Seniors’ Access to Critical Medications Act of 2025

Bill Number

H.R. 2484

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-04-29: Ordered to be Reported by the Yeas and Nays: 38 - 7.

Last Updated

2026-06-09T08:06:02Z

AI-Generated Summary

Purpose

The "Seniors' Access to Critical Medications Act of 2025" aims to improve Medicare beneficiaries' access to certain outpatient prescription drugs by creating a temporary exception to rules that restrict physicians from referring patients to their own practices for these services. This addresses potential barriers in drug dispensing while maintaining safeguards against conflicts of interest.

Key Provisions

• Exception to Physician Self-Referral Prohibition: Amends the Social Security Act (Section 1877(b)) to allow physicians or their group practices to dispense specific outpatient prescription drugs covered under Medicare Part D (the program's drug benefit) without violating the "Stark Law," which prohibits self-referrals for certain health services to prevent financial incentives influencing care.
• Applies to drugs furnished from January 1, 2026, to December 31, 2030.
• Requires:
• The drug must be prescribed by the referring physician or another in the same group practice.
• The patient must have an ongoing relationship with the prescribing physician or practice.
• The patient must have had at least one in-person visit with the physician or practice in the prior year for non-drug services paid by Medicare.
• Drugs must be dispensed from the same building as the physician's practice by the physician, a group member, or someone directly supervised by them, via in-person pickup or mail/delivery.
• Billing must be done by the physician, group practice, or a wholly owned entity.
• Clarifies that this does not change any existing Medicare Part D rules, such as those for drug coverage or pharmacy networks.
• Government Accountability Office (GAO) Study and Report:
• Directs the GAO (an independent agency that audits government programs) to study changes in drug dispensing by pharmacies or networks under Medicare Part D after the law's enactment.
• Examines: Increases in dispensing volumes; ownership or integration with physician practices; common features of drug-dispensing arrangements (e.g., by specialty, contracts with insurers or wholesalers, conflict-of-interest mitigations); and factors influencing prescribing patterns.
• Requires a report to Congress within three years, excluding any proprietary or identifying details about specific pharmacies.
• Medicare Improvement Fund Adjustment: Reduces the fund's appropriation (a pot of money for Medicare quality improvements) from $1,804,000,000 to $1,786,000,000, likely to offset the bill's costs.

Significant Changes to Existing Law

• Introduces a new, time-limited exception (paragraph (6)) to the Stark Law's ban on self-referrals for designated health services, specifically targeting Part D-covered outpatient drugs dispensed in physician offices.
• Expands allowable dispensing methods (e.g., mail or courier) within physician practices, which were previously restricted to prevent financial self-dealing.
• Mandates a GAO study to monitor implementation, providing data for potential future adjustments to anti-referral rules—no prior similar study is referenced in the bill.

Potential Impacts

• On Citizens (Medicare Beneficiaries): Could enhance access to critical medications for seniors by allowing convenient pickup or delivery from trusted physicians, reducing travel or delays, especially in rural or underserved areas; however, it may raise concerns about over-prescribing if safeguards fail.
• On Government Agencies: Centers for Medicare & Medicaid Services (CMS) must enforce the new exception and define terms like "ongoing relationship"; GAO conducts oversight study; Congress receives report for policy review. The fund reduction may limit resources for other Medicare improvements.
• On International Relations: No direct impacts, as the bill focuses on domestic Medicare operations.
• Broader Effects: May encourage more physician practices to integrate pharmacies, potentially lowering administrative costs but increasing scrutiny on drug utilization patterns.

Main Stakeholders Affected

• Physicians and Group Practices: Gain flexibility to dispense drugs directly, potentially increasing revenue and patient convenience, but must comply with strict conditions to avoid penalties.
• Medicare Beneficiaries (Primarily Seniors): Benefit from easier access to Part D drugs but could face indirect effects if prescribing patterns shift due to financial incentives.
• Pharmacies and Drug Supply Chain Participants: Independent pharmacies may see reduced volume if physician offices capture more dispensing; includes pharmacy benefit managers, wholesalers, and insurers affected by new arrangements.
• Government Entities: CMS (implementation and enforcement), GAO (study), and Congress (oversight and funding decisions).
• Healthcare Providers: Other practitioners in group practices who can prescribe or dispense under the exception.

Notable Legal, Constitutional, or Political Implications

• Legal: Temporarily relaxes Stark Law (a key anti-kickback statute) to promote access, but includes patient protections (e.g., in-person encounter requirement) to mitigate abuse risks; the GAO study ensures accountability without identifying individuals, respecting privacy laws. Does not alter Part D's fraud protections.
• Constitutional: No apparent challenges; aligns with Congress's authority over federal spending programs like Medicare.
• Political: Bipartisan sponsorship (Republican and Democratic cosponsors) suggests broad support for senior healthcare access; the fund offset demonstrates fiscal responsibility. The sunset date (2030) and study allow for evaluation, potentially influencing future healthcare reforms amid debates on drug pricing and physician incentives.

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

Sponsor

Rep. Harshbarger, Diana [R-TN-1]

Cosponsors (26)

Rep. Wasserman Schultz, Debbie [D-FL-25], Rep. Miller, Carol D. [R-WV-1], Rep. Soto, Darren [D-FL-9], Rep. Crenshaw, Dan [R-TX-2], Rep. Davis, Donald G. [D-NC-1], Rep. Gottheimer, Josh [D-NJ-5], Rep. Krishnamoorthi, Raja [D-IL-8], Rep. Wilson, Joe [R-SC-2], Rep. Steube, W. Gregory [R-FL-17], Rep. Miller-Meeks, Mariannette [R-IA-1], Rep. Malliotakis, Nicole [R-NY-11], Rep. Moran, Nathaniel [R-TX-1], Rep. Estes, Ron [R-KS-4], Rep. Balderson, Troy [R-OH-12], Rep. Golden, Jared F. [D-ME-2], Rep. Pingree, Chellie [D-ME-1], Rep. Bean, Aaron [R-FL-4], Rep. Rulli, Michael A. [R-OH-6], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Riley, Josh [D-NY-19], Rep. Burchett, Tim [R-TN-2], Rep. Sewell, Terri A. [D-AL-7], Rep. Kelly, Mike [R-PA-16], Rep. Hudson, Richard [R-NC-9], Rep. Elfreth, Sarah [D-MD-3], Rep. Kiggans, Jennifer A. [R-VA-2]

Recent Actions

• 2025-04-29: Ordered to be Reported by the Yeas and Nays: 38 - 7.
• 2025-04-29: Committee Consideration and Mark-up Session Held
• 2025-03-31: 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.
• 2025-03-31: 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.
• 2025-03-31: Introduced in House
• 2025-03-31: Introduced in House

Bill Versions

• Seniors’ Access to Critical Medications Act of 2025 — issued 2025-03-31 — PDF (7 pages)