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Centers for Medicare & Medicaid Services

View Public Comments for Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decisions

Zoghbi, MD, FACC, William
American College of Cardiology (ACC)

January 28, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Coverage with Evidence Development (CED) Draft Guidance for the Public, Industry, and CMS Staff

Dear Dr. Jacques:

The American College of Cardiology (ACC) appreciates this opportunity to comment on the CED draft guidance. ACC is transforming cardiovascular care and improving heart health through continuous quality improvement, patient-centered care, payment innovation and professionalism. The College is a 40,000 member nonprofit medical society comprised of physicians, nurses, nurse practitioners, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at

The College shared its perspective and ideas in response to the previous public comments solicitation and at the MEDCAC convened on this topic. As stated in those interactions, the ACC supports the use of CED to provide Medicare beneficiaries with prompt access to new technologies/services when early evidence suggests, but does not yet convincingly demonstrate, a net benefit for beneficiaries. The Draft Guidance appears to move in that general direction by placing emphasis on Coverage with Study Participation (CSP) as CMS’ current conceptualization of CED. Definition of four factors for consideration that may warrant application of CED will be helpful for patients, cardiologists, and other interested parties.

Creation of applicable standards for applying and ending CED further clarifies areas we previously felt were vague. These standards align with our recent experience on CED of transcatheter aortic valve replacement (TAVR). The proposed standards of scientific integrity and Medicare relevance also appear reasonable.

We are pleased to see accommodations for follow up studies to address outstanding evidence gaps based on interim analysis with pre-agreed public criteria. CMS’ willingness to address ongoing coverage with investigators is helpful, but we remain concerned about misalignment of CED with the end of the study and/or the agency’s review of the scientific results. CMS acknowledges the potential for “noncoverage between the end of the study and the agency’s review of scientific results.” We suggest CMS allow for additional data collection by providing ongoing coverage for additional patients under a format similar to the continued access protocol used by FDA.

Finally, limitations continue to exist as CMS and FDA evaluate new technologies for their respective purposes—reasonable and necessary on one hand, safe and effective on the other. While perhaps not a topic for this document, we suggest that any potential steps be taken to align CED studies with FDA’s post-approval study requirements.

Thank you for considering these comments. Please contact James Vavricek, Senior Specialist for Regulatory Affairs, at or 202-375-6421 if you need any further information.


William Zoghbi, MD, FACC