Request for Information; Advanced Explanation of Benefits and Good Faith Estimate for Covered Individuals
Request for information.
CFR Part: "5 CFR Chapter I"; "26 CFR Chapter I"; "29 CFR Chapter XXV"; "45 CFR Subchapter B"
RIN Number: "RIN 3206-AO45"; "RIN 1545-BQ37"; "RIN 1210-AC14"; "RIN 0938-AU98"
Citation: "87 FR 56905"
Document Number: "CMS-9900-NC"
Page Number: "56905"
"Proposed Rules"
Agency: "
SUMMARY: This document is a request for information (RFI) to inform DOL, HHS, and the
DATES:
To be assured consideration, comments must be received at one of the addresses provided below by
ADDRESSES: In commenting, refer to file code CMS-9900-NC.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the "Submit a comment" instructions.
2. By regular mail. You may mail written comments to the following address ONLY:
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to the following address ONLY:
Please allow sufficient time for mailed comments to be received before the close of the comment period.
For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Customer Service Information: Information from OPM on health benefits plans offered under the FEHB Program can be found on the OPM website (www.opm.gov/healthcare-insurance/healthcare/). Individuals interested in obtaining information from the
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. The Departments and OPM post all comments received before the close of the comment period on the following website as soon as possible after they have been received: www.regulations.gov. Follow the search instructions on that website to view public comments. The Departments and OPM will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that an individual will take actions to harm another individual. The Departments and OPM continue to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.
I. Background On
FOOTNOTE 1 Public Law 116-260 (
FOOTNOTE 2 Under 45 CFR 149.610(a)(2)(vii) through (viii), "[h]ealth care provider (provider)" is defined for purposes of the GFE requirements as "a physician or other health care provider who is acting within the scope of practice of that provider's license or certification under applicable State law, including a provider of air ambulance services." "Health care facility (facility)" is defined for purposes of the GFE requirements as "an institution (such as a hospital or hospital outpatient department, critical access hospital, ambulatory surgical center, rural health center, federally qualified health center, laboratory, or imaging center) in any State in which State or applicable local law provides for the licensing of such an institution, that is licensed as such an institution pursuant to such law or is approved by the agency of such State or locality responsible for licensing such institution as meeting the standards established for such licensing." END FOOTNOTE
FOOTNOTE 3 See 86 FR 55980, 55983 at FN 12. END FOOTNOTE
If the uninsured (or self-pay) individual schedules an item or service to be furnished by the provider or facility at least 3 business days in advance of the date the item or service is expected to be furnished, the GFE must be provided within 1 business day after the date of scheduling the item or service. However, if the item or service is scheduled at least 10 business days in advance of the date the item or service is expected to be furnished, or if the uninsured (or self-pay) individual requests the information, the GFE must be provided no later than 3 business days after the date of the request. /4/ These provisions apply beginning on
FOOTNOTE 4 PHS Act section 2799B-6. END FOOTNOTE
Internal Revenue Code (Code) section 9816(f), Employee Retirement Income Security Act of 1974 (ERISA) section 716(f), and PHS Act section 2799A-1(f), as added by section 111 of title I of Division BB of the CAA, require group health plans and health insurance issuers offering group or individual health insurance coverage, upon receiving a GFE regarding an item or service as described in PHS Act section 2799B-6, to send a covered individual, through mail or electronic means, as requested by the covered individual, an advanced explanation of benefits (AEOB) in clear and understandable language. Pursuant to 5 U.S.C. 8902(p), FEHB carriers must comply with AEOB requirements in the same manner as those provisions apply to a group health plan or health insurance issuer offering group or individual health insurance coverage. The plan, issuer, or carrier must provide an AEOB to the covered individual no later than 1 business day after the plan, issuer, or carrier receives the GFE. However, if such item or service was scheduled at least 10 business days before such item or service is to be furnished (or if the covered individual requested the information) the plan, issuer, or carrier must provide an AEOB to the covered individual within 3 business days after the date on which the plan, issuer, or carrier receives the GFE or request. The AEOB must include the following information: (1) the network status of the provider or facility; (2) the contracted rate for the item or service, or if the provider or facility is not a participating provider or facility, a description of how the covered individual can