[Federal Register Volume 90, Number 104 (Monday, June 2, 2025)]
[Proposed Rules]
[Pages 23303-23308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09858]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
RIN 1545-BR51
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AC30
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 147
[CMS-9882-NC]
RIN 0938-AV64
Request for Information Regarding the Prescription Drug Machine-
Readable File Requirement in the Transparency in Coverage Final Rule
AGENCIES: Internal Revenue Service, Department of the Treasury;
Employee Benefits Security Administration, Department of Labor; Centers
for Medicare & Medicaid Services, Department of Health and Human
Services.
ACTION: Request for information.
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SUMMARY: This document is a request for information (RFI) regarding the
prescription drug machine-readable file disclosure requirements in the
Transparency in Coverage final rules. The Departments of Labor, Health
and Human Services (HHS), and the Treasury (the Departments) are
issuing this RFI to gather input regarding implementation of the
prescription drug machine-readable file disclosure requirements under
the Transparency in Coverage final rules, including what modifications
to the disclosure requirements or additional technical implementation
guidance might be necessary to better ensure the accurate and timely
completion of the prescription drug file.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below by July 2, 2025.
ADDRESSES: Written comments may be submitted to the address specified
below. Any comment that is submitted will be shared among the
Departments. Please do not submit duplicates.
Comments will be made available to the public. Warning: Do not
include any personally identifiable information (such as name, address,
or other contact information) or confidential business information that
you do not want publicly disclosed. All comments are posted on the
internet exactly as received and can be retrieved by most internet
search engines. No deletions, modifications, or redactions will be made
to the comments received, as they are public records. Comments may be
submitted anonymously.
In commenting, please refer to file code 1210-AC30. The Departments
cannot accept comments by facsimile (FAX) transmission. Comments must
be submitted in one of the following two 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 mail. You may mail written comments to the following address
ONLY: Office of Health Plan Standards and Compliance Assistance,
Employee Benefits Security Administration, Room N-5653, U.S. Department
of Labor, 200 Constitution Avenue NW, Washington, DC 20210, Attention:
1210-AC30.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
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 comments are posted on
the following website as soon as possible after they have been
received: https://www.regulations.gov. Follow the search instructions
on that website to view public comments.
FOR FURTHER INFORMATION CONTACT:
Alexander Krupnick, Internal Revenue Service, Department of the
Treasury, at (202) 317-5500.
Elizabeth Schumacher, Employee Benefits Security Administration,
Department of Labor, at (202) 693-8335.
Kendra May, Centers for Medicare & Medicaid Services, Department of
Health and Human Services, at (301) 448-3996.
Customer Service Information: Individuals interested in obtaining
information from the Department of Labor (DOL) concerning private
sector employment-based health coverage laws may submit a question at
askEBSA.dol.gov, call the Employee Benefits Security Administration
(EBSA) Toll-Free Hotline at 1-866-444-EBSA (3272) or visit the DOL's
website (www.dol.gov/agencies/ebsa). In addition, information from HHS
on private health insurance coverage and nonfederal governmental group
health plans can be found on the Centers for Medicare & Medicaid
Services (CMS) website (www.cms.gov/cciio), and information on
healthcare reform can be found at www.HealthCare.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Departments are soliciting information from the public to
inform future rulemaking or guidance on prescription drug price
transparency. As discussed below, in 2020 the Departments issued the
Transparency in Coverage final rules (TiC final rules) \1\ requiring
group health plans and health insurance issuers offering group or
individual health insurance coverage to make available to the public,
among other things, certain information relating to prescription drug
expenditures.
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\1\ 85 FR 72158 (Nov. 12, 2020).
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The Departments previously deferred enforcement of the provisions
of the TiC final rules relating to prescription drug expenditures in
published guidance, as discussed below.\2\ However, transparency in
healthcare pricing is a priority, and the Departments intend to
implement disclosure requirements related to prescription drug
expenditures and effectuate the goals of greater price transparency
including transparency related to prescription drug pricing. In
addition, President Trump issued an Executive Order to prioritize
improving existing price transparency requirements and ensuring that
patients have the information they
[[Page 23304]]
need to make well-informed decisions about their healthcare.\3\
Accordingly, the Departments now seek the public's feedback on ways to
effectively implement or amend the disclosure requirements related to
prescription drug expenditures in the TiC final rules.
