S 3551 — PROTECT for Rare Act

Bill Text

• Introduced Introduced in Senate Current html December 17, 2025

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends existing law to provide for the coverage of certain drugs used in the treatment or management of rare diseases under Medicare, Medicaid, and private health insurance plans.

• 42 U.S.C. 1395x(t)(2)

  or used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States

  Expands the definition of acceptable drug regimens to include those for rare diseases.

• 42 U.S.C. 1395x(t)(2)

  prior subparagraph (A) → 3

  Creates a new requirement for drugs treating rare diseases to be supported by peer-reviewed literature and not contraindicated.

• 42 U.S.C. 1395w-104(e)(4)(A)(i)

  or in the case of a covered part D drug used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States

  Allows for the inclusion of drugs for rare diseases in the part D drug coverage.

• 42 U.S.C. 1396r-8(k)(6)

  for a covered outpatient drug-- → for a covered outpatient drug-- (A) which is approved under the Federal Food, Drug, and Cosmetic Act; (B) which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i); or (C) which, in the case of a drug used to treat or manage a disease or condition affecting 200,000 or fewer individuals in the United States

  Expands the definition of medically accepted indication for outpatient drugs to include those used for rare diseases.

• 42 U.S.C. 1396r-8(d)(4)(C)

  compendia → sources

  Updates terminology from 'compendia' to 'sources' for clarity.

• 42 U.S.C. 300gg-111

  A group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide an expedited process pursuant to section 2719 by which a participant, beneficiary, or enrollee, or a designee or prescribing physician (or other prescriber, as appropriate) of the participant, beneficiary, or enrollee, may appeal any denial of coverage for a drug or biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351

  Introduces an expedited appeals process for coverage denials related to drugs for rare diseases.

• 29 U.S.C. 1185

  A group health plan or a health insurance issuer offering group health insurance coverage shall provide an expedited process pursuant to section 2719 of the Public Health Service Act

  Ensures that coverage appeals for rare disease medications are expedited.

• 29 U.S.C. 1001

  A group health plan shall provide an expedited process pursuant to section 2719 of the Public Health Service Act

  Mandates an expedited process for appealing drug coverage denials across group health plans.

Action History

1. December 17, 2025

   Introduced in Senate

2. December 17, 2025

   Read twice and referred to the Committee on Finance.

Sponsors

• Thomas Tillis · Primary
• Martin Heinrich · Cosponsor

Subjects