Comment on CMS-2026-1255-0001
Regeneron PharmaceuticalsSupportBusiness
Summary: Regeneron Pharmaceuticals, Inc. argues that the current Medicare Advantage (MA) regulation allowing step therapy for Part B drugs violates the Medicare statute by providing inferior benefits compared to Original Medicare. The company urges CMS to rescind the regulation and, in the interim, issue guidance prohibiting MA plans from requiring patients to fail on multiple drugs before accessing a physician's first-choice medication.
Dear Administrator Oz,
Regeneron Pharmaceuticals, Inc. (Regeneron) submits these comments in response to the Request for Information on Step Therapy (Step Therapy RFI) within the Interoperability Standards and Prior Authorization for Drugs Proposed Rule issued by the Centers for Medicare & Medicaid Services (CMS).1 Regeneron appreciates the opportunity to provide the comments below.
Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. It is Regeneron’s mission to use the power of science to bring new medicines to patients over and over again, and our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.