Applications for Medicare Part D plans: PDP Plans, MA-PD Plans, Cost Plans, PACE organizations, SAE and EGWP

Forms and Documents

Document Name	Status
Form CMS-10137 CY 2012-Applications for Medicare Part D Plans; PDP Plans, MA-PD Plans, Cost Plans, PACE Organizations, SAE and EGWP Form and Instruction	Modified
Attachment 2 2013 Application Comment Tracker.xlsx Supplementary Document	2012-01-17
2013 Application 60-Day Comment tracker.xlsx Supplementary Document	2011-11-02
CMS-10137_Summary_2013_Part_D_Application_Revisions.pdf Supplementary Document	2011-11-02
CMS-10137.Supporting_Statement (2-15-12).docx Supporting Statement A	2012-02-15

IC Document Collections

IC ID	Document Title	Status
43672	CY 2012-Applications for Medicare Part D Plans; PDP Plans, MA-PD Plans, Cost Plans, PACE Organizations, SAE and EGWP Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0936	ICR Reference No: 201111-0938-002
Status: Historical Active	Previous ICR Reference No: 201009-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Applications for Medicare Part D plans: PDP Plans, MA-PD Plans, Cost Plans, PACE organizations, SAE and EGWP
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: 02/17/2012
	Date Received in OIRA: 11/04/2011
Terms of Clearance: This ICR is approved for 12 months as it is associated with CMS's annual "Call Letter." Since the Call Letter discusses the information to be contained in the applications and the method by which they shall be submitted to CMS, in the Call Letter CMS shall (a) provide a reference to this OMB control number whenever the Part D application requirements are discussed, (b) provide an estimate of the burden entailed, and (c) indicate that CMS has issued a 60 day Federal Register notice for this ICR inviting public comments on the burden estimates and utility associated with this collection. CMS shall ensure that enough time is provided to the public to allow for both the 60 day and 30 day public comment periods. Per the PRA, OMB approval must be secured prior to the date by which Medicare Part D plans will need to submit these applications. The timing of the Call Letter and the 60 day and 30 day Federal Register notices should therefore be carefully considered and coordinated. Consistent with the PRA, this ICR should be re-submitted along with the publication of the draft "forthcoming guidance" documents to the extent the guidance document will result in new information collection, recordkeeping, or disclosure requirements or result in changes to burden or capital costs from existing requirements.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	36 Months From Approved	02/29/2012
Responses	178	0	295
Time Burden (Hours)	2,322	0	3,576
Cost Burden (Dollars)	0	0	0

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Abstract: The Applications for Part D sponsors to offer qualified prescription drug coverage are completed by entities seeking approval to offer Part D benefits under the Medicare Prescription Drug Benefit program established by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and is codified in section 1860D of the Social Security Act (the Act).

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Authorizing Statute(s): PL: Pub.L. 111 - 148 6005 Name of Law: Pharmacy benefit managers transparency requirements
   PL: Pub.L. 108 - 173 1860D Name of Law: Medicare Prescription Drug Benefit Program
   Statute at Large: 18 Stat. 1860 Name of Statute: null
   PL: Pub.L. 111 - 148 3310 Name of Law: Reducing Wasteful dispensing of outpatient drugs in LTC facilities
   PL: Pub.L. 111 - 148 3314 Name of Law: Including cost incurred by AIDS drug assistance programs and Indian Health services
  

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:
	76 FR 38655	07/01/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 62414	10/07/2011
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
CY 2012-Applications for Medicare Part D Plans; PDP Plans, MA-PD Plans, Cost Plans, PACE Organizations, SAE and EGWP	CMS-10137, CMS-10137, CMS-10137, CMS-10137, CMS-10137	2013 Application for PDP and MA-PD Service Area Expansion ,   2013 New Medicare Advantage Prescription Drug Plan (MA-PD ,   Application_for_New_PACE_Plan ,   2013 Application for New Cost Plan ,   2013 Application for New Prescription Drug Plan (PDP)

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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	178	295	0	-234	117	0
Annual Time Burden (Hours)	2,322	3,576	0	178	-1,432	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: Cutting Redundancy

Short Statement: The Part D applications have been revised, and as a result, decreased the overall burden due to removing redundant sections of the applications. Further, legislation was enacted and became effective, and regulations issued, since the last revision of these documents. As a result, new attestations were added to the applications, and several attestations were clarified or corrected to address current CMS policy (see Supporting Statement for more detail). Burden hours for the 30-day posting are unchanged from those indicated in the 60-day comment period posting.

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Annual Cost to Federal Government: $140,000

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]? Yes

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: 11/04/2011

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