Medicare Prescription Drug Benefit Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CPCMDBGMEAGFinalUpdatedspreadsheet03242010PRA20092010(16).xlsx	Supplementary Document	Uploaded 2010-07-30	Available
Response to Comment.docx	Supplementary Document	Uploaded 2010-07-30	Available
CMS-10141.Attachment 3 (Covered Agent Information Sheets Workbook)-11-07-08.xls	Supplementary Document	Uploaded 2009-05-06	Available
CMS-10141.Attachment 4 (Agent Compensation Information Workbook)-11-07-08.xls	Supplementary Document	Uploaded 2009-05-06	Available
FINALCPCMDBGMEAGSupportingstmntUpdated3252010changes(5).docx	Supporting Statement A	Uploaded 2010-08-11	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8823	Medicare Prescription Drug Benefit Program (Benes)		Modified
187164	Medicare Prescription Drug Benefit Program (PLAN)-(CMS-10141)	Other-Compensation Certification	Modified

ICR Details

OMB Control No: 0938-0964	ICR Reference No: 201008-0938-020
Status: Historical Active	Previous ICR Reference No: 200905-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Prescription Drug Benefit Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/10/2011
	Date Received in OIRA: 08/30/2010
Terms of Clearance: 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.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved	09/30/2012
Responses	43,153,271	0	38,152,764
Time Burden (Hours)	36,520,101	0	34,730,676
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: Statute at Large: 18 Stat. 1860 Name of Statute: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AP77	Final or interim final rulemaking	75 FR 19678	04/15/2010

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 20365	04/19/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 43168	07/23/2010
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	43,153,271	38,152,764	4,973,234	27,273	0	0
Annual Time Burden (Hours)	36,520,101	34,730,676	1,775,489	13,936	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: MDBG - 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. The increase in burden associated with 423.153(d) is associated with the burden associated with the MTM requirement. The new requirement which requires sponsors to perform MTMP that at least include interventions for beneficiaries and prescribers, annual comprehensive reviews and quarterly targeted medication reviews. MEAG - 423.562, 423.564, 423.568, 423.570, 423.572, 423.578, 423.580, 423.582, 423.584, 423.590. The increase in burden occurred because of new notice requirements created in CMS-4085-F. Other changes to burden requirements were due to a decrease in the number of Part D plans.

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Annual Cost to Federal Government: $200,000

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: 08/30/2010

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