obtain information on providers and facilities that are participating; (3) the GFE received from the provider or facility; (4) a GFE of the amount the plan or coverage is responsible for paying; (5) the amount of any cost sharing which the covered individual would be responsible for paying with respect to the GFE received from the provider or facility; (6) a GFE of the amount that the covered individual has incurred towards meeting the limit of the financial responsibility (including with respect to deductibles and out-of-pocket maximums) under the plan or coverage as of the date of the AEOB; and (7) disclaimers indicating whether coverage is subject to any medical management techniques (including concurrent review, prior authorization, and step-therapy or fail-first protocols). The AEOB must also indicate that the information provided is only an estimate based on the items and services reasonably expected to be furnished, at the time of scheduling (or requesting) the item or service, and is subject to change; and any other information or disclaimer the plan, issuer, or carrier determines is appropriate and that is consistent with information and disclaimers required under this section of the statute. These provisions apply with respect to plan years (in the individual market, policy years) beginning on or after
HHS issued regulations implementing PHS Act section 2799B-6 related to GFEs for uninsured (or self-pay) individuals in interim final rulemaking that was published in the
FOOTNOTE 5 Requirements Related to Surprise Billing; Part II, 86 FR 55980, 55983 (
FOOTNOTE 6 Id.; FAQs about Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 49 (
II. Solicitation of Public Comments
Recognizing the complex issues involved in developing regulations to implement Code section 9816(f), ERISA section 716(f), and PHS Act sections 2799A-1(f) and 2799B-6, the Departments and OPM are requesting information from the public on a range of issues to better inform future rulemaking. The Departments and OPM welcome comments from all interested members of the public, including individuals potentially eligible to receive an AEOB, organizations serving or representing the interests of such individuals, health care providers and facilities, group health plans and health insurance issuers, carriers, third-party vendors, states, standards development organizations, and other health programs.
A. Transferring Data From Providers and Facilities to Plans, Issuers, and Carriers
As noted previously, the Departments and OPM have not yet established regulatory standards for the transfer of GFE data from providers and facilities to plans, issuers, and carriers. However, as CMS indicated in a blog post on
FOOTNOTE 7 Interoperability and the
FOOTNOTE 8 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for
FOOTNOTE 9 CMS supports
FOOTNOTE 10 85 FR 25510. END FOOTNOTE
The Departments and OPM invite the public to use their expertise and the information in this section to respond to the questions in this
* What issues should the Departments and OPM consider as they weigh policies to encourage the use of a FHIR-based API for the real-time exchange of AEOB and GFE data?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires the Secretary of HHS to adopt standards and operating rules for certain transactions that apply to covered entities (health plans, health care clearinghouses, and certain health care providers). The types of transactions to which these requirements apply are specified in section 1173(a)(2) of the Social Security Act. However, transactions related to advance cost estimates, such as exchanges of AEOB and GFE data, are not contemplated in section 1173(a)(2) of the Social Security Act and are therefore not among the financial and administrative transactions for which the Secretary of HHS must adopt HIPAA standards. As such, no law or regulation currently requires plans, issuers, carriers, providers, or facilities to use a specific transaction standard to exchange AEOB or GFE data. Instead, the Secretaries of the
Although HIPAA Administrative Simplification provisions do not apply to the exchange of AEOB and GFE data, HIPAA Privacy and Security requirements do. Plans, issuers, carriers, providers, and facilities that conduct certain health care transactions electronically are generally considered covered entities under the HIPAA Privacy and Security Rules and must comply with HIPAA Privacy and Security requirements in exchanging AEOB and GFE data. /11/
FOOTNOTE 11 45 CFR part 160 and subparts A and E of 45 CFR part 164. END FOOTNOTE
The Departments and OPM solicit feedback on the following:
* What privacy concerns does the transfer of AEOB and GFE data raise, considering these transfers would list the individual's scheduled (or requested) item or service, including the expected billing and diagnostic codes for that item or service? Does the exchange of AEOB and GFE data create new or unique privacy concerns for individuals enrolled in a plan or coverage? Are there any special considerations that Departments should take into account regarding individuals who are enrolled in a plan or coverage along with other members of their household? How should the Departments and OPM address these concerns?