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\2\ See FAQs About Affordable Care Act Implementation Part 61
(FAQs Part 61) (Sept. 27, 2023), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-61.pdf and https://www.cms.gov/files/document/faqs-about-affordable-care-act-implementation-part-61.pdf; FAQs About
Affordable Care Act and Consolidated Appropriations Act, 2021
Implementation Part 49 (FAQs Part 49), Q1 (Aug. 20, 2021), available
at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/affordable-care-act-faqs-49-2021.pdf
and https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf.
\3\ See Executive Order 14221, ``Making America Healthy Again by
Empowering Patients With Clear, Accurate, and Actionable Healthcare
Pricing Information,'' 90 FR 11005 (Feb. 28, 2025). Executive Order
14221 was issued on February 25, 2025, and was published in the
Federal Register on February 28, 2025.
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A. Statutory Background, Executive Order 13877, and the TiC Final Rules
The Patient Protection and Affordable Care Act (Pub. L. 111-148)
was enacted on March 23, 2010, and the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, PPACA)
reorganized, amended, and added to the provisions of part A of title
XXVII of the Public Health Service (PHS) Act relating to health
coverage requirements for group health plans and health insurance
issuers in the group and individual markets.\4\
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\4\ The PPACA also added section 715 to the Employee Retirement
Income Security Act of 1974 (ERISA) and section 9815 to the Internal
Revenue Code (Code) to incorporate the provisions of part A of title
XXVII of the PHS Act, PHS Act sections 2701 through 2728, making
them applicable to group health plans and health insurance issuers
providing coverage in connection with group health plans.
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Section 2715A of the PHS Act, incorporated into section 715 of the
Employee Retirement Income Security Act of 1974 (ERISA) and section
9815 to the Internal Revenue Code (Code), provides that group health
plans and health insurance issuers offering group or individual health
insurance coverage must comply with section 1311(e)(3) of the PPACA,\5\
which addresses transparency in health coverage and imposes certain
reporting and disclosure requirements on health plans that are seeking
certification as qualified health plans (QHPs) that may be offered on
an Exchange (as defined by section 1311(b)(1) of the PPACA). A plan or
coverage that is not offered through an Exchange and that is subject to
section 2715A of the PHS Act is required to submit the information
required to the Secretary of HHS and the relevant state's insurance
commissioner, and to make that information available to the public.
Together these statutory provisions require the majority of private
health plans to disseminate comprehensive information to provide
transparency in coverage.\6\
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\5\ Paragraph (A) of section 1311(e)(3) of the PPACA requires a
plan seeking certification as a QHP to make the following
information available to the public and submit it to state insurance
regulators, the Secretary of HHS, and the Exchange (1) Claims
payment policies and practices; (2) periodic financial disclosures;
(3) data on enrollment; (4) data on disenrollment; (5) data on the
number of claims that are denied; (6) data on rating practices; (7)
information on cost-sharing and payments with respect to any out-of-
network coverage, and (8)information on enrollee and participant
rights under Title I of the PPACA. Paragraph (A) also requires a
plan seeking certification as a QHP to submit any ``[o]ther
information as determined appropriate by the Secretary.'' Paragraph
(C) of section 1311(e)(3) of the PPACA requires plans, as a
requirement of certification as a QHP, to permit individuals to
learn the amount of cost sharing (including deductibles, copayments,
and coinsurance) under the individual's coverage that the individual
would be responsible for paying with respect to the furnishing of a
specific item or service by an in-network provider in a timely
manner upon the request of the individual. Paragraph (C) specifies
that, at a minimum, such information must be made available to the
individual through an internet website and through other means for
individuals without access to the internet.
\6\ While PHS Act section 2715A generally applies to group
health plans and health insurance issuers, certain plans and health
insurance coverage are not subject to these transparency provisions,
such as grandfathered health plans as defined under PPACA section
1251.
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On June 24, 2019, President Trump issued Executive Order 13877,
``Improving Price and Quality Transparency in American Healthcare to
Put Patients First.'' \7\ Executive Order 13877 sought to improve
transparency in healthcare and empower patients to make fully informed
decisions about their healthcare. As Executive Order 13877 noted,
``patients often lack both access to useful price and quality
information and the incentives to find low-cost, high-quality care.''
