It will ensure effective oversight of transplant centers by advancing coordination between CMS, State survey agencies, the Health Resources and Services Administration, the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.

“This is a major milestone in our efforts to make sure that people needing transplants get the best possible care, while giving transplant centers and physicians comprehensive and reliable guidance,” said Leslie V. Norwalk, CMS acting administrator. “This rule both improves the current transplant outcome measure requirements and strengthens the protection of the health and safety of patients and living donors.”

In recent decades, remarkable strides in transplantation technology and pharmacology have turned organ transplantation into a mainstream treatment for many patients in end stage organ failure. CMS issued coverage decisions related to heart transplants in 1987, liver transplants in 1991, lung transplants in 1995, and intestine transplants in 2001 and updated in 2006. Kidney transplant centers have been regulated in the Code of Federal Regulations since 1976. This rule will consolidate all transplant center requirements into one regulation.

All transplant centers that continue to participate in Medicare, including kidney transplant centers, are required to submit a request for initial approval. Once approved by Medicare, transplant centers are eligible for re-approval every 3 years.

Transplant centers with current Medicare approval, that have applied for initial approval within 180 days from the effective date of the final rule may continue to provide transplant services and receive payment from Medicare until CMS makes a decision on the transplant center’s request for approval.