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Employee Benefits Security Administration, Department of Labor.
Proposed rule; extension of the comment period.
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.
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.
You may submit comments, identified by RIN 1210-AB37, by one of the following methods:
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. ( printed 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.
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).
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]
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]
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).
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.
1. 90 FR 16441 (April 18, 2025).
Back to Citation2. 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/.
Back to Citation3. Consolidated Appropriations Act, 2026, Division J, Title VII, section 6702.
Back to Citation4. 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)”).
Back to Citation5. Consolidated Appropriations Act, 2026, Division J, Title VII, section 6701.
Back to Citation[FR Doc. 2026-04084 Filed 2-27-26; 8:45 am]
BILLING CODE 4510-29-P