Under Medicare Part B, the Center for Medicare & Medicaid Services (CMS) has the authority to make a Medicare National Determination (NCD) to evaluate whether a service or prescription drug is reasonable and necessary. Under certain circumstances, CMS can link coverage of an item or service to participation in an approved clinical study or to the collection of additional clinical data. This policy is referred to as coverage with evidence development (CED).
In this session, staff presented a draft chapter and recommendation to allow states to follow a Medicare NCD or CED requirements. This presentation provides an overview of the draft chapter and discusses some outstanding questions the Commission raised in the December 2022 meeting.
The Commission then discussed options for two recommendations. The first option for recommendation 3.1 would allow states to follow all Medicare NCDs for drugs, even if it does not include CED requirements. The second option would allow states to only follow the CED requirements included in a Medicare NCD.
Recommendation 3.2 would require managed care plans to follow the state’s coverage decision regarding drugs subject to a Medicare NCD or CED. The presentation provides the rationale for making the recommendations and potential implications on different stakeholders.
On Friday, January 27, 2023, the Commission voted to approve a recommendation that calls on Congress to allow states to follow the CED requirements included in a Medicare NCD. The Commission also approved the recommendation to require managed care plans to follow the state’s coverage decision regarding drugs based on CED requirements implemented under a Medicare NCD.