This bill aims to establish an exception from the Medicare drug price negotiation program for certain manufacturers. Beginning in 2029, qualifying single source drugs from a research and development-intensive small biotech manufacturer will be exempt from negotiation. A "small biotech manufacturer" is defined as one that has five or fewer qualifying single source drugs and is not owned or controlled by a foreign government. To be considered "research and development-intensive," a small biotech manufacturer must invest an "applicable percent" of its net revenue from the previous three years into research and development. This applicable percent ranges from 30% for a manufacturer with one qualifying drug to 70% for one with five drugs. The exception also stipulates that if an exempted manufacturer is acquired by a non-qualifying entity after 2029, the drug will lose its exception. Manufacturers must submit an annual application with financial data and a certification, and a dispute resolution process will be established for eligibility determinations.
This bill aims to establish an exception from the Medicare drug price negotiation program for certain manufacturers. Beginning in 2029, qualifying single source drugs from a research and development-intensive small biotech manufacturer will be exempt from negotiation. A "small biotech manufacturer" is defined as one that has five or fewer qualifying single source drugs and is not owned or controlled by a foreign government. To be considered "research and development-intensive," a small biotech manufacturer must invest an "applicable percent" of its net revenue from the previous three years into research and development. This applicable percent ranges from 30% for a manufacturer with one qualifying drug to 70% for one with five drugs. The exception also stipulates that if an exempted manufacturer is acquired by a non-qualifying entity after 2029, the drug will lose its exception. Manufacturers must submit an annual application with financial data and a certification, and a dispute resolution process will be established for eligibility determinations.