October 5, 1998

The Honorable Donna E. Shalala
Secretary of Health and Human Services
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Shalala:

I am writing to request your immediate response to a matter of serious concern to me because it could affect the ability of your Department to pay the costs of organ transplantation for Medicare or Medicaid patients. As you know, there will be an attempt in Congress to use the appropriations process as a vehicle to block implementation of the Department's April 2 rule intended to reduce inequities in the Organ Procurement Transplantation Network (OPTN) and ensure the accountability of the government's contractor, the United Network for Organ Sharing. In addition, the State of Louisiana has sued the Department in a separate attempt to block the rule and enforce a State law limiting the sharing of organs outside the State.

The Department's discussion of the April 2 OPTN regulation stated that "in order to be a rule or requirement of the OPTN and therefore mandatory or binding on OPOs [organ procurement organizations] and hospitals participating in Medicare or Medicaid, the Secretary must have given formal approval to the rule or requirement. Violations of section 1138 could result in withholding of reimbursement under Medicare or Medicaid." I want to know as soon as possible whether there are any circumstances that could arise if the language found in section 213 of H.R. 4274 is enacted that would result in Medicare or Medicaid funds not being available to reimburse transplant operations for persons who are participants in those programs. Medicare and Medicaid are the primary payers of transplant surgeries and I want to know whether blocking the April 2 rule could be a death sentence for thousands of patients in need of a transplant.

I request that the Department promptly evaluate its responsibilities under Section 1138, should Congress or the Federal Courts remove your authority to issue enforceable guidelines for the OPTN. I know you share my concern about any action, legislative or judicial, that would adversely affect those who may depend on Medicare or Medicaid for their very survival.

Please respond in writing to the following questions as soon as possible:

1. If section 1138 is violated is the withholding of Medicare and Medicaid funds discretionary or mandatory?

2. If enacted, would language such as that found in section 213 of H.R. 4274 ("the rider") either require or authorize the Department to withhold Medicare or Medicaid funds from any hospital?

3. If not, are there any other scenarios that could arise during the time the rider is in effect that would require or authorize the withholding of such funds? Examples of such scenarios include, but are not limited to, enactment of state laws on organ sharing similar to Louisiana's as well as changes by the OPTN in its rules and requirements applicable to OPOs and hospitals.

4. A court in Louisiana has temporarily enjoined the April 2 regulation from taking effect. What impact could this or any other litigation have on section 1138 and the withholding of Medicare or Medicaid funds?

5. Does the Department have authority to give formal approval to a rule or requirement of the OPTN if the rider is in effect or if the Department is enjoined from enforcing the April 2 regulation? Could the Department otherwise promulgate and enforce allocation regulations other than the April 2 regulation in order avoid a violation of section1138?

Thank you for your prompt attention to this matter.

Sincerely,

JOHN D. DINGELL
RANKING MEMBER

cc: The Honorable Tom Bliley
The Honorable Michael Bilirakis
The Honorable Sherrod Brown

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