Rep. McMorris Rodgers Concerned About National Coverage Determination's (NCD) Impact on Innovation

The House Energy and Commerce Health Subcommittee held a hearing entitled “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology,” focusing on how the Centers for Medicare & Medicaid Services (CMS) defines “reasonable and necessary” criteria for Medicare coverage, the recent national coverage determination (NCD) policy for Alzheimer’s disease drugs, and the Transitional Coverage for Emerging Technologies (TCET) pathway for medical devices.

Health Subcommittee Chairman Guthrie (R-KY) expressed his disappointment with the Biden Administration’s decision to limit Medicare coverage of newly approved Alzheimer’s disease drugs to those who participate in clinical registries; he also cited concerns over the TCET pathway, saying the new path would limit the number of devices approved. In addition, the Chairman discussed the use of value-based contracting within Medicare Advantage.

Committee Chair McMorris Rodgers (R-WA) expressed her continued concern over the cost of implementing the Inflation Reduction Act and future Medicare drug price negotiations. The Chair also stated that predictability is necessary for companies to bring devices and products to market, and CMS’ use of “reasonable and necessary” criteria restricted access for Medicare beneficiaries to receive potentially life-saving treatments.

July 18, 2023

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