[Federal Register Volume 91, Number 40 (Monday, March 2, 2026)]
[Proposed Rules]
[Pages 10033-10034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04084]
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DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2550
RIN 1210-AB37
Improving Transparency Into Pharmacy Benefit Manager Fee
Disclosure; Extension of Comment Period
AGENCY: Employee Benefits Security Administration, Department of Labor.
ACTION: Proposed rule; extension of the comment period.
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SUMMARY: This document extends the comment period on the Department's
Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure
proposed rule. The proposed rule would require providers of pharmacy
benefit management services and affiliated providers of brokerage and
consulting services to disclose information about their compensation to
fiduciaries of self-insured group health plans subject to the Employee
Retirement Income Security Act (ERISA), for purposes of ERISA's
statutory prohibited transaction exemption for services arrangements.
The proposed rule was published in the Federal Register on January 30,
2026, with a comment deadline of March 31, 2026. On February 3, 2026,
the Consolidated Appropriations Act, 2026 amended ERISA to add several
provisions relating to providers of pharmacy benefit management
services. Consequently, the Department is extending the comment period
for an additional 15 days, to April 15, 2026, to allow interested
persons to address whether the rule should be adjusted due to these new
statutory provisions.
DATES: The comment period for the proposed rule published January 30,
2026, at 91 FR 4348, is extended. Comments should be received on or
before April 15, 2026.
ADDRESSES: You may submit comments, identified by RIN 1210-AB37, by one
of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail or Personal Delivery: Office of Regulations and
Interpretations, Employee Benefits Security Administration, Room N-
5655, U.S. Department of Labor, 200 Constitution Avenue NW, Washington,
DC 20210.
Instructions: All submissions received must include the agency name
and Regulation Identifier Number (RIN) for this rulemaking. Comments
received, including any personal information provided, will be posted
without change to http://www.regulations.gov and http://www.dol.gov/ebsa, and made available for public inspection at the Public Disclosure
Room, N-1513, Employee Benefits Security Administration, 200
Constitution Avenue NW, Washington, DC 20210. Persons submitting
comments electronically are encouraged not to submit paper copies. We
encourage commenters to include supporting facts, research, and
evidence in their comments. When doing so, commenters are encouraged to
provide citations to the published materials referenced, including
active hyperlinks. Likewise, commenters who reference materials which
have not been published are encouraged to upload relevant data
collection instruments, data sets, and detailed findings as a part of
their comment. Providing such citations and documentation will assist
us in analyzing the comments.
[[Page 10034]]
Warning: Do not include any personally identifiable or confidential
business information that you do not want publicly disclosed. Comments
are public records posted on the internet as received and can be
retrieved by most internet search engines.
Docket: Go to the Federal eRulemaking Portal at https://www.regulations.gov for access to the rulemaking docket, including the
plain-language summary of the proposed rule of not more than 100 words
in length required by the Providing Accountability Through Transparency
Act of 2023.
FOR FURTHER INFORMATION CONTACT: Stephen Sklenar or Saliha Moore,
Office of Regulations and Interpretations, Employee Benefits Security
Administration, Department of Labor, at 202-693-8513. This is not a
toll-free number.
Customer service information: Individuals interested in obtaining
general information from the Department of Labor concerning Title I of
ERISA may call the EBSA Toll-Free Hotline at 1-866-444-EBSA (3272) or
visit the Department's website (www.dol.gov/agencies/ebsa).
SUPPLEMENTARY INFORMATION: In Executive Order 14273, Lowering Drug
Prices by Once Again Putting Americans First, President Trump
instructed the Department to propose regulations to improve employer
health plan transparency into the direct and indirect compensation
received by pharmacy benefit managers.\1\ Businesses that provide
pharmacy benefit management services (hereinafter ``PBMs'' unless
otherwise specified) to ERISA-covered self-insured group health plans
have acquired significant influence over prescription drug costs in
recent years. By addressing the influence of PBMs and promoting
transparent pricing, President Trump's Executive Order aims to create a
fairer and more competitive prescription drug market that lowers costs
and ensures accountability across the healthcare system.\2\
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\1\ 90 FR 16441 (April 18, 2025).
