Bill > S1930

This bill amends the Social Security Act to create an exception for research and development-intensive small biotech manufacturers from the Medicare drug price negotiation program starting in 2029. The bill defines a "small biotech manufacturer" as a company with 5 or fewer qualifying single source drugs that is not owned or controlled by a foreign government. To qualify for the exemption, these manufacturers must invest a certain percentage of their net revenue (ranging from 30% to 70%, depending on the number of drugs they have) into research and development over the previous three years. Manufacturers must submit an annual application to the Secretary of Health and Human Services with detailed information about their revenue and research spending, and certify the accuracy of their submission. If a small biotech manufacturer is acquired by a larger company that does not meet the research and development-intensive criteria, the drug will no longer be exempt from the negotiation program. The bill also establishes a dispute resolution process for manufacturers who are denied the exemption, which must be completed before the selected drug publication date for that year.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/1930/all-info