Additionally, the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program /12/ consists of specified standards, implementation specifications, and certification criteria that health IT modules, including electronic health records systems, can meet.
FOOTNOTE 12 See ONC Health IT Certification Program, available at https://www.healthit.gov/topic/certification-ehrs/certification-health-it. END FOOTNOTE
* How could updates to this program support the ability of providers and facilities to exchange GFE information with plans, issuers, and carriers or support alignment between the exchange of GFE information and the other processes providers and facilities may engage in involving the exchange of clinical and administrative data, such as electronic prior authorization?
* Would the availability of certification criteria under the ONC Health IT Certification Program for use by plans, issuers, and carriers, or health IT developers serving plans, issuers, and carriers, help to enable interoperability of API technology adopted by these entities?
Many providers and facilities exchange information with plans, issuers, and carriers using manual or paper-based technologies, such as portals, fax machines, or call centers. Up to 46 percent of prior authorization requests are still submitted by fax, and 60 percent require a telephone call during the prior authorization process. /13/ The Departments and OPM are also interested in understanding if there are plans, issuers, and carriers that are small, rural, or have other characteristics (such as being new or financially vulnerable, or operating only in the individual or small group market), such that deploying standards-based API technology might pose a significant barrier to the plan's, issuer's, or carrier's ability to provide coverage to consumers.
FOOTNOTE 13
* What, if any, burdens or barriers would be encountered by small, rural, or other providers, facilities, plans, issuers, and carriers in complying with industry-wide standards-based API technology requirements for the exchange of AEOB and GFE data? How many small, rural, or other providers, facilities, plans, issuers, and carriers would encounter these burdens or barriers in complying with such technology requirements?
* Are there any approaches that the Departments and OPM should consider, or flexibility that should be provided (such as an exception or a phased-in approach to requiring providers and payers to adopt a standards-based API to exchange AEOB and GFE data), to account for small, rural, or other providers, facilities, plans, issuers, and carriers?
* If the Departments and OPM were to provide such flexibility, what factors should they consider in defining eligible providers, facilities, plans, issuers, and carriers?
B. Other Policy Considerations
In addition to issues related to how providers and facilities would transfer GFEs to plans, issuers, and carriers, there are also issues related to ensuring that providers and facilities transfer the necessary data for plans, issuers, and carriers to prepare accurate AEOBs that take into account how the No Surprises Act's or a State's surprise billing laws may affect an individual's benefits related to the items or services specified in the AEOB, and the individual's financial responsibility for these items or services. /14/ Under the No Surprises Act and its implementing regulations, nonparticipating providers of nonemergency items or services performed with respect to a visit to certain participating facilities are generally prohibited from charging individuals cost-sharing amounts greater than those that would apply in-network, and are prohibited from balance billing the individual; and, for these services, plans and issuers must count this cost sharing toward any in-network deductibles and out-of-pocket maximums. The same general standards also apply with respect to emergency services (including post-stabilization services, under certain circumstances) performed by nonparticipating providers and facilities, and to air ambulance services furnished by nonparticipating air ambulance service providers.
