Medicare Part C and Part D Program Audit Protocols (CMS-10717)

Forms and Documents

Document	Type	Status	Availability
Form CMS-10717 Independent Validation Auditor (IVA) Validation Report	Form and Instruction	Modified	Available
Form CMS-10717 CMS Request for Additional Information (RAI)/Sponsor Response	Form and Instruction	Modified	Available
Form CMS-10717 Attendance Log for Meetings/Webinars/Conferences	Form	Modified	Available
Form CMS-10717 Independent Validation Audit Work Plan	Form and Instruction	Modified	Available
Form CMS-10717 Root Cause Analysis	Form and Instruction	Modified	Available
Form CMS-10717 Formulary and Benefits Administration (FA) Root Cause Analysis and Impact Analysis	Form and Instruction	Modified	Available
Form CMS-10717 Organization Determinations, Appeals, and Grievances (ODAG) ODAG Timeliness Mitigation Analysis (ODAG-TMA)	Form and Instruction	Modified	Available
Form CMS-10717 Part C Organization Determinations, Appeals, and Grievances (ODAG)Classification of Requests Root Cause Analysis and Impact Analysis	Form and Instruction	Modified	Available
Form CMS-10717 Part C Organization Determinations, Appeals, and Grievances (ODAG) Processing of Coverage Requests Root Cause Analysis and Impact Analysis	Form and Instruction	Modified	Available
Form CMS-10717 Special Needs Plans Care Coordination (SNPCC) HRA Timeliness Mitigation Analysis (HRA-TMA)	Form and Instruction	Modified	Available
Form CMS-10717 Special Needs Plans Care Coordination (SNPCC) Root Cause Analysis and Impact Analysis	Form and Instruction	Modified	Available
Form CMS-10717 Part D Coverage Determinations, Appeals, and Grievances (CDAG) Classification of Requests Root Cause Analysis and Impact Analysis	Form and Instruction	Modified	Available
Form CMS-10717 Part D Coverage Determinations, Appeals, and Grievances (CDAG) Processing of Coverage Requests Root Cause Analysis and Impact Analysis	Form and Instruction	Modified	Available
Form CMS-10717 Special Needs Plans - Care Coordination Supplemental Questionnaire	Form and Instruction	Modified	Available
Form CMS-10717 Part D Formulary and Benefit Administration (FA) Supplemental Questionnaire	Form and Instruction	Modified	Available
Form CMS-10717 Compliance Program Effectiveness (CPE) Customized Organizational Structure and Governance PowerPoint Presentation	Form and Instruction	Modified	Available
Form CMS-10717 Compliance Program Effectiveness (CPE) Compliance Oversight Questionnaire	Form and Instruction	Modified	Available
Form CMS-10717 Pre Audit Issue Summary	Form	Modified	Available
CMS-10717_SupportingStatementA_.docx	Supporting Statement A	Uploaded 2026-07-06	Available
60-day comments.pdf	Public Comments	Uploaded 2026-07-01	Available
CMS10717_ResponseTo60DayComments.pdf	Supplementary Document	Uploaded 2026-06-30	Available
CombinedMasterCrosswalk_60day.pdf	Supplementary Document	Uploaded 2026-06-30	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
242160	Yearly Industry-Wide Timeliness Monitoring Project (TMP)		Removed
242155	Program Audits	Form and Instruction	Modified	Independent Validation Auditor (IVA) Validation Report
242155	Program Audits	Form and Instruction	Modified	CMS Request for Additional Information (RAI)/Sponsor Response
242155	Program Audits	Form	Modified	Attendance Log for Meetings/Webinars/Conferences
242155	Program Audits	Form and Instruction	Modified	Independent Validation Audit Work Plan
242155	Program Audits	Form and Instruction	Modified	Root Cause Analysis
242155	Program Audits	Form and Instruction	Modified	Formulary and Benefits Administration (FA) Root Cause Analysis and Impact Analysis
242155	Program Audits	Form and Instruction	Modified	Organization Determinations, Appeals, and Grievances (ODAG) ODAG Timeliness Mitigation Analysis (ODAG-TMA)
242155	Program Audits	Form and Instruction	Modified	Part C Organization Determinations, Appeals, and Grievances (ODAG)Classification of Requests Root Cause Analysis and Impact Analysis
242155	Program Audits	Form and Instruction	Modified	Part C Organization Determinations, Appeals, and Grievances (ODAG) Processing of Coverage Requests Root Cause Analysis and Impact Analysis
242155	Program Audits	Form and Instruction	Modified	Special Needs Plans Care Coordination (SNPCC) HRA Timeliness Mitigation Analysis (HRA-TMA)
242155	Program Audits	Form and Instruction	Modified	Special Needs Plans Care Coordination (SNPCC) Root Cause Analysis and Impact Analysis
242155	Program Audits	Form and Instruction	Modified	Part D Coverage Determinations, Appeals, and Grievances (CDAG) Classification of Requests Root Cause Analysis and Impact Analysis
242155	Program Audits	Form and Instruction	Modified	Part D Coverage Determinations, Appeals, and Grievances (CDAG) Processing of Coverage Requests Root Cause Analysis and Impact Analysis
242155	Program Audits	Form and Instruction	Modified	Special Needs Plans - Care Coordination Supplemental Questionnaire
242155	Program Audits	Form and Instruction	Modified	Part D Formulary and Benefit Administration (FA) Supplemental Questionnaire
242155	Program Audits	Form and Instruction	Modified	Compliance Program Effectiveness (CPE) Customized Organizational Structure and Governance PowerPoint Presentation
242155	Program Audits	Form and Instruction	Modified	Compliance Program Effectiveness (CPE) Compliance Oversight Questionnaire
242155	Program Audits	Form	Modified	Pre Audit Issue Summary
242155	Program Audits	Instruction	Modified

