42 C.F.R. § 423.756 Procedures for imposing sanctions.
Title 42 - Public Health
(a) Notice of sanction and opportunity to respond—(1) Notice of sanction. Before imposing the intermediate sanctions specified in paragraph (c) of this section, CMS— (i) Sends a written notice to the Part D sponsor stating the nature and basis of the proposed sanction; and (ii)Sends the Office of the Inspector General a copy of the notice. (2) Opportunity to respond. CMS allows the Part D sponsor 15 days from receipt of the notice to provide evidence that it has not committed an act or failed to comply with the requirements described in §423.752, as applicable. CMS may allow a 15-day addition to the original 15 days upon receipt of a written request from the Part D sponsor. To be approved, the request must provide a credible explanation of why additional time is necessary and be received by CMS before the end of the 15-day period following the date of receipt of the sanction notice. CMS does not grant an extension if it determines that the Part D sponsor's conduct poses a threat to an enrollee's health and safety. (b) Informal reconsideration. If, consistent with paragraph (a)(2) of this section, the Part D sponsor submits a timely response to CMS' notice of sanction, CMS conducts an informal reconsideration that— (1) Consists of a review of the evidence by an CMS official who did not participate in the initial decision to impose a sanction; and (2) Gives the Part D sponsor a concise written decision setting forth the factual and legal basis for the decision that affirms or rescinds the original determination. (c) Specific sanctions. If CMS determines that a Part D sponsor has acted or failed to act as specified in §423.752 and affirms this determination in accordance with paragraph (b) of this section, CMS may— (1) Require the Part D sponsor to suspend acceptance of applications made by Medicare beneficiaries for enrollment in the sanctioned plan during the sanction period; (2) In the case of a violation under §423.752(a), suspend payments to the Part D sponsor for Medicare beneficiaries enrolled in the sanctioned plan during the sanction period; and (3) Require the Part D sponsor to suspend all marketing activities for the sanctioned plan to Medicare enrollees. (d) Effective date and duration of sanctions—(1) Effective date. Except as provided in paragraph (d)(2) of this section, a sanction is effective 15 days after the date that the organization is notified of the decision to impose the sanction or, if the Part D sponsor seeks reconsideration in a timely manner under paragraph (b) of this section, on the date specified in the notice of CMS' reconsidered determination. (2) Exception. If CMS determines that the Part D sponsor's conduct poses a serious threat to an enrollee's health and safety, CMS may make the sanction effective on a date before issuance of CMS' reconsidered determination. (3) Duration of sanction. The sanction remains in effect until CMS notifies the Part D sponsor that CMS is satisfied that the basis for imposing the sanction is corrected and is not likely to recur. (e) Termination by CMS. In addition to or as an alternative to the sanctions described in paragraph (c) of this section, CMS may decline to authorize the renewal of an organization's contract in accordance with §423.507(b)(2) and (b)(3), or terminate the contract in accordance with §423.509. (f) Civil money penalties. (1) If CMS determines that a Part D sponsor has committed an act or failed to comply with a requirement described in §423.752, CMS notifies the OIG of this determination, and also notifies OIG when CMS reverses or terminates a sanction imposed under this part. (2) In the case of a violation described in §423.752(a), or a determination under §423.752(b) based upon a violation under §423.509(a)(4) (involving fraudulent or abusive activities), in accordance with the provisions of part 1003 of this chapter, the OIG may impose civil money penalties on the Part D sponsor in accordance with part 1003 of this chapter in addition to, or in place of, the sanctions that CMS may impose under paragraph (c) of this section. (3) In the case of a determination under §423.752(b) other than a determination based upon a violation under §423.509(a)(4), CMS may impose civil money penalties on the Part D sponsor in the amounts specified in §423.758 in addition to, or in place of, the sanctions that CMS may impose under paragraph (c) of this section.
Title 42: Public Health
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart O—Intermediate Sanctions
§ 423.756 Procedures for imposing sanctions.
