Under Medicare Part B, the Centers for Medicare & Medicaid (CMS) Services has the authority to make a national coverage determination (NCD) on 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). Because of the requirements of the Medicaid Drug Rebate Program, state Medicaid programs do not have similar authority to restrict drug coverage or require the collection of additional data in the same way Medicare can.
This session builds on the information presented at the September 2022 meeting and takes the next step toward a recommendation that would allow states, at their option, to follow a Medicare NCD. The presentation included a draft recommendation to make a statutory change that gives states the authority to exclude or otherwise restrict drug coverage based on a Medicare NCD, including any CED requirements. The presentation provided the rationale for making this recommendation and potential implications for different stakeholders.