A CMS advisory committee last week issued 10 recommendations for revising the agencys 7-year-old clinical-trial funding policya list of requirements that determine whether the CMS will pay for Medicare beneficiaries participation in drug research trials.
The move has the potential to boost Medicare spending on clinical research by recruiting more elderly and minority patients to participate in drug research, though estimates on how much Medicare spends on clinical research werent immediately available from the CMS.
While supporting the recommendations, the changes could have gone further to entice participation from the aged and elderly, according to Ivy Baer, director and regulatory counsel for the Association of American Medical Colleges Health Care Affairs Division. Baer said she would like to see the CMS engage in a broader review of the funding policy and address who is responsible for the care of trial participants experiencing long-term adverse events. Even with the revisions, this issue remains out there, and its a disincentive for seniors to participate, Baer said.
Other revisions to the policy aim to increase efficacy and safety monitoring of newly approved drugs; make research outcomes more readily available to physicians and the general public; and broaden the scope of investigational services that would be covered under the policy.
The advisory committee recommendations include adding Food and Drug Administration-approved post-market studies to the list of CMS-covered clinical trials; requiring all CMS-covered studies to publish their results; and paying for investigational services that the CMS would cover outside of the trial.
Baer said she hopes the recommendation will simplify coverage qualifications for research hospitals. What we need to talk to our hospitals about is: Are the new rules clear enough that (hospitals) wont do the (reimbursement) billing wrongthat if they submit a claim in good faith they wont have it come back as a false claim because the rules werent clear.
CMS Coverage and Analysis Group Director Steve Phurrough, who is also a physician, said the proposed changes should clarify some coverage and protocol issues left murky and incomplete under the current policy. There were some things that werent clear, such as our definition of routine costs covered by the CMS, he said.
Tom Cavalieri, a geriatrician and director of the New Jersey Institute for Successful Aging at the University of Medicine and Dentistry of New Jerseys School of Osteopathic Medicine, believes the proposed changes could have a positive effect on clinical trial funding and create more drugs to treat age-related diseases.
Elderly patients often have conditions that only have a chance of being treated by investigational drugs, Cavalieri said. The CMS increased coverage will provide greater access, and the policy will also encourage pharmaceutical companies to include elderly in their trials, he said.