Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)
Dear Dr. Jacques:
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N). Specifically, our comments oppose CMS’ draft decision to apply coverage with evidence development (CED) to beta-amyloid Positron Emission Tomography (PET Aß) imaging. Instead, we express support for Medicare coverage of this innovative and promising technology used in the early detection and treatment of Alzheimer's disease (AD) or cognitive impairment.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
As the representative of an industry that is devoted to improving health care through the discovery of new diagnostics and therapies, BIO supports the Department of Health and Human Services’ (HHS’) initiatives to accelerate research on detection, treatment, and prevention of AD through its National Plan to Address Alzheimer’s Disease released by the Assistant Secretary for Planning and Evaluation (ASPE) on January 9, 2012. The Plan’s initiatives include expanding research and tools for clinicians, especially in the realm of emerging technologies and new approaches in clinical testing. In comments submitted February 8, 2012, BIO emphasized that any framework for improving diagnosis and care for serious, complex illnesses, such as AD, must include measures to provide access to innovative diagnostic and treatment options. As such, BIO has a particular concern with actions by the Centers for Medicare and Medicaid Services (CMS) that may continue to limit patient access to PET Aß imaging.