FOOTNOTE 14 Code section 9816(f), ERISA section 716(f), and PHS Act section 2799A-1(f). END FOOTNOTE
Additionally, with respect to post-stabilization services furnished by nonparticipating providers or facilities, and nonemergency services performed by nonparticipating providers with respect to patient visits to certain participating facilities, the nonparticipating provider or facility under certain circumstances may seek the individual's consent to waive those protections. /15/ The Departments and OPM request comment on the following questions in order to understand how to ensure that plans, issuers, and carriers have the requisite information to prepare an AEOB that takes into account an individual's consent, or lack of consent, to waiving balance billing and cost-sharing protections. /16/
FOOTNOTE 15 For more detailed information on these requirements, see 86 FR 36872. END FOOTNOTE
FOOTNOTE 16 References to the GFE in these questions refer to the GFE that providers and facilities must provide to plans, issuers, and carriers with respect to individuals enrolled in a plan or coverage (and seeking to have a claim for the item or service submitted to such plan or coverage) upon scheduling an item or service or requesting a GFE, as specified in section 2799B-6 of the PHS Act, as opposed to the GFE required to be included in the notice and consent to be treated by a nonparticipating provider under section 2799B-2(d)(2)(B) of the PHS Act and 45 CFR 149.420(d)(2). END FOOTNOTE
* Should a nonparticipating provider of nonemergency services be required to inform a plan, issuer, or carrier, as part of or concurrently with the GFE, whether the requested or scheduled items or services would be furnished with respect to the individual's visit to a participating facility? Should this requirement depend on whether the GFE was requested, as opposed to whether the furnishing of the items or services has been scheduled?
* In instances in which it is permissible for a nonparticipating provider or facility to request consent from an individual to waive the No Surprises Act's balance billing and cost-sharing protections, should the provider or facility be required to inform a plan, issuer, or carrier of the individual's consent, as part of or concurrently with providing the GFE, if it has already obtained the individual's consent? Should the nonparticipating provider or facility also be required to inform a plan, issuer, or carrier if the provider or facility intends to seek consent, or if the individual has already declined to give consent?
* If a nonparticipating provider is required to inform a plan, issuer, or carrier about the facility in which services are scheduled to be furnished, or if a nonparticipating provider or facility is required to inform a plan, issuer, or carrier about the status of a consent to waive the No Surprises Act's balance billing and cost-sharing protections, how should the nonparticipating provider or facility communicate the information? For example, should it be communicated as part of the GFE or in a separate document?
* In some cases in which an appointment for a nonparticipating provider or facility to furnish items or services at a facility is scheduled at least 72 hours prior to the date on which the individual is to be furnished the items or services, the provider (or the participating facility on behalf on the provider) or facility may provide notice and seek the patient's consent to waive the No Surprises Act's balance billing and cost-sharing protections not later than 72 hours prior to the date on which the individual is to be furnished the items or services. In cases in which the appointment is scheduled within 72 hours prior to the date on which the items or services are to be furnished, providers and facilities are required to provide the notice on the date the appointment to furnish the items or services is scheduled. When an individual is provided the notice on the same date that the items or services are to be furnished, providers and facilities are required to provide the notice no later than 3 hours prior to furnishing items or services to which the notice and consent requirements apply. If a nonparticipating provider or facility is required to inform a plan, issuer, or carrier, as part of or concurrently with the GFE, about the status of a consent to waive the No Surprises Act's balance billing and cost-sharing protections, how should the notice and consent timing requirement be coordinated with AEOB and GFE timing requirements?
Additionally, provisions of the No Surprises Act's or a State's surprise billing laws may affect an individual's benefits related to the items and services specified in an AEOB, as well as the individual's financial responsibility for those items or services. Therefore, the Departments and OPM seek information on the following:
* Generally, how should the AEOB reflect the way in which the No Surprises Act's or a State's surprise billing and cost-sharing protections may affect an individual's benefits related to the items or services specified in an AEOB, and the individual's financial responsibility for these items or services?
* In instances in which a plan, issuer, or carrier has been notified by a provider or facility that consent has been obtained from an individual to waive the No Surprises Act's or a State's surprise billing and cost-sharing protections, should the cost and benefit data in the AEOB explicitly reflect that those protections do not apply? Should the AEOB specifically state that the data is premised on the relevant provisions not applying as a result of the individual's consent? Should the AEOB reflect two different sets of cost and benefit data instead, one set reflecting that the No Surprises Act's or a State's surprise billing and cost-sharing protections do not apply, and one set reflecting the application of these protections (to account for the possibility that the individual might later revoke consent /17/ )?
