requirements related to surprise billing; part iii

22,828, Estimated Number of Annual Responses: https://www.naics.com/business-lists/counts-by-naics-code/.). The Requirements Related to Surprise Billing, Part II, establishes a federal independent dispute resolution process that will be used by out-of-network providers, facilities, air ambulance services, group and individual market plans and issuers if there is an unsuccessful open negotiation. of the RFA requires the agency to present a final regulatory flexibility analysis of these final rules. The Departments estimate that 140,270 physicians, on average, bill on an out-of-network basis. Acting Assistant Secretary, Employee Benefits Security Administration, U.S. Department of Labor. v. This results in an industry average of $3.8 million per air ambulance base. The October 2021 interim final rules also provided, prior to vacatur in On October 28, 2021, the Texas Medical Association, a trade association representing physicians, and a Texas physician filed a lawsuit against the Departments and the Office of Personnel Management (OPM), asserting that certain provisions of the October 2021 interim final rules relating to the certified IDR entities' consideration of the QPA, as well as additional factors related to items and services that are not air ambulance services, should be vacated. The teaching status, case mix, and scope of services of the facility that furnished the qualified IDR item or service, if applicable. (1) Many of these comments addressed the information required by the July 2021 interim final rules that must be shared about the QPA, the importance of this disclosure, and how additional disclosures related to the QPA would be useful in the context of the Federal IDR process, particularly when the QPA is based on a service code or modifier that is different than the one the provider or facility billed. 86 FR 55980 (October 7, 2021). Texas Medical Association Patient Protections and Requirements Related to Emergency Services under Section 2719A of the Public Health Service Act B. H.R. If the certified IDR entity determines that the issuer's offer best represents the value of the qualified IDR service, the certified IDR entity should select the issuer's offer. No additional information is submitted by either party. 94. Furthermore, the requirement to disclose this additional information will increase transparency by ensuring that the provider, facility, or provider of air ambulance services has sufficient information about the QPA to submit an informed offer, including how it relates to the billed claim. v. 71. imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (APA) and are not likely to have a significant economic impact on a substantial number of small entities. [80] that agencies use to create their documents. Other commenters requested that the Departments replace the QPA as the baseline in the Federal IDR process with a different amount, such as the actual amount paid to a particular out-of-network provider for the same or similar item or service or the median contracted rate based on the amount negotiated under each contract the provider has with a plan or issuer. Independent dispute resolution process for air ambulance services (temporary). The regulatory text in these final rules does not include the provisions that the District Court reasoned would have the effect of imposing such a presumption. Further, the facility submits additional information showing the contracted rates used to calculate the qualifying payment amount for the qualified IDR item or service were based on a level of service that is typical in cases in which the services are delivered by a facility that is not a level 1 trauma center and that does not have the capability to provide the scope of services provided by a level 1 trauma center. The Regulatory Flexibility Act (RFA)[90] (D) The Departments are finalizing standards for the written decision that are intended to achieve transparency and consistency in the Federal IDR process. The Departments are accounting for the additional costs associated with these final rules due to parts of the July 2021 interim final rules and October 2021 interim final rules being finalized. For air ambulance services, this information includes information related to the following factors: (1) quality and outcomes measurements of the provider that furnished the air ambulance services; (2) the acuity of the condition of the participant or beneficiary receiving the air ambulance service, or the complexity of furnishing the service to the participant or beneficiary; (3) training, experience, and quality of the medical personnel that furnished the air ambulance services; (4) ambulance vehicle type, including the clinical capability level of the vehicle; (5) population density of the point of pick- In response to comments requesting additional transparency and explanation, these final rules also provide that the certified IDR entity's written decision must include an explanation of its determination, including what information the certified IDR entity determined demonstrated that the offer selected as the out-of-network rate is the offer that best represents the value of the qualified IDR item or service, including the weight given to the QPA and any additional credible information submitted in accordance with these final rules. 