The Center for American Principles submitted a public comment to the Centers for Medicare & Medicaid Services (CMS) raising concerns with proposed changes to the treatment of fixed drug combinations under the Medicare Drug Price Negotiation Program.
In the comment, CAP warns that the proposed rule could prematurely subject newly developed therapies to government price controls by treating certain new fixed drug combinations as the same “Qualifying Single Source Drug” (QSSD) as older products. CAP argues that this approach would devalue patent protections and discourage investment in follow-on medical innovation.
CAP emphasizes that improvements to existing medicines—including new routes of administration—can provide significant benefits to patients. For example, developing an injectable version of an intravenous therapy may allow patients to administer treatment themselves rather than traveling to a clinic for an infusion, improving access and adherence for patients with mobility limitations, those living in rural communities, and those requiring frequent treatment.
CAP urges CMS to more narrowly define QSSDs and treat products containing an added active ingredient that enables a change in the route of administration as separate drugs. Doing so would preserve incentives for continued investment in innovative treatments and help ensure patients continue to benefit from improvements to existing medicines.