National Coverage Analysis (NCA) Tracking Sheet

Transplant Centers: Re-Evaluation of Criteria for Medicare Approval

CAG-00061N

Issue

Medicare criteria for transplant centers have historically considered the facility. The criteria include a requirement that the facility have a minimum of 2 years experience prior to Medicare approval. Recently, several transplant teams have changed facilities and have made the argument that Medicare approval more appropriately should rest with the transplant team rather than the institution itself. Specifically, supporters of transferring teams believe that the physical location of the team is not significant to outcomes, but rather the experience of the transplant team is critical for Medicare approval.

Medicare coverage decisions are evidence-based decisions. We are looking for scientific evidence and data to support an analysis and re-evaluation of the Medicare transplant facility criteria.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Internal CMS request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/26/2000
Expected NCA Completion Date
09/24/2000
Public Comment Period
07/26/2000 - 08/25/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
07/26/2000

Contacts

Lead Analysts
Jackie Sheridan-Moore
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

May 5, 2000

Posting to web soliciting scientific evidence.

Questions in need of evidence:

Is there scientific evidence or data that support that safety, effectiveness, and medical appropriateness can be determined through evaluation of the experience of the transplant team rather than through evaluation of the facility?

Are there any members of the transplant team (transplant physician, transplant surgeon, immunologist, infectious disease specialist, pulmonologist, pathologist, radiologist, nursing, social services, blood banking) who could be replaced by any currently employed license holder in that discipline without affecting significantly the result of the transplant procedure? What evidence is there to support this conclusion?

When a transplant team transfers facilities, what assurances are there that the team retains the patient selection and patient management protocols that contributed to the outcomes achieved in the previous facility? What evidence is there to support this conclusion?

What evidence is there that a facility that has lost a transplant team will achieve the same or similar outcomes with a replacement team?

June 26, 2000

Received documents from CHRISTUS Santa Rosa Memorial Hospital in response to web solicitation which, together with our own research, formed the basis of a formal request for a national coverage decision.

July 26, 2000

Decision made revising Medicare criteria for approval of transplant centers. See Decision Memo dated July 26, 2000.