This ``generally leave[s] patients and taxpayers worse off than would a
more transparent system.'' \8\ To fulfill their responsibility under
Executive Order 13877, the Departments proposed \9\ and subsequently
finalized the TiC final rules.\10\ The TiC final rules published by the
Departments on November 12, 2020, implemented section 1311(e)(3) of the
PPACA. As described above, section 1311(e)(3) of the PPACA and section
2715A of the PHS Act address transparency in health coverage and
require group health plans and health insurance issuers offering group
or individual health insurance coverage to make certain information
available to the public.
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\7\ 84 FR 30849 (June 27, 2019). Executive Order 13877 was
issued on June 24, 2019, and was published in the Federal Register
on June 27, 2019.
\8\ Id.
\9\ 84 FR 65464 (Nov. 27, 2019).
\10\ 85 FR 72158 (Nov. 12, 2020).
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The TiC final rules require non-grandfathered group health plans
and health insurance issuers offering non-grandfathered group or
individual health insurance coverage to disclose cost-sharing
information for all covered items and services to participants,
beneficiaries, and enrollees through an internet-based self-service
tool or, if requested by the individual, on paper. These provisions of
the TiC final rules require plans and issuers to disclose cost-sharing
information upon request to a participant, beneficiary, or enrollee and
implement paragraph (C) of section 1311(e)(3) of PPACA.
The TiC final rules also require non-grandfathered group health
plans and health insurance issuers offering non-grandfathered group or
individual health insurance coverage to disclose on a public website
three separate machine-readable files containing certain information
regarding healthcare pricing under the plan or coverage. The machine-
readable file disclosure requirements are intended to make healthcare
pricing information accessible and useful to consumers and other
stakeholders (including employers, and other purchasers of health
care),\11\ support efforts to lower healthcare costs by driving
competition,\12\ and to supplement state transparency efforts.\13\
These provisions of the TiC final rules requiring plans and issuers to
disclose in-network negotiated rates, out-of-network allowed amounts
and the associated billed charges, and negotiated rates and historical
net prices for prescription drugs implement paragraph (A) of section
1311(e)(3) of the PPACA. The provisions requiring the disclosure of
out-of-network allowed amounts specifically implement the requirement
in section 1311(e)(3)(A)(vii) to provide information on ``payments with
respect to any out-of-network coverage.'' In addition to payment
information on out-of-network charges, the Secretary of HHS determined
that payment information on in-network rates and prescription drugs is
also appropriate information to require plans and issuers to disclose
to provide transparency in coverage under section 1311(e)(3)(A)(ix).
The machine-readable file disclosure requirements of the TiC final
rules are applicable for plan years (in the individual market, policy
years) beginning on or after January 1, 2022.
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\11\ 85 FR 72158, 72161 (Nov. 12, 2020).
\12\ Id.
\13\ 85 FR 72158, 72162.
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B. Prescription Drug Machine-Readable File Disclosure Requirement of
the TiC Final Rules
As relevant here, pursuant to the TiC final rules, non-
grandfathered group health plans and health insurance issuers offering
non-grandfathered group or individual health insurance
[[Page 23305]]
coverage must disclose to the public on an internet website, on a
monthly basis, the negotiated rates and historical net prices for
covered prescription drugs in a separate prescription drug machine-
readable file that is publicly available and accessible to any person
free of charge and without conditions.\14\
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\14\ In addition to the prescription drug machine-readable file,
plans and issuers must publish separate machine-readable files
disclosing in-network provider negotiated rates for covered items
and services, as well as historical out-of-network allowed amounts
and billed charges for covered items and services. See 26 CFR
54.9815-2715A3(b)(1), 29 CFR 2590.715-2715A3(b)(1), and 45 CFR
147.212(b)(1).
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Specifically, with respect to prescription drugs, plans and issuers
must make available to the public a machine-readable file containing
the following information:
for each coverage option offered by a group health plan or
health insurance issuer, the name and the 14-digit Health Insurance
Oversight System (HIOS) identifier, or, if the 14-digit HIOS identifier
is not available, the 5-digit HIOS identifier, or, if no HIOS
identifier is available, the Employer Identification Number (EIN); \15\
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\15\ This requirement was clarified in the Departments'
Paperwork Reduction Act (CMS-10715, 10/15/21) to allow reporting
HIOS ID numbers at the 10-digit level, or, if the 10-digit HIOS
identifier is not available, the 5-digit HIOS identifier, and
reporting of only EIN data if no relevant HIOS number is available.
