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On March 27, 2007, the Centers for Medicare & Medicaid Services (CMS) updated the National Coverage Determination (NCD) for Artificial Hearts and Related Devices (NCD Manual 100-3 ยง20.9), specifically the section related to ventricular assist devices (VADs). The updated policy only impacts the facility criteria for hospitals seeking coverage of VADs when implanted under the destination therapy clinical criteria. All currently approved facilities must demonstrate to CMS that they meet the updated criteria. Briefly, the new criteria are as follows: - At least one surgeon the hospital's VAD team must have experience implanting at least 10 VADs (as bridge to transplantation or as destination therapy) or artificial hearts during the recent 36 months;
- Hospitals must participate in the Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS), a registry funded by the National Heart Lung and Blood Institute of the National Institutes of Health;
- Hospitals must obtain Joint Commission certification under the Disease Specific Certification Program for Ventricular Assist Devices by March 27, 2009; and
- Hospitals listed on the existing approved facilities list must meet the updated criteria.
Hospitals that are not currently on the Medicare approved facilities list can become approved at any time by gaining certification from the Joint Commission. The clinical patient selection criteria for VADs implanted as destination therapy remain unchanged. Coverage of VADs for post-cardiotomy and bridge to transplantation also remain unchanged. Process for Maintaining Facility Approval At the end of April 2007, a letter was sent to the 69 currently approved hospitals and in order to demonstrate that the hospital meets the new criteria they must reply with a letter that includes all of the following: - A listing of the clinical experience over the most recent 36 months of at least one surgeon on the hospital's VAD team that delineates:
- The type of VADs and/or artificial hearts implanted (manufacturer name and model);
- The clinical indication for the implant (e.g., post-cardiotomy, bridge to transplantation, or destination therapy); and
- The date of implantation.
- A statement attesting to INTERMACS participation; and
- The signature of a high-level hospital administrator (e.g., CEO, CFO, etc.).
Responses must be received by July 31, 2007, and should be mailed to: Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21244-1850 Hospitals that do not respond will be removed from the Medicare approved facilities list. Hospitals that do not meet the updated March 27, 2007, facility criteria will also be removed from the list. Once removed, hospitals can only be reinstated as a Medicare approved facility by obtaining Joint Commission certification. Further, CMS will not accept new applications from facilities not currently on the approved facilities list.
Page Last Modified: 08/08/2008 8:08:01 AM
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