CMS maintains clinical trial policy

The Centers for Medicare & Medicaid Services (CMS) said it will not impose proposed changes to its clinical trial policy that would have made it more difficult for Medicare beneficiaries to get coverage of trial expenses. On July 19, CMS had proposed to impose additional standards, require an approval process to determine whether a study met those standards and clarify items and services that would be covered in approved trials. Citing the recent enactment of the FDA Amendments Act of 2007, as well as public comments it had received, CMS said a change would be "inappropriate" at this time. CMS said it plans to review the new law, which includes new requirements for registration of clinical trials, and work with other agencies in the Department of Health and Human Services (HHS) "to avoid imposing duplicative or inconsistent obligations."

Last week, the American Society of Clinical Oncology (ASCO) urged the public to ask their senators to sign a letter from Sens. Benjamin Cardin (D-Md.) and Sam Brownback (R-Kan.) to CMS opposing the policy change. The letter stated that under the proposed policy, clinical trials would be subject to a "detailed, burdensome and duplicative" certification process, instead of automatic coverage for trials conducted under federal funding or the auspices of regulatory agencies. The senators also said the policy may "significantly hamper enrollment of Medicare beneficiaries in clinical research." ...