Medicare Parts C and D Program Audit Protocols and Data Requests (CMS-10191)

Forms and Documents

Document	Type	Status	Availability
Form CMS-10191 Medicare Parts C and D Program Audit Protocols and Data Requests	Form and Instruction	Modified	Available
10191 Crosswalk From 30 Day Comments.pdf	Supplementary Document	Uploaded 2020-05-22	Available
10191PRACrosswalk60Dto30D.pdf	Supplementary Document	Uploaded 2020-05-22	Available
10191 30D Comment Summaries.pdf	Supplementary Document	Uploaded 2020-02-10	Available
Supporting Statement A 10191 - Clean 5.22.2020.docx	Supporting Statement A	Uploaded 2020-05-22	Available
1019160DCommentSummaries.pdf	Supplementary Document	Uploaded 2020-02-10	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
43683	Medicare Parts C and D Program Audit Protocols and Data Requests	Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1000	ICR Reference No: 201912-0938-020
Status: Active	Previous ICR Reference No: 201612-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Parts C and D Program Audit Protocols and Data Requests (CMS-10191)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/04/2020
	Date Received in OIRA: 01/07/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	207	0	241
Time Burden (Hours)	39,456	0	52,261
Cost Burden (Dollars)	0	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 intend to combine all Part C and Part D guides into one universal guide as it will promote efficiency and effectiveness and reduce financial and time burdens for both CMS and Medicare-contracting entities.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1857 Name of Statute: null
   Statute at Large: 18 Stat. 1860 Name of Statute: null
  

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 71427	12/27/2019
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
Medicare Parts C and D Program Audit Protocols and Data Requests	CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191, CMS-10191	CPE Program Area Audit Process and Data Request ,   CPE Compliance Officer Questionnaire ,   CPE Audit Organizational Structure and Governance PPT Template ,   Accountability for Oversight of First-Tier, Downstream and Related Entities Questionnaire ,   SIU/FWA Prevention and Detection Questionnaire ,   FA Audit Process and Data Request ,   ODAD Audit Process and Data Request ,   SNP-MOC Audit Process and Data Request ,   CDAG CDM Impact Analysis ,   CDAG GRV Impact Analysis ,   Pre Audit Issue Summary ,   FA Impact Analysis ,   ODAG DIS Impact ,   ODAG GRV Impact ,   SNP MOC ICP ICT Impact ,   SNP MOC Impact ,   SNP MOC Training Impact ,   ODAG CDM Impact ,   ODAG PMNT Impact ,   CDAG Audit Process and Data Request ,   SNP-MOC Questionnaire

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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	207	241	0	0	-34	0
Annual Time Burden (Hours)	39,456	52,261	0	0	-12,805	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: Decrease in burden has occurred due to an estimate in responding sponsoring organizations that will will be subject to data collections and the number of responses. Within the 5 protocols, we removed columns within the universes that were no longer needed (e.g., to better align with regulatory changes) or to promote consistency across the program-area instructions. We also removed several CDAG and ODAG universes entirely, renumbered the remaining CDAG universes and removed duplicative or unnecessary SNP-MOC compliance standards. Finally, we added a SNPMOC questionnaire to this collection request.

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Annual Cost to Federal Government: $7,637,934

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: 01/07/2020

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