The Plan Benefit Package (PBP) and Formulary Submission for Advantage (MA) Plans and Prescription Drug Plans (PDPs) (CMS-R-262)

Forms and Documents

Document Name	Status
CY2017 PRA 60-day comments 12102015.pdf Supplementary Document	2015-12-18
CY2017_PBP_Sprtng_Stmnt_CMS response_v2_Clean.docx Supporting Statement A	2016-04-06

IC Document Collections

IC ID	Document Title	Status
43667	CY2017 Plan Benefit Package (PBP) Software and Formulary Submission (CMS-R-262) Instruction	Modified

ICR Details

OMB Control No: 0938-0763	ICR Reference No: 201512-0938-009
Status: Historical Active	Previous ICR Reference No: 201412-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: The Plan Benefit Package (PBP) and Formulary Submission for Advantage (MA) Plans and Prescription Drug Plans (PDPs) (CMS-R-262)
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: 04/07/2016
	Date Received in OIRA: 12/22/2015
Terms of Clearance: As this ICR is associated with the issuance of annual guidance, this ICR must be revised accordingly each year.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved	02/28/2018
Responses	5,448	0	5,872
Time Burden (Hours)	52,902	0	56,411
Cost Burden (Dollars)	0	0	0

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Abstract: CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 101 Name of Law: Prescription Drug, Improvement, and Modernization Act of2003 (MMA)
  

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:
	80 FR 57619	09/24/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 79045	12/18/2015
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
CY2017 Plan Benefit Package (PBP) Software and Formulary Submission (CMS-R-262)	CMS-R-262, CMS-R-262, CMS-R-262, CMS-R-262, CMS-R-262, CMS-R-262, CMS-R-262, CMS-R-262	Medication Therapy Management Program (MTMP) ,   CY 2017 PBP Data Entry System Screens - Section A ,   CY 2017 PBP Data Entry System Screens - Section B ,   CY 2017 PBP Data Entry System Screens - Section B (VBID) ,   CY 2017 PBP Data Entry System Screens - Section C ,   CY 2017 PBP Data Entry System Screens - Section D ,   CY 2017 PBP Data Entry System Screens - Section Rx ,   CY 2017 PBP Data Entry System Screens - Section Rx (VBID)

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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	5,448	5,872	0	0	-424	0
Annual Time Burden (Hours)	52,902	56,411	0	0	-3,509	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 change to burden is attributable to a decrease in the number of formulary submissions as well as a decrease in the number of reporting organizations. Additionally, the cost to the Government increased due to changes to federal staff salaries and the costs of maintaining the functionality of the modules increasing slightly. This results in a net decrease of overall burden to industry, but an increase to burden to the individual entities. The number of reporting organizations decreased from 598 contracts to 552 contracts based on the most recent numbers extracted from HPMS. This number represents the total number of organizations that will submit at least one (1) PBP. Because an organization can submit a formulary that covers multiple contract numbers, only a subset of the 552 organizations will submit distinct formularies.

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Annual Cost to Federal Government: $892,272

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 12/22/2015

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