating the average contract price. These rules are designed to ensure that when a plan or issuer adjusts contracted rates with participating providers and facilities based on modifier codes, those payment adjustments are reasonably reflected in the median contracted rate.
These interim final rules state that where a plan or issuer has contracted rates for a service code that vary by provider specialty, the contracted media rate, if any, is calculated separately for each provider specialty. These Interim Final Rules define “providers in the same or similar specialty” as a provider's specialty as identified by the plan or issuer consistent with the plan's or issuer's usual business practice. This definition is intended to give plans or issuers the flexibility needed to calculate the contracted median rate based on their contracting practices with participating providers. When a plan or issuer's standard business practice for identifying a provider's specialization for contracting purposes and other business needs differs, the plan or issuer should use the method of identifying the practice's specialization that it uses for contracting purposes.
Departments considered requiring a plan or issuer to calculate separate contractually agreed median rates for each provider specialty, but concluded that this approach would result in more instances where the plan or issuer does not have sufficient information to determine calculate the QPAs using its contracted rates. In addition, the departments understand that not all plans or issuers vary contracted rates based on the provider's specialty. In this case, requiring plans and issuers to calculate separate median contract rates for each provider's specialty would increase the overhead associated with calculating the QPA without increasing the accuracy of the QPA. As the No Surprises Act generally relies on the use of contracted rates to determine QPA, Departments conclude that plans and issuers should be required to calculate median contracted rates separately by provider specialty only where the plan or Issuer varies its contractual rates depending on the provider otherwise specialty.
With respect to air ambulance services, all providers of air ambulance services (including inter-facility transport) shall be considered a specialty of a single provider for the purposes of these Interim Final Rules. The Departments understand that contracted rates may vary depending on whether the air ambulance services are provided using a fixed wing aircraft or a rotorcraft. However, these distinctions based on vehicle type are reflected in the QPA methodology established under these Interim Final Rules through the use of service codes specific to fixed-wing or rotary-wing aircraft. Therefore, the Departments understand that contracted median fares for fixed-wing and rotorcraft will be determined separately based on the requirement of these Interim Final Rules that contracted median fares be based on the contracted fares for the same or similar item or service. and concluded that it would be redundant to require plans and issuers to also calculate separate median contract rates based on vehicle type.
Ministries also know that hospital air ambulance providers sometimes have lower tariffs than independent non-hospital air ambulance providers. However, the departments believe that since participants, beneficiaries and enrollers often do not have the opportunity to choose their air ambulance provider, they should not be required to pay higher co-insurance amounts (e.g. co-insurance or deductible). simply because their assigned air ambulance provider has negotiated higher contracted rates to cover their higher costs, or because they have a different revenue model than other types of air ambulance providers. This approach is consistent with the approach taken by these Interim Final Rules in relation to facilities, discussed in the following section of this preamble, which also generally does not provide for separate median contract rates that are due based on the characteristics of a particular facility are calculated. Departments have concluded that this interpretation is consistent with the law's intent to protect individuals from surprise medical bills.
When a plan or issuer has contracted emergency service rates that vary by type of facility (i.e., whether a facility is a hospital emergency department or an independent, stand-alone emergency department), the median contracted rate for each Facility separately calculates such facility type. Plans and issuers subject to the protections of the No Surprises Act must cover emergency services in both types of facilities. However, Departments are aware that plans and issuers have typically not contracted with independent, standalone emergency departments, perhaps reflecting the historical ability of independent, standalone emergency departments (before the passage of the No Surprises Act) to charge higher fees
However, these interim final rules do not allow plans or issuers to calculate a median contracted rate based on other characteristics of facilities that could cause contracted rates to vary, e.g. B. whether a hospital is an academic medical center or a teaching hospital. Given that participants, beneficiaries, and enrollers with medical emergencies will typically go to (or be taken to) the nearest or most appropriate emergency department, the departments believe that individuals should generally not be required to pay higher co-payments ( z co-insurance or a deductible) based on characteristics of the emergency entity that may affect the contracted rate with plans and issuers, but which are unrelated or incidental to the entity's role as a provider of emergency services.
Under the No Surprises Act, plans and issuers must calculate the median contracted price for an item or service using contracted prices for the same or a similar item or service performed in the geographic region in which the item or service is provided the service is provided. The No Surprises Act directs departments, in consultation with the National Association of Insurance Commissioners (NAIC), to establish through rulemaking the geographic regions to be used in determining QPA, taking into account access to items and services in rural and underserved areas , including areas of healthcare workforce shortages as defined in Section 332 of the PHS Act.
In deliberating on the geographic regions to be applied under the No Surprises Act, the NAIC recommended that the geographic regions correspond to the applicable valuation range used for the purposes of the valuation rules for single markets and small group markets under Section 2701 of the PHS Act 45 CFR 147.102, where States are given the flexibility to set up alternative geographic regions. However, some states define assessment areas by county, resulting in a large number of assessment areas in a state, some of which may include very few, if any, facilities and providers. Therefore, adopting the rating range definitions as the default for geographic regions could result in a large number of geographic regions for which a plan or issuer would need to calculate separate median contractual rates, as well as a large number of geographic regions without sufficient information where the median contract rate is affected by outliers.
After consultation with the NAIC, as part of these interim final rules, departments establish geographic regions that reflect differences in healthcare costs based on whether care is provided in urban or rural areas. Departments believe these geographic regions account for access to items and services in rural and underserved areas, including areas with health care workforce shortages, as defined in Section 332 of the PHS Act. The Departments intend to monitor the impact of these geographic regions and update these regions regularly as appropriate, taking into account the findings of the report submitted under Section 109(a) of the No Surprises Act, which addresses, inter alia, access to items and services of healthcare in rural areas and areas with a shortage of healthcare professionals.
In defining "geographical regions," departments have sought not only to minimize instances where a plan or issuer does not have sufficient information to calculate the median of contracted interest rates in a given geographic region, but also to minimize instances limit where a plan or issuer has only the minimum amount of information to meet the sufficient information standard, as discussed later in this preamble. Using larger geographic regions, for which plans and issuers are likely to have more information, should reduce the likelihood that the median contracted interest rates will be skewed by contracts in which the parties agreed to pay particularly large or small amounts.
Under these Interim Final Rules, for goods and services other than air ambulance services, a geographic region is generally defined as a region for each metropolitan statistical area (MSA) in a state and a region consisting of all other parts of the state. The delineations for MSAs are set by the U.S. Office of Management and Budget (OMB) and approved by the U.S. Census Bureau released.
However, if a plan or issuer does not have sufficient information under this definition to calculate the median of the contracted rates for an item or service provided in an MSA, then the plan or issuer must include all MSAs in the state as a single Consider region when calculating the median contract price for the item
These interim final rules establish alternative geographic regions in relation to air ambulance services. Given the nature of air ambulance services, the rarity with which they are provided compared to other types of items and services subject to the No Surprises Act and the lower prevalence of participating air ambulance service providers, the departments have decided not to apply for a Define geographic regions based on MSAs, as narrow regions would lead to more cases of insufficient information.
Therefore, for air ambulance services, a geographic region means a region made up of all of the MSAs in the state and a region made up of all other parts of the state. If a plan or issuer does not have sufficient information to calculate the median of contracted rates for an air ambulance service using this definition of a geographic region, these interim final rules apply to broader regions based on census subdivisions - i.e. H. a region consisting of all MSAs in each census division and a region consisting of all other parts of the census division. Since air ambulance services can be provided over long distances, these interim final rules provide that the geographic region in which to request air ambulance services is determined on the basis of the pick-up location, i.e. H. the person's location at the time the person is placed on board the air ambulance. This approach is generally consistent with prevailing market practices for both private and public payers.
The No Surprises Act provides that rulemaking establishing the methodology for determining QPA must take into account payments made by a plan or issuer other than on a service fee basis. Ministries are aware that there are many types of alternative reimbursement arrangements that are not standard reimbursement arrangements. For example, under a bundled payment agreement, plans and issuers can reimburse a vendor for multiple items and services under a single billing code. Other payers have per capita agreements where a provider or group of providers receive a fixed amount per member per month.
The departments understand that when a plan or issuer has a total or partial surrender payment arrangement, the plan or issuer also typically uses an internal method to assess claims for those payments, which are made on a capitalized basis. For example, a plan or issuer with capitation arrangements may have an underlying fee schedule that is used to calculate an individual's cost sharing. The departments believe it is appropriate for the plan or issuer to use the same method of assigning a value where a plan or issuer has an underlying fee schedule used to determine cost sharing under non-fee-for-service -Contracts is used on the item or service for the purpose of the QPA determination. This approach is used by plans and issuers in other similar contexts, including when providing data for the risk adjustment program
Therefore, in the case of these alternative payment models, these Interim Final Rules provide that, where underlying fee schedule rates are available, the issuer must calculate a contracted median price for each item or service using the underlying schedule rates for the relevant items and services. The term “Underlying Charge Rate” means the rate for a Covered Item or Service from a particular Participating Vendor, Vendor, or Entity that a group health plan or health insurance issuer uses to determine a Participant, Beneficiary, or Participant's co-payment for the item or the service if this price differs from the contractually agreed price.
Departments considered alternative approaches to accommodate non-fee-for-service agreements, such as B. Requiring plans and issuers to calculate median contract rates for service packages, or allowing plans or issuers to ignore certain types of non-fee-for-service contracts for purposes of calculating the contracted media rate. However, the approach set out in these interim final rules ensures that the calculation of the contracted median approach takes into account a range of different contractual arrangements, including cases where a plan or issuer uses different types of contract models with different providers and facilities. Using an underlying fee table or derived amount allows plans or issuers to essentially convert each of their non-fee-for-service contracts into fee-for-service agreements to calculate the contracted median rate. By avoiding instances where plans or issuers may have been forced to breach some of their contracts, this approach minimizes the number of instances where a plan or issuer does not have sufficient information to calculate a contractually agreed median rate and ensures agreements pay off Over-service volumes are reflected in the QPA. Additionally, this approach results in the calculation of a QPA that matches a service code (or service code modifier).
Departments agree that under certain capitalized and pooled payment arrangements, vendor payments may be reconciled retrospectively to reflect usage, value adjustments or other weighting factors that may affect a vendor's final payment. In addition, payers and providers may agree to certain incentive payments during contracting to encourage the delivery of higher quality and less expensive healthcare to participants, beneficiaries or enrollers over time. These interim final rules stipulate that plans and issuers must exclude risk-sharing, bonuses or penalties, and other incentive-based and retrospective payments or payment adjustments when calculating the median contract rates. The departments believe that the exclusion of these payments and payment adjustments from the contracted median rates used to determine cost sharing for items and services provided by non-participating vendors or facilities is consistent with how the Cost-sharing is typically calculated for intra-network items and services. when the cost sharing amount is typically determined at or near the time an item or service is performed and is not adjusted for changes in the amount ultimately paid to the provider or entity as a result of incentives or voting processes.
The No Surprises Act provides that where the median contract price is determined as of January 31, 2019, the QPA for items and services provided in 2022 is calculated by adding the percentage increase in the consumer price index to the median contract price for increases all urban consumers (US city average) (CPI-U) over 2019, percentage increase over 2020, and percentage increase over 2021. The No Surprises Act also provides that the QPA for 2022 will then be annual for those during that time items and services provided will be adjusted in 2023 or a subsequent year. Therefore, the increase for any year is the CPI-U for the year as defined divided by the CPI-U for the previous year. The combined percentage increase for 2019, 2020, and 2021 used to determine the 2022 amount is the product of the CPI-U increases for 2019, 2020, and 2021 multiplied together. For each year, the factor is the quotient of the CPI-U for the current year divided by the CPI-U for the previous year. Example: For an item or service provided in 2023, the QPA 2023 is equal to the QPA 2022 multiplied by the CPI-U 2022/CPI-U 2021.
These interim final rules provide specifications for calculating the CPI-U percentage increase to ensure all plans and issuers adjust the percentage in a consistent manner. To ensure this consistency, these interim final rules require plans and issuers to calculate increases using factors determined by the Treasury Department and the IRS and published in guidance from the IRS. In determining the factors, these interim final rules provide that the percentage increase for each year is calculated using the CPI-U published by the DOL's Bureau of Labor Statistics. For this purpose, the CPI-U for each calendar year is the average of the CPI-U at the end of the 12-month period ending August 31 of the calendar year, rounded to the nearest 10 decimal places. This allows departments to provide the percentage increase factor before January 1st of each applicable year, with sufficient time to adjust the QPAs for the year.
These interim final rules provide specific rules for calculating the QPA for items or services for which a plan or issuer generally determines the reimbursement level for the same or similar items or services by multiplying the contracted rate by another unit such as time or mileage. In these cases, indexing the contracted median approach used to calculate the QPA would result in an amount that does not reflect the other units generally considered when calculating the intra-network payment amount. Therefore, when the reimbursement level is determined using this approach, these interim final rules specify that the QPA is calculated by determining the median contracted rate for that item or service, indexing that median amount according to the rules for indexing that would otherwise apply and then applying the appropriate multipliers. These interim final regulations also provide specific instructions for calculating the QPA for anesthesia services and for certain service codes for air ambulance services.
Payers generally calculate payment amounts for anesthesia services by dividing the negotiated anesthesia conversion factor rate negotiated between the payer and the provider (expressed in dollars per unit) with (1) the base unit for the anesthesia benefit code, (2) the time unit and (3) the physical state modifier unit. The base unit, time unit and physical condition modifier unit are specific to the person receiving the anesthesia services. These units are not expressed in dollars per unit, nor do they vary by contract. The base units for an anesthesia service code are the American Society of Anesthesiologists Relative Value Guide base units for that service code. The time unit represents the length of time that the anesthesia services were provided and is measured in 15-minute increments or a fraction thereof for the purposes of the QPA methodology. The physical condition modifier on an application is a standard modifier that describes the physical condition of the patient and is used to distinguish between the different levels of complexity of the anesthesia services provided and is expressed as a unit with a value between zero (0) and three (3).
These interim final rules provide a method for calculating the QPA for these anesthesiology services that reflects the manner in which providers are generally paid for these services. To calculate the QPA for anesthesia services provided in 2022, these interim final rules require that the plan or issuer first use the median contracted rate for the anesthesia conversion factor (determined in accordance with the methodology for calculating median contracted rates for service code modifier combinations) for the same or a similar item or service as of January 31, 2019 and increase this amount to reflect changes in the CPI-U using the methodology described earlier in this section of the preamble. This amount is referred to as the indexed average contract rate. The plan or issuer must then multiply this indexed median contract rate for the anesthesia conversion factor by the sum of the base unit (using the value given in the most recently published edition (at the time of delivery) of the American Society of Anesthesiologists Relative Value Guide), Unit of time and modifier units for the physical condition of the participant, beneficiary or participant for whom anesthesia services are provided to determine the QPA.
To calculate the QPA for anesthesia services provided in 2023 or any subsequent year, the plan or issuer must use the indexed median of the contracted rate for the anesthesia conversion factor and that amount by the percentage increase in the CPI-U from the prior year adapt the methodology described earlier in this section of the preamble.
Payers often partially reimburse air ambulance services using air mileage service codes (A0435 and A0436) and reimbursement levels reflecting the number of miles that an individual has transported on air ambulance, referred to as miles loaded. Payment amounts are calculated by multiplying the negotiated rate for the service code, referred to in this rule as the mileage rate, by the number of miles loaded. These interim final rules provide a method for calculating the QPA for these airmiles service codes that reflects the manner in which providers are generally paid for the service codes.
In order to calculate QPA for the portion of air ambulance services billed using airmiles service codes provided in 2022, the plan or issuer must first increase the contracted media rate per 26 CFR 54.9816-6T(c)(1). . (i), 29 CFR 2590.716-6(c)(1)(i) or 45 CFR 149.140(c)(1)(i), as applicable. This amount is referred to as the indexed average mileage rate. The plan or issuer must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant, beneficiary or registrant to determine the QPA.
In order to calculate QPA for air ambulance services billed using airmiles service codes (A0435 and A0436) rendered in 2023 or any subsequent year, the plan or issuer must increase the indexed average airmileage rate used for such services rendered im was determined immediately in the previous year, using the methods specified in 26 CFR 54.9816-6T(c)(1)(ii), 29 CFR 2590.716-6(c)(1)(ii) or 45 CFR 149.140(c)(1) (ii), as applicable. The plan or issuer must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant, beneficiary or registrant to determine the QPA.
Section 9816(a)(3)(E)(iii) of the Code, Section 716(a)(3)(E)(iii) of ERISA and Section 2799A-1(a)(3)(E)(iii) of the PHS Act, as added by the No Surprises Act, establish an alternative method of determining the QPA in cases where a group health plan or health insurance issuer offering group or individual health insurance coverage does not have sufficient information to determine the median of the contracted agreed rates to be charged in 2019 and for newly insured items or services in the first insurance year after 2019.
Under these interim final rules, a plan or issuer is deemed to have sufficient information to calculate the median contracted interest rate if, as of January 31, 2019, the plan or issuer has at least three contracted interest rates around the median to be calculated according to the contractually agreed interest rates using the methodology in these interim final rules. According to the departments, while a median contracted rate could be calculated using a smaller number of contracts, the requirement for a minimum of three contracted rates is supported by the law's guidance to calculate a median rather than an average. In addition, the ministries have determined that three contracted prices for a given item or service in a geographic region represent the minimum number of contracts needed to adequately reflect typical market negotiations while reducing the potential for outlier prices affecting the Unduly affect calculation of QPA.
Pursuant to Section 9816(a)(3)(E)(iii) of the Code, Section 716(a)(3)(E)(iii) of ERISA, Section 2799A-1(a)(3)(E)(iii). ) of the PHS Act and these interim final rules, if a plan or issuer does not initially have sufficient information to calculate the contracted median rate based on contracted rates as of 31 January 2019 (or for new plans and coverage or new service codes, as discussed more fully in this section of the preamble) later receives sufficient information, the plan or issuer must calculate the QPA using the contracted median approach for the first year of sufficient information. The first year of sufficient information is defined as: (1) In the case of an item or service for which a plan or issuer does not have sufficient information to calculate the median contracted rates in 2019, the first year after 2022 to which the plan applies or the issuer has sufficient information to calculate the median of the contracted interest rates in the year immediately preceding that first year after 2022; and (2) in the case of a newly insured item or service, the first year after the first year of coverage for that item or service with respect to such plan or coverage for which the plan or issuer has sufficient information to calculate the median of the contracted rates in the year immediately preceding that first year.
In cases where contract rates for a year after 2019 must be used to calculate the median contract rate, a plan or issuer is deemed to have sufficient information to calculate the median contract rate for a year if, with respect to that year, both exist the following conditions are met: (1) the plan or issuer has at least three contracted interest rates as of January 31 of the year immediately preceding that year to calculate the median of the contracted interest rates in accordance with the methodology in these interim final rules; and (2) the contracted rates represent (or are reasonably expected to be) at least 25 percent of the total number of claims paid for that item or service for that year in respect of all sponsor's (or administrative entity's) plans. , if applicable) or any cover offered by the issuer that is offered on the same insurance market.
The requirement that a plan or issuer have at least three contracted prices for a particular item or service in a geographic region is the same as the requirement that applies when determining whether there is sufficient information to contract a to calculate the median agreed price for items and services rendered during 2022 using the median contracted interest rates as of January 31, 2019. However, the minimum claim volume requirement of 25 percent applies if only contracted interest rates for years after 2019 are used to determine Whether a plan or issuer has sufficient information to calculate the median contracted interest rate in the first year of sufficient information. While departments have no concerns about manipulation of the QPA in most cases where the contracted media approach is based on 2019 contracted rates, departments recognize the potential for plans and issuers to engage in selective contracting practices, artificially altering the contracted median rate in cases where contracted rates for the subsequent year are used to determine the QPA. Therefore, this requirement will help ensure that when post-2019 contracted rates are used to calculate an average contracted rate, those grid contracts represent a reasonable proportion of a plan's or issuer's total exposure and are not designed to exceed the QPA to manipulate.
In cases where a plan or issuer does not have "sufficient information" to calculate a contracted median rate, the No Surprises Act directs the plan or issuer to determine the QPA through the use of any database established under the the departments are stipulated by issued regulations not to have any
These interim final rules set standards for databases, known as eligible databases, that can be used to determine the QPA. State all-payer claims databases are categorically eligible under these Interim Final Rules because they have been specifically identified as free of conflicts of interest and have sufficient information reflecting the allowable amounts in Section 9816(a)(3)(E)(iii). . I) of the Code, Section 716(a)(3)(E)(iii)(I) of ERISA and Section 2799-1(a)(3)(E)(iii)(I) of the PHS Act . Other third-party databases may also be eligible provided all of the following conditions are met.
First, the database or the organization that maintains the database must not be affiliated with, owned or controlled by, or under common control with, any health insurance issuer, healthcare provider, facility or air ambulance service provider, or any member of the same controlled group such companies stand. For example, if the majority of the members of the governing body of a database, or the organization administering the database, are affiliated with a health insurance issuer, the database would be considered a conflict of interest under these interim final rules because it is controlled by the issuer. For example, if an issuer owns 40 percent of the stock in the organization that maintains a database and its subsidiary owns an additional 20 percent of the stock in the organization that maintains the database, the database would be considered a conflict of interest under these interim final rules, since it actually controlled by the issuer. As a third example, if an issuer and the organization maintaining a database are both subsidiaries of the same parent organization, the database would be considered a conflict of interest under these Interim Final Rules because it is affiliated with the issuer. From the departmental perspective, this standard is critical to ensure the independence of any database used to determine the QPA. Departments seek opinions on whether a database should not be affiliated with, owned or controlled by other entities such as plan sponsors or third party administrators to avoid a conflict of interest. The Ministries are also seeking advice on whether to establish a specific threshold that a party's minority holding must meet or exceed to create a conflict of interest for the purposes of these interim final rules.
For purposes of applying the Controlled Group Rules to an Eligible Database, a Controlled Group means a group of two or more individuals who are treated as one under Section 52(a), 52(b), 414(m) or 414 of the Code employer is treated (Ö). The Treasury Department and IRS are considering whether further guidance is required under Section 52(a) or (b) of the Code to address either organizations exempt from tax under Section 501(a) of the Code or nonprofit organizations that while not exempt are exempt from tax under Section 501(a) of the Code, have no members or shareholders entitled to receive distributions of the income or property of the organization (including on dissolution) or who otherwise hold equity interests similar to those set out in Generally held by owners of for-profit units. Pending further guidance, these two types of organizations can either rely on a reasonable, good faith application of Section 52(a) and (b) of the Code (taking into account the reasons for which the Controlled Group Rules were included in the definition an authorized database) or apply the rules set forth in 26 CFR 1.414(c)-5(a) through (d) (but replace “more than 50 percent” instead of “at least 80 percent” wherever it appears at 26 CFR 1.414(c)-5).
Second, the database must have sufficient information reflecting the intra-network amounts paid by group health insurance plans or health insurance issuers that offer group or individual health insurance coverage to providers, facilities or providers of air ambulance services for relevant items and services provided in the relevant region . The Divisions recognize that a database used to calculate QPA should contain sufficient data to reflect true market dynamics in a given geographic region. However, to provide flexibility in the initial implementation of the No Surprises Act, these interim final rules do not provide a specific definition of when a database is considered sufficient information. The departments are seeking input on how to define when a database has sufficient information, including whether to identify specific criteria that a claims database would need to meet to demonstrate that it has sufficient information to identify network-internal payment amounts for providers or facilities reflect applicable geographic region, such as B. A requirement that the database represents a certain minimum percentage of damage volume for the region.
Third, the database must be able to distinguish amounts paid by commercial payers, such as e.g. group health insurance plans and health insurance companies offering group or individual health insurance coverage, paid to participating providers and facilities, from all other entitlement data, e.g. B. Amounts billed by non-participants Providers or entities and amounts paid by public payers, including the Medicare program under Title XVIII of the Social Security Act, the Medicaid program under Title XIX of the Social Security Act (or a demonstration project under Title XI of the Social Security Act ),
To calculate the QPA for an item or service provided in 2022 (or in the case of newly covered items or services, the first year of coverage) using an eligible database, the plan or issuer must first identify the same rate in the database as the median the in-network allowable amounts for the same or similar item or service in the geographic region in the year immediately preceding the year in which the item or service was provided (or, in the case of a newly covered item or service, the year immediately preceding the first year of coverage ). The departments believe that the amounts for items and services allowed on the network are a reasonable approximation of contracted rates, and that if insufficient information is available to calculate the QPA based on the median of a plan's contracted rates or Calculating issuers, using the median amounts allowed on the network for all private payers in a credible database, is a reasonable way to approximate the median contracted fees for items and services in the given geographic region. The departments also believe that determining the QPA for an item or service using the median of the amounts allowed on the network for the same or similar item or service in the geographic region in the year immediately preceding the year in which the item or the service has been provided is reasonably likely to result in any level of cost sharing that exists
Once the median amount allowed in the network is determined, that rate is increased by the percentage increase in CPI-U over the previous year using the methodology described earlier in this section of the preamble. For each subsequent year prior to the first satisfactory information year, the plan or issuer must increase the QPA applicable to items or services provided in the immediately preceding year by the percentage increase in CPI-U over the preceding year. Plans and issuers must continue to use this method until the first year of sufficient information, at which point the plan or issuer must calculate the contracted median and determine the QPA using the standard method discussed earlier in this section of the preamble.
These interim final rules require plans and issuers to use a consistent methodology when relying on an approved database. Specifically, a plan or issuer using one database must use the same database for a specific item or service to determine the QPA for that item or service through the last day of the calendar year, and if for some items or another database is selected as services, the basis for that selection must be one or more factors not directly related to the price of those items or services (e.g., sufficient data for those items or services).
Finally, these interim final rules codify Section 9816(d) of the Code, Section 716(d) of ERISA and Section 2799A-1(d) of the PHS Act as added by the No Surprises Act, which provide that a scheme or issuer of the uses a suitable database to determine the QPA due to insufficient information, bears all costs associated with access to this database. The departments solicit comments on ways to ensure that schemes and issuers are charged only reasonable costs for access to such databases and that companies that provide appropriate databases are transparent about their fees and fee structures associated with this process.
The No Surprises Act directs departments to establish a method for a group health insurance plan sponsor or health insurance issuer that did not offer a plan or coverage in a geographic region in 2019 to determine QPAs for the first year that the plan or Coverage is offered by geographic region. For each additional year, this amount is increased by the percentage increase in the consumer price index for all urban consumers compared to the previous year.
The Departments recognize that while a sponsor or issuer may be new to offering coverage in a geographic region, the sponsor or issuer may have sufficient existing provider contracts under another current coverage in the geographic region where an item or service is provided to calculate the QPA. The departments clarify that it is not necessary to establish specific procedures for calculating the QPA in these situations. Therefore, under these Interim Final Rules, if the plan or issuer otherwise offers coverage in a geographic region for a year after 2019, has sufficient information to calculate an average contracted rate in 2019 in the geographic region in which the Article or the service is provided, the QPA will be determined using the standard method for calculating median contract rates discussed earlier in this section of the preamble.
The Ministries recognize that the standard method would not be available, however, in cases where the plan or issuer does not have sufficient information to calculate a contracted median rate in the geographic region where the item or service is provided, as in situations where the sponsor or issuer did not offer a plan or coverage in 2019. In this case, the plan or issuer must determine the QPA according to the rules applicable to plans or issuers with insufficient information or for newly covered items and services, including using an appropriate database as discussed earlier in this section of the preamble.
For each subsequent year that the plan or coverage is offered in the geographic region, the plan or issuer must increase the QPA for items or services provided in the immediately preceding year by the percentage increase in CPI-U over the previous year to determine the QPA for items and services performed that year. Under this approach, new plans and coverages that do not initially have sufficient information to calculate a contracted median rate are required to indefinitely use a QPA based on information for the first policy year from an authorized database, controlled only by the inflation adjustment is updated. The Divisions are seeking comment on whether the methodology should instead allow for new plans and coverage to transition in an applicable first sufficient information year to calculate a QPA using median contract rates.
When service codes are created, plans and issuers may not be able to calculate the QPA using the approaches discussed previously because neither the plan, issuer nor authorized databases have sufficient information regarding the new service code. This situation can arise for new service codes when the service codes describe items or services that were not previously widely available. This situation can also arise when service codes are significantly revised, resulting in new service codes or new descriptors for existing service codes that significantly change the types of services that would be billed using the original service codes. In this case, the plan, issuer, or authorized database may have sufficient information about rates for items and services billed under the service code prior to the revision, but this information may no longer reflect the rates charged with the rates under the billed items and services associated revised service code. The No Surprises Act does not specify a method for calculating the QPA in these circumstances. However, Departments believe there is a need for these interim final rules to establish a method that plans and issuers can rely on to calculate QPAs for new service codes during periods when legitimate databases cannot reasonably be expected to have sufficient data feature Calculate a QPA.
These Interim Final Rules define “new service code” as a service code created or substantially revised in a year after 2019. The plan or issuer must first identify a reasonably related service code that existed in the immediately preceding year. For example, a reasonably related service code could be another service code within the same code family, or could encompass services that represent similar relative units of value. This associated service code is used as a benchmark for
The departments believe that while Medicare payment rates can vary significantly from rates paid by plans and issuers, it is reasonable to use Medicare payment rates to approximate the relative costs of two different but reasonably related benefit codes. Therefore, if CMS has established a Medicare program payment rate for an item or service billed under the new service code, the plan or issuer must calculate the proportion of the rate that Medicare will pay for the item or service billed under the new service code compared to the rate Medicare pays for the item or service under the associated service code (both rates disregarding any value-based purchase agreement adjustments that could result in bonuses or deductions) , and multiply this ratio by the QPA for the related service code for the year the item or service is provided.
Departments recognize that in some cases, the Medicare program may not immediately establish a payment rate for items and services billed under a new service code. Therefore, these interim final rules establish a secondary approach to determining the QPA in these situations. Specifically, for items and services billed using a new service code for which Medicare has not established a payment rate, the plan or issuer must calculate the QPA by first calculating the ratio of the rate that the plan or issuer charges for one The item or service provided reimbursed under the new service code compared to the rate that the plan or issuer reimbursed for an item or service under the associated service code (the relativity ratio), and then the relativity ratio with the QPA for the item or service multiplied, which is billed under the associated service code. These interim final rules do not specify any particular method that plans and issuers must use to calculate this rate of relativity. However, the departments expect plans and issuers to use an appropriate method to perform the calculation and seek comment on whether future regulations should establish additional requirements for determining the relativity ratio. For example, plans and issuers could be required to calculate the ratio using the medians or averages of the contracted rates for each of the two services. However, the departments recognize that it may take time for plans and issuers to receive negotiated rates for new service codes and therefore the medians or mean values may change over time. Alternatively, schemes and issuers could be required to calculate the relativity ratio using interest rates from a contract, based on the assumption that negotiated interest rates within a given contract would generally yield a similar relativity ratio. The Departments believe that using rates from two different contracts would not constitute an appropriate method of calculating the relativity ratio, as this approach could introduce variations in the relativity ratio from factors unrelated to the relative cost of providing the item, or performance, such as the bargaining power of the contracting parties.
Subject to the methodology in these interim final rules, for items or services provided in a subsequent year (prior to the first year with sufficient information for that item or service related to that plan or coverage, or prior to the first year, for the one appropriate database contains sufficient information in the immediately preceding year), the plan or issuer must calculate the QPA by increasing the QPA calculated for the previous year by the percentage increase in the CPI-U over the immediately preceding year.
However, for an item or service billed using a new service code and provided in the first year of sufficient information for such item or service in relation to such plan or coverage or provided in the first year for which an authorized database contains sufficient information. To enable the plan or issuer to calculate the QPA using the processes generally applicable when an issuer or plan has insufficient information, the plan or issuer must calculate the QPA in accordance with 26 CFR 54.9816- Calculate 6T(c)(3), 29 CFR 2590.716 -6(c)(3) or 45 CFR 149.140(c)(3), as applicable. Once the plan or issuer or an authorized database has sufficient information to calculate a QPA, the QPA for a new service code would be calculated using the contracted median approach of the plan or issuer or the median of the amounts allowed in the network in the authorized database .
The departments are seeking comment on alternative approaches that could be used to determine the QPA for new service codes.
The No Surprises Act directs departments to specify the information a plan or issuer must share with a non-participating provider or emergency response entity when establishing a QPA.
Departments recognize that providers, emergency facilities and air ambulance providers subject to the surprise billing rules need transparency on how the QPA was determined. This information is also important for the negotiation process. In addition, IDR bodies are required by law to consider the QPA when selecting a bid submitted by the parties as part of the IDR process. Therefore, in order to decide whether to initiate the IDR process and which bid to submit, a provider, emergency facility, or air ambulance service provider needs to know not only the value of the QPA, but also certain information about how it was calculated.
Departments strive to provide transparent and meaningful disclosure of the calculation of QPA while minimizing the administrative burden on plans and issuers. These interim final rules therefore require that plans and issuers make certain disclosures upon each initial payment or refusal notice and that plans and issuers provide additional information upon request of the provider or institution. This information must be provided in writing, either paper or electronic, to a non-participating provider, emergency facility, or air ambulance service provider, as applicable, if the QPA is to serve as an approved amount.
First, a plan or issuer must provide the QPA for each affected item or service.
Second, a plan or issuer must provide a statement confirming that, based on the determination of the plan or issuer: (1) the QPA applies for purposes of the recognized amount (or, in the case of air ambulance services, for the calculation of the participant amount ). , Beneficiary or Participant cost-sharing) and (2) any QPA shared with Provider or Facility determined in accordance with the methodology described in these Interim Final Rules. These interim final rules require a statement from the plan or issuer that the QPA applies for purposes of the recognized amount so providers and entities understand that the plan or issuer has determined that neither an all-payer model agreement nor specific state law is used to calculate a participant's, beneficiary's or enroller's co-payment, but that co-payment was calculated using the QPA. With respect to air ambulance services, the statement ensures that air ambulance service providers understand that the QPA and not the charged fee applies
Third, a plan or issuer must provide a statement that the provider or entity, if applicable, wishes to initiate a 30-day open negotiation period to determine the amount of the total payment, the provider or entity may contact the appropriate person or office to open initiate negotiations and that if the 30-day open negotiation period does not result in a decision, the provider or facility in general may initiate the IDR process within 4 days of the end of the open negotiation period. The plan or issuer must also provide contact information, including a telephone number and email address, for the appropriate office or individual to initiate open negotiations for the purpose of determining a payment amount (including cost sharing) for that item or service.
In addition, upon request from the provider or facility, a plan or issuer must provide timely information as to whether the QPA includes contracted rates not established on a service fee basis for the specific items and services issuance and whether the QPA for those items and services is based on the underlying fee rates or a derived amount was determined. If an associated service code was used to determine the QPA for a new service code, a plan or issuer must provide information to identify which associated service code was used. If an appropriate database was used to determine the QPA, a plan or issuer must provide information to determine which database was used to determine the QPA.
Finally, if requested, a plan or issuer must provide a statement that the plan's or issuer's contractual rates include risk-sharing, bonuses, penalties, or other incentive-based or retrospective payments or payment adjustments for the affected items and services excluded for QPA calculation purposes. Information on whether the contracted media approach precludes this type of payment adjustment will better inform the open negotiation and IDR process.
The departments seek comment on these disclosure requirements and what additional information a plan or issuer should disclose to a provider or entity through the QPA, either in all cases or upon request. The departments are also seeking advice on whether a specific definition or standard is required to ensure that information provided upon request is disclosed in a timely manner.
The No Surprises Act requires regulations to be made to establish a process whereby group health insurance plans and issuers of health insurance offering group or individual health insurance coverage are inspected by the relevant Minister or the relevant State agency to ensure that those plans and Covers meet the requirements of Application of a QPA and that the QPA applied for meets the definition of the No Surprises Act in relation to the relevant year.
HHS and state enforcement responsibilities for overseeing compliance by health insurance issuers with federal insurance market reforms are set out in the PHS statute. Pursuant to Section 2723(a)(1) of the PHS Act, as amended by the No Surprises Act, States have primary enforcement authority over health insurance issuers with respect to the provisions of Parts A and D of Title XXVII of the PHS Act. Under this framework, HHS has enforcement authority over issuers in a state if the Secretary of HHS determines that the state fails to materially enforce a provision (or provisions) of Part A or D of Title XXVII of the PHS Act.
DOL and the Treasury Department generally have primary enforcement authority over private sector employment-based group health plans. The IRS has jurisdiction over certain church plans. HHS also has primary enforcement authority over non-state plans, such as B. those funded by state and local employers.
Departments will generally use existing processes to ensure compliance with Code, ERISA and PHS Act requirements applicable to group health insurance plans and health insurance issuers, including provisions added by the No Surprises Act. HHS' enforcement procedures related to the federal insurance market reforms of the PHS Act are set out in Section 2723 of the PHS Act and 45 CFR 150.101
In cases where a particular state law or all-payer model agreement does not apply for purposes of determining the off-grid rate, the off-grid rate will be determined either by agreement between the provider or facility and the plan or Issuer specified ; or through an IDR procedure if no agreement can be reached and such a procedure is initiated. If the parties agree on a payment amount prior to the date that a certified IDR agency makes a decision regarding such items or services, that agreed amount will be the off-network rate. Otherwise, the off-grid rate is the payment amount established by the certified IDR agency for the items or services.
