April 9th, 2014
Editor’s note: This post is published in conjunction with the April issue of Health Affairs, which features a series of articles on Alzheimer’s disease.
In September of 2013, CMS issued its final decision memo that concluded positron emission tomography- amyloid beta (PET Aβ) imaging is “not reasonable or necessary”, finding “insufficient evidence” that use of this diagnostic tool would improve health outcomes for patients with dementia or neurodegenerative disease. As such, PET Aβ imaging to help diagnose Alzheimer’s disease (AD) is not a covered service for Medicare beneficiaries except for those enrolled in CMS-approved clinical trials.
CMS’ final decision underscores the emerging new paradigm for coverage decision-making, requiring innovators not only to demonstrate to FDA’s satisfaction that their products are effective, but also to prove to CMS and other payors that their use will improve clinical outcomes. This paradigm will increase confidence in the value and health benefit of new technologies, although it will make the path to coverage more difficult and uncertain for diagnostic developers.Read the rest of this entry »