February 12, 2004

Sean Tunis, MD, MPH
Chief Medical Officer
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Mail-Stop – S3-01-02
Baltimore, MD 21244-1850

Dear Dr. Tunis,

NASPE–Heart Rhythm Society welcomes the opportunity to respond to your interest in revision of the CMS pacemaker policy as was discussed at our last meeting. Our response is based on the supposition that results of clinical trials often provide insights about new indications for pacemaker therapy as well as conditions for which pacemakers do not provide any benefit or may cause harm. We share your view that coverage policies should be based on scientific evidence whenever possible and they should reflect a systematic analysis of existing data. The Society’s Committee on Health Policy, the Executive Committee, and the Board of Trustees carefully considered this issue. The recommendations outlined below represent a consensus among the Society’s leadership.

The most comprehensive study of indications for pacemakers is embodied in the CC/AHA/NASPE Guidelines, which undergo frequent revision based on advances in the field. The most recent document entitled Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: ACC/AHA/NASPE 2002 Guideline was published in Circulation and the Journal of the American College of Cardiology. It can also be found on the ACC web site (http://www.acc.org/)

The methodology used to develop these guidelines has evolved over nearly 20 years. It is important to understand these methods to appreciate the weight we attach to these recommendations. The process is fully described at: http://www.acc.org/clinical/manual/manual_index.htm. The guidelines are intended to provide recommendations applicable in the United States, but they generally appeal to an even broader international audience. The primary objective is to give practitioners, patients, and policymakers an explicit description of the projected benefits of therapy as well as potential harms or risks. These guidelines are based on a comprehensive review of relevant research by leading authorities in the field. Cardiologists, other experts in the field of cardiology or cardiovascular research, and representatives from other organizations contribute to the development of the guidelines. Their composite clinical expertise is germane to the creation of guideline recommendations that are useful to a broad spectrum of practitioners. Evidence used to support the guidelines is based on the following peer-reviewed, published documents:

• Randomized controlled trials
• Meta-analysis
• Systematic reviews of evidence
• Diagnostic studies using comparison with a gold standard

The results from unpublished data are usually not considered. Only trials presented at a major national or international scientific meeting are allowed, but when unpublished trial data are discussed, the text clearly states that the data are preliminary.

Despite all the evidence that may be available for writing the guidelines, they ultimately depend on expert interpretation to formulate recommendations. The reality is that much evidence falls into a “grey zone” of uncertainty, and the evidence from multiple trials may lead to divergent conclusions. Sometimes the evidence applies to specific sub-populations, it may be methodologically weak, or it may be insufficient to make a definitive decision. Indisputable recommendations based on an abundance of incontrovertible evidence are uncommon. Once recommendations are written, a Classification of Recommendation and Level of Evidence grade must be assigned to each recommendation. These are as follows:

Classification of Recommendations

Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective.

Class II: Conditions for which there is conflicting evidence and/or divergence of opinion about the usefulness/efficacy of a procedure or treatment.

IIa. Weight of evidence/opinion is in favor of usefulness/efficacy
IIb. Usefulness/efficacy is less well established by evidence/opinion

Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective, and in some cases may be harmful.

Level of Evidence

Level A: Data derived from multiple randomized clinical trials
Level B: Data derived from a single randomized trial, or non-randomized studies
Level C: Consensus opinion of experts.

It is important to recognize that any combination of Classifications of Recommendations and Levels of Evidence is possible. A recommendation could be Class I based on expert opinion in the absence of large-scale studies (Evidence Level C). A Class IIb recommendation could be assigned Evidence Level A if multiple randomized controlled trials lead to divergent conclusions. Moreover, a Level of Evidence B or C does not imply that the recommendation is weak. Many important questions do not lend themselves to experimentation or have not yet been addressed by high quality investigations. Sometimes, the relevance of a clinical problem mandates a recommendation even in the absence of optimal data.

NASPE-Heart Rhythm Society strongly advocates the ACC/AHA/NASPE pacemaker guidelines as the basis for CMS coverage decisions. The guidelines provide considerable detail, they are exhaustively researched, they have been considered by a broad group of experts, and they have undergone a demanding peer review process. They represent the consensus of the three highly regarded professional organizations with nearly 20 years of experience in writing guidelines. The guidelines are practical and they have undergone a test of time. Class III recommendations provide a clear and reasonable basis for the decision not to provide coverage for a specific problem. However, the criteria for this life-saving technology should be inclusive when there is a divergence of opinion because of incomplete or conflicting evidence. These Class II indications constitute a small minority of the pacemakers implanted in the United States. Class II conditions are appropriate for coverage provided that the physician clearly documents the reason the pacemaker was recommended. If representatives from CMS have specific questions about certain conditions for which a coverage decision is in question, NASPE-Heart Rhythm Society would be willing to provide information pertaining to that specific indication.

We also recognize your interest in the appropriate selection of patients for cardiac resynchronization therapy (biventricular pacing). All the clinical trials conducted thus far have emphasized the need for optimal medical therapy before the decision is made to recommend cardiac resynchronization therapy. Studies are in progress at many leading medical centers to identify patients who are most likely to benefit from cardiac resynchronization therapy and to optimize implantation techniques. A NASPE-Heart Rhythm Society Task Force has been assigned the responsibility to specifically address this issue, and their recommendations will be provided to CMS after appropriate review and approval by the Society. It will undoubtedly be addressed in the next ACC/AHA/NASPE edition of the guideline recommendations.

If you would like to discuss this issue in further detail in either a conference call or a meeting, please contact Amy Melnick, Vice President, Health Policy to arrange at 202-327-5430 or amelnick@naspe.org. Thank you very much for your willingness to work with NASPE – Heart Rhythm Society as you consider revising this policy.

Sincerely,

Michael Cain, MD
President
NASPE-Heart Rhythm Society


Bruce Lindsay, MD
Chair, Committee on Health Policy
NASPE-Heart Rhythm Society
 

Cc: Steven Phurrough, MD
Director, Office of Standards and Quality