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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10717 Yearly Industry-Wide Timeliness Monitoring Project (TMP)	Form and Instruction	New	Repair queued
Form CMS-10717 Special Needs Plans - Care Coordination Supplemental Questionnaire	Form and Instruction	New	Repair queued
Form CMS-10717 Root Cause Analysis	Form	New	Repair queued
Form CMS-10717 Independent Validation Audit Work Plan	Form and Instruction	New	Repair queued
Form CMS-10717 First Tier, Downstream, and Related Entities Operations Oversight Questionnaire	Form and Instruction	New	Repair queued
Form CMS-10717 Part D Formulary and Benefit Administration (FA) Supplemental Questionnaire	Form and Instruction	New	Repair queued
Form CMS-10717 CPE Compliance Officer Questionnaire	Form and Instruction	New	Repair queued
Form CMS-10717 Pre Audit Issue Summary	Form	New	Repair queued
60D_Comments_Summary508.pdf	Supplementary Document	Uploaded 2020-06-04	Repair queued
Crosswalk_60D_Comments508.pdf	Supplementary Document	Uploaded 2020-06-04	Repair queued
CMS-10717 Supporting_Statement_A.docx	Supporting Statement A	Uploaded 2020-06-04	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
242160	Yearly Industry-Wide Timeliness Monitoring Project (TMP)		New
242160	Yearly Industry-Wide Timeliness Monitoring Project (TMP)	Form and Instruction	New
242155	Program Audits	Form and Instruction	New	Special Needs Plans - Care Coordination Supplemental Questionnaire
242155	Program Audits	Form	New	Root Cause Analysis
242155	Program Audits	Form and Instruction	New	Independent Validation Audit Work Plan
242155	Program Audits	Form and Instruction	New	First Tier, Downstream, and Related Entities Operations Oversight Questionnaire
242155	Program Audits	Form and Instruction	New	Part D Formulary and Benefit Administration (FA) Supplemental Questionnaire
242155	Program Audits	Form and Instruction	New	CPE Compliance Officer Questionnaire
242155	Program Audits	Form	New	Pre Audit Issue Summary
242155	Program Audits	Instruction	New

ICR Details

OMB Control No: 0938-1395	ICR Reference No: 202006-0938-004
Status: Historical Active	Previous ICR Reference No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/08/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/05/2020
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2024	36 Months From Approved
Responses	179	0	0
Time Burden (Hours)	36,082	0	0
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 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: US Code: 42 USC 1395w–27
US Code: 42 USC 1395w-112

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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 66912	12/06/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 34450	06/04/2020
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Program Audits	CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717, CMS-10717	Pre Audit Issue Summary ,   CPE Compliance Officer Questionnaire ,   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
Yearly Industry-Wide Timeliness Monitoring Project (TMP)

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ICR Summary of Burden

table that charts list 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	179	0	0	179	0	0
Annual Time Burden (Hours)	36,082	0	0	36,082	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 total number of routine program audits is estimated at 25 and the corresponding total burden is 17,525 hours. The total hourly burden for the industry wide timeliness monitoring project remains at 120.5 hours per respondent. As described above, the number of respondents for this timeliness monitoring project is 154 Sponsoring organizations per year. Consequently, the total burden for the industry wide monitoring effort is 18,557 hours.

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Annual Cost to Federal Government: $8,513,400

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: 06/05/2020

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