Comment on CMS-2026-2080-0001

I am a registered nurse with ICU experience, currently completing an Adult-Gerontology Acute Care Nurse Practitioner program. I am commenting because the price of a medication is one of the most common reasons I have seen patients and families make impossible choices, and because I will soon hold prescriptive authority and face those same choices directly with patients. This comment addresses the discussion of projected program savings in the Regulatory Impact Analysis by lowering drug prices and making prescription drugs more affordable. I strongly support this rule. The core problem it addresses is real: a small number of single-source, patent-protected drugs, often with no competing product, account for an outsized share of what Medicare spends. When Jonas Salk developed the polio vaccine, he chose not to patent it, telling a national television audience that patenting it would be like patenting the sun, and the vaccine's development was funded largely through public donations rather than any single company's expected return (Pathan, 2024). That is not how most high-cost therapies are developed and priced today, and I don't think that shift has been good for patients. CMS's own framing is that this program both saves money and protects the pipeline for future treatments, and I largely agree with that framing. However, the proposed rule describes savings to the Medicare funds without describing whether any portion of that value could be directed toward the research the market structurally underfunds, especially rare disease research, which by definition will never be commercially attractive no matter how urgently it's needed. My recommendation: direct CMS to study and report on mechanisms for reinvesting Negotiation Program savings into public rare-disease research, possibly through an expanded Orphan Drug grants structure. Naturally, medicine advances fastest when curing people of diseases and profiting from it are at least loosely aligned. Unfortunately, for an increasing number of very expensive drugs, the latter is much more important than the former to pharmaceutical companies, and patients and providers alike can feel that gap. I support finalizing CMS-4215-P, and I'd ask the agency to build on it by connecting the savings this program generates to the research it isn't yet designed to fund. Reference Pathan SR, Sharma KB. Beyond Profit: The Ethical Compass of Banting and Salk in Medical Innovation. Cureus. 2024 Apr 6;16(4):e57698. doi: 10.7759/cureus.57698. PMID: 38711690; PMCID: PMC11070890.