Part D Drug Management Program (CMS-10874)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10874 Model Sponsor Information Transfer Memorandum	Form	New	Available
Form CMS-10874 Model Prescriber Inquiry Letter	Form	New	Available
Form CMS-10874 Alternate Second Notice	Form	New	Available
Form CMS-10874 Second Notice	Form	New	Available
Form CMS-10874 Initial Notice	Form	New	Available
Form CMS-10874 Part D Drug Management Program	Form	New	Repair queued
CMS 10874 Supporting Statement A (CMS-4205-P version 5).docx	Supporting Statement A	Uploaded 2024-01-12	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
264405	Part D Drug Management Program	Form	New	Model Sponsor Information Transfer Memorandum
264405	Part D Drug Management Program	Form	New	Model Prescriber Inquiry Letter
264405	Part D Drug Management Program	Form	New	Alternate Second Notice
264405	Part D Drug Management Program	Form	New	Second Notice
264405	Part D Drug Management Program	Form	New	Initial Notice
264405	Part D Drug Management Program	Form	New
264405	Part D Drug Management Program	Instruction	New

ICR Details

OMB Control No: 0938-1465	ICR Reference No: 202312-0938-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CM CPC
Title: Part D Drug Management Program (CMS-10874)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 04/21/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/12/2024
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): US Code: 42 USC 1860D-4(c)(5)(A) Name of Law: Social Security Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV24	Proposed rulemaking	88 FR 78476	11/15/2023

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 78476	11/15/2023
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Part D Drug Management Program	CMS-10874, CMS-10874, CMS-10874, CMS-10874, CMS-10874	Initial Notice ,   Second Notice ,   Alternate Second Notice ,   Model Prescriber Inquiry Letter ,   Model Sponsor Information Transfer Memorandum

---

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection package, in which we include information collection instructions and related burden from CMS-10141 (OMB control number 0938-0964). We are requesting approval of this separate ICR in an effort to improve clarity regarding the DMP and its information collection instruments. We have accounted for the reduction of burden for case management, sending notices, and data disclosure associated with the change in definition of “exempted beneficiary” proposed in CMS-4205-P. We revised the DMP notices, letter, and memorandum to incorporate the change in definition of “exempted beneficiary” proposed in CMS-4205-P and to include revisions determined necessary through program operation. We are not removing any burden associated with sponsors no longer sending a Retraction Notice for Exempted Beneficiaries – sponsors will instead send an Alternate Second Notice under changes proposed in CMS-4205-P – because the Retraction Notice was not accounted for in CMS-10141. For accuracy, we updated the number of Part D sponsors, beneficiaries receiving case management and/or coverage restrictions under their plan’s DMP, and beneficiaries who transfer plans while receiving case management and/or coverage restrictions under their plan’s DMP.

---

Annual Cost to Federal Government: $44,653

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  No

---

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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/12/2024

---