[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: 42CFR486.314]



[Page 646-648]

 

                         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.  486.314  Appeals.



    If an OPO's de-certification is due to involuntary termination or 

non-renewal of its agreement with CMS, the OPO may appeal the de-

certification on substantive and procedural grounds.

    (a) Notice of initial determination. CMS mails notice to the OPO of 

an initial de-certification determination. The notice contains the 

reasons for the determination, the effect of the determination, and the 

OPO's right to seek reconsideration.



[[Page 647]]



    (b) Reconsideration. (1) Filing request. If the OPO is dissatisfied 

with the de-certification determination, it has 15 business days from 

receipt of the notice of de-certification to seek reconsideration from 

CMS. The request for reconsideration must state the issues or findings 

of fact with which the OPO disagrees and the reasons for disagreement.

    (2) An OPO must seek reconsideration before it is entitled to seek a 

hearing before a hearing officer. If an OPO does not request 

reconsideration or its request is not made timely, the OPO has no right 

to further administrative review.

    (3) Reconsideration determination. CMS makes a written reconsidered 

determination within 10 business days of receipt of the request for 

reconsideration, affirming, reversing, or modifying the initial 

determination and the findings on which it was based. CMS augments the 

administrative record to include any additional materials submitted by 

the OPO, and a copy of the reconsideration decision and sends the 

supplemented administrative record to the CMS hearing officer.

    (c) Request for hearing. An OPO dissatisfied with the CMS 

reconsideration decision, must file a request for a hearing before a CMS 

hearing officer within 40 business days of receipt of the notice of the 

reconsideration determination. If an OPO does not request a hearing or 

its request is not received timely, the OPO has no right to further 

administrative review.

    (d) Administrative record. The hearing officer sends the 

administrative record to both parties within 10 business days of receipt 

of the request for a hearing.

    (1) The administrative record consists of, but is not limited to, 

the following:

    (i) Factual findings from the survey(s) on the OPO conditions for 

coverage.

    (ii) Data from the outcome measures.

    (iii) Rankings of OPOs based on the outcome data.

    (iv) Correspondence between CMS and the affected OPO.

    (2) The administrative record will not include any privileged 

information.

    (e) Pre-Hearing conference. At any time before the hearing, the CMS 

hearing officer may call a pre-hearing conference if he or she believes 

that a conference would more clearly define the issues. At the pre-

hearing conference, the hearing officer may establish the briefing 

schedule, sets the hearing date, and addresses other administrative 

matters. The hearing officer will issue an order reflecting the results 

of the pre-hearing conference.

    (f) Date of hearing. The hearing officer sets a date for the hearing 

that is no more than 60 calendar days following the receipt of the 

request for a hearing.

    (g) Conduct of hearing. (1) The hearing is open to both parties, CMS 

and the OPO.

    (2) The hearing officer inquires fully into all the matters at issue 

and receives in evidence the testimony of witnesses and any documents 

that are relevant and material.

    (3) The hearing officer provides the parties with an opportunity to 

enter an objection to the inclusion of any document. The hearing officer 

will consider the objection and will rule on the document's 

admissibility.

    (4) The hearing officer decides the order in which the evidence and 

the arguments of the parties are presented and the conduct of the 

hearing.

    (5) The hearing officer rules on the admissibility of evidence and 

may admit evidence that would be inadmissible under rules applicable to 

court procedures.

    (6) The hearing officer rules on motions and other procedural items.

    (7) The hearing officer regulates the course of the hearing and 

conduct of counsel.

    (8) The hearing officer may examine witnesses.

    (9) The hearing officer takes any action authorized by the rules in 

this subpart.

    (h) Parties' rights. CMS and the OPO may:

    (1) Appear by counsel or other authorized representative, in all 

hearing proceedings.

    (2) Participate in any pre-hearing conference held by the hearing 

officer.

    (3) Agree to stipulations as to facts which will be made a part of 

the record.



[[Page 648]]



    (4) Make opening statements at the hearing.

    (5) Present relevant evidence on the issues at the hearing.

    (6) Present witnesses, who then must be available for cross-

examination, and cross-examine witnesses presented by the other party.

    (7) Present oral arguments at the hearing.

    (i) Hearing officer's decision. The hearing officer renders a 

decision on the appeal of the notice of de-certification within 20 

business days of the hearing.

    (1) Reversal of de-certification. If the hearing officer reverses 

CMS' determination to de-certify an OPO in a case involving the 

involuntary termination of the OPO's agreement, CMS will not terminate 

the OPO's agreement and will not de-certify the OPO.

    (2) De-certification is upheld. If the de-certification 

determination is upheld by the hearing officer, the OPO is de-certified 

and it has no further administrative appeal rights.

    (j) Extension of agreement. If there is insufficient time prior to 

expiration of an agreement with CMS to allow for competition of the 

service area and, if necessary, transition of the service area to a 

successor OPO, CMS may choose to extend the OPO's agreement with CMS.

    (k) Effects of de-certification. Medicare and Medicaid payments may 

not be made for organ procurement services the OPO furnishes on or after 

the effective date of de-certification. CMS will then open the de-

certified OPO's service area for competition as set forth in Sec.  

486.316(c).