\2\ See Fact Sheet: President Donald J. Trump Announces Actions
to Lower Prescription Drug Prices (April 15, 2025) (``The
[Executive] Order builds off [the Administration's] critical work
and reevaluates the role of middlemen by: Improving disclosure of
fees that pharmaceutical benefit managers (PBMs) pay to brokers for
steering employers to utilize their services . . .''), https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-announces-actions-to-lower-prescription-drug-prices/.
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The Department's Improving Transparency Into Pharmacy Benefit
Manager Fee Disclosure proposed rule responds to the President's
directive. The proposed rule was issued under ERISA section 408(b)(2),
which is a statutory prohibited transaction exemption that exempts
certain arrangements between ERISA-covered plans (including self-
insured group health plans) and service providers that otherwise would
be prohibited transactions under ERISA section 406. The proposed rule
would require providers of pharmacy benefit management services and
affiliated providers of brokerage and consulting services to provide
robust disclosures to responsible plan fiduciaries of self-insured
group health plans regarding their compensation for such services,
including the advance disclosure of compensation they reasonably expect
to receive. The proposed rule also includes audit provisions designed
to ensure that the responsible plan fiduciaries can verify the accuracy
of the disclosures. These provisions would allow the responsible plan
fiduciaries to assess the reasonableness of the contracts or
arrangements with these service providers, including the reasonableness
of the service providers' compensation.
The Consolidated Appropriations Act, 2026 (CAA, 2026) was signed
into law on February 3, 2026, after the publication of the Improving
Transparency Into Pharmacy Benefit Manager Fee Disclosure proposed
rule. CAA, 2026 amended ERISA section 408(b)(2) in several ways
relevant to providers of pharmacy benefit management services,
including by adding disclosure requirements, requirements to pass
through to the plan rebates received from certain parties in the
pharmaceutical supply chain, and related audit requirements.\3\ Amended
ERISA section 408(b)(2) also provides specific regulatory authority to
the Secretary of Labor.\4\
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\3\ Consolidated Appropriations Act, 2026, Division J, Title
VII, section 6702.
\4\ See ERISA section 408(b)(2)(B)(iii) (``A covered service
provider shall disclose to a responsible plan fiduciary, in writing,
the following (in accordance with regulations issued by the
Secretary, addressing time, manner, and content of such disclosures)
. . .''); ERISA section 408(b)(2)(C)(ii)(II) (``[T]he Secretary may
issue regulations governing--(aa) procedures for the remittance of
rebates, fees, alternative discounts, and other remuneration under
subclause (I)(aa); (bb) any audit pursuant to this subparagraph; and
(cc) the timing, manner, and content of the disclosure of rebates,
fees, alternative discounts, and other remuneration under subclause
(I)(bb) as well as other information the Secretary determines
necessary for the responsible plan fiduciary to consider the
reasonableness of the contract or arrangement (provided that such
information does not include personally identifiable health
information or protected health information subject to established
individual privacy and nondiscrimination requirements under law)'').
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CAA, 2026 also amended ERISA by adding a new section 726 entitled
``Oversight of Entities that Provide Pharmacy Benefit Management
Services.'' \5\ Section 726 requires among other things that entities
that provide pharmacy benefit management services to certain group
health plans (including through health insurance issuers) make reports
to the group health plans. The reports must include specified
information with respect to drugs covered by the group health plan and
must be made every six months (or, at the request of the group health
plan, every quarter).
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\5\ Consolidated Appropriations Act, 2026, Division J, Title
VII, section 6701.
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The Department's goal remains to improve employer health plan
transparency into the direct and indirect compensation received by
pharmacy benefit managers. In the Department's view, the CAA, 2026
ERISA amendments reflect Congressional support for transparency into
pharmacy benefit management practices as well as for the Department's
regulatory authority under ERISA section 408(b)(2). The Department
therefore asks interested persons to address, as part of their comments
on the proposed rule, whether the rule should be adjusted in light of
the CAA, 2026 amendments to ERISA, and if so, what adjustments are
needed. For example, the Department seeks comment on whether specific
provisions of the rule should be revised or whether new provisions
should be added, in order to minimize complexity or align with the new
statutory provisions, while continuing to fulfill the stated
transparency goals of the proposal.
Signed at Washington, DC.
Daniel Aronowitz,
Assistant Secretary, Employee Benefits Security Administration,
Department of Labor.
[FR Doc. 2026-04084 Filed 2-27-26; 8:45 am]
BILLING CODE 4510-29-P