Andrew Hresko, Cardiovascular Roundtable
On October 30, the Centers for Medicare and Medicaid Services (CMS) finalized an update to the national coverage determination (NCD) for bridge-to-transplant (BTT) and destination therapy (DT) ventricular assist devices (VADs). The new NCD defines the required multidisciplinary VAD team, changes accreditation and registry reporting requirements, and attempts to clarify BTT and DT patient selection criteria. Below, I’ve outlined the changes and what they mean for current and aspiring VAD programs.
Takeaway #1: DT programs need to have a NCD-defined multidisciplinary team in place within the next year
The updated NCD defines the multidisciplinary VAD team that is required for reimbursement. The team, which must be in place by October 30, 2014, includes:
- A cardiothoracic surgeon who has implanted at least 10 durable, intracorporeal, left ventricular BTT or DT VADs in the previous three years and at least one in the previous year
- An advanced heart failure cardiologist with clinical competence in medical and device-based management (including VADs) and clinical competence managing patients before and after a heart transplant
- A VAD program coordinator
- A social worker
- A palliative care specialist
The NCD requires that all members of the team be based at the hospital and have prior experience working with VAD patients.
While these new staffing requirements represent a big leap from the previous staffing standards, they are in line with the teams that progressive VAD programs have assembled. The three institutions we profile in our recent publication Blueprint for Heart Failure Centers are all already using similar VAD team structures. Adoption of palliative care specialists is less widespread than employing coordinators and social workers, but the American College of Cardiology (ACC) and American Heart Association (AHA)’s most recent joint guideline for heart failure management does recommend including one on a VAD team.
Takeaway #2: Hospitals can get certified for DT VAD care from any CMS-approved organization
Under previous versions of the NCD, a hospital had to receive the Joint Commission’s Advanced Certification in Ventricular Assist Devices to be eligible for Medicare reimbursement. Last week’s update changes this requirement. Instead of being credentialed by the Joint Commission, hospitals can be accredited by any CMS-approved organization as having the previously described multidisciplinary team in place. CMS is currently accepting applications for organizations to be recognized as approved DT VAD credentialing bodies. Once applications have been processed, CMS will provide a list of all approved credentialing organizations on its website.
Takeaway #3: INTERMACS participation no longer required
The updated NCD removes the requirement that DT VAD programs participate in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). While acknowledging that reporting to a national registry benefits quality improvement initiatives, benchmarking, and clinical research, CMS felt that because it has no further questions as to the reasonability and necessity of VADs for the indications covered in the NCD, gathering information through INTERMACS is no longer a necessary provision for reimbursement.
CMS also decided not to finalize a previously proposed requirement that hospitals track VAD patient outcomes in a way that would be comparable to other institutions. Commenters on the proposed NCD expressed concern that this requirement could result in hundreds of incompatible attempts to recreate INTERMACS.
As a result of these decisions, CMS will not require any public reporting or outcomes tracking for VADs. However, INTERMACS will not be dismantled, and institutions will likely continue to voluntarily report to the registry.
Takeaway #4: CMS attempts to clarify BTT and DT patient selection criteria
The new NCD makes two changes to the patient selection criteria for BTT VADs. First, patients are now required to be active on the Organ Procurement and Transplantation Network (OPTN)’s waitlist for a new heart. Patients who are temporarily inactive for any reason–“Status 7” on the list–are now ineligible for BTT VADs. Second, CMS removed language suggesting that BTT patients must receive a transplant as soon as medically reasonable. This change reflects mounting evidence that BTT patients are often less at-risk than many medically managed patients on the OPTN list.
For DT VADs, the update clarifies that the characterization of a patient as ineligible for a heart transplant, and thus eligible for a DT VAD, is based only on information available at the time of the VAD implant, and removes the word “permanent” from the description of a DT VAD. This clarification acknowledges that some patients do become medically eligible for transplant after receiving a DT VAD if comorbidities such as excessive weight or kidney dysfunction resolve after implantation. In fact, in response to commentary on the proposed update, CMS explicitly states that implantation of a DT VAD does not preclude a patient from later receiving a new heart.
BTT and DT designations still a source of debate
While these changes do help clarify which patients are eligible for BTT and DT implants, they also muddle the distinction between the two.
Some groups, including the ACC and AHA, have argued that many DT VADs are more appropriately viewed as “bridge-to-decision,” buying time so the decision to reclassify the patient as BTT and make them eligible for a future transplant can be made after comorbidities have been treated or managed. Likewise, BTT patients may see their disease progress to the point where they are no longer eligible for transplant. Other bridge-to-decision patients who have neither completed the rigorous evaluation needed to be included on the OPTN list, nor been deemed ineligible for a transplant may also benefit from VADs.
The fluid distinction between BTT and DT patients and the potential benefits of implantation in bridge-to-decision cases have led some to propose eliminating the designations altogether. CMS stops short of such a radical change because of concerns over device longevity and lack of explicit standards for the bridge-to-decision status. But the trend of borderline cases being designated as DT and later reassessed, which has already been observed in some hospitals, may continue with this explicit admission that DT patients can be reclassified as BTT and later receive a transplant.
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