The No Surprises Act and these interim final regulations establish several procedural requirements applicable to group health insurance plans and health insurance issuers to ensure billing disputes occur
Therefore, it is important that a group health plan or health insurance issuer be aware of all notices and consents given under these Interim Final Rules for items and services it covers that would otherwise be subject to the surprise billing provisions in the Act and these Interim Final Rules. As discussed later in this preamble, the interim final rules issued by HHS in this rulebook require providers and facilities, plans and issuers to notify when the notification and approval criteria are met. Without receiving this information, a plan or issuer must assume that the person has not waived the protections provided in these interim final rules and must therefore calculate the cost sharing, apply the cost sharing to deductibles and excess limits, and make all payments to providers and facilities before a person has met the applicable deductible. In cases where a plan or issuer receives this information, it can rely on the provider's or entity's representation to be true and accurate, unless and until the plan or issuer knows or reasonably should know otherwise. Thus, if a provider or entity notifies a plan or issuer that the notice and consent described in these interim final rules has been given and received properly and in a timely manner, the plan or issuer may rely on that information and, for example, make an application for -network cost sharing for the relevant items and services, unless and until the scheme or issuer knows or reasonably should know that notice and consent has not been given and received properly and in a timely manner. In cases where a plan or issuer believes that notice has not been given and received in a proper and timely manner, the plan or issuer should, notwithstanding any provider or entity's assertion to the contrary, apply the cost sharing and other requirements set out in these preliminary final rules and governs applicable state law, including by reprocessing claims that have not been processed in accordance with these requirements. The plan or issuer may also file a complaint against the provider or entity as set forth in these interim final rules at 45 CFR 149.450.
Sections 9816(a)(1)(iv)(I) and 9817(a)(3)(A) of the Code, Sections 716(a)(1)(iv)(I) and 717(a)(3) . )(A) of ERISA, Sections 2799A-1(a)(1)(iv)(I) and 2799A-2(a)(3)(A) of the PHS Act and these interim final rules require plans and issuers to be no later than Send “an initial payment or notice of refusal to pay” 30 calendar days after a nonparticipating provider or entity submits an invoice related to the items and services that fall within the scope of the new surprise billing protection for emergency services , non-emergency services provided by non-participating providers at participating facilities, and air ambulance services provided by non-participating air ambulance service providers. Because plans and issuers cannot meet this requirement unless the plan or issuer first determines that the billed items and services are covered by the plan or coverage, these interim final rules require that the plan or issuer such determination shall be made no later than 30 calendar days after a non-participating provider or facility submits an invoice in respect of the items and services falling within the scope of the new surprise billing protection for emergency services, non-emergency services provided by non-participating providers in participating facilities and air ambulance services provided by non-participating providers fall from air ambulance services.
The Ministries specify in these Interim Final Rules that the 30 calendar day period generally begins on the date on which the plan or issuer receives the information necessary to decide on a claim for payment for such services, which is generally referred to as "Clean claim" is known under many existing state laws. Where possible, the Departments encourage providers and entities to include information on whether surprise billing protection applies to an item or service in the application form itself. With respect to non-emergency services, HHS requires, pursuant to 45 CFR 149.420(i), that non-participating providers (or the participating facility on behalf of the non-participating provider) provide timely notice to the plan or issuer that the item or service will be provided during a visit was at a participating healthcare facility. Additionally, in all cases, vendors and facilities must notify the plan or issuer as required by either 45 CFR 149.410(e) or 45 CFR 149.420(i) whether the requirements for notification and consent are met even when the invoice is submitted on the invoice or in a separate document. The departments are seeking comments with recommendations on how standard HIPAA claim filing transactions might be modified to allow for the filing of different types of information about the claim itself. In particular, the departments solicit comment on how standard HIPAA claim filing transactions might be amended to include whether surprise billing protections apply to the items and services included in a claim, whether the item or service is during of a visit to a participating healthcare facility and whether the requirements for notification and consent are met. The initial payment period of 30 calendar days also does not prohibit payments outside of the 30 calendar day period for future adjustments due to payment errors, e.g. The departments expect plans and issuers to act reasonably and in good faith when requesting additional information, providing specific details to ensure the requester, provider or entity understands what is required to satisfy the claim. Departments may establish additional standards when departments identify instances of abuse and gambling where plans and issuers unduly delay an initial payment or send a denial notice to vendors because the vendor did not submit a clean claim. The departments are seeking comment on whether additional standards are needed to prevent abusive payment practices for receivables. Subject to these Interim Final Rules, a denial-of-payment notice with respect to an item or service for which services are subject to surprise billing protection means written notice from the plan or issuer to the provider or facility that payment will be made for the item or service is not provided by the plan or coverage and explains the reason for rejection. For example, a payment refusal notice could be issued if the item or service is covered but subject to a deductible that is greater than the approved amount.
According to the departments, the law's reference to an “initial” payment does not refer to an initial installment. Rather, this initial payment should be an amount that the plan or issuer reasonably intends to pay in full
These interim final rules do not require plans and issuers to make a minimum initial payment to providers or facilities when making an initial payment. However, several state accounting laws set standards for minimum initial payment amounts. For example, in Washington State, within 30 calendar days of receipt of a claim that will be billed the state balance, issuers must pay an off-grid provider or entity a commercially reasonable amount reduced by the applicable cost-sharing amount of protections that apply. Requiring an initial minimum payment amount may help reduce the number of cases submitted to arbitration in some states and could help reduce the number of cases submitted to the federal IDR process established under the No Surprises Act be supplied.
Departments are seeking advice on whether future rulemaking should set a minimum payment rate or method for a minimum initial payment and, if so, what that rate or method should be. For example, a minimum payment rate could be a certain percentage of the Medicare rate, a certain percentage of the plan's or issuer's QPA for the item or service, an amount calculated in the same way that the plan or issuer normally calculates the payment for charged for the specific item or services to non-participating vendors or entities, an amount that represents the highest amount that would result from the use of two or more of these or other methods or any other method. To the extent that comments suggest that a percentage of a rate calculated or determined in a particular way would be appropriate, Departments seek comment on an appropriate specific percentage. The Ministries are also seeking advice on whether a minimum payment rate should be defined as a commercially reasonable rate based on payments for the same or similar services in a similar area, without requiring any specific methodology. In addition, the departments are seeking comments on the impact of these provisions on underserved and rural communities and other communities facing provider shortages.
Departments recognize that the timeframes for adjudicating claims after service under the Claims and Appeals Rules under Section 2719 of the PHS Act and the timeframes for submitting an initial payment or refusal to pay notice under those final rules may not always coincide. The departments seek to minimize confusion as to what types of disputes should be resolved through a plan or the issuer's internal complaints and grievances procedure rather than the IDR procedure established by the No Surprises Act.
The ERISA Claims Procedure Regulations require group health plans to notify an claimant of a benefit assessment for post-employment claims no later than 30 days after receipt of the claim. A plan may generally extend this period once by up to 15 days for matters beyond the plan's control, including where the claimant fails to provide information necessary to resolve the claim. In such cases, the plan may notify the applicant within 30 days that they have provided insufficient information, and the plan must give the applicant at least 45 days to provide additional information. After the information is provided, the plan has 15 days to make a decision. Requests that result in a determination of adverse benefit (ADD) may be appealed within 180 days of receipt of notification of the ADD. The requirements of the ERISA Application Procedures Regulations are incorporated by reference into the requirements for internal applications and appeals and external reviews added to Section 2719 of the PHS Act by the Affordable Care Act and therefore, subject to limited exceptions, apply to all non- Grandfather Group health insurers and health insurance companies that offer non-grandfathered coverage in the group and in individual markets.
Generally, if an originally submitted application is a clean application, the timeframes for the relevant determinations would be adjusted according to these interim final rules and the ERISA rule for the application process. However, if an application is submitted without sufficient information to make a performance assessment, the plan would only have 15 days under the ERISA Application Process Regulation to make a decision once the application is resubmitted with the additional information. However, under the No Surprises Act and these Interim Final Rules, the plan would have up to 30 calendar days to send a denial or initial payment from the time the claim was resubmitted to the off-grid provider for more information. Consistent with the requirement that plans and issuers submit an initial payment or notice of non-payment within 30 calendar days of a provider or entity submitting a clean application, the Ministries are clarifying that the ERISA regime for the application process, although would require plans to make a performance assessment Within 15 days of resubmitting a claim with additional information, plans and issuers have 30 calendar days (that's an additional 15 days) to make an initial payment to a nonparticipating provider or facility or a to send a separate payment refusal notification.
The departments note that there is also a significant difference between an ABD, which can be challenged through a plan's or issuer's claims and appeals procedures, and a refusal to pay or an initial payment that is less than the amount charged under those provisional ones final rules, which can be disputed through the open negotiated procedure or through the IDR procedure. Generally, if the determination of a claim results in a participant, beneficiary, or participant being personally liable for payments to a provider or entity, that determination may be an ABD contested in a plan's or issuer's claims and appeals process can be. Conversely, if: (1) the determination of a claim results in a determination that does not affect the amount owed by the participant, beneficiary or participant; (2) the dispute relates only to payment amounts due under the Plan to Provider; and (3) Provider has no recourse against Subscriber, Beneficiary or Registeree, the decision is not an ABD and the payment dispute may be resolved through open negotiation or the IDR process. This clarification is in line with previous guidance in the ERISA Claims Procedures Regulation FAQ, which explained that the Regulation, in relation to on-network services, does not apply to healthcare provider requests for payments that are owed to the provider, but are due to the claimant , when the provider has no recourse against the claimant for amounts not paid in whole or in part by the plan.
Section 9816(a)(2)(B)(iv) of the Code, Section 716(a)(2)(B)(iv) of ERISA and Section 2799A-1(a)(2)(B)(iv) of the PHS Act directs departments to establish a process for receiving complaints about violations of the application of QPA requirements by group health insurance plans and health insurance issuers that offer group or individual health insurance. The Departments believe that the appeals process to effectively enforce the No Surprises Act balance sheet protection should extend to all consumer protection and balance sheet statement requirements as described in these interim final rules applicable to group health insurance and health insurance companies offering group or individual health insurance . As such, these Interim Final Rules establish a process by which Departments will address complaints of plan and issuer violations of the requirements under Sections 9816 and 9817 of the Code, Sections 716 and 717 of ERISA, and Sections 2799A-1 and 2799A- obtain. 2 of the PHS Act. The departments are seeking comment on whether the grievance process should be limited to the QPA or expanded as outlined in these interim final rules.
The No Surprises Act also adds Section 2799B-4(b)(3) of the PHS Act, which directs HHS to establish a procedure for receiving consumer complaints regarding breaches by health care providers, facilities and air ambulance service providers with respect to balance sheet accounting requirements comply with Sections 2799B-1, 2799B-2, 2799B-3 and 2799B-5 of the PHS Act and respond to such complaints within 60 days. Therefore, HHS is issuing interim final rules only for HHS to establish a process through which HHS will receive complaints about violations of these requirements by healthcare providers, facilities and air ambulance service providers.
For purposes of the Complaints Procedure for plans and publishers, providers, facilities, and air ambulance service providers, these Interim Final Rules define a complaint as a written or oral communication indicating that a plan or publisher may have violated Sections 9816 or 9817 of the Code , Sections 716 or 717 of ERISA, or Sections 2799A-1, 2799A-2 of the PHS Act, or a potential violation of Sections 2799B-1 by a provider, facility or provider of air ambulance services, 2799B-2, 2799B-3 and 2799B -5 of the PHS Act, whether or not there is an actual breach. A Complainant is any person or their authorized representative who files a Complaint under these Interim Final Rules.
Departments seek to minimize the burden of filing a complaint and attempt to request only the information necessary to process the complaint and conduct an investigation when deemed necessary. Therefore, these Interim Final Rules provide that departments will consider a Complaint filed on the date that departments receive an oral or written statement of the complaint containing information sufficient to identify the parties involved (including the Plan Sponsor, if the complaint involves a group health plan) and the act or omission that is the subject of the complaint. The information may also include the time of the alleged infringement and the state where the alleged infringement occurred. Departments are seeking comment on the information required to file a complaint and the definitions in this section.
The departments have considered whether a complaint should be filed within a specified period of time after the alleged violation. The departments understand that timely action is required to investigate and decide on billing matters and therefore considered whether complainants should be required to file a complaint regarding an alleged breach of the requirements in these interim final regulations by a plan, issuer, healthcare provider or Providers of air ambulance services to be submitted within 90 or 180 calendar days after becoming aware of the alleged violation. With no time requirement for filing a complaint, departments may be restricted from referring the complainant to other state or federal resolution processes with time requirements, such as IDR processes as described in Sections 9816 and 9817 of the Code, Sections 716 and 717 of ERISA and Sections 2799A-1 and 2799A-2 of the PHS Act. However, the departments believe that any complaint should be dealt with and investigated appropriately to ensure that any necessary enforcement action can be taken. Therefore, these Interim Final Rules do not include a time limit within which a complaint must be filed. The departments seek advice on whether a complainant should be required to file a complaint within a specific time limit and, if so, within what time limit a complaint should be made for the purposes of this section.
Section 2799B-4 of the PHS Act directs HHS to respond within 60 days of receipt to complaints of violations of accounting billing protections by healthcare providers, facilities and air ambulance service providers. Ministries believe that the timing for responding to complaints about plans and issuers should be the same as for providers to ensure a timely resolution. Therefore, upon receipt of the information necessary to file a complaint regarding a plan or issuer, the departments will provide information to complainants pursuant to Section 9816(a)(2)(B)(iv) of the Code, Section 716(a)(2) answers. (B)(iv) of ERISA and Section 2799A-1(a)(2)(B)(iv) of the PHS Act no later than 60 business days after receipt of the complaint. Likewise, HHS will respond to a processed complaint regarding a healthcare provider, facility or air ambulance service provider under Section 2799B-4 of the PHS Act no later than 60 business days after receipt of the complaint.
The response will be given orally or in writing and will acknowledge receipt of the complaint, inform the complainant of their rights and obligations under the complaint procedure and describe the next steps in the complaint resolution process. Departments may also request additional information necessary to process the complaint. The information requested may include an explanation of benefits, applications processed, information about the healthcare provider, facility or air ambulance involved; information about the plan or issuer covering the individual; Information to assist in determining whether the service was an emergency service or a non-emergency service; the summary plan description, policy, certificate, contract of insurance, membership booklet, statement of coverage, or other evidence of coverage that the plan or issuer makes available to its participant, beneficiary, or enroller; Documents about facts asserted in the complaint that are in the complainant's possession or otherwise accessible to him; or other information the departments may need to establish fact for an investigation.
HHS may also request additional information to process a complaint under Section 2799B-4 of the PHS Act
The response can be made immediately after receipt of the complaint or thereafter, but no later than 60 business days from the receipt of the complaint. The next steps in the complaint resolution process may include referring the complainant to another appropriate state or federal resolution process, referring a complainant to the state or federal regulator with enforcement jurisdiction, or initiating an investigation for enforcement action. The Ministries will make reasonable efforts, consistent with the practices of the authorities, to inform the complainant of the outcome of any such investigation or enforcement action, including an explanation of the results, any solution or corrective action taken. The departments will also use reasonable efforts to notify the complainant if the complaint is referred to another state or federal regulator. The Divisions seek advice on whether a Complainant should receive notification of the Complaint Outcome within a specific time limit, and if so, within what time period a Complainant should receive notification for the purposes of this Section.
The Departments intend to provide the public with a seamless complaints-making experience by establishing a system for receiving all complaints on behalf of all complainants in accordance with Section 9816(a)(2)(B)(iv) of the Code, Section 716( a )(2)(B)(iv) of ERISA and Sections 2799A-1(a)(2)(B)(iv) and 2799B-4 of the PHS Act. The departments understand that a complainant may not know which department is responsible for enforcement; Therefore, the departments intend to provide a system that will route complaints to the appropriate department for processing, investigation and enforcement action if necessary. Departments will publish guidelines on where the public can submit complaints and welcome comments on the operations, safeguards, user experiences, or any other aspect of this complaints system. Departments are also seeking comments on ways to ensure consumers are aware of this system and how to use it.
The Ministries aim to uphold Executive Order 13985 and all civic protections related to non-discrimination and accessibility as mentioned in the previous sections. Departments will make all reasonable efforts to implement a robust complaints procedure, including but not limited to acknowledgments of receipt of a complaint, explanations of rights and information requested, explanations of findings and referral to other authorities. The departments ensure that the complaints procedure is accessible to all individuals, that communication and language needs are met and that all individuals are able to understand the options available to them and the information requested from them. Departments solicit comments from individuals in underserved and rural communities, minority communities and others affected by persistent poverty or inequality on specific barriers to the grievance process and solutions to address those barriers and ensure equal access to all aspects of the grievance process.
In the Patient Protections Final Rule, the Divisions have finalized regulations on the provisions of Section 2719A of the PHS Act relating to patient protections in relation to the choice of healthcare professionals and emergency services.
To reflect these legislative changes, these interim final regulations add a waiver to the current patient protection regulations codified in the final patient protection regulation and codify the regulations related to the choice of healthcare professionals into 26 CFR 54.9822-1T , 29 CFR without material change 2590.722 and 45 CFR 149.310. These interim final rules make minor technical changes to the original regulations for the sake of clarity.
The Departments note that although the substantive requirements of these regulations have not changed, the No Surprises Act extends the applicability of patient protection for healthcare professional choice to existing health insurance plans. Patient protection under Section 2719A of the PHS Act applies only to non-grandfathered group health insurance plans and issuers of health insurance that offer non-grandfathered group or individual health insurance coverage. In contrast, patient protection under the No Surprises Act applies generally to all group health plans and both group and individual health plans, including existing health plans.
These interim final rules apply generally to group health plans and health insurers that provide group or individual health insurance coverage with respect to plan years (in the
The No Surprises Act amends Section 1251(a) of the Affordable Care Act to provide that sections 2799A-1, 2799A-2 and 2799A-7 of the PHS Act apply to grandfathered health plans for plan years commencing on or after January 1, 2008 January start. 2022. Therefore, these interim final rules apply to grandfathered health plans (as defined in 26 CFR 54.9815-1251, 29 CFR 2590.715-1251, and 45 CFR 147.140). In addition, these Interim Final Rules apply to certain non-grandfathered health insurance policies in the individual and small group markets for which CMS has announced that it will not take enforcement action in relation to certain specific market requirements despite the fact that coverage has expired in compliance with those requirements (sometimes referred to as grandfathering or referred to as transition plans).
These interim final rules do not apply to medical reimbursement agreements or other account-based plans as described in 26 CFR 54.9815-2711(d)(6)(i), 29 CFR 2590.715-2711(d)(6)(i) ), and 45 CFR 147.126 (d)(6)(i) that condition reimbursements on a specified maximum dollar amount over a period of time, since the benefit design of such plans renders inapplicable concepts related to surprise billing and healthcare professional selection.
By law, certain plans and coverages are not subject to these interim final rules. This includes a plan or coverage consisting solely of Excluded Benefits,
These interim final rules do not apply to retiree-only plans. Section 732(a) of ERISA generally provides that Part 7 of ERISA — and section 9831(a) of the Code generally provides that Chapter 100 of the Code — does not apply to plans with fewer than two participants who are current employees are (including pensioners). only plans that cover fewer than two participants who are currently employees). Title XXVII of the PHS Act, as amended by the Affordable Care Act, no longer contains a parallel provision in Section 2721(a) of the PHS Act. However, as explained in previous rulebooks, HHS will not enforce the requirements of Title XXVII of the PHS Act with respect to non-state retiree-only plans and encourages states to take a similar approach with respect to health care coverage for retirees-only plans.
These interim final rules generally apply to traditional compensation plans, i.e. H. Plans that do not have networks of providers or facilities. However, the Departments recognize that compensation plans may have unique benefit concepts that render certain provisions of these interim final regulations irrelevant. For example, chargeback billing requirements for non-emergency services provided by non-participating providers at specific participating facilities would never be triggered if a plan did not have a network of participating facilities. On the other hand, such requirements could be triggered by plans that have participating institutions but no participating providers, either for certain types of providers or at all. In addition, requirements unrelated to whether a plan or coverage has a network of participating providers or facilities, such as B. The requirement that emergency services be covered without prior approval determination, even if the services are off-network based, apply to traditional compensation plans.
Departments are seeking advice on whether there are other plans with unique benefit concepts that should be exempted from all or some of these interim final rules.
In addition to the new provisions applicable to group health insurance and health insurance issuers discussed in Section III of this preamble, the No Surprises Act adds a new Part E of Title XXVII of the PHS Act which establishes requirements applicable to healthcare providers, facilities, and Air ambulance service providers. Specifically, the No Surprises Act adds new Sections 2799B-1, 2799B-2, 2799B-3 and 2799B-5 of the PHS Act that protect participants, beneficiaries and participants in group health plans and group and individual health plans to offset bills by allowing nonparticipating providers , facilities and providers of air ambulance services shall be prohibited from charging or holding liable individuals an amount in excess of the intra-network cost sharing determined under the on-balance-sheet accounting rules where the on-balance-sheet accounting rules apply. This includes: (1) when emergency services are provided by a nonparticipating provider or emergency facility; (2) when non-emergency services are provided by a non-participating provider at a participating healthcare facility; and (3) when air ambulance services are provided by a non-participating air ambulance service provider.
Under 5 U.S.C. 8902(p), as added by the No Surprises Act, Sections 2799B-1, 2799B-2, 2799B-3 and 2799B-5 of the PHS Act apply to a healthcare provider, facility and provider of air ambulance services in relation to a insured person in a health insurance plan offered by a FEHB carrier in the same manner as they apply in relation to a participant, beneficiary or participant in a group health plan or group or individual health insurance coverage offered by a health insurance provider. These interim final rules apply to a healthcare provider, facility and air ambulance service provider in
With respect to post-stabilization services provided by non-participating emergency facilities or non-participating providers, and non-emergency-related services provided by non-participating providers at participating healthcare facilities (including non-participating off-site providers that provide items or services, a person in the context of a visit to such a healthcare facility), the prohibitions on balance billing do not apply if the participant, beneficiary or participant receives a specific notice and the person acknowledges and consents to receipt of the information in the notice, on the protection of balance billing to waive with respect to the non-participating emergency facility or non-participating providers to which the notice and consent apply. Under the No Surprises Act and these interim final regulations, certain types of non-emergency care provided by non-participating care providers at a participating healthcare facility are not subject to the notification and consent provisions, so the prohibitions on balance accounting apply without exception.
Because the law and these Interim Final Rules authorize HHS to impose civil penalties on facilities and providers that violate these requirements, nonparticipating providers should take the necessary steps to ensure compliance, including by determining whether a particular item or a particular service is provided in circumstances that would trigger surprise billing protection. For example, non-participating providers providing non-emergency services at a facility must determine whether the facility is a participating healthcare facility in order to determine whether compensation billing protections apply. In this regard, nonparticipating providers and nonparticipating emergency response organizations must communicate in a timely manner with plans and issuers when the cost sharing limitations in these interim final rules do not apply because the notification and consent criteria (described more fully elsewhere in this preamble) have been met . These Interim Final HHS Rules address the steps providers and facilities must take to ensure compensation billing and cost sharing protections are applied appropriately and in accordance with the law.
HHS also recognizes that compliance with these requirements may force nonparticipating providers and nonparticipating emergency facilities to refrain from billing individuals directly, even in cases not subject to these requirements. For example, the protections that apply to non-emergency services provided by a nonparticipating provider at a participating healthcare facility apply only with respect to services for which benefits are paid or covered by the plan or coverage. A nonparticipating provider may not have the information necessary to determine whether the Services are an insured benefit under the plan or coverage. As a result, the nonparticipating provider may need to bill the plan or issuer directly for the services to determine whether the protections apply. Otherwise, the provider risks violating the law and these preliminary final regulations by billing private individuals. HHS recognizes that non-participating providers and facilities often bill individuals directly for off-grid services, leaving it up to the individual to submit the bill to plan or coverage. HHS is inviting comment on the impact this change will have on nonparticipating providers and facilities, as well as plans and issuers who receive invoices from nonparticipating providers and facilities.
In cases where a Provider or Facility charges a Subscriber, Beneficiary, or Enrolled for services in violation of the law and these Interim Final Rules, the Secretary of HHS (the Secretary) may impose civil penalties in states where HHS directly enforces the remainder billing regulations in relation to healthcare providers, facilities and air ambulance service providers. However, the law provides that the Secretary shall waive the penalties with respect to any health care provider, facility or air ambulance service provider that does not knowingly violate the provisions with respect to a participant, beneficiary or participant if such provider or facility within within 30 days of the breach, withdraw the bill in violation of this provision and pay the healthcare plan or person, as applicable, an amount equal to the difference between the amount billed and the amount billed under the provision may, plus interest at a rate determined by the Secretary. HHS intends to address enforcement of the No Surprises Act requirements that apply to healthcare providers, facilities and air ambulance service providers in future rulemaking.
Pursuant to the No Surprises Act and these Interim Final Rules, the safeguards limiting cost-sharing and prohibiting balance billing do not apply to certain non-emergency services or certain post-stabilization services provided as part of emergency care where the non-participating provider or non-participating emergency facility , which provides those items or services, notifies the participant, beneficiary, or registrant, the individual acknowledges receipt of the information in the notification, and the individual agrees to the protection of the balance of accounts related to the non-participating emergency facility or the non-participating emergency facility Participating entity to waive the provider named in the notice.
Non-emergency services provided by a non-participating provider at a participating healthcare facility are exempt from cost-sharing and remainder billing protection if the notification and consent requirements are met. In contrast, the notification and consent exception does not apply to emergency medical services, with the exception of postal stabilization services, in certain circumstances, or air ambulance services. A Nonparticipating Provider or Emergency Response Facility may seek notification and consent from the individual to settle the bill for postal stabilization services only if a Participant, Beneficiary, or Enroller has received emergency services and that individual's condition has stabilized, and then only if certain additional conditions are met. Such terms are described later in this preamble and codified at 45 CFR 149.410(b).
If an individual receives notification but does not provide (or withdraws) their consent to opt out of their protections when processing balances, those protections will remain in place. A provider or facility may, subject to other state or federal laws, refuse to treat the individual if the individual does not consent.
The requirements relating to the notification and consent exception are set forth in Section 2799B-2 of the PHS Act, as amended by the No Surprises Act, and implemented in 45 CFR 149.410 and 45 CFR 149.420 of the HHS Interim Final Rules, where the Requirements are described for post stabilization and non-emergency services respectively. These Interim Final Rules describe the requirements related to the content, method and timing of the notice and consent notices; language access requirements; Exceptions to the Applicability of the Notice and Consent Process; requirements for retention of notice and consent documents; and requirements to notify the plan or issuer of the consent of the participant, beneficiary, or enrollee.
The No Surprises Act and these Interim Final Rules permit a person to waive the protection of balance bills after receiving written notice containing detailed information intended to ensure that individuals knowingly pay out-of-pocket expenses (including charges related to balance bills ) for care received from a nonparticipating provider or emergency facility. HHS believes that the option to opt out of balance statement protection may be valuable to individuals in certain instances where they knowingly and intentionally seek care from a nonparticipating provider. For example, a person with a complex medical condition may wish to be treated by a specialist who is not part of their plan's network. If that specialist does not treat the person, unless the specialist can bill the person directly for the treatment (and bill the person for the remainder of the bill), that person may wish to forgo the protection of the remainder of the bill. HHS seeks comment on striking the right balance between allowing a specialist to refuse treatment for an individual unless the specialist can settle the individual's bill while ensuring that the individual is not pressured, to waive the protection of the remaining invoice. HHS believes it is important that this consumer protection does not constitute a barrier to obtaining off-network services when an individual is knowingly seeking such care. However, it is equally important that individuals are not unknowingly subject to a balance sheet settlement. Therefore, the No Surprises Act and these Interim Final Rules permit an individual only in limited circumstances and only where the non-participating providers or non-participating emergency facility have served reasonable notice to the participant, beneficiary or enrollee explaining the relevant consumer's protections and the Effects of Consent.
Section 2799B-2(d)(1)(A) of the PHS Act requires providers and facilities to use a written notice provided by HHS in guidelines. Therefore, these Interim Final Rules require providers and facilities to provide notification using the standard notification document provided by HHS in Guidance. The standard notification document contains the elements required by law in a way that is intended to be easy to read and understand. The notification must be made in accordance with the guidelines issued by HHS. HHS believes that the requirement to use the standard notice will help ensure that the notice contains the content required to be included in the notice under the No Surprises Act and these Interim Final Rules. In all cases, providers and entities must adapt the document to include information specific to the individual (e.g. by identifying the provider or entity, if applicable, and adding the good faith estimated amount).
HHS is concerned that individuals may less carefully review the notice if it is embedded with other information or accompanied by additional consent forms. Therefore, these Interim Final Rules require that the Notice be submitted with the Consent Document and that those documents together be physically separate from other documents and not attached to or incorporated into them. Providers and institutions must submit the notification in a timely manner. Notice must be in writing and be given on paper or, where practicable, electronically, at the option of the individual. The notice must meet applicable language access requirements as described in this HHS Interim Final Rule. A participating healthcare facility may issue the notice on behalf of the non-participating provider.
Notice may be given to the person's authorized representative on behalf of the person and consent may be given by the authorized agent on behalf of the person. These interim final rules state that for the purposes of 45 CFR 149.410 and 149.420, an authorized representative is a person authorized under state law to give consent on behalf of the participant, beneficiary, or enrollee, provided that the person is not a Affiliated Provider is Facility or an Associate of Facility, unless such Provider or Associate is a family member of the Participant, Beneficiary or Enroller. Although treating providers may be entitled to consent to treatment under state law, HHS believes that providers generally should not be permitted to receive notices or consent to treatment from a nonparticipating provider or facility because the There is a high likelihood of inherent financial strain or professional conflicts of interest. The same concerns apply to employees at the facility where the items or services are provided. HHS also believes that these concerns are unwarranted for any provider or facility employee who is a family member of the individual based on their perceived interest in the well-being of the individual or provider unaffiliated with the provider or facility facility which Care. HHS believes these restrictions provide important consumer protections to ensure that an individual's authorized representative is acting in the best interests of the individual and not the interests of the provider or entity. HHS is seeking comment on whether and how the term "family member" should be defined. HHS is sensitive to concerns that some individuals may not have an officially recognized family relationship or other documented legal partnership under applicable state law with people they consider family. Therefore, in interpreting this requirement, HHS will interpret the term "family member" broadly to include such individuals prior to issuing additional guidance.
To ensure that a Participant, Beneficiary, Enrolled or Authorized Agent has an opportunity to properly review and consent to a notification of receipt of items or services provided by a Non-Participating Vendor or Emergency Response Facility and to the To waive protection of balance statement, Provider or Institution must give such notice within the time specified in the Articles of Association and this Interim Final Rule. As specified in Section 2799B-2(d) of the PHS Act, if a person is a
This 3-hour requirement is intended to address situations where an individual may be asked to provide consent just before a vendor provides the item or service, which may prevent their consent from being truly voluntary. Stakeholders have recommended that notification and consent procedures should not be available when an individual visits a participating facility and is being cared for by a non-participating provider from which the individual has not received services (e.g., physician). Stakeholders expressed concern that such providers could deliver the notification at the time of its appearance for consultation and the person could feel compelled to consent to the care. HHS believes that the requirement for notification to be given no later than 3 hours prior to the provision of items or services helps ensure that individuals can voluntarily provide informed consent without the option of informed consent being fully available in cases to remove in which the appointment is made same day as the date on which the services are scheduled. HHS seeks input on whether such a time limit is a reasonable approach and whether the 3-hour requirement should be shorter or longer to best ensure consent is freely given while facilitating timely access to care. For example, HHS is interested in understanding whether there are situations where these time requirements can unduly delay access to critical care, including in the context of post-stabilization care.
As previously noted, a provider or facility must provide the written notification using the form specified by HHS in the Guidance, modified to reflect the requirements set forth in 45 CFR 149.420(d) (and 45 CFR 149.410(b)(2 ) contains information specified, for postal stabilization services, as applicable).
The notice must state that the healthcare provider providing the items or services is a nonparticipating provider, or that the healthcare facility providing the items or services is a nonparticipating emergency facility, as the case may be, with respect to the healthcare plan or the Cover. The provider or facility must customize the form to identify the provider or facility by name. This will help ensure that individuals understand which specific providers or facilities they would waive their settlement billing protection for.
The notice must include the good faith estimate that such Nonparticipating Provider or Emergency Response Facility may charge the individual for the applicable items and services, including any items or services that the Nonparticipating Provider may provide in connection with such articles and services reasonably expected. In the case of a non-participating emergency facility, the notice must include the good faith estimate for such items or services as may reasonably be expected to be provided by the non-participating emergency facility or by non-participating providers as part of the visit to such facility will. HHS includes the requirement to disclose items and services that are reasonably expected to be provided to ensure that the participant, beneficiary or enroller has an accurate understanding of the cost of care. As explained in Section IV.A.2.iv of this preamble, individuals may not waive the protection of the remainder of the bill for items or services arising out of unforeseen, urgent medical needs arising at the time of delivery of an item or service for the nonparticipating provider or entity met the notification and consent criteria.
Non-participating suppliers who submit this notice will be required to make a good faith quotation only for the items or services they would provide and will not be required to make a good faith quotation for any item or service that provided by other providers in the facility. However, if a Nonparticipating Vendor has not met the Notification and Consent Criteria, the individual will be entitled to compensation and cost sharing protections with respect to items and services provided by that Nonparticipating Vendor, even if another Nonparticipating Vendor satisfies the notification has and consent criteria related to the same visit. If they so choose, multiple Nonparticipating Vendors that provide related items and services to an individual may provide a single notice to the individual, provided that: (1) the name of each Vendor is expressly identified on the Notice Document; (2) each Vendor shall include in the Notice a good faith estimate for the items and services it provides, and the Notice shall identify which Vendor is providing which items and services within the good faith estimate; and (3) the individual has the opportunity to consent to the waiver of credit billing protections with respect to each provider separately.
HHS believes that an individual cannot agree to the waiver of compensation billing and cost-sharing protection unless informed of their potential liability with respect to facility and provider fees associated with receiving post stabilization services at a nonparticipating emergency facility. Therefore, non-participating emergency facilities must provide in the written notice the good faith estimate that the participant, beneficiary or registrant may be charged for items or services provided by the non-participating emergency facility or non-participating providers with respect to the visit to such facility (including any item or service reasonably expected to be provided by the non-participating emergency facility or non-participating providers in connection with such items or
HHS recognizes that nonparticipating providers and nonparticipating emergency facilities are generally unable to calculate an individual's final out-of-pocket expenses (including remaining bills) for items and services covered in part or in full by the individual's plan or coverage are. Therefore, the good faith estimate should reflect the amount that the provider or entity expects to charge for the provision of such items or services, even if the provider or entity intends to bill the plan or coverage directly. In calculating this good faith estimate, the provider or facility is expected to use the same process and considerations used to calculate the good faith estimate required under Section 2799B-6(2) of the PHS -law is required. HHS is seeking comment on the method by which this good faith estimate should be calculated and expects this requirement to be reflected in future rulemaking. The notification must make it clear that the provision of the good faith estimate in the notification or the individual's consent to treatment does not constitute a contract with respect to the fees estimated for such items and services or a contract binding the participant, beneficiary or participant who to be handled by that provider or facility. HHS is seeking advice on whether the provider or facility should be required to include information about what may be covered by the individual's plan or coverage and an estimate of the individual's expenses.
The notice shall include information as to whether prior authorization or other care management restrictions may be required before such items or services may be obtained at the Facility or from the Provider. HHS recognizes that there may be challenges for non-participating providers or facilities in determining what pre-approvals and other care management restrictions may apply to a plan or coverage in which they do not participate. Therefore, providers and entities may provide general information to meet this requirement, but HHS encourages them to contact the issuer to the extent possible or plan for such restrictions so that they can include specific information in the notice. HHS interprets this statute as requiring information about prior approval or care management requirements that extend to care provided by providers and facilities so that participants, beneficiaries, and enrollers understand all requirements associated with their care prior to receiving treatment and agree to a settlement settlement. Requiring the notice to include details of pre-approval or care management requirements could make the information more useful to individuals compared to general information about what requirements may apply, but may make the provision of notices too burdensome for providers and facilities. HHS is seeking comment on whether providers and facilities should instead be required to include in the notice specific information about prior approval and care management requirements applicable to all items and services covered by the notice. HHS also solicits comments on barriers or other burdens that nonparticipating providers or entities face in obtaining this information from a plan or issuer.
The notification must clearly state that the individual is under no obligation to consent to the receipt of such items or services from such non-participating provider or emergency facility. The notification must indicate that the individual may instead seek treatment at an available Participating Provider or Participating Emergency Department in relation to the Plan or coverage, if applicable, and that in-network co-payment rates will apply in such cases.
