S. 1930 — Small Biotech Innovation Act

This section establishes an exception from the Medicare Drug Price Negotiation Program for qualifying single-source drugs of research and development-intensive small biotech manufacturers for initial price applicability years beginning with 2029. (As background, the program selects high-cost single-source Part D and Part B drugs without generic or biosimilar competition for price negotiation with manufacturers.) The exception applies to drugs of a small biotech manufacturer—defined as one with 5 or fewer qualifying single-source drugs that is not owned by, controlled by, or organized under the laws of a foreign covered nation (as defined in 10 U.S.C. 4872(f))—that invests at least the applicable percent of its average net revenue from the prior three years in research and development, where the applicable percent is 30% for 1 drug, 40% for 2 drugs, 50% for 3 drugs, 60% for 4 drugs, or 70% for 5 drugs. To qualify annually, the manufacturer must submit an application to the Secretary with revenue and R&D expenditure data, a certification of accuracy, and other specified information; drugs lose eligibility if the manufacturer is acquired after 2029 by a non-qualifying entity, effective the following plan year; and the Secretary must provide a dispute resolution process concluding by the selected drug publication date.