Medicare Prescription Drug Benefit Program

Forms and Documents

Document Name	Status
explanation of burden changes.doc Supplementary Document	2009-09-09
PRA2009updated.xls Supplementary Document	2009-09-09
PRA2009updated.xls Supplementary Document	2009-05-06
CMS-10141.Attachment 4 (Agent Compensation Information Workbook)-11-07-08.xls Supplementary Document	2009-05-06
CMS-10141.Attachment 3 (Covered Agent Information Sheets Workbook)-11-07-08.xls Supplementary Document	2009-05-06
CMS-10141_Supporting_Statement2009 (6).doc Supporting Statement A	2009-09-09

IC Document Collections

IC ID	Document Title	Status
8823	Medicare Prescription Drug Benefit Program (Benes)	Modified
187165	Medicare Prescription Drug Benefit Program (Plan) Other-Agent Compensation Information	Removed
187164	Medicare Prescription Drug Benefit Program (PLAN)-(CMS-10141) Other-Compensation Certification	Modified

ICR Details

OMB Control No: 0938-0964	ICR Reference No: 200905-0938-002
Status: Historical Active	Previous ICR Reference No: 200901-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Prescription Drug Benefit Program
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/15/2009
	Date Received in OIRA: 05/28/2009
Terms of Clearance: This ICR is approved consistent with revised supporting statement, 9/9/09 explanation of burden changes, and revised burden spreadsheet. Though this ICR is approved for 3 years, CMS is reminded that any substantive changes that occur because of agency discretion (e.g. due to changes in the annual Call Letter or 45 day Advance Notice) must be approved before the changes are implemented. Changes that are implemented prior to ICR approval will be considered PRA violations.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved	09/30/2009
Responses	38,152,764	0	38,179,679
Time Burden (Hours)	34,730,676	0	34,671,257
Cost Burden (Dollars)	0	0	0

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Abstract: The voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA specifies that the prescription drug benefit program will be available to beneficiaries on January 1, 2006. Coverage for the prescription drug benefit will be provided under private prescription drug plans, or through Medicare Advantage prescription drug plans. Organizations offering drug plans will have flexibility in the design of the prescription drug benefit.

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Authorizing Statute(s): 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:
0938-AP52	Final or interim final rulemaking	73 FR 54226	09/18/2008

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 11585	03/18/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 24013	05/22/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Medicare Prescription Drug Benefit Program (Benes)
Medicare Prescription Drug Benefit Program (PLAN)-(CMS-10141)
Medicare Prescription Drug Benefit Program (Plan)

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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	38,152,764	38,179,679	0	-87	-26,828	0
Annual Time Burden (Hours)	34,730,676	34,671,257	0	-4,263	63,682	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: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: Section - 423.892 The burden associated with this requirement is the time and effort necessary for a sponsoring entity to submit the required notification to CMS. CMS significantly reduced the burden estimate associated with Subpart R, Section 423.892, based on actual experience since these estimates were last published. Fewer plan sponsors have reported a change in ownership to CMS than was originally estimated. In addition, total plan sponsor participation in the program has been adjusted to reflect actual experience. Sections - 423.48, 423.104, 423.120(b), 423.128 (a) (e), 423.153 (b) (c) (d), 423.505(d) (f) 423.800 (b) The increase in burden occurred because of the increased number of respondents (Part D sponsors) participating in the program. The estimated burden per respondent has generally remained the same from the initial estimates. Also, some burden estimates under the original package have been subsumed under other collection packages.

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Annual Cost to Federal Government: $0

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: 05/28/2009

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