Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026.

Bill Number

H.R. 8143

Origin Chamber

House

Congress

119th Congress, Session 2

Status

Introduced

Latest Action

2026-03-27: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Last Updated

2026-04-08T12:23:28Z

AI-Generated Summary

Purpose

The Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 (H.R. 8143) aims to lower prescription drug costs for Medicare Part D enrollees by requiring prescription drug plan (PDP) sponsors that use formularies—a list of covered drugs—to prioritize cheaper generic drugs and biosimilar biological products (lower-cost versions of biologic medicines) over their more expensive brand-name counterparts.

Key Provisions

• Effective Date: Applies to plan years beginning on or after January 1, 2027.
• Mandatory Formulary Inclusion:
• Each covered generic drug (a lower-cost version of a brand-name drug approved via an abbreviated process) with a wholesale acquisition cost (WAC, the manufacturer's list price to wholesalers) less than its reference brand-name drug must be placed in a preferred position (better formulary tier with lower patient out-of-pocket costs).
• At least two covered biosimilar biological products (FDA-approved alternatives to brand biologics) with WAC less than their reference biologic must also be placed in a preferred position.
• Access Restrictions Ban:
• PDP sponsors cannot impose stricter limits on these generics or biosimilars—such as prior authorization (needing approval before coverage) or step therapy (trying another drug first)—than those on the reference brand-name drugs/biologics.
• Limits cannot effectively reduce availability of the cheaper options compared to brand-name versions.
• Definitions (key terms clarified in the bill):
• Covered generic drug: Multiple-source drug under Medicare Part D, approved under FDA's abbreviated pathway.
• Covered biosimilar biological product: Interchangeable or non-interchangeable biosimilar under Medicare definitions.
• Preferred position: More favorable tier and lower costs for patients.

Significant Changes to Existing Law

• Amends Section 1860D-4(b)(3) of the Social Security Act (Medicare Part D rules on formularies) by adding a new subparagraph (J).
• Introduces first-time mandatory inclusion and equal-access rules for lower-cost generics and biosimilars, shifting from voluntary practices to requirements enforced by the Centers for Medicare & Medicaid Services (CMS).

Potential Impacts

• Medicare Enrollees (Seniors): Reduced out-of-pocket costs and easier access to affordable equivalents, potentially saving money on common prescriptions.
• PDP Sponsors: Must revise formularies, which could alter drug pricing negotiations and increase administrative burdens.
• Government Agencies (CMS): Greater oversight role in enforcing compliance, possibly lowering overall Medicare Part D spending.
• Drug Market: Boosts use of generics/biosimilars, pressuring brand-name prices downward.
• No Direct International Impact: Focuses on U.S. Medicare program.

Main Stakeholders Affected

• Primary Beneficiaries: Medicare Part D enrollees, especially seniors relying on high-cost drugs.
• Regulated Entities: PDP sponsors (private insurers offering Part D plans).
• Drug Manufacturers: Generic and biosimilar producers (gain preferred status); brand-name/reference drug makers (face competition).
• Oversight Body: CMS (enforces rules via plan approvals and penalties).

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens CMS authority over formularies without new funding; relies on existing WAC data for enforcement. Potential for lawsuits if sponsors claim undue burden.
• Constitutional: No apparent issues; aligns with Congress's spending power over Medicare.
• Political: Bipartisan sponsorship (Democrat and Republicans); promotes cost savings in entitlement programs amid debates on drug pricing, but could face opposition from brand-name pharma lobbies.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Matsui, Doris O. [D-CA-7]

Cosponsors (2)

Rep. Miller-Meeks, Mariannette [R-IA-1], Rep. Auchincloss, Jake [D-MA-4]

Recent Actions

• 2026-03-27: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
• 2026-03-27: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
• 2026-03-27: Introduced in House
• 2026-03-27: Introduced in House

Bill Versions

• Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026. — issued 2026-03-27 — PDF (5 pages)