MCAC Debates Clinical Research Coverage
BY LAUREN UZDIENSKI, DECEMBER 19, 2006
We attended last Wednesday's MCAC panel in Baltimore, convened to discuss revisions to CMS' clinical research policy. The panel recommended changes to the terminology and scope of CMS coverage; voting questions covered the definition of a good clinical study, changes to Medicare-specific standards, the process by which studies are determined to be good clinical studies, and definitions of terms like "routine costs" and "investigational clinical services." The panel was largely comprised of pharma and oncology interests, but several points will resonate with orthopedic device manufacturers.
One proposal, which panelists largely supported during their discussion, would require all clinical studies to be registered at ClinicalTrials.gov. This would alert patients to the studies that were open for enrollment, creating an opportunity for broader, more robust data. A corollary to that proposal would require that study protocol specify how and when results would be released. This could mark a major shift in investigators' autonomy over their data.
Another relevant proposal concerned enrollment. CMS suggested that a study's enrollment contain "sufficient" numbers of Medicare beneficiaries, which would help demonstrate that the device would benefit Medicare populations. There was concern over the vague use of "sufficient" and whether it would lead to establishing patient quotas. But with clearer terms and in the absence of quotas, panelists encouraged studies to gear their enrollment toward relevant populations (e.g., hypertension studies shouldn't have enrollment of exclusively white men, seeing as the condition affects women as well as other races.) Companies seeking to broaden the scope of a product's application would benefit from representative data.
CMS currently covers "routine costs" (a term that may be defined more specifically in the new policy) in trials that are funded by the NIH, CDC and a handful of other government agencies. It was suggested that CMS cover not only studies funded by those goverment agencies, but studies that are approved but not funded by a federal agency. The panel seemed split on this proposal, but if it is accepted in the new policy, it could open the door to CMS coverage of studies conducted by private companies.
Amid discussions of semantics and exclusion criteria, one panelist made an important point: CMS policy should strive to remove barriers for Medicare enrollees, not create them. Bringing Medicare recipients into clinical research produces more data on a population that has particular susceptibilities to disease and injury, providing a unique evidenciary approach to furthering quality of care.
A draft of the revised policy is expected in January.