107. The certified IDR entity must then consider the additional information submitted by the nonparticipating provider, provided the information relates to circumstances described in paragraphs (c)(4)(iii)(B) through (D) of this section and relates to the offer for the payment amount for the qualified IDR item or service that is the subject of the payment determination. The annual cost for small providers of air ambulance services is estimated as: $339,836 0.5 36.8% = $62,530. Although downcoding is being defined for the first time in these final rules, the concept was reflected in both sets of interim final rules. In considering either form of information, the certified IDR entity should evaluate whether the information is credible and should not give weight to information that is not credible. Federal IDR Process for Nonparticipating Providers or Nonparticipating Emergency Facilities, ii. (F) The rationale for the certified IDR entity's decision, including the extent to which the decision relied on the criteria in paragraphs (c)(4)(iii)(B) through (D) of this section; (h) As discussed in more detail later in this preamble, upon review of the comments the Departments received on the information that must be shared about the QPA when a service is downcoded and with respect to the Federal IDR process, and in light of the District Court's memorandum opinions and orders in This information is determined to be credible by the certified IDR entity, but the certified IDR entity finds that the information does not demonstrate that the provider's level of training and experience relates to the offer for the payment amount for the qualified IDR item or service that is the subject of the payment determination (for example, the information does not show that the provider's level of training and experience was necessary for providing the qualified IDR service that is the subject of the payment determination to the particular patient, or that the training or experience made an impact on the care that was provided). The provider submits an offer equal to the amount that would have been the qualifying payment amount had the service code not been downcoded. LifeNet Federal Register :: Requirements Related to Surprise Billing Many commenters on the July 2021 interim final rules stressed that the methodology to calculate the QPA should be transparent, and that the Departments should expand the range of information that is shared with providers, facilities, and providers of air ambulance services with the QPA. The issuer submits an offer that is higher than the qualifying payment amount and that is equal to the facility's contracted rate (adjusted for inflation) for the previous year with the issuer for the qualified IDR service. 84,475 hours $50.76 = $4,287,951. The process for a certified IDR entity to select an offer in a dispute related to qualified IDR services that are air ambulance services is essentially the same as that for other qualified IDR items or services. The Departments also estimate that there are 44 FEHB carriers. Title: 88. PDF Requirements Related to Surprise Billing; Part II - American Society of More information and documentation can be found in our [82] Though neither set of interim final rules specifically defines a term for this practice, the interim final rules described the practice and explained that it was permissible under certain circumstances. The issuer also submits additional written information that includes the documentation disclosed to the nonparticipating provider under 54.9816-6(d)(1)(ii) at the time of the initial payment (which describes why the service code was downcoded). Requirements Related to Surprise Billing; Part II 6. that after considering the QPA, additional information requested by the certified IDR entity from the parties, and all of the credible information submitted by the parties that is consistent with the requirements and is not prohibited information, the certified IDR entity must select the offer closest to the QPA, unless the certified IDR entity determined that the credible information submitted by the parties clearly demonstrates that the QPA is materially different from the appropriate out-of-network rate, or if the offers are equally distant from the QPA but in opposing directions. Applicability date. Ambulance vehicle type, including the clinical capability level of the vehicle. In general. In such an instance, the certified IDR entity could determine that the QPA based on the downcoded service code does not sufficiently encompass the complexity of furnishing the qualified IDR service because it was based on a service code for a different service from the one furnished. Contracted rates are frequently based on a percentage of rates payable by a public payor, such as Medicare. Thus, HHS will account for approximately 42,652 hours with an equivalent cost of approximately $2,164,990. A majority of commenters raised similar points with regard to the Federal IDR process for both non-air ambulance items and services and air ambulance As with disputes related to qualified IDR items or services that are not air Texas Medical Association. and the Congressional Review Act.[46]. [31] In addition, if the parties submit information related to more than one of the additional factors, the certified IDR entity should also consider whether the information submitted regarding those factors is already accounted for by information submitted relating to other credible information submitted to the certified IDR entity in relation to another factor and, if so, should not weigh this information more than once. Those commenters stated that the approach taken would shield consumers from surprise bills and ever higher insurance premium costs. $555,427. On October 7, 2021, the Departments published the October 2021 interim final rules. Health Insurance Coverage Bulletin. (March 2020). individuals with employer-sponsored health coverage and 33.2 million individuals with other private coverage), there are 33.3 air transports per 100,000 individuals, of which 69 percent result in out-of-network bills. 72. (C) The certified IDR entity must also consider information provided by a party in response to a request by the certified IDR entity under 54.9816-8T(c)(4)(i)(A)( Start Printed Page 52626 related to qualified IDR services that are air ambulance services is generally the same as the process applicable to disputes related to qualified IDR items or services that are not air ambulance services. Specifically, the Departments are of the view that additional information would be helpful in cases in which the plan or issuer has downcoded the billed claim to ensure that providers, facilities, and providers of air ambulance services receive the relevant information from a plan or issuer that is needed to engage in a productive open negotiation period. PDF Fact Sheet - U.S. Department of Labor As explained later in this preamble, the Departments are of the view that it is appropriate to exercise their authority under this provision, and that it is in accordance with these statutory provisions, to adopt a Federal IDR process that encourages a consistent methodology for evaluation of information when making a payment determination. Not later than 30 business days after the selection of the certified IDR entity, the certified IDR entity must notify parties to the dispute of the selection of the offer and provide a written decision,[18] The July 2021 interim final rules and October 2021 interim final rules generally apply to group health plans and health insurance issuers offering group or individual health insurance coverage (including grandfathered health plans) with respect to plan years (in the individual market, policy years) beginning on or after January 1, 2022; and to health care providers and facilities, and providers of air ambulance services with respect to items and services provided during plan years (in the individual market, policy years) beginning on or after January 1, 2022.