[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR486.304]

[Page 623-624]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS--Table of Contents
 
   Subpart G--Conditions for Coverage: Organ Procurement Organizations
 
Sec. 486.304  General requirements.

    (a) Designation--a condition for payment. Payment may be made under 
the Medicare and Medicaid programs for organ procurement costs 
attributable to payments made by an OPO only if the organization has 
been designated by the Secretary as an OPO, payment to which may be 
treated as organ procurement costs for reimbursement of hospitals under 
Medicare and Medicaid.
    (b) Requirements for designated status. To be the designated OPO for 
a service area, an entity must do the following:
    (1) Submit to CMS a written application for designation, using the 
application form prescribed by CMS.
    (2) Be certified as a qualified OPO.
    (3) Participate in the Organ Procurement and Transplantation Network 
as specified in Sec. 486.308.
    (4) Enter into an agreement with CMS that meets the requirements set 
forth in paragraph (c) of this section.
    (5) Upon its initial designation, meet the requirements at Sec. 
486.310(a)(3) or Sec. 486.310(b)(4), as appropriate, concerning working 
relationships with hospitals or transplant centers. During the initial 
designation period, the OPO is not required to demonstrate compliance 
with Sec.Sec. 486.310(a)(1) and (a)(2) or Sec. 486.310(b)(1), which set 
forth performance standards for OPOs.
    (6) To be redesignated after an initial designation period, comply 
with all the requirements of this subpart, including those at Sec. 
486.310, which set forth performance standards for OPOs.
    (7) Obtain CMS approval before entering into any change of 
ownership, merger, consolidation, or change in its service area (see 
Sec. 486.318, which sets forth requirements concerning approval for 
changes in ownership and service area). Failure to do so could result in 
termination.
    (8) Enter into a working relationship with any hospitals, including 
transplant centers, in the OPO's service area that request a working 
relationship.
    (c) Agreement with CMS. An OPO must enter into an agreement with 
CMS. The agreement is effective upon submission by the OPO and 
acceptance by CMS, but may be terminated by either party. If an OPO 
agreement is terminated, payment for organ procurement services 
attributable to that OPO will not be made for services furnished on or 
after the effective date of termination. In the agreement, the OPO must 
agree to do the following:

[[Page 624]]

    (1) Maintain compliance with the requirements of titles XVIII and 
XIX of the Act, section 1138 of the Act, and applicable regulations, 
including the conditions set forth in this subpart, and the regulations 
of the OPTN approved and issued by the Secretary, and to report promptly 
to the Secretary any failure to do so.
    (2) File a cost report in accordance with Sec. 413.24(f) of this 
chapter within 3 months after the end of each fiscal year.
    (3) Permit CMS to designate an intermediary to determine the interim 
payment rate payable to the transplant hospitals for services provided 
by the OPO and to make a determination of reasonable cost based on the 
cost report it files.
    (4) Provide budget or cost projection information as may be required 
to establish an initial interim payment rate.
    (5) Pay to CMS amounts that have been paid by CMS to transplant 
hospitals as Medicare payment for organ recovery fees and that are 
determined to be in excess of the reasonable cost of the services 
provided by the OPO.
    (6) Not charge an individual for items or services for which that 
individual is entitled to have payment made under the Medicare program.
    (7) Maintain and make available to CMS, the Comptroller General, or 
their designees data that show the number of organs procured and 
transplanted.
    (8) Maintain data in a format that can be readily continued by a 
successor OPO and turn over to CMS copies of all records, data, and 
software necessary to ensure uninterrupted service by a successor OPO 
that may be designated for all or part of its service area. Records and 
data subject to this requirement include records on individual donors 
(including identifying data and data on organs retrieved), records on 
transplant candidates (including identifying data and data on immune 
system and other medical indications), and procedural manuals and other 
materials used in conducting OPO operations. Donor records must include 
at least information identifying the donor (for example, name, address, 
date of birth, social security number), the organs and tissues (when 
applicable) retrieved, date of the organ retrieval, and test results.
    (d) When OPOs may apply for designation. Entities may apply for 
designation whenever a service area becomes an open area.
    (e) Designation periods--(1) General. An OPO is normally designated 
for 2 years. A designation period may not exceed 2 years but may be 
shorter.
    (2) Redesignation. Redesignation must occur at least every 2 years 
and be completed before the end of an existing designation period.
    (3) Interim designation. CMS may designate an organization for an 
interim designation period if the period is needed in order for CMS to 
make a final designation determination.
    (i) The interim designee may be either the OPO previously designated 
for the service area or another organization.
    (ii) The interim designation period does not exceed 180 days after 
the normal designation period has expired.
    (iii) The interim designee must meet all requirements of section 
371(b) of the Public Health Service Act (42 U.S.C. 273(b)) regarding 
qualified OPOs and must not be out of compliance with the requirements 
of section 1138(b)(1) (B) through (E) of the Act regarding requirements 
for payment of organ procurement costs under title XVIII or title XIX of 
the Act.

[53 FR 6549, Mar. 1, 1988, as amended at 59 FR 46514, Sept. 8, 1994 
Redesignated and amended at 60 FR 50447, 50448, Sept. 29, 1995; 60 FR 
53877, Oct. 18, 1995; 61 FR 19743, May 2, 1996]