A legislative bill allowing Medicare Part D and Medicaid to cover drugs for off-label for treating rare diseases has been introduced into Congress for consideration by Rep. Neal Dunn (R-Panama City) and other congressional representatives.
Off-label drugs would be covered â€œif there is peer-reviewed medical literature that indicates its use is appropriateâ€ for rare disease treatment under the proposed PROTECT Rare Act, a news release from Dunnâ€™s office said.
â€œI hear from many of my constituents who fear that restrictions on off-label drugs threatens not only their quality of life but also their chance of survival,â€ Dunn said. â€œIt is important that rare disease patients have access to proven courses of treatment that include off-label uses of drugs when no other viable treatment options exist.â€
The bill would also require private insurance plans to create an â€œexpedited review process for coverage requests.â€
Other representatives who introduced the bill are Rep. Doris Matsui (D-CA), Rep. Mike Thompson (D-CA), and Mike Kelly (R-PA).
â€œTo ensure that these patients have access to appropriate care, Medicare and Medicaid must be given increased flexibility to cover such treatments if widely available research suggests their use is appropriate,â€ Dunn said.
The legislation is still under consideration and has to be approved by both the House of Representatives and Senate, and then signed into law by the president, before it is official.