[6]. Neither party submits any additional information. Considerations for air ambulance services. The initial payment must reflect what the payer considers to be payment in full. In total, the Departments estimate that certified IDR entities, TPAs, and issuers will incur costs of approximately $0.4 million annually to provide payment determination notifications and the additional QPA information required under these final rules. The disclosure requirements at 45 CFR 149.430 regarding patient protections against balance billing are applicable as of January 1, 2022. However, in the Departments' view, this would have resulted in uncertainty regarding the Federal IDR process, because certain aspects of the process would be governed by the October 2021 interim final rules as published in the Texas Medical Association IFR. According to SBA size standards,[98] As discussed in the analysis of the October 2021 interim final rules, the total annualized cost associated with the October 2021 interim final rules is $517 million, using the 7 percent discount rate. 2018 National Emergency Department Inventory. (2021). 5. PDF Initial AMA Summary of Interim Final Rule (Part 2): Requirements Payment Determination Standards Under the Federal IDR Process, 3. This information must be provided in writing, either on paper or electronically, to a nonparticipating provider, facility, or provider of air ambulance services, as applicable, when the QPA serves as the recognized amount. 86 FR 36872, 36900 (July 13, 2021). Cong. 92. A nonparticipating emergency facility and an issuer are parties to a payment determination in the Federal IDR process. Tex. No Surprises Act Definition, Improved Healthcare Transparency The District Court in Conclusion. Unless the head of an agency determines that a final rule is not likely to have a significant economic impact on a substantial number of small entities, section 604[91] ( In the October 2021 interim final rules, the Departments estimated that there are 16,992 emergency and other health care facilities, including 6,090 hospitals,[60] Start Printed Page 52643 26 CFR 54.9816-6T(b)(2)(iii), 29 CFR 2590.716-6(b)(2)(iii), 45 CFR 149.140(b)(2)(iii). the Federal Register. The Departments considered the possibility of not replacing the provisions vacated by the District Court. Along with the offer, the nonparticipating emergency facility submits additional written information showing that the scope of services available at the nonparticipating emergency facility was critical to the delivery of care for the qualified IDR item or service provided, given the particular patient's acuity, and the information is determined to be credible by the certified IDR entity. The Departments estimate that the annual cost to prepare this notice of the certified IDR entity's determination for air ambulance claims is $0.3 million. [64] 33. LifeNet This increased transparency will inform the provider's, facility's, or provider of air ambulance services' decision whether to initiate open negotiation and the Federal IDR process, as well as its determination of the amount that it submits as its offer. Along with the offer, the nonparticipating provider submits additional written information regarding the level of training and experience of the provider, and the information is determined to be credible by the certified IDR entity, but the certified IDR entity finds that the provider does not demonstrate that the level of training and experience relates to the offer for the appropriate payment amount for the qualified IDR item or service that is the subject of the payment determination (for example, the information does not show that the level of training and experience was necessary to provide the qualified IDR service or that the training or experience made an impact on the care that was provided). As noted in Table 1 (Accounting Statement) the Departments estimate the additional total annualized cost associated with the parts these final rules to be $5.9 million, using the 7 percent discount rate. The Departments lack data on the number of non-physician providers who would be impacted. The Departments anticipate that these States will incur a small incremental cost when making changes to their laws. 08/24/2022 at 11:15 am. Facts. Avoidance of Double-Counting Information, C. Payment Determinations Under the Federal IDR Process for Air Ambulance Services, D. The Certified IDR Entity's Written Decision, i. 2) The market share held by the provider or facility or that of the plan or issuer in the geographic region in which the qualified IDR item or service was provided. 601 The Departments understand that many plans and issuers make initial payments that are equivalent to or are informed by the corresponding QPA for the item or service at issue. Regarding air ambulance services, these final rules state that the certified IDR entity must consider the QPA for the applicable year for the same or similar service and then consider all additional permissible information to determine the appropriate out-of-network rate. The facility submits an offer that is higher than both the qualifying payment amount and the contracted rate (adjusted for inflation) for the previous year with the issuer for the qualified IDR service. 