The Final Rule (42 CFR Part 121) effective March 16, 2000, further defines the terms and conditions for operation of the OPTN. The Final Rule defines a standard framework for policies, requiring the OPTN to establish Policy Criteria, Policy Objectives and Performance Measures with procedures for continuous evaluation and reporting. Under the terms of the Final Rule, policies intended to be binding upon OPTN members are developed through the OPTN committees and Board of Directors and then submitted to the Secretary of HHS for final approval. The Rule also states that a transplant center must remain a member in good standing. If the member remains non-compliant after due process by the OPTN Membership and Standards Committee, the Board may deem a non-compliant center a Member Not in Good Standing. The case may then be forwarded for review to the Secretary, who could ultimately revoke that center’s eligibility to participate in Medicare. (OPTN Glossary May 2021)
Glossary Term