[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Proposed Rules]
[Pages 56905-56912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19798]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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 

  Federal Register / Vol. 87 , No. 179 / Friday, September 16, 2022 / 
Proposed Rules  

[[Page 56905]]



OFFICE OF PERSONNEL MANAGEMENT

5 CFR Chapter I

RIN 3206-AO45

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Chapter I

RIN 1545-BQ37

DEPARTMENT OF LABOR

Employee Benefits Security Administration

29 CFR Chapter XXV

RIN 1210-AC14

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Subchapter B

[CMS-9900-NC]
RIN 0938-AU98


Request for Information; Advanced Explanation of Benefits and 
Good Faith Estimate for Covered Individuals

AGENCY: Office of Personnel Management (OPM); Internal Revenue Service, 
Department of the Treasury; Employee Benefits Security Administration 
(EBSA), Department of Labor (DOL); and Centers for Medicare & Medicaid 
Services (CMS), Department of Health and Human Services (HHS).

ACTION: Request for information.

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SUMMARY: This document is a request for information (RFI) to inform 
DOL, HHS, and the Treasury (collectively, the Departments) and OPM's 
rulemaking for advanced explanation of benefits (AEOB) and good faith 
estimate (GFE) requirements of the No Surprises Act, which was enacted 
as part of the Consolidated Appropriations Act, 2021 (CAA). This RFI 
seeks information and recommendations on transferring data from 
providers and facilities to plans, issuers, and carriers; other policy 
approaches; and the economic impacts of implementing these 
requirements.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below by November 15, 2022.

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: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-9900-NC, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    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: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-9900-NC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    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: 
    Padma Babubhai Shah, Office of Personnel Management (OPM), (202) 
606-4056.
    Emily Ames, Centers for Medicare & Medicaid Services (CMS), (301) 
492-4246.
    William Fischer, Internal Revenue Service (IRS), (202) 317-5500.
    Elizabeth Schumacher or Frank Kolb, Employee Benefits Security 
Administration (EBSA), (202) 693-8335.
    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 Department of Labor (DOL) 
concerning employment-based health coverage laws may call the EBSA 
Toll-Free Hotline at 1-866-444-EBSA (3272) or visit DOL's website 
(www.dol.gov/ebsa). In addition, information from HHS on private health 
insurance for consumers can be found on the CMS website (www.cms.gov/cciio) and information on the No Surprises Act can be found at 
www.cms.gov/NoSurprises.

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 December 27, 2020, the Consolidated Appropriations Act, 2021 
(CAA), which includes the No Surprises Act, was enacted.\1\ The No 
Surprises Act provides Federal protections against surprise billing and 
limits out-of-network cost sharing under many of the circumstances in 
which surprise bills arise most frequently. Surprise billing occurs 
when an individual receives an unexpected medical bill from a health 
care provider or facility, including providers of air ambulance 
services, after receiving medical services from a provider or facility 
that, usually unknown to the covered individual, is a nonparticipating 
provider or facility in the individual's health plan or health 
insurance coverage.
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    \1\ Public Law 116-260 (December 27, 2020).
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    Public Health Service (PHS) Act section 2799B-6, as added by 
section

[[Page 56906]]

