MEDICARE ANNOUNCES CLINICAL TRIAL POLICY
The Centers for Medicare & Medicaid Services (CMS) announced today that it has decided to make no change to the clinical trial policy (CTP) national coverage determination (NCD) issued on July 9, 2007, at this time, and is not imposing additional conditions for coverage.
The decision to make no change is based on a thorough review and consideration of comments from the public, and the enactment of the Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85 of September 27, 2007 (2007 FDA AA).
In a July 19, 2007, proposed decision, CMS proposed to impose additional standards, require an approval process to determine if a study met those standards, and clarify the items and services that would be covered in approved trials.
CMS received numerous comments from the public with regard to the authority of CMS to establish standards and provide limitations to coverage within research studies, as well as comments that the proposed policy was confusing and that CMS should use notice and comment rulemaking to provide a longer transition period for clinical trials to prepare for these changes.
After the close of the public comment period for the July 19 proposed decision, the 2007 FDA AA was enacted, which included significant new requirements for registration of clinical trials and additional authority for other HHS agencies. The CMS intends to review this new legislation and to work with other HHS components to avoid imposing duplicative or inconsistent obligations.
Following much careful consideration of the public comments and this new legislation, the agency has decided that a change to the July 9, 2007, NCD would be inappropriate at this time.
The CMS firmly believes that any policy that covers costs associated with beneficiary participation in clinical research should meet two main objectives:
1. Ensure that Medicare beneficiaries are participating in high quality studies that provide appropriate protections for the patients enrolled. This requires that the organization responsible for the studies adhere to appropriate and recognized standards.
2. Ensure that Medicare beneficiaries have access to clinical studies. This requires that Medicare approve coverage of specific trials prospectively to ensure providers are confident of payment for services provided to Medicare beneficiaries.
In addition to a thorough review of the 2007 FDA AA, CMS intends to continue to review all aspects of its clinical trial policy to ensure that Medicare beneficiaries enrolling in clinical trails are assured of receiving safe and high quality care.
“Making no change to the July 9, 2007, clinical trial policy national coverage determination enables Medicare beneficiaries to continue, as before, participation in clinical research studies with the support of Medicare,” Acting CMS Administrator Kerry Weems said. “The CMS will continue to work to further refine the policy, as appropriate, in order to ensure the quality and appropriateness of trials that enroll Medicare beneficiaries.”
Details of the current coverage for clinical trials are available at the CMS coverage website at