Collection of Drug Event Data from Contracted Part D Providers For Payments (CMS-10174)

Forms and Documents

Document Name	Status
CMS-10174 - Supporting Statement A - Passback2.docx Supporting Statement A	2018-11-09
Crosswalk_082118.doc Supplementary Document	2018-11-09

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

ICR Details

OMB Control No: 0938-0982	ICR Reference No: 201801-0938-007
Status: Active	Previous ICR Reference No: 201309-0938-034
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Collection of Drug Event Data from Contracted Part D Providers For Payments (CMS-10174)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/06/2018
	Date Received in OIRA: 01/25/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved
Responses	1,409,828,464	0	0
Time Burden (Hours)	2,820	0	0
Cost Burden (Dollars)	0	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.

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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
   Statute at Large: 18 Stat. 1860 Name of Statute: null
  

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:
	82 FR 14517	03/21/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 31609	07/07/2017
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Collection of Drug Event Data from Contracted Part D Providers For Payments (CMS-10174)

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ICR Summary of Burden

	Total Approved	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	1,409,828,464	0	0	0	248,394,399	1,161,434,065
Annual Time Burden (Hours)	2,820	0	0	0	497	2,323
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 estimate has been increased approximately 21.4% (the responses increased from 1,161,434,065 to 1,409,828,464 while the hours increased from 2,323 to 2,820) from the burden estimate in the last approved PRA package. The increase is a result of the growth of Medicare beneficiaries enrolled in Part D, which also resulted in an increase in the average number of PDEs per year. This change reflects actual numbers from the most recent 3 years of the Part D program. The number of Part D contracts has also increased by 12, from 767 in our currently approved ICR to 779 in this iteration. There were 54 data elements in the last version of the Supporting Statement. There are now 57 data elements in order to reconcile payments more effectively and provide better program oversight. Specifically, Field # 55 was added Field # 56 was added Field # 57 was added Additionally, Field # 51 was changed from Gap Discount Override Code to OAP Indicator. None of the data element changes have any measurable effect on our burden estimates.

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Annual Cost to Federal Government: $16,200,000

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? Uncollected

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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: 01/25/2018

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