Comment on CMS-2026-2080-0001

Public Comment Submission Docket ID: CMS-2026-0001 (CMS-4215-P / RIN 0938-AV90) Title: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule ​I. Introduction & Statement of Interest ​I am submitting this public comment regarding the Centers for Medicare & Medicaid Services (CMS) Proposed Rule published on June 16, 2026, titled Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program (CMS-4215-P / RIN 0938-AV90). ​My perspective is informed by over 20 years of clinical experience as an Health professional in the healthcare industry, alongside 14 years of dedicated service as a federal law enforcement officer. This background provides a unique dual perspective on frontline patient care operations, supply chain vulnerabilities, and the critical importance of rigorous regulatory compliance and administrative transparency. ​I commend CMS for moving to codify the regulations governing the Medicare Drug Price Negotiation Program under 42 CFR Part 429. To ensure the program achieves its statutory intent without compromising clinical access or market integrity, I respectfully submit the following recommendations. ​II. Specific Comments on Proposed Regulations ​1. Identification and Ranking of Selected Drugs (§§ 429.100, 429.105, 429.120) ​Preserving Top-50 Transparency (§ 429.100): CMS proposes limiting the annual public release of negotiation-eligible drugs to the top 30 ranked drugs, reducing public transparency from the top-50 list previously published. From an operational and health systems perspective, full transparency is critical for hospital systems, clinical providers, and inventory managers to anticipate shifts in drug availability and pricing dynamics. Categorizing ranks #31–50 as "less meaningful" overlooks how clinical organizations plan for long-term pipeline shifts. ​Recommendation: CMS should retain the requirement to publish the top 50 ranked negotiation-eligible drugs annually to support operational readiness across the healthcare sector. ​Precision in Expenditure Calculations (§ 429.105(c)): The proposal to calculate combined Part B and Part D expenditures to the cent (rather than rounding to the dollar) to break ranking ties is a practical regulatory improvement that reduces ambiguity. ​2. Fixed Combination Drugs & New Formulations (§ 429.125(b)(4)) ​Preventing Extended Monopolies without Clinical Advance: CMS proposes a narrow exception for fixed combination drugs when a new formulation introduces an active moiety enabling an alternative route of administration under the same NDA/BLA holder. While alternative delivery routes (e.g., IV to subcutaneous) can improve patient adherence, regulatory pathways must ensure that minor reformulations are not utilized primarily to delay generic or biosimilar competition. ​Recommendation: CMS should require Primary Manufacturers seeking inclusion under § 429.125(b)(4)(i) to provide concrete clinical data demonstrating a verified Therapeutic Advance (§ 429.20) or direct addressing of an Unmet Medical Need (§ 429.20), rather than relying strictly on administrative product changes. ​3. Biosimilar Delay Requests & Enforcement (§§ 429.110, 429.130) ​High Likelihood Standard (§ 429.110(d)): Requiring "clear and convincing evidence" that a biosimilar will be operationally ready and actively marketed before the High Likelihood Deadline is vital to prevent anti-competitive delay tactics. ​Recommendation: CMS should establish an automatic post-delay audit framework. If a manufacturer obtains a delay under § 429.110 but fails to engage in Bona Fide Marketing (§ 429.130) without verifiable regulatory justification, CMS should immediately apply statutory rebate penalties under § 429.110(i) and refer the matter to the Federal Trade Commission (FTC) for antitrust review. ​4. Primary Manufacturer Reporting & NDC Updates (§ 429.100(d)–(e)) ​30-Day Advance Notice: The requirement for Primary Manufacturers to notify CMS at least 30 calendar days prior to introducing new National Drug Codes (NDC-11s) or modifying product listings is essential for program oversight. ​Recommendation: CMS should explicitly outline that failure to meet this 30-day reporting window will result in Civil Monetary Penalty (CMP) enforcement under § 429.200 to ensure full compliance. ​III. Conclusion ​Codifying these parameters into 42 CFR Part 429 establishes a vital foundation for the Medicare Drug Price Negotiation Program. Incorporating robust clinical verification standards for reformulations and strict compliance mechanisms for market delays will ensure the program fulfills its statutory mandate while safeguarding patient care and system integrity. ​Respectfully, ​Valentina Hansen Health Professional & Healthcare Compliance Specialist Former Federal Law Enforcement Officer