Medicare Prescription Drug Coverage and Your Rights (CMS-10147)

Forms and Documents

Document Name	Status
Form CMS-10147 Standardized Pharmacy Notice Form	Modified
CMS-10147 - Supporting Statement A.docx Supporting Statement A	2021-03-25

IC Document Collections

IC ID	Document Title	Status
37927	Standardized Pharmacy Notice Form	Modified

ICR Details

OMB Control No: 0938-0975	ICR Reference No: 202103-0938-014
Status: Received in OIRA	Previous ICR Reference No: 201804-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Prescription Drug Coverage and Your Rights (CMS-10147)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/26/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	49,681,292	0
Time Burden (Hours)	827,690	0
Cost Burden (Dollars)	0	0

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Abstract: Pursuant to 42 CFR 423.562(a)(3) and 423.128(b)(7)(iii), Part D plan sponsors must arrange with their network pharmacies to provide a printed copy of the standardized pharmacy notice to enrollees (beneficiaries) at the point of sale when an enrollee's prescription cannot be filled.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1860
   Statute at Large: 18 Stat. 1852
  

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:
	86 FR 3159	01/14/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 15943	03/25/2021
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
Standardized Pharmacy Notice	CMS-10147	Notice: Medicare Prescription Drug Coverage and Your Rights

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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	49,681,292	0	0	0	9,581,292	40,100,000
Annual Time Burden (Hours)	827,690	0	0	0	159,624	668,066
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 159,624 hour increase in burden is an adjustment that is based on the increased number of applicable pharmacies (+8,000 pharmacies) and the increased number of standardized pharmacy notices (+9,581,292 notices) that are likely to be distributed based on using more accurate CY 2018 Public Use File and prescription drug event data.

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Annual Cost to Federal Government: $0

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: 03/26/2021

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