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the National Drug Code (NDC), and the proprietary and
nonproprietary name assigned to the NDC by the Food and Drug
Administration, for each covered prescription drug item or service
under each coverage option offered by a plan or issuer;
the negotiated rates; and
historical net prices.\16\
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\16\ 26 CFR 54.9815-2715A3(b)(1)(iii), 29 CFR 2590.715-
2715A3(b)(1)(iii), and 45 CFR 147.212(b)(1)(iii).
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In disclosing the negotiated rates,\17\ such rates must be:
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\17\ For a definition of negotiated rate, see 26 CFR 54.9815-
2715A1(a)(2)(xvi), 29 CFR 2590.715-2715A1(a)(2)(xvi), and 45 CFR
147.210(a)(2)(xvi).
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reflected as a dollar amount, with respect to each NDC
that is furnished by an in-network provider, including an in-network
pharmacy or other prescription drug dispenser;
associated with the National Provider Identifier (NPI),
Tax Identification Number (TIN), and Place of Service Code for each in-
network provider, including each in-network pharmacy or other
prescription drug dispenser; and
associated with the last date of the contract term for
each provider-specific negotiated rate that applies to each NDC.\18\
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\18\ 26 CFR 54.9815-2715A3(b)(1)(iii)(C), 29 CFR 2590.715-
2715A3(b)(1)(iii)(C), and 45 CFR 147.212(b)(1)(iii)(C).
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Likewise, historical net prices \19\ must be:
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\19\ For a definition of historical net price, see 26 CFR
54.9815-2715A1(a)(2)(xi), 29 CFR 2590.715-2715A1(a)(2)(xi), and 45
CFR 147.210(a)(2)(xi).
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reflected as a dollar amount, with respect to each NDC
that is furnished by an in-network provider, including an in-network
pharmacy or other prescription drug dispenser;
associated with the NPI, TIN, and Place of Service Code
for each in-network provider, including each in-network pharmacy or
other prescription drug dispenser; and
associated with the 90-day time period that begins 180
days prior to the publication date of the machine-readable file for
each provider-specific historical net price that applies to each NDC
(except that a group health plan or health insurance issuer must omit
such data in relation to a particular NDC and provider when disclosing
such data would require the plan or issuer to report payment of
historical net prices calculated using fewer than 20 different claims
for payment).20 21
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\20\ 26 CFR 54.9815-2715A3(b)(1)(iii)(D), 29 CFR 2590.715-
2715A3(b)(1)(iii)(D), and 45 CFR 147.212(b)(1)(iii)(D).
\21\ The TiC final rules also clarify that nothing in 26 CFR
54.9815-2715A3(b)(1)(iii)(D), 29 CFR 2590.715-2715A3(b)(1)(iii)(D),
and 45 CFR 147.212(b)(1)(iii)(D) requires the disclosure of
information that would violate any applicable health information
privacy law.
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As the Departments stated in the preamble to the TiC final rules,
public disclosure of the historical net prices takes into account
rebates, discounts, dispensing fees, administrative fees, and other
price concessions. Together with disclosure of the negotiated rate,
upon which cost sharing is based, disclosure of the historical net
price provides important pricing information for achieving the goals of
transparency and ensuring that individuals have access to meaningful
prescription drug pricing information.\22\ The prescription drug
machine-readable file must be publicly available and accessible to any
person free of charge and without conditions, such as establishment of
a user account, password, or other credentials, or submission of
personally identifiable information to access the file.\23\ Plans and
issuers must update the machine-readable file monthly and clearly
indicate the date that the files were most recently updated.\24\ To
avoid unnecessary duplication, the TiC final rules set forth a special
rule for insured group health plans, providing that, to the extent
coverage under a group health plan consists of group health insurance
coverage, an issuer may provide the required information on behalf of
the plan pursuant to a written agreement between the plan and issuer to
do so. In the event the issuer agrees to provide the required
information via such written agreement but fails to do so, the issuer,
but not the plan, violates the transparency disclosure
requirements.\25\ The TiC final rules further clarify that plans and
issuers may also satisfy the requirements by entering into a written
agreement under which another party (such as a third-party
administrator or healthcare claims clearinghouse) will provide the
required information. However, the plan must monitor the other party to
ensure that the entity is providing the required disclosure.\26\ In the
event the party with which the group health plan or health insurance
issuers has entered a written agreement fails to provide the required
information, the plan or issuer violates the transparency disclosure
requirements.\27\
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\22\ 85 FR 72158, 72238 (Nov. 12, 2020).
