Coverage with Evidence Development

Background

On July 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision on coverage for beta amyloid (Aβ) imaging.  In the decision, CMS stated there is insufficient evidence that the scan will improve health outcomes for patients with dementia or other neurodegenerative diseases.

Earlier in 2013, SNMMI joined with the Alzheimer’s Association and developed appropriate use criteria (AUC) recommending when it is appropriate for a patient to receive the test. SNMMI submitted comments to CMS stressing that they should immediately cover Aβ imaging following the clinical scenarios outlined in the AUC.

Current Status

On September 27, 2013 CMS released their final decision memo for beta-amyloid positron emission tomography (PET) in dementia and neurodegenerative disease (CAG-00431N).  SNMMI was disappointed that the final decision requires coverage with evidence development (CED). Under the decision, CMS will cover one PET scan to exclude Alzheimer's disease, but only for patients participating in specific clinical studies under a CED program, which grants conditional reimbursement upon collection of specific data.

Appropriate use criteria jointly developed by the Alzheimer’s Association and SNMMI demonstrated that more than adequate evidence exists for Medicare to cover beta-amyloid PET. CMS coverage for this imaging test would give physicians an additional tool that could change patient management, leading to better health outcomes for patients and assisting families making care decisions.

SNMMI appreciates that in its final decision, CMS included CED with short-term outcomes related to changes in management. A test that can rule out Alzheimer’s disease can result in patients being taken off powerful medications that can be costly and are not indicated for their condition. That is a positive outcome. Although Alzheimer’s disease is the leading cause of memory loss, several other factors—such as other neurodegenerative diseases, strokes, thyroid problems or medications—can cause similar symptoms. Ruling out Alzheimer’s disease also has significant outcomes for a patient’s family and caregivers. SNMMI looks forward to working with all stakeholders to establish an appropriate method to meet the required CED process so that we can offer this valuable test to our patients.

SNMMI will soon be launching a comprehensive education program for physicians who will be referring patients and those who will be reading the scans. Additionally, SNMMI is developing technical procedure guidelines for ensuring quality in the performance of the scans.