Author + information
- Published online September 5, 2017.
- Frederick M. Masoudi, MD, MSPH, FACCa and
- William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science & Quality, Education and Publications, American College of Cardiologyb,∗ ()
- aDivision of Cardiology, Department of Medicine, University of Colorado Denver, Aurora, Colorado
- bAmerican College of Cardiology, Washington, DC
- ↵∗Address for correspondence:
Dr. William J. Oetgen, American College of Cardiology, 2400 N Street NW, Washington, DC 20037.
With the publication of the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) in 2005 (1), the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Decision (NCD) for the implantation of implantable cardioverter-defibrillators (ICDs) that expanded payment for primary prevention defibrillators in patients with nonischemic cardiomyopathy and severe left ventricular systolic dysfunction (2).
This expansion in coverage was accompanied by a coverage with evidence decision (CED), which required patients receiving ICDs for primary prevention in the Medicare population to be enrolled in either an approved clinical trial or in a national registry that would support the understanding of the outcomes of patients receiving this therapy (2). Subsequently, the American College of Cardiology (ACC) developed the National Cardiovascular Data Registry (NCDR) ICD Registry (3), which was recognized by the CMS as a qualifying data collection system for the purposes of the CED. Since that time, the NCDR ICD Registry has been the standard for understanding patient selection, care, and outcomes in patients receiving ICD therapy.
In May 2017, CMS announced a review of the NCD for ICDs and requested comments from the public and the profession. In June 2017, the ACC and the Heart Rhythm Society crafted and submitted a joint comment letter signed by their respective presidents, Mary Norine Walsh, MD, FACC, and George Van Hare, MD, FHRS. With respect to the clinical evidence, the comment recommends updated indications for ICD placement (4). The original CMS criteria and the criteria recommended by the ACC and Heart Rhythm Society are summarized in Tables 1 and 2.
Given that the CMS NCD, including the registry CED mandate, is under review, it is timely to consider the contributions of the ICD Registry to our understanding of the care and outcomes of patients receiving this therapy. Currently, more than 1,800 hospitals participate in the program, and 80% of these value the registry beyond the mandate, collecting data for their ICD procedures irrespective of payer or clinical indication for therapy. Participating centers receive nationally benchmarked feedback on the quality of care and outcomes delivered to their patients. Thus, the ICD Registry has served as the foundation for quality improvement of ICD utilization across the country. The model of a national registry to support Food and Drug Administration post-market requirements, CMS coverage with evidence mandates, and national quality improvement has been extended successfully to other cardiovascular procedures, including transcatheter valves (5) and left atrial appendage occlusion devices (3).
Because more than 1.7 million ICD implantations have been recorded in the ICD Registry, and because these data have been linked to Medicare claims for the purposes of ascertaining outcomes after the implantation procedure, the program has yielded more than 75 peer-reviewed scientific papers. These studies have advanced our understanding of device selection, care, and outcomes nationally, addressing key questions of the effectiveness, safety, equity, and efficiency of care. These studies have exponentially increased the value of the ICD Registry data well beyond the specific issues outlined in the original CED; their validity has been substantially enhanced with the availability of a true national denominator of patients receiving this therapy. Studies that advance our understanding of the translation of clinical trials and guidelines into contemporary clinical practice on a national scale would have been impossible without a registry that supported the CED.
The ICD Registry has been a model of professional transparency, accountability, and science in exchange for expanded payment for devices. Ultimately, the registry mandate in the original CMS CED has supported better patient care and science to advance our understanding of the role of ICDs in the care of patients who are at risk for sudden cardiac death. In the re-evaluation of the registry mandate in the CED, these benefits must be considered. Given that the indications for ICD therapy will change with this update, patients, physicians, and policy-makers will need valid contemporary data to ensure the optimal use of these devices and to achieve better outcomes.
- 2017 American College of Cardiology Foundation
- Centers for Medicare & Medicaid Services
- American College of Cardiology
- Walsh M.N.,
- Van Hare G.F.
- The Society of Thoracic Surgeons, American College of Cardiology