Regulation

PBM disclosure rule – tracking Labor Dept final rule and compliance

CVS Caremark and Express Scripts Inc. reached settlements with the Federal Trade Commission to cap insulin costs and disclose compensation paid to brokers. Publication of the final rule in the Federal Register would establish the regulatory framework for these fee disclosures.

The story so far

written Oct 28

What is happening

Pharmacy benefit managers (PBMs) face mandatory transparency requirements and fee disclosure rules that determine how billions of dollars in prescription drug costs are reported to federal regulators 19. The Federal Trade Commission (FTC) reached a settlement with CVS Caremark on July 14, 2026, requiring the company to adopt "cost-plus" reimbursement models and cap out-of-pocket insulin costs 57. This agreement, which the FTC estimates will save consumers $8.5 billion over 10 years, also mandates the disclosure of compensation paid to brokers and consultants 45.

Express Scripts Inc. (ESI) has also reached a settlement with the FTC to resolve antitrust litigation concerning insulin pricing 24. A similar settlement involving OptumRx is currently in progress 2. While these agreements increase transparency, analysts note they do not fully address the practice of PBMs marketing their own drugs 2.

What to watch

The publication of the final rule in the Federal Register would establish the formal regulatory framework for PBM fee disclosures. A statement from the Department of Labor (DOL) regarding the compliance deadline would confirm when PBMs must begin submitting these mandatory disclosures.

The issuance of enforcement guidance or a formal notice by the DOL would clarify how the agency intends to monitor PBM transparency. The resolution of any court injunctions or legal challenges, such as the June 23, 2026, filing by Express Scripts to block the release of contract details in Texas, would settle the extent of public disclosure requirements 8.

Read the full brief · how we got here

How we got here

The 2026 Consolidated Appropriations Act, passed on February 3, 2026, shifted federal policy toward mandatory PBM transparency 1. Following this legislation, the DOL proposed new regulations in early 2026 to improve oversight of PBM fee disclosures 9. The agency extended the public comment period for these requirements on March 2, 2026, to allow for further industry input 10.

Legal challenges to transparency have emerged at the state level alongside federal actions. Express Scripts filed for a declaratory judgment in Texas on June 23, 2026, seeking to prevent the Texas A&M University System from releasing unredacted contract information under public disclosure laws 8.

References · 8
  1. 1mintz.com — PBM Policy and Legislative Update — Fall 2026 | Mintz
  2. 2healthaffairs.org — Analyzing The Federal Trade Commission’s Pharmacy Benefit Manager Settlements
  3. 4ftc.gov — FTC Secures Major Settlement with Caremark, Resolving Antitrust Case Against Second Drug Middleman | Federal Trade Commission
  4. 5duanemorris.com — Duane Morris LLP - Pharmacy Benefit Manager Reaches Settlement with FTC Requiring Changes to Drug Pricing and Practices
  5. 7healthcarefinancenews.com — FTC announces settlement with Caremark, resolving PBM lawsuit | Healthcare Finance News
  6. 8mintz.com — PBM Challenges Public Disclosure Laws in Texas to Protect Confidential Information | Mintz
  7. 9federalregister.gov — Improving Transparency Into Pharmacy Benefit Manager ... - Federal Register
  8. 10federalregister.gov — Improving Transparency Into Pharmacy Benefit Manager ... - Federal Register

What would close this

0 of 4 met
The Labor Department publishes the final rule in the Federal Register.open
The compliance deadline for PBMs to submit disclosures is reached.open
The Department of Labor issues an enforcement guidance or notice.open
Any court injunction or legal challenge to the rule is resolved.open
If none of these happen, this page closes automatically on .

Timeline

1newest first
Link

When we started following: FTC secures settlements with major PBMs as 2026 Consolidated Appropriations Act mandates federal drug supply chain reforms

Federal regulation of Pharmacy Benefit Managers (PBMs) has shifted toward mandatory transparency following the passage of the 2026 Consolidated Appropriations Act on February 3, 2026 1. The Federal Trade Commission (FTC) has reached settlements with Express Scripts Inc. (ESI) and CVS Caremark to resolve antitrust litigation regarding insulin pricing and vertical integration 24. A similar settlement with OptumRx is reportedly in progress 2.

Key Compliance and Regulatory Actions:

  • CVS Caremark Settlement: Announced July 14, 2026, the agreement requires the PBM to adopt "cost-plus" reimbursement models, cap insulin out-of-pocket costs, and disclose broker and consultant compensation 57. The FTC estimates the deal will lock in $8.5 billion in consumer savings over 10 years 4.
  • Department of Labor (DOL) Oversight: The DOL proposed new regulations in early 2026 to improve PBM fee disclosures 9. The comment period for these transparency requirements was extended on March 2, 2026 10.
  • State-Level Litigation: Express Scripts filed for a declaratory judgment in Texas on June 23, 2026, to block the Texas A&M University System from releasing unredacted contract details under public disclosure laws 8.

Market Impact: While the FTC claims these settlements will increase transparency and protect community pharmacies 4, analysts note the agreements do not fully address PBMs marketing their own drugs 2. The industry is currently adapting to federal legislative activity and oversight recorded through June 2026 1.