42 CFR § 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;
(3) A declaration of the subject category or categories as described in § 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 § 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 § 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 -
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.
(i) Background information,
(ii) For existing arrangements, complete copies of all operative documents,
(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 5.41;
(5) Signed certifications by the requestor(s), as described in § 1008.37 of this part;
(6) 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
(7) Each requesting party's Taxpayer Identification Number.