Washington, DC – The Medical Imaging & Technology Alliance (MITA) - the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices  – is disappointed by the Centers for Medicare & Medicaid Services (CMS) decision on February 22, 2023, to continue to severely restrict beneficiary access to FDA approved treatments for Alzheimer’s disease. This represents a tremendous setback for patients living with this debilitating disease. 

Further, CMS continues to limit access to beta-amyloid Positron Emission Tomography (PET) scans that are used to help more accurately identify individuals most at risk of developing Alzheimer's disease. In 2013, CMS defended its National Coverage Decision (NCD) under the Coverage with Evidence Development (CED) policy citing a lack of evidence to demonstrate improved health outcomes in order to make a reasonable and necessary coverage determination. Over these past 10 years, more than 40 peer-reviewed clinical studies have been published to substantiate national Medicare coverage for beta-amyloid PET. Yet, despite the extensive repository of data available that exists today, this CED continues to penalize patients by restricting their access to this precision diagnostic tool. PET scans were essential in the clinical development of current FDA-approved amyloid-targeted treatments, as well as those being developed. The same diagnostic tools should be accessible to physicians evaluating patients in the office or hospitals.  

MITA urges CMS to immediately revisit its February 22 decision with special consideration of its impact on innovation in treatment and care for those seniors living with Alzheimer’s disease. MITA also urges CMS to make a decision on the pending reconsideration of national coverage of amyloid PET and allow reimbursement without CED and without a one scan per lifetime limit.