Comment on CMS-2026-2080-0001

Comment on the Collection of Information and Regulatory Impact Analysis CMS-4215-P Docket ID: CMS-2026-2080 FR Doc. 2026-12059 91 FR 36236 To the Centers for Medicare & Medicaid Services: I submit this comment on the Collection of Information and Regulatory Impact Analysis sections of the proposed rule codifying the Medicare Drug Price Negotiation Program and related Medicare Prescription Drug Benefit Program policies. Statutory and Administrative Hook The statutory hook is sections 1191 through 1198 of the Social Security Act, as added by the Inflation Reduction Act, which establish the Medicare Drug Price Negotiation Program for certain high-expenditure, single-source drugs and biological products. The administrative hook is the Paperwork Reduction Act review of the information CMS proposes to collect to implement, administer, monitor, and enforce those requirements. Administrative Choke Point: Manufacturer Data Submissions The negotiation program depends on the completeness, accuracy, comparability, and timeliness of manufacturer submissions. If the information collection is too narrow, too aggregated, or too difficult for CMS to analyze, the negotiation framework may appear strong on paper while leaving CMS without the evidence needed to evaluate clinical benefit, therapeutic alternatives, research and development costs, federal support, market data, patent and exclusivity information, and manufacturer revenues. The choke point is not only the negotiation methodology. It is the data pipeline that feeds it. Human Consequence: Affordability and Access For Medicare beneficiaries, the negotiation program is not an abstract economic model. It affects whether essential medications remain affordable, whether out-of-pocket costs decline, and whether access improves for people with chronic, disabling, or life-threatening conditions. A weak information-collection system can delay, distort, or weaken the negotiation process, with direct consequences for patient access and program spending. Structural Question Will the proposed information collections give CMS enough structured, verifiable, and comparable data to support negotiation decisions, evaluate manufacturer claims, monitor compliance, and create a clear administrative record? Recommendations to Strengthen the Collection I urge CMS to ensure that the collection instruments capture, at minimum: Clinical benefit data sufficient to compare therapeutic alternatives, including subgroup and real-world evidence; Manufacturer revenue and cost data, including net revenues, rebates, discounts, and federal support for research or development; Research and development cost information disaggregated by phase; Market data, including utilization patterns, patient demographics, and common indications; Patent and exclusivity information, including settlements and secondary patents; Data-quality assurances, including certification, auditability, and correction pathways. CMS should clarify how it will validate manufacturer submissions, resolve discrepancies, and incorporate corrected or supplemental data into negotiation timelines. Accuracy of Burden Estimate The PRA burden estimate should reflect not only the act of submitting data, but also the internal review, legal analysis, data extraction, documentation, certification, and correction processes required for manufacturers to submit accurate and complete information. The Regulatory Impact Analysis should also address CMS’s implementation needs, including data ingestion, validation, analysis, audit capacity, and record-management systems. A collection that generates complex data has practical utility only if CMS can analyze and rely on that data within statutory timelines. Enhancing Clarity, Quality, and Utility CMS should ensure that: Key definitions are clear and consistently applied; Data formats are standardized across manufacturers and therapeutic classes; Submission portals support secure uploads, version control, correction histories, and audit logs; CMS publishes aggregate, non-identifying information about negotiation inputs to enhance transparency without disclosing protected proprietary data. Principle A negotiation program is only as strong as the information that supports it. When Congress directs CMS to negotiate drug prices, the data collection beneath those negotiations must be robust enough to reveal clinical value, economic reality, and the public investment that helped make the drug possible. Respectfully submitted, Makita Thatcher Georgia resident