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Medical Coding News Archives

Changes to Coverage for Ventricular Assist Devices

February 13, 2014:

Karen Kachur, Clinical/Technical Editor

In a final decision released in October 2013, the Centers for Medicare and Medicaid Services (CMS) announced a number of changes to its national coverage policy for ventricular assist devices (VAD).

In February of last year, CMS began reconsidering its coverage of ventricular assist devices (VADs), both as a bridge to transplant (BTT) and as destination therapy (DT). Although a reconsideration request involved only amending facility criteria to include the DNV Healthcare Inc. (DNV) Mechanical Circulatory Support Certification Program as an acceptable credential for facilities implanting devices, CMS reviewed existing evidence for patient selection and facility criteria for the use of durable VADs for end-stage congestive heart failure as well.

Below are the changes CMS announced:

  • CMS renumbered VAD-related policies and incorporated them into a subsection of section 20.9 (Artificial Hearts and Related Devices) of the NCD Manual. Subsection 20.9.1 is titled “Ventricular Assist Devices.” This new section also includes existing coverage of VADs for postcardiotomy, BTT, and DT.
  • The patient must be active on the waiting list maintained by the Organ Procurement and Transplantation Network (OPTN).
  • The following requirement has been eliminated: a “Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable. Ideally, the Medicare-approved heart transplant centers should determine patient-specific timetables for transplantation, and should not maintain such patients on VADs if suitable hearts become available.”
  • Although the evidence did not warrant changes to current patient selection criteria for coverage of a VAD as destination therapy, the agency did revise the language in new section 20.9.1 to clarify that identifying patients who are not candidates for heart transplantation is based on information available at the time of VAD implant. The word “permanent” was also deleted from the description of DT.
  • Facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities until October 30, 2014. After this date, these facilities must be in compliance with the criteria as determined by a credentialing organization, and new facilities must meet the criteria as a condition of coverage of this procedure as DT under section 1862(a)(1)(A), which delineates the specific facility and staffing requirements.
  • The requirement was removed for participation in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).

The NCD does not address coverage of VADs for right ventricular support, biventricular support, or those patients under age 18, with complex congenital heart disease, or with acute heart failure without a history of chronic heart failure. Coverage in these situations will be made by local Medicare administrative contractors (MACs).


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