§ 411.380 - When CMS issues a formal advisory opinion.

§ 411.380 When CMS issues a formal advisory opinion.

Cross Reference

Link to an amendment published at 84 FR 63192, Nov. 15, 2019.

(a) CMS considers an advisory opinion to be issued once it has received payment and once the opinion has been dated, numbered, and signed by an authorized CMS official.

(b) An advisory opinion contains a description of the material facts known to CMS that relate to the arrangement that is the subject of the advisory opinion, and states CMS's opinion about the subject matter of the request based on those facts. If necessary, CMS includes in the advisory opinion material facts that could be considered confidential information or trade secrets within the meaning of 18 U.S.C. 1095.

(c)

(1) Except as set forth in paragraph (c)(2) of this section, CMS issues an advisory opinion , in accordance with the provisions of this part , within 90 60 working days after the date on which it has formally accepted accepts the advisory opinion request.

(i) In the case of a request for a determination that an

advisory opinion, or, for requests

arrangement or course of conduct is indistinguishable in all material aspects from another arrangement or course of conduct that was the subject of a prior opinion, CMS issues an advisory opinion within 30 working days after the date on which it formally accepts the advisory opinion request.

(ii) In the case of a request that CMS determines, in its discretion,

involve

involves complex legal issues or highly complicated fact patterns, CMS issues an advisory opinion within a reasonable time period after the date on which it formally accepts the advisory opinion request.

(

2

iii) If the

90th day

last day of the 60-working day or 30-working day time period falls on a Saturday, Sunday, or Federal holiday,

the time period ends

CMS may issue the advisory opinion at the close of business on the first business day following the weekend or holiday

;

.

(

3

2) The

90-day period

applicable time period for issuing an advisory opinion is suspended from the time CMS

'

;

(i) Notifies the requestor that the costs have reached or are likely to exceed the triggering amount as described in § 411.375(c)(2) until CMS receives written notice from the requestor to continue processing the request;

(ii) Requests additional information from the requestor until CMS receives the additional information;

(iii) Notifies the requestor of the full amount due until CMS receives payment of this amount; and

(iv) Notifies the requestor of the need for expert advice until CMS receives the expert advice.

(d) After CMS has notified the requestor of the full amount owed and has received full payment of that amount, CMS issues the advisory opinion and promptly mails it to the requestor by regular first class U.S. mail.

[69 FR 57229, Sept. 24, 2004, as amended at 84 FR 63192, Nov. 15, 2019]