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

Forms and Documents

Document Name	Status
3- CY2011_RESPONSE_CMS-R-262_PBP_30_Day_Comments_03092010_final.docx Supplementary Document	2010-03-24
Response to TERMS OF CLEARANCE.docx Supplementary Document	2010-01-08
4-CY2011_RESPONSE_CMS-R-262_PBP_60_Day_Comments_03102010_REVISED.docx Supplementary Document	2010-03-24
Appendix_B_PBP_2011_List_of_Changes_12142009_final.pdf Supplementary Document	2010-01-06
Appendix_A_CY2011_PBP_Sprtng_Stmnt_03192010.docx Supporting Statement A	2010-03-24

IC Document Collections

IC ID	Document Title	Status
43667	CY2011 Plan Benefit Package (PBP) Software and Formulary Submission - CMS-R-262 Other-Record Layout	Modified

ICR Details

OMB Control No: 0938-0763	ICR Reference No: 201001-0938-002
Status: Historical Active	Previous ICR Reference No: 200901-0938-005
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)
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: 04/02/2010
	Date Received in OIRA: 01/12/2010
Terms of Clearance: This ICR is approved consistent with revised supporting statement and burden/cost estimates. As this ICR is associated with the issuance of annual guidance, this ICR is approved for one year. During this time, and in response to public comments that suggest the burden estimates may not be accurate, CMS shall either (1) add a data element/question question to accurately determine burden at the end of the PBP - (e.g., “How long did this reporting process take to complete? Please include all time spent gathering and synthesizing information, attending training sessions, and entering such information into the computer system.”) or (2) ask a purposive sample of 9 plans for an estimate of the total burden associated with this collection, with the plans varying on important dimensions such as a size of plan, scope of plan coverage (e.g. national, regional, local), and type of plan (MA vs PDP). Finally, CMS is encouraged to provide more thorough responses to public comments in future submissions with clearer explanations for why the burden estimates are changing. Previous terms of clearance remain in effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2011	36 Months From Approved	09/30/2010
Responses	6,878	0	4,988
Time Burden (Hours)	18,020	0	12,113
Cost Burden (Dollars)	1,171,323	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:
	74 FR 52236	10/09/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 1059	01/08/2010
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
CY2011 Plan Benefit Package (PBP) Software and Formulary Submission - CMS-R-262

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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	6,878	4,988	0	0	1,890	0
Annual Time Burden (Hours)	18,020	12,113	0	0	5,907	0
Annual Cost Burden (Dollars)	1,171,323	0	0	0	1,171,323	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:

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Annual Cost to Federal Government: $944,635

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 01/12/2010

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