This post was authored by Lee Goldberg, MD, MPH, FACC, heart failure and transplant section chair.

The Centers for Medicare & Medicaid Services (CMS) made a number of important changes to the national coverage determination (NCD) for ventricular assist devices (VAD) in October 2013. DNV Healthcare Inc. requested review of the NCD to consider the position held by the Joint Commission as the only entity approved to accredit VAD programs. In response to this request, CMS will create standards any entity must meet in order to accredit VAD programs.

CMS made other important changes to the NCD that impact VAD programs. First, CMS decided to keep the bridge to transplant and destination therapy coverage categories. This decision rejected the suggestion made by the ACC and a number of other stakeholders that these categories reflect neither the way programs select patients nor the medical uncertainty that is often present when a VAD is implanted. 

For the bridge to transplant indication, CMS has clarified that the patient must be actively listed for heart transplant on the waitlist maintained by the Organ Procurement and Transplantation Network by a Medicare approved heart transplant center before the VAD is placed. However, the wording has become more flexible in regards to how quickly a bridge to transplant candidate should be transplanted, indicating that transplant centers should determine “patient specific timetables for transplantation.”

For destination therapy, CMS did not make any changes to the selection criteria citing a lack of evidence. They clarified, however, that destination therapy is strictly defined as a patient who is not a transplant candidate at the time the VAD is placed. This implies that some patients classified as destination therapy will ultimately be re-evaluated and become transplant eligible. For this reason, all VADs placed in patients who are not actively listed for heart transplant could be considered destination VADs.

Another implication is that non-transplant VAD Centers will need to be closely affiliated to one or more heart transplant centers in order to allow for rapid transplant candidacy assessment.

CMS changed and added several requirements as part of the certification of VAD programs. These new requirements must be met immediately by new programs. All existing Joint Commission certified VAD programs must meet the requirements by October 30.

CMS now formally requires a heart team to manage destination VAD patients, similar to what is required for transplant.  The team members must support shared decision making with patients and their families and must be based at the facility with the accredited program. The heart team must include at least one cardiothoracic surgeon who has placed 10 VADs, at least one cardiologist trained in advanced heart failure and cardiac transplant, a VAD program coordinator, a social worker and a palliative care specialist. The ACC believes these elements are already in place at high quality VAD programs and supported the requirement of a multidisciplinary heart care team as the best structure to allow for high quality VAD outcomes.

The most controversial change in the NCD is the removal of the requirement that centers report their data to the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). However, facilities must maintain a database of patients and their outcomes in order to monitor quality and benchmark against other facilities. The ACC acknowledged that CMS cannot require indefinite registry participation and suggested INTERMACS can still play a role in evaluating outcomes, detecting complications and advancing the field of ventricular assist devices.

The NCD does not address biventricular assist devices, extracorporeal membrane oxygenation or right ventricular devices, or the use of ventricular assist devices in the setting of acute heart failure.

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