8902(p) issued by the Office of Personnel Management that specify how certain provisions of the No Surprises Act apply to health benefit plans offered by carriers under the Federal Employees Health Benefits Act. The preamble to the July 2021 interim final rules also noted that modifiers affect the payment v. The No Surprises Act generally prohibits surprise billing to individuals in the following 3 scenarios: Items/services provided at an out-of-network facility. 77. These sections contain limitations on cost sharing and requirements for the timing of initial payments and notices of denial of payment for air ambulance services furnished by nonparticipating providers of air ambulance services, and allow plans and issuers and nonparticipating providers of air ambulance services to access the Federal IDR process described in section 9816 of the Code, section 716 of ERISA, and section 2799A-1 of the PHS Act. [11] Requirements Related to Surprise Billing: Policy Update 1) Upon review of the comments the Departments received on the Federal IDR process, and in light of the District Court's memorandum opinions and orders in Commenters also stated that it was not unreasonable to require a party to document why the QPA is not the appropriate payment amount. Texas Medical Association Under the October 2021 interim final rules, the certified IDR entity must explain its payment determination and the underlying rationale in a written decision submitted to the parties and the Departments, in a form and manner specified by the Departments. 63. 7805, unless otherwise noted. (2) 2) Federal Regulations: Requirements Related to Surprise Billing; Part II 51. should verify the contents of the documents against a final, official This regulatory action seeks to minimize costs to providers, facilities, providers of air ambulance services, plans, issuers, TPAs, and certified IDR entities. documents in the last year, 38 Qualified IDR item or service has the same meaning as set forth in 26 CFR 54.9816-8T(a)(2)(xii), 29 CFR 2590.716-8(a)(2)(xii), and 45 CFR 149.510(a)(2)(xii). Start Printed Page 52646 The Departments estimate there will be 4,968 claims for air ambulance services submitted to the Federal IDR process each year. Accordingly, a plan or issuer cannot refuse to accept the standard notice of initiation of open negotiation from a provider, facility, or provider of air ambulance services because the provider or facility did not utilize the plan's or issuer's online portal when the standard notice of initiation of open negotiation is provided in a manner consistent with the requirements of the July 2021 and October 2021 interim final rules. The interim final rules were deemed to be economically significant. 53. Centers for Medicare and Medicaid Services. The Departments assume for this calculation that half of the cost will fall on the providers, providers of air ambulance services, and facilities and the remaining half will fall on plans, issuers, and FEHB carriers. 2022-18202 Filed 8-24-22; 11:15 am], updated on 11:25 AM on Monday, June 12, 2023, updated on 8:45 AM on Monday, June 12, 2023. DOL and the Department of the Treasury will each account for a cost burden of approximately $383,119. The effects in Table 1 reflect non-quantified impacts and estimated direct monetary costs resulting from the provisions of these final rules. [58] See Section III of the 119, as amended by Pub. Tex.). 1) The level of training, experience, and quality and outcomes measurements of the provider or facility that furnished the qualified IDR item or service (such as those endorsed by the consensus-based entity authorized in section 1890 of the Social Security Act). In particular, the No Surprises Act added new provisions applicable to group health plans and health insurance issuers offering group or individual health insurance coverage to Subchapter B of chapter 100 of the Internal Revenue Code (Code), Part 7 of the Employee Retirement Income Security Act (ERISA), and Part D of title XXVII of the Public Health Service Act (PHS Act). See 29 CFR 2520.104-20, 2520.104-21, 2520.104-41, 2520.104-46, and 2520.104b-10. Available at Example 1), the certified IDR entity must consider the qualifying payment amount. Start Printed Page 52622 For more details, please refer to the Paperwork Reduction Act analysis, found in section V of this preamble. Therefore, the Departments are of the view that it is more appropriate to make changes to the Federal IDR process for both non-air ambulance and air ambulance items and services in these final rules. ASPE Office of Health Policy. These final rules will help ensure that certified IDR entities carefully evaluate all credible non-duplicative information. The issuer submits an amount equal to the QPA as its offer, with no additional information. headings within the legal text of Federal Register documents. The Departments considered finalizing the additional factors other than the QPA that a certified IDR entity may consider when submitted by one of the disputing parties without addressing the possibility that these factors may already have been accounted for in the QPA. In the Departments' view, greater predictability in the Federal IDR process would encourage parties to settle disputes through open negotiation or earlier through the offer and acceptance of an adequate initial payment, which would increase efficiencies in how disputes are handled and ultimately lead to lower administrative costs associated with health care. (A) www.RegInfo.gov. Start Printed Page 52633 Start Printed Page 52621 Assuming that 17,435 non-air ambulance claims and 4,968 air ambulance claims are submitted to the Federal IDR process each year, only one percent of small health plans will be impacted. ( 45. 86 FR 36872 (July 13, 2021) and 86 FR 55980 (October 7, 2021). The total annual burden for all issuers and TPAs for providing the additional information related to the QPA is estimated to be 85,303 hours with an equivalent cost of approximately $4.3 million. The October 2021 interim final rules provide that, not later than 30 business days after the selection of the certified IDR entity, the certified IDR entity must select one of the offers submitted by the plan or issuer or the provider, facility, or provider of air ambulance services as the out-of-network rate for the qualified IDR item or service.