In cases where postal stabilization services are provided by a non-participating provider at a participating emergency facility, the notice must include a list of all participating providers at the participating emergency facility that are capable of providing the items or services concerned. The notice must inform the individual that, at their option, they may be referred to such a participating provider. HHS is inviting comments on the format and content of the list of recommendations to be included in the notice, including any challenges providers may have in providing this information and any additional requirements that should apply to providers when providing this information to the individual pass it on.
In order to comply with the notification and consent requirements of the No Surprises Act and these Interim Final Rules, the nonparticipating provider, participating healthcare facility on behalf of the nonparticipating provider, or nonparticipating emergency facility must obtain from the participant, beneficiary, or enroller the certification of the person, that they agree to be treated and the balance billed by the non-participating emergency facility or provider if the individual elects to receive such items or services. Consent must be freely given, meaning that the individual has consented voluntarily, without undue influence, fraud, or coercion. An incomplete consent document will be treated as a lack of consent and remainder billing protections will still apply.
As with the advisory document, providers and facilities must use the standard consent document specified by HHS in the guidelines, and the consent document must be provided in accordance with these guidelines. The Consent Document provided in the Guidance provides the information (or fillable fields for the information) to be included in the Consent Form according to these Interim Final Rules and further described in this section of the Preamble. Providers and facilities must customize the document to include information specific to the individual. In addition, as previously noted, these Interim Final Rules require that consent be accompanied by the notification document and that those documents be delivered together at the same time, physically separate from, and not attached to or incorporated into, any other document. The consent document must be signed (including by electronic signature) by the individual or the individual's authorized representative.
The Nonparticipating Provider, the Participating Healthcare Facility on behalf of the Nonparticipating Provider, or the Nonparticipating Emergency Response Facility must deliver a copy of the signed Notice and Consent to the individual in person, by mail, or by email, at the individual's option.
The notice and consent documents must meet applicable language access requirements as described in these Interim Final Rules. The signed Consent Document must confirm that the individual has been provided with the written notice as described in these Interim Final Rules in the form chosen by the individual. The signed declaration of consent must also confirm this
The consent document must state that by signing the consent document, the individual consents to be treated by the non-participating provider or emergency facility and understands that the individual may be billed with a settlement bill and be subject to cost-sharing requirements applicable to services shall apply that are provided by non-participating service providers or non-participating emergency facilities. In the case of a non-participating Vendor requesting consent, the individual, by signing the consent document, agrees to waive the remainder billing and co-payment protection only for the item(s) or service(s) expressly identified by the notice(s). providers are provided. In HHS's view, an individual cannot provide informed consent to waive balance statement protections with respect to an unidentified vendor because the individual would not be aware that the individual would be billed a balance statement for items or services provided by that vendor could become. In addition, the individual may choose to waive protections of balance billing in respect of items or services provided by none, some, or all of the non-participating providers listed in the Notice.
The signed consent document must include the date the individual received the written notice and the date the individual signed such consent to provide the items or services covered by the notice. To ensure consent is given prior to receiving the item or service, HHS also requires that the signed consent document include the time the individual signed the consent.
The signed consent provided by the individual constitutes the individual's consent to receive the information contained in the notification document and includes a confirmation that he or she may be billed for the receipt of the items or services. Consent does not constitute a contractual agreement as to any estimated fee or amount contained in the Notice or Consent Document, or any contract obliging the Participant, Beneficiary or Enroller to be treated by that provider or entity. Consent obtained by Provider or Institution under this notice and consent process does not in any way replace or modify the requirements for informed medical consent otherwise required by Provider or Institution under state law or codes of medical ethics is required.
The Participant, Beneficiary or Enroller may withdraw consent by giving written notice to the Provider or Entity prior to the provision of the items or services. If an individual withdraws consent, the remainder billing protections for applicable items or services provided after withdrawal apply as if consent had never been provided. HHS believes that the ability to withdraw consent is a critical safeguard to ensure that balance statement protections are only waived where individuals knowingly, intentionally, and voluntarily provide informed consent. HHS is seeking comment on whether additional rules or guidance are needed on how an individual may withdraw consent.
A nonparticipating provider or emergency response facility providing a notice under section 2799B-2(d) of the PHS Act to a participant, beneficiary, or enrollee, or an authorized representative of such person, must use the notice in one of the 15 most commonly used Make languages available in the geographic region in which the subject facility is located. HHS believes that individuals cannot provide meaningful consent if they cannot understand the information in the written notice and consent documents. Therefore, these interim final rules also require that the notification and consent document be made available in one of the 15 most prevalent languages in the geographic region in which the entity in question is located. Providers and facilities are required to translate the standard notification and consent documents specified by HHS in the guidelines into the applicable 15 languages.
A provider or entity meets this requirement if it provides the notice and consent documents in the 15 most common languages in its state. However, HHS recognizes that in some cases, particularly in larger states or metropolitan areas, these 15 languages may not adequately represent the languages spoken by the population served by the provider or facility.
HHS has considered various applicable standards in defining such geographic regions and is seeking input as to the appropriate standard. The goal of HHS is to implement a standard that ensures that language accessibility requirements match the needs of the people served by the provider or facility, while addressing inconsistencies in the way such geographical Regions are intended to mitigate. HHS is interested in comments on the use of Metropolitan Statistical Areas (MSAs),
As noted earlier in this section, HHS believes that individuals cannot provide meaningful consent if they cannot understand the information contained in the written notice and consent document. These Interim Final Rules therefore add a language access requirement to accommodate circumstances where the individual cannot understand any of the 15 languages in which the Notice and Consent Document are available. If the individual's preferred language is not one of the top 15 most commonly used languages in which the documents will be provided by the non-participating provider or emergency response facility, or the individual's language in which the notice and consent documents will be provided , cannot understand, as reported by the individual who
The provider or facility should provide the notification and consent documents or qualified interpreting services, where applicable, in the preferred language indicated by the individual. Individuals should be asked in which language they would prefer to communicate in writing or orally regarding health care information. A person's preference for written and oral communication may not be the same, and a person's preference may not correlate with the person's native language.
In interpreting the legal requirements related to language access in the notification and consent process, HHS recognizes that communication, language and literacy barriers are associated with reduced quality of care, poorer health outcomes and increased utilisation.
Providers and facilities must also comply with other state and federal laws regarding voice access, as applicable. HHS reminds healthcare providers and organizations that recipients of federal financial assistance must comply with federal civil rights laws that prohibit discrimination. These laws include Section 1557 of the Affordable Care Act,
HHS recognizes that the technical nature of these safeguards may present natural barriers for individuals or their authorized representatives when considering their options. Numerous studies have shown that consumers' understanding of common health insurance concepts varies and that many are unable to accurately answer questions about their health plan's benefit design or healthcare costs.
The notification and consent exception does not apply with respect to some non-emergency items or services.
First, as specified in Section 2799B-2(b) of the PHS Act, in relation to non-
Additionally, as noted in Section 2799B-2(c) of the PHS Act, the notification and consent exception does not apply to items or services provided because of unanticipated, urgent medical needs that may arise at the time an item or service is provided arise for which a non-participating vendor met the notification and consent criteria. For example, even if an individual has agreed to waive residual settlement and cost-sharing protections on the network in relation to items and services provided by certain non-participating providers in connection with knee surgery, that individual has not consented, nor is it Permits Providers to consent under the Act and these Interim Final Rules to waive these protections with respect to unforeseen, urgent medical needs that arise during knee surgery. Because individuals lack the information necessary to provide informed consent to waive balance billing and co-payment protection for unanticipated, urgent medical needs, HHS has determined that the rationale for the statutory exception for notification and consent does not apply to unforeseen urgent medical needs extends needs related to non-emergency services also apply to unforeseen urgent post-stabilization services. Therefore, these interim final rules provide that any notice and consent given with respect to the provision of specific items or services will not extend to additional items or services provided in response to unanticipated, urgent medical needs either under a nonparticipating provider a participating facility or post-stabilization services.
The law authorizes HHS to broaden the definition of ancillary services to include items and services provided by other types of vendors. HHS is seeking comment on other ancillary services that should be considered ineligible for the notice and consent exception. HHS is particularly interested in comments on whether there are other ancillary services where individuals are likely to have little control over the particular vendor providing items or services. HHS believes that the notice and consent processes are the least appropriate for these types of providers. HHS is also interested in comments on the types of ancillary services for which surprise bills are most common and whether they should be added to the definition of ancillary services not subject to the notice and consent exception. Finally, HHS is seeking comment on what criteria HHS should use when deciding whether to add other ancillary services to the definition.
In addition, the law authorizes HHS to provide a list of advanced diagnostic laboratory tests that would not be considered ancillary services under this definition. All such expanded diagnostic laboratory tests would continue to be subject to the surprise billing protections described in these Interim Final Rules, but the notice and consent exemption procedure would be available for those tests as well. HHS is seeking comment on the criteria HHS should consider in determining whether an expanded diagnostic laboratory test should be exempt from the definition of ancillary benefits and any specific expanded diagnostic laboratory tests that qualify as eligible for the notice and consent exemption should.
Pursuant to Section 2799B-2(e) of the PHS Act and these Interim Final Rules, nonparticipating emergency care facilities, participating healthcare facilities and nonparticipating providers are required to retain written notification and consent documents for at least 7 years from the date the subject matter or service was provided would. In particular, where a nonparticipating emergency facility obtains a signed consent from a participant, beneficiary, or registrant, or an authorized representative of such person, for an item or service provided to the person by the facility or a nonparticipating provider at such facility the establishment of these retained the written notice and consent for a period of 7 years. If a participating healthcare facility receives a signed consent from a participant, beneficiary, or enroller, or an authorized representative of such person, for an item or service provided to the person by a nonparticipating provider at such facility, the facility must provide written consent retain notice and consent for a period of 7 years. If a non-participating Provider obtains a signed consent from a participant, beneficiary, or enrollee, or an authorized representative of such person, the Provider may either coordinate with Institution to allow Institution to retain the written notice and consent for a period of 7 years, or Provider must retain written notice and consent for a period of 7 years. HHS interprets the retention requirement to apply to both providers and entities to ensure that all notice and consent documents are properly retained, regardless of how they are obtained.
For any item or service provided by a nonparticipating provider or emergency facility, the provider (or the participating entity on behalf of the nonparticipating provider) or the nonparticipating emergency facility, as the case may be, must provide the plan or issuer with timely notice of: whether the settlement statement and in - The item or service is covered by the protection of network cost sharing and provide the plan or issuer with a signed copy of all signed written notices and consent documents. With respect to the non-emergency services described in 45 CFR 149.410(a), the non-participating provider (or participating facility on behalf of the provider) must provide timely notice to the plan or issuer that the item or service will be available during a visit to a participating Company was rendered hospital. With respect to post-stabilization services, the nonparticipating provider or emergency facility must notify the plan or issuer whether all of the conditions described in 45 CFR 149.410(b) with respect to each of the items and services to which the invoice applies are met Will be submitted. With respect to non-emergency services only, in cases where the non-participating provider bills the participant, beneficiary or enroller directly (to the extent permitted by these Interim Final Rules), the provider (or participating healthcare facility on behalf of the provider) satisfy the requirement to notify the plan or issuer in a timely manner by attaching the notification to the bill to the person.
In interpreting legal requirements, HHS recognizes that it is critical that a group health plan or health insurance issuer understand whether compensation billing and cost-sharing requirements apply on the network, including whether an item or service is available during a visit provided at a participating healthcare facility and if notification has been provided and consent has been given, which items and services have been consented to, where those items and
HHS is seeking comment on whether additional rules would be helpful regarding the process and timing for such notification, including the definition of "timely," and what processes would be most efficient for submitting the notification, including any existing processes required for submission of the information could be used . HHS is particularly interested in comments on the requirement that providers or entities provide the plan or issuer with a copy of the signed written notice and consent document, including comments on the barriers and burdens associated with such a requirement and recommendations how best to ensure plans and plans Issuers have information about the notice and consent documents without unduly burdening providers and facilities.
Section 2799B-3 of the PHS Act, as amended by the No Surprises Act, requires providers and facilities to make disclosures to protect patients from accounting claims. Among other things, the law requires healthcare providers and facilities (including a hospital emergency department or an independent, stand-alone emergency room) to make them publicly available, post them on a provider's or facility's public website (if applicable), and make them available to participants provide , beneficiaries and registrants a unilateral notice of the remainder billing requirements and prohibitions applicable to the provider or entity under Sections 2799B-1 and 2799B-2 of the PHS Act. The notice must include information about any applicable governmental requirements and how to contact the appropriate state and federal authorities if the individual believes that the provider or entity has violated the accounting rules. These interim final regulations codify the legal requirements and information that these disclosures must contain. Additionally, as previously noted, under Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c) of the PHS Act, plans and issuers are required to provide plain language information about the prohibition against balance settlement and information to contact appropriate state and federal authorities in the event that an individual believes that such provider or facility has violated the prohibition on balance settlement. These disclosure requirements apply to plan years beginning on or after January 1, 2022. At the same time, to reduce the burden and facilitate compliance with these disclosure requirements, the departments are issuing a model disclosure notice that healthcare providers, institutions, group health insurance companies and healthcare issuers may, but do not have to, use to meet the disclosure requirements related to settlement billing protection to fulfill. The Departments consider the use of the model notice in accordance with the attached instructions to be good faith compliance with the disclosure requirements of Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c). of the PHS Act when all other applicable requirements are met. Ministries may address these requirements in more detail in future guidelines or regulations. Until such guidelines or regulations become effective and applicable to implement the requirements of Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c) of the PHS Act, plans and issuers should maintain good diligent compliance with them legal regulations.
These disclosures are critical to raising awareness and improving the public's understanding of federal and state accounting protections. The purpose of these disclosures is to enable individuals to better understand the protections afforded to financial statements under applicable state and federal law. In addition, these disclosures are important to ensure that individuals can identify violations of these Interim Final Rules and related government regulations and, where appropriate, file complaints against providers and facilities. These disclosures further efforts to achieve the objectives of the No Surprises Act and to ensure that individuals are aware of their rights and the options available to them. These interim final rules codify the disclosure requirements for vendors and facilities at 45 CFR 149.430. These requirements apply to healthcare providers and healthcare facilities (including independent stand-alone emergency departments). These interim final rules include requirements related to the content of the unilateral disclosure, methods of disclosure, timing of disclosure to individuals, exceptions to the requirements, and a special rule to avoid unnecessary duplication in relation to vendors. These disclosure requirements do not apply to air ambulance service providers because Section 2799B-3 of the PHS Act requires providers and facilities to disclose information about the requirements and prohibitions applicable to the provider or facility under Section 2799B-1 of the PHS Act ( in Regarding Compensation Billing for Emergency Services) and PHS Act 2799B-2 (relating to Compensation Billing for Non-Emergency Services Provided by Nonparticipating Providers at certain Participating Facilities), but not under PHS Act Section 2799B-5 (in relation to remaining billing for air ambulance services). Although this provision does not apply to air ambulance service providers because the definition of healthcare provider in 45 CFR 149.30 excludes air ambulance service providers, HHS encourages air ambulance service providers to provide clear and understandable information about the requirements and prohibitions on the balance sheet for air ambulance services.
The Act and these Interim Final Rules require that the disclosure must include a clear and understandable statement explaining the requirements and prohibitions imposed on the provider or entity under Sections 2799B-1 and 2799B-2 of the PHS Act and its Implementing Rules, prohibitions on balance billing apply in cases of emergency and non-emergency services performed by a nonparticipating provider at certain participating facilities, as described earlier in this preamble.
In addition, the disclosure must include clear and understandable language explaining any applicable legal requirements in relation to the amounts that such provider or entity may charge a participant, beneficiary or enrollee upon receipt of payment, if any,
HHS recognizes that there may be some state laws that protect consumers better than PHS Act Sections 2799B-1 and 2799B-2 and their implementing regulations. For example, state law could prohibit an individual from consenting to a balance statement in more circumstances than those in which balance statement is prohibited under these sections and their implementing rules. If the more protective state law results in certain provisions of Sections 2799B-1 and 2799B-2 of the PHS Act and their implementing rules not being applicable to the provider or facility, the provider or facility is not required to use a language with Information on the non-applicable provisions to be included in disclosures on state requirements and prohibitions, to the extent permitted by state law. However, the provider or entity would still be required to include information about all provisions in Sections 2799B-1 and 2799B-2 of the PHS Act and their implementing regulations in the disclosures, which would continue to apply to the provider or entity.
Finally, the law and these Interim Final Rules require that disclosures include clear and understandable language providing contact information for appropriate state and federal authorities to whom an individual may contact if the individual believes that the Provider or Facility has breached any requirement described in the Notice. If only one federal or state agency has oversight of providers or facilities in the state, the disclosure may include contact information for only that agency.
To reduce the burden on healthcare providers and facilities, HHS has developed a template notice that healthcare providers and facilities may accept but are not required to use. HHS would assume that a provider or entity using the HHS-developed sample notice is in compliance with these state disclosure rules for information related to sections 2799B-1 and 2799B-2 of the PHS Act and their implementing regulations. HHS encourages states to develop model language to assist healthcare providers and facilities in complying with disclosure requirements related to applicable legal requirements and contact information. If a state develops a model language consistent with Section 2799B-3 of the PHS Act, HHS will consider a vendor or entity that makes appropriate use of the state-developed model language to be compliant with the state requirement to provide information about the state's laws take protection.
To ensure clear and understandable language for required information, HHS encourages healthcare providers and facilities to use plain language in disclosure statements and to consider user testing when developing such communications.
In addition, HHS reminds healthcare providers and entities that these communications must comply with applicable federal civil rights laws, including requiring providers and entities to take reasonable steps to provide meaningful access to persons with limited English skills and appropriate steps to ensure effective communication with individuals ensure with disabilities, including accessibility of information and communication technology.
HHS is seeking comment on the content of the required disclosures. Consistent with Executive Order 13985 and the civil rights protections cited in these Interim Final Rules, HHS specifically solicits comments from minority and underserved communities, including those with limited English proficiency, those who prefer information in alternative and accessible formats, those who are otherwise disadvantageous are affected by, for example, persistent poverty and inequality, as well as stakeholders serving these communities, what additional barriers may exist to ensuring that individuals can read, understand, and consider disclosure information, and what actions HHS may consider to address to address and remove these obstacles.
The law and these interim final regulations require that every healthcare provider and facility must make the required disclosure publicly available and (if applicable) post it on a public website for that provider or facility. In addition, Providers and Facilities are required to provide a unilateral notice to individuals who are participants, beneficiaries or participants in group health insurance coverage or individual health insurance coverage offered by a health insurance issuer.
To satisfy the requirement to post the disclosure on a public website, the disclosure, or a link to such disclosure, must be searchable on the provider's or entity's public website. HHS believes that the required disclosure information would not be publicly available unless displayed in a manner that is easily accessible and accessible and that ensures the information is available to the general public, including discoverability by the public Search engines . For example, HHS believes that a public website must be freely accessible without setting up a user account, password or other credentials, accepting terms or conditions, and not providing personally identifiable information such as a name or email address. HHS is seeking advice on whether additional regulatory standards are needed regarding disclosure on a vendor's or entity's public website to ensure that the information is available to the public.
These interim final rules provide that a healthcare provider or facility that does not have its own website is not required to make a disclosure on a public website. HHS understands that most facilities subject to the requirements in Sections 2799B-1 and 2799B-2 of the PHS Act would generally have a website, but recognizes that providers providing services at such facilities may don't have their own website.
To comply with required public disclosure, providers and facilities must display the required disclosure information on a sign prominently displayed at the healthcare provider or facility location. HHS would display a sign as highly visible if the sign was placed in a central location, e.g. B. where people arrange care, register for appointments or pay bills. Such locations would allow individuals to learn about available protections before or at the time of service or payment. HHS believes that an essential part of implementing these requirements is ensuring that individuals are aware of protections against surprise billing. HHS recognizes that some vendors may not have publicly accessible locations and has determined that requiring a sign to be prominently displayed in a non-public location would not further the purpose of disclosure. Therefore, vendors without a publicly accessible location are not required to make the disclosures required by 45 CFR 149.430(c)(2).
Finally, the law and these interim final regulations require that healthcare providers and facilities provide required disclosure information in a unilateral notice to individuals who are participants, beneficiaries, or participants in a group health plan or group or individual health insurance plan offered by a health insurance company. Notification must be given in person, or by post or email, at the choice of the participant, beneficiary or enrollee. As stipulated in the Articles of Incorporation, required disclosure to individuals must be limited to one page. HHS interprets the law to allow the disclosure notice to be a double-sided page. These interim final rules state that the one-page disclosure must not contain any print that is smaller than a 12-point font. These specifications are important to ensure that the one-page document is designed and presented in a form that is readable by the person or their representative and that it contains sufficient content to meet the requirements of these interim final regulations.
HHS is seeking comment on these disclosure methods, including whether additional methods of providing information should be required or permitted. HHS is particularly interested in comments as to whether the disclosure information could be posted in a location other than a prominently displayed sign at the provider's or facility's location. In addition, HHS is inviting comments on ways to ensure that required disclosure information posted on a public website is accessible to individuals.
These interim final rules generally require that a healthcare provider or facility provide the notice to participants, beneficiaries, or enrollers no later than the date and time that the provider or facility requests payment from the individual (including co-payment requests made around time of a visit to the provider or facility). In cases where the entity or provider is not requesting payment from the individual, the notice must be given no later than the date that the provider or entity submits a claim for payment to the plan or issuer.
HHS believes the notice is most effective in helping individuals understand their rights and protections under federal and state accounting accounting laws and to protect individuals from improper billing when individuals receive the notice in accordance with this time requirement . The requirement ensures that the disclosures are meaningful and that individuals are aware of their rights before or at the time of payment, which will likely help individuals avoid paying bills that are prohibited under state or federal accounting rules. However, these interim final rules provide flexibility for providers and institutions as to when disclosures to individuals must be made. Vendors and facilities may provide individuals with the required disclosures earlier. For example, they might provide notification when a person makes an appointment, or when other standard notification disclosures (such as disclosure of privacy practices for protected health information
In developing these interim final rules, HHS considered allowing providers or facilities to provide disclosure annually or only at the time a patient schedules service, but wanted to ensure that the timing of disclosure is relevant when the person may experience a disclosure violation Surprise Billing Protection. HHS encourages providers and entities to provide individuals with notices at a time that maximizes the effectiveness of the notice.
HHS is seeking comment on this time requirement and whether another time requirement would be more appropriate.
Although Section 2799B-3 of the PHS Act could be construed as applying generally to all healthcare providers and facilities, these interim final rules include two exceptions to the general obligation to provide disclosures related to accounting protections. First, healthcare providers are not required to provide the information required under this section if they are not providing an item or service in a healthcare facility or in connection with visits to a healthcare facility. Second, healthcare providers are required to provide the required disclosures only to individuals to whom they provide items or services, and only when those items or services are provided in a healthcare facility or in connection with a visit to a healthcare facility. HHS further notes that disclosure under PHS Act Section 2799B-3 is required only to persons who are participants, beneficiaries, or participants in a group health insurance plan or group or individual health insurance plan offered by a health insurance issuer. However, as stated in 5 U.S.C. 8902(p), Section 2799B-3 of the PHS Act also applies to a healthcare provider and facility with respect to an insured person in a FEHB plan. Disclosure requirements are not required with respect to other individuals seeking care from a provider or facility.
Although the law does not specifically provide for these exceptions, HHS believes these exceptions serve two important purposes. First, they seek to avoid unnecessary confusion among individuals who might otherwise receive disclosure in circumstances where the protection of balance accounting would never apply. For example, providing disclosure of balance statement protections in a general practitioner's office could lead individuals to mistakenly assume that balance statement protections exist where they do not. Second, the exceptions aim to implement the legal requirement without creating additional undue burdens on providers and entities by ensuring that disclosures are narrowly targeted to relevant individuals.
HHS believes these exceptions are consistent with balance
HHS is seeking comment on these exceptions and whether there are other scenarios that should be considered.
HHS recognizes that there may be some instances where an individual may receive two disclosure notices - one from a provider providing items or services at a healthcare facility and the other from the healthcare facility itself. These interim final rules include a special rule to streamline the provision of required disclosures to the public and one-way communication to individuals, and to avoid unnecessary duplication of disclosures related to providers delivering care in a healthcare setting. This special rule does not apply with respect to the requirement that each healthcare provider or facility make the required disclosure on a public website of that provider or facility. While Section 2799B-3 of the PHS Act does not specifically provide a special rule to prevent unnecessary duplication of effort in relation to providers, HHS believes this special rule serves an important purpose in implementing these requirements while reducing unnecessary burden and burden on providers . In addition, HHS believes this special rule will also help reduce potential consumer confusion by allowing individuals to receive a disclosure notice only when receiving services from a provider that provides items or services in a healthcare facility , both of disclosure requirements.
The Special Rule provides that to the extent that a Provider provides an item or service covered under the Plan or Coverage in a healthcare facility (including a hospital emergency department or an independent, standalone emergency department), the Provider shall provide the Disclosure requirements met when the entity agrees to provide the information in the required form and manner pursuant to a written agreement. In such a case, the disclosure must include information about the balance sheet accounting requirements and prohibitions that apply to both entities
Providers entering into these agreements with institutions are encouraged to monitor the institution's compliance with these requirements. Additionally, if a Vendor has knowledge that required disclosure information is not being provided in the manner specified in these Interim Final Rules, HHS encourages the Vendor to work with the entity to correct the non-compliance as soon as possible, or the appropriate governmental authority Notify agency or HHS, in states where HHS enforces this requirement.
HHS recognizes that Vendors and Facilities often bill separately for items and services provided by Vendor and Facility and is considering whether the special rule may not apply in these cases. However, HHS concluded that the application of the special rule is appropriate in these situations because the information need not be included on the invoice itself. Although these Interim Final Rules provide some flexibility as to when notification is made, HHS anticipates that disclosure to the individual will generally be made at the point of care. Therefore, requiring the provider and facility to provide separate notifications when billing separately could result in the individual receiving multiple notifications for the same visit. Duplicate paperwork could overwhelm or confuse the receiving individual, which could distract from the primary purpose of clarifying and making known the protections that may apply to the individual. Additionally, HHS believes that requiring a provider to separately post a disclosure within a facility is of limited value added and may pose compliance challenges for providers who do not have a designated place within a facility. Therefore, the special regulation applies regardless of whether the provider and facility bill together or separately.
Because the special rule does not apply with respect to the requirement that every healthcare provider and facility make required disclosures available on the provider's or facility's public website, HHS believes that this special rule helps achieve the objectives and eliminates unnecessary duplication for providers and entities, while promoting safeguards to ensure individuals receive the necessary disclosure information and are aware of their rights. HHS believes that this special arrangement does not diminish the positive effects of the disclosure requirement. This special rule will continue to help ensure that individuals are aware of their rights in relation to protecting patients from surprise bills.
HHS is seeking comment on this special rule and whether there are other circumstances that might warrant a special rule to avoid unnecessary duplication. Additionally, HHS is seeking comment on whether providers should be required rather than encouraged to monitor and report when a facility fails to meet the requirements set forth in these interim final regulations.
The No Surprises Act adds Section 2799B-4(b)(3) of the PHS Act, which directs HHS to establish a process for receiving consumer complaints regarding breaches of accounting requirements by healthcare providers, facilities and air ambulance service providers under Sections 2799B-1 , 2799B-2, 2799B-3 and 2799B-5 of the PHS Act and to respond to such complaints within 60 days. As such, the Interim Final Rules establish an HHS-only grievance process for healthcare providers, facilities and air ambulance service providers that runs in parallel with the HHS
As discussed earlier in this preamble, when billing surprise protection applies and the off-network tariff exceeds the amount on which the cost-sharing is based (provided by a non-participating emergency facility for emergency services and by a non-participating one for non-emergency services provider at a participating healthcare facility, the approved amount, and for services provided by a nonparticipating air ambulance service provider, is the lower of the amounts billed or the QPA), a group health plan, or a health insurance issuer offering groups or individuals The Medical coverage must pay the provider or facility the difference between the off-grid rate and the deductible, including in cases where a person has not met their deductible (in which case the deductible is the accepted Bet rag). , or whichever is less than the QPA). Disaster plans generally do not provide benefits for a plan year until the annual cost-sharing limit in Section 1302(c)(1) of the ACA is met, except for coverage of preventive benefits under Section 2713 of the PHS Act and at least three primary care visits. A contingency plan cannot meet the new billing protections, specifically the obligation to make a payment to a provider or facility before the registrant meets the annual cost-sharing limit while meeting the definition of a contingency plan in section 1302(e). . by ACA. Because the No Surprises Act does not contain language that eliminates contingency plans or exempts contingency plans from the requirements of the Act, HHS interprets the Act to permit contingency plans to make payments under PHS Act Sections 2799A-1 or 2799A-2, without losing their status as contingency plans. HHS is therefore amending 45 CFR 156.155 in these Interim Final Rules to specify that a disaster plan must provide benefits under Sections 2799A-1 and 2799A-2 of the PHS Act and its implementing rules or other applicable state statutes that provide similar surprise billing protections for individuals. Additionally, a healthcare plan is not treated as a disaster plan because the plan provides for benefits prior to the annual cost-sharing limit in Section 1302(c)(1) of the ACA, as required by Sections 2799A-1 and 2799A-2 of the PHS Act or either applicable state law that provides similar protections to individuals.
The OPM's Interim Final Rules, through new 5 CFR 890.114 in Subpart A, protects individuals covered by the FEHB program from surprise medical bills for emergency services, air ambulance services provided by non-participating providers, and non-emergency services provided by non-participating providers Participating Providers at Participating Healthcare Facilities in certain circumstances in the same manner as Departmental Rules protect Participants, Beneficiaries or Enrollers. The Departments' Interim Final Rules apply generally in relation to compliance by FEHB airlines with the No Surprises Act, except to the extent differences are necessary for clarification or reasonable application in connection with the FEHB program. In considering the application of the Departments' interim regulations in relation to the FEHB program, it is important to recognize that all FEHB airlines offer fully insured health insurance plans, taking into account premium payments as per the terms of the contract, and no health insurance plan is self-insured by OPM or the federal government. OPM is seeking comment on this approach and whether there should be further consideration in the application of these Interim Final Rules in the context of the FEHB program.
The FEHB Contract Terms govern state laws relating to coverage or benefits (including payments related to benefits) pursuant to 5 U.S.C. 8902(m)(1). Such precedence renders certain state laws inapplicable for purposes of determining acceptable off-grid amounts and charges pursuant to 26 CFR Part 54, 29 CFR Part 2590, and 45 CFR Part 149. However, pursuant to bilateral negotiation of the FEHB contract terms, OPM and Carrier may agree to use state law to determine the total amount payable, making the amount, method, or procedure under state law for determining the total amount payable an effective condition of the federally regulated, state-enforced contract. Accordingly, in this case, the FEHB contract terms regulate the method of determining the recognized amounts and off-network tariffs. In the absence of an FEHB contract clause that contains a state amount, method or procedure for determining the total amount payable (including an amount determined under an All-Payer Model Agreement under Section 1115A of the Social Security Act), the lesser of either the billed amount or the QPA is considered an eligible amount under the FEHB plan. In the absence of a FEHB contract clause that contains an applicable state IDR procedure, the state IDR procedure governs the determination of off-grid tariffs in cases of failed open negotiations.
Enforcement of these Interim Final Rules with respect to FEHB airlines is generally subject to the OPM authorities set forth herein and 5 U.S.C.
The No Surprises Act and these Interim Final Rules contain defined terms specific to the requirements and implementation of the Act. Definitions of key terms relating to enforcement of 5 U.S.C. 8902(p) is generally consistent with departmental regulations, with certain exceptions. For purposes of compliance with these Terms, the terms "health insurance plan or plan," "issuer or issuer of health insurance," and "participant, beneficiary, or participant" are replaced by the terms "health benefit plan," "sponsor," and "enrolled or insured person," respectively.
Complaints related to the provisions of Part D of Title XXVII of the PHS Act relating to air carriers and FEHB plans will generally be resolved in accordance with the interim final regulations of the departments. OPM will coordinate with departments to ensure that complaints that are amenable to OPM resolution under the FEHB program statute, regulations or contracting authorities are escalated to OPM.
Under 5 U.S.C. 8912, the United States district courts, along with the United States Court of Federal Claims, have original jurisdiction over any civil action or claim against the United States arising out of the FEHBA. Pursuant to new paragraph (e) at 5 CFR 890.107, in the event of a dispute under these Interim Final Rules, an action for equitable relief based on 5 U.S.C. Chapter 89, which is based on 5 U.S.C. 8902(p) and subject to 5 CFR Part 890, must be brought against OPM by December 31 of the 3rd year following the year in which the disputed services were performed. OPM is seeking comment on changes to its Judicial Review Regulations.
OPM seeks opinion on the appropriate manner of complying with Sections 9816, 9817 and 9822 of the Code; Sections 716, 717 and 722 of ERISA; and Sections 2799A-1, 2799A-2 and 2799A-7 of the PHS Act as applied to FEHB carriers, including the adequacy and usability of the definitions and any additional changes to the Departments' regulatory provisions that need to be adjusted for proper implementation in the FEHB program.
For purposes of 5 U.S.C. 8902(p), HHS Interim Final Rules for Healthcare Providers, Facilities and Air Ambulance Service Providers apply with respect to insured persons in an FEHB plan in the same manner as they apply to participants, beneficiaries and enrollers of a group health plan or group or individual health insurance , which is offered by a health insurer. OPM seeks advice on the appropriate manner of complying with 5 U.S.C. 8902(p) and sections 2799B-1, 2799B-2, 2799B-3 and 2799B-5 of the PHS Act.
In accordance with the provisions of Section III.D. of this preamble, OPM will not apply these interim final rules to health insurance plans that are retiree-only plans.
Section 9833 of the Code, Section 734 of ERISA and Section 2792 of the PHS Act empower the Ministers of Treasury, Labor and HHS (collectively the Secretaries) to promulgate any interim final regulations which they consider necessary or appropriate to the Regulations of Chapter 100 of the Code, Part 7 of Subtitle B of Title I of ERISA and Title XXVII of the PHS Act.
In addition, pursuant to Section 553(b) of the Administrative Procedures Act (APA) (5 U.S.C. 551
The No Surprises Act was enacted on December 27, 2020 as Title I of Division BB of the Consolidated Appropriations Act, 2021. The cost sharing and settlement accounting requirements for plans, issuers, healthcare providers, facilities and providers of air ambulance services in the No Surprises Act apply to plan years (insurance years in individual markets) beginning on or after January 1, 2022. Although this Effective Date might have allowed the regulations, if promulgated with the full notice and comment process, to be applicable in time for the application date of the provisions of the No Surprises Act, this timeframe would not have provided sufficient time for regulated entities to comply with the requirements implement. These interim final rules require plans and issuers to make significant changes to how they pay for items and services subject to cost sharing and settlement billing protections, including implementing claims handling procedures to ensure claims for Items and services subject to this protection will be processed in accordance with the requirements of these preliminary final provisions. Group health insurance plans and health insurance issuers that offer group or individual health insurance coverage must reflect these changes when setting their premium or contribution rates and making other changes to plan or benefit design. In some cases, issuers need time to obtain approval for these changes prior to the relevant plan or insurance year. The Departments and OPM understand that the plans and issuers have already considered the statutory provisions in the No Surprises Act when developing draft 2022 plans and preliminary interest rates. The publication of these rules as interim final rules, rather than as a notice of proposed rulemaking, may allow plans and issuers to consider the final rules in the final determination of rates and plan offerings.
The interim final rules place new requirements on facilities, healthcare providers and air ambulance service providers regarding when they are allowed to settle invoices for items and services. These requirements include new requirements related to how providers and facilities must account for items and services provided off-network, requirements related to the provision of notifications and obtaining consents to protect account balance billing in certain circumstances, and requirements for Disclosure of Billing Account Balance Information Publicly, on a Public Website, and to Participants, Beneficiaries, and Enrollers. Healthcare providers and facilities need time to implement these new requirements to ensure compliance by January 1, 2022.
These Interim Final Rules provide important protections for Participants, Beneficiaries and Enrollers against balance settlements. For people receiving balance bills, the costs can be astronomical and devastating.
Section 2723 of the PHS Act empowers states to enforce the requirements in Part D of Title XXVII of the PHS Act with respect to issuers. Section 2799B-4 of the PHS Act authorizes states to enforce the requirements in Part E of Title XXVII of the PHS Act with respect to providers and healthcare facilities (including an air ambulance service provider). In both sections, HHS has an obligation to enforce such requirements if a state does not substantially enforce them. To ensure effective oversight of these new requirements once they become effective, states need time to evaluate the requirements contained in these interim final regulations and to notify HHS if they have not enacted legislation to enforce these requirements or otherwise not doing will enforce such requirements. States that choose to enforce the requirements may need time to update their regulations or laws and develop procedures to enforce the new requirements. Delaying the rules to allow for notification and comment processes would not give states sufficient time to evaluate the new requirements and notify HHS of their ability to enforce.
In addition, the Act requires the Secretaries to issue regulations on the QPA methodology (including the definition of geographic regions for purposes of the methodology) by July 1, 2021; Information that plans or issuers are required to share with nonparticipating providers or entities, as applicable, regarding the plan or the issuer's determination of the QPA; and a process for receiving complaints related to the QPA. Allowing time for a full disclosure and commenting process before July 1, 2021 would not have given departments sufficient time to develop and publish these rules by the statutory deadline.
