CMS extends comment period for OPO, transplant center rules 60 days; new due date now June 6.

Bowing to pressure from a number of transplant groups, including the American Society of Transplant Surgeons and the Organ Procurement and Transplantation Network Transplant Administrators organization, the Centers for Medicare and Medicaid Services (CMS) has extended the comment period on the proposed rules for organ procurement organizations (OPO) and US transplant centers.

Individuals and organizations now have an additional 60-days from the original April 4 deadline--June 6--to submit their comments on the CMS' 2 proposed rules - Conditions for Coverage for Organ Procurement Organizations and Medicare Program: Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants.

CMS Senior Policy Analyst Marcia Newton made the announcement during the national audioconference on the CMS proposed rules for transplant centers presented by Transplant News and the National Kidney Foundation on March 23. Newton told participants the CMS had decided to extend the comment period 60 days and that the announcement would appear in the March 25 Federal Register.

Organ Procurement Organization extension

In the Federal Register notice CMS Administrator Mark McClellan, MD, explained the agency's rationale for the extension. "The proposed rule contains multiple new technical, structural, and performance requirements, including new procedures for re-certification of OPOs and new outcome performance measures based on organ donor potential. Due to the large number of proposed new requirements and the technical nature of the proposed outcome performance measures, we are extending the comment period to ensure sufficient time for the public to review and comment on the proposed requirements."

For further information contact Marcia Newton - [phone]

Transplant Center Conditions of Participation extension

McClellan used virtually the same language to explain the transplant center extension that affects all of the nation's heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers.

"The proposed rule set forth the first comprehensive hospital conditions of participation (CoPs) for transplant centers that perform organ transplants," McClellan said. "The proposed rule contains multiple new technical, structural, and performance requirements, including new procedures for approval and re-approval of transplant centers and new outcome performance measures. Due to the large number of proposed new requirements and the technical nature of the proposed outcome performance measures, we are extending the comment period to ensure sufficient time for the public to review and comment on the proposed requirements."

For further information contact - Eva Fung [phone]