FOOTNOTE 17 See 86 FR 36909 (discussing individuals' right to revoke consent regarding items and services not yet furnished). END FOOTNOTE
* In instances in which the plan, issuer, or carrier, at the time it is preparing the AEOB, has knowledge that the No Surprises Act's or a State's surprise billing and cost-sharing protections would apply unless individual consent has been given, but the plan, issuer, or carrier does not know whether consent has been given by the individual to waive those protections, should the AEOB include two sets of cost and benefit data, one set that would apply if consent is given, and one set that would apply if consent is not given?
The AEOB content requirements are similar to the Transparency in Coverage internet-based self-service tool requirements. /18/ Under those Transparency in Coverage requirements, plans, issuers, and carriers /19/ must make available to covered individuals (or an authorized representative) personalized enrollee cost-sharing information, including, when applicable, in-network rates for all covered health care items and services through an internet-based self-service tool and in paper form upon request. This information must be available for plan years (in the individual market, policy years) beginning on or after
FOOTNOTE 18 Transparency in Coverage, 85 FR 72158 (
FOOTNOTE 19 OPM instructed FEHB carriers to comply with the Transparency in Coverage Final Rule in Carrier Letter 2021-03 (
FOOTNOTE 20 85 FR 72182 through 72190. END FOOTNOTE
FOOTNOTE 21 26 CFR 54.9815-2715A2(c)(1); 29 CFR 2590.715-2715A2(c)(1); and 45 CFR 147.211(c)(1). END FOOTNOTE
* To what extent could the Departments' and OPM's coordination of the internet-based self-service tool requirements with AEOB requirements help minimize the burden on plans, issuers, and carriers in implementing both requirements?
* Can plans, issuers, and carriers leverage technical work done to comply with the internet-based self-service tool requirements to help streamline the process for complying with AEOB requirements?
* What, if any, obstacles would be encountered if plans, issuers, and carriers were required to provide AEOBs to covered individuals for all covered items or services (rather than a specified subset, similar to the rule for the first year of the internet-based self-service tool requirement) beginning with the first year of implementation of the AEOB provisions?
Some stakeholders have commented that a plan, issuer, or carrier providing a covered individual with an AEOB should also be required to provide a copy of the AEOB to the provider or facility that furnished the plan, issuer, or carrier with the GFE.
* Are there reasons why the Departments and OPM should or should not propose a requirement that plans, issuers, and carriers provide a copy of the AEOB to the provider or facility, as opposed to allowing such a transfer but not requiring it?
Code section 9816(f), ERISA section 716(f), and PHS Act section 2799A-1(f) allow covered individuals to make a request for an AEOB directly to their plan, issuer, or carrier. The plan, issuer, or carrier must provide an AEOB upon request to the covered individual no later than 3 business days after the date on which the plan, issuer, or carrier receives the request. /22/ The Departments and OPM are interested in recommendations for implementing this provision without placing unnecessary burden on plans, issuers, carriers, providers, and facilities.
FOOTNOTE 22 The plan, issuer, or carrier must provide the AEOB no later than 1 business day after the plan, issuer, or carrier receives the GFE, or if such item or service was scheduled at least 10 business days before such item or service is to be furnished (or if the covered individual requested the information), the plan, issuer, or carrier must provide an AEOB to the covered individual within 3 business days after the date on which the plan, issuer, or carrier receives the GFE or request. Code section 9816(f), ERISA section 716(f), and PHS Act section 2799A-1(f). END FOOTNOTE
* What, if any, burdens or barriers should be considered if the Departments and OPM propose to require plans, issuers, and carriers to communicate a covered individual's request for an AEOB to a particular provider or facility in order to receive GFE information from the provider or facility for use in formulating the requested AEOB?
