Reasonable and Necessary

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Earlier this month the Centers for Medicare & Medicaid Services (CMS) released a draft decision on coverage of Beta Amyloid Positron Emission Tomography (PET) in dementia and neurodegenerative disease. CMS’ preference is only to provide one scan per individual if that person is enrolled in a clinical trial and not to provide coverage in the clinical setting for others with dementia or neurodegenerative diseases until further evidence is developed supporting how Beta Amyloid PET improves health outcomes.

Recognizing that this imaging tool plays an important role in the current and future development of treatments for dementia and neurodegenerative diseases, the Alliance for Aging Research joined with others in the Alzheimer’s and aging community in April to call on CMS to provide coverage of Beta Amyloid PET without further evidence (also known as CED, or Coverage with Evidence Development). Our groups supported broader use of this tool in accordance with criteria developed by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging. Unfortunately, this and other calls for broader coverage to date have not compelled CMS to deem Beta Amyloid PET “reasonable and necessary,” the Agency’s two overarching criteria for coverage.

If CMS releases a final CED decision in October, it will take 7-10 years to generate the data required. This will delay uptake of this technology in clinical practice for a decade or more. In that time, almost 7 million people will have Alzheimer’s, an increase from the near 5 million people who currently live with the disease.

Ask yourself is quicker progress toward better diagnosis and a cure reasonable and necessary? If the answer is yes, I encourage you to submit a comment to CMS before August 2, 2013.