\23\ 26 CFR 54.9815-2715A3(b)(2), 29 CFR 2590.715-2715A3(b)(2),
and 45 CFR 147.212(b)(2).
\24\ 26 CFR 54.9815-2715A3(b)(3), 29 CFR 2590.715-2715A3(b)(3),
and 45 CFR 147.212(b)(3).
\25\ 26 CFR 54.9815-2715A3(b)(4)(i), 29 CFR 2590.715-
2715A3(b)(4)(i), and 45 CFR 147.212(b)(4)(i).
\26\ 85 FR 72208.
\27\ 26 CFR 54.9815-2715A3(b)(4)(ii), 29 CFR 2590.715-
2715A3(b)(4)(ii), and 45 CFR 147.212(b)(4)(ii).
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Finally, the prescription drug machine-readable file must be made
available in a form and manner specified in guidance issued by the
Departments.\28\ Since issuance of the TiC final rules, the Departments
have published this technical implementation guidance on GitHub, a
forum that allows stakeholders to engage directly with the Departments
regarding technical and other implementation questions and
challenges.\29\ As discussed below, however, the Departments have not
issued final form-and-manner guidance implementing the prescription
drug machine-readable file requirement.
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\28\ 26 CFR 54.9815-2715A3(b)(2), 29 CFR 2590.715-2715A3(b)(2),
and 45 CFR 147.212(b)(2).
\29\ See, https://github.com/CMSgov/price-transparency-guide.
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C. Litigation and Guidance
Following issuance of the TiC final rules and enactment of the CAA,
but before the respective reporting requirements went into effect, a
number of legal and operational challenges caused the Departments to
delay
[[Page 23306]]
enforcement of the TiC final rules and the CAA's respective
prescription drug reporting requirements.\30\
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\30\ Shortly after the Departments finalized the TiC final
rules, the Consolidated Appropriations Act, 2021 (Pub. L. 116-260)
was enacted on December 27, 2020 (the CAA), which among other
things, imposed new transparency requirements pertaining to
reporting prescription drug expenditures. Plans and issuers must
annually report to the Departments certain information about
prescription drug expenditures under Code section 9825(a), ERISA
section 725(a), and PHS Act section 2799A-10(a).
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First, on August 10, 2021, the Chamber of Commerce of the United
States and the Tyler (Texas) Area filed suit in the U.S. District Court
for the Eastern District of Texas challenging the Departments' issuance
of the TiC final rules.\31\ The Chamber of Commerce alleged, among
other things, that the requirement to disclose the prescription drug
machine-readable file exceeded the Departments' statutory authority,
was not a logical outgrowth of the proposed rule, and was otherwise
arbitrary and capricious. Second, on August 12, 2021, the
Pharmaceutical Care Management Association (PCMA) filed suit in the
U.S. District Court for the District of Columbia, also challenging the
issuance of the TiC final rules.\32\ Its complaint made similar
allegations.
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\31\ Complaint, Chamber of Commerce of the United States of
America, et al., v. U.S. Department of Health & Hum. Servs., et al.,
No. 6:21-cv-309, Dkt. 1 (E.D. Tex. Aug. 10, 2021).
\32\ Complaint, Pharmaceutical Care Management Association v.
U.S. Department of Health & Hum. Servs., et al., No. 1:21-cv-02161,
Dkt. 1 (D.D.C. Aug. 12, 2021).
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In addition to these two lawsuits, the Departments received
inquiries from stakeholders seeking guidance on how to comply with the
new prescription drug reporting requirements under the CAA.
Stakeholders noted the difficulty in operationalizing their reporting
systems by the CAA's statutory deadline of December 27, 2021, and the
TiC final rules' deadline of January 1, 2022, as well as their
``concern about potentially duplicative and overlapping reporting
requirements for prescription drugs'' in the CAA and TiC final
rules.\33\
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\33\ See FAQs Part 49, Q1, supra note 2.
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In response to the lawsuits and stakeholder concerns, the
Departments issued FAQs Part 49 on August 20, 2021.\34\ These FAQs, in
part, addressed the prescription drug reporting requirements of the TiC
final rules and the CAA. With respect to the TiC final rules, the
Departments announced that they would defer enforcement of the
prescription drug machine-readable file requirement ``pending further
rulemaking'' and consideration of ``whether the prescription drug
machine-readable file requirement remains appropriate'' given the
reporting requirements of the CAA.\35\
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\34\ See FAQs Part 49.
