March 21,2007

Sen. Grassley Comments on New Federal Rule for Organ Transplant Centers, Pledges Continued Oversight of Organ Transplant System


TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308 for Sen. Grassley
RE: CMS Conditions of Participation for Transplant Centers
DA: March 22, 2007

Sen. Chuck Grassley today commented on the Conditions of Participation for Transplant Centers issued today by the Centers for Medicare and Medicaid Services. The CMS description is attached.

Sen. Grassley’s comment:

“This rule seems to reflect a much stronger commitment by the executive branch to improving and ensuring accountability of the organ transplant system. Donors and recipients deserve heightened focus on patient safety and system integrity. I hope these new standards will give Medicare beneficiaries greater peace of mind, result in improved transplant care and, ultimately, save lives. Fairness, transparency and accountability are vital to maintaining the public trust that is fundamental to an organ transplant system that serves the public good.”

Sen. Grassley began scrutiny of the federal bureaucracy’s oversight of the transplant system in the fall of 2005, following controversies at St. Vincent Medical Center in California. In April 2006, he asked the Government Accountability Office to review federal efforts to oversee the transplant system. Here is the text of his request for that study.


April 14, 2006

The Honorable David M. Walker

Comptroller General of the United States

United States Government Accountability Office

441 G Street, N.W.

Washington, DC 20548

Dear Comptroller General Walker:

The Senate Committee on Finance (Committee) has exclusive jurisdiction over, among other things, the Medicare and Medicaid programs. As Chairman of the Committee, I have a responsibility to protect the more than 80 million Americans who receive health care coverage, including organ transplants, under those programs. While I am satisfied that the Health Resources and Services Administration (HRSA) has taken appropriate steps to address the recent issues of "line jumping" and other violations of organ procurement policies at St. Vincent Medical Center in Los Angeles California and the news reports of serious problems with the University of California Irvine Medical Center liver transplant program, I remain concerned that these examples may indicate more systemic problems underlying organ procurement in this country.

Accordingly, I request that your office conduct a review of HRSA's, the United Network for Organ Sharing (UNOS), and the Centers for Medicare & Medicaid Services' (CMS) oversight of the organ procurement system. The review should determine the extent and effectiveness of HRSA, UNOS, and CMS coordination to assure an equitable, safe and effective organ procurement system. Specifically, I'm interested to know the extent to which these entities can:

  • Prevent and detect violations of organ procurement and distribution rules by organ procurement organizations (OPO) and organ transplant centers;
  • identify organizational problems that negatively impact patient health care (e.g., insufficient or lack of staff available to conduct initial patient evaluations, organ transplant surgeries, or post-operative follow-up);
  • take appropriate corrective action when violations of organ procurement and distribution rules, CMS conditions of coverage, or other systemic problems leading to negative patient outcomes are identified; and
  • assure a smooth transition to another transplant center for patients who are affected by the closure or de-certifying of an organ transplant program.

I ask that your office keep my Committee staff apprised of your review of the aforementioned matter.


Charles E. Grassley