[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR486.312]



[Page 646]

 

                         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 

 

Subpart G_Requirements for Certification and Designation and Conditions 

              for Coverage: Organ Procurement Organizations

 

Sec.  486.312  De-certification.



    (a) Voluntary termination of agreement. If an OPO wishes to 

terminate its agreement, the OPO must send CMS written notice of its 

intention to terminate its agreement and the proposed effective date. 

CMS may approve the proposed date, set a different date no later than 6 

months after the proposed effective date, or set a date less than 6 

months after the proposed effective date if it determines that a 

different date would not disrupt services to the service area. If CMS 

determines that a designated OPO has ceased to furnish organ procurement 

services to its service area, the cessation of services is deemed to 

constitute a voluntary termination by the OPO, effective on a date 

determined by CMS. CMS will de-certify the OPO as of the effective date 

of the voluntary termination.

    (b) Involuntary termination of agreement. During the term of the 

agreement, CMS may terminate an agreement with an OPO if the OPO no 

longer meets the requirements for certification at Sec.  486.303. CMS 

may also terminate an agreement immediately in cases of urgent need, 

such as the discovery of unsound medical practices. CMS will de-certify 

the OPO as of the effective date of the involuntary termination.

    (c) Non-renewal of agreement. CMS will not voluntarily renew its 

agreement with an OPO if the OPO fails to meet the requirements for 

certification at Sec.  486.318, based on findings from the most recent 

re-certification cycle, or the other requirements for certification at 

Sec.  486.303. CMS will de-certify the OPO as of the ending date of the 

agreement.

    (d) Notice to OPO. Except in cases of urgent need, CMS gives written 

notice of de-certification to an OPO at least 90 days before the 

effective date of the de-certification. In cases of urgent need, CMS 

gives written notice of de-certification to an OPO at least 3 calendar 

days prior to the effective date of the de-certification. The notice of 

de-certification states the reasons for de-certification and the 

effective date.

    (e) Public notice. Once CMS approves the date for a voluntary 

termination, the OPO must provide prompt public notice of the date of 

de-certification and such other information as CMS may require through 

publication in local newspapers in the service area. In the case of 

involuntary termination or non-renewal of an agreement, CMS provides 

public notice of the date of de-certification through publication in 

local newspapers in the service area. No payment under titles XVIII or 

XIX of the Act will be made with respect to organ procurement costs 

attributable to the OPO on or after the effective date of de-

certification.