[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR121.10]

[Page 657-658]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 121_ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK--
Table of Contents
 
Sec. 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 Sec. 121.3(c) for 
membership in the OPTN;
    (ii) Reviewing applications submitted under Sec. 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 
Sec. 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 Sec. 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;

[[Page 658]]

    (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.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56661, Oct. 20, 1999]