Medicare Compliance & Reimbursement
Should You Be Wary Of Proposed Clinical Trial?
Clinical trials examining the off-label uses of four colorectal cancer therapies are drawing fire from leading cancer organizations.
The Association of Community Cancer Centers and 12 state oncology societies are urging CMS to withdraw a Nov. 1, 2004, draft national coverage decision. The NCD deals with nine clinical trials, sponsored by the National Cancer Institute, which would gather data on xaliplatin, irinotecan, cetuximab, and bevacizumab.
Despite the need for clinical trials that investigate new cancer therapies, the NCD process should not be used "to pioneer an untested approach to Medicare coverage of advanced drugs and biologicals," the Dec. 30, 2004, letter reads.
The ACCC also commented that the many unanswered questions - how coverage will be affected inside and outside of the trials, where they will be located, what treatments will be included and which providers can participate - cast doubt on CMS' goals and intentions.
Instead: The groups advised CMS to "focus its limited resources on enhancing processes already in place," including Medicare's current local coverage rules that facilitate access to innovative therapies.
To read the comment, go to: www.accc-cancer.org/news/ncdcomments.pdf.
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