Solicitation for Applications for Medicare Prescription Drug Plan 2021 Contracts (CMS-10137)

Forms and Documents

Document Name	Status
Form CMS-10137 Solicitation for Applications for Medicare Prescription Drug Plan 2021 Contracts Form and Instruction	Modified
CMS 10137 Response to Public Commnets.docx Supplementary Document	2019-12-11
Part_D_Summ_2021_Application_Revisions_technical__substantive_v30_day.pdf Supplementary Document	2019-12-11
CMS-10137 - Supporting Statement A _ 30 Day_ clean.docx Supporting Statement A	2019-12-11

IC Document Collections

IC ID	Document Title	Status
43672	Solicitation for Applications for Medicare Prescription Drug Plan 2021 Contracts Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0936	ICR Reference No: 201912-0938-006
Status: Active	Previous ICR Reference No: 201812-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Solicitation for Applications for Medicare Prescription Drug Plan 2021 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: 07/21/2020
	Date Received in OIRA: 12/11/2019
Terms of Clearance: Previous terms continue: This ICR is approved for 12 months as it is associated with CMS's annual "Call Letter." Because 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 practical 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 30day 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	07/31/2021	36 Months From Approved	07/31/2020
Responses	290	0	256
Time Burden (Hours)	1,385	0	2,351
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 3314 Name of Law: Including cost incurred by AIDS drug assistance programs and Indian Health services
   PL: Pub.L. 111 - 148 3310 Name of Law: Reducing Wasteful dispensing of outpatient drugs in LTC facilities
   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 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:
	84 FR 41991	08/16/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 67464	12/10/2019
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
Solicitation for Applications for Medicare Prescription Drug Plan 2021 Contracts	CMS-10137, CMS-10137	Solicitation for Application for Medicare Prescription Drug Plan 2021 Contracts ,   PACE Medicare Part D Application

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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	290	256	0	34	0	0
Annual Time Burden (Hours)	1,385	2,351	0	-966	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: The burden per applicant has decreased since the 2020 application cycle due to a reduction in the number of attestations and an adjustment to the requirements for SAE applicants that significantly reduced the number of attestations that they need to complete. Overall, the estimated time for completing the prescription drug applications is 1,384.79 hours. This is a 966.29 hour decrease from the estimate of 2,351.08 hours for the 2020 prescription drug application.

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Annual Cost to Federal Government: $140,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 12/11/2019

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