Dear Heart Rhythm Society Member,

As you know, the Centers for Medicare and Medicaid Services has expanded primary prevention ICD coverage for patients at risk of sudden cardiac arrest. This coverage decision will directly lead to saving patient's lives which is what we have dedicated ourselves to and what the Heart Rhythm Society's mission is all about. The Heart Rhythm Society is preparing detailed instructions and compliance policies on implementing this new Medicare coverage policy for your practice and your institution. We will be sending this information to Heart Rhythm Society members in the next few days and will post on the Heart Rhythm Society website:

I want to thank those members who directly took action and became involved in the coverage process which gave us an opportunity to provide clinical input and guidance into the treatment of patients at risk of sudden cardiac arrest. Your expertise mattered and helped establish a public record of support for ICD coverage, physician device selection and the importance of trained heart rhythm specialists implanting devices.

Providing patient access (SCD-HeFT criteria) to proven medical technology (ICDs) through the implementation of evidence based medicine was a key advocacy goal of the Heart Rhythm Society these past nine months. Achieving Medicare coverage for SCD-HeFT patients, preserving physician's ability to choose the appropriate device, and the importance of mandating trained heart rhythm specialists implant ICDs have been at the center of the Society's advocacy priorities. Communicating these issues to CMS and the media has required a persistent and coordinated effort. The leadership of the Heart Rhythm Society met with CMS officials numerous times and submitted formal comments on a number of issues associated with appropriate arrhythmia care for our patients and the importance of sudden cardiac arrest prevention. The expertise of the Heart Rhythm Society was clearly noted when CMS called on the Heart Rhythm Society to Chair the National ICD Registry Working Group to provide recommendations to CMS on the new ICD Registry requirement.

Advocacy Effectiveness:

CMS responded to the majority of the Society's concerns and made policy changes to reflect the opinion of the practicing heart rhythm specialist. In the final coverage decision, CMS adopted all of the following Heart Rhythm Society recommendations.

• HRS recommended that the draft coverage decision be revised to include patients with LVEF of 35% or less.
• HRS recommended that CMS consider extending coverage of CRT-D therapy to patients with Class IV heart failure.
• HRS recommended that the term “shock only” be removed from the coverage decision.
• ICD Registry for Primary Prevention ICD Therapy: HRS strongly supported the need for hospitals and providers to be certified as competent in ICD implantation.

In the Final Coverage Decision CMS states the following: “As with any invasive procedure, physicians who insert ICDs must be appropriately trained and fully competent to perform the implantation. For an acceptable risk-benefit consideration, patients should not be harmed by the implantation of the device. CMS strongly encourages credentialing and certification of physicians who insert ICDs by appropriate national organizations, such as the Heart Rhythm Society (HRS) or boards of medical specialties, to ensure the safety of Medicare beneficiaries. CMS also believes that provider credentialing and certification should be tracked and included in any and all registries and data collection systems. This information is valuable for informing patients as part of effective clinical decision-making and will provide useful data on procedural outcomes associated with different levels of provider training and expertise.”

This statement from CMS is based on the Heart Rhythm Society Clinical Competency Statement: Training Pathways for Implantation of Cardioverter Defibrillators and Cardiac Resynchronization Devices--Endorsed by ACC Foundation

According to the Heart Rhythm Society Statement, defining providers and hospitals as competent in ICD implantation means the following:

• American Board of Internal Medicine Clinical Cardiac Electrophysiology Board Certification
• Completion of ACC COCAT Criteria during a cardiology fellowship for device implantation. This is then followed by successfully passing NASPExAM or another suitable nationally recognized examination. NASPExAM has been administered by the National Board of Medical Examiners since 1986 and tests physician competency to manage patients receiving cardiac pacemakers and implantable defibrillators.
• Completion of the Heart Rhythm Society ICD implantation guidelines for non-electrophysiologists (referenced above)
  

Educational Course – Alternate Training Pathways

The following educational course has been developed for those heart rhythm specialists in the community who seek to be certified as competent as outlined in the Heart Rhythm Society Clinical Competency Statement: Training Pathways for Implantation of Cardioverter Defibrillators and Cardiac Resynchronization Devices. The program provides information that is critical in understanding the utilization of various ICD and CRT device techniques. The Course, - ICDs and Cardiac Resynchronization Devices: Fundamentals of Patient Selection, Implantation, and Follow-up will be held April 7-9, 2005. The Course will cover the latest advances in ICD and CRT delivered through lectures, hands-on workshops, and case-based interactive sessions and will covert topics including: ICD design and technology, Indications for ICDs and CRT and results of clinical trials, implantation techniques, management of complications, and more.

Communicating Guidelines to Hospitals:

The Heart Rhythm Society will be communicating with every hospital in the United States where ICD implants are occurring the importance of the various pathways to competency as outlined above. We will encourage hospitals to adopt these training pathways as a means to ensure appropriate patient care for those receiving an ICD and will stress to the hospitals that “ CMS strongly encourages credentialing and certification of physicians who insert ICDs “ and that such certification will be tracked in the national registry.

This is an exciting, yet challenging time for the electrophysiology community as we begin implementing the largest Medicare coverage decision to date. We have an opportunity to reduce unnecessary death due to sudden cardiac arrest. The Heart Rhythm Society will continue to provide the resources you need to help make that happen. It is a privilege working on these issues on behalf of the membership of the Heart Rhythm Society.

If you have questions related to the implementation of the SCD-HeFT coverage decision, please contact Amy Melnick or Brian Outland at the Heart Rhythm Society at 202-464-3400 or amelnick@hrsonline.org or lmiller@hrsonline.org. If you need more information regarding the educational course, NASPExAM, or the Clinical Competency Statement, please contact Jacy Hanson at jhanson@hrsonline.org.

Sincerely,

Stephen C. Hammill, MD
President
Heart Rhythm Society