CMS Issues Draft of Revised Clinical Trial Policy, Renamed Clinical Research Policy

April 11, 2007 Download PDF

On April 10, 2007, CMS issued a draft of its revised Clinical Trial Policy, renamed Clinical Research Policy. The draft policy was issued after CMS’s consideration of public comments on the agency’s July 10, 2006 coverage tracking sheet announcing the reconsideration of the September 19, 2000 Clinical Trial Policy. CMS also considered recommendations from the December 13, 2006 Medicare Evidence Development and Coverage Advisory Committee (MedCAC) after further consideration by a panel of federal agencies. There will be a 30 day public comment period on the draft Clinical Research Policy followed by issuance of a final policy 60 days later.

Among other changes, the draft Clinical Research Policy:

  • Renames the seven highly desirable characteristics of a clinical research study as “General Standards for a Scientifically Sound and Technically Sound Clinical Research Study;”
  • “Deems” FDA required and approved post-approval studies as meeting the general standards of a scientifically and technically sound clinical research study;
  • “Deems” studies conducted under a National Coverage Determination requiring Coverage with Evidence Development (CED) as meeting the general standards of a scientifically and technically sound clinical research study;
  • Expands “deemed” studies to those approved by any HHS agency, the Department of Veterans Affairs and the Department of Defense;
  • Requires a written protocol for research studies;
  • Revises the Medicare coverage requirements for a clinical study and renames the requirements as “Medicare -Specific Standards,” which include, among other requirements:
    • an explanation in the research protocol of how the results are generalizable to the Medicare population;
    • a discussion in the research protocol of inclusion criteria and consideration of relevant subpopulations (as defined by age, gender, race/ethnicity, socioeconomic or other factors);
    • study results, negative or positive, must be published;
  • Clarifies and renames “routine clinical services” that will be covered under the policy;
  • Clarifies and defines administrative services that Medicare will not cover;
  • Defines investigational clinical services that may be covered for clinical research studies or through CED.

Manufacturers conducting clinical trials on drugs, biologics or medical devices that treat Medicare covered diseases or injuries should review the draft policy carefully and consider commenting on the draft policy.