The Center for Medicare and Medicaid Services (CMS) recently issued a controversial draft decision to disallow reimbursements for a newly FDA-approved amyloid positron emission tomography (PET) scan. This could have widespread ramifications for patients needing such tests in the future.
“The PET scan technology empowers doctors to more accurately diagnose patients that may be suffering from hard to diagnose forms of dementia,” wrote Dr. Wayne Winegarden, Senior Fellow at the Pacific Research Institute, in a critique of the decision. “With this more accurate diagnostic tool, doctors are better able to design appropriate treatment plans for patients.”
If finalized, the decision would require additional clinical trials and further CMS review of the process, during which only trial participants would receive full reimbursement from Medicare. “Ironically, the review program used by CMS—officially known as the Coverage with Evidence Development (CED) program—was designed to incent medical innovation,” wrote Winegarden. “More often than not, however, the CED program has been used to obstruct innovation rather than incentivize it.”
Reactions to the decision have varied among researchers, medical manufacturers and Medicare recipients. The United States Alzheimer’s Foundation and Eli Lilly and Company, manufacturer of an FDA-approved amyloid tracer for the imaging process, have objected to the draft and urged the CMS to reconsider. However, several Alzheimer’s researchers have applauded the decision, voicing caution and skepticism regarding the use of amyloid imaging for Alzheimer’s detection.
The FDA-CMS disagreement also raises broader questions regarding coverage, funding and widespread access to new treatments. While critics such as Winegarden see the CED as inherently stifling to senior healthcare, others view it and similar review processes as necessary in a taxpayer-funded system.