Solicitation for Applications for Medicare Prescription Drug Plan 2023 Contracts (CMS-10137)

Forms and Documents

Document Name	Status
Form CMS-10137 Solicitation for Applications for Medicare Prescription Drug Plan 2023 Contracts Form and Instruction	Modified
CMS-10137 - Supporting Statement A _.docx Supporting Statement A	2021-10-26
CMS 10137 Response to 60 day Public Comments.docx Supplementary Document	2021-10-13
Crosswalk - Part_D_Summ_2023_Application_.pdf Supplementary Document	2021-09-02

IC Document Collections

IC ID	Document Title	Status
43672	Solicitation for Applications for Medicare Prescription Drug Plan 2023 Contracts Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0936	ICR Reference No: 202109-0938-003
Status: Received in OIRA	Previous ICR Reference No: 202101-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Solicitation for Applications for Medicare Prescription Drug Plan 2023 Contracts (CMS-10137)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/27/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2024
Responses	382	331
Time Burden (Hours)	1,716	1,550
Cost Burden (Dollars)	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
   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. 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
  

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:
	86 FR 32935	06/23/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 59165	10/26/2021
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 2023 Contracts	CMS-10137, CMS-10137	Solicitation for Application for Medicare Prescription Drug Plan 2023 Contracts ,   PACE Medicare Part D Application

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ICR Summary of Burden

	Total Request	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	382	331	0	51	0	0
Annual Time Burden (Hours)	1,716	1,550	0	166	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The estimated time for completing the prescription drug applications is 1,715.99 hours. This is a 166.44 hour increase from the estimate of 1,549.55 hours for the 2022 prescription drug application. However, the actual number of 2022 applicants was much higher than anticipated and, so the burden for the number of applications received for 2022 was 1,719.66, hours, 170.11 hours more than the estimated burden for 2022. This increase was due to an increase in the burden per applicant and two substantive changes to the application for 2022. One attestation was added for an organization to verify that they are organized under the laws of a state. Another attestation was split into two attestations, so organizations can verify separately whether they are affected by the restrictions in 42 CFR §423.509 or the restrictions in 42 CFR §§ 423.507, 423.508, or 423.510. This added .04 hours (approximately 2 minutes) to the time it takes to complete an initial 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: 10/27/2021

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