An article in the May 27 New England Journal of Medicine provides some interesting, and perhaps unintended, insights into the new world that is emerging as government takes a more active role in decisions about the relative value of medical procedures. "CMS's landmark decision on CT colonography—examining the relevant data" (10.1056/NEJMp0904408 at NEJM.org) praised the decision to deny Medicare coverage for CT colonography and argued that it was correctly grounded because clinical studies of the procedure had failed to consider its effectiveness in the Medicare population.
The argument certainly has a surface appeal. Our bodies do change as we age, and those changes can affect how physicians approach diagnosis and therapy. But if you probe a little deeper, as Diagnostic Imaging senior editor James Brice did online ("Differing views explain why Medicare rejected CT colonography," DiagnosticImaging.com, Daily News, May 28) and in the Overread section of this issue, a number of confounding factors enter the picture.
At least three of the authors of the NEJM piece were members of CMS or its advisory committees prior to the CMS coverage decision. Dr. Steve E. Phurrough, former director of coverage and analysis at CMS, was the chief author of the February 2009 proposed decision memo that determined that the clinical evidence for CTC was not strong enough to justify Medicare payment. Dr. Marcel E. Salive is director of CMS's medical and surgical services division. Dr. Rita F. Redberg is a cardiologist at the University of California, San Francisco and a former member of the Medicare Coverage Advisory Committee, which evaluates the efficacy of new therapies and diagnostic techniques for the program. Redberg and Dr. Sanket S. Dhruva, a UCSF resident who was first author on the NEJM article, authored a 2008 paper in the Archives of Internal Medicine describing differences between clinical trial participants and Medicare beneficiaries in evidence for national coverage decisions. This does not refute their argument, but it does show that they are not exactly disinterested parties.
More troubling are the implications of comments by Dr. C. Daniel Johnson, lead investigator in the American College of Radiology Imaging Network's National CT Colonography trial. In an interview with Diagnostic Imaging, Johnson challenged the assertion that ACRIN data were not representative because the population was too young.
"We know the biology and behavior of colorectal tumors are the same for seniors as for people under the age of 65," he said.
He also noted that he and other ACRIN representatives met in Washington with CMS to describe the trial's approach and methods and drew no objections on the age question.
Johnson is planning to break out the findings of more than 500 Medicare subjects from the ACRIN trial to answer questions posed in the final decision. Those data could be published in the next year. We wish him luck in doing so and anticipate that the age issue raised by CMS will prove specious, at least in the case of CT colonography.
But the whole affair points to a continuing struggle: The people who wrote the NEJM article retain friends in high places like CMS. Phurrough is now a medical officer for the federal Agency for Healthcare Research and Quality, which could end up playing a significant role in applying comparative effectiveness research to payment policy. Physicians and their representatives will need to play close attention to processes like this to assure that politics does not trump science.