HR 2484 · 119th Congress

Seniors’ Access to Critical Medications Act of 2025

Medicare drug benefitphysician self-referral rulesprescription drug dispensingStark lawseniors' health care
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Last action 2025-04-29

Sponsored by Rep. Harshbarger, Diana [R-TN-1] (R) — TN

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The bill would create a temporary five-year exception, from 2026 through 2030, to the Medicare physician self-referral (Stark) law so physicians could dispense prescription drugs directly from their offices without violating self-referral rules, provided they meet conditions like an ongoing patient relationship and a prior in-person visit.

It would also require the Government Accountability Office to study and report on pharmacies that see sharp increases in dispensing after the change, examining how many are physician-owned, to help Congress assess whether the flexibility invites conflicts of interest.

What this bill would do

What it would do

The bill would amend the Medicare physician self-referral law (the Stark law) to add a temporary exception allowing physicians to dispense covered Medicare Part D outpatient drugs from their own office—including by in-person pickup, mail, or courier—between January 1, 2026, and December 31, 2030. To qualify, the prescribing physician (or a same-practice colleague) must have an ongoing relationship with the patient, the patient must have had a face-to-face visit for non-drug services within the prior year, and the dispensing physician or practice must bill for the drug.

It would also direct the Government Accountability Office to study pharmacies or pharmacy networks that see significant increases in Part D drug dispensing after enactment, including how many are physician-owned or integrated into physician practices, and report findings to Congress within three years. Separately, it would lower the statutory funding level of the Medicare Improvement Fund from $1,804,000,000 to $1,786,000,000, apparently to offset the bill's cost. The exception does not change other Part D program requirements.

Key provisions

  1. 1Would create a temporary exception, from January 1, 2026 through December 31, 2030, letting physicians dispense Part D drugs from their office without violating the self-referral law.Sec. 2(a)
  2. 2Would require the prescribing physician have an ongoing relationship with the patient and a prior face-to-face visit within one year for non-drug services.Sec. 2(a)
  3. 3Would require the dispensing physician or their group practice to bill for the drug, including drugs dispensed by an entity wholly owned by the physician or practice.Sec. 2(a)
  4. 4Would direct the Government Accountability Office to study pharmacies with significant dispensing increases after enactment and their ties to physician practices, reporting to Congress within three years.Sec. 2(b)
  5. 5Would reduce the statutory funding level of the Medicare Improvement Fund from $1,804,000,000 to $1,786,000,000.Sec. 3

Who would be affected

Physicians and group practices that prescribe and could newly dispense Part D drugs from their offices, Medicare beneficiaries who receive prescriptions this way, the Centers for Medicare & Medicaid Services, the Government Accountability Office conducting the study, and the Medicare Improvement Fund whose statutory funding level would be reduced.

Why it matters

Physicians who dispense drugs in-office could avoid Stark law liability for five years, potentially making it easier for seniors to obtain prescriptions without a separate pharmacy trip. Because physicians would also bill for the drugs they dispense, the arrangement raises questions about financial conflicts of interest, which the required GAO study is meant to help Congress evaluate.

What would change

Changes to existing law

Amends Section 1877(b) of the Social Security Act (Physician Self-Referral Law / Stark law), 42 U.S.C. 1395nn(b) (Sec. 2(a))

Adds a new temporary exception (2026-2030) allowing physicians to dispense certain Part D outpatient drugs from their office under specified conditions.

Amends Section 1898(b)(1) of the Social Security Act, Medicare Improvement Fund, 42 U.S.C. 1395iii(b)(1) (Sec. 3)

Reduces the fund's statutory funding level from $1,804,000,000 to $1,786,000,000.

Agencies directed to act

Government Accountability OfficeCenters for Medicare & Medicaid Services

Effective dates

  • The physician self-referral exception for dispensing Part D drugs appliesSec. 2(a)2026-01-01
  • The physician self-referral exception for dispensing Part D drugs endsSec. 2(a)2030-12-31
  • The GAO report on pharmacy dispensing changes is due to CongressSec. 2(b)(2)Within 3 years of enactment

Funding and costs

  • $1,786,000,000

    Revised statutory funding level of the Medicare Improvement Fund, reduced from $1,804,000,000Sec. 3

How implementation would work

The Department of Health and Human Services would need to define "ongoing relationship" for purposes of the new exception, and physicians would need to document qualifying face-to-face visits, prescribing, and billing to rely on the exception. The Government Accountability Office would compare Part D dispensing volumes before and after enactment to identify pharmacies or networks with significant increases, analyze their ownership ties to physician practices, and submit a report to Congress within three years, without disclosing identifying or proprietary information about specific pharmacies.

Legislative status & sources

Latest action

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

2025-04-29

Official CRS summary

Show the CRS summary

This bill temporarily expands flexibilities under the Stark law (i.e., the Physician Self-Referral Law) for certain physicians who dispense covered outpatient drugs under the Medicare prescription drug benefit at the physician's office location (e.g., through an integrated pharmacy). The Stark law generally prohibits physicians from referring patients to receive services that are payable under Medicare or Medicaid from entities in which the physician or an immediate family member has a financial relationship.

Specifically, the bill allows, from 2026-2030, physicians to dispense such drugs from the physician's office, including through in-person pickup by a caregiver or via mail, if (1) the physician prescribed the drug, (2) the beneficiary has an ongoing relationship with the physician, (3) the beneficiary had at least one face-to-face visit with the physician in the prior year, and (4) the physician bills for the drug. These requirements also apply to physicians within the same group practice.

The Government Accountability Office must report on pharmacies or pharmacy networks that dispense significantly more covered drugs under the Medicare prescription drug benefit after the bill's enactment, the extent to which such pharmacies and networks are owned by physicians or integrated into physician practices, and the common characteristics of these types of arrangements.

From the Congressional Research Service.

Legislative subjects

Congressional oversight; Government studies and investigations; Health; Health personnel; Medicare; Prescription drugs

Congressional Bill

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HR 2484: Seniors’ Access to Critical Medications Act of 2025 | Legislation Reporter