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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10191 Medicare Parts C and D Program Audit Protocols and Data Requests	Form and Instruction	Modified	Available
2017_30_day_Comment_Response_Document_Passback1_032817 CLEAN.pdf	Supplementary Document	Uploaded 2017-04-05	Available
2017_60_day_Comment_Response_Document.pdf	Supplementary Document	Uploaded 2016-12-09	Available
CMS-10191 - Supporting Statement A - Passback3 (002)_MOEG edits CLEAN.docx	Supporting Statement A	Uploaded 2017-04-05	Available

IC Document Collections

Information collection document groups

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: 201612-0938-003
Status: Historical Active	Previous ICR Reference No: 201307-0938-024
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: 04/12/2017
	Date Received in OIRA: 12/12/2016
Terms of Clearance: As discussed with CMS, any collection of information by CMS with regard to the effort to collect coverage determinations and appeals information for each of the 201 sponsoring organizations in the MA and Part D programs prior to the approval of this package is in violation of the Paperwork Reduction Act and will be noted in the Information Collection Budget.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2020	36 Months From Approved	04/30/2017
Responses	241	0	195
Time Burden (Hours)	52,261	0	23,595
Cost Burden (Dollars)	0	0	0

---

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.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 38187	06/13/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 76946	11/04/2016
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

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, CMS10191, 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 Self-Assessment Questionnaire ,   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 ,   CDAG AUDIT PROCESS AND DATA REQUEST ,   CDAG Supplemental Questions ,   ODAG AUDIT PROCESS AND DATA REQUEST ,   ODAG Supplemental Questions ,   SNP-MOC AUDIT PROCESS AND DATA REQUEST ,   MTM PILOT AUDIT PROCESS AND DATA REQUEST ,   CDAG CDM Impact Analysis ,   CDAG GRV Impact Analysis ,   FA Impact Analysis ,   MTM Impact Analysis ,   ODAG CDM Impact Analysis ,   ODAG DIS Impact Analysis ,   ODAG GRV Impact Analysis ,   ODAG PMNT Impact Analysis ,   SNP-MOC ICP ICT Impact Analysis ,   SNP-MOC Impact Analysis ,   SNP-MOC Training Impact Analysis ,   Pre-Audit Issues Summary

---

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	241	195	0	46	0	0
Annual Time Burden (Hours)	52,261	23,595	0	28,666	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: Under Routine Audits, the total hour burden has been adjusted from 121 hours to 701 hours to more accurately reflect the entirety of the audit process. Additionally, PACE organizations have been removed from this collection request and will be submitted under a different PRA package, as the collection instruments and burden estimates for this collection and a PACE audit differ greatly. Additionally, ad hoc audits have been removed from the burden estimate because ad hoc audits have not exceeded 3 per year in the last 5 years and routine audits have not exceeded 30 in the last 3 years. Therefore, we believe the total number of 40 routine audits more accurately reflects the burden associated with this collection. Consequently, the total burden has been adjusted from 23,595 hours to 28,040 hours. Additionally, we increased the number of respondents who will submit coverage determinations, organization determinations and appeals universes, as we will be conducting industry-wide monitoring of timeliness to be used for Star Rating purposes. The changes to the burden are reflected and discussed in this document. We have also prepared a detailed crosswalk of all the changes to the burden, as well as crosswalks detailing all changes to documents from the 60-day to the 30-day comment period. Please see the crosswalks for changes.

---

Annual Cost to Federal Government: $10,623,354

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

---

Common Form ICR:  No

---

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: 12/12/2016

---