UNOS DonateLife

April 23, 2007

Statement from UNOS President Sue V. McDiarmid Regarding Federal Oversight of Transplantation

United Network for Organ Sharing (UNOS) commends recent efforts to establish new criteria and clarify existing processes for federal oversight of the nation's transplant system.

On March 30, 2007, the Centers for Medicare and Medicaid Services (CMS) of the U.S. Department of Health and Human Services published a Final Rule regarding transplant program certification under the Medicare Conditions of Participation. The regulation is effective June 28, 2007. The rule establishes new criteria for approval and re-approval of transplant centers and provides additional Medicare Conditions of Participation for transplant hospitals.

The Final Rule provides comprehensive Federal oversight of these vital processes while acknowledging, and in some instances incorporating, the functions of the Organ Procurement and Transplantation Network (OPTN). UNOS operates the OPTN under contract with HHS' Health Resources and Services Administration (HRSA). As stated in its responses to public comment, CMS intends for OPTN policies and the Final Rule requirements to "complement but not duplicate each other."

We welcome this cooperative approach to oversight, joining the efforts of CMS, HRSA and the OPTN. We believe that this rule, in conjunction with a series of recently implemented OPTN standards and policies, will greatly enhance the quality of the nation's organ transplant system and strengthen the protection of patient health and safety.

The CMS rule complements existing OPTN standards, for example in establishing new criteria for pediatric transplant hospitals and living donor transplantation programs. In other areas CMS will incorporate OPTN requirements, such as reporting of transplant data.

Also over the last several months, UNOS has provided extensive information to Sen. Charles Grassley, ranking member of the Senate Finance Committee, to assist in a study by the Committee regarding the nation's transplant system. Sen. Grassley's questions have focused on processes in place to ensure patient safety and quality of care, as well as ongoing efforts to improve these processes. These inquiries have led to productive dialogue. They have provided UNOS a significant opportunity not only to explain OPTN policy and standards, but to reconsider them and identify areas for further enhancement. We appreciate this opportunity and continue to seek improvements throughout the OPTN policy development and monitoring process. Sen. Grassley's interest has benefited the transplant system and the patients served by it.

Over the past three years under the leadership of HRSA, the organ donation rates in the U.S. have increased dramatically. That success together with these improvements in oversight prompted by Senator Grassley, HRSA, UNOS and CMS have resulted in a stronger, more vibrant national organ transplant system serving the tens of thousands who need lifesaving organ transplants.