CMS Decides Not to Change Clinical Trial Policy, for NowCMS Decides Not to Change Clinical Trial Policy, for Now

The agency said it will hold off on implementing the policy until it has time to review the FDA Amendments Act of 2007, which grants new authorities to various branches of the Department of Health and Human Services regarding clinical trials. It said it wants to make sure that the new policy does not duplicate or conflict with any of the new FDAAA requirements.Kirk Dobbins, counsel for Washington, DC law firm King & Spalding's FDA/healthcare practice, told MD&DI yesterday that the proposed policy is unnecessary and potentially burdensome. "CMS wants to be sure that all of the clinical research for which Medicare coverage was sought met minimum standards, but government-sponsored trials already undergo a lot of rigorous review to make sure they meet certain standards," he said. "The intent is valid, but I don't understand why they need to devise their own standards. And the legal implications for sponsors and primary investigators could be significant if they certify that they met the standards and then happen to find out later that they missed a required element."