42 CFR 121.10 – Reviews, evaluation, and enforcement
(a) Review and evaluation by the Secretary. The Secretary or her/his designee may perform any reviews and evaluations of member OPOs and transplant programs which the Secretary deems necessary to carry out her/his responsibilities under the Public Health Service Act and the Social Security Act.
(b) Review and evaluation by the OPTN. (1) The OPTN shall design appropriate plans and procedures, including survey instruments, a peer review process, and data systems, for purposes of:
(i) Reviewing applications submitted under § 121.3(c) for membership in the OPTN;
(ii) Reviewing applications submitted under § 121.9(b) to be a designated transplant program; and
(iii) Conducting ongoing and periodic reviews and evaluations of each member OPO and transplant hospital for compliance with these rules and OPTN policies.
(2) Upon the approval of the Secretary, the OPTN shall furnish review plans and procedures, including survey instruments and a description of data systems, to each member OPO and transplant hospital. The OPTN shall furnish any revisions of these documents to member OPOs and hospitals, after approval by the Secretary, prior to their implementation.
(3) At the request of the Secretary, the OPTN shall conduct special reviews of OPOs and transplant programs, where the Secretary has reason to believe that such entities may not be in compliance with these rules or OPTN policies or may be acting in a manner which poses a risk to the health of patients or to public safety. The OPTN shall conduct these reviews in accordance with such schedules as the Secretary specifies and shall make periodic reports to the Secretary of progress on such reviews and on other reviews conducted under the requirements of this paragraph.
(4) The OPTN shall notify the Secretary in a manner prescribed by the Secretary within 3 days of all committee and Board of Directors meetings in which transplant hospital and OPO compliance with these regulations or OPTN policies is considered.
(c) Enforcement of OPTN rules—(1) OPTN recommendations. The Board of Directors shall advise the Secretary of the results of any reviews and evaluations conducted under paragraph (b)(1)(iii) or paragraph (b)(3) of this section which, in the opinion of the Board, indicate noncompliance with these rules or OPTN policies, or indicate a risk to the health of patients or to the public safety, and shall provide any recommendations for appropriate action by the Secretary. Appropriate action may include removal of designation as a transplant program under § 121.9, termination of a transplant hospital’s participation in Medicare or Medicaid, termination of a transplant hospital’s reimbursement under Medicare and Medicaid, termination of an OPO’s reimbursement under Medicare and Medicaid, if the noncompliance is with a policy designated by the Secretary as covered by section 1138 of the Social Security Act, or such other compliance or enforcement measures contained in policies developed under § 121.4.
(2) Secretary’s action on recommendations. Upon the Secretary’s review of the Board of Directors’ recommendations, the Secretary may:
(i) Request further information from the Board of Directors or the alleged violator, or both;
(ii) Decline to accept the recommendation;
(iii) Accept the recommendation, and notify the alleged violator of the Secretary’s decision; or
(iv) Take such other action as the Secretary deems necessary.