[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: 42CFR1008.36]



[Page 1214-1215]

 

                         TITLE 42--PUBLIC HEALTH

 

      GENERAL--HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 1008_ADVISORY OPINIONS BY THE OIG--Table of Contents

 

    Subpart D_Submission of a Formal Request for an Advisory Opinion

 

Sec.  1008.36  Submission of a request.





    (a) A request for a formal advisory opinion must be submitted in 

writing. An original and 2 copies of the request should be addressed to 

the headquarter offices of the OIG.

    (b) Each request for an advisory opinion must include--

    (1) To the extent known to the requestor, the identities, including 

the names and addresses, of the requestor and of all other actual and 

potential parties to the arrangement, that are the subject of the 

request for an advisory opinion;

    (2) The name, title, address, and daytime telephone number of a 

contact person who will be available to discuss the request for an 

advisory opinion with the OIG on behalf of the requestor;

    (3) A declaration of the subject category or categories as described 

in Sec.  1008.5 of this part for which the advisory opinion is 

requested. To the extent an individual or entity requests an advisory 

opinion in accordance with Sec. Sec.  1008.5(a)(3) or (a)(5) of this 

part, the requesting individual or entity should identify the specific 

subsections of sections 1128, 1128A or 1128B of the Act or the specific 

provision of Sec.  1001.952 of this chapter about which an advisory 

opinion is sought:

    (4) A complete and specific description of all relevant information 

bearing on the arrangement for which an advisory opinion is requested 

and on the circumstances of the conduct, \1\ including--

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    \1\ The requestor is under an affirmative obligation to make full 

and true disclosure with respect to the facts regarding the advisory 

opinion being requested.

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    (i) Background information,

    (ii) For existing arrangements, complete copies of all operative 

documents,



[[Page 1215]]



    (iii) For proposed arrangements, complete copies of all operative 

documents, if possible, and otherwise descriptions of proposed terms, 

drafts, or models of documents sufficient to permit the OIG to render an 

informed opinion,

    (iv) Detailed statements of all collateral or oral understandings, 

if any, and

    (v) If applicable, a designation of trade secrets or confidential 

commercial or financial information in the manner described in 45 CFR 

5.65;

    (5) Signed certifications by the requestor(s), as described in Sec.  

1008.37 of this part;

    (6) A check or money order payable to the Treasury of the United 

States in the amount of $250, as discussed in Sec.  1008.31(b) of this 

part;

    (7) A declaration regarding whether an advisory opinion in 

accordance with part 411 of this title has been or will be requested 

from CMS about the arrangement that is the subject of the advisory 

opinion request; and

    (8) Each requesting party's Taxpayer Identification Number.



(Approved by the Office of Management and Budget under control number 

0990-0213)



[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38325, July 16, 1998]