The Centers for Medicare & Medicaid Services (CMS) released a proposed rule codifying aspects of the Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program introduced under the Inflation Reduction Act. In new comments for the record, Director of Health Care Policy Michael Baker makes the case that CMS should finalize a minimal regulatory framework, focusing solely on the provisions specifically required by law and avoiding regulating areas unaddressed by the authorizing statute.

An excerpt:

CMS should align the proposed rule with statutory requirements for the Medicare Drug Price Negotiation Program without unnecessarily expanding it. The best course is to finalize a narrow framework that closely follows the statute and establishes clear, objective procedures for initial price applicability year 2029 and subsequent years. The end of the temporary guidance period should mark a transition toward greater procedural discipline, transparency, and stability. It should not become a basis for converting discretionary implementation choices into permanent requirements or extending the MDPNP beyond the boundaries established by Congress.

CMS should withdraw proposed regulations around changing fixed-combination therapies, exclude off-label uses as independent renegotiation triggers, decline to codify the fixed one-time-therapy calculation, and substantially narrow the remaining new policies. It should also ensure that future guidance cannot create binding obligations or amend the substance of the Negotiation Program Agreement.

Read the analysis.