\35\ See id. at Q1. The Departments also deferred enforcement of
the TiC final rules' other two machine-readable file requirements
until July 1, 2022. See id. at Q1 and Q2.
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Further, the Departments acknowledged in the FAQs ``the significant
operational challenges that plans and issuers may encounter in
complying with'' the CAA's reporting requirements.\36\ The Departments
``anticipate[d] that plans and issuers may also need additional time to
modify contractual agreements to enable disclosure and transfer of the
required data between various entities; to develop internal processes
and procedures; and to identify, compile, prepare, and validate the
required data.'' \37\ In recognition of these challenges, the
Departments announced their intent to ``defer enforcement'' of the
CAA's first deadline for reporting on December 27, 2021, and the second
deadline for reporting on June 1, 2022, pending the issuance of
regulations or further guidance.\38\
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\36\ Id. at Q12.
\37\ Id.
\38\ Id.
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In response, the Chamber of Commerce and PCMA dismissed their
respective lawsuits without prejudice.\39\ CMS also released a
statement on their GitHub technical guidance repository indicating that
the Departments would not issue guidance with respect to the form and
manner of the TiC final rules' prescription drug machine-readable
file.\40\ To date, the Departments have not issued notice-and-comment
rulemaking to revisit the prescription drug machine-readable file
disclosure requirement and have not issued finalized form-and-manner
guidance with respect to the prescription drug machine-readable file.
However, on November 23, 2021, the Departments and the Office of
Personnel Management (OPM) issued interim final rules implementing the
separate reporting requirements added by the CAA, including the
prescription drug reporting requirements.\41\
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\39\ See Notice of Voluntary Dismissal, Chamber of Commerce of
the United States of America, et al., v. U.S. Department of Health &
Hum. Servs., et al., No. 6:21-cv-309, Dkt. 12 (E.D. Tex. Aug. 25,
2021); Notice of Voluntary Dismissal, Pharmaceutical Care Management
Association v. U.S. Department of Health & Hum. Servs., et al., No.
1:21-cv-2161, Dkt. 14 (D.D.C. Dec. 1, 2021).
\40\ See https://github.com/CMSgov/price-transparency-guide.
\41\ See Prescription Drug and Health Care Spending, 86 FR 66662
(Nov. 23, 2021). OPM joined the Departments to require the
submission of information from Federal Employees Health Benefits
plans in the same manner as plans and issuers must provide such data
to the Departments under Code section 9825, ERISA section 725, and
PHS Act section 2799A-10.
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On March 23, 2023, the Foundation for Government Accountability
(FGA) sued the Departments over the deferral of enforcement of the
prescription drug machine-readable file disclosure requirement
announced in FAQs Part 49.\42\ The FGA's complaint alleged that the
Departments, in deferring enforcement of the prescription drug machine-
readable file disclosure requirement through guidance, had effectively
amended the TiC final rules outside of notice-and-comment rulemaking,
in violation of the Administrative Procedure Act. On September 27,
2023, the Departments released FAQs Part 61.\43\ FAQs Part 61 rescinded
Q1 of FAQs Part 49, which had expressed the Departments' general policy
of deferring enforcement of the TiC final rules' prescription drug
machine-readable file disclosure requirement pending further
consideration in a future rulemaking.\44\
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\42\ See Complaint, Foundation for Government Accountability v.
U.S. Department of Health & Hum. Servs., et al., No. 2:23-cv-207,
Dkt. 1 (M.D. Fla. Mar. 23, 2023).
\43\ FAQs About Affordable Care Act Implementation Part 61 (FAQs
Part 61) (Sept. 27, 2023), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-61.pdf and https://www.cms.gov/files/document/faqs-about-affordable-care-act-implementation-part-61.pdf.
\44\ See id. at Q1.
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The Departments announced that they would enforce the requirement
``on a case-by-case basis, as the facts and circumstances warrant.''
\45\ The Departments further indicated that they did not intend to
engage in rulemaking regarding the prescription drug machine-readable
file disclosure requirement in the near term but intended to ``develop
technical requirements and an implementation timeline in future
guidance that sufficiently account for any reliance interests that
plans and issuers may have developed with regard to FAQs Part 49.''
