PROTECT for Rare Act

This bill would expand when Medicare and Medicaid count a drug's use as medically accepted if the drug treats or manages a disease or condition affecting 200,000 or fewer people in the United States. For these rare conditions, a use could qualify if it is supported by peer-reviewed medical literature or clinical guidelines and is not listed as not indicated in standard drug compendia or as contraindicated on the FDA-approved label. For Medicaid, support from an expert identified by a medical society could also qualify. The bill would also require private group and individual health plans to offer a faster appeal process when they deny coverage of such drugs. These changes would take effect starting January 1, 2027.

Full text and official record on Congress.gov

Sponsors

• Thom Tillis Republican sponsor
• 1 cosponsors