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Centers for Medicare & Medicaid Services

View Public Comments for CED Public Solicitation

Flood, Kathleen
Chief Executive Officer
American Society of Nuclear Cardiology
January 20, 2012 Louis Jacques, M.D. Director, Coverage and Analysis Group Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services Mail Stop C1-12-28 7500 Security Boulevard Baltimore, MD 21244 VIA ELECTRONIC SUBMISSION RE: Coverage with Evidence Development; Request for Comments Dear Dr. Jacques: The American Society of Nuclear Cardiology (ASNC) appreciates the opportunity to provide input to the Centers for Medicare and Medicaid Services (CMS) as the Agency reviews its coverage with evidence development (CED) policy. ASNC is a greater than 4,700 member professional medical society which provides a variety of continuing medical education programs related to nuclear cardiology and cardiovascular computed tomography, develops standards and guidelines for training and practice, promotes accreditation and certification within the nuclear cardiology field, and is a major advocate for furthering research and excellence in nuclear cardiology and cardiovascular computed tomography. ASNC understands that CMS has a responsibility to ensure that Medicare program services meet the “reasonable and necessary” requirement imposed by statute. We support coverage with evidence development as an important mechanism to achieve this mandated function. CED is an avenue to provide coverage for new technology or other services where large scale studies may be unwarranted or inappropriate. ASNC believes the CED process should be used to enhance patient access to innovative services that have demonstrated the potential for patient benefit. Coverage with evidence development should not be used to restrict patient access to services. We encourage CMS to structure a revised CED process that is timelier from start to finish. For example, ASNC would support efforts to establish a “fast track” process that includes pre-established data collection requirements for a specified time period, eliminating the need for tying CED to the limitations of the complex National Coverage Determination (NCD) process. A “fast track” process should have well defined clinical questions, shorter time frames, and a clearly outlined pathway for data analysis and evaluation that is presented at the initiation of the CED process. We also urge the Agency to ensure that any CED process, “fast track” or otherwise, does not disrupt existing coverage under local coverage determination (LCD) policies. Lastly, we encourage CMS to remain open and willing to engage in partnerships with professional medical societies as we work toward the goal of providing high quality care for Medicare beneficiaries. Professional medical societies work through research, education, and the development of clinical guidelines and policy, as partners in spurring innovation. In particular, professional medical societies serve a critical role as a conduit to foster the exchange of information disseminated by CMS to practitioners in the field. Thank you for your consideration of these comments. If you have questions or require additional information, please contact Kathleen Flood at Sincerely, John Mahmarian, MD President American Society of Nuclear Cardiology