\46\ Following issuance of this guidance, FGA voluntarily dismissed its
lawsuit against the Departments.\47\
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\45\ Id.
\46\ Id.
\47\ Stipulation of Dismissal, Foundation for Government
Accountability v. U.S. Department of Health & Hum. Servs., et al.,
No. 2:23-cv-207, Dkt. 46 (M.D. Fla. Sept. 30, 2023).
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D. Executive Order 14221
On February 25, 2025, President Trump issued Executive Order 14221,
``Making America Healthy Again by Empowering Patients With Clear,
Accurate, and Actionable Healthcare Pricing Information'' (Executive
Order
[[Page 23307]]
14221).\48\ Executive Order 14221 stated that ``[m]aking America
healthy again will require empowering individuals with the best
information possible to inform their life and healthcare choices'' and
that building on the TiC final rules will make more meaningful price
information available to patients to support a more competitive,
innovative, affordable, and higher quality healthcare system. To that
end, the Executive Order prioritizes the promotion of universal access
to clear and accurate healthcare prices, including by improving
existing price transparency requirements, increasing enforcement of
price transparency requirements, and identifying opportunities to
further empower patients with meaningful price information.
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\48\ 90 FR 11005 (Feb. 28, 2025). The Executive Order was issued
on February 25, 2025, and was published in the Federal Register on
February 28, 2025.
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Among other things, Executive Order 14221 directs the Departments
to take all necessary and appropriate action to rapidly implement and
enforce healthcare price transparency regulations, including by issuing
within 90 days of the date of the Executive Order guidance or proposed
regulatory action updating enforcement policies designed to ensure
compliance with the transparent reporting of complete, accurate, and
meaningful data.
In support of Executive Order 14221 and the Departments' stated
commitment to furthering meaningful disclosure of prescription drug
pricing information the Departments now seek input from the public on
ways to effectively implement or amend the prescription drug machine-
readable file requirement, as provided below.
II. Solicitation of Comments
The Departments request comments from all interested stakeholders
to gain a better understanding of the issues related to compliance
with, and implementation of, the prescription drug machine-readable
file disclosure requirements. The TiC final rules made substantial,
initial progress towards the goals of promoting greater price
transparency in healthcare and empowering individuals with the
information they need to actively and effectively participate in the
healthcare system, promoting competition which may bring down overall
costs.
However, the Departments now seek additional input from the public
to better understand how to support a market-driven healthcare system
by giving consumers the information they need to make informed
decisions about their healthcare, and healthcare purchases,
specifically including prescription drugs. Making this information
widely and easily available will ultimately foster a more competitive,
innovative, affordable, and higher quality healthcare system. The
Departments are particularly interested in feedback related to
prescription drug disclosure requirements on the following topics: the
required data elements, including potential additional or alternative
data elements and other general implementation concerns.
A. Required Data Elements, Including Potential Additional or
Alternative Data Elements
1. Improvements to disclosure requirements: Are there existing data
elements described in 26 CFR 54.9815-2715A3(b)(1)(iii), 29 CFR
2590.715-2715A3(b)(1)(iii), and 45 CFR 147.212(b)(1)(iii) that would be
more useful if reported in a different form or manner? Are there ways
to simplify the reporting schema to streamline disclosure to relieve
reporting burdens? What are the appropriate metadata elements that
should be required to be associated with the public disclosure file?
Are there any improvements to disclosure requirements that would be
particularly useful to interested parties including consumers,
employers, and other purchasers of health care?
2. Unnecessary or irrelevant disclosures: Are there any data
elements that are currently in the public disclosure requirement with
respect to prescription drugs that are not relevant or useful and could
be removed in order to simplify the reporting schema while maintaining
the integrity of the prescription drug pricing disclosure requirements?
Should the Departments remove any data elements, and why? Are there
ways to reduce the volume of redundant or duplicative data?
3. Disclosure of dosage units: How do plans, issuers, and PBMs
store and manage pricing information for dosage units of prescription
drugs? Should the Departments require a standardized format for
disclosing dosage units and supply periods for prescription drugs
(e.g., by 7-day, 30-day, or 90-day supply, by each dosage, or some
other standardized dosage unit)? Should the Departments require
disclosure of the quantity of the drug on which the price is reported?
