CMS Withdraws Clinical Trial Policy Proposed Modifications and Creates New Questions

On October 17, the Centers for Medicare and Medicaid Services (CMS) announced that it was not moving forward with controversial proposed changes to its clinical trial policy. CMS’s clinical trial policy governs the circumstances under which care furnished to Medicare beneficiaries participating in clinical trials may qualify for coverage and payment under Medicare. CMS’s decision is just the latest in a growing saga of the promulgation of proposed modifications to this policy, followed by retrenchment, driven by an increasing concern with the rising costs of prescription drug coverage to the federal government. In the wake of this most recent announcement, CMS has left unresolved a couple of key questions.

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