For the above reasons, the Ministries and the OPM have determined that it is impractical and contrary to the public interest to provide a full announcement and commenting on the regulations prior to the entry into force of these Interim Final Rules and that it is in the public interest to allow Interim Final Rules announce rules.
These interim final rules implement provisions of the No Surprises Act, enacted by Congress as part of the CAA, protecting participants, beneficiaries and enrollers in group health plans and group and individual health plans from unexpected medical bills when they receive emergency services, non-emergency services from non-emergency services Participating Providers at certain Participating Facilities and, in certain circumstances, air ambulance services.
The departments and OPM
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is required, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, distributional effects and equity impacts). Executive Order 13563 supplements and reinforces the principles, structure and definitions for regulatory review set out in Executive Order 12866.
Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule: (1) having an annual impact on the economy of US$100 million or more in one year or adversely and a sector of the economy that significantly affects productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal government or community (also referred to as "economically significant"); (2) create a serious inconsistency or otherwise interfere with any action taken or proposed by any other authority; (3) material changes in the budgetary impact of any grant, royalty or loan program or the rights and obligations of recipients; or (4) the raising of new legal or policy issues arising from statutory mandates, the President's priorities, or the policies set forth in the Executive Order.
For major regulations with an economically significant impact (e.g. $100 million or more in one year), a regulatory impact analysis must be prepared and a “significant” regulatory action is subject to OMB review. The Departments estimate that this regulatory action is expected to have an economic impact of US$100 million or more in at least one year, meeting the definition of an “economically significant rule” under Executive Order 12866. As such, the departments have provided an assessment of the potential costs, benefits and transfers associated with these interim final regulations. In accordance with the provisions of Executive Order 12866, these interim final rules have been reviewed by OMB.
An unexpected medical bill is an unexpected bill from a healthcare provider or entity that occurs when a Participant, Beneficiary, or Enroller receives medical services from a provider (including an air ambulance service provider) or entity that, generally unbeknownst to the Participant, is the Beneficiary or Participant is a non-participating provider or facility with respect to the person's insurance coverage. Surprise bills usually occur in situations where a patient is unable to select a provider (including an air ambulance service provider) or emergency facility and ensure that they are only cared for by providers or emergency facilities that participate in their coverage. A recent survey found that two-thirds of adults worry about being able to afford unexpected medical bills for themselves and their families, and 41 percent of adults with health insurance have received a surprise medical bill in the last two years.
The No Surprises Act provides federal protection against surprise bills and limits off-network cost sharing in many of the circumstances where surprise medical bills most commonly occur. These interim final rules implement provisions of the No Surprises Act that protect individuals in certain circumstances from unexpected medical bills for emergency services, air ambulance services provided by non-participating providers and non-emergency related services provided by non-participating providers at participating facilities .
The provisions in these interim final rules ensure that participants, beneficiaries and enrollers with health insurance are protected from surprise medical bills. People with health insurance can have peace of mind, lower their deductibles, hit their deductible and excess limits sooner, and may have better access to medical care. Plans, issuers, healthcare providers, facilities and air ambulance service providers will incur costs to comply with the requirements of these interim final regulations. In accordance with OMB Circular A-4, Table 1 presents a financial statement summarizing the departments' assessment of the benefits, costs and transfers associated with this regulatory action. Departments are unable to quantify all benefits, costs and transfers of these interim final rules, but have attempted to describe these unquantified impacts where possible. The impacts in Table 1 reflect unquantified impacts and estimated direct monetary costs resulting from the provisions of these interim final regulations.
There is extensive research into the frequency of off-network providers and facilities charging patients for items and services provided at on- and off-network healthcare facilities. Most of these studies analyze claim data to identify cases that could potentially result in a surprise medical bill. The studies show that surprise bills are a significant problem for consumers across the country and across all types of coverage. For example, an analysis of claims data from large group health insurers found that although rates varied from state to state, an average of 18 percent of emergency room visits resulted in individuals receiving a surprise medical bill
A study using group health plan claims data from 2007-2014 showed that in 2014, 20 percent of inpatient hospital admissions that originated in the emergency department, 14 percent of outpatient emergency department visits, and 9 percent of elective inpatient admissions were likely to result Surprise medical bills. In approximately 40 percent of inpatient admissions and more than half of outpatient cases with surprise bills, issuers paid for claims at the network level, so patients may have been billed for the remainder.
For elective surgeries, analysis of claims data from a major issuer found that between 2012 and 2017, an off-network bill occurred over 20 percent of the time when the primary surgeon and facility were on-network, resulting in potential settlement bills of between $1,255 and $1,255 $3,449. Occurrence of out-of-network billing was associated with significantly higher total charges and out-of-pocket expenses for patients compared to cases without out-of-network billing.
Researchers have also attempted to estimate the amount of surprise bills patients receive. A study using 2015 claim data from a major issuer for services performed at hospitals within the network concluded that the average potential balance bills from anesthesiologists, pathologists, radiologists and resident surgeons were $1,171, $177, $115 and $7,420, respectively.
Surprise bills are often associated with certain medical specialties, particularly those whose services cannot be actively “purchased” by consumers. Researchers analyzing claims data from a major issuer for the period 2010-2016 found that emergency room visits related to medical transport often resulted in off-network bills (resulting in off-network bills in 85.6 percent of incidents). with outpatient clinics) and the following medical specialties: emergency medicine (32.6 percent), anesthesiology (22.8 percent), internal medicine (23.8 percent), cardiology (20.9 percent), general practice (20.1 percent), radiology (18.1 percent), general surgery (13.3 percent), and pediatrics (8.4 percent). For inpatient admissions in hospitals within the network, the study showed that, in addition to patient transport (81.6 percent of cases with ambulances), bills outside the network were most frequently incurred by the following specialists: Emergency medicine (42.6 percent of all inpatient admissions with at least 1 request from the respective specialty), internal medicine (25.3 percent), radiology (22.6 percent), pathology (22.2 percent), cardiology (19.6 percent), anesthesiology (19.3 percent), general practice (18.2 percent) , and obstetrics and gynecology (0.8 percent).
As discussed earlier in this preamble, several studies have shown that a large percentage of off-network invoices come from independent laboratories. An analysis of 2008-2016 claims data for people with group health insurance found that the proportion of off-network lab spend has increased and that utilization and prices for off-network lab testing have increased compared to in-network testing during this period. The number of off-network lab tests grew 18.9 percent each year, while the number of on-network lab tests grew 2.3 percent each year. The study authors speculated that large providers of laboratory services have sufficient market power to set high prices off-network and that financial incentives could influence clinician usage.
Providers who choose to stay off-network typically do so because it doesn't impact their patient volume. The ability to settle bills is often leveraged by such providers to obtain higher in-network payments when they join plans or issuers' networks. Higher in-network payments result in higher rewards,
The use of air rescue services often leads to surprising bills. A Government Accountability Office (GAO) study analyzed private health insurance claims from 2012 and 2017 to describe the extent to which medical transport is performed off-network.
As costs associated with air ambulance transportation continue to rise, GAO reported that air ambulance service providers are reporting more network contracts.
A study using data from 2014–2017 from three major issuers to assess the proportion of air ambulance claims that are off-network and the prevalence and magnitude of possible surprise bills found that 77 percent of air ambulance transports are off-network were. Network and about 40 percent of air ambulance transports resulted in potential residual bills. Bills averaged about $19,851, in addition to the standard off-network co-payment, which averaged $561. The study also found that for off-network rotary vane exposures, issuers paid the full vendor billed fees about 48 percent of the time, for an average of $35,733, and that for in-network vendors, the billed fees were paid in full only 7 percent of the time was paid for. They found that self-insured plans fully paid off-network claims 50 percent of the time, while fully insured plans fully paid claims 38 percent of the time.
A study that used claims data from a major issuer to assess the potential impact of off-network ambulance services from 2013 to 2017 found a total of 1,498,600 ambulance encounters, of which 29,972 (2 percent) were air ambulance encounters, and of those 26,375 (88 percent) were rotorcraft and 3,597 (12 percent) were fixed-wing. The study further found that the prevalence of potential medical surprise billing was an estimated 73 percent for rotary wing transports (18,463) and 70 percent (2,518) for fixed wing transports.
A number of studies have examined government investigations or consumer complaints to obtain information about the amount of the remaining bill and the costs associated with ambulance transport. A study reviewed state investigations and found that in North Dakota, of 20 complaints against an air ambulance service provider that billed a total of $884,244 (average $44,212 per flight), 33 percent of the charges were covered by insurance. In another nine states, the study found that 55 complaints resulted in total charges of $3.8 million, or an average of $77,000 per trip; and in Montana, the study found that the average off-network rate from the 19 bills analyzed was $53,397.
A study of off-network billing in emergency departments examined how some providers use off-network billing to increase payments. The study found that off-network physician fees in emergency rooms accounted for 637 percent of Medicare payments, which is on average 2.4 times higher than on-network payment rates for identical services. The study also found that emergency room physicians received net rates of 266 percent of Medicare payments, a higher percentage of Medicare payments than most other specialists.
Another study, using 2017 claims data from 3 major emitters, examined spending on emergency services most commonly associated with surprise bills: emergency physicians, radiologists, anesthesiologists, pathologists, ambulatory emergency services, and ground ambulance services .
A study using 2015 claim data from a major issuer for services rendered at on-network hospitals examined the impact of policies that would prevent anesthesiologists, pathologists, radiologists and resident surgeons from billing their balances and reduce their on-network payments by 164 percent Medicare payments. The study concluded that such a reduction in payments would result in savings of 13.4 percent in expenses for physicians and 3.4 percent in expenses for those with employer-sponsored insurance, or approximately $40 billion per year is equivalent to.
Unexpected bills lead to higher expenses and create financial anxiety and medical debt for consumers.
Additionally, off-network cost sharing and surprise bills do not typically count towards an individual's deductible or maximum spending limits. As a result, people with surprising bills may struggle to reach these limits despite potentially having high health care spending. This can result in limited access to care, as high medical costs can cause individuals to delay or forgo medical care. In a 2017 survey, 64 percent of respondents said they had delayed care in the past year due to high medical costs, and 44 percent said they would forego care if they paid their expenses out of pocket
Surprising medical bills can not only cause financial difficulties, but also cause consumers to switch providers in the future. Analysis of a large national sample of claims for obstetric patients who had two deliveries covered by insurance found that 11 percent of patients received a surprise medical bill for their first delivery and were 13 percent more likely to switch hospitals for their second delivery than Patients in whom this was not the case.
People living in rural areas face socioeconomic and health disparities.
As of February 5, 2021, 33 states have enacted laws offering consumers some protection regarding balance bills.
Even within a state that has such protections in place, these protections typically apply only to individuals enrolled in group or individual health insurance, since ERISA generally preempts state laws governing private employer-sponsored self-insured group health insurance plans. (Some state laws allow ERISA-covered plans to elect state-law consumer protection and payment assessment process.) In addition, states are limited in their ability to address surprise bills involving out-of-state providers are.
The air ambulance industry currently functions and operates differently within the healthcare system than any other entity or service, just somewhat due to the uniqueness of the service. There are limited ways for states and the US Department of Transportation (DOT) to regulate their operations. States and the DOT have limited authority under the ADA to regulate an air carrier's fare, route, or service, including an air ambulance operator, in air transportation.
State laws appear to provide consumers with some protection from chargebacks. A study analyzing the impact of the New York State law concluded that the law resulted in a 34 percent reduction in contingency bills in the state and a 9 percent reduction in payments for emergency room physicians.
The provisions in these Interim Final Rules protect participants, beneficiaries, or enrollers with health insurance from unanticipated bills for emergency services, air ambulance services provided by non-participating providers, and non-emergency services provided by non-participating providers at participating facilities, in certain circumstances. Providers can no longer offset a person's bill for emergency services. A provider may charge an individual for certain postal stabilization services and for services provided by nonparticipating providers at certain participating facilities only if the provider or facility notifies the subscriber, beneficiary, or enroller and the individual obtains consent to the Off-network care and billing via the balance. In addition, provisions ensuring that all relevant civil rights protections are upheld and that communication with consumers is accessible in understandable language and at an appropriate level of literacy help effectively extend these protections to minority and underserved communities.
These interim final rules also state that for emergency services provided by a nonparticipating provider or emergency facility, and for non-emergency services provided by nonparticipating providers at a participating healthcare facility, cost sharing is generally calculated as follows: as if the total amount that would have been charged by a participating emergency facility or provider for the services equaled the recognized amount for such services as defined by the Act and these Interim Final Regulations, while for non-participating air ambulance service providers the cost sharing will generally be calculated as if the total amount billed for the services by a participating air ambulance service provider was the lesser of the billed amounts or QPA, as in the Act tz and defined in these interim final regulations.
In addition, these Interim Final Rules require that these co-payment amounts be credited against any in-network deductible or in-network maximum deductible applied under the plan or coverage in the same manner as if such cost-sharing payments were made in respect of services provided by a Participating Vendor, Facility or Air Ambulance Provider.
For example, consider a case included in Vox's project,
Therefore, those with health insurance, including members of minorities and underserved communities, are likely to see a significant reduction in their balance sheet billing, reducing a source of anxiety, financial stress and medical debt. They will also experience a reduction in their out-of-pocket expenses as they are only liable for their in-network co-payments when they are being cared for by non-participating providers, emergency facilities and air ambulance service providers, which now count towards their deductible and co-payment ceilings, allowing individuals to meet these reach limits earlier. As discussed earlier in this preamble, a significant number of people forgo or delay seeking care because of the cost of care. A reduction in the cost of care is likely to improve access to care and enable people to receive the treatment they need that they might otherwise have neglected or foregone due to concerns about the cost of care.
These interim final rules also establish a complaints procedure for receiving and resolving complaints related to this new protection against surprise bills. The Departments believe this will result in better compliance with accounting requirements and ensure that all individuals, including those belonging to minorities and underserved communities, can benefit from the protections provided by the No Surprises Act and these interim final regulations. The departments are also soliciting comments from members of minority and underserved communities to help identify barriers for individuals to exercising their rights under the No Surprises Act and guidance on removing such barriers.
The No Surprises Act expands the applicability of patient protections for healthcare professional choices to grandfathered health plans. Participants, beneficiaries, and enrollers in grandfathered plans can now nominate any participating GP who is available to enroll the participant, beneficiary, or enroller. When patients are able to choose doctors they trust and have a good relationship with, they are more likely to achieve better health outcomes.
The potential financial savings for consumers as a result of the safeguards in these interim final rules are significant. Beginning January 1, 2022, individuals nationwide will no longer receive unexpected medical bills for off-grid emergency services, non-emergency related services provided by non-participating providers at certain participating healthcare facilities, or air ambulance services. The Departments understand that some of these savings will instead result in cost transfers from participants, beneficiaries and enrollers to group health plans or issuers, as discussed later in this preamble, or ultimately may be paid by individuals in the form of increased health insurance premiums, which may be used in the future regulation are discussed. However, Ministries understand that there are potentially additional cost savings for individuals, but are unaware of comprehensive national data quantifying the potential financial benefits to individuals from the surprise billing protections contained in these rules and invite stakeholders to provide relevant data exchanges that would help The departments quantify this potential financial benefit to consumers.
Plans, issuers, healthcare providers, facilities and air ambulance service providers will incur significant costs to comply with the requirements of these interim final regulations.
These interim final rules establish that for emergency services provided by a nonparticipating provider or emergency facility, and for non-emergency services provided by nonparticipating providers at a participating healthcare facility, co-payment is generally calculated as whether the total amount charged for the services of a participating emergency facility or provider would have been the acceptable amount for such services within the meaning of the No Surprises Act and these Interim Final Rules. For non-participating air ambulance service providers, cost sharing will generally be calculated as if the total amount that would have been charged for the Services by a participating air ambulance service provider equals the invoiced amount or QPA, as defined in, whichever is lower in the Articles of Association and in these provisional final provisions. In addition, these Interim Final Rules require that such cost-sharing must also be credited against any intra-network deductible or intra-network deductible cap applied under the plan or coverage in the same manner as if such cost-sharing payments were made in respect of services, provided by a participating provider, facility or air ambulance service provider.
Under these interim final rules, co-payments for emergency services provided by a non-participating provider or emergency facility and for non-emergency services provided by non-participating providers at a participating healthcare facility must be calculated based on the "approved amount." which is: (1) an amount determined by an applicable model all-payer agreement under Section 1115A of the Social Security Act, (2) if there is no such applicable model all-payer agreement, an amount determined by a particular state law is determined, or (3) if there is no such applicable all-payer model agreement or particular state law, the lesser of the amounts billed for the Services or the QPA, which is generally the median of the contracted amounts Tariffs of the plan or issuer for the item are, or services included in d he respective geographic region are provided. For air ambulance services, subject to these interim final regulations, planners and issuers are generally required to use the QPA to calculate cost sharing.
Significant costs will be incurred by plans and issuers to calculate the eligible amount and applicable cost sharing amount. Departments assume that self-insured group health plans will incur the costs of third-party administrators (TPAs). The departments estimate a total of 1,758 companies - 1,553 issuers
Issuers and TPAs must also revise their SOPs to include processes related to off-network claims, acknowledged amounts, and QPA, and provide training for their billing staff and customer service representatives. The departments estimate that for each issuer or TPA, it will take a business operations specialist 40 hours (at $81.06 hourly wage) and 16 hours for a senior manager (at $114.24 hourly wage) to overhaul standard operations Procedure with a total cost of approximately $5,070. In addition, departments estimate that an average of 10 employees at each issuer and TPA will receive 4 hours of training at a cost of $1,824. For all 1,758 issuers and TPAs, the total cost of revising SOPs and training is $12.1 million. The departments assume that these one-time costs will be incurred in 2021 and that new employees will be trained as part of the usual onboarding process with minimal additional effort.
Healthcare and emergency facilities will also incur costs to revise their standard operating procedures and train their staff on notification and consent requirements, patient disclosure and off-network billing. The departments estimate that there are 16,992 emergency and healthcare facilities (6,090 hospitals,
Air ambulance service providers also incur costs for revising their standard operating procedures and training their employees on off-network billing. The departments estimate that for each air ambulance provider, it will take a business operations specialist 40 hours and a senior manager 16 hours to revise the SOPs, resulting in a total cost of approximately $5,070. In addition, an average of 10 employees receive 4 hours of training for each vendor at a cost of approximately $1,824. The total on-time cost for each air ambulance service provider will be approximately $6,894 in 2021. The total one-time cost for 75 air ambulance service providers
The departments estimate that grandfathering plans and issuers will incur a total cost of approximately $4,516,225 in 2022 to provide participants, beneficiaries and enrollers with the legal notice to designate a primary care provider. Self-insured plans that elect state law will incur a one-time cost of $50,708 in 2022 to include disclosure in plan documents. TPAs and issuers will also incur approximately $55.4 million in costs annually to exchange information related to QPAs with nonparticipating providers, nonparticipating emergency response facilities, and nonparticipating air ambulance service providers. In addition, issuers and TPAs incur costs for making the plan or issuer publicly available, posting it on a public website, and disclosing it in any patient protection versus balance billing performance statement. The departments estimate 2021 one-time costs for all issuers and TPAs at $699,245 and ongoing annual costs from 2022 at approximately $23.4 million. These costs are discussed in detail in the Paperwork Reduction Act section of this preamble.
Nonparticipating providers and nonparticipating emergency facilities may settle a participant, beneficiary, or enroller's bill if certain notification and consent requirements have been met. Providers and facilities incur costs for preparing the notification, notifying and obtaining patient consent, maintaining records, and notifying plans and issuers. HHS estimates that the one-time cost of preparing the notice and consent documents in 2021 will be approximately $22.6 million. The ongoing annual costs of providing notice and obtaining consent, record keeping, and notifying plans and issuers are estimated to be approximately $117.2 million as of 2022. In addition, individuals providing notice and, where applicable, the Received consent, reading and understanding the notice will cost approximately $99.1 million annually as of 2022. These costs are discussed in detail in the Paperwork Reduction Act section of this preamble.
Health care providers and entities also incur costs for making it publicly available, posting it on a public provider or entity website, and providing a one-page disclosure statement to protect patients from surprise billing and for providers and for participants, beneficiaries, and enrolled entities to close of arrangements for entities to provide disclosure on behalf of providers, HHS estimates the total one-time cost that will be incurred in 2021
The No Surprises Act directs departments to establish a process for receiving complaints about violations of the application of the QPA by group health insurance plans and health insurance issuers offering group or individual health insurance. Natural and legal persons who file a complaint in connection with surprising bills also incur costs for this. As discussed in the "Paperwork Reduction Act" section of the preamble, the departments estimate the associated costs to be approximately $97,452 per year beginning in 2022. In addition, the federal government will incur one-time costs in 2021 of approximately $16 million -$100 to build IT system to receive and process complaints, another $3 million to update existing systems in 2021, and ongoing annual costs of about $1.6 million in 2021, 9 $.9 million in 2022, $10.1 million in 2023, and $10.3 million in 2024 and beyond for processing of received complaints and for system maintenance.
As previously mentioned, those with protections against surprise billing are likely to experience a reduction in out-of-pocket expenses. This can increase their use of healthcare, which could lead to an overall increase in healthcare spending.
Departments are seeking comment on these estimates and any additional costs incurred by schemes, issuers, providers and facilities.
The provisions in these interim final regulations will result in reduced personal spending by individuals. In situations where unexpected bills are currently occurring, participants, beneficiaries and enrollers are only responsible for an approximate amount of the co-payment that they would have paid if the services were provided by a participating emergency facility, provider or air provider emergency services. Plans and issuers are now required to pay for some expenses for items and services provided by nonparticipating facilities, providers and air ambulance service providers that they have not previously paid for. Thus, spending is shifted from specific individuals to plans and issuers. In addition, it is possible that the off-network rates charged by some providers, including air ambulance providers, and facilities are lower than they would have been had the providers and facilities been able to offset the bills for the individuals. Such situations result in transfers from providers and facilities to individuals. If there is a drop in payments to some participating providers, as is the case with on-network payments for emergency room physicians in New York State,
As discussed earlier in this preamble, these Interim Final Rules are the first of several rules implementing the No Surprises Act and the transparency provisions of Title II of Division BB of the CAA. Later this year, the departments intend to issue additional regulations, including regulations on the federal IDR process. The impact of the provisions of the No Surprises Act on premiums will depend on provisions not included in these interim final regulations and therefore a more detailed analysis will be included in future regulations.
In preparing the interim final rules, departments considered several alternative approaches.
The departments also considered requiring plans and issuers to calculate separate median contract rates for facilities based on characteristics of facilities, e.g. B. by distinguishing teaching hospitals from non-teaching hospitals, rather than distinguishing based solely on whether the facility is an emergency department of a hospital or an independent, stand-alone emergency department. Departments decided against this approach as it would result in a higher median contract rate for facilities with higher operating costs and is not clearly provided for in the definition of QPA in the No Surprises Act. The departments believe that the different operating costs in facilities with different characteristics should not have such
In relation to the calculation of a separate QPA for each item and service for each geographic region, the Divisions considered whether each geographic region should be defined as an applicable valuation area, as required for the purposes of the individual and small group market valuation rules under PHS Act 2701 Section and is defined in 45 CFR 147.102, which allows states the flexibility to set up alternative geographic regions. However, some states define assessment areas by county, resulting in a large number of assessment areas in a state, some of which may have few or no facilities and providers. Therefore, adopting the rating range as the geographic region standard could result in a large number of geographic regions for which a plan or issuer would need to calculate separate median contractual rates, a large number of geographic regions without sufficient information, and a large number of geographic regions Number of geographic regions where the median contract rate is affected by outliers. Therefore, the interim final regulations do not adopt this approach to defining geographic regions.
Regarding the legal requirement for plans and issuers to calculate separate QPAs for each insurance market, including for self-insured group health insurance plans, the departments considered whether the market for self-insured group health insurance plans should be limited only to self-insured group health plans offered by the same plan sponsor. However, this could result in insufficient information being more common with a self-insured plan, so the interim final rules instead define the self-insured market as all self-insured group health insurance plans offered by the same plan sponsor, or at the option of the plan sponsor, all self-insured group health insurance plans that Administered by the same entity responsible for determining the QPA on behalf of the Plan (including any third-party administrator appointed by the Plan).
Regarding the definition of participating healthcare facility and participating emergency facility, the departments have considered excluding facilities that have only individual agreements with a plan or issuer. However, the departments are convinced that this could harm the participants, beneficiaries or enrollers. When people are provided care, generally non-emergency, under an individual agreement, they should not have to worry about possible surprise bills. The exclusion of facilities with case-by-case agreements from the definitions of Participating Facilities and Participating Emergency Services would contradict the intention of the departments to protect individuals from unexpected medical bills.
The Paperwork Reduction Act of 1995 (PRA) requires HHS to provide 30 days' notice
• The need for information collection and its usefulness in performing the proper duties of our agency.
• The accuracy of the HHS estimate of the information collection effort.
• The quality, usefulness and clarity of the information to be collected.
• Recommendations for minimizing the burden of collecting information on the concerned public, including automated collection techniques.
HHS is soliciting public comments on each of the required items under Section 3506(c)(2)(A) of the PRA for the following information collection requirements (ICRs).
To derive wage estimates, departments generally used data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for perks and overheads) to estimate the burden associated with ICRs.
As stated, the estimated hourly wages of the employees have been adjusted by a factor of 100 percent. This is necessarily a rough adjustment, since fringe benefits and overheads vary significantly from employer to employer, and the methods of estimating these costs vary widely from study to study. However, there is no practical alternative and the departments believe that doubling hourly wages to estimate total costs is a reasonably accurate estimation method.
These interim final rules require plans and issuers to provide certain information regarding the QPA to nonparticipating vendors or nonparticipating emergency facilities in cases where the recognized amount is related to an item or service provided by the vendor or facility , to which QPA complies (and overall cases subject to these rules for non-participating air ambulance service providers). Specifically, plans and issuers must provide providers (including air ambulance providers) and facilities with the following information when making an initial payment or notifying a payment refusal: (1) The QPA for each affected item or service; (2) a statement certifying that the plan or issuer has determined that the QPA applies for the purposes of the approved amount (or, in the case of air ambulance services, for the calculation of the participant's, beneficiary's or enroller's co-payment) and has respectively become a QPA determined in accordance with the methodology set forth in these Interim Final Rules; (3) a statement that the provider or entity, if applicable, wishes to initiate a 30-day open negotiation period for the purpose of determining the total payment amount, the provider or entity may contact the appropriate person or entity to initiate an open negotiation, and that if the 30-day negotiation period does not result in a decision, the provider or entity in general may initiate the independent dispute resolution process within 4 days of the end of the open negotiation period; and (4) contact information, including telephone number and email address, for the appropriate person or office to initiate open negotiations for the purpose of establishing a payment amount (including cost sharing) for that item or service. In addition, the plan or issuer must provide the following information in a timely manner upon request from the provider or facility: (1) Whether the QPA for the affected items and services included contracted rates that were not a service fee basis for those specific items and services and whether the QPA for those items and services was determined using the underlying fee schedule rates or a derived amount; (2) if an associated service code was used to determine the QPA for a new service code, information identifying the associated service code; (3) if the plan or issuer used an appropriate database to determine the QPA, information identifying which database was used; and (4) if requested, a statement that the plan's or issuer's contractual rates include risk-sharing, bonus or other incentive-based or retrospective payments or payment adjustments for covered items and services excluded for purposes of the QPA calculation.
Departments expect TPAs to provide this information on behalf of self-insured plans. In addition, the departments anticipate that issuers and TPAs will automate the process of creating and providing this information in a format similar to an explanation of the benefits as part of the system used to calculate the QPA. The cost to issuers and TPAs of making the changes
The ministries estimate that a total of 1,758 issuers and TPAs will be burdened by complying with this provision. Currently, 14 states have established some payment standards for services provided by non-participating providers or non-participating emergency facilities. As such, departments anticipate that issuers and TPAs may need to calculate the QPA for two-thirds of claims involving non-participating providers or non-participating emergency facilities.
In 2018, there were approximately 39,690,940 emergency department visits for patients with individual market or group health insurance.
The departments estimate that for each issuer or TPA, it will take a medical secretary 10 minutes (at an hourly rate of $37.50 per hour) to prepare the documentation and attach it to any payment or denial notice or declaration of performance made to the nonparticipating vendor or the facility is sent. The departments assume that this information will be transmitted electronically at minimal cost. The total annual effort for all issuers and TPAs to provide the QPA information and certification along with 5,068,512 payments or denial notices is estimated at approximately 844,752 hours at a corresponding cost of approximately $31.7 million.
The departments anticipate that 50 percent of the 5,068,512 QPA information sent to nonparticipating providers or nonparticipating emergency response facilities will result in requests to provide additional information and plans, and that the issuers will send additional information to approximately 2,534. 256 providers or institutions must send. Departments estimate that it will take a medical secretary 15 minutes (at an hourly rate of $37.50) to prepare the document and transmit it to the provider or facility that requested it. The departments assume that this information will be transmitted electronically with minimal additional effort. The estimated total exposure across all issuers and TPAs is approximately 633,564 hours per year with a corresponding cost of approximately $23.8 million.
The total annual effort for all issuers and TPAs to provide the initial and additional information related to QPA is 1,478,316 hours with a corresponding cost of $55,436,853. Since DOL, the Treasury Department and HHS share responsibility, HHS will bear 50 percent of the charge, or approximately 739,158 hours of charge, at a corresponding cost of approximately $27,718,427. The ministries are asking for comments on these load estimates.
The No Surprises Act requires rulemaking to establish a process by which group health insurance plans and health insurance issuers offering group or individual health insurance coverage are reviewed by the relevant Minister or State Agency to ensure that those plans and coverages meet requirements the application of a QPA and that the QPA applied meets the definition of the No Surprises Act in relation to the relevant year.
These Interim Final Rules include an audit provision that states that departments' existing enforcement procedures apply to ensure that a plan or coverage meets the requirements to determine and apply a QPA consistent with these Interim Final Rules.
HHS has primary enforcement authority over issuers (in a state when the Secretary of HHS determines that a state does not substantially enforce a provision (or provisions) of Part A or D of Title XXVII of the PHS Act) and not on Federal level state plans as sponsored by state and local employers and expected to conduct no more than 9 audits annually. Therefore, under 44 U.S.C. exempt from the PRA. 3502(3)(A)(i).
These interim final rules allow self-insured group health insurance plans, including self-insured non-state plans, to voluntarily consent to state law that provides a method for determining the co-payment amount or total amount payable under such plan. where a state has elected to expand access to such plans to meet its obligations under Section 9816(a)-(d) of the Code, Section 716(a)-(d) of ERISA and Section 2799A-1(a) to comply with -(d) the PHS Act. A self-insured plan that has elected to opt-in to a state law must prominently display in its plan materials describing coverage of off-network services a statement that the plan has opted-in to a particular state law and that Relevant identifies state (or states), and provides a general description of the items and services offered by nonparticipating facilities and providers that fall under the indicated state law.
Based on available data, HHS estimates that there are approximately 84 self-insured non-state plans in New Jersey, Nevada, Virginia and Washington
The No Surprises Act directs departments to establish a process for receiving complaints about violations of the application of QPA requirements by group health insurance plans and health insurance issuers that offer group or individual health insurance under Section 9816(a)(2)(B). iv) of the Code, Section 716(a)(2)(B)(iv) of ERISA and Section 2799A-1(a)(2)(B)(iv) of the PHS Act and violations by healthcare providers, facilities and provider of air
HHS estimates that an average of 3,600 accounting complaints are filed annually by vendors, facilities, air ambulance service providers, plans and issuers. HHS estimates each complainant will take 30 minutes (at an hourly rate of $54.14).
These interim final rules further require that when a group health insurance plan or health insurance issuer requires designation by a subscriber, beneficiary, or registrant of a primary care provider, the plan or issuer must provide a notice informing each subscriber (in the single market, primary subscriber) of the terms of the plan or coverage and your right to designate a first responder. For group health plans and group health coverage, the notice must be included whenever the plan or issuer provides a participant with a summary plan description or other similar description of benefits under the plan or coverage. For individual health insurance coverage, the notice must be included whenever the issuer issues a policy, certificate or health insurance contract to a primary subscriber. These interim final rules also include a sample language to meet notification requirements. The No Surprises Act expands the applicability of patient protections for healthcare professional choices to grandfathered health plans. Patient protection under Section 2719A of the PHS Act applies only to non-grandfathered group health insurance plans and issuers of health insurance that offer non-grandfathered group or individual health insurance coverage. In contrast, patient protection under the No Surprises Act applies generally to all group health plans and both group and individual health plans, including existing health plans. Therefore, the patient protection requirements for the selection of healthcare professionals under this interim final rule will now apply to existing health insurance plans for plan years beginning on or after January 1, 2022.
In order to comply with patient protection disclosure requirements, state and local government plans and issuers in each market are required to inform policyholders of their plans' policies regarding the designation of a general practitioner and for obstetric or gynecological visits, and there is a one-time expense and cost of the inclusion of the notice in the plan documents. Non-federal government plans and individual market plans that are not currently grandfathered have already incurred the one-time cost of preparing and incorporating this notice into their existing plan documents.
There are an estimated 90,126 non-governmental employers that offer employee health plans and 388 health insurance issuers in the individual market. HHS estimates that there are approximately 14,417 employer-sponsored grandfathering plans and approximately 837,543 individual market grandfathering policies, with approximately 6,055 non-federal government grandfathering plans offering HMO and point-of-service (POS) options.
It is estimated that 5,450 grandfathered non-state plans and individual market policies will be subject to this notification requirement in 2022. While not all HMO, EPO, and POS options require a primary care physician designation or prior approval or referral prior to an OB/GYN visit, HHS cannot estimate this number. Therefore, this estimate should be viewed as an overestimate of the number of companies affected.
These Interim Final Rules will continue to serve as the model language for the Notice. It is estimated that each plan or issuer would require a Compensation and Benefits Manager (at an hourly rate of $131.88) to spend 10 minutes customizing the sample notice to the plan's specifications. Each plan or issuer also requires clerical staff (at an hourly rate of $38.86) to spend 5 minutes adding the notice to the plan's documents. The estimated total load for each plan or issuer is 0.25 hours with a corresponding cost of approximately $25. In 2022, the estimated total annual load across all 5,450 plans and issuers will be approximately 1,362 hours with a corresponding cost of approximately $137,430. In 2023 there will be no additional charges and costs for preparing the notice as all plans and issuers will bear the charges and costs until 2022.
HHS estimates that approximately 1.8 million non-state policyholders are on grandfathering plans, with one estimate
HHS will be revising the charge currently authorized under OMB control number 0938-1094 (Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act, CMS-10330, Expiring July 31, 2022) to reflect this charge carry.
The No Surprises Act and these Interim Final Rules require that a plan or issuer covering emergency services do so without requiring the individual or healthcare provider to obtain prior approval and regardless of whether the healthcare provider providing the emergency services a Participating Provider or a Participating Emergency Department with respect to the Services (regardless of the department of the hospital where such items and services are provided). Emergency Services include any additional items and services covered by a plan or coverage after a Subscriber, Beneficiary or Participant has been stabilized (referred to as Post-Stabilization Services) unless certain notification and consent requirements are met. The No Surprises Act and these Interim Final Rules also apply to protection against surprise billing in the case of non-emergency services provided by non-participating providers during a visit to a participant, beneficiary or enroller at participating healthcare facilities, unless it notification and consent as set forth in these interim final rules are met. The requirements related to notice and consent, applicable exceptions, and timing are set forth in Section 2799B-2 of the PHS Act and implemented in 45 CFR 149.410 and 45 CFR 149.420 of these Interim Final Rules.
To meet the notification and consent requirements of these Interim Final Rules, nonparticipating providers and nonparticipating emergency response facilities must provide notice to the participant, beneficiary, or registrant, meet certain timing requirements, and obtain the participant, beneficiary, or registrant's consent as required by 45 CFR 149.420 and these interim final rules. The notice provided must: (1) state that the healthcare provider or facility is a nonparticipating provider or facility; (2) a good faith estimate of what the person may be charged for, including any items or services reasonably expected to be provided in connection with such items and services; (3) provide information as to whether prior authorization or other care management restrictions may be required; and (4) clearly state that consenting to the receipt of such items or services is optional and that the participant, beneficiary or registrant may instead seek treatment from an available participating provider, in which case the individual's responsibility for sharing costs in - Network level. In cases where postal stabilization services are provided by a non-participating provider at a participating emergency facility, the notice must also include a list of the participating providers at the participating emergency facility that are capable of providing the items or services concerned and the person above them information can be referred to such a participating provider at their choice. In addition, a Nonparticipating Provider or Emergency Response Facility must provide the Participant, Beneficiary, or Enrollee, or such person's authorized representative, with the notice and consent documents in one of the 15 most widely spoken languages of the State or geographic region that reasonably reflects such Provide the geographic region served by the facility in question. If the individual's preferred language is not among the 15 most commonly provided languages or the individual cannot understand the language in which the notice and consent document are provided, a qualified interpreter must be provided for the individual.
