Medicaid Managed Care and Supporting Regulations (CMS-10108)

Forms and Documents

Document Name	Status
Crosswalk Chart_final.docx Supplementary Document	2016-06-27
CMS-10108 - Supporting Statement A [rev 12-08-2016].docx Supporting Statement A	2016-12-08
COI Comments for PRA_FINAL (rev 05-23-2016).docx Supplementary Document	2016-05-24

IC Document Collections

IC ID	Document Title	Status
8764	Medicaid Managed Care Regulations (States) 42 CFR 438.6, 438.10, 438.50, 438.202, 438.722, 438.724, and 438.810	Modified
179886	Medicaid Managed Care Regulations (Private Sector) 42 CFR 438.8, 438.10, 438.12, 438.102, 438.207, 438.208, 438.210, 438.236, 438.240, 438.242, 438.404, and 438.416	Modified

ICR Details

OMB Control No: 0938-0920	ICR Reference No: 201605-0938-016
Status: Historical Active	Previous ICR Reference No: 201506-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicaid Managed Care and Supporting Regulations (CMS-10108)
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: 12/16/2016
	Date Received in OIRA: 05/24/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	12/31/2016
Responses	22,564,877	0	9,813,796
Time Burden (Hours)	1,371,968	0	1,797,823
Cost Burden (Dollars)	0	0	0

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Abstract: These information collections requirements implement regulations that allow states greater flexibility to implement mandatory managed care programs, implement new beneficiary protections, and eliminate certain requirements viewed by state agencies as impediments to the growth of managed care programs. Information collected includes information about managed care programs, grievances and appeals, enrollment broker contracts, and managed care organizations capacity to provide health care services.

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Authorizing Statute(s): US Code: 42 USC 438.50 Name of Law: State Plan Requirements
   US Code: 42 USC 438.56 Name of Law: Disenrollment: Requirements and limitations
   US Code: 42 USC 438.102 Name of Law: Provider-enrollee communications
   US Code: 42 USC 438.114 Name of Law: Emergency and post-stabilization services
   US Code: 42 USC 438.202 Name of Law: State responsibilities
   US Code: 42 USC 438.204 Name of Law: Elements of State quality strategies
   US Code: 42 USC 438.8 Name of Law: Provisions that apply to PIHPs and PAHPs
   US Code: 42 USC 438.206 Name of Law: Availablity of services
   US Code: 42 USC 438.207 Name of Law: Assurances of adequate capacity and services
   US Code: 42 USC 438.242 Name of Law: Health information systems
   US Code: 42 USC 438.402 Name of Law: General requirements
   US Code: 42 USC 438.240 Name of Law: Quality assessment and performance improvement program
   US Code: 42 USC 438.404 Name of Law: Notice of Action
   US Code: 42 USC 438.406 Name of Law: Handling of grievances and appeals
   US Code: 42 USC 438.410 Name of Law: Expedited resolution of appeals
   US Code: 42 USC 438.414 Name of Law: Information about the grievance system to providers
   US Code: 42 USC 438.416 Name of Law: Record keeping and reporting requirements
   US Code: 42 USC 438.604 Name of Law: Data that must be certified
   US Code: 42 USC 438.710 Name of Law: Due process: Notice of sanction and pre-determination hearing
   US Code: 42 USC 438.408 Name of Law: Resolution and notification: Grievances and appeals
   US Code: 42 USC 438.722 Name of Law: Disenrollment during termination hearing process
   US Code: 42 USC 438.724 Name of Law: Notice to CMS
   US Code: 42 USC 438.810 Name of Law: Expenditures for enrollment broker services
   US Code: 42 USC 438.10 Name of Law: Information Requirements
   US Code: 42 USC 438.6 Name of Law: Contract Requirements
   US Code: 42 USC 438.12 Name of Law: Provider Discrimination prohibited
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AS25	Final or interim final rulemaking	81 FR 27498	05/06/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 31098	06/01/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 27498	05/06/2016
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Medicaid Managed Care Regulations (States) 42 CFR 438.6, 438.10, 438.50, 438.202, 438.722, 438.724, and 438.810
Medicaid Managed Care Regulations (Private Sector) 42 CFR 438.8, 438.10, 438.12, 438.102, 438.207, 438.208, 438.210, 438.236, 438.240, 438.242, 438.404, and 438.416

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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	22,564,877	9,813,796	0	12,751,081	0	0
Annual Time Burden (Hours)	1,371,968	1,797,823	0	-425,855	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: Changing Regulations

Short Statement: The May 6, 2016, final rule adds hours and decreases hours for several currently approved requirements. Overall, the burden has decreased by 425,855 hours. The number of responses has increased by 12,751,081.

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Annual Cost to Federal Government: $35,807,519

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

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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: 05/24/2016

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