Many individuals have multiple forms of health insurance coverage, including those to which AEOB requirements do not apply (such as Federal health care programs like Medicare, Medicaid, and TRICARE; /23/ and excepted benefits such as limited-scope dental and vision benefits). /24/
FOOTNOTE 23 A Federal health care program (as defined in section 1128B(f) of the Social Security Act) is not considered to be a "group health plan," "health insurance coverage," "individual health insurance coverage," "group health insurance coverage," or a "health insurance issuer," as referenced in Code section 9832, ERISA section 733, and PHS Act section 2791. END FOOTNOTE
FOOTNOTE 24 Code section 9832(c)(2), ERISA section 733(c)(2), PHS Act section 2791(c)(2) exclude limited-scope dental or vision benefits, if offered separately, from the Code, ERISA, and PHS Act requirements, respectively. END FOOTNOTE
* What approaches should be considered when proposing requirements related to the AEOB and GFE that account for, or do not account for, secondary and tertiary payers?
* What approaches should be considered to address application of the requirements related to the AEOB and GFE that account for, or do not account for, unique benefit designs, such as account-based plans?
Code section 9816(f)(2), ERISA section 716(f)(2), and PHS Act section 2799A-1(f)(2) provide that in the case of a covered individual scheduled to receive an item or service that is a specified item or service, the Secretaries may modify any timing requirements relating to the provision of the AEOB to such covered individual with respect to such specified item or service. Under the statute, the term "specified item or service" means an item or service that has low utilization or significant variation in costs (such as when furnished as part of a complex treatment), as specified by the Secretaries. /25/ The statute also provides that any modification made by the Secretaries may not result in the provision of the notification after the covered individual has been furnished the specified item or service. /26/ The Director of OPM (Director) may modify any timing requirements relating to the provision of the AEOB to a FEHB covered individual in the same manner as any modification is authorized to be made by the Secretaries, subject to OPM regulation and FEHB contract terms.
FOOTNOTE 25 Code section 9816(f)(2)(B), ERISA section 716(f)(2)(B), and PHS Act section 2799A-1(f)(2)(B). END FOOTNOTE
FOOTNOTE 26 Code section 9816(f)(2)(A), ERISA section 716(f)(2)(A), and PHS Act section 2799A-1(f)(2)(A). END FOOTNOTE
* What factors should the Departments and OPM consider when determining what items or services have low utilization or significant variation in costs (such as when furnished as part of a complex treatment) for the purposes of modifying AEOB timing requirements, and why?
* What are some examples of items or services that have low utilization or significant variation in costs (such as when furnished as part of a complex treatment) that the Departments and OPM should consider designating as specified items or services? Would designation of items or services as specified items or services vary by provider or facility type, or other variables, and why?
* How should AEOB timing requirements be modified with respect to the specified items or services, and why?
PHS Act section 2799B-6 requires GFEs, among other things, to include the expected billing and diagnostic codes for such items or services. Code section 9816(f)(1), ERISA section 716(f)(1), and PHS Act section 2799A-1(f)(1) require AEOBs to include the contracted rate under a plan or coverage for items or services (based on the billing and diagnostic codes provided by the provider or facility) expected to be provided by participating providers or participating facilities. Following issuance of interim final rules for GFEs for uninsured (or self-pay) individuals, HHS received feedback from providers and facilities that it is not always possible to provide a diagnosis code without first seeing and evaluating an individual, particularly with respect to initial screening visits or evaluation and management visits; or if there is not a relevant diagnosis code for an item or service, such as for certain dental screenings or procedures. In response to this feedback, HHS indicated in guidance that a provider or facility is required to provide a diagnosis code only where one is required for the calculation of the GFE for an uninsured (or self-pay) individual. /27/
FOOTNOTE 27 FAQs About Consolidated Appropriations Act, 2021 Implementation--Good Faith Estimates (GFE) for Uninsured (or Self-Pay) Individuals--Part 2 (
* The Departments and OPM are interested in plans', issuers', and carriers' perspectives on whether a diagnosis code would be required for the calculation of the AEOB. Are there items or services for which a plan, issuer, or carrier would not be able to determine points of information such as: (1) the contracted rate; (2) the coverage level (that is, if the plan or issuer covers an item or service associated with one diagnosis at a higher rate than an item or service associated with another); or (3) whether an item or service is covered (that is, if the item or service is covered for one diagnosis but not another) for an item or service based on the service code and other information in the GFE in the absence of a diagnosis code?