In addition to providing the required notification and consent, nonparticipating emergency care facilities, participating healthcare facilities, and nonparticipating providers are required to retain written notification and consent documentation for at least 7 years from the date the subject item or service was furnished. When the notification and consent requirements described in this interim final rule are met, the
In order to comply with the notice and consent requirements of the Act and these Interim Final Provisions, nonparticipating providers and nonparticipating emergency response facilities must provide notice to the participant, beneficiary or enroller. HHS provides mandatory notice and consent forms in guidelines that require customization by the provider or facility.
HHS anticipates that emergency and healthcare facilities will issue the notification and obtain consent on behalf of nonparticipating providers, retain records, and notify plans and issuers. HHS estimates that a total of 17,467 healthcare facilities and emergency departments (including 475 hospital-affiliated satellite and 270 independent freestanding emergency departments) will be subject to these requirements. HHS anticipates that for hospital-affiliated standalone emergency rooms, notification and consent will be developed by the parent hospital. Therefore, 16,992 emergency and healthcare facilities are commissioned to create the notification and consent documents. HHS estimates that for each facility it takes an attorney 1 hour (at an hourly rate of $143.18) to read and understand the notice and consent forms and make any required and applicable changes, an administrative assistant half an hour (at a hourly rate of $143.18). $38.86) to make changes to the provided notice and consent documents and prepare the final documentation, a computer programmer 1 hour (at an hourly rate of $91.96) to digitize and publish to a shared network server or fillable versions thereof to transfer notification and consent documents to networked computers and a computer and information systems manager half an hour (at an hourly rate of $155.52) to verify the accessibility of the notification and consent documents and ensure their functionality. HHS also estimates that each facility incurs an additional cost of approximately $1,000 (at $500 per document) to hire an outside firm to translate the notice and consent documents into the 15 most common languages in the state or geographic region translate that reasonably reflects the geographic region served by the facility in question. HHS estimates the one-time first-year burden that will be incurred in 2021 to make changes, prepare the final releases, translate the notice and consent documentation, and make it available to providers within the facility is approximately 3 hours for each facility, with corresponding cost of about $1,332. For all 16,992 emergency and healthcare facilities, HHS estimates a total one-time first-year exposure of 50,976 hours at a corresponding cost of approximately $22.6 million.
To meet the notification and consent requirements of 45 CFR 149.420 regarding postal stabilization services, when emergency services are provided by nonparticipating providers or nonparticipating emergency facilities, the provider or facility must provide the participant, beneficiary, or enroller with notice and consent to the Obtain treatment from the nonparticipating emergency department or provider. HHS estimates that there are approximately 5,533 emergency rooms (including hospital-owned satellite and independent freestanding emergency rooms).
HHS estimates that it takes each person receiving notification and consent from an emergency facility an average of 45 minutes (at an hourly rate of $54.14) to read and understand and sign the required notification and consent documents, resulting in what is required Total cost of about 41 USD leads. For all 663,436 individuals who could potentially receive the notification and consent documents, HHS estimates a total annual exposure of 497,577 hours at a total associated annual cost of approximately $26.9 million.
To meet the notification and consent requirements of 45 CFR 149.420 related to non-emergency services
HHS estimates that there are approximately 16,722 healthcare facilities that are subject to the reporting requirements outlined in these interim final regulations and will have ongoing annual costs and charges beginning in 2022. Based on 2016 data, HHS estimates there will be 11,107,056 health visits to nursing facilities annually for surgical and non-surgical procedures for individuals with group health insurance or individual market coverage
HHS estimates that it takes each person receiving the notification an average of 45 minutes (at an hourly rate of $54.14) to read and understand the required notification, at a total cost of $41. For every 1,777,129 people who could receive the notification document, HHS estimates a total annual exposure of 1,332,847 hours at a total associated annual cost of $72.2 million. HHS anticipates that nonparticipating providers (or the participating entities on behalf of the providers) will notify the plan or issuer and provide a copy of the signed notice and consent documents along with the participating entity's claim electronically at minimal cost.
For all emergency and healthcare facilities, the total ongoing burden is 3,104,001 hours per year and the total cost, including printing and material costs, will be approximately $117,228,780 annually beginning in 2022. For all consumers to read and understand the total annual load The notice period is 1,830,424 hours with a corresponding price of $99,099,147 as of 2022.
Section 2799B-3 of the PHS Act, as amended by the No Surprises Act and codified at 45 CFR 149.430, requires providers and facilities to provide disclosures to protect patients from chargebacks. In particular, healthcare providers and facilities (including a hospital emergency room or an independent, free-standing emergency room) are required to make an one-page publicly available, post it on a public provider or facility website, and make it available to participants, beneficiaries, and enrolled-page Contingency Billing Protection Notice, which must include information about any applicable government requirements and how to contact the appropriate state and federal authorities if the individual believes the provider or facility has violated accounting rules. The required notice must include clear and understandable language that explains the requirements and prohibitions related to the remainder billing prohibitions in cases of emergency services and in cases of non-emergency services performed by a non-participating provider at specific participating facilities and Explain any other applicable condition and provide contact information for appropriate state and federal authorities that an individual may contact if they believe that the Provider or Facility has violated any requirement described in the Notice.
Healthcare providers and organizations are required to publish the disclosure publicly and make it publicly available through a public, free-access website that is easily accessible without barriers, including through search engines, and that ensures that the information is accessible to the general public are. HHS anticipates that Providers and Facilities will enter into arrangements for Facilities to provide the disclosure on behalf of Providers and that the required language and information will be developed, published within the Facility, and published by the Facility on a public website. This will reduce the effort and costs for the individual provider. Many facilities and providers can secure an agreement at minimal cost if they renew their contracts before 2022. For any facility whose contracts with providers are not scheduled to be renewed before 2022, the obligation to enter into agreements related to this disclosure will vary based on the number of providers practicing at the facility. HHS estimates that it takes an average attorney for each entity 2 hours (at $143.18 hourly) to draft an agreement and an administrative assistant 2 hours (at $38.86 hourly) to e-mail all vendors sign to deliver copies. The total burden for all 17,467 facilities is 69,868 hours with a corresponding cost of approximately $6,359,385 that will be incurred as a one-time cost in 2021. HHS cannot estimate how many vendors will be charged with signing the agreement, but anticipates that the burden of signing each agreement will be minimal. In the years to come, this agreement can be included in the contract between facilities and providers at no additional cost.
HHS estimates that a total of 17,467 healthcare facilities (including 475 satellite hospital-affiliated and 270 independent emergency departments) will incur burdens and costs to comply with this provision. HHS anticipates that disclosure for hospital-affiliated freestanding emergency rooms will be developed by the parent hospital. HHS estimates that it takes an average attorney for each facility 2 hours (at $143.18 per hour) to read and understand the provided notice and write additional, clear and understandable language if necessary, an administrative assistant 30 minutes (at $143.18 per hour). at an hourly rate of $38.86) to prepare the final document for distribution and make the information publicly available within the facility, and a computer programmer 1 hour (at an hourly rate of $91.96) to write the information on a separate or existing website to be published searchable and make the content available in an easily downloadable format. The burden is higher for entities in states with state statutes or model all-payer arrangements, but lower for entities in states without state statutes. HHS anticipates that each facility will post a one-page document in at least two conspicuous locations, e.g. where individuals plan care, book appointments, or pay bills, and estimates that each facility incurs a printing cost of $0.10 (at $0.05 per page for printing and supplies) to meet the required Post disclosure information prominently in every healthcare facility. HHS estimates that hospitals post an average of 6 notifications and incur an additional cost of $0.20 each. Additionally, HHS estimates that each of the 475 hospital-affiliated freestanding ERs will post an average of two notices, each costing $0.10. HHS estimates the one-time burden that will be incurred in 2021 to develop, prepare and publish the required disclosure information for each facility at approximately 3.5 hours, at a corresponding cost of approximately $398. For all facilities, HHS estimates a total one-time burden of 59,472 hours at an associated cost of approximately $6.8 million, including materials and printing costs. HHS recognizes that there are some small vendors and facilities that do not maintain or provide a publicly accessible website. Such companies are not required to make any disclosure on any public website. Therefore, HHS considers the estimate to be a high-end estimate.
HHS encourages states to develop language to assist providers and facilities in complying with this disclosure requirement. There are currently 33 states that have enacted laws to offer consumers some protection from surprise bills. Some or all of these states may choose to develop a model language. HHS estimates that it will take a lawyer 2 hours (at $143.18 hourly rate) and an administrative assistant 1 hour (at $38.86 hourly rate) to develop and modify the model language. The total one-time charge that will be incurred in 2021 for each state is 3 hours with a corresponding cost of approximately $325. For all 33 states, HHS estimates the total one-time exposure to be 99 hours at a cost of approximately $10,732.
In addition to requiring providers and entities to publicly post the required disclosures and make them publicly available through a public website, providers and entities must provide individuals with the required disclosure information in a unilateral notice. Required notification must be given in person, by post, or by email, at the choice of the participant, beneficiary, or enrollment, no later than the date that the healthcare provider or facility requires payment from the individual (including payment requests). for co-payments made at the time of a visit to the healthcare provider or facility), or in relation to persons from whom the healthcare facility or healthcare provider does not require payment, no later than the date on which the healthcare provider or healthcare facility requires payment The Institution submits a claim to the group health insurance fund or health insurance issuer. HHS anticipates that to reduce effort and cost, facilities will elect to provide the individual (or their elected agent) with the required disclosures at the time the individual is processed for a visit, at check-in, or other standard disclosures are shared with individuals with minimal additional burden. HHS estimates there will be approximately 39,690,940 emergencies
HHS is seeking comment on these exposure estimates. In particular, HHS is seeking comment on the costs and burdens of posting the required information on a public website. HHS is also seeking comment on the number of facilities that will be impacted by these requirements and the number of people that would be required to receive the required notification.
Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c) of the PHS Act require plans and issuers to make plans and issuers publicly available, post on a public website the plan or issuer and Include in any declaration of performance for an item or service to which the requirements of Section 9816 of the Code, Section 716 of ERISA and Section 2799A-1 of the PHS Act apply, information in plain language about the provisions in those sections, and Sections 2799B-1 and 2799B-2 of the PHS Act and other applicable state laws relating to the settlement of off-grid balances and information on how to contact the appropriate state and federal authorities if any person believes that such provider or facility has violated the prohibition of the balance sheet statement.
Departments anticipate that plans and issuers will use the model notice developed by HHS and that TPAs will develop the notice for self-insured plans. The departments estimate that for each plan or issuer it takes an average of 2 hours (at an hourly rate of $143.18 per hour) for an attorney to read and understand the notice provided and, if necessary, compose additional, clear and understandable wording, an Administrative Record Assistant 30 minutes (at an hourly rate of $38.86 per hour) to prepare the final document for distribution and make the information publicly available within the facility, and a computer programmer 1 hour (at an hourly rate of $91.96 per hour) to complete the Publish information on a separate or existing website to make it searchable and make the content easily available
Departments anticipate plans and issuers will also include disclosure along with explanation of benefits at no additional cost. Using the same assumptions used to estimate the number of disclosures provided by nonparticipating facilities and nonparticipating providers, departments estimate that issuers and TPAs will include disclosures to approximately 39,690,940 people receiving services in emergency facilities , and 11,107,056 people receiving services outside of emergency healthcare facilities, for a total of 50,797,996 disclosures. Departments estimate that 66 percent of these notices will be mailed, and the cost of printing will be $0.05 per page.
HHS has submitted a copy of this final rule to OMB for review of the rule's information collection requirements. The requirements will not come into effect until approved by OMB.
To obtain copies of the supporting statement and all associated forms for the collections covered by this Rule (CMS-9909-IFC), please visit the CMS website at
As part of an ongoing effort to reduce administrative burden and respondent burden, Departments are conducting a pre-consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and ongoing collections of information in accordance with the PRA to express. This helps ensure that the public understands the ministries' survey instructions, respondents can provide the requested data in the desired format, the reporting burden (time and financial resources) is minimized, the survey tools are clearly understood, and the ministries can properly assess the impact the survey requirements for the respondents.
Under the PRA, an agency may not conduct or sponsor an information collection and an individual is not required to respond to it unless they have a valid OMB control number.
The information collections are summarized as follows:
These Interim Final Rules require that when a group health plan or health insurance issuer requires the designation of a provider by a participant, beneficiary, or insured, the plan or issuer must provide a notice informing each participant (in the individual market, primary care provider subscribers) of the terms of the plan or coverage and your right to designate a first responder. For group health plans and group health coverage, the notice must be included whenever the plan or issuer provides a participant with a summary plan description or other similar description of benefits under the plan or coverage. For individual health insurance coverage, the notice must be included whenever the issuer issues a policy, certificate or health insurance contract to a primary subscriber. These interim final rules include a sample language to meet notification requirements. The No Surprises Act extends the applicability of patient protection to healthcare professional choices. Patient protection under Section 2719A of the PHS Act applies only to non-grandfathered group health insurance plans and issuers of health insurance that offer non-grandfathered group or individual health insurance coverage. In contrast, patient protection under the No Surprises Act applies generally to all group health plans and both group and individual health plans, including existing health plans. Therefore, the patient protection requirements for the selection of healthcare professionals under this interim final rule will now apply to existing health insurance plans for plan years beginning on or after January 1, 2022.
DOL estimates that there are 2.5 million ERISA covered plans. Data from the Kaiser/HRET 2020 employer-sponsored health care survey shows that 16 percent of companies that provide health care offer at least one grandfathered health plan. DOL estimates that five percent of plans will relinquish their grandfathered status in 2021. Data from the Kaiser/HRET 2020 Employer-Sponsored Healthcare Survey also shows that 11 percent of plans have an HMO option and that 31 percent of plans offer a POS option. Therefore, DOL estimates that 161,148 grandfathering plans will be subject to this notification requirement in 2022.
While not all HMO and POS options require a GP designation or prior approval or referral prior to an OB/GYN visit, DOL cannot estimate this number. Therefore, these estimates should be considered as an overestimate of the number of companies affected.
For each of the plans, a Compensation and Benefits Manager must spend 10 minutes customizing the sample notification to meet the plan's specifications at an hourly rate of $134.21.
Each plan also requires office workers to spend 5 minutes adding the notification to the plan's documents at an hourly rate of $55.14. In 2022, this translates to a load of 13,429 hours at a converted cost of $740,473.
Thus, the total hourly load associated with this ICR is 40,287 hours at a corresponding cost of $4,345,075. DOL shares this burden equally with the Treasury. Therefore, the total hourly load for DOL and Treasury is approximately 20,143 hours each at a corresponding cost of $2,172,537.
The departments assume that the disclosure obligation will only involve printing and material costs, since the final regulations specify a model language that can be incorporated into existing planning documents, such as an SPD. The departments estimate that the notice will take half a page, will cost five cents per page for printing and supplies, and 58.2 percent of the notices will be delivered electronically.
DOL estimates that there are 62.6 million ERISA insured policyholders. Data from the Kaiser/HRET 2020 employer-sponsored health care survey shows that 14 percent of insured workers are enrolled in a grandfathered plan. DOL estimates that 5 percent of plans would de-grandfathered each year in 2021. Data from the Kaiser/HRET 2020 employer-sponsored health care survey also shows that 13 percent of insured workers have an HMO option and 8 percent of insured workers have an HMO option. DOL estimates plans will produce
These interim final rules require plans and issuers to provide certain information to nonparticipating vendors or nonparticipating emergency facilities in cases where the recognized amount related to an item or service provided by a nonparticipating vendor or emergency facility will, who is QPA. In particular, plans and issuers must provide providers (including air ambulance providers) and facilities with the following information when making an initial payment or notifying a payment refusal: (i) The QPA for each affected item or service; and (ii) a statement certifying that the plan or issuer has determined that the QPA applies for purposes of the approved amount (or, in the case of air ambulance services, for the calculation of the participant's, beneficiary's or participant's co-payment), and that each QPA determined in accordance with 26 CFR 54.9816-6T(d), 29 CFR 2590.716-6, or 45 CFR 149.140, as appropriate. In addition, upon request from the provider or facility, the plan or issuer must provide the following information in a timely manner: (i) Whether the QPA for the affected items and services included contracted rates that were not on a service fee basis for those specific items and services and whether the QPA for those items and services was determined using the underlying rates of charge or a derived amount; (ii) information, if any, to determine which database was used to determine the QPA; and (iii) if applicable, a statement that the plan's or issuer's contractual rates include risk-sharing, bonus or incentive-based payments for covered items and services (if applicable) that have been excluded for purposes of calculating the QPA.
As previously discussed in HHS's PRA section, the total annual charge for all issuers and TPAs to provide the initial and additional information related to QPA is 1,478,316 hours at a corresponding cost of $55,436,853. Because HHS, DOL, and the Treasury share responsibility, it is estimated that 50 percent of the charge will be borne by HHS, 25 percent by Treasury, and the remaining 25 percent by DOL. Thus, HHS will account for approximately 739,158 hours of stress at a corresponding cost of approximately $27,718,427. DOL and the Treasury will each account for 369,579 hours of stress at a corresponding cost of approximately $13,859,214.
The No Surprises Act directs departments to establish a process for receiving complaints about breaches of the application of the QPA by group health insurance plans and health insurance issuers offering group or individual health insurance, and breaches by health care providers, facilities and air ambulance providers of the requirements of Sections 2799B- 2 and 2799B-3 of the PHS Act. The Departments define a Complainant as any person or their authorized representative making a Complaint as described and defined in these Interim Final Rules. These regulatory actions are being taken in accordance with the requirements of the No Surprises Act, which directs departments to establish a procedure for balance settlement complaints relating to plans and issuers, and directs HHS to establish a procedure for balance settlement complaints relating to providers and create facilities.
As previously discussed in the HHS PRA section, the total effort for all complainants is estimated at 1,800 hours, with a corresponding annual cost of approximately $97,452. Because HHS, DOL, and the Treasury share responsibility, it is estimated that 50 percent of the charge will be borne by HHS, 25 percent by Treasury, and the remaining 25 percent by DOL. HHS will account for approximately 900 hours of exposure at a corresponding cost of approximately $48,726. DOL and the Treasury Department will each account for approximately 450 stress hours at a corresponding cost of approximately $24,363.
The interim final rules allow plans to voluntarily elect state law that provides a method for determining the co-payment amount or total amount payable under such a plan when a state has elected to expand access to such plans to comply with its obligations under Section 9816(a)-(d) of the Code, Section 716(a)-(d) of ERISA and Section 2799A-1(a)-(d) of the PHS Act. A plan that has elected to opt for state law must prominently display a statement that the plan has opted for a particular state law in its plan materials describing coverage of off-grid services, the state (or the States) identify and include a general description of the items and services provided by Nonparticipating Facilities and Providers that are governed by the designated State law.
There are currently four states where self-insured plans can participate: Nevada, New Jersey, Washington, and Virginia. According to the Nevada Department of Health and Human Services' 2020 annual report, 20 private entities or organizations have elected to participate in the state's accounting billing law. Additionally, according to the Virginia State Corporation Commission, 231 private self-insured plans in Virginia have elected to participate in the state's accounting billing law.
DOL estimates that an administrative assistant with a salary of $55.14 will need 1 hour to gather information and verify information.
The average number of participants in a self-insured ERISA-covered plan electing under the four state balance sheet accounting laws is 9,724.
Thus, the average 3-year hourly load is 309 hours with a corresponding cost of $25,143. The average cost burden over three years is $107.
Section 9820(c) of the Code, Section 720(c) of ERISA and Section 2799A-5(c) of the PHS Act require plans and issuers to make plans and issuers publicly available, post on a public website the plan or issuer and Include in any declaration of performance for an item or service to which the requirements of Section 9816 of the Code, Section 716 of ERISA and Section 2799A-1 of the PHS Act apply, information in plain language about the provisions in those sections, and Sections 2799B-1 and 2799B-2 of the PHS Act and other applicable state laws relating to the settlement of off-grid balances and information on how to contact the appropriate state and federal authorities if any person believes that such provider or facility has violated the prohibition of the balance sheet statement.
As previously discussed in HHS' PRA section, the total burden across all issuers and TPAs is 6,153 hours, with a corresponding cost of $699,245 in 2021. With HHS, DOL and Treasury sharing responsibility, it is estimated that 50 percent of the burden will be incurred is charged by HHS, 25 percent of the charge by the Treasury Department, and the remaining 25 percent by the DOL. HHS will account for approximately 3,077 hours at a corresponding cost of approximately $349,622. DOL and the Treasury each account for approximately 1,539 hours at a corresponding cost of approximately $174,811.
As of 2022, the total burden across all issuers and TPAs is estimated at 558,778 hours with a corresponding cost of $21,714,111. The total cost of printing and materials to mail 33,526,677 notices is $1,676,334 annually. Because HHS, DOL, and the Treasury share responsibility, it is estimated that 50 percent of the charge will be borne by HHS, 25 percent by Treasury, and the remaining 25 percent by DOL. Thus, HHS accounts for 279,389 hours at a corresponding cost of $10,857,056 and printing and materials costs of $838,167 beginning in 2022. DOL and Treasury each account for 139,695 hours at a corresponding cost of $419,084.
Thus, the three-year average hourly burden associated with this requirement for DOL and the Treasury is 93,643 hours each, at a corresponding cost of $7,354,578. The three-year average cost burden for DOL and Treasury is $279,389 each.
The Burden Summary below includes the following ICRs: (1) Information to be Shared About the QPA (26 CFR 54.9816-6T(d), 29 CFR 2590.716-6(d)), (2) Surprise Medical Bill Complaint Procedure ( 26 CFR 54.9816- 7T, 29 CFR 2590.716-7), (3) Opt-In State Balance Bill Process (26 CFR 54.9816-3T, 29 CFR 2590.716-3), and (4) Plan and Issuer Disclosure on Patient Protections Against Balance Billing.
Der Regulatory Flexibility Act (RFA), (5 U.S.C. 601
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires agencies to assess the expected costs and benefits and take certain other actions before issuing a proposed rule or a final rule for which a public notice of proposed rulemaking has been issued, which includes a federal mandate This may result in total state, local or tribal government or private sector spending of $100 million in 1995 dollars in any year, adjusted annually for inflation. In 2021, that threshold is around $158 million. These interim final rules were not preceded by a general communication of proposed rulemaking and therefore the requirements of the UMRA do not apply.
Executive Order 13132 outlines basic principles of federalism. It requires federal agencies to meet certain criteria when formulating and implementing policies that have "significant direct impacts" on the states, the federal-state relationship, or the distribution of powers and responsibilities between the different levels of government. Federal agencies making regulations that have these implications for federalism must consult with state and local officials and describe the extent of their consultation and the nature of the state and local officials' concerns in the preamble to the interim final regulations.
These interim final rules protect participants, beneficiaries, or enrollers in group health plans and group and individual health plans, and insured persons in FEHB plans from unexpected medical bills for emergency services, air ambulance services provided by non-participating providers, and non-emergency services provided by non-participating providers Provided to Providers at Participating Facilities under certain circumstances. A number of states currently have laws regarding unexpected medical bills. The departments believe that Congress did not intend to replace state accounting legislation, but rather to supplement those legislation. The provisions of this provisional final order are in line with the general approach of the law to supplement state law. In addition, the No Surprises Act and these Interim Final Rules recognize states' traditional role as primary regulators of health insurance issuers, providers and institutions. The No Surprises Act authorizes states to enforce the new health insurance coverage requirements, including those related to balance sheet accounting, with respect to issuers, providers, facilities and providers of air ambulance services, with HHS enforcing enforcement only in cases where the state has notified HHS that the state does not have the authority to enforce them or does not otherwise enforce them, or HHS has determined that a state has not substantially enforced the requirements.
Consistent with Executive Order 13132's requirement that agencies scrutinize any policy that might affect federalism or limit states' policymaking space, departments have sought to consult with and with affected states collaborating, including attending conferences, speaking with and attending conferences of the NAIC, and consulting with state insurance officials on a state basis. In addition, as required by the No Surprises Act, the departments consulted the NAIC to determine the geographic regions to be used in the methodology used to calculate the QPA.
OPM concluded that it would be inappropriate for the FEHB plans to adopt disparate state standards and, consistent with the FEHBA, state legislation would be enacted under bilaterally negotiated FEHB treaties as appropriate.
In developing these interim final regulations, departments sought to balance states' interests in regulating health insurance issuers, providers, and facilities with the need to ensure each state at least the minimum federal level consumer protections. Thus, the departments met the requirements of Executive Order 13132.
These interim final rules are governed by the provisions of the Congressional Review Act of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
Office of Personnel Management policies are conducted in accordance with the procedures set forth in 5 U.S.C. 8902(p) and 5 U.S.C. 8913.
Treasury regulations are issued pursuant to the powers contained in Sections 7805 and 9833 of the Code.
Department of Labor regulations are enforced in accordance with the procedures set forth in 29 U.S.C. 1002, 1135, 1182, 1185d, 1191a, 1191b and 1191c; Order of the Minister of Labor 1-2011, 77 FR 1088 (9 January 2012).
Department of Health and Human Services regulations are enforced in accordance with the provisions of Sections 2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS Act (42 U.S.C. 300gg—300gg-63, 300gg-91 , 300gg- 92, 300gg-94, 300gg-300gg139), as amended; Sections 1311 and 1321 of the ACA (42 U.S.C. 13031 and 18041).
Administrative Practices and Procedures, Government Employees, Health Care Institutions, Health Insurance, Health Care Professionals, Hostages, Iraq, Kuwait, Lebanon, Military Personnel, Reporting and Record-Keeping Obligations, Retired.
Excise taxes, healthcare, health insurance, pensions, reporting and record keeping.
Continuing coverage, disclosure, employee benefit plans, group health plans, health care, health insurance, child sickness benefits, reporting and record keeping.
Healthcare, health insurance, reporting and record-keeping requirements.
Healthcare, health insurance, reporting and record-keeping requirements and government regulation of health insurance.
Balance billing, health care, health insurance, reporting and record-keeping requirements, surprise billing, government regulation of health insurance, transparency of coverage.
Administrative Practices and Procedures, Advertising, Advisory Committees, Ageism, Alaska, Realtors, Citizenship and Naturalization, Civil Rights, Conflicts of Interest, Consumer Protection, Grant Programs - Health, Grant Administration, Healthcare, Health Insurance, Health Maintenance Organization (HMO), Medical Records, Hospitals, Indians, Persons with Disabilities, Intergovernmental Relations, Credit Programs – Health, Medicaid, Organization and Functions (Government Agencies), Prescription Drugs, Public Assistance Programs, Reporting and Record-Keeping Requirements, Gender Discrimination, State and Local Governments, Sunshine Act, Technical Assistance, Women, Youth.
For the reasons given in the preamble, the Office of Personnel Management amends 5 CFR part 890 as follows:
5 U.S.C. 8913; Sec. 890.102, also issued under Sections 11202(f), 11232(e) and 11246(b) of Pub. L. 105-33, 111 Stat. 251; Sec. 890,111, also issued pursuant to Section 1622(b) of Pub. L. 104-106, 110 Stat. 521 (36 USC 5522); Sec. 890,112, also issued under Section 1 of Pub. L. 110-279, 122 Stat. 2604 (2 USC 2051); Sec. 890.113, also issued under Section 1110 of Pub. L. 116-92, 133 Stat. 1198 (5 USC 8702 note); Sec. 890,301, also issued pursuant to Section 311 of Pub. L. 111-3, 123 Stat. 64 (26 USC 9801); sec. 890.302(b), also issued under Section 1001 of Pub. L. 111-148, 124 Stat. 119, amended by Pub. L. 111-152, 124 Stat. 1029 (42 USC 300gg-14); Sec. 890,803 also issued under 50 U.S.C. 3516 (formerly 50 U.S.C. 403p) and 22 U.S.C. 4069c and 4069c-1; Subsection L also issued under Section 599C of Pub. L. 101-513, 104 Stat. 2064 (5 USC 5561 note), as amended; and subsection M, also issued under Section 721 of Pub. L. 105-261 (10 USC 1108), 112 Stat. 2061
(e) A claim for equitable relief based on 5 U.S.C. Chapter 89, which is based on 5 U.S.C. 8902(p) and subject to 5 CFR Part 890, must be brought against OPM by December 31 of the 3rd year following the year in which the disputed services were performed.
(a) A carrier must comply with the requirements described in 26 CFR 54.9816-3T through 54.9816-6T, 54.9817-1T and 54.9822-1T, 29 CFR 2590.716-3 through 2590.716-6, 2590.717-1 and 2590.722, and 45 CFR 101.4.931, 149.930 through 149.140 and 149.310 apply in the same manner as these provisions apply to a group health plan or health insurance issuer offering group or individual health insurance coverage, subject to 5 U.S.C. 8902(m)(1) and the provisions of the Contract of Carriage. For the purposes of applying these sections, it is assumed that all carriers on the market offer health benefits for large groups.
(b) For the purposes of the provisions referred to in paragraph (a) of this Section:
(c) If a complaint challenges an airline's action or inaction in relation to the surprise billing provisions, OPM will coordinate with the Departments of Health and Human Services, Labor and the Department of Treasury to resolve the complaint.
Accordingly, 26 CFR Part 54 is amended as follows:
26 USC 7805 unless otherwise noted.
(a)
(b)
(c)
Unless otherwise noted, the definitions in this section and §54.9801-2 govern the application of the provisions of Sections 9801 through 9825 and 9831 through 9834.
(1)
(2)
(3)
(4)
(i) failure of the Employer or other responsible party to transfer the Awards in a timely manner;
(ii) If the individual no longer resides, lives or works in the service area of an HMO or similar program (whether or not the individual has a choice) and no other COBRA continuation protection is available to the individual; or
(iii) If the person suffers a claim that would meet or exceed a lifetime limit on all benefits and there is no other COBRA continuation coverage for the person.
(1) A federally qualified health maintenance organization (as defined in Section 1301(a) of the PHS Act);
(2) An organization recognized as a health preservation organization under state law; or
(3) A similar organization regulated under national solvency law in the same manner and to the same extent as such health maintenance organization.
(1) The deductible or capped year used under the plan;
(2) If the plan does not impose deductibles or limits on an annual basis, then the plan year is the policy year;
(3) If the plan does not require annual deductibles or limits and either the plan is uninsured or the insurance policy is not renewed annually, then the plan year is the employer's tax year; or
(4) Otherwise, the plan year is the calendar year.
(1) has an expiration date specified in the Contract that is less than 12 months after the original effective date of the Contract and has an aggregate term, taking into account renewals or renewals, of no more than 36 months;
(2) With respect to policies for which the commencement of insurance is prior to January 1, 2019, in the contract and any application documentation provided in connection with enrollment for such insurance, in at least 14 point typeface the language in the following Notice 1, except for the heading "Notice 1" with any additional information required by applicable state law:
This coverage is not required to meet certain federal market requirements for health insurance, primarily those contained in the Affordable Care Act. Review your policy carefully to ensure you are aware of any exclusions or limitations related to coverage for pre-existing medical conditions or healthcare services (such as hospitalization, emergency services, maternity care, preventative care, prescription medication, and mental health and substance use disorders services). Your policy may also include lifetime and/or annual dollar limits on healthcare benefits. If this coverage expires or you become ineligible for this coverage, you may have to wait until an open enrollment period to obtain alternative health coverage. In addition, this coverage is not a “minimum essential coverage”. If you don't have minimum coverage for a month in 2018, you may have to make a payment when you file your tax return unless you're eligible for an exemption from the requirement to have health insurance for that month.
(3) With respect to policies with a Cover Commencement Date on or after January 1, 2019, the contract and any application documentation provided in connection with enrolling in such cover shall use the language in the following notice in at least 14 points -Font clearly displayed 2, except for the “Note 2” heading, with any additional information required by applicable state law:
This coverage is not required to meet certain federal market requirements for health insurance, primarily those contained in the Affordable Care Act. Review your policy carefully to ensure you are aware of any exclusions or limitations related to coverage for pre-existing medical conditions or healthcare services (such as hospitalization, emergency services, maternity care, preventative care, prescription medication, and mental health and substance use disorders services). Your policy may also include lifetime and/or annual dollar limits on healthcare benefits. If this coverage expires or you become ineligible for this coverage, you may have to wait until an open enrollment period to obtain alternative health coverage.
(4) If a court invalidates the 36-month maximum specified in paragraph (1) of this Definition or its applicability to any person or circumstance, the remaining provisions and their applicability to any other person or circumstance shall remain in effect.
(a)-(b) [Reserved]
(c)
(a)
(b)
(a)
(b)
(1) Optional benefits as described in §54.9831-1(c).
(2) Short Term Limited Insurance as defined in §54.9801-2.
(3) Health insurance arrangements or other account-based group health insurance plans as described in §54.9815-2711(d).
The definitions in §54.9801-2T apply to §§54.9816-4T through 54.9816-7T, 54.9817-1T and 54.9822-1T unless otherwise noted. In addition, for purposes of Sections 54.9816-4T through 54.9816-7T, 54.9817-1T and 54.9822-1T, the following definitions apply:
(1) A Hospital (as defined in Section 1861(e) of the Social Security Act);
(2) a hospital outpatient department;
(3) A critical access hospital (as defined in Section 1861(mm)(1) of the Social Security Act); and
(4) An ambulatory surgical center as described in Section 1833(i)(1)(A) of the Social Security Act.
(1) is geographically separate and separately licensed from a hospital under applicable state law; and
(2) Provision of emergency services as described in §54.9816-4T(c)(2)(i).
(1) Subject to paragraph (3) of this definition, in any jurisdiction having a particular statute in force, the amount determined under that statute;
(2) Subject to paragraph (3) of this definition, in a State which has no particular state law in force -
(i) Subject to paragraph (2)(ii) of this definition, if the nonparticipating provider or emergency facility and the plan agree on a payment amount (including if the agreed amount is the initial payment required by the plan pursuant to Section 54.9816-4T (b)(3)(iv)(A), §54.9816-5T(c)(3) or §54.9817-1T(b)(4)(i), 29 CFR 2590.716-4(b)(3)( iv)(A), 2590.716-5(c)(3) or 2590.717-1(b)(4)(i) or 45 CFR 149.110(b)(3)(iv)(A) , 149.120(c)( 3) or 149.130(b)(4)(i), as applicable, or agreed through negotiation in relation to such item or service), the agreed amount; or
(ii) If the Nonparticipating Provider or Emergency Response Facility and the Plan entered the independent dispute resolution (IDR) procedure pursuant to Section 9816(c) or 9817(b) of the Internal Revenue Code, Section 716(c) or 717(b) of ERISA or Section 2799A-1(c) or 2799A-2(b) of the PHS Act, as applicable, and do not consent prior to the date on which a certified IDR body renders a decision with respect to such item or service determines the level of any such determination under this subsection; or
(3) In a state that has an All-Payer Model Agreement under Section 1115A of the Social Security Act applicable in respect of the Plan; the non-participating provider or non-participating emergency facility; and the item or service, the amount that the state will authorize for the item or service under the All-Payer Model Agreement.
(1) Subject to paragraph (3) of this definition, in a jurisdiction having a particular state statute in force, the amount determined in accordance with that statute.
(2) Subject to paragraph (3) of this definition, in a country in which no particular state law is in force, the lesser of the following applies:
(i) The amount that is the Qualifying Payment Amount (as determined pursuant to §54.9816-6T); or
(ii) The amount charged by the Vendor or Facility.
(3) In a state that has an All-Payer Model Agreement under Section 1115A of the Social Security Act applicable in respect of the Plan; the non-participating provider or non-participating emergency facility; and the item or service, the amount that the state will authorize for the item or service under the All-Payer Model Agreement.
(a)
(b)
(1) Without the need for prior approval determination, even if the Services are provided off-network.
(2) Regardless of whether the healthcare provider providing the emergency services is a participating provider or participating emergency facility with respect to the services.
(3) If the emergency services are provided by a non-participating provider or emergency facility -
(i) Without imposing any administrative requirements or limitations on coverage more restrictive than the requirements or limitations applicable to emergency services received from Participating Providers and Participating Emergency Facilities.
(ii) without imposing cost-sharing requirements higher than the requirements that would apply if the Services were provided by a participating provider or emergency facility.
(iii) By calculating the cost sharing requirement as if the total amount billed by such participating provider or emergency facility for the Services equaled the approved amount for those Services.
(iv) There Plan—
(A) No later than 30 calendar days after Provider or Facility submits the invoice for the Services (or, in cases where the recognized amount is determined by a particular state statute or all-payer model agreement, such other timeframe as specified by state law or All-Payer Model Agreement), determines whether the Services are covered under the Plan and, if the Services are covered, sends to the Provider or Facility, as applicable, an initial payment or notice of non-payment. For purposes of this paragraph (b)(3)(iv)(A), the 30 calendar day period begins on the date the Plan receives the information necessary to determine a payment claim for the Services.
