Ways and Means Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
This bill amends the Social Security Act to establish an exception for certain **research and development-intensive small biotech manufacturers** from the Medicare drug price negotiation program, effective for initial price applicability years beginning in 2029. The primary purpose is to support innovation by exempting smaller, R&D-focused drug developers from these price controls. To qualify, a manufacturer must be a **small biotech manufacturer**, meaning it has five or fewer qualifying single-source drugs and is not controlled by a foreign government from a covered nation. It must also be **research and development-intensive**, investing an "applicable percent" of its average net revenue from the previous three years into R&D, with this percentage ranging from 30% to 70% based on the number of drugs. Manufacturers are required to submit annual applications with financial data and certifications to the Secretary to demonstrate eligibility. The exception includes a provision that if a qualifying manufacturer is acquired by a non-qualifying entity after 2029, its drugs will lose the exception. Additionally, the Secretary must establish a **dispute resolution process** for manufacturers to appeal eligibility determinations.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
This bill amends the Social Security Act to establish an exception for certain **research and development-intensive small biotech manufacturers** from the Medicare drug price negotiation program, effective for initial price applicability years beginning in 2029. The primary purpose is to support innovation by exempting smaller, R&D-focused drug developers from these price controls. To qualify, a manufacturer must be a **small biotech manufacturer**, meaning it has five or fewer qualifying single-source drugs and is not controlled by a foreign government from a covered nation. It must also be **research and development-intensive**, investing an "applicable percent" of its average net revenue from the previous three years into R&D, with this percentage ranging from 30% to 70% based on the number of drugs. Manufacturers are required to submit annual applications with financial data and certifications to the Secretary to demonstrate eligibility. The exception includes a provision that if a qualifying manufacturer is acquired by a non-qualifying entity after 2029, its drugs will lose the exception. Additionally, the Secretary must establish a **dispute resolution process** for manufacturers to appeal eligibility determinations.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.