No material or nonsubstantive change to a currently approved collection
No
Regular
12/26/2024
Requested
Previously Approved
11/30/2027
11/30/2027
62,248
62,248
152,585
152,585
0
0
Pursuant to Section 1860D-4(c)(5)(A) of the SSA, Part D sponsors will use the standardized and model documents to communicate with providers, enrollees, and other sponsors. Specifically, Part D sponsors may use the Model Part D Drug Management Program Prescriber Inquiry Letter to inform providers that their patient’s pattern of use or history of use of FADs is potentially unsafe and has prompted a case management review under the plan’s DMP. Part D sponsors must use the standardized Initial Notice and Second Notice, or Alternate Second Notice, to inform enrollees, following identification by CMS’s OMS and subsequent case management, whether the beneficiaries have been identified as being potentially at risk or at risk for abuse or misuse of FADs. Part D sponsors may use the Model Part D Drug Management Program Sponsor Information Transfer Memorandum to communicate to a gaining sponsor the enrollee’s history of misuse or abuse of FADs.
This is a new information collection request, in which we include information collection instruments and related requirements/burden from CMS-10141 (OMB control number 0938-0964) along with changes associated with our April 23, 2024 (89 FR 30448) final rule (CMS-4205-F, RIN 0938-AV24).
Overall, the collection consists of: 319 respondents, 62,248 responses, and 152,585 hours.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.