(B) Pays directly to the Nonparticipating Provider or Entity an Aggregate Plan Payment equal to the amount by which the off-network tariff for the Services exceeds the Cost Sharing Amount for the Services (as determined in accordance with paragraphs (b)(3 )(ii) and (iii) of this section), less any initial payment amount made pursuant to paragraph (b)(3)(iv)(A) of this section. All plan payment must be made in accordance with the timing requirement described in Section 9816(c)(6), or in cases where the off-grid rate is determined under a specific state statute or all-payer model agreement, such as other timeframes , as determined by state law or All-Payer Model Agreement.
(v) By offsetting any co-payment payments made by the Subscriber or Beneficiary in relation to the Emergency Services against any network deductible or maximum network co-payment (including the annual cost-sharing cap under Section 2707(b) of the Public Health Service Act) (if applicable) in the under the plan (and the in-network deductible and in-network maximum deductibles must be applied) in the same manner as if they were cost-sharing payments in respect of emergency services provided by a participating provider or emergency facility.
(4) Without limiting what constitutes a medical emergency (as defined in paragraph (c)(1) of this section) based solely on diagnostic codes.
(5) Without regard to any other term or condition of coverage, except -
(i) The exclusion or coordination of benefits (to the extent not in conflict with emergency medical benefits as defined in paragraph (c)(1) of this section).
(ii) An Affiliation or Waiting Period (each as defined in §54.9801-2).
(iii) Applicable Co-payment.
(c)
(1)
(2)
(I)
(B) To the extent of the capabilities of the staff and facilities available at the hospital or independent, free-standing emergency department, such other medical evaluations and treatments as may be required under Section 1867 of the Social Security Act (42 U.S.C. 1395dd) or as required would be required under this section if this section applied to an independent, stand-alone emergency department to stabilize the patient (regardless of the department of the hospital where such further evaluation or treatment is provided).
(ii)
(
(
(B) The items and services described in paragraph (c)(2)(ii)(A) of this section are not included as emergency services if all of the conditions in 45 CFR 149.410(b) are met.
(3)
(d)
(a)
(b)
(c)
(1) May not charge a higher cost sharing for the items and services than the cost sharing that would apply if the items or services had been provided by a Participating Vendor.
(2) Must calculate the cost sharing requirements as if the total amount charged by such participating supplier for the items and services was equal to the approved amount for the items and services.
(3) No later than 30 calendar days after Vendor submits the invoice for the Items or Services (or, in cases where the recognized amount is determined by a particular state law or All-Payer Model Agreement, such other timeframe as specified under state law or All-Payer Model Agreement) must determine whether the items and services are covered under the plan and, if the items and services are covered, send an initial payment or a payment denial notice to the provider. For purposes of this paragraph (c)(3), the 30 calendar day period begins on the date the Plan receives the information necessary to determine a payment claim for the Items or Services.
(4) Must pay directly to the Non-Participating Provider an Aggregate Plan Payment equal to the amount by which the Off-Line Rate for the affected items and services exceeds the Cost Sharing Amount for the items and services (as determined in accordance with paragraphs (c )(1) and (2) of this section), less an initial payment amount made pursuant to paragraph (c)(3) of this section. All plan payment must be made in accordance with the timing requirement described in Section 9816(c)(6) or, in cases where the off-grid rate is determined under a specific state statute or all-payer model agreement, such timing as set forth by state law or All-Payer Model Agreement.
(5) Must apply all co-payment payments made by the participant or beneficiary against all intra-network deductibles and intra-network deductible caps (including the annual cost-sharing cap under Section 2707(b) of the Public Health Service Act) (if applicable) under the plan (and the intra-network Deductibles and excess excess amounts must be applied) in the same manner as if such cost sharing payments were made with respect to items and services provided by a Participating Vendor.
(d)
(a)
(1)
(2)
(3)
(i) a government all-payer claims database; or
(ii) Third party databases that –
(A) not affiliated with any health insurance issuer or healthcare provider, facility or provider of air ambulance services (or any member of the same controlled group as or under common control with such entity). For the purposes of this paragraph (a)(3)(ii)(A), the term Controlled Group means a group of two or more persons who are classified as a single person pursuant to Sections 52(a), 52(b), 414 Employer is treated (m) or 414(o) of the Internal Revenue Code of 1986, as amended;
(B) has sufficient information reflecting the intra-network amounts paid by group health insurance plans or health insurance issuers that offer group or individual health insurance coverage to providers, facilities or providers of air ambulance services for relevant items and services provided in the relevant geographic region ; and
(C) Has the ability to distinguish amounts paid to participating providers and entities from commercial payers, such as entities, and amounts paid by public payers, including the Medicare program under Title XVIII of the Social Insurance Act, the Medicaid Program under Title XIX of the Social Insurance Act (or a demonstration project under Title XI of the Social Insurance Act) or the Children's Health Insurance Program under Title XXI of the Social Insurance Act.
(4)
(i) a hospital emergency department; or
(ii) An independent, free-standing emergency department.
(5)
(6)
(i) In the case of an item or service for which the Plan does not have sufficient information to calculate the median of the contracted prices described in paragraph (b) of this section in 2019, the first year after 2022, for the the plan applies sufficient information to calculate the median of those contracted rates in the year immediately preceding that first year after 2022; and
(ii) In the case of a newly insured item or service, the first year following the first year of coverage for that item or service in respect of the Plan for which the Plan has sufficient information to determine the median of the contracted rates in accordance with Paragraph to be calculated (b) of this section in the year immediately preceding that first year.
(7)
(i) For items and services other than air ambulance services –
(A) Subject to paragraphs (a)(7)(i)(B) and (C) of this Section, one region for each metropolitan statistical area as defined by the U.S. Office of Management and Budget and approved by the U.S. Census publishes Bureau, in a state, and a region that consists of all other parts of the state.
(B) If a Plan does not have sufficient information to calculate the median of the contract prices described in paragraph (b) of this Section for an item or service included in a category specified in paragraph (a)(7)(i) geographic region described (A) of this section, a region consisting of all metropolitan statistical regions as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau publishes, in the state, and a region, which consists of all other parts of the state.
(C) When a Plan does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this Section for an Item
(ii) For air ambulance services –
(A) Subject to paragraph (a)(7)(ii)(B) of this Section, a region consisting of all metropolitan statistical areas as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau publishes in the state and a region comprised of all other parts of the state determined based on pickup location (as defined in 42 CFR 414.605).
(B) When a Plan does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section for an air ambulance service operating in a geographic region described in paragraph (a)(7)(ii). provided (A) of this section is a region consisting of all urban statistical areas as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau publishes, in each census division and a region consisting of all other parts of the census division, as determined by the U.S. Census Bureau described based on pickup location (as defined in 42 CFR 414.605).
(8)
(i) The individual market (other than short-term, limited-duration insurance or individual health insurance, which consists entirely of optional benefits).
(ii) The Large Groups Market (except for Coverage consisting solely of Exempted Services).
(iii) The Small Groups Market (other than Coverage consisting solely of Exempted Benefits).
(iv) In the case of a self-insured group health plan, all self-insured group health plans (except for account-based plans, as defined in §54.9815-2711(d)(6)(i) and plans consisting solely of optional benefits) of the same plan sponsor or at choice Plan Sponsor's all self-insured group health insurance plans administered by the same entity (including a third-party administrator appointed by the plan), unless otherwise permitted by law, who is responsible for calculating the qualifying payment amount on behalf of the plan.
(9)
(10)
(11)
(12)
(13)
(14)
(fifteen)
(i) the plan has at least three contracted rates as of January 31, 2019 to calculate the median of the contracted rates in accordance with paragraph (b) of this section; or
(ii) For an item or service provided in a year after 2022 and used to determine the first sufficient information year –
(A) the plan has at least three contracted rates as of January 31 of the year immediately preceding that year to calculate the median of the contracted rates in accordance with paragraph (b) of this section; and
(B) The contracted installments referred to in paragraph (a)(15)(ii)(A) of this section represent (or are reasonably expected to represent) at least 25 percent of the total number of claims paid for that item or service make this up). in that year in relation to all of the Sponsor's (or Administrative Entity pursuant to paragraph (a)(8)(iv) of this Section, if applicable) plans offered in the same insurance market.
(16)
(17)
(b)
(2)
(i) Calculate the median contracted rate in relation to all plans of that sponsor (or the administrative entity referred to in paragraph (a)(8)(iv) of this section, if applicable) offered in the same insurance market;
(ii) Calculate the median contracted rate using the full contracted rate applicable to the service code, except that the plan –
(A) Calculate separate median contract rates for CPT code modifiers
(B) For anesthesia services, calculate an average contracted rate for the anesthesia conversion factor for each service code;
(C) For air ambulance services, calculate an average contracted rate for air miles service codes (A0435 and A0436); and
(D) If contract prices otherwise vary as a result of the application of a modifier code, calculate a separate median contract price for each such service code modifier combination;
(iii) Calculate in the case of payments made by a plan that are not on a service fee basis (e.g. relevant items or services. If the plan does not have an underlying fee schedule rate for the item or service, it must use the derived amount to calculate the contracted median approach; and
(iv) Exclude risk-sharing, bonuses, penalties or other incentive-based or post-payment payments or payment adjustments.
(3)
(ii) Where a Plan has emergency service contracted rates that vary by facility type for a service code, the median contracted rate for each facility of the same or similar facility type will be charged separately.
(c)
(A) The combined percentage increase for 2019, 2020 and 2021 will be published in Internal Revenue Service guidance. The Treasury Department and Internal Revenue Service calculate the percentage increase using the CPI-U published by the Department of Labor's Bureau of Labor Statistics.
(B) For the purposes of this paragraph (c)(1)(i), the CPI-U for each calendar year is the average of the CPI-U at the end of the 12-month period ending August 31 of the calendar year, on 10 Rounded decimals.
(C) The combined percentage increase for 2019, 2020 and 2021 is calculated as follows:
(ii) For any item or service (other than items or services described in paragraphs (c)(1)(iii) to (vii) of this Section) performed in 2023 or any subsequent year, the Plan calculate the Qualifying Payment Amount by increasing the Qualifying Payment Amount determined pursuant to paragraph (c)(1)(i) of this Section for such item or service rendered in the immediately preceding year by the amount determined by the Department of the Treasury and the Internal published percentage increase Revenue Service.
(A) The percentage increase for each year after 2022 will be published in Internal Revenue Service guidance. The Treasury Department and Internal Revenue Service calculate the percentage increase using the CPI-U published by the Department of Labor's Bureau of Labor Statistics.
(B) For the purposes of this paragraph (c)(1)(ii), the CPI-U for each calendar year is the average of the CPI-U at the end of the 12-month period ending August 31 calendar year, on 10 Rounded decimals.
(C) The combined percentage increase for each year is calculated as CPI-U current year/CPI-U previous year.
(iii) For anesthesia services provided in 2022, the plan must calculate the qualifying payment amount by first calculating the median of the contracted rate for the anesthesia conversion factor (as determined pursuant to paragraph (b) of this section) for the same or a similar article or service under such plans on January 31, 2019 pursuant to paragraph (c)(1)(i) of this section (referred to in this section as the indexed median contracted rate for the anesthesia conversion factor). The plan must then multiply the indexed median contract rate for the anesthesia conversion factor by the sum of the base unit, time unit and modifier units of the physical condition of the participant or beneficiary for whom anesthesia services are being provided to determine the qualifying payment amount.
(A) The base units for an anesthesia service code are the base units for that service code specified in the most recent edition (at the time of service) of the Relative Value Guide of the American Society of Anesthesiologists.
(B) The time unit is measured in 15-minute increments or a fraction thereof.
(C) The physical condition modifier on an application is a standard modifier that describes the patient's physical condition and is used to distinguish between different levels of complexity of the anesthesia services provided and is expressed as a unit with a value between zero (0) and three (3).
(D) The Anesthesia Conversion Factor is expressed in dollars per unit and is a contractually negotiated rate with the plan.
(iv) For anesthesia services provided in 2023 or any subsequent year, the plan must calculate the qualifying payment amount by first increasing the indexed median of the contracted rate for the anesthesia conversion factor calculated in accordance with paragraph (c)(1 )(iii) of this Agreement shall be determined in section for such Services provided in the immediately preceding year pursuant to paragraph (c)(1)(ii) of this section. The plan must then multiply this amount by the sum of the base unit, time unit and physical condition modifier units for the participant or beneficiary to whom anesthesia services are being provided to determine the qualifying payment amount.
(v) For air ambulance services billed using airline mile service codes (A0435 and A0436) made available in 2022, the plan must calculate the qualifying payment amount for services billed using airline mile service codes by first the contracted median rate is increased (as determined pursuant to paragraph (b) of this Section), pursuant to paragraph (c)(1)(i) of this Section (referred to in this Section as indexed median mileage). The plan must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant or beneficiary to determine the qualifying payment amount.
(A) The mileage rate is expressed in dollars per mile flown loaded, is expressed in legal miles (not nautical miles) and is a contractual rate negotiated with the Plan.
(B) The number of miles loaded is the number of miles that a patient is transported in the air ambulance.
(C) The Qualifying Payment Amount for other Service Codes related to Air Ambulance Services will be calculated in accordance with paragraphs (c)(1)(i) and (ii) of this Section.
(vi) For air ambulance services billed using airline mileage service codes (A0435 and A0436) provided in 2023 or any subsequent year, the plan must calculate the qualifying payment amount by first incrementing the indexed average airline mile rate that is determined under paragraph (c)(1)(v) of this section for those services provided in the immediately preceding year pursuant to paragraph (c)(1)(ii) of this section. The plan must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant or beneficiary to determine the qualifying payment amount.
(vii) For any other item or service for which a plan determines payment for the same or similar item or service generally by multiplying a contracted rate by another unit value, the plan must calculate the qualifying payment amount using a method approved by the similar is the method of payment required under paragraphs (c)(1)(iii) through (vi) of this Section and reasonably reflects the method of payment for the same or similar items or services.
(2)
(i) For the first year that the Group Health Plan is offered in such Region –
(A) If the Plan has sufficient information to calculate the median of the Contracted Rates described in paragraph (b) of this Section, the Plan shall calculate the Qualifying Payment Amount in accordance with paragraph (c)(1) of this Section for Items and Services covered by the plan and delivered in the first year; and
(B) If the Plan does not have sufficient information to calculate the median of the contracted prices described in paragraph (b) of this Section for an item or service provided in a Geographic Region, the Plan shall use the Qualifying Payment Amount determine for the item or service referred to in paragraph (c)(3)(i) of this Section.
(ii) For each subsequent year that the Group Health Insurance Plan is offered in the Region, the Plan shall calculate the Qualifying Payment Amount by incrementing the Qualifying Payment Amount determined pursuant to this paragraph (c)(2) for the items and services rendered immediately becomes the previous year in accordance with paragraph (c)(1)(ii), (iv) or (vi) of this Section, as applicable.
(3)
(i) For an item or service provided in 2022 (or, in the case of a newly covered item or service, during the first year of insurance for the item or service relating to the plan or coverage), must The plan will calculate the chargeable payment amount by first finding the rate corresponding to the median of the amounts allowed on the network for the same or similar item or service provided in the geographic region in the year immediately preceding the year in which the item is made or the service was rendered (or, in the case of a Newly Covered Item or Service, the year immediately preceding that first year of coverage) determined by the Plan through the use of an Authorized Database, and then increasing that rate by the percentage increase in the CPI-U is increased over the previous year. For purposes of this Section, in cases where an eligible database is used to determine the qualifying payment amount with respect to an item or service provided during a calendar year, the Plan must use the same database to determine the qualifying payment amount for that item or service provided up to the last day of the calendar year and if a different database is selected for some items or services, the basis for that selection must be one or more factors not directly related to the price of those items or services (e.g. sufficient data for those items or services).
(ii) For an item or service provided in a Subsequent Year (prior to the first year of sufficient information for such item or service with respect to this Plan), the Plan must calculate the Qualifying Payment Amount by calculating the Qualifying Payment Amount increased, which was determined according to paragraph (). c)(3)(i) of this section or paragraph (c)(3)(ii), as applicable, for that item or service for the year immediately preceding such subsequent year by the percentage increase in CPI-U over such prior year ;
(iii) For an item or service provided in respect of such plan in the first year of sufficient information for such item or service, the plan must meet the qualifying payment amount pursuant to paragraph (c)(1)(i), (iii) calculate ) or (v) of this section, as applicable, except that in applying this paragraph to such item or service, the reference to “established in 2022” shall be taken as a reference to during that first sufficient information year provided, the reference to “in the year 2019” will be treated as a reference to such year with sufficient information and the increase described in this paragraph will not apply; and
(iv) For an item or service provided in respect of this Plan in a year subsequent to the first year of sufficient information for such item or service, the Plan shall pay the qualifying payment amount pursuant to paragraph (c)(1)( ii) ), (iv) or (vi) of this section, as applicable, except that in applying this paragraph to such item or service, the reference to “provided in 2023 or any subsequent year” shall be understood as Reference to provided in the year is treated year after that first reasonable information year or any subsequent year.
(4)
(i) For an item or service provided in 2022 (or, in the case of a newly covered item or service, during the first year of coverage for the item or service relating to the plan), the plan must have a reasonably related service identify code that existed in the immediately preceding year and—
(A) If the Centers for Medicare & Medicaid Services has established a Medicare payment rate for the item or service billed under the new service code, the plan must calculate the qualifying payment amount by first calculating the ratio of the rate for the Medicare pays item or service billed under the new service code compared to the rate Medicare pays for the item or service billed under the associated service code, and then multiplying the ratio by the qualifying payment amount for an item or service billed under the associated service code the year in which the item or service is provided.
(B) If the Centers for Medicare & Medicaid Services has not established a Medicare payment rate for the item or service billed under the new benefit code, the plan must calculate the qualifying payment amount by first calculating the ratio of the rate that the plan reimbursed for the item or service billed under the new service code is compared to the rate the plan reimburses for the item or service billed under the associated service code, and then multiplies the ratio by the qualifying
(ii) For any item or service provided in any subsequent year (prior to the first year of sufficient information for such item or service in relation to such plan or coverage, or prior to the first year for which an eligible Database contains sufficient information to calculate a Tariff under paragraph (c)(3)(i) of this Section in the immediately preceding year), the Plan must calculate the Qualifying Payment Amount by using the ) of this Section or this paragraph (c)(4)(ii), as applicable, for that item or service for the year immediately preceding the following year by the percentage increase in CPI-U over the previous year;
(iii) For an item or service that has been provided in the first year of sufficient information for such item or service in relation to such plan or in the first year for which an eligible database has sufficient information to generate a rate pursuant to paragraph ( c)(3)(i) of this section in the immediately preceding year, the plan or issuer must calculate the qualifying payment amount in accordance with paragraph (c)(3) of this section.
(d)
(1) Upon an initial payment or payment refusal notice pursuant to Section 54.9816-4T, Section 54.9816-5T, or Section 54.9817-1T:
(i) The qualifying payment amount for each affected item or service;
(ii) A statement to confirm that based on the determination of the Plan -
(A) The Qualifying Payment Amount shall apply for the purposes of the Approved Amount (or, in the case of air ambulance services, for the calculation of the Participant's, Beneficiary's or Enroller's co-payment); and
(B) Any qualifying payment amount shared with Provider or Facility has been determined in accordance with this Section;
(iii) A statement that the Provider or Entity, if applicable, wishes to initiate a 30-day open negotiation period for the purpose of determining the Total Payment Amount, the Provider or Entity may contact the appropriate person or entity to initiate an open negotiation, and that if the 30-day negotiation period does not result in a decision, the provider or entity in general may initiate the independent dispute resolution process within 4 days of the end of the open negotiation period; and
(iv) Contact information, including telephone number and email address, for the appropriate person or entity to initiate open negotiations for the purpose of determining a payment amount (including cost sharing) for that item or service.
(2) In good time at the request of the provider or facility:
(i) Information as to whether the qualifying payment amount for the items and services concerned included contracted rates that were not based on a fee for the service for those specific items and services, and whether the qualifying payment amount for those items and services was calculated using the base value was determined tariff rates or derived amounts;
(ii) if a Plan uses an appropriate database pursuant to paragraph (c)(3) of this Section to determine the Qualifying Payment Amount, information identifying which database was used; and
(iii) If an Associated Service Code was used to determine the Qualifying Payment Amount for an item or service billed under a new Service Code pursuant to paragraph (c)(4)(i) or (ii) of this Section, information identifying the associated service code; and
(iv) If applicable, a statement that the contracted rates of the plan include risk-sharing, bonus, penalty or other incentive-based or retrospective payments or payment adjustments for the items and services concerned (if any) that have been excluded for calculation purposes of the qualifying payment amount.
(e)
(f)
(g)
(a)
(b)
(1) The cost-sharing requirements in relation to the Services shall be the same requirements that would apply if the Services were provided by a participating air ambulance service provider.
(2) The cost-sharing obligation shall be calculated as if the total amount billed for the services by a participating air ambulance service provider was equal to the lesser of the qualifying payment (as pursuant to §54.9816-6T) or the Amount invoiced for the Services.
(3) The cost sharing amounts must be credited against all in-network deductibles and in-network caps (including the annual cost sharing cap under Section 2707(b) of the Public Health Service Act) (as applicable) under the plan (and the in-network deductibles and in-network caps must be applied). applied) in the same manner as if the cost sharing payments were made in respect of services provided by a participating air ambulance service provider.
(4) The plan must -
(i) No later than 30 calendar days after submission of the invoice for the Services by the Air Ambulance Service Provider, to determine whether the Services are covered under the Plan and, if the Services are covered, to send an initial payment to the Provider or a reminder of the refusal to pay. For the purposes of this paragraph (b)(4)(i), the 30 calendar day period shall commence on the date on which the Plan receives the information necessary to determine a claim for payment for the Services.
(ii) make directly to the non-participating provider providing such air ambulance services an aggregate plan payment equal to the amount by which the off-network fare for the Services exceeds the cost-sharing amount for the Services (as determined pursuant to paragraph (b)( 1) and (2) of this Section), less any initial payment amounts made pursuant to paragraph (b)(4)(i) of this Section. All plan payment must be made in accordance with the timing requirement described in Section 9817(b)(6), or in cases where the off-grid rate is determined under a particular state statute or all-payer model agreement, such as other timeframes as determined by state law or All-Payer Model Agreement.
(c)
(a)
(ii)
(iii)
(A)
(B)
(2)
(ii)
(iii)
(A)
(
(B)
(
(3)
(B)
(ii)
(A) Provides coverage for obstetric or gynecological care; and
(B) Requires nomination by a participant or beneficiary of a participating primary care provider.
(iii)
(A) waive any exclusions of coverage under the terms of the Plan relating to coverage for obstetric or gynecological care; or
(B) Exclude the affected group health plan from requiring the obstetrician or gynecologist to notify primary health care
(iv)
(A)
(
(B)
(
(C)
(
(D)
(
(4)
(A) Pursuant to paragraph (a)(1)(i) of this Section, any participating primary provider available to accommodate the participant or beneficiary may be designated;
(B) Pursuant to paragraph (a)(2)(i) of this Section, with respect to a child, any participating physician specializing in pediatrics may be designated as a first responder; and
(C) Subject to paragraph (a)(3)(i) of this section, the plan shall not require approval or referral for obstetric or gynecological care by a participating healthcare professional who specializes in obstetrics or gynecology.
(ii)
(iii)
(A) For plans that require or permit the designation of primary care providers by subscribers or beneficiaries, insert:
[Group Health Insurance Plan Name] generally [requires/allows] designation of a primary provider. You have the right to nominate any GP who is part of our network and is willing to host you or your family members. [If the plan automatically designates a primary provider, insert: Until you make that designation, [group health plan name] will designate one for you.] For information on selecting a primary provider and for a list of participating primary providers, contact the [Plan Administrator] at [insert contact information].
(B) For plans that require or permit the designation of a primary carer for a child, add the following:
For children, you can designate a pediatrician as the primary care provider.
(C) For plans that cover obstetric or gynecologic care that require a participant or beneficiary to designate a primary care provider, add the following:
You do not need prior approval from [Group Health Plan Name] or anyone else (including a primary care physician) to access obstetrics or gynecology care from an obstetrics or gynecology healthcare professional in our network. However, healthcare professionals may be required to follow certain procedures, including obtaining prior approval for certain services, following a pre-approved treatment plan, or referral procedures. For a list of participating healthcare professionals specializing in obstetrics or gynecology, contact the [Plan Administrator] at [insert contact information].
(b)
For the reasons set out in the preamble, the Department of Labor amends 29 CFR Part 2590 as follows:
29 USC 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a-n, 1191, 1191a, 1191b and 1191c; Sec. 101(g), publication. L.104-191, 110 Stat. 1936; Sec. 401(b), publication. L. 105-200, 112 Stat. 645 (42 USC 651 note); Sec. 512(d), publication. L. 110-343, 122 Stat. 3881; Sec. 1001, 1201 and 1562(e), Pub. L. 111-148, 124 Stat. 119, amended by Pub. L. 111-152, 124 Stat. 1029; Division M, pub. L. 113-235, 128 Stat. 2130; Pub. L. 116-260 134 Stat. 1182; Order of the Minister of Labor 1-2011, 77 FR 1088 (9 January 2012).
(c)
(a)
(b)
(a)
(b)
(1) Optional benefits as described in § 2590.732.
(2) Short-term, time-limited insurance pursuant to §2590.701-2.
(3) Health insurance arrangements or other account-based group health insurance plans as described in §2590.715-2711(d).
The definitions in this part apply to §§ 2590.716 through 2590.722 unless otherwise noted. In addition, for purposes of Sections 2590.716 through 2590.722, the following definitions apply:
(1) A Hospital (as defined in Section 1861(e) of the Social Security Act);
(2) a hospital outpatient department;
(3) A critical access hospital (as defined in Section 1861(mm)(1) of the Social Security Act); and
(4) An ambulatory surgical center as described in Section 1833(i)(1)(A) of the Social Security Act.
(1) is geographically separate and separately licensed from a hospital under applicable state law; and
(2) Provision of emergency services as described in §2590.716-4(c)(2)(i).
(1) Subject to paragraph (3) of this definition, in any jurisdiction having a particular statute in force, the amount determined under that statute;
(2) Subject to paragraph (3) of this definition, in a State which has no particular state law in force -
(i) Subject to paragraph (2)(ii) of this definition, when the nonparticipating provider or emergency facility and the plan or issuer agree on a payment amount (including where the agreed amount is the initial payment sent by the plan). or issuer under 26 CFR 54.9816-4T(b)(3)(iv)(A), 54.9816-5T(c)(3) or 54.9817-1T(b)(4)(i); § 2590.716-4(b)(3)(iv)(A), § 2590.716-5(c)(3) or § 2590.717-1(b)(4)(i) or 45 CFR 149.110(b)(3 )(iv )(A), 149.120(c)(3) or 149.130(b)(4)(i), as applicable, or agreed through negotiation in relation to such item or service), the agreed amount ; or
(ii) If the nonparticipating provider or emergency facility and plan or issuer enters the independent dispute resolution (IDR) process pursuant to Section 9816(c) or 9817(b) of the Internal Revenue Code, Section 716(c) or 717 ( b) of ERISA or Section 2799A-1(c) or 2799A-2(b) of the PHS Act, as applicable, and do not agree prior to the date on which a certified IDR body makes a decision in relation to that subject; or service under such subsection, the amount of such determination; or
(3) In a state that has a model all-payer agreement under Section 1115A of the Social Security Act applicable with respect to the plan or issuer; the non-participating provider
(1) Subject to paragraph (3) of this definition, in a jurisdiction having a particular state statute in force, the amount determined in accordance with that statute.
(2) Subject to paragraph (3) of this definition, in a country in which no particular state law is in force, the lesser of the following applies:
(i) The amount that is the Qualifying Payment Amount (as determined pursuant to §2590.716-6); or
(ii) The amount charged by the Vendor or Facility.
(3) In a state that has a model all-payer agreement under Section 1115A of the Social Security Act applicable with respect to the plan or issuer; the non-participating provider or non-participating emergency facility; and the item or service, the amount that the state will authorize for the item or service under the All-Payer Model Agreement.
(a)
(b)
(1) Without the need for prior approval determination, even if the Services are provided off-network.
(2) Regardless of whether the healthcare provider providing the emergency services is a participating provider or participating emergency facility with respect to the services.
(3) If the emergency services are provided by a non-participating provider or emergency facility -
(i) Without imposing any administrative requirements or limitations on coverage more restrictive than the requirements or limitations applicable to emergency services received from Participating Providers and Participating Emergency Facilities.
(ii) without imposing cost-sharing requirements higher than the requirements that would apply if the Services were provided by a participating provider or emergency facility.
(iii) By calculating the Cost Sharing Requirement as if it were the total amount that would have been charged for the Services by such Participating Provider
(iv) The plan or issuer—
(A) No later than 30 calendar days after Provider or Facility submits the invoice for the Services (or, in cases where the recognized amount is determined by a particular state statute or all-payer model agreement, such other timeframe as specified under state law or All-Payer Model Agreement), determines whether the Services are covered by the plan or coverage and, if the Services are covered, sends to the Provider or Institution, as the case may be, an initial payment or a Notice of Refusal Payment. For purposes of this paragraph (b)(3)(iv)(A), the 30 calendar day period begins on the date the plan or issuer receives the information necessary to determine a claim for payment for the Services .
(B) Pays directly to the Nonparticipating Provider or Facility an Aggregate Plan or Coverage Payment equal to the amount by which the Off-Line Rate for the Services exceeds the Cost Sharing Amount for the Services (as determined pursuant to Sections ( b)(3)(ii) and (iii) of this section), less any initial payment amounts made pursuant to paragraph (b)(3)(iv)(A) of this section. The aggregate plan or coverage payment must be made in accordance with the timing requirement described in Section 716(c)(6) of ERISA, or in cases where the off-grid charge is determined under a particular state statute or all-payer model contract, a other time frame established by state law or the all-payer model contract.
(v) By offsetting any cost sharing payments made by the Subscriber or Beneficiary in respect of the Emergency Services against any network deductible or network deductible maximum (including the annual cost sharing cap under Section 2707(b) of the PHS Act) (if applicable) under the plan or coverage (and the in-network deductible and in-network maximum deductibles must be applied) in the same manner as for co-payment payments related to emergency services provided by a participating provider or emergency facility.
(4) Without limiting what constitutes a medical emergency (as defined in paragraph (c)(1) of this section) based solely on diagnostic codes.
(5) Without regard to any other term or condition of coverage, except -
(i) The exclusion or coordination of benefits (to the extent not in conflict with emergency medical benefits as defined in paragraph (c)(1) of this section).
(ii) An affiliation or waiting period (each as defined in § 2590.701-2).
(iii) Applicable Co-payment.
(c)
(1)
(2)
(I)
(B) To the extent of the capabilities of the staff and facilities available at the hospital or independent, free-standing emergency department, such other medical evaluations and treatments as may be required under Section 1867 of the Social Security Act (42 U.S.C. 1395dd) or as required would be required under this section if this section applied to an independent, stand-alone emergency department to stabilize the patient (regardless of the department of the hospital where such further evaluation or treatment is provided).
(ii)
(
(
(B) The items and services described in paragraph (c)(2)(ii)(A) of this section are not included as emergency services if all of the conditions in 45 CFR 149.410(b) are met.
(3)
(d)
(a)
(b)
(c)
(1) May not charge a higher cost sharing for the items and services than the cost sharing that would apply if the items or services had been provided by a Participating Vendor.
(2) Must calculate the cost sharing requirements as if the total amount charged by such participating supplier for the items and services was equal to the approved amount for the items and services.
(3) No later than 30 calendar days after invoicing the items or services
(4) Must pay directly to the Non-Participating Provider an Aggregate Plan Fee or Coverage Fee equal to the amount by which the off-grid rate for the affected items and services increases the cost-sharing amount for the items and services (as provided for in paragraphs (c )(1) and (2) of this section), less an initial payment amount made pursuant to paragraph (c)(3) of this section. The aggregate plan or coverage payment must be made in accordance with the timing requirement described in Section 716(c)(6) of ERISA, or in cases where the off-grid charge is determined under a particular state statute or all-payer model contract, a other time frame established by state law or the all-payer model contract.
(5) Must apply all co-payment payments made by the participant or beneficiary against all in-network deductibles and in-network deductible caps (including the annual cost-sharing cap under Section 2707(b) of the PHS Act ) (if applicable) under the plan or coverage (and the in-network deductibles and excess limits must be applied) in the same manner as if such co-payments were made in respect of items and services provided by a Participating Vendor.
(d)
(a)
(1)
(2)
(3)
(i) a government all-payer claims database; or
(ii) Third party databases that –
(A) not affiliated with any health insurance issuer or healthcare provider, facility or provider of air ambulance services (or any member of the same controlled group as or under common control with such entity). For the purposes of this paragraph (a)(3)(ii)(A), the term Controlled Group means a group of two or more persons who are classified as a single person pursuant to Sections 52(a), 52(b), 414 Employer is treated (m) or 414(o) of the Internal Revenue Code of 1986, as amended;
(B) has sufficient information reflecting the intra-network amounts paid by group health insurance plans or health insurance issuers that offer group health insurance coverage to providers, facilities or providers of air ambulance services for relevant items and services in the relevant geographic region; and
(C) Has the ability to recover amounts paid to participating providers and entities by commercial payers, such as amounts paid by public payers, including the Title XVIII Social Security Act Medicare program, the Title XIX Medicaid program of the Social Insurance Act (or a demonstration project under Title XI of the Social Insurance Act) or the Children's Health Insurance program under Title XXI of the Social Insurance Act.
(4)
(i) a hospital emergency department; or
(ii) An independent, free-standing emergency department.
(5)
(6)
(i) In the case of an item or service for which the plan or coverage does not contain sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section in 2019, the first year after 2022, for which the plan or issuer has sufficient information to calculate the median of those contracted interest rates in the year immediately prior to that first year after 2022; and
(ii) In the case of a newly insured item or service, the first year following the first year of coverage for that item or service in respect of such plan or coverage for which the plan or issuer has sufficient information to establish the Calculate the median of the contractually agreed rates described in paragraph (b) of this section in the year immediately preceding that first year.
(7)
(i) For items and services other than air ambulance services –
(A) Subject to paragraphs (a)(7)(i)(B) and (C) of this Section, one region for each metropolitan statistical area as defined by the U.S. Office of Management and Budget and approved by the U.S. Census publishes Bureau, in a state, and a region that consists of all other parts of the state.
(B) If a plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section for an item or service that is in a category specified in paragraph (a)(7)( i)(A) of this Section, a region consisting of all metropolitan statistical areas as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau published in the state, and a region made up of all other parts of the state.
(C) If a plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section for an item or service that is in a category specified in paragraph (a)(7)( i)(B) of this section, a region consisting of all urban statistical areas as defined by U.S. Office of Management and Budget and approved by the U.S. Census Bureau publishes, in each census division and a region made up of all other parts of the census division, as determined by the U.S. Census Bureau described.
(ii) For air ambulance services –
(A) Subject to paragraph (a)(7)(ii)(B) of this Section, a region consisting of all metropolitan statistical areas as described by the U.S. Office of
(B) If a plan or issuer does not have sufficient information to calculate the median contracted rates in accordance with paragraph (b) of this Section for an air ambulance operating in a geographic region specified in paragraph (a)(7)(ii) (A) of this section, a region consisting of all urban statistical areas as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau, in each census division and a region made up of all other parts of the census division, as determined by the U.S. Census Bureau described based on pickup location (as defined in 42 CFR 414.605).
(8)
(i) The individual market (other than short-term, limited-duration insurance or individual health insurance, which consists entirely of optional benefits).
(ii) The Large Groups Market (except for Coverage consisting solely of Exempted Services).
(iii) The Small Groups Market (other than Coverage consisting solely of Exempted Benefits).
(iv) In the case of a self-insured group health plan, all self-insured group health plans (other than account-based plans, as defined in §2590.715-2711(d)(6)(i) and plans consisting solely of optional benefits) of the same plan sponsor or at the plan sponsor's option all self-insured group health insurance plans administered by the same entity (including a third-party administrator appointed by the plan), unless otherwise permitted by law, who is responsible for calculating the qualifying payment amount on behalf of the plan.
(9)
(10)
(11)
(12)
(13)
(14)
(fifteen)
(i) the plan or issuer has at least three contracted interest rates as of January 31, 2019 to calculate the median of the contracted interest rates in accordance with paragraph (b) of this section; or
(ii) For an item or service provided in a year after 2022 and used to determine the first sufficient information year –
(A) the plan or issuer has at least three contracted interest rates as of January 31 of the year immediately preceding that year to calculate the median of the contracted interest rates in accordance with paragraph (b) of this section; and
(B) The contracted installments referred to in paragraph (a)(15)(ii)(A) of this section represent (or are reasonably expected to represent) at least 25 percent of the total number of claims paid for that item or service make this up). in that year in relation to all plans of the sponsor (or the administrative entity referred to in paragraph (a)(8)(iv) of this section, if applicable) or all covers offered by the issuer that are offered in the same insurance market.
