Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts (CMS-10137)

Forms and Documents

Document Name	Status
Form CMS-10137 Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts Form and Instruction	Modified
CMS-10137 - Supporting Statement 2018 Applications [rev 11-04-2016 by OSORA PRA].docx Supporting Statement A	2016-11-04

IC Document Collections

IC ID	Document Title	Status
43672	Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0936	ICR Reference No: 201610-0938-010
Status: Historical Active	Previous ICR Reference No: 201509-0938-014
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts (CMS-10137)
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: 01/23/2017
	Date Received in OIRA: 11/04/2016
Terms of Clearance: Previous terms continue: 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	01/31/2018	36 Months From Approved	05/31/2017
Responses	160	0	230
Time Burden (Hours)	1,565	0	2,109
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): 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
   PL: Pub.L. 108 - 173 1860D Name of Law: Medicare Prescription Drug Benefit Program
   PL: Pub.L. 111 - 148 6005 Name of Law: Pharmacy benefit managers transparency requirements
  

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:
	81 FR 44610	07/08/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 75409	10/31/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts	CMS-10137, CMS-10137	Medicare Part D Application for New PACE Organizations 2017 Contract Year ,   Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts

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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	160	230	0	-70	0	0
Annual Time Burden (Hours)	1,565	2,109	0	-544	0	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: Miscellaneous Actions

Short Statement: Dates within the application has been revised to reflect changes for 2018 application cycle. Instructions have been revised to clarify requirements and application elements associated with specific application type. References to regulatory requirements and guidance have been updated to reflect changes for the 2018 cycle. None of the changes have any burden implications such that the hourly burden per applicant is unchanged. Overall, the estimated time for completing the prescription drug applications is 1,565 hours. This is a 544 hour decrease from the 2017 prescription drug application. Based on prior years’ experience CMS has determined that the estimated the number of 2018 applicants should be adjusted by -70 to properly reflect the decrease in MA-PD organizations seeking to apply to contract with CMS. Specifically, CMS estimates that for 2018 there will be as many applications as were actually received for 2017, and the majority of those received will be expansions of existing contracts, which require 60% fewer hours to complete.

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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: 11/04/2016

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