112 of title I of Division BB of the CAA, requires providers and 
facilities,\2\ upon an individual's scheduling of an item or service, 
or upon an individual's request, to inquire if the individual is 
enrolled in a group health plan or group or individual health insurance 
coverage. If the individual is enrolled in a plan or coverage and is 
seeking to have a claim for such item or service submitted to such plan 
or coverage, providers and facilities must provide to the plan, issuer, 
or carrier, a good faith estimate (GFE) of the expected charges for 
furnishing the scheduled item or service (and any items or services 
reasonably expected to be provided in conjunction with those items or 
services, including those provided by another provider or facility), 
along with the expected billing and diagnostic codes for these items or 
services. If the individual is not enrolled or is not seeking to have a 
claim for such item or service submitted to such plan or coverage (that 
is, an uninsured or self-pay individual), providers and facilities must 
provide the GFE directly to the individual, as described in PHS Act 
section 2799B-6 and implementing regulations at 45 CFR 149.610. The 
Department of Health and Human Services (HHS) interprets the 
requirements described in PHS Act section 2799B-6 to apply to providers 
and facilities furnishing items or services to individuals covered by 
the Federal Employees Health Benefits (FEHB) Program in the same manner 
as for individuals enrolled in a group health plan or group or 
individual health insurance coverage.\3\
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    \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.''
    \3\ See 86 FR 55980, 55983 at FN 12.
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    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 January 1, 2022.
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    \4\ PHS Act section 2799B-6.
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    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 
January 1, 2022.
    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 Federal Register on October 7, 
2021, but deferred enforcement of the portion of PHS Act section 2799B-
6 related to GFEs for covered individuals who are seeking to have a 
claim submitted to their plan or issuer for scheduled items or 
services.\5\ In the preamble to that rule (and as stated in guidance 
issued by the Departments), the Departments also deferred enforcement 
of Code section 9816(f), ERISA section 716(f), and PHS Act section 
2799A-1(f) related to the requirement that plans and issuers provide an 
AEOB.\6\ The decision to defer enforcement was made in response to 
stakeholder requests that the Departments first establish standards for 
the data transfer from providers and facilities to plans and issuers, 
and give plans, issuers, providers, and facilities enough time to build 
the infrastructure necessary to support the transfers. The Departments 
agreed that compliance with these sections was likely not possible by 
January 1, 2022, and indicated an intent to undertake notice and 
comment rulemaking in the future to implement these provisions, 
including establishing appropriate data transfer standards. Until that 
time, HHS is deferring enforcement of the

[[Page 56907]]

requirement that providers and facilities must provide a GFE to plans 
and issuers for covered individuals enrolled in a health plan or 
coverage and seeking to have a claim submitted for scheduled (or 
requested) items or services to their plan or coverage, and the 
Departments are deferring enforcement of the requirement that plans and 
issuers must provide these covered individuals with an AEOB. FEHB 
carriers' compliance will be concurrent and consistent with 
implementing regulations issued by the Departments, subject to OPM 
regulation and FEHB contract terms.
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    \5\ Requirements Related to Surprise Billing; Part II, 86 FR 
55980, 55983 (October 7, 2021), available at https://www.federalregister.gov/documents/2021/10/07/2021-21441/requirements-related-to-surprise-billing-part-ii.
    \6\ Id.; FAQs about Affordable Care Act and Consolidated 
Appropriations Act, 2021 Implementation Part 49 (August 20, 2021), 
Q6, available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-49.pdf.
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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 December 8, 2021,\7\ the Health Level 7 
(HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) 
standard holds potential for supporting interoperability and enabling 
new entrants and competition throughout the health care industry. FHIR 
is a standard that was developed specifically to support 
interoperability and securely facilitate the exchange of health care 
information between systems. In the time since the FHIR standard was 
first created, the health care industry has rapidly embraced the 
standard through substantial investments in industry pilots, 
specification development, and the deployment of FHIR-based Application 
Programming Interfaces (APIs) supporting a variety of business 
needs.\8\ Some industry-led FHIR AcceleratorTM programs, 
such as Da Vinci and CARIN,\9\ have created implementation guides (IGs) 
that CMS has recommended for use in meeting the requirements of the CMS 
Interoperability and Patient Access final rule for Patient Access and 
Provider Directory APIs.\10\ In 2021, the Da Vinci FHIR 
AcceleratorTM program launched a Patient Cost Transparency 
project dedicated to developing an IG that could be used to exchange 
AEOB and GFE information. This IG uses a FHIR-based API for exchange of 
AEOB and GFE data from providers to payers and is currently published 
as a Standard for Trial Use (STU). The current version of the STU is 
useable by industry today, and the Patient Cost Transparency workgroup 
continues to revise and update draft standard versions based on public 
comments received through the ballot process. The ballot process 
supports industry consensus on the IG and ensures its usability by all 
stakeholders--including payers, providers, and vendors--to ultimately 
serve patients and ensure they have access to the information they 
need.
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    \7\ Interoperability and the Connected Health Care System 
(December 8, 2021), available at https://www.cms.gov/blog/interoperability-and-connected-health-care-system.
    \8\ Medicare and Medicaid Programs; Patient Protection and 
Affordable Care Act; Interoperability and Patient Access for 
Medicare Advantage Organization and Medicaid Managed Care Plans, 
State Medicaid Agencies, CHIP Agencies and CHIP Managed Care 
Entities, Issuers of Qualified Health Plans on the Federally-
Facilitated Exchanges, and Health Care Providers (CMS 
Interoperability and Patient Access final rule), 85 FR 25510 (May 1, 
2020), available at https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-05050.pdf.
    \9\ CMS supports Da Vinci and CARIN by funding contracts to 
build implementation guides (IGs). CARIN is an accelerator project 
responsible for the IG used for the Patient Access API. Other 
accelerators include Gravity (social risk data), Codex (Cancer), and 
Helios (Public Health).
    \10\ 85 FR 25510.
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    The Departments and OPM invite the public to use their expertise 
and the information in this section to respond to the questions in this 
RFI in their comments. The input may help inform development of future 
regulations.
     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 Treasury, Labor, and HHS (the Secretaries) have 
general rulemaking authority to establish standards necessary to 
implement the provisions of Code section 9816(f), ERISA section 716(f), 
and PHS Act section 2799A-1(f).
    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\
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    \11\ 45 CFR part 160 and subparts A and E of 45 CFR part 164.
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    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.
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    \12\ See ONC Health IT Certification Program, available at 
https://www.healthit.gov/topic/certification-ehrs/certification-health-it.