(16)
(17)
(b)
(2)
(i) Calculate the contractual median approach in relation to all plans of that sponsor (or the administrative entity referred to in paragraph (a)(8)(iv) of this section, if applicable) or all coverages offered by that issuer in the same insurance market;
(ii) Calculate the contracted median rate using the full contracted rate applicable to the service code, except that the plan or issuer must:
(A) Calculate separate median contract rates for CPT code modifiers “26” (occupational component) and “TC” (technical component);
(B) For anesthesia services, calculate a mean contract price for the
(C) For air ambulance services, calculate an average contracted rate for air miles service codes (A0435 and A0436); and
(D) If contract prices otherwise vary as a result of the application of a modifier code, calculate a separate median contract price for each such service code modifier combination;
(iii) In the case of payments made by a plan or issuer other than on a service fee basis (e.g. bundled or capitation payments), calculate a contracted median rate for each item or service using the underlying tariff rates the related items or services. If the plan or issuer does not have an underlying fee schedule rate for the item or service, it must use the derived amount to calculate the contracted media rate; and
(iv) Exclude risk-sharing, bonuses, penalties or other incentive-based or post-payment payments or payment adjustments.
(3)
(ii) If a plan or issuer has contracted rates for emergency services that vary by facility type for a service code, the median contracted rate for each facility of the same or similar facility type will be calculated separately.
(c)
(A) The combined percentage increase for 2019, 2020 and 2021 will be published in Internal Revenue Service guidance. The Treasury Department and Internal Revenue Service calculate the percentage increase using the CPI-U published by the Department of Labor's Bureau of Labor Statistics.
(B) For the purposes of this paragraph (c)(1)(i), the CPI-U for each calendar year is the average of the CPI-U at the end of the 12-month period ending August 31 of the calendar year, on 10 Rounded decimals.
(C) The combined percentage increase for 2019, 2020 and 2021 is calculated as follows:
(ii) For any item or service (other than items or services described in paragraphs (c)(1)(iii) to (vii) of this Section) performed in 2023 or any subsequent year, the Plan or issuer qualifying calculate payment amount by increasing the qualifying payment amount determined pursuant to paragraph (c)(1)(i) of this Section for such item or service provided in the immediately preceding year by the percentage increase published by the Treasury Department and the tax office.
(A) The percentage increase for each year after 2022 will be published in Internal Revenue Service guidance. The Treasury Department and Internal Revenue Service calculate the percentage increase using the CPI-U published by the Department of Labor's Bureau of Labor Statistics.
(B) For the purposes of this paragraph (c)(1)(ii), the CPI-U for each calendar year is the average of the CPI-U at the end of the 12-month period ending August 31 calendar year, on 10 Rounded decimals.
(C) The combined percentage increase for each year is calculated as CPI-U current year/CPI-U previous year.
(iii) For anesthesia services provided in 2022, the plan or issuer must calculate the qualifying payment amount by first taking the median of the contracted rate for the anesthesia conversion factor (as determined pursuant to paragraph (b) of this section) for the same or increases similar items or services under such plans or coverages on January 31, 2019 in accordance with paragraph (c)(1)(i) of this section (referred to in this section as the indexed median contracted rate for anesthesia conversion). Factor). The plan or issuer must then multiply the indexed mean contracted rate for the anesthesia conversion factor by the sum of the base unit, time unit and modifier units of the physical condition of the participant or beneficiary for whom anesthesia services are being provided to determine the qualifying payment amount.
(A) The base units for an anesthesia service code are the base units for that service code specified in the most recent edition (at the time of service) of the Relative Value Guide of the American Society of Anesthesiologists.
(B) The time unit is measured in 15-minute increments or a fraction thereof.
(C) The physical condition modifier on an application is a standard modifier that describes the patient's physical condition and is used to distinguish between different levels of complexity of the anesthesia services provided and is expressed as a unit with a value between zero (0) and three (3).
(D) The anesthesia conversion factor is expressed in dollars per unit and is a contractual rate negotiated with the plan or issuer.
(iv) For anesthesia services provided in 2023 or any subsequent year, the plan or issuer must calculate the qualifying payment amount by first increasing the indexed median of the contracted rate for the anesthesia conversion factor calculated pursuant to paragraph (c) (1)(iii) is determined. of this section for such services provided in the immediately preceding year pursuant to paragraph (c)(1)(ii) of this section. The plan or issuer must then multiply that amount by the sum of the base unit, time unit, and physical condition modifier units for the participant or beneficiary to whom anesthesia services are being provided to determine the qualifying payment amount.
(v) For air ambulance services billed using airline mile service codes (A0435 and A0436) made available in 2022, the plan or issuer must calculate the qualifying payment amount for services billed using airline mile service codes, by first increasing the Contracted Median Rate (as determined pursuant to paragraph (b) of this Section), pursuant to Paragraph (c)(1)(i) of this Section (referred to in this Section as the Indexed Median Air Mile Rate). The plan or issuer must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant or beneficiary to determine the qualifying payment amount.
(A) The mileage rate is expressed in dollars per mile flown loaded, is expressed in legal miles (not nautical miles) and is a contractual rate negotiated with the plan or issuer.
(B) The number of miles loaded is the number of miles that a patient is transported in the air ambulance.
(C) The Qualifying Payment Amount for other Service Codes related to Air Ambulance Services will be calculated in accordance with paragraphs (c)(1)(i) and (ii) of this Section.
(vi) For air ambulance services billed using airline mileage service codes (A0435 and A0436) provided in 2023 or any subsequent year, the plan or issuer must calculate the qualifying payment amount by first using the determined indexed average airline mile rate increased in accordance with paragraph (c)(1)(v) of this section for such services provided in the immediately preceding year in accordance with paragraph (c)(1)(ii) of this section. The plan or issuer must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant or beneficiary to determine the qualifying payment amount.
(vii) For any other item or service for which a plan or issuer determines payment for the same or similar item or service generally by multiplying a contracted rate by another unit value, the plan or issuer must calculate the qualifying payment amount using a method charge that is similar to the method required in paragraphs (c)(1)(iii) through (vi) of this section and reasonably reflects the method of payment for the same or similar items or services.
(2)
(i) For the first year that Group Health Plan or coverage is offered in that Region –
(A) If the plan or issuer has sufficient information to calculate the median of the contracted interest rates described in paragraph (b) of this section, the plan or issuer shall calculate the qualifying payment amount in accordance with paragraph (c)(1) of this Section for items and services covered by the plan or coverage provided during the first year; and
(B) If the plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section for an item or service provided in a geographic region, the plan or issuer must use the qualifying Payment determines amount for the item or service in accordance with paragraph (c)(3)(i) of this section.
(ii) For each subsequent year that the Group Health Insurance Plan or coverage is offered in the Region, the Plan or Issuer shall calculate the Qualifying Payment Amount by incrementing the Qualifying Payment Amount determined pursuant to this paragraph (c)(2). ) for the goods and services provided in the immediately preceding year in accordance with paragraph (c)(1)(ii), (iv) or (vi) of this Section, as applicable.
(3)
(i) For an item or service provided in 2022 (or, in the case of a newly covered item or service, during the first year of insurance for the item or service relating to the plan or coverage), must the plan or issuer calculates the qualifying payment amount by first finding the rate equal to the median of the allowable intra-network amounts for the same or similar item or service provided in the geographic region in the year immediately preceding the year in which the item or the service was rendered (or, in the case of a Newly Covered Item or Service, the year immediately preceding such first year of coverage) as determined by the plan or issuer through the use of an eligible database, and then increasing that rate by the percentage increase in CPI-U over Previous year. For the purposes of this section, in cases where an authorized database is used to determine the qualifying payment amount with respect to an item or service rendered during a calendar year, the plan or issuer must use the same database to determine the qualifying payment amount of that by item or service provided on the last day of the calendar year, and if a different database is selected for some items or services, the basis for that selection must be one or more factors not directly related to the price of those items or services (such as sufficient data for those items or services).
(ii) For an item or service provided in a subsequent year (prior to the first year of sufficient information for such item or service in relation to such plan or coverage), the plan or issuer must pay the qualifying payment amount Calculate by increasing the Qualifying Payment Amount determined pursuant to paragraph (c)(3)(i) of this Section or this paragraph (c)(3)(ii), as applicable, for that item or service for the year immediately preceding this Subsequent year, by the percentage increase in CPI-U over the previous year;
(iii) For an item or service provided in respect of such plan or coverage in the first year of sufficient information for such item or service, the plan or issuer must make the qualifying payment amount pursuant to paragraph (c)( 1)(i), (iii) or (v) of this section, as applicable, except that in applying this paragraph to such item or service, the reference to “provided in 2022” shall be taken as a reference to during of that first sufficient information year provided, the reference to “in 2019” shall be treated as a reference to such year of sufficient information and the increase described in this paragraph shall not apply; and
(iv) For any item or service rendered in relation to such plan or coverage in any year after the first year of sufficient information for such item or service, the plan or issuer shall pay the qualifying payment amount pursuant to paragraph (c)(1)(ii), (iv) or (vi) of this section, as applicable, except that in applying this paragraph to such item or service, the reference to “in the year 2023 or in a subsequent year” is treated as a reference to be provided during the year after such first sufficient information year or in a subsequent year.
(4)
(i) For an item or service provided in 2022 (or, in the case of a Newly Covered Item or Service, during the first year of insurance for the item or service relating to the Plan or Coverage), must the plan or issuer identifies an appropriately related service code that existed in the immediately preceding year, and—
(A) If the Centers for Medicare & Medicaid Services has established a Medicare payment rate for the item or service billed under the new service code, the plan or issuer must calculate the qualifying payment amount by first calculating the ratio of the Medicare calculated the rate paid for the item or service billed under the new service code by the rate Medicare pays for the item or service billed under the associated service code, and then multiplying the ratio by the qualifying payment amount for an item or service billed under the associated service code for
(B) If the Centers for Medicare & Medicaid Services has not established a Medicare payment rate for the item or service billed under the new service code, the plan or issuer must calculate the qualifying payment amount by first calculating the ratio of the rate , the plan or issuer reimburses the item or service billed under the new service code versus the rate the plan or issuer reimburses for the item or service billed under the associated service code, and then multiplies the ratio by the qualifying payment amount for a Item or service billed under the associated service code.
(ii) For any item or service provided in any subsequent year (prior to the first year of sufficient information for such item or service in relation to such plan or coverage, or prior to the first year for which an eligible database contains sufficient information to calculate a rate under paragraph (c)(3)(i) of this section in the immediately preceding year), the plan or issuer must calculate the qualifying payment amount by using the rate specified in paragraph (c)(4)( i) certain qualifying payment amount increases this Section or paragraph (c)(4)(ii), as applicable, for that item or service for the year immediately preceding the following year by the percentage increase in CPI-U over the previous year;
(iii) For any item or service that, in the first year of sufficient information for such item or service in relation to such plan or coverage, or in the first year for which an eligible database has sufficient information, to a rate pursuant to paragraph (c)(3)(i) of this section in the immediately preceding year, the plan or issuer must calculate the qualifying payment amount pursuant to paragraph (c)(3) of this section.
(d)
(1) Upon any initial payment or payment refusal notice pursuant to section 2590.716-4, section 2590.716-5, or section 2590.717-1 of this part:
(i) The qualifying payment amount for each affected item or service;
(ii) A statement to confirm that based on the determination of the plan or issuer -
(A) The Qualifying Payment Amount will apply for the purposes of the Approved Amount (or, in the case of air ambulance services, for the calculation of the Participant's or Beneficiary's co-payment); and
(B) Any qualifying payment amount shared with Provider or Facility has been determined in accordance with this Section;
(iii) A statement that the Provider or Entity, if applicable, wishes to initiate a 30-day open negotiation period for the purpose of determining the Total Payment Amount, the Provider or Entity may contact the appropriate person or entity to initiate an open negotiation, and that if the 30-day negotiation period does not result in a decision, the provider or entity in general may initiate the independent dispute resolution process within 4 days of the end of the open negotiation period; and
(iv) Contact information, including telephone number and email address, for the appropriate person or entity to initiate open negotiations for the purpose of determining a payment amount (including cost sharing) for that item or service.
(2) In good time at the request of the provider or facility:
(i) Information as to whether the qualifying payment amount for the items and services concerned included contracted rates that were not based on a fee for the service for those specific items and services, and whether the qualifying payment amount for those items and services was calculated using the base value was determined tariff rates or derived amounts;
(ii) if a plan or issuer uses an approved database pursuant to paragraph (c)(3) of this section to determine the qualifying payment amount, information identifying which database was used; and
(iii) If an Associated Service Code was used to determine the Qualifying Payment Amount for an item or service billed under a new Service Code pursuant to paragraph (c)(4)(i) or (ii) of this Section, information identifying the associated service code;
(iv) If applicable, a statement that the plan's or issuer's contractual rates include risk-sharing, bonuses, penalties or other incentive-based or retrospective payments or payment adjustments for the items and services concerned (if any) that have been excluded for purposes of calculating the qualifying payment amount.
(e)
(f)
(a)
(2)
(I)
(ii)
(b)
(2) DOL will notify the complainant orally or in writing of the receipt of the complaint no later than 60 working days after receipt of the complaint. DOL will include a reply acknowledging receipt of the complaint, informing the complainant of their rights and obligations under the complaint process, and describing the next steps in the complaint resolution process. As part of the response, DOL may request additional information necessary to process the complaint. Such additional information may include:
(i) explanations of services;
(ii) processed claims;
(iii) information about the healthcare provider, facility or air ambulance service provider concerned;
(iv) information about the group health insurance plan or health insurance issuer that covers the individual;
(v) information to assist in determining whether the service was an emergency service or a non-emergency service;
(vi) The summary plan statement, policy, certificate, contract of insurance,
(vii) documents relating to the facts of the Complaint in the Complainant's possession or otherwise accessible to him; or
(viii) Any other information DOL may need to establish facts for an investigation.
(3) DOL will use reasonable efforts consistent with governmental practices to notify the Complainant of the outcome of the Complaint after the Submission has been processed through appropriate methods established by DOL. A Complaint is considered processed after DOL has reviewed the Complaint and accompanying information and made a Findings Statement. Based on the nature of the complaint and the plan or issuer involved, DOL -
(i) refer the Complainant to another appropriate federal or state arbitration process;
(ii) notify the Complainant and use reasonable efforts to refer the Complainant to the appropriate state or federal regulator if DOL receives a Complaint where another entity has jurisdiction to enforce the Plan or Issuer;
(iii) refer the plan or issuer to an investigation for enforcement action; or
(iv) provide the complainant with an explanation of the resolution of the complaint and any corrective action taken.
(a)
(b)
(1) The cost-sharing requirements in relation to the Services shall be the same requirements that would apply if the Services were provided by a participating air ambulance service provider.
(2) The cost-sharing obligation shall be calculated as if the total amount billed for the services by a participating air ambulance service provider was equal to the lesser of the qualifying payment (as pursuant to §2590.716-6) or the Amount invoiced for the Services.
(3) Cost sharing amounts must be credited against all in-network deductibles and in-network maximum deductibles (including the annual cost sharing cap under Section 2707(b) of the PHS Act) (if applicable). be applied under the plan or coverage (and the in-network deductibles and excess limits must be applied) as if the co-payment payments were made in respect of services provided by a participating air ambulance service provider.
(4) The plan or issuer must -
(i) Not later than 30 calendar days after the Air Ambulance Provider has submitted the invoice for the Services, determine whether the Services are covered under the Plan or Cover and, if the Services are covered, send the Provider an initial refusal to pay or refusal to pay. For the purposes of this paragraph (b)(4)(i), the 30 calendar day period begins on the date on which the plan or issuer receives the information necessary to determine a payment claim for the Services.
(ii) pay directly to the non-participating provider providing such air ambulance services an aggregate plan fee or coverage fee equal to the amount by which the tariff for the off-network services exceeds the co-payment amount for the services (as determined in accordance with the paragraphs (b)(1) and (2) of this section), less an initial payment amount made pursuant to paragraph (b)(4)(i) of this section. The aggregate plan or coverage payment must be made in accordance with the timing requirement described in Section 717(b)(6) of ERISA, or in cases where the off-grid charge is determined under a particular state statute or all-payer model contract, a other time frame established by state law or the all-payer model contract.
(c)
(a)
(ii)
(iii)
(A)
(B)
(2)
(ii)
(iii)
(A)
(
(B)
(
(3)
(B)
(ii)
(A) Provides coverage for obstetric or gynecological care; and
(B) Requires nomination by a participant or beneficiary of a participating primary care provider.
(iii)
(A) waive any exclusions of coverage under the terms of the Plan or the health plan with respect to coverage for obstetric or gynecological care; or
(B) Prevent the affected group health plan or health insurance issuer from requiring that the obstetrics or gynecology provider inform the primary care professional or plan or issuer of treatment decisions.
(iv)
(A)
(
(B)
(
(C)
(
(D)
(
(4)
(A) Pursuant to paragraph (a)(1)(i) of this Section, any participating primary provider available to accommodate the participant or beneficiary may be designated;
(B) Pursuant to paragraph (a)(2)(i) of this Section, with respect to a child, any participating physician specializing in pediatrics may be designated as a first responder; and
(C) Subject to paragraph (a)(3)(i) of this section, the plan shall not require approval or referral for obstetric or gynecological care by a participating healthcare professional who specializes in obstetrics or gynecology.
(ii)
(iii)
(A) For plans and issuers that require or permit the designation of primary care providers by participants or beneficiaries, insert:
[Name of group health insurance or health insurance issuer] [requires/permits] designation of a primary provider in general. You have the right to nominate any GP who is part of our network and is willing to host you or your family members. [If the plan or health plan automatically designates a primary care provider, insert: Until you make this designation, [group health plan or health insurance issuer name] will designate one for you.] Information on Selecting a Primary Care Provider , and for a list of participating primary care providers, contact the [plan administrator or issuer] at [insert contact information].
(B) For plans and issuers that require or permit the designation of a primary carer for a child, add the following:
For children, you can designate a pediatrician as the primary care provider.
(C) For plans and issuers that provide obstetric or gynecologic care coverage and require designation by a participant or beneficiary of a primary care provider, add the following:
You do not need prior approval from [name of group health plan or issuer] or any other person (including a general practitioner) to access obstetric or gynecological care from a healthcare professional in our network who specializes in obstetrics or gynecology. However, healthcare professionals may be required to follow certain procedures, including obtaining prior approval for certain services, following a pre-approved treatment plan, or referral procedures. A list of participating healthcare professionals specializing in obstetrics or gynecology is available from [plan administrator or issuer] at [insert contact information].
(b)
For the reasons stated in the preamble, the Department of Health and Human Services amends 45 CFR Parts 144, 147, 149, and 156 as follows:
42 USC 300gg to 300gg-63, 300gg-91, 300gg-92 and 300gg-111 to 300gg-139 as amended.
The addition reads as follows:
(d) Part 149 of this subchapter implements the provisions of Parts D and E of Title XXVII of the PHS Act applicable to group health insurance plans, health insurance issuers in the group and individual markets, health care providers and facilities, and air ambulance providers.
(a) For purposes of 45 CFR Parts 144 through 149, all health insurance coverage is generally divided into two markets - the group market and the individual market. The group market is further divided into the large group market and the small group market.
(b) The coverage provided under 45 CFR Parts 144 through 149 for individuals and employers (and other health insurance carriers offered in conjunction with a group health plan) is determined by whether that coverage is achieved in the small group market, the large group market Group market or individual market.
(c) Insurance coverage provided to associations but not related to employment and sold to individuals is not considered group insurance under 45 CFR Parts 144 through 149. If coverage is offered to an association member other than in connection with a group health plan , coverage is considered individual health insurance coverage for purposes of 45 CFR Parts 144 through 149. Coverage is considered coverage in the individual market, regardless of whether it is considered group coverage under state law. When health insurance coverage is offered in conjunction with a group health insurance plan as defined in 45 CFR 144.103, it qualifies as group health insurance coverage as defined in 45 CFR Parts 144-149.
(d) Provisions for CMS enforcement of Parts 146, 147, 148 and 149 are contained in Part 150 of this subchapter.
For the purposes of Parts 146 (Group Market), 147 (Group and Individual Market), 148 (Individual Market), 149 (Surprise Settlement and Transparency) and 150 (Enforcement) of this Sub-Chapter, the following definitions apply unless otherwise specified:
42 USC 300gg to 300gg-63, 300gg-91, 300gg-92 and 300gg-111 to 300gg-139 as amended and Section 3203, Pub. L. 116-136, 134 Stat. 281
(c)
42 USC 300gg-111 through 300gg-139, as amended.
(a)
(b)
(a)
(2) The requirements in Subpart E of this Part apply to healthcare providers, healthcare facilities and providers of air ambulance services.
(b)
(1) Exempted benefits as described in §§ 146.145 and 148.220 of this subchapter.
(2) Short-term insurance of limited duration as defined in section 144.103 of this subchapter.
(3) Medical reimbursement agreements or other account-based group health insurance plans, as described in § 147.126(d) of this subchapter.
The definitions in part 144 of this subchapter apply to this part unless otherwise stated. In addition, for the purposes of this part, the following definitions apply:
(1) A Hospital (as defined in Section 1861(e) of the Social Security Act);
(2) a hospital outpatient department;
(3) A critical access hospital (as defined in Section 1861(mm)(1) of the Social Security Act); and
(4) An ambulatory surgical center as described in Section 1833(i)(1)(A) of the Social Security Act.
(1) is geographically separate and separately licensed from a hospital under applicable state law; and
(2) Provision of emergency services as described in §149.110(c)(2)(i).
(1) Subject to paragraph (3) of this definition, in any jurisdiction having a particular statute in force, the amount determined under that statute;
(2) Subject to paragraph (3) of this definition, in a State which has no particular state law in force -
(i) Subject to paragraph (2)(ii) of this definition, when the nonparticipating provider or emergency facility and the plan or issuer agree on a payment amount (including where the agreed amount is the initial payment sent by the plan). or issuer under 26 CFR 54.9816-4T(b)(3)(iv)(A), 54.9816-5T(c)(3) or 54.9817-1T(b)(4)(i), 29 CFR 2590.716-4 ( b)(3)(iv)(A), 2590.716-5(c)(3) or 2590.717-1(b)(4)(i);
(ii) If the nonparticipating provider or emergency facility and plan or issuer enters the independent dispute resolution (IDR) process pursuant to Section 9816(c) or 9817(b) of the Internal Revenue Code, Section 716(c) or 717 ( b) of ERISA or Section 2799A-1(c) or 2799A-2(b) of the PHS Act, as applicable, and do not agree prior to the date on which a certified IDR body makes a decision in relation to that subject; or service under such subsection, the amount of such determination; or
(3) In a state that has a model all-payer agreement under Section 1115A of the Social Security Act applicable with respect to the plan or issuer; the non-participating provider or non-participating emergency facility; and the item or service, the amount that the state will authorize for the item or service under the All-Payer Model Agreement.
(1) Subject to paragraph (3) of this definition, in a jurisdiction having a particular state statute in force, the amount determined in accordance with that statute.
(2) Subject to paragraph (3) of this definition, in a country in which no particular state law is in force, the lesser of the following applies:
(i) The amount that is the Qualifying Payment Amount (as determined pursuant to §149.140); or
(ii) The amount charged by the Vendor or Facility.
(3) In a state that has a model all-payer agreement under Section 1115A of the Social Security Act applicable with respect to the plan or issuer; the non-participating provider or non-participating emergency facility; and the item or service, the amount that the state will authorize for the item or service under the All-Payer Model Agreement.
(a)
(b)
(1) Without the need for prior approval determination, even if the Services are provided off-network.
(2) Regardless of whether the healthcare provider providing the emergency services is a participating provider or participating emergency facility with respect to the services.
(3) If the emergency services are provided by a non-participating provider or emergency facility -
(i) Without imposing any administrative requirements or limitations on coverage more restrictive than the requirements or limitations applicable to emergency services received from Participating Providers and Participating Emergency Facilities.
(ii) without imposing cost-sharing requirements higher than the requirements that would apply if the Services were provided by a participating provider or emergency facility.
(iii) By calculating the cost sharing requirement as if the total amount billed by such participating provider or emergency facility for the Services equaled the approved amount for those Services.
(iv) The plan or issuer—
(A) No later than 30 calendar days after Provider or Facility submits the invoice for the Services (or, in cases where the recognized amount is determined by a particular state statute or all-payer model agreement, such other timeframe as specified under state law or All-Payer Model Agreement), determines whether the Services are covered by the plan or coverage and, if the Services are covered, sends to the Provider or Institution, as the case may be, an initial payment or a Notice of Refusal Payment. For purposes of this paragraph (b)(3)(iv)(A), the 30 calendar day period begins on the date the plan or issuer receives the information necessary to determine a claim for payment for the Services .
(B) Pays directly to the Nonparticipating Provider or Facility an Aggregate Plan or Coverage Payment equal to the amount by which the Off-Line Rate for the Services exceeds the Cost Sharing Amount for the Services (as determined pursuant to Sections ( b)(3)(ii) and (iii) of this section), less any initial payment amounts made pursuant to paragraph (b)(3)(iv)(A) of this section. The total plan or coverage payment must be made in accordance with the timing requirement described in Section 2799A-1(c)(6) of the PHS Act, or in cases where the off-grid charge is determined under a particular state statute or all- Payer model contract, another time frame established by state law or all-payer model contract.
(v) By offsetting any co-payment payments made by the Subscriber, Beneficiary or Enroller in relation to the Emergency Services against any network deductible or maximum network deductible (including the annual cap on co-payment under Section 2707(b) of the PHS Act ) (if applicable) under the plan or coverage (and the in-network deductible and in-network excess limits must be applied) in the same manner as if the cost-sharing payments were made in respect of emergency services provided by a participating provider or participating emergency facilities have been provided.
(4) Without limiting what constitutes a medical emergency (as defined in paragraph (c)(1) of this section) based solely on diagnostic codes.
(5) Without regard to any other term or condition of coverage, except -
(i) The exclusion or coordination of benefits (to the extent not in conflict with emergency medical benefits as defined in paragraph (c)(1) of this section).
(ii) An affiliation or waiting period (each as defined in §144.103 of this subchapter).
(iii) Applicable Co-payment.
(c)
(1)
(2)
(I)
(B) To the extent of the capabilities of the staff and facilities available at the hospital or independent, free-standing emergency department, such other medical evaluations and treatments as may be required under Section 1867 of the Social Security Act (42 U.S.C. 1395dd) or as required would be required under this section if this section applied to an independent, stand-alone emergency department to stabilize the patient (regardless of the department of the hospital where such further evaluation or treatment is provided).
(ii)
(
(
(B) The items and services described in paragraph (c)(2)(ii)(A) of this section are not included as emergency services if all of the conditions in §149.410(b) are met.
(3)
(d)
(a)
(b)
(c)
(1) May not charge a higher cost sharing for the items and services than the cost sharing that would apply if the items or services had been provided by a Participating Vendor.
(2) Must calculate the cost sharing requirements as if the total amount charged by such participating supplier for the items and services was equal to the approved amount for the items and services.
(3) No later than 30 calendar days after Vendor submits the invoice for the Items or Services (or, in cases where the recognized amount is determined by a particular state law or All-Payer Model Agreement, such other timeframe as specified under state law or All-Payer Model Agreement) must determine whether the items and services are covered under the plan or coverage and, if the items and services are covered, send the Provider an initial payment or a notice of non-payment. For the purposes of this paragraph (c)(3), the 30 calendar day period begins on the date on which the plan or issuer receives the information necessary to decide on a claim for payment for the items or services.
(4) Must pay directly to the Non-Participating Provider an Aggregate Plan Fee or Coverage Fee equal to the amount by which the off-grid rate for the affected items and services increases the cost-sharing amount for the items and services (as provided for in paragraphs (c )(1) and (2) of this section), less an initial payment amount made pursuant to paragraph (c)(3) of this section. The total plan or coverage payment must be made in accordance with the timing requirement described in Section 2799A-1(c)(6) of the PHS Act, or in cases where the off-grid charge is determined under a particular state statute or all- Payer model contract, another time frame established by state law or all-payer model contract.
(5) Must apply all co-payment payments made by the participant, beneficiary or registrant against all network deductibles and network co-payment caps (including the annual co-payment cap under Section 2707(b) of the PHS Act) (if applicable) under the plan or coverage (and the in-network deductibles and excess limits must be applied) in the same manner as if such co-payments were made with respect to a Participating Provider's items and services.
(d)
(a)
(b)
(1) The cost-sharing requirements in relation to the Services shall be the same requirements that would apply if the Services were provided by a participating air ambulance service provider.
(2) The cost-sharing obligation shall be calculated as if the total amount billed for the services by a participating air ambulance service provider was equal to the lesser of the qualifying payment (as pursuant to § 149.140) or the billing amount for Services.
(3) Cost sharing amounts must be credited against all in-network deductibles and in-network maximum deductibles (including the annual cost sharing cap under Section 2707(b) of the PHS Act) (if applicable). be applied under the plan or coverage (and the in-network deductibles and excess limits must be applied) as if the co-payment payments were made in respect of services provided by a participating air ambulance service provider.
(4) The plan or issuer must -
(i) Not later than 30 calendar days after the Air Ambulance Provider has submitted the invoice for the Services, determine whether the Services are covered under the Plan or Cover and, if the Services are covered, send the Provider an initial refusal to pay or refusal to pay. For the purposes of this paragraph (b)(4)(i), the 30 calendar day period begins on the date on which the plan or issuer receives the information necessary to determine a payment claim for the Services.
(ii) pay directly to the non-participating provider providing such air ambulance services an aggregate plan fee or coverage fee equal to the amount by which the tariff for the off-network services exceeds the co-payment amount for the services (as determined in accordance with the paragraphs (b)(1) and (2) of this section), less an initial payment amount made pursuant to paragraph (b)(4)(i) of this section. The total plan or coverage payment must be made in accordance with the timing requirement described in Section 2799A-2(b)(6) of the PHS Act, or in cases where the off-grid charge is determined under a particular state statute or all- Payer model contract, another time frame established by state law or all-payer model contract.
(c)
(a)
(1)
(2)
(3)
(i) a government all-payer claims database; or
(ii) Third party databases that –
(A) not affiliated with any health insurance issuer or healthcare provider, facility or provider of air ambulance services (or any member of the same controlled group as or under common control with such entity). For the purposes of this paragraph (a)(3)(ii)(A), the term Controlled Group means a group of two or more persons who are classified as a single person pursuant to Sections 52(a), 52(b), 414 Employer is treated (m) or 414(o) of the Internal Revenue Code of 1986, as amended;
(B) has sufficient information reflecting the intra-network amounts paid by group health insurance plans or health insurance issuers that offer group or individual health insurance coverage to providers, facilities or providers of air ambulance services for relevant items and services provided in the relevant geographic region ; and
(C) Has the ability to distinguish amounts paid to participating providers and entities from commercial payers, such as entities, and amounts paid by public payers, including the Medicare program under Title XVIII of the Social Insurance Act, the Medicaid Program under Title XIX of the Social Insurance Act (or a demonstration project under Title XI of the Social Insurance Act) or the Children's Health Insurance Program under Title XXI of the Social Insurance Act.
(4)
(i) a hospital emergency department; or
(ii) An independent, free-standing emergency department.
(5)
(6)
(i) In the case of an item or service for which the plan or coverage does not contain sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section in 2019, the first year after 2022, for which the plan or issuer has sufficient information to calculate the median of those contracted interest rates in the year immediately prior to that first year after 2022; and
(ii) In the case of a newly insured item or service, the first year following the first year of coverage for that item or service in respect of such plan or coverage for which the plan or issuer has sufficient information to establish the Calculate the median of the contractually agreed rates described in paragraph (b) of this section in the year immediately preceding that first year.
(7)
(i) For items and services other than air ambulance services –
(A) Subject to paragraphs (a)(7)(i)(B) and (C) of this Section, one region for each metropolitan statistical area as defined by the U.S. Office of Management and Budget and approved by the U.S. Census publishes Bureau, in a state, and a region that consists of all other parts of the state.
(B) If a plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section for an item or service that is in a category specified in paragraph (a)(7)( i)(A) of this Section, a region consisting of all metropolitan statistical areas as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau published in the state, and a region made up of all other parts of the state.
(C) If a plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section for an item or service that is in a category specified in paragraph (a)(7)( i)(B) of this section, a region consisting of all urban statistical areas as defined by U.S. Office of Management and Budget and approved by the U.S. Census Bureau publishes, in each census division and a region made up of all other parts of the census division, as determined by the U.S. Census Bureau described.
(ii) For air ambulance services –
(A) Subject to paragraph (a)(7)(ii)(B) of this Section, a region consisting of all metropolitan statistical areas as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau publishes in the state and a region comprised of all other parts of the state determined based on pickup location (as defined in 42 CFR 414.605).
(B) If a plan or issuer does not have sufficient information to calculate the median contracted rates in accordance with paragraph (b) of this Section for an air ambulance operating in a geographic region specified in paragraph (a)(7)(ii) (A) of this section, a region consisting of all urban statistical areas as defined by the U.S. Office of Management and Budget and approved by the U.S. Census Bureau, in each census division and a region made up of all other parts of the census division, as determined by the U.S. Census Bureau described based on pickup location (as defined in 42 CFR 414.605).
(8)
(i) The individual market (other than short-term, limited-duration insurance or individual health insurance, which consists entirely of optional benefits).
(ii) The Large Groups Market (except for Coverage consisting solely of Exempted Services).
(iii) The Small Groups Market (other than Coverage consisting solely of Exempted Benefits).
(iv) In the case of a self-insured group health plan, all self-insured group health plans (other than account-based plans as defined in §147.126(d)(6)(i) of this subchapter and plans consisting solely of optional benefits) of the same plan sponsor or at the election of the plan sponsor Plan sponsor all self-insured group health insurance plans administered by the same entity (including a third-party administrator appointed by the plan), to the extent otherwise permitted by law, responsible for calculating the qualifying payment amount on behalf of the plan.
(9)
(10)
(11)
(12)
(13)
(14)
(fifteen)
(i) the plan or issuer has at least three contracted interest rates as of January 31, 2019 to calculate the median of the contracted interest rates in accordance with paragraph (b) of this section; or
(ii) For an item or service provided in a year after 2022 and used to determine the first sufficient information year –
(A) the plan or issuer has at least three contracted interest rates as of January 31 of the year immediately preceding that year to calculate the median of the contracted interest rates in accordance with paragraph (b) of this section; and
(B) The contracted installments referred to in paragraph (a)(15)(ii)(A) of this section represent (or are reasonably expected to represent) at least 25 percent of the total number of claims paid for that item or service make this up). in that year in relation to all plans of the sponsor (or the administrative entity referred to in paragraph (a)(8)(iv) of this section, if applicable) or all covers offered by the issuer that are offered in the same insurance market.
(16)
(17)
(b)
(2)
(i) Calculate the contractual median approach in relation to all plans of that sponsor (or the administrative entity referred to in paragraph (a)(8)(iv) of this section, if applicable) or all coverages offered by that issuer in the same insurance market;
(ii) Calculate the contracted median rate using the full contracted rate applicable to the service code, except that the plan or issuer must:
(A) Calculate separate median contract rates for CPT code modifiers “26” (occupational component) and “TC” (technical component);
(B) For anesthesia services, calculate an average contracted rate for the anesthesia conversion factor for each service code;
(C) For air ambulance services, calculate an average contracted rate for air miles service codes (A0435 and A0436); and
(D) If contract prices otherwise vary as a result of the application of a modifier code, calculate a separate median contract price for each such service code modifier combination;
(iii) In the case of payments made by a plan or issuer other than on a service fee basis (e.g. bundled or capitation payments), calculate a contracted median rate for each item or service using the underlying tariff rates the related items or services. If the plan or issuer does not have an underlying fee schedule rate for the item or service, it must use the derived amount to calculate the contracted media rate; and
(iv) Exclude risk-sharing, bonuses, penalties or other incentive-based or post-payment payments or payment adjustments.
(3)
(ii) If a plan or issuer has contracted rates for emergency services that vary by facility type for a service code, the median contracted rate for each facility of the same or similar facility type will be calculated separately.
(c)
(A) The combined percentage increase for 2019, 2020 and 2021 will be published in Internal Revenue Service guidance. The Treasury Department and Internal Revenue Service calculate the percentage increase using the CPI-U published by the Department of Labor's Bureau of Labor Statistics.
(B) For the purposes of this paragraph (c)(1)(i), the CPI-U for each calendar year is the average of the CPI-U at the end of the 12-month period ending August 31 of the calendar year, on 10 Rounded decimals.
(C) The combined percentage increase for 2019, 2020 and 2021 is calculated as follows:
(ii) For any item or service (other than items or services described in paragraphs (c)(1)(iii) to (vii) of this Section) performed in 2023 or any subsequent year, the Plan or issuer qualifying calculate payment amount by increasing the qualifying payment amount determined pursuant to paragraph (c)(1)(i) of this Section for such item or service provided in the immediately preceding year by the percentage increase published by the Treasury Department and the tax office.
(A) The percentage increase for each year after 2022 will be published in Internal Revenue Service guidance. The Treasury Department and Internal Revenue Service calculate the percentage increase using the CPI-U published by the Department of Labor's Bureau of Labor Statistics.
(B) For the purposes of this paragraph (c)(1)(ii), the CPI-U for each calendar year is the average of the CPI-U at the end of the 12-month period ending August 31 calendar year, on 10 Rounded decimals.
