PROTECT for Rare Act
Sponsored By: Senator Thomas Tillis
Introduced
Summary
Expands coverage and creates expedited appeals for drugs treating rare diseases. This bill would require Medicare, Medicaid, and private health plans to treat drug uses for conditions affecting 200,000 or fewer people as eligible for coverage when supported by peer‑reviewed medical literature or clinical guidelines and not contraindicated in FDA labeling or listed as not indicated in relevant compendia.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Broader Medicare coverage for rare uses
This bill would expand Medicare coverage rules so items, services, and Part D drugs used to treat diseases or conditions affecting 200,000 or fewer people in the U.S. could count as medically accepted uses when supported by peer‑reviewed medical literature or clinical guidelines and not listed as "not indicated" in the named compendia or contraindicated in FDA labeling. The change would apply to items and services furnished on or after January 1, 2027, and to Part D drugs for plan years beginning on or after January 1, 2027. Existing FDA approvals and compendia citations would remain recognized as coverage bases.
Faster appeals for rare-disease drugs
This bill would require group and individual health plans and issuers to offer an expedited internal and external appeals process for denials of certain drugs and biologics used to treat diseases or conditions affecting 200,000 or fewer people in the U.S. The expedited process would apply when the product is FDA‑approved or licensed and the use is supported by approved labeling or by peer‑reviewed literature or clinical guidelines that are not unfavorably reviewed in the named compendia and not listed as a contraindication in FDA labeling. The rule would apply to plan years beginning on or after January 1, 2027.
More Medicaid coverage for rare drugs
This bill would expand Medicaid's definition of a "medically accepted indication" for covered outpatient drugs used to treat diseases or conditions that affect 200,000 or fewer people in the U.S. Medicaid could cover such a use when peer‑reviewed medical literature, clinical guidelines, or an expert from a relevant medical society supports the use, provided the use is not listed as "not indicated" in the compendia and is not contraindicated in FDA labeling. The change would keep FDA approvals and compendia citations as existing coverage bases. It would apply to outpatient drugs furnished on or after January 1, 2027.
Sponsors & CoSponsors
Sponsor
Thomas Tillis
NC • R
Cosponsors
Martin Heinrich
NM • D
Sponsored 12/17/2025
Roll Call Votes
No roll call votes available for this bill.
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