The PROTECT for Rare Act expands drug coverage for patients with rare diseases affecting 200,000 or fewer people in the United States across Medicare, Medicaid, and private health insurance. Under Medicare and Medicaid, the bill allows coverage of drugs used to treat rare conditions when supported by peer-reviewed medical literature or clinical guidelines, even if those uses are not officially approved by the FDA. For private insurance, the bill requires health plans to establish expedited appeal processes so patients and their doctors can quickly contest denials of coverage for FDA-approved drugs used to treat rare diseases when evidence supports their effectiveness. All provisions take effect on January 1, 2027, affecting Medicare beneficiaries, Medicaid enrollees, and people with employer-sponsored or individual health insurance coverage. The bill does not specify new federal funding, instead modifying existing coverage rules within these three health insurance programs.
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