(C) The combined percentage increase for each year is calculated as CPI-U current year/CPI-U previous year.
(iii) For anesthesia services provided in 2022, the plan or issuer must calculate the qualifying payment amount by first taking the median of the contracted rate for the anesthesia conversion factor (as determined pursuant to paragraph (b) of this section) for the same or increases similar items or services under such plans or coverages on January 31, 2019 in accordance with paragraph (c)(1)(i) of this section (referred to in this section as the indexed median contracted rate for anesthesia conversion). Factor). The plan or issuer must then multiply the indexed mean contracted rate for the anesthesia conversion factor by the sum of the base unit, time unit and modifier units for the physical condition of the participant, beneficiary or participant to whom anesthesia services are provided to determine the qualifying payment amount.
(A) The base units for an anesthesia service code are the base units for that service code specified in the most recent edition (at the time of service) of the Relative Value Guide of the American Society of Anesthesiologists.
(B) The time unit is measured in 15-minute increments or a fraction thereof.
(C) The physical condition modifier on an application is a standard modifier that describes the patient's physical condition and is used to distinguish between different levels of complexity of the anesthesia services provided and is expressed as a unit with a value between zero (0) and three (3).
(D) The anesthesia conversion factor is expressed in dollars per unit and is a contractual rate negotiated with the plan or issuer.
(iv) For anesthesia services provided in 2023 or any subsequent year, the plan or issuer must calculate the qualifying payment amount by first increasing the indexed median of the contracted rate for the anesthesia conversion factor calculated pursuant to paragraph (c) (1)(iii) is determined. of this section for such services provided in the immediately preceding year pursuant to paragraph (c)(1)(ii) of this section. The plan or issuer must then multiply that amount by the sum of the base unit, time unit, and physical condition modifier units for the participant, beneficiary, or participant receiving anesthesia services to determine the qualifying payment amount.
(v) For air ambulance services billed using airline mile service codes (A0435 and A0436) made available in 2022, the plan or issuer must calculate the qualifying payment amount for services billed using airline mile service codes, by first increasing the Contracted Median Rate (as determined pursuant to paragraph (b) of this Section), pursuant to Paragraph (c)(1)(i) of this Section (referred to in this Section as the Indexed Median Air Mile Rate). The plan or issuer must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant, beneficiary or registrant to determine the qualifying payment amount.
(A) The mileage rate is expressed in dollars per mile flown loaded, is expressed in legal miles (not nautical miles) and is a contractual rate negotiated with the plan or issuer.
(B) The number of miles loaded is the number of miles that a patient is transported in the air ambulance.
(C) The Qualifying Payment Amount for other Service Codes related to Air Ambulance Services will be calculated in accordance with paragraphs (c)(1)(i) and (ii) of this Section.
(vi) For air ambulance services billed using airline mileage service codes (A0435 and A0436) provided in 2023 or any subsequent year, the plan or issuer must calculate the qualifying payment amount by first using the determined indexed average airline mile rate increased in accordance with paragraph (c)(1)(v) of this section for such services provided in the immediately preceding year in accordance with paragraph (c)(1)(ii) of this section. The plan or issuer must then multiply the indexed average flight mile rate by the number of loaded miles provided to the participant, beneficiary or registrant to determine the qualifying payment amount.
(vii) For any other item or service for which a plan or issuer determines payment for the same or similar item or service generally by multiplying a contracted rate by another unit value, the plan or issuer must calculate the qualifying payment amount using a method charge that is similar to the method required in paragraphs (c)(1)(iii) through (vi) of this section and reasonably reflects the method of payment for the same or similar items or services.
(2)
(i) For the first year that group health insurance coverage, group health insurance coverage or individual health insurance coverage is offered in that region –
(A) If the plan or issuer has sufficient information to calculate the median of the contracted interest rates described in paragraph (b) of this section, the plan or issuer shall calculate the qualifying payment amount in accordance with paragraph (c)(1) of this Section for items and services covered by the plan or coverage provided during the first year; and
(B) If the plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph (b) of this section for an item or service provided in a geographic region, the plan or issuer must use the qualifying Payment determines amount for the item or service in accordance with paragraph (c)(3)(i) of this section.
(ii) For each subsequent year that the Group Health Insurance Plan, Group Health Insurance Coverage, or Individual Health Insurance Coverage is offered in the Region, as applicable, the Plan or Issuer shall calculate the Qualifying Payment Amount by incrementing the Qualifying Payment Amount determined below paragraph (c) (2) for the goods and services provided in the immediately preceding year in accordance with paragraph (c)(1)(ii), (iv) or (vi) of this Section, as applicable.
(3)
(i) For an item or service provided in 2022 (or, in the case of a newly covered item or service, during the first year of insurance for the item or service relating to the plan or coverage), must the plan or issuer calculates the qualifying payment amount by first finding the rate equal to the median of the allowable intra-network amounts for the same or similar item or service provided in the geographic region in the year immediately preceding the year in which the item or the service was rendered (or, in the case of a Newly Covered Item or Service, the year immediately preceding such first year of coverage) as determined by the plan or issuer through the use of an eligible database, and then increasing that rate by the percentage increase in CPI-U over Previous year. For the purposes of this section, in cases where an authorized database is used to determine the qualifying payment amount with respect to an item or service rendered during a calendar year, the plan or issuer must use the same database to determine the qualifying payment amount of that by item or service provided on the last day of the calendar year, and if a different database is selected for some items or services, the basis for that selection must be one or more factors not directly related to the price of those items or services (such as sufficient data for those items or services).
(ii) For an item or service provided in a subsequent year (prior to the first year of sufficient information for such item or service in relation to such plan or coverage), the plan or issuer must pay the qualifying payment amount Calculate by increasing the Qualifying Payment Amount determined pursuant to paragraph (c)(3)(i) of this Section or this paragraph (c)(3)(ii), as applicable, for that item or service for the year immediately preceding this Subsequent year, by the percentage increase in CPI-U over the previous year;
(iii) For an item or service provided in respect of such plan or coverage in the first year of sufficient information for such item or service, the plan or issuer must make the qualifying payment amount pursuant to paragraph (c)( 1)(i), (iii) or (v) of this section, as applicable, except that in applying this paragraph to such item or service, the reference to “provided in 2022” shall be taken as a reference to during of that first sufficient information year provided, the reference to “in 2019” shall be treated as a reference to such year of sufficient information and the increase described in this paragraph shall not apply; and
(iv) For any item or service rendered in relation to such plan or coverage in any year after the first year of sufficient information for such item or service, the plan or issuer shall pay the qualifying payment amount pursuant to paragraph (c)(1)(ii), (iv) or (vi) of this section, as applicable, except that in applying this paragraph to such item or service, the reference to “in the year 2023 or in a subsequent year” is treated as a reference to be provided during the year after such first sufficient information year or in a subsequent year.
(4)
(i) For an item or service provided in 2022 (or, in the case of a Newly Covered Item or Service, during the first year of insurance for the item or service relating to the Plan or Coverage), must the plan or issuer identifies an appropriately related service code that existed in the immediately preceding year, and—
(A) If the Centers for Medicare & Medicaid Services has established a Medicare payment rate for the item or service billed under the new service code, the plan or issuer must calculate the qualifying payment amount by first calculating the ratio of the Medicare rate paid for the item or service billed under the new service code by the rate Medicare pays for the item or service billed under the associated service code, and then multiplying the ratio by the qualifying payment amount for an item or service billed under the associated service Code for the year in which the item or service is provided.
(B) If the Centers for Medicare & Medicaid Services has not established a Medicare payment rate for the item or service billed under the new service code, the plan or issuer must calculate the qualifying payment amount by first calculating the ratio of the rate , the plan or issuer reimburses the item or service billed under the new service code versus the rate the plan or issuer reimburses for the item or service billed under the associated service code, and then multiplies the ratio by the qualifying payment amount for a Item or service billed under the associated service code.
(ii) For any item or service provided in any subsequent year (prior to the first year of sufficient information for such item or service in relation to such plan or coverage, or prior to the first year for which an eligible database contains sufficient information to calculate a rate under paragraph (c)(3)(i) of this section in the immediately preceding year), the plan or issuer must calculate the qualifying payment amount by using the rate specified in paragraph (c)(4)( i) certain qualifying payment amount increases this Section or paragraph (c)(4)(ii), as applicable, for that item or service for the year immediately preceding the following year by the percentage increase in CPI-U over the previous year;
(iii) For any item or service that, in the first year of sufficient information for such item or service in relation to such plan or coverage, or in the first year for which an eligible database has sufficient information, to a rate pursuant to paragraph (c)(3)(i) of this section in the immediately preceding year, the plan or issuer must calculate the qualifying payment amount pursuant to paragraph (c)(3) of this section.
(d)
(1) For each initial payment or refusal to pay under Section 149.110, Section 149.120 or Section 149.130:
(i) The qualifying payment amount for each affected item or service;
(ii) A statement to confirm that based on the determination of the plan or issuer -
(A) The Qualifying Payment Amount shall apply for the purposes of the Approved Amount (or, in the case of air ambulance services, for the calculation of the Participant's, Beneficiary's or Enroller's co-payment); and
(B) Any qualifying payment amount shared with Provider or Facility has been determined in accordance with this Section;
(iii) A statement that, if the provider or facility so requests
(iv) Contact information, including telephone number and email address, for the appropriate person or entity to initiate open negotiations for the purpose of determining a payment amount (including cost sharing) for that item or service.
(2) In good time at the request of the provider or facility:
(i) Information as to whether the qualifying payment amount for the items and services concerned included contracted rates that were not based on a fee for the service for those specific items and services, and whether the qualifying payment amount for those items and services was calculated using the base value was determined tariff rates or derived amounts;
(ii) if a plan or issuer uses an approved database pursuant to paragraph (c)(3) of this section to determine the qualifying payment amount, information identifying which database was used; and
(iii) If an Associated Service Code was used to determine the Qualifying Payment Amount for an item or service billed under a new Service Code pursuant to paragraph (c)(4)(i) or (ii) of this Section, information identifying the associated service code; and
(iv) If applicable, a statement that the plan's or issuer's contractual rates include risk-sharing, bonuses, penalties or other incentive-based or retrospective payments or payment adjustments for the items and services concerned (if any) that have been excluded for purposes of calculating the qualifying payment amount.
(e)
(f)
(g)
(a)
(2)
(I)
(ii)
(b)
(2) HHS will notify the complainant verbally or in writing of the receipt of the complaint no later than 60 working days after receipt of the complaint. HHS will include a response acknowledging receipt of the complaint, informing the complainant of their rights and responsibilities under the complaints process, and describing the next steps in the complaints process. As part of the response, HHS may request additional information necessary to process the complaint. Such additional information may include:
(i) explanations of services;
(ii) processed claims;
(iii) information about the healthcare provider, facility or air ambulance service provider concerned;
(iv) information about the group health insurance plan or health insurance issuer that covers the individual;
(v) information to assist in determining whether the service was an emergency service or a non-emergency service;
(vi) the summary plan statement, policy, certificate, contract of insurance, membership booklet, statement of coverage, or other evidence of coverage that the plan or issuer makes available to participants, beneficiaries, or enrollers;
(vii) documents relating to the facts of the Complaint in the Complainant's possession or otherwise accessible to him; or
(viii) Any other information required by HHS to establish facts for an investigation.
(3) HHS will use reasonable efforts, consistent with governmental practices, to notify the complainant of the outcome of the complaint after the submission has been processed through appropriate methods established by HHS. A Complaint is considered processed after HHS has reviewed the Complaint and supporting information and made a Findings Finding. Based on the nature of the complaint and the affected plan or issuer, HHS may -
(i) refer the Complainant to another appropriate federal or state arbitration process;
(ii) notify the complainant and use reasonable efforts to refer the complainant to the appropriate state or federal regulator if HHS receives a complaint where another entity has jurisdiction to enforce the plan or issuer;
(iii) refer the plan or issuer to an investigation for enforcement action under 45 CFR Part 150; or
(iv) provide the complainant with an explanation of the resolution of the complaint and any corrective action taken.
(a)
(ii)
(iii)
(A)
(B)
(2)
(ii)
(iii)
(A)
(
(B)
(
(3)
(B)
(ii)
(A) Provides coverage for obstetric or gynecological care; and
(B) Requires nomination by a participant, beneficiary or enroller of a participating primary care provider.
(iii)
(A) waive any exclusions of coverage under the terms of the Plan or the health plan with respect to coverage for obstetric or gynecological care; or
(B) Prevent the affected group health plan or health insurance issuer from requiring that the obstetrics or gynecology provider inform the primary care professional or plan or issuer of treatment decisions.
(iv)
(A)
(
(B)
(
(C)
(
(D)
(
(4)
(A) Pursuant to paragraph (a)(1)(i) of this Section, any Participating GP available to accommodate the Participant, Beneficiary or Enroller may be designated;
(B) Pursuant to paragraph (a)(2)(i) of this Section, with respect to a child, any participating physician specializing in pediatrics may be designated as a first responder; and
(C) Subject to paragraph (a)(3)(i) of this section, the plan shall not require approval or referral for obstetric or gynecological care by a participating healthcare professional who specializes in obstetrics or gynecology.
(ii)
(iii)
(A) For plans and issuers that require or permit the designation of primary care providers by participants, beneficiaries or participants, insert:
[Name of group health insurance or health insurance issuer] [requires/permits] designation of a primary provider in general. You have the right to nominate any GP who is part of our network and is willing to host you or your family members. [If the plan or health plan automatically designates a primary care provider, insert: Until you make this designation, [group health plan or health insurance issuer name] will designate one for you.] Information on Selecting a Primary Care Provider , and for a list of participating primary care providers, contact the [plan administrator or issuer] at [insert contact information].
(B) For plans and issuers that require or permit the designation of a primary carer for a child, add the following:
For children, you can designate a pediatrician as the primary care provider.
(C) For plans and issuers that provide obstetric or gynecologic care coverage and require designation by a participant, beneficiary, or registrant of a primary care provider, add the following:
You do not need prior approval from [name of group health plan or issuer] or any other person (including a general practitioner) to access obstetric or gynecological care from a healthcare professional in our network who specializes in obstetrics or gynecology. However, healthcare professionals may be required to follow certain procedures, including obtaining prior approval for certain services, following a pre-approved treatment plan, or referral procedures. A list of participating healthcare professionals specializing in obstetrics or gynecology is available from [plan administrator or issuer] at [insert contact information].
(b)
(a)
(1) A nonparticipating emergency facility shall not charge the participant, beneficiary, or enroller for any payment for such emergency services and shall not be liable (as described in 26 CFR 54.9816-4T(c)(2), 29 CFR 2590.716-4(c)( 2) and §149.110(c)(2), if applicable) that exceeds the cost sharing requirement for such services (as determined pursuant to 26 CFR 54.9816-4T(b)(3) (ii) and (iii), 29 CFR 2590.716). -4(b)(3)(ii) and (iii) and § 149.110(b)(3)(ii) and (iii), as applicable).
(2) A Nonparticipating Provider may not provide the Subscriber, Beneficiary, or Enroller with any payment amount for an Emergency Service (as defined in 26 CFR 54.9816-4T(c)(2), 29 CFR 2590.716-4(c)(2), and §149.110(c )(2), as applicable), provided to such person by such provider in relation to such medical emergency and visit for which the person is receiving emergency hospital or independent emergency department services that exceeds the cost-sharing requirement for such service (as in accordance with 26 CFR 54.9816-4T(b)(3)(ii) and (iii), 29 CFR 2590.716-4(b)(3)(ii) and (iii) and § 149.110(b)(3 )(ii) and (iii), as applicable).
(b)
(1) The treating emergency doctor or treating service provider establishes that the participant,
(2) The provider or entity providing such additional items and services satisfies the notification and consent criteria of §149.420(c) through (g) with respect to such items and services, provided that the written notification additionally satisfies paragraphs (b)(2) complies with )(i) and (ii) of this Section, as applicable. For the purpose of applying this paragraph (b)(2), a reference in §149.420 to a nonparticipating provider shall be deemed a nonparticipating emergency facility.
(i) In the case of a participating emergency facility and a non-participating provider, the written notice must also include a list of all participating providers at the facility that are capable of providing such affected items and services and a notice that the participant, beneficiary or Enrolled Persons may be referred to such Participating Provider at their sole discretion.
(ii) In the case of a non-participating emergency facility, the written notice must include the good faith estimate that the participant, beneficiary or registrant may be charged for items or services provided by the non-participating emergency facility or by non-participating providers provided in relation to the visit to such facility (including any item or service reasonably expected to be provided by the non-participating emergency facility or non-participating providers in connection with such item or service).
(3) The participant, beneficiary, or enroller (or an authorized representative of such person) is able to receive the information described in § 149.420 as determined by the treating emergency physician or treating provider using reasonable medical judgment and provide informed consent in accordance with this section in accordance with applicable state law. For the purposes of this section and § 149.420, an authorized representative is an individual authorized under state law to give consent on behalf of the participant, beneficiary or enrollee, provided that the individual is not an affiliated provider or employee of the entity Entity, unless such provider or employee is a family member of the participant, beneficiary or enrollee.
(4) The provider or facility complies with any additional requirements or prohibitions that may be imposed by state law.
(c)
(d)
(e)
(f)
(a)
(b)
(1) Ancillary services, i. H.
(i) items and services related to emergency medicine, anaesthesiology, pathology, radiology and neonatology, whether provided by a physician or a naturopath;
(ii) items and services provided by resident surgeons, clinicians and critical care physicians;
(iii) diagnostic services, including radiology and laboratory services; and
(iv) Items and services provided by a non-Participating Vendor if there is no Participating Vendor that can provide such items or services at that Facility.
(2) Items or services provided as a result of unanticipated, urgent medical needs arising at the time the item or service is provided, regardless of whether the Nonparticipating Provider meets the notification and consent criteria in paragraph (c) of this Section Has.
(c)
(1) Provide the participant, beneficiary or enrollee with a written notice in paper form or, where practicable, in electronic form, as elected by the person, containing the information required under paragraph (d) of this section, if such written notice exists under the condition:
(i) In accordance with the guidelines issued by HHS and in the form and manner set forth in such guidelines;
(ii) with the Consent Document and will be provided physically separate from any other document and will not be attached to or incorporated into any other document; and
(iii) To any such Participant, Beneficiary or Enroller -
(A) No later than 72 hours prior to the date such items or services are provided to the person, if the appointment for the provision of such items or services is scheduled at least 72 hours prior to the date on which the person is provided such items and services are to be provided; or
(B) On the date the date for which such items or services are scheduled to be performed, if the date is scheduled within 72 hours of the date such items or services are scheduled to be performed. If an individual receives the notification on the same day that the items or services are to be provided, providers and facilities must provide the notification no later than 3 hours prior to the provision of items or services to which the notification and consent requirements apply.
(2) He obtains from the Participant, Beneficiary or Enroller the consent described in paragraph (e) of this Section to be treated by the Non-Participating Provider. An authorized agent may receive the notification on behalf of a participant, beneficiary or registrant and may provide consent on behalf of the participant, beneficiary or registrant. For the purposes of this section and §149.410, an authorized representative is an individual authorized under state law to give consent on behalf of the participant, beneficiary or enrollee, provided that the individual is not an affiliated provider or employee of the entity Entity, unless such provider or employee is a family member of the participant, beneficiary or enrollee. The consent must—
(i) provided voluntarily, i.e. H. the individual is free to consent without undue influence, fraud or coercion;
(ii) obtained in accordance with and in the manner and manner set out in the guidelines issued by HHS; and
(iii) not withdrawn in writing by the Participant, Beneficiary or Registeree prior to receipt of the items and services to which consent applies.
(3) Provide a copy of the signed written notice and consent to the participant, beneficiary or enrollee in person or by mail or email, at the choice of the participant, beneficiary or enrollee.
(d)
(1) Indicate that the healthcare provider is a nonparticipating provider with respect to the healthcare plan or coverage.
(2) Provide the good faith estimate that such Non-Participating Provider may charge the Participant, Beneficiary, or Enroller for the applicable items and services (including any items or services reasonably expected to be provided provided by the Non-Participating Vendor in connection with such items). or Services), including notification that the provision of the Quotation or the consent to be dealt with pursuant to paragraph (e) of this Section does not constitute a contract with respect to the fees estimated for such items and services or a contract binding the Subscriber, the Beneficiary, binds , or enrolled patient to be treated by that provider or facility.
(3) Provide a statement that prior authorization or other care management restrictions may be required before receiving such items or services at the Facility.
(4) clearly state that consenting to receive such items and services from such non-participating provider is optional and that the participant, beneficiary or registrant will instead utilize an available participating provider with respect to the plan or coverage, if any and that in such cases the cost-sharing responsibility of the Participant, Beneficiary or Enroller shall not exceed the responsibility that would apply in relation to such item or service provided by a Participating Provider in relation to such Plan.
(e)
(1) certifies in clear and understandable language that the Participant, Beneficiary or Enroller -
(i) Provided with the written notice referred to in paragraph (c) of this Section in the form elected by the Participant, Beneficiary or Registrant.
(ii) Advises that the payment of any such fee by the Participant, Beneficiary or Registrant may not be counted toward satisfying any restriction imposed by the Plan or Cost Sharing Coverage, including a statement that such payment may does not apply to any deductible within the network or the maximum deductible amount applicable under the plan or coverage.
(2) states that by signing the consent, the individual agrees to be treated by the non-participating provider and understands that the individual may receive a compensation bill and be subject to cost-sharing requirements applicable to services provided by the non-participating provider participating providers are provided.
(3) Documents the time and date that the Participant, Beneficiary, or Enroller received the written notice described in paragraph (c) of this Section and the time and date that the individual consented to the provision of these Articles or Services has signed such non-participating providers.
(f)
(2) If the individual's preferred language is not one of the top 15 most commonly used languages in which the nonparticipating provider (or the participating healthcare facility on behalf of the nonparticipating provider) provides the notification and consent document and the individual provides the Does not understand language to which the notification and consent document is provided, the notification and consent criteria in paragraph (c) of this section are not met, unless the non-participation
(g)
(h)
(I)
(j)
(a)
(b)
(1) A statement explaining the requirements and prohibitions applicable to the healthcare provider or facility pursuant to Sections 2799B-1 and 2799B-2 of the PHS Act and their implementing rules in Sections 149.410 and 149.420;
(2) A statement, if any, explaining any governmental legal requirements regarding the amounts payable by such provider or entity in respect of an item or service to a participant, beneficiary or participant in a group health plan or group or individual health insurance plan may charge for insurance coverage offered by a health insurer with which such provider or facility has no contractual relationship, upon receipt of payment, if any, under the plan or coverage for that item or service and any applicable ones Cost Sharing of such Participant, Beneficiary or Enroller; and
(3) A statement providing contact information for appropriate state and federal authorities who an individual may contact if the individual believes that the provider or facility has failed to comply with any requirement described in the notice.
(c)
(1) With respect to required disclosure on a public website, the information described in paragraph (b) of this section, or a link to such information, must appear on a searchable home page of the provider's or facility's website. A Vendor or entity that does not have its own website is not required to make any disclosure under this paragraph (c)(1).
(2) With respect to required public disclosure, a provider or entity shall post the information described in paragraph (b) of this Section on a prominently displayed sign at the location of the provider or entity. A Provider that does not have a publicly accessible location is not required to make any disclosure under this paragraph (c)(2).
(3) With respect to required disclosure to any person who is a participant, beneficiary or enroller of a group health insurance plan or group or individual health insurance offered by a health insurer, a provider or entity shall provide the information described in paragraph (). b) of this section in a one-sided (double-sided) notice with a font size of at least 12 points. Notification must be given in person, or by post or email, at the choice of the participant, beneficiary or enrollee.
(d)
(e)
(1) If the Provider does not provide goods or services in a healthcare facility or in connection with visits to healthcare facilities; or
(2) To persons to whom the Provider provides items or services when such items or services are not provided in a healthcare facility or in connection with a visit to a healthcare facility.
(f)
(g)
(a)
(b)
(a)
(2)
(I)
(ii)
(b)
(2) HHS will notify the complainant verbally or in writing of the receipt of the complaint no later than 60 working days after receipt of the complaint. HHS will include a response acknowledging receipt of the complaint, informing the complainant of their rights and responsibilities under the complaints process, and describing the next steps in the complaints process. As part of the response, HHS may request additional information that may be necessary to process the complaint. Such additional information may include:
(i) invoices from healthcare providers, air ambulances or healthcare facilities;
(ii) healthcare provider, air ambulance provider, or network status of the healthcare facility;
(iii) information about the participant's, beneficiary's or enroller's health plan or health insurance coverage;
(iv) information to assist in determining whether the service was an emergency or non-emergency service;
(v) documents relating to the facts of the complaint in the Complainant's possession or otherwise accessible to him; or
(vi) Any other information required by HHS to establish facts for an investigation.
(3) HHS will use reasonable efforts, consistent with governmental practices, to notify the complainant of the outcome of the complaint after the submission has been processed through appropriate methods established by HHS. A Complaint is considered processed after HHS has reviewed the Complaint and supporting information and made a Findings Finding. Depending on the nature of the complaint, HHS may -
(i) refer the Complainant to another appropriate federal or state arbitration process;
(ii) notify the complainant and use reasonable efforts to refer the complainant to the appropriate state or federal regulatory agency if HHS receives a complaint where another entity has enforcement authority over the healthcare provider, air ambulance provider, or healthcare facility;
(iii) refer the healthcare provider, air ambulance provider, or healthcare facility to an investigation for enforcement action under 45 CFR Part 150; or
(iv) provide the complainant with an explanation of the resolution and corrective action taken.
42 USC 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082 and 26 U.S.C. 36B.
The revision and addition read as follows:
(a) * * *
(3) Provides coverage for essential health care benefits in accordance with Section 1302(b) of the Affordable Care Act, except that the plan does not provide benefits for any plan year (except as provided in paragraphs (a)(4), (b), and (c) of this Section) until the annual cost sharing limit in Section 1302(c)(1) of the Affordable Care Act is reached.
(c)
FAQs
Who is responsible for the compliance of airworthiness directives? ›
Aircraft owners and operators are responsible for ensuring compliance with the requirements of all ADs that apply to their aircraft. Anyone who operates a product that does not meet therequirements of an applicable AD is in violation of 14 CFR 39.7.
What is an Airworthiness Directive AD )? What 14 CFR part provides details and the compliance dates for ADs? ›Airworthiness Directives ( AD s) are legally enforceable regulations issued by the FAA in accordance with 14 CFR part 39 to correct an unsafe condition in a product. Part 39 defines a product as an aircraft, engine, propeller, or appliance.
Is airworthiness directive compliance mandatory? ›Who has to comply with ADs? No person may operate a product to which an AD applies, except in accordance with the requirements of the AD. Furthermore, the owner or operator of an aircraft is required by 14 CFR 91.403 to maintain the aircraft in compliance with all ADs.
How do you write an airworthiness directive? ›- A description of the unsafe condition.
- The product to which the AD applies.
- The required corrective action or operating limitations, or both.
- The AD effective date.
- A compliance time.
- Where to go for more information.
- Information on alternative methods of compliance with the requirements of the AD.
Rule 50 of the Aircraft Rules, 1937 empowers the Director General of Civil Aviation (DGCA) to issue certificate of airworthiness or Special Certificate of Airworthiness of an Aircraft.
Who is responsible to review the airworthiness certificate? ›Explanation: The pilot in command of an aircraft is responsible to review the airworthiness certificate, maintenance records, and other required paperwork to assess and verify that the aircraft is airworthy.
Can you fly without an airworthiness certificate? ›(b) No person may operate a civil aircraft unless the airworthiness certificate required by paragraph (a) of this section or a special flight authorization issued under § 91.715 is displayed at the cabin or cockpit entrance so that it is legible to passengers or crew.
What are the 3 types of airworthiness directives? ›- Notice of Proposed Rulemaking ( NPRM ), followed by a Final Rule.
- Final Rule; Request for Comments.
- Emergency ADs.
The FAA will issue airworthiness directives when they've determined a product meets two criteria: An unsafe condition exists in a product; and, The condition is likely to exist or develop in other products of the same type design.
Which are the 3 key elements in the definition of airworthiness? ›2.1 Definition of Airworthiness
In this definition, three key elements deserve particular consideration: safe conditions, possession of the necessary requirements, and allowable limits.
What is required for an airworthiness certificate? ›
The Certification Process
Conduct certain ground and flight tests to demonstrate that the airplane meets the FAA standards. Evaluate the airplane to determine the required maintenance and operational suitability for introduction of the aircraft into service.
Airworthiness Directives (AD notes) are to be complied with within the required time limit, and the fact of compliance, the date of compliance, and the method of compliance are recorded in the aircraft's maintenance records." Generally there are regular ADs and emergency ADs.
What are the three certificates the FAA issues pertaining to airworthiness? ›14 CFR Part 21 defines three separate certifications: type, production, and airworthiness. Type certification is the approval of the design of the aircraft and all component parts (including propellers, engines, control stations, etc.).
What are airworthiness directives issued by the FAA pursuant to 14 CFR Part 39? ›Airworthiness Directives ( ADs ) are legally enforceable rules issued by the FAA in accordance with 14 CFR part 39 to correct an unsafe condition in a product. 14 CFR part 39 defines a product as an aircraft, aircraft engine, propeller, or appliance.
What regulations are in the terms and conditions of a standard airworthiness certificate? ›A standard airworthiness certificate remains valid as long as the aircraft meets its approved type design, is in a condition for safe operation and maintenance, preventative maintenance, and alterations are performed in accordance with 14 CFR parts 21, 43, and 91.
What are the two types of airworthiness certificates? ›A pilot can attain two types of airworthiness certificates: A Standard Airworthiness Certificate or a Special Airworthiness Certificate. FAA requirements must be met to be eligible for any airworthiness certificate, including type, production, and airworthiness.
Who's responsible for ensuring an aircraft is maintained in airworthiness condition? ›Airworthiness is Your Responsibility
worked on the airplane, but in fact, 14 CFR section 91.403(a) says the owner/operator is primarily responsible for maintaining the aircraft in an airworthy condition to include Airworthiness Directive (AD) compliance.
For up to three seats, primary category aircraft certification costs around US$1m, US$25m for a general aviation aircraft and hundreds of millions of dollars for a commercial aircraft; certification delays can cost millions of dollars and can decide a program's profitability.
How long does it take to certify an aircraft? ›Amended type certificates typically take 3-5 years to complete. By comparison, the certification of a new aircraft type can take between 5 and 9 years.
Who is responsible for determining if an aircraft is in condition for safe flight a certificated aircraft mechanic The pilot in command the owner or operator? ›The FAA is very clear in its intent that only airworthy aircraft should be operated. The regulation places responsibility on the pilot in command by stating, "The pilot in command of a civil aircraft is responsible for determining whether that aircraft is in condition for safe flight.
Who controls certification of pilots and enforcement of operational regulations? ›
The FAA issues and enforces regulations covering manufacturing, operating, and maintaining aircraft. The FAA also certifies airmen and airports that serve air carriers.
What two certificates must be in the aircraft at all times? ›The letters stand for the documents that must be carried aboard an airplane. They are an airworthiness certificate, registration certificate, operating limitations, and weight and balance information.
What aircraft can I fly without a license? ›Aircraft under the FAA's 14 CFR Part 103 ultralight category does not require a pilot's license to fly. There are helicopters, fixed-wing planes, and gliders that fall under this category that can be flown without a license, but you will require additional training to fly them safely.
How important is the certificate of airworthiness? ›Why is airworthiness important? An airworthiness certificate proves the safety of an aircraft. Whether you are looking to sell your aircraft or provide commercial transport services, without an airworthiness certificate, potential buyers or customers will view your aircraft as unsafe and take their business elsewhere.
What is difference between a type certificate and an airworthiness certificate C of A? ›But there is only one Type Certificate for an unmodified Cessna, and it is issued to Cessna, Inc. On the other hand, an Airworthiness Certificate is issued for each aircraft individually and certifies that this here particular airplane is airworthy.
What is the difference between an airworthiness directive and a service bulletin? ›Are Service Bulletins the Same as Airworthiness Directives? No. The FAA issues Airworthiness Directives (ADs) and aircraft manufacturers issue Service Bulletins (SBs). ADs are legally enforceable regulations, in accordance with 14 CFR part 39, to correct an unsafe condition that exists in a product.
What are airworthiness codes? ›The Airworthiness Code is designed to provide practical guidance on the key airworthiness topics for owners and operators of general aviation aircraft and includes: • The Airworthiness System. • Airworthiness Responsibilities of an owner/operator. • The Part-ML Maintenance Programme.
What are the 2 types of compliance? ›There are two main types of compliance that denote where the framework is coming from: corporate and regulatory. Both corporate and regulatory compliance consist of a framework of rules, regulations and practices to follow.
What 2 documents certificates must be on board all US aircraft which must be displayed? ›- The Airworthiness Certificate is issued by the FAA and deems an aircraft's design to be legal for operation. ...
- The Registration certificate is similar to the registration of your car. ...
- The Operating Limitations of the airplane must be on board.
The two categories of airspace are: regulatory and nonregulatory. Within these two categories, there are four types: controlled, uncontrolled, special use, and other airspace.
What are the 4 risk elements aviation? ›
RISK ELEMENTS IN ADM take into consideration the four fundamental risk elements: the pilot, the aircraft, the environment, and the type of operation that comprise any given aviation situation.
What are the 4 major categories of aircraft? ›Normal, Utility, Acrobatic, and Commuter Category Airplanes: 14 CFR part 23. Transport Category Airplanes: 14 CFR part 25.
What are the 3 types of aviation? ›However, there are a few different sectors of aviation, with three being the main pillars that uphold the aviation industry as a whole: commercial, general, and military aviation.
WHO issues certificate of airworthiness? ›Rule 50 of the Aircraft Rules, 1937 empowers the Director General of Civil Aviation (DGCA) to issue certificate of airworthiness or Special Certificate of Airworthiness of an Aircraft.
How long does a Certificate of Airworthiness last for? ›Certificates of Airworthiness are non-expiring and require a valid Airworthiness Review Certificate in order to operate under the provisions of the C of A.
Who is responsible to review the airworthiness certificate? ›Explanation: The pilot in command of an aircraft is responsible to review the airworthiness certificate, maintenance records, and other required paperwork to assess and verify that the aircraft is airworthy.
What actions do airworthiness directives require? ݤ 39.11 What actions do airworthiness directives require? Airworthiness directives specify inspections you must carry out, conditions and limitations you must comply with, and any actions you must take to resolve an unsafe condition.
Who is responsible for the airworthiness of the aircraft? ›Airworthiness is Your Responsibility
worked on the airplane, but in fact, 14 CFR section 91.403(a) says the owner/operator is primarily responsible for maintaining the aircraft in an airworthy condition to include Airworthiness Directive (AD) compliance.
Check out the FAA's website www.faa.gov/regulations_policies/airworthiness_directives/ where you can sign up for alerts. Visit rgl.faa.gov to search for ADs using a manufacturer or model number. You can also go directly to the Federal Register's site at www.federalregister.gov/agencies/federal-aviation-administration.
Where is the record of compliance with airworthiness directives? ›Where is the record of compliance of airworthiness directives or service bulletins normally indicated? The aircraft maintenance records (generally in the form of logbooks) are the correct place to record compliance with FAA Airworthiness Directives or manufacturer's service bulletins.
When must airworthiness directives be complied with? ›
Airworthiness Directives (AD notes) are to be complied with within the required time limit, and the fact of compliance, the date of compliance, and the method of compliance are recorded in the aircraft's maintenance records."
Can an aircraft fly without the airworthiness certificate? ›Airworthiness Certification
Part 91 prohibits the operation of civil aircraft without an airworthiness certificate, in violation of any term of the applicable airworthiness certificate, or in violation of any applicable FARs. The FAA issues both "standard" and "special" airworthiness certificates.
(a) Except as provided in § 91.715, no person may operate a civil aircraft unless it has within it the following: (1) An appropriate and current airworthiness certificate.
Which directive contains requirements for certificate of airworthiness? ›This Civil Aviation Directive 8301 – Certificate of Airworthiness is published by the Chief Executive Officer under Section 24O of the Civil Aviation Act 1969 [Act 3] and come into operation on 1st May 2021.
Where can you obtain information on compliance requirements? ›- local, state, territory or commonwealth government departments or regulatory agencies.
- industry associations.
- Internet.
- legal professionals.
- media.
- unions.
Airworthiness Directives (AD's): Notification to owners and operators of certified aircraft that a known safety deficiency with a particular model of aircraft, engine, avionics or other system exists and must be corrected. VOR Check: Due every 30 days if the aircraft is to be operated IFR.
What are the airworthiness requirements? ›Defining Airworthiness:
Two main factors determine if an aircraft is airworthy: The aircraft conforms to its type certificate and authorized modifications; and. The aircraft must be in condition for safe operation.
Non-compliance with an Airworthiness Directive (AD) renders your aircraft un-airworthy in the eyes of the FAA. As a result, your in-flight insurance coverage will no longer be valid under most insurance policies (in addition, the aircraft is not legal for flight with the FAA).
What makes a certificate of airworthiness invalid? ›It becomes invalid when the aircraft is destroyed or taken out of service permanently.