Comment on CMS-2026-2080-0001

MARA Rating Company AG is an independent rating organisation established under Swiss law that produces standardized, calibrated assessments of reimbursement risk for pharmaceutical products. MARA maintains a calibration registry of health technology assessment decisions issued by major assessment bodies, against which its assessment outputs are periodically recalibrated. MARA has no commercial relationship with any manufacturer of a selected drug, holds no financial position in any pharmaceutical security, and has published no assessment of any drug in the Negotiation Program. MARA's calibration data derive from decisions of the main health technology assessment institutions worldwide. MARA holds no calibration data on Negotiation Program outcomes and makes no claim of predictive capability with respect to any maximum fair price. MARA supports the objectives of the Negotiation Program and accepts that the determination of a maximum fair price under section 1194(e) is committed to the Secretary's discretion, as CMS states at 91 FR 36284. MARA proposes no constraint on that discretion and does not comment on the substance of any price determination. MARA submits two comments, set out in the attachment, concerning documentation and administrability: 1. Consistency of the concise justification (§ 429.510(e), § 429.520). CMS specifies evidence-quality criteria in detail but proposes a qualitative, collective approach to the integration step. MARA suggests the concise justification follow a consistent documented structure across selected drugs, identifying material factors, direction of adjustment, and principal evidence relied upon. This requires no disclosure of weights or manufacturer-submitted information. 2. Determination of the evidence set and its date (§ 429.20, § 429.605). The definitions of "therapeutic advance" and "unmet medical need" refer to the time of consideration without specifying it. Because renegotiation eligibility under § 429.605 turns on a material change in a section 1194(e) factor, and change requires a baseline, MARA suggests CMS fix and retain a dated evidence set for each selected drug. Full reasoning, including MARA's operating experience with qualitative integration methods, is provided in Attachment 1.