4. Remuneration details: What specific data elements should the
Departments require to provide meaningful disclosure of pre-rebate and
post-rebate pricing? Should the Departments require plans and issuers
to provide specific data pertaining to bundled payment arrangements or
any alternative payment models in a manner that shows actual prices?
5. Identification of entities: Should the Departments require plans
and issuers to identify the PBM or other service provider, if any, that
manages a plan's or coverage's pharmacy benefits, to facilitate better
comparison of prices and data between plans and coverages? Would there
be any benefit or burden associated with requiring a plan or issuer to
identify pharmacies that are affiliated with the plan's or coverage's
PBM and would such benefit be worth the added burden?
6. Exclusions: Are there any items or services that are typically
processed under a plan's or coverage's pharmacy benefits that should be
excluded from the prescription drug machine-readable file for any
reason? For example, are there items or services typically processed
under a pharmacy benefit that are not prescription drugs, that are
already published in one of the other machine-readable files, or that
may be omitted because they constitute confidential business data or
intellectual property?
7. Benefits structure: Are there any prescription drugs that are
typically processed under a plan's or coverage's medical benefits or
under its pharmacy benefits depending on the setting in which the items
or services are provided? To the extent that prescription drugs that
are processed under a plan's or coverage's medical benefits are
disclosed in the in-network or out-of-network machine-readable files,
are there benefits to requiring that such drugs be disclosed in the
prescription drug machine-readable file in addition to the other
machine-readable files? For example, would such duplication reveal
disparities in pricing of prescription drugs based on the setting in
which they are administered or the vendor that processes the benefit?
8. Alignment: Are there ways the Departments should align the TiC
prescription drug reporting requirements with the prescription drug
data reporting requirements under the Hospital Price Transparency rule?
\49\
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\49\ 45 CFR Sec. 180.50 (Nov. 27, 2019).
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B. General Implementation Questions
1. Implementation timeline: Have any plans or issuers begun
building the infrastructure needed and if so, to what extent has that
been completed?
2. Operational feedback: Are there operational, formatting, or
technical considerations that would improve and quicken the
Departments' ability to begin enforcement of the required
[[Page 23308]]
prescription drug machine-readable file while maintaining data
integrity?
3. Leveraging existing infrastructure: Are plans and issuers able
to leverage the infrastructure used to implement the in-network rates
and out-of-network allowed amounts machine-readable files to comply
with these requirements, and to what extent are they able to do so?
4. File format: What challenges and advantages would result from
requiring that machine-readable prescription drug files be delivered in
JSON or CSV file formats?
5. State approaches and innovation: Are there state laws with
requirements similar to the prescription drug machine-readable file
disclosure requirements that could serve as models for implementing or
amending the requirements under 26 CFR 54.9815-2715A3(b)(1)(iii), 29
CFR 2590.715-2715A3(b)(1)(iii), and 45 CFR 147.212(b)(1)(iii)? If so,
in what ways are these state laws directly comparable to 26 CFR
54.9815-2715A3(b)(1)(iii), 29 CFR 2590.715-2715A3(b)(1)(iii), and 45
CFR 147.212(b)(1)(iii)? Are there other innovations that states have
employed with respect to prescription drug reporting that the
Departments should consider implementing?
6. File size optimization: Are there steps that the Departments can
take, either in regulations, technical implementation guidance, or
otherwise, to minimize the size of the prescription drug machine-
readable files while ensuring data therein remains useful and relevant?
7. Compliance costs: What actions could the Departments take to
minimize the compliance costs of implementing and maintaining the
prescription drug machine-readable file disclosure requirements of the
TiC final rules?
III. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping, or third-party disclosure
requirements under the Paperwork Reduction Act of 1995 (PRA). However,
Section II of this document does contain a general solicitation of
comments in the form of a request for information. In accordance with
the implementing regulations of the 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. Consequently, there is no need for review by the Office of
Management and Budget under the authority of the PRA.
Signed at Washington, DC.
Philip J. Lindenmuth,
Acting Associate Chief Counsel (Employee Benefits, Exempt
Organizations, and Employment Taxes), Internal Revenue Service,
Department of the Treasury.
Signed at Washington, DC.
Helen H. Morrison,
Benefits Tax Counsel, Department of the Treasury.
Signed at Washington, DC.
Timothy Hauser,
Deputy Assistant Secretary for Program Operations, Employee Benefits
Security Administration, Department of Labor.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-09858 Filed 5-30-25; 8:45 am]
BILLING CODE 4510-29-P