CMS’ Refusal to Reimburse Everyday Americans for Critical Diagnostic Tool for Alzheimer's Ruled Arbitrary by Federal Court; UsAgainstAlzheimer’s Urges CMS to Reverse Coverage Determination

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WASHINGTON, DC, August 4, 2016—The Centers for Medicare & Medicaid Services (CMS) decision not to reimburse everyday Americans for using what the FDA determined to be an effective diagnostic tool was found to be “arbitrary and capricious” by a Federal court. The reason? Because Medicare is reimbursing for a less effective diagnostic tool and did not explain why it would not do so for a more innovative tool.

Medicare's decision-making raises an important question: Why is Medicare discriminating against innovation in the fight against the most costly and feared disease in America?

The diagnostic in question, a beta-amyloid positron emission tomography scan (Amyloid PET Scan), allows a physician to rule out Alzheimer’s as a cause of a patient's loss of memory if the scan is negative, which would give comfort to millions of Americans who fear Alzheimer's – a critical tool for Americans and their doctors as new reports indicate that 1 in 5 cases of Alzheimer’s disease is misdiagnosed.

As new evidence has unearthed personal risk-reduction strategies that can delay or lessen symptoms for those with an early diagnosis of Alzheimer's, now is the moment when innovative diagnostic tools should be made more available.

UsAgainstAlzheimer’s is urging CMS to reimburse for Amyloid PET scans and protect Americans’ right to know their own health status.

“CMS' Amyloid PET decision denies everyday Americans their right to know the cause of their health impairment and to identify the treatment best suited to improve their health outcomes. This is an injustice that must be righted,” said UsAgainstAlzheimer’s Co-Founder and Chairman, George Vradenburg, whose organization has activated hundreds of patients and caregivers to tout the benefits Amyloid PET scans and submit comments to CMS. “As we prepare for the arrival of innovative medicines for Alzheimer's, patients need access to these innovative diagnostic tools essential to determine what medicine is right for each of us. Americans should demand that Medicare reimburse for this diagnostic.”

The recent U.S. District Court case (Kort v. Burwell) was rendered in a connection with a challenge by patients to a National Coverage Determination by CMS in 2013 to deny coverage of Amyloid PET scans. The agency based its non-coverage decision on a perceived lack of evidence that the Amyloid PET scans would improve patient outcomes. Yet, the agency previously had approved Medicare coverage for a similar positron emission tomography (PET) scan that aids in the diagnosis of other cognitive conditions without requiring evidence development.

For patients, the accurate diagnosis as a result of an Amyloid PET scan would complement evidence-based risk-reduction strategies that can be pursued by patients to improve resistance to Alzheimer’s disease symptoms. For example, as recently reported by AARP, these methods include exercising regularly, eating healthy, staying mentally and socially engaged, sleeping well and engaging in purposeful activities.

The court’s ruling did not order CMS to reimburse for Amyloid PET scans, but it has directed CMS to explain the inconsistent determinations, a positive first step among the many actions needed to ensure that this diagnostic tool and future innovations are accessible for Americans. According to a recent analysis issued by ResearchersAgainstAlzheimer’s, 17 new Alzheimer’s in Phase III Clinical Trials are on pace to launch in the next five years. However, non-coverage decisions by payers could ultimately jeopardize the accessibility of these innovations.

“The current situation does not fully remedy health system-readiness concerns that need to be addressed as industry is poised to welcome new Alzheimer’s treatments in the near future,” Vradenburg said. “We are urging all Americans to be active on social media, engage your members of Congress and write letters to CMS and demand that this tool be covered. We must act now.”

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UsAgainstAlzheimer’s is an innovative non-profit organization demanding – and delivering – a solution to Alzheimer’s. Driven by the suffering of millions of families, UsAgainstAlzheimer’s presses for greater urgency from government, industry and the scientific community in the quest for an Alzheimer's cure – accomplishing this through effective leadership, collaborative advocacy, and strategic investments.

Founded in 2010, UsAgainstAlzheimer’s has worked across sectors to: (1) secure the national goal of preventing and effectively treating Alzheimer’s by 2025 and help secure nearly $500 million in additional public funding for Alzheimer’s research over the past few years; (2) drive global efforts that resulted in the leaders of the world’s most powerful nations, the G7 group, to embrace a similar 2025 goal and to call for greater levels of research investment and collaboration; and (3) forge industry commitments to improve efficiencies for an expedited drug discovery and approval process. 

Contact: Tim Tassa

Phone: 202-263-2580

Email: ttassa@usagainstalzheimers.org