ICR Details

OMB Control No: 0938-1395	ICR Reference No: 202606-0938-024
Status: Received in OIRA	Previous ICR Reference No: 202310-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Part C and Part D Program Audit Protocols (CMS-10717)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/06/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2027
Responses	30	182
Time Burden (Hours)	12,795	36,444
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:
	90 FR 59834	12/22/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 41039	07/06/2026
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
Program Audits	CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717	Pre Audit Issue Summary ,   Compliance Program Effectiveness (CPE) Compliance Oversight Questionnaire ,   Compliance Program Effectiveness (CPE) Customized Organizational Structure and Governance PowerPoint Presentation ,   Part D Formulary and Benefit Administration (FA) Supplemental Questionnaire ,   Special Needs Plans - Care Coordination Supplemental Questionnaire ,   Part D Coverage Determinations, Appeals, and Grievances (CDAG) Processing of Coverage Requests Root Cause Analysis and Impact Analysis ,   Part D Coverage Determinations, Appeals, and Grievances (CDAG) Classification of Requests Root Cause Analysis and Impact Analysis ,   Special Needs Plans Care Coordination (SNPCC) Root Cause Analysis and Impact Analysis ,   Special Needs Plans Care Coordination (SNPCC) HRA Timeliness Mitigation Analysis (HRA-TMA) ,   Part C Organization Determinations, Appeals, and Grievances (ODAG) Processing of Coverage Requests Root Cause Analysis and Impact Analysis ,   Part C Organization Determinations, Appeals, and Grievances (ODAG)Classification of Requests Root Cause Analysis and Impact Analysis ,   Organization Determinations, Appeals, and Grievances (ODAG) ODAG Timeliness Mitigation Analysis (ODAG-TMA) ,   Formulary and Benefits Administration (FA) Root Cause Analysis and Impact Analysis ,   Root Cause Analysis ,   Independent Validation Audit Work Plan ,   Attendance Log for Meetings/Webinars/Conferences ,   CMS Request for Additional Information (RAI)/Sponsor Response ,   Independent Validation Auditor (IVA) Validation Report
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	30	182	0	-152	0	0
Annual Time Burden (Hours)	12,795	36,444	0	-23,649	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: CMS reduced the hours necessary to conduct validation activities from 200 hours for all organizations to 165 hours, 100 hours, and 10 hours in regards to the various program audits. In addition to the changes, CMS also removed the burden associated with the Part C Timeliness Monitoring Project. The timeliness monitoring project was included as part of this protocol package, but CMS no longer collects industry wide data or conducts this monitoring effort, so all associated burden has been removed from this supporting statement.

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Annual Cost to Federal Government: $7,898,760

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: 07/06/2026

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