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CMS Technology Block May Affect Alzheimer's Patients

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While health law reform and expansion of insurance coverage comes with good intentions, there are many other decisions that are seemingly shifting care in the opposite direction.

While health law reform and expansion of insurance coverage comes with good intentions, there are many other decisions that are seemingly shifting care in the opposite direction. A recent Centers for Medicare & Medicaid Services (CMS) draft decision, if approved, would deny payment for new PET scan technology which can provide patients with earlier and more accurate diagnosis of Alzheimer’s disease versus other forms of dementia.

“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, a Senior Fellow at the Pacific Research Institute. “With this more accurate diagnostic tool, doctors are better able to design appropriate treatment plans for patients. Thanks to an earlier diagnosis, the PET scan empowers patients to plan for the disease more effectively and enroll in clinical trials should they choose this option.”

The PET scan technology was recently given US Food and Drug Administration (FDA) approval. Such approvals can often take quite some time, especially when the group considers newer medical technologies. However, there are newer regulations that allow the CMS to require agreement of all FDA-approved devices before they are available for public consumption. Any dissonance from the CMS could force the technology to go through an entirely new approval process, meaning many medical devices like the PET scan would remain unavailable to patients at risk for diseases like Alzheimer’s.

Dr Winegarden adds, “The review program used by CMS—officially known as the Coverage with Evidence Development (CED) program–was designed to incent medical innovation. More often than not, however, the CED program has been used to obstruct innovation rather than incentivizing it. With respect to the PET scan technology, CMS decision, if finalized, would require additional clinical trials and data collection to ensure that the new technology meets CMS’ standards.”

There have been other similar innovations the CMS has blocked, which Dr Winegarden suggests is a problem for medical innovation and improving patient health outcomes.

“In the long-term, the national march away from a patient-centered health care system and toward a bureaucracy-centered health care system needs to be reversed,” Dr Winegarden concludes. “While systemic reforms are necessary, targeted reforms, such as eliminating the CED program entirely, helps to eliminate barriers that are diminishing medical innovation, increasing health care costs, and lowering health care quality.”

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