Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a) (CMS-10261)

Forms and Documents

Document Name	Status
CMS Response to 30 day comments.pdf Supplementary Document	2019-12-20
CMS -10261- Supporting Statement_2.0 Final redline_2.docx Supporting Statement A	2019-12-20
CMS Response to Public Comments Received for CMS 10261 DMAO responses 08....pdf Supplementary Document	2019-09-13

IC Document Collections

IC ID	Document Title	Status
186859	Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a) Instruction	Modified

ICR Details

OMB Control No: 0938-1054	ICR Reference No: 201909-0938-008
Status: Active	Previous ICR Reference No: 201807-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a) (CMS-10261)
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: 04/06/2020
	Date Received in OIRA: 09/13/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	12/31/2021
Responses	4,752	0	3,962
Time Burden (Hours)	187,926	0	166,824
Cost Burden (Dollars)	0	0	0

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Abstract: CMS' regulatory authority to establish reporting requirements for Part C Medicare Advantage (MA) organizations is described in 42 CFR 422.516 (a). It is noted that each MA organization 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, and while safeguarding the confidentiality of the doctor-patient relationship, statistics and other information with respect to the following: (1) The cost of its operations. (2) The patterns of utilization of its services. (3) The availability, accessibility, and acceptability of its services. (4) To the extent practical, developments in the health status of its enrollees. (5) Other matters that CMS may require. With both growth in the number of participating organizations and the types of plan "packages" available to Medicare beneficiaries, the need for more extensive, in depth, and effective monitoring has increased. Therefore, CMS is requesting a 3 year OMB approval of additional Part C data reporting.

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Authorizing Statute(s): PL: Pub.L. 110 - 275 164 Name of Law: MIPPA
   PL: Pub.L. 115 - 123 50323 Name of Law: BBA
  

Citations for New Statutory Requirements: PL: Pub.L. 115 - 123 50323 Name of Law: BBA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT59	Final or interim final rulemaking	84 FR 15680	04/16/2019

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 17166	04/24/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 47958	09/11/2019
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
Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a)

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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	4,752	3,962	0	790	0	0
Annual Time Burden (Hours)	187,926	166,824	0	21,102	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: A new data element C was added for Telehealth Reporting for clarification purposes. Despite the additional element there were no changes to the per burden estimate because the number of elements for Telehealth are now equivalent to the number of data elements for the Part C Rewards and Incentives reporting section. However, the number of contracts reporting in 2019 has increased to 594 from 566, accordingly the annual burden was adjusted to 187,926.

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Annual Cost to Federal Government: $300,000

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? Uncollected

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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: 09/13/2019

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