Implantable Defibrillators

CMS began a modified NCD process on January 1, 2004 (See Changes to the National Coverage Determination Process ). This Tracking Sheet template will shortly be modified to reflect those changes. Until that time the Expected Completion Date above is the date by which we will post the draft decision memorandum for public comment. We are also beginning, as of this posting date, our standard, initial 30 day comment period on this NCD and are interested in scientific input relevant to the issue under consideration.

We are specifically interested in comments on each of the four trials mentioned above and well as evidence to support the appropriate selection of various types of ICDs for differing patient populations.

View Requestor Letter [PDF, 70KB].

Since the results of the DEFINITE and COMPANION trials were published May 20, 2004, after the close of our initial comment period, CMS would like to invite the public to participate in a second 30-day comment period beginning today. We are interested in receiving comments on the results of these two trials and how they should impact Medicare’s review of implantable defibrillators. Due to the short time frame, the preferred method of receiving comments is by emailing the Lead Analyst (listed above). Comments may also be submitted by mail to her attention at 7500 Security Blvd., Mailstop C1-09-06, Baltimore, MD 21244.

Comments [PDF, 2MB] from the first 30-day public comment period are now available for viewing.

CMS is interested in receiving feedback on additional questions surrounding the appropriate use of implantable defibrillators. We ask that the public submit comments based on the published literature, not practice patterns, for the following questions:

1. What is the evidence surrounding the necessity of threshold testing at the time of implantation?
2. What is the evidence of benefits and risks of adding anti-tachycardia pacing to the function of an implantable defibrillator, including the risk of an additional lead?
3. Is there sufficient scientific justification for development of an ICD patient registry to collect information to better identify predictors of ICD firing for ventricular fibrillation (as a proxy for sudden cardiac death)?

The public comment period announced on 6/23/04 will last 30-days and close on 7/23/04.

Comments [PDF, 129KB] from the second 30-day public comment period (5/25-6/25) are now available for viewing.

Two comments that were inadvertently missing from the second 30-day public comment posting are now included and available for viewing.

Comments [PDF, 1MB] from the third 30-day public comment period (6/23-7/23) are now available for viewing.

CMS is posting a draft Decision Memorandum for a 30-day public comment period. CMS is particularly interested in comments on the following:

• CMS interpretation of the evidence;
• CMS decision;
• Data elements and design features of a national registry to ensure that it would be effective, least costly and least burdensome to providers;
• Appropriate device selection criteria and the CMS recommendation to require medical justification when implanting more sophisticated devices.

Instructions for submitting public comments are available at http://www.cms.hhs.gov/coverage/8h.asp.

The National ICD Registry Workgroup, chaired by the Heart Rhythm Society, provided CMS with guidance and recommendations in implementing an ICD registry. The Workgroup included members of medical professional societies, academia and industry. They made recommendations regarding the purpose of the registry, questions to be answered by the registry, patient enrollment, data elements, provider criteria and registry management. The Workgroup's letter [PDF, 60KB] to CMS is now available.

Comments [PDF, 2MB] received between 9/28/04 and 10/28/04 on the proposed national coverage decision are now available for viewing.

CMS initiated this national coverage decision (NCD) process with the expectation that the final decision would be posted no later than December 28, 2004, in accordance with the accelerated time frame established by the Sec. 731 of the MMA. As has long been the standard, when the basis for an NCD is a clinical trial, CMS requires publication of the trial results in a peer-reviewed journal before those results can be used as the basis for implementing a national coverage decision. The results of the SCD-HeFT trial, the major source of evidence used in this NCD, have not yet been published in a peer-reviewed journala critical step in validating the evidence underlying this coverage determination.

CMS now understands that while it is still possible that the results of the trial may be published prior to the planned completion date, it is not certain that they will be. CMS intends to post the final coverage decision on December 28 if the trial results are published on or before that date. If the publication of the trial is delayed beyond December 28, CMS will post a final decision on that date maintaining current ICD coverage, per the MMA timeframes. We will also immediately open a new reconsideration of this ICD coverage on December 29, with the intention of posting and implementing a final decision within one week following the publication of the SCD-HeFT trial results. While the MMA requires a 30 day comment period for each NCD, CMS may decide to post the final decision without completing the full comment period, unless the final published report is not fully consistent with the data that is already under review.

CMS is posting additional information related to the proposed ICD registry including the registry hypotheses [PDF, 10KB] and data elements [PDF, 28KB]. This information is being made available in advance of the final coverage decision to allow time for the public to become familiar with the data elements and prepare for future data collection efforts.

Because the SCD-HeFT results have not yet appeared in any peer-reviewed journal, CMS is now posting the final decision memorandum maintaining previous coverage. Section 731 of the MMA requires that CMS issue a final decision within 9 months of having accepted the request for an NCD, which in this case occurred on 3/30/04. CMS is therefore closing this decision and will re-open the process on 12/29/04 with the intention of issuing a second decision after the publication is available.