Collection of Prescription Drug Data from MA-PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments (CMS-10174)

Forms and Documents

Document Name	Status
CMS-10174 - Supporting Statement A (CMS-4192-P v7-final version).docx Supporting Statement A	2022-05-18

IC Document Collections

IC ID	Document Title	Status
43675	Collection of Drug Event Data from Contracted Part D Providers For Payments (CMS-10174) Instruction	Modified
253715	New Burden Estimates Resulting from Policy related Reflect Pharmacy Price Concessions in the Negotiated Price	New

ICR Details

OMB Control No: 0938-0982	ICR Reference No: 202205-0938-017
Status: Received in OIRA	Previous ICR Reference No: 202108-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Collection of Prescription Drug Data from MA-PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments (CMS-10174)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/18/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2025
Responses	1,499,966,801	1,499,238,090
Time Burden (Hours)	14,920	2,998
Cost Burden (Dollars)	0	0

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Abstract: CMS requires contracted Part D providers to submit prescription drug event (PDE) records as required by the Medicare Prescription Drug Improvement, and Modernization Act of 2003. The PDE data is then used in the Payment Reconciliation System to perform the annual Part D payment reconciliation, any PDE data within the Coverage Gap Phase of the Part D benefit is used for invoicing in the CGDP, and the data are part of the report provided to the Secretary of the Treasury for Section 9008. CMS has used PDE data to create summarized dashboards and tools, including the Medicare Part D Drug Spending Dashboard & Data, the Part D Manufacturer Rebate Summary Report, and the Medicare Part D Opioid Prescribing Mapping Tool. The data are also used in the Medicare Trustees Report. Due to the market sensitive nature of PDE data, external uses of the data are subject to significant limitations. However, CMS does analyze the data on a regular basis to determine drug cost and utilization patterns in order to inform programmatic patterns and to develop informed policy in the Part D program.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1860
   PL: Pub.L. 108 - 173 101 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU30	Proposed rulemaking	87 FR 1842	01/12/2022

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Collection of Drug Event Data from Contracted Part D Providers For Payments (CMS-10174)
New Burden Estimates Resulting from Policy related Reflect Pharmacy Price Concessions in the Negotiated Price

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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	1,499,966,801	1,499,238,090	0	0	728,711	0
Annual Time Burden (Hours)	14,920	2,998	0	0	11,922	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: The burden has increased due to proposed requirements at 42 CFR 423.100, a one time burden of 11,920 hours.

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Annual Cost to Federal Government: $13,000,000

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.     Yes

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: 05/18/2022

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