Standardized Pharmacy Notice: Your Prescription Cannot be Filled (f/k/a 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 - Passback2 CLEAN.docx Supporting Statement A	2018-02-26
Crosswalk- CMS-10147_07102017Clean.docx Supplementary Document	2017-09-21
Response to Public Comments-Pharmacy Notice_CLEAN.DOCX Supplementary Document	2017-09-21

IC Document Collections

IC ID	Document Title	Status
37927	Standardized Pharmacy Notice Form	Modified

ICR Details

OMB Control No: 0938-0975	ICR Reference No: 201709-0938-002
Status: Historical Active	Previous ICR Reference No: 201408-0938-016
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Standardized Pharmacy Notice: Your Prescription Cannot be Filled (f/k/a Medicare Prescription Drug Coverage and Your Rights) (CMS-10147)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/27/2018
	Date Received in OIRA: 09/21/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved	02/28/2018
Responses	40,100,000	0	37,620,240
Time Burden (Hours)	668,066	0	626,749
Cost Burden (Dollars)	0	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 Name of Statute: null
   Statute at Large: 18 Stat. 1852 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 16843	04/06/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 37453	08/10/2017
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Standardized Pharmacy Notice	CMS-10147, CMS-10147	Notice: Medicare Prescription Drug Coverage and Your Rights ,   Notice (Spanish): La cobertura de Medicare de las recetas médicas y sus derechos

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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	40,100,000	37,620,240	0	2,479,760	0	0
Annual Time Burden (Hours)	668,066	626,749	0	41,317	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement: We propose to revise the notice and accompanying instructions to enhance the clarity and accuracy of the notice and instructions. We also propose to add language that informs beneficiaries of their rights under Section 504 of the Rehabilitation Act of 1973 (Section 504), by alerting the beneficiary to CMS’s nondiscrimination practices and the availability of alternate forms of this notice, if needed. The annual hourly burden associated with this collection is estimated to be 668,066 hours. The annual hourly burden in the 2014 PRA submission for this collection was 626,749 hours. The 41,317 hour increase in burden is an adjustment that is based on the increased number of applicable pharmacies (+6,000 pharmacies) and the increased number of standardized pharmacy notices (+2,479,760 notices) that are likely to be distributed based on CY 2016 prescription drug event data. Reconciling the burden increase: 41,313 hr = 2,479,760 x 0.01666. We attribute the 4 hour difference (41,317 hr – 41,313 hr) to 1 min/response rounding differences (when converted to hours) between this 2017 iteration and the currently approved 2014 iteration. We are also adjusting our cost estimates based on current BLS wage data for pharmacy technicians. In this iteration we are doubling that wage to account for burden and overhead.

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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? 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: 09/21/2017

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