In developing processes for the AEOB and GFE for covered individuals, some industry groups have suggested that the provider or facility should verify the individual's enrollment status in a health plan or coverage for the scheduled (or requested) items or services with the plan, issuer, or carrier. Based on the results of this verification, the provider or facility would either provide the individual with a GFE that meets the requirements for GFEs for uninsured (or self-pay) individuals under 45 CFR 149.610, or provide a GFE for covered individuals to the individual's plan, issuer, or carrier. /28/ The Departments and OPM are interested in feedback on the potential impacts on providers, facilities, plans, issuers, or carriers if this verification were to be required.
FOOTNOTE 28
* What, if any, additional burden would be created by requiring providers, facilities, plans, issuers, and carriers to conduct (1) verification to determine whether an individual is uninsured, self-pay, or enrolled in a health plan or coverage for AEOB and GFE purposes; (2) verification of coverage for each item or service expected to be included in an AEOB or GFE; or (3) verification of coverage from multiple payers? Do providers and facilities already perform these types of verifications in the regular course of business, such that minimal additional burden would be imposed?
* Would it alleviate burden to allow providers and facilities, for purposes of verifying coverage, to rely on an individual's representation regarding whether the individual is enrolled in a health plan or coverage and seeking to have a claim for the items or services submitted to the plan or coverage? What might be the implications of taking this approach?
On
FOOTNOTE 29 86 FR 7009 (
underserved, marginalized, and adversely affected by persistent poverty and inequality." Executive Order 13985 also directs each agency to assess whether, and to what extent, its programs and policies perpetuate systemic barriers to opportunities and benefits for people of color and other underserved communities.
Consistent with Executive Order 13985, the Departments and OPM are exploring how best to ensure that plans', issuers', and carriers' communication to covered individuals is accessible, linguistically tailored, and at an appropriate literacy level. The Departments and OPM also remind plans, issuers, and carriers of any existing obligations to comply with requirements to provide effective communication (including materials disseminated by way of electronic and information technology for individuals with disabilities) under the Americans with Disabilities Act of 1990 and section 504 of the Rehabilitation Act of 1973, to provide meaningful access for individuals with limited English proficiency under title VI of the Civil Rights Act of 1964, and to comply with nondiscrimination requirements under section 1557 of the Affordable Care Act.
The Departments and OPM request public comment and feedback on the following questions:
* What unique barriers and challenges do underserved and marginalized communities face in understanding and accessing health care that the Departments and OPM should account for in implementing the AEOB and GFE requirements for covered individuals?
* What steps should the Departments and OPM consider to help ensure that all covered individuals, particularly those from underserved and marginalized communities, are aware of the opportunity to request AEOBs and GFEs and are able to utilize the information they receive in order to facilitate meaningful decision-making regarding their health care?
* Code section 9816(f), ERISA section 716(f), and PHS Act sections 2799A-1(f) and 2799B-6 require the AEOB and GFE to be provided in clear and understandable language. What additional approaches should be considered that would facilitate the provision of AEOBs and GFEs that are accessible, linguistically tailored, and at an appropriate literacy level for covered individuals, particularly those from underserved and marginalized communities and those with disabilities or limited English proficiency? Is there any specific language or phrasing that should be used to help mitigate any potential consumer confusion?
* Should the Departments and OPM consider adopting AEOB language access requirements that are similar to the Departments' existing requirements for group health plans and health insurance issuers, such as the internal claims and appeals and external review and Summary of Benefits and Coverage (SBC) requirements to provide oral language services, notices in non-English languages, and non-English language statements in English versions of notices indicating how to access language services? /30/ If so, what is the best way to ensure that information about language access services is communicated far enough in advance to facilitate the provision of the AEOB in the language that is most accessible to the individual?
