Medicare Prescription Drug Benefit Program - IRASA (CMS-10141)

Forms and Documents

Document Name	Status
Form CMS-10141 Preparation and Issuance of Model Notices (section 423.120(c)(6)) Form and Instruction	Modified
Form CMS-10141 Medicare Prescription Drug Benefit Program (Plans) Form and Instruction	Modified
CMS-10141 - Supporting Statement A__.docx Supporting Statement A	2024-12-03
Crosswalk 10141.pdf Supplementary Document	2024-12-03

IC Document Collections

IC ID	Document Title	Status
8823	Medicare Prescription Drug Benefit Program (Benes)	Modified
272789	Utilization Management Committee and Health Equity 422.137	New
231341	Preparation and Issuance of Model Notices (section 423.120(c)(6)) Form and Instruction	Modified
217122	Business Continuity Plans under 422.504(o) and 423.505(p)	Unchanged
209891	State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))	Modified
187164	Medicare Prescription Drug Benefit Program (Plans) Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0964	ICR Reference No: 202412-0938-003
Status: Received in OIRA	Previous ICR Reference No: 202302-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Prescription Drug Benefit Program - IRASA (CMS-10141)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/04/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2025
Responses	87,014,803	695,802,400
Time Burden (Hours)	25,409,037	25,506,943
Cost Burden (Dollars)	593,251,773	599,698,399

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Abstract: The purpose of this revision is to account for the burden resulting from the submission of an IRASA reconciliation file. In order for CMS to pay the statutorily-mandated IRA subsidy amount for contract year 2023, Part D sponsors must submit data necessary for CMS to determine that subsidy through the IRASA reconciliation file. The burden associated with the IRASA reconciliation file relates to compiling and sending the file to CMS. The reconciliation file will only be submitted for contract year 2023. In addition, the drug management program (DMP) sections have been revised to remove one-time burden associated with establishing DMPs and initial programming of standardized and model communications. As all Part D sponsors were required to have a DMP by January 1, 2022, this burden is no longer needed. Also, there is a revision associated with a change in burden estimate to create business continuity plans to account for the net increase in responses to account for new plans required to develop business continuity strategies and to account for the increased number of expected exception requests. Part D plans and, to the extent applicable, MA organizations will use the information discussed below to comply with the eligibility and other requirements associated with their participation in Part D. CMS will use this information from plan sponsors and States to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and ensure that correct information is disclosed to potential and current enrollees. The new information collection will allow CMS to ensure sponsors have plans in place to restore business operations following a disruption of regular operations. Medicare beneficiaries will use the information provided by the Part D sponsors to make decisions regarding Part D enrollment as well as grievance and appeal requests.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 101 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
   Statute at Large: 18 Stat. 1860
   US Code: 42 USC 1395w-115 Name of Law: SUBSIDIES FOR PART D ELIGIBLE INDIVIDUALS FOR QUALIFIED PRESCRIPTION DRUG COVERAGE
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 73420	09/10/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 9579	12/03/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Preparation and Issuance of Model Notices (section 423.120(c)(6))	CMS-10141	Model Precluded Provider Letter
Business Continuity Plans under 422.504(o) and 423.505(p)
Medicare Prescription Drug Benefit Program (Benes)
Medicare Prescription Drug Benefit Program (Plans)	CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141	Part C and D Model Precluded Provider Letter ,   3a - 2022 Model Part D Explanation of Benefits (All Sections Included) ,   3b - Exhibit A: Example Cover Page of the Model Part D EOB ,   3c - Exhibit B: Examples of Section 1 (the List of Prescriptions) ,   3d - Exhibit C: Example of Section 2 (Drug Payment Stages) ,   3e - Exhibit D: Example of Section 3 (Amounts and Definitions for TrOOP and Total Drug Costs) ,   3f - Exhibit E: Example of Section 4 (Changes to the Formulary) ,   3g - Exhibit F: Example of Sections 5 and 6 (Information for Reference) ,   3h - Exhibit G: Example of a Part D EOB (All Sections Included)
State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))
Utilization Management Committee and Health Equity 422.137

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	87,014,803	695,802,400	0	-608,787,597	0	0
Annual Time Burden (Hours)	25,409,037	25,506,943	0	-97,906	0	0
Annual Cost Burden (Dollars)	593,251,773	599,698,399	0	-6,446,626	0	0

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The previously approved supporting statement contained 690,557,096 responses and 25,506,943 burden hours. We are revising this estimate to 87,014,803 responses and 25,409,037 burden hours (see Table 15). Total responses decreased by 603,542,293 (690,557,096 –87,014,803) and the annual burden hours decreased by 97,906 (25,506,943-25,409,037). The net change in responses and burden primarily reflects the extraction of §423.128(b), Part D Explanation of Benefits, and §423.153 Drug Utilization Management, Quality Assurance, Medication Therapy Management (MTM), and Drug Management Programs, from this package. In addition, 4205-F proposes changes to the SEP under §423.38(c)(35) that are accounted for in this package. Changes are also indicated for Utilization Management Committees under §422.137. We also note the revisions in burden estimate due to fewer Part D contracts in 2023 compared to 2022 (990 in 2022 and 966 in 2023).

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Annual Cost to Federal Government: $875

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

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Common Form ICR:  No

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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: 12/04/2024

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