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[[Page 56908]]

     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.
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    \13\ America's Health Insurance Plans (AHIP), New Fast PATH 
Initiative Aims to Improve Prior Authorization for Patients and 
Doctors (January 6, 2020), available at https://www.ahip.org/new-fast-path-initiative-aims-to-improve-prior-authorization-for-patients-and-doctors/.
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     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.
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    \14\ Code section 9816(f), ERISA section 716(f), and PHS Act 
section 2799A-1(f).
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    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\
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    \15\ For more detailed information on these requirements, see 86 
FR 36872.
    \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).
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     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,

[[Page 56909]]

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\)?
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    \17\ See 86 FR 36909 (discussing individuals' right to revoke 
consent regarding items and services not yet furnished).
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     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 
January 1, 2023, with respect to the 500 items and services identified 
by the Departments in Table 1 in the preamble to the Transparency in 
Coverage final rule; \20\ and with respect to all covered items and 
services, for plan or policy years beginning on or after January 1, 
2024.\21\ The Departments and OPM request input on how these 
requirements interact, or could interact, with AEOB requirements.
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    \18\ Transparency in Coverage, 85 FR 72158 (November 12, 2020), 
available at https://www.govinfo.gov/content/pkg/FR-2020-11-12/pdf/2020-24591.pdf; 26 CFR 54.9815-2715A2(b); 29 CFR 2590.715-2715A2(b); 
and 45 CFR 147.211(b).
    \19\ OPM instructed FEHB carriers to comply with the 
Transparency in Coverage Final Rule in Carrier Letter 2021-03 
(February 17, 2021), available at https://www.opm.gov/healthcare-insurance/healthcare/carriers/2021/2021-03.pdf.
    \20\ 85 FR 72182 through 72190.
    \21\ 26 CFR 54.9815-2715A2(c)(1); 29 CFR 2590.715-2715A2(c)(1); 
and 45 CFR 147.211(c)(1).
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     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.
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    \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).
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     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\

[[Page 56910]]

and excepted benefits such as limited-scope dental and vision 
benefits).\24\
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    \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.
    \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.
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     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.
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    \25\ Code section 9816(f)(2)(B), ERISA section 716(f)(2)(B), and 
PHS Act section 2799A-1(f)(2)(B).
    \26\ Code section 9816(f)(2)(A), ERISA section 716(f)(2)(A), and 
PHS Act section 2799A-1(f)(2)(A).
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     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\
---------------------------------------------------------------------------

    \27\ FAQs About Consolidated Appropriations Act, 2021 
Implementation--Good Faith Estimates (GFE) for Uninsured (or Self-
Pay) Individuals--Part 2 (April 5, 2022), available at https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Guidance-Good-Faith-Estimates-FAQ-Part-2.pdf.
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     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.
---------------------------------------------------------------------------

    \28\ See Council for Affordable Quality Healthcare, Inc. (CAQH) 
Committee on Operating Rules for Information Exchange (CORE), 
Establishing the Building Blocks for Price Transparency: Industry 
Guidance on Provider to Payer Approaches for Good Faith Estimate 
Exchanges (2021), available at https://www.caqh.org/sites/default/files/CORE%20-%20Price%20Transparency%20Whitepaper_v4.pdf.
---------------------------------------------------------------------------

     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 January 20, 2021, President Biden issued Executive Order 13985, 
``Advancing Racial Equity and Support for Underserved Communities 
Through the Federal Government,'' \29\ directing that as a policy 
matter, ``the Federal government should pursue a comprehensive approach 
to advancing equity for all, including people of color and others who 
have been historically
---------------------------------------------------------------------------

    \29\ 86 FR 7009 (January 20, 2021), available at https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf.