FOOTNOTE 30 For example, the rules governing internal claims and appeals and external review processes under 26 CFR 54.9815-2719(e), 29 CFR 2590.715-2719(e), and 45 CFR 147.136(e) require plans and issuers to provide oral language services, notices in non-English languages, and non-English language statements in English versions of notices indicating how to access language services, with respect to notices sent to an address in a
C. Economic Impacts
The Departments and OPM are interested in understanding the potential economic impacts of implementing requirements related to the AEOB and GFE for covered individuals.
* Specifically, the Departments and OPM are interested in estimates of the time and cost burdens on providers and facilities, and separately on plans, issuers, and carriers, for building and maintaining a standards-based API for the real-time exchange of AEOB and GFE data.
* The Departments and OPM also seek comment on the extent to which providers, facilities, plans, issuers, and carriers are building and maintaining standards-based APIs for multiple purposes, or already have standards-based APIs in place that they can leverage to implement AEOB and GFE requirements. The Departments and OPM are also interested in how establishing standards-based APIs for these purposes may align with other HHS program requirements to implement standards-based APIs, such as requirements for certain payers covered under the CMS Interoperability and Patient Access final rule /31/ to use specific standards to implement the Patient and Provider Access APIs, as well as requirements applicable to health IT developers with health IT modules certified to certain criteria under the ONC Health IT Certification Program that provide standards-based API technology to providers and facilities as part of certified health IT products. In circumstances in which providers, facilities, plans, issuers, and carriers use or plan to use standards-based API technology for multiple purposes, the Departments and OPM are interested in estimates of the time and cost burden specifically related to AEOB and GFE implementation, separated out from the total cost of implementing and using this technology for multiple purposes, to accurately reflect the burden of implementing AEOB and GFE requirements.
FOOTNOTE 31 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for
* What would be the costs for purchasing and implementing a standards-based API for the real-time exchange of AEOB and GFE data from a third-party vendor, compared to building standards-based API functionality in-house? What percent of providers, facilities, plans, issuers, and carriers are likely to either purchase and implement the API via a third-party vendor compared to building and implementing the API in-house? How do these costs compare to alternative methods of exchanging AEOB and GFE data, such as through an internet portal or by fax?
In the Requirements Related to Surprise Billing; Part II interim final rule, HHS estimated that a total of 511,748 providers associated with health care facilities, individual physician practitioners, and wholly physician-owned private practices would incur the burden and costs associated with generating a GFE for uninsured (or self-pay) individuals. /32/
FOOTNOTE 32 86 FR 56080 (
* Are there factors that should be considered that might alter the number of providers and facilities that would incur the burden and cost of providing a GFE to plans, issuers, and carriers for covered individuals?
Some states have adopted laws requiring providers and facilities; or plans and issuers; or both providers and facilities and payers, to provide cost estimates to consumers before health care items or services are furnished. These laws vary with respect to the entities covered, the items or services to which requirements apply, how individualized the estimates must be, the format and timing of the estimates, the contents of the estimates, other accompanying requirements, and enforcement of these requirements. The Departments and OPM request feedback on the potential impacts of these policies.
* The Departments and OPM are interested in studies or other evidence related to the implementation and any effects of State laws that require entities to provide expected charges for health care items or services to consumers in advance of receiving these items or services. The Departments and OPM are particularly interested in publicly available studies or evidence.
* Is there other information that the Departments and OPM could find useful for quantifying the benefits of implementing requirements related to AEOB and GFE for covered individuals?
III. Collection of Information Requirements
Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the
This
The Departments and OPM will actively consider all input as the Departments and OPM develop future regulatory proposals or future subregulatory policy guidance. The Departments and OPM may or may not choose to contact individual responders. These communications would be for the sole purpose of clarifying statements in the responders' written responses. Contractor support personnel may be used to review responses to this
Signed at
Associate Director, Healthcare and Insurance,
Signed at
Associate Chief Counsel (Employee Benefits, Exempt Organizations, and Employment Taxes)
Signed at
Benefits Tax Counsel,
Signed at
Acting Assistant Secretary,
Secretary,
[FR Doc. 2022-19798 Filed 9-14-22;
BILLING CODE 6523-63-P; 4830-01-P; 4510-29-P; 4120-01-P
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