Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols (CMS-10717)

Forms and Documents

Document Name	Status
CMS10717SupportingStatementA.docx Supporting Statement A	2023-10-16
ResponsesToCommentsReceived60Day.pdf Supplementary Document	2023-10-13
10717Crosswalk.pdf Supplementary Document	2023-10-13

IC Document Collections

IC ID	Document Title	Status
242160	Yearly Industry-Wide Timeliness Monitoring Project (TMP)	Modified
242155	Program Audits Instruction	Modified

ICR Details

OMB Control No: 0938-1395	ICR Reference No: 202310-0938-002
Status: Received in OIRA	Previous ICR Reference No: 202006-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols (CMS-10717)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/17/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2024
Responses	182	179
Time Burden (Hours)	36,444	36,082
Cost Burden (Dollars)	0	0

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Abstract: 42 CFR 422.502 describes CMS' regulatory authority to evaluate, through inspection or other means, Medicare Advantage Part C organizations. These records include books, contracts, medical records, patient care documentation and other records that pertain to any aspect of services performed, reconciliation of benefit liabilities, and determination of amounts payable. 42 CFR 423.503 states that CMS must oversee a Part D plan sponsor's continued compliance with the requirements for a Part D plan sponsor. 423.514 states that the Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics regarding areas such as cost of operations, patterns of utilization availability, accessibility, and acceptability of services. CMS developed a strategy to address our oversight and audit responsibilities within the context of limited audit/oversight resources. We have combined all Part C and Part D guides into one universal guide promoting efficiency and effectiveness and reducing financial and time burdens for both CMS and Medicare-contracting entities.

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Authorizing Statute(s): US Code: 42 USC 1395w-112 Name of Law: REQUIREMENTS FOR AND CONTRACTS WITH PRESCRIPTION DRUG PLAN (PDP) SPONSORS
   US Code: 42 USC 1395w–27 Name of Law: CONTRACTS WITH MEDICARE+CHOICE ORGANIZATIONS
  

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:
	88 FR 26551	05/01/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 71367	10/16/2023
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Program Audits	CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717	Pre Audit Issue Summary ,   CPE Compliance Officer Questionnaire Compliance Officer Questionnaire (CO-Q) ,   Part D Formulary and Benefit Administration (FA) Supplemental Questionnaire ,   First Tier, Downstream, and Related Entities Operations Oversight Questionnaire ,   Independent Validation Audit Work Plan ,   Root Cause Analysis ,   Special Needs Plans - Care Coordination Supplemental Questionnaire ,   Attendance Log for Meetings/Webinars/Conferences
Yearly Industry-Wide Timeliness Monitoring Project (TMP)

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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	182	179	0	0	3	0
Annual Time Burden (Hours)	36,444	36,082	0	0	362	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: No

Burden Reduction Due to:

Short Statement: CMS has made minimal changes to the collection request. These changes do not impact the burden estimate. The number of respondents for this timeliness monitoring project has increased to 157 Sponsoring organizations per year. Consequently, the total burden for the industry wide monitoring effort has increased to 18,919 hours, which has increased the total burden to 36,082.

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Annual Cost to Federal Government: $8,472,875

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]? 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? 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: 10/17/2023

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