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[[Page 56911]]

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?
---------------------------------------------------------------------------

    \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 United States county where ten 
percent or more of the population residing in the county is literate 
only in the same non-English language. Additionally, the SBC and 
Uniform Glossary regulations at 26 CFR 54.9815-2715(a)(5), 29 CFR 
2590.715-2715(a)(5), and 45 CFR 147.200(a)(5) require group health 
plans and health insurance issuers to provide the SBC in a 
culturally and linguistically appropriate manner, in accordance with 
the thresholds and standards of 26 CFR 54.9815-2719(e), 29 CFR 
2590.715-2719(e), and 45 CFR 147.136(e). The regulations governing 
the style and format of summary plan descriptions (SPD) under ERISA 
at 29 CFR 2520.102-2 require the SPD to be provided in non-English 
languages if, for a plan that covers fewer than 100 participants, 25 
percent or more of all plan participants are literate only in the 
same non-English language; or, for a plan that covers 100 or more 
participants, if the lesser of: (1) 500 or more participants; or (2) 
10 percent or more of all plan participants are literate only in the 
same non-English language.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \31\ Medicare and Medicaid Programs; Patient Protection and 
Affordable Care Act; Interoperability and Patient Access for 
Medicare Advantage Organization and Medicaid Managed Care Plans, 
State Medicaid Agencies, CHIP Agencies and CHIP Managed Care 
Entities, Issuers of Qualified Health Plans on the Federally-
Facilitated Exchanges, and Health Care Providers Final Rule, 85 FR 
25510 (May 1, 2020), available at https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-05050.pdf.
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     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?

[[Page 56912]]

    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\
---------------------------------------------------------------------------

    \32\ 86 FR 56080 (October 7, 2021).
---------------------------------------------------------------------------

     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 Federal Register or other publications, regardless of 
the form or format thereof, provided that no person is required to 
supply specific information pertaining to the commenter, other than 
that necessary for self-identification, as a condition of the agency's 
full consideration, are not generally considered information 
collections and therefore not subject to the PRA.
    This RFI is issued solely for information and planning purposes; it 
does not constitute a Request for Proposal (RFP), applications, 
proposal abstracts, or quotations. This RFI does not commit the U.S. 
Government to contract for any supplies or services or make a grant 
award. Further, the Departments and OPM are not seeking proposals 
through this RFI and will not accept unsolicited proposals. Responders 
are advised that the U.S. Government will not pay for any information 
or administrative costs incurred in response to this RFI; all costs 
associated with responding to this RFI will be solely at the interested 
party's expense. The Departments and OPM note that not responding to 
this RFI does not preclude participation in any future procurement, if 
conducted. It is the responsibility of the potential responders to 
monitor this RFI announcement for additional information pertaining to 
this request. In addition, the Departments and OPM will not respond to 
questions about the policy issues raised in this RFI.
    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 RFI. Responses to this notice are not offers and 
cannot be accepted by the U.S. Government to form a binding contract or 
issue a grant. Information obtained as a result of this RFI may be used 
by the U.S. Government for program planning on a non-attribution basis. 
Responders should not include any information that might be considered 
proprietary or confidential. This RFI should not be construed as a 
commitment or authorization to incur cost for which reimbursement would 
be required or sought. All submissions become U.S. Government property 
and will not be returned. In addition, the Departments and OPM may 
publicly post the public comments received, or a summary of those 
public comments.

    Signed at Washington DC.
Laurie Bodenheimer,
Associate Director, Healthcare and Insurance, Office of Personnel 
Management.

    Signed at Washington DC.
Rachel D. Levy,
Associate Chief Counsel (Employee Benefits, Exempt Organizations, and 
Employment Taxes) Internal Revenue Service, Department of the Treasury.

    Signed at Washington DC.
Carol A. Weiser,
Benefits Tax Counsel, Department of the Treasury.

    Signed at Washington DC.
Ali Khawar,
Acting Assistant Secretary, Employee Benefits Security Administration, 
U.S. Department of Labor.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-19798 Filed 9-14-22; 4:15 pm]
BILLING CODE 6523-63-P; 4830-01-P; 4510-29-P; 4120-01-P