American College of Cardiology
January 17, 2012
Louis Jacques, MD
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
RE: CED Public Solicitation
Dear Dr. Jacques:
The American College of Cardiology (ACC) appreciates this opportunity to comment on role of CED in the Medicare program. 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 http://www.cardiosource.org/ACC.
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. We are familiar with this process through the use of ACC’s National Cardiovascular Data Registry (NCDR) for data collection as a condition of coverage for implanted cardioverter defibrillators (ICDs) for the purpose of primary prevention. Based on that experience, we feel several aspects of CED could be improved.
First, the largest shortcoming we perceive with CED is that it has been underutilized as a tool to diffuse and evaluate technologies/services more quickly and effectively. CED can be used to expand access to promising services for the collection of clinical data that addresses key questions of concern to CMS, clinician, and patients. We do not support CED when it is used primarily as a tool to limit access to technologies/services with the perceived potential for inappropriate use or overutilization.
Second, we have found it difficult to anticipate when CMS will consider CED. Additional guidance from CMS on circumstances when CED will be considered would be helpful. Such guidance could address the level of already existing evidence needed to qualify for CED, and the degree to which issues such as the availability of alternative treatments, risk of the service under consideration, and the likelihood of developing useful evidence within a reasonable timeframe might influence the agency’s decision to implement CED. Further exploration of the use of CED in unique circumstances where very limited evidence for a service/technology of great potential benefit exists would be helpful as well.
Third, CED policies often do not appear to incorporate a specific timeline or process for evaluating results and making subsequent coverage decisions. CED policies should include the following elements:
- Well-defined clinical questions formulated with input from clinical experts and the specialties most likely to provide the services in question.
- A reasonable timeframe for evaluation of data collected as part of the CED.
- Data analysis plans outlining how CMS will use data collected through CED.
- Evaluation criteria that describe how CMS will determine whether evidence collected through CED is sufficient to justify national coverage.
- A flexible mechanism for modifying data capture elements as knowledge evolves through ongoing analysis during the CED period.
Finally, CMS should encourage the use of existing research and data collection infrastructure. Registries such as NCDR provide a valuable, cost-effective infrastructure to meet CED requirements while also fostering improvements in the quality of care. By using national registries the resource burden to capture clinical data would be significantly minimized, since in many cases the same data are captured as part of a national registry. Additionally national registries offer data quality procedures that would benefit CMS by helping to improve the overall quality and completeness of the data.
Thank you for this opportunity to contribute to this review of CED. Please contact James Vavricek, Senior Specialist for Regulatory Affairs, at email@example.com or 202-375-6421 if you need any further information.
David R. Holmes, Jr., MD, FACC