Information Collection Requirements Referenced in HIPAA for the Group Market, Supporting Regulations 45 CFR 146, and forms/instructions (CMS-10430)

Forms and Documents

Document Name	Status
Form CMS-10430 Information Collection Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health Service Act Form and Instruction	Modified
CMS-10430 - Supporting Statement 072716.pdf Supporting Statement A	2016-07-29

IC Document Collections

IC ID	Document Title	Status
43664	Information Collection Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health Service Act Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0702	ICR Reference No: 201603-0938-016
Status: Historical Active	Previous ICR Reference No: 201408-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: 18923
Title: Information Collection Requirements Referenced in HIPAA for the Group Market, Supporting Regulations 45 CFR 146, and forms/instructions (CMS-10430)
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: 08/16/2016
	Date Received in OIRA: 03/23/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	08/31/2016
Responses	100,758	0	39,831,442
Time Burden (Hours)	2,555	0	3,760,421
Cost Burden (Dollars)	0	0	0

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Abstract: Sections 2723 and 2761 of the Public Health Service Act (PHS Act) direct the Centers for Medicare and Medicaid Services (CMS) to enforce a provision (or provisions) of title XXVII of the PHS Act (including the implementing regulations in parts 144, 146, 147, and 148 of title 45 of the Code of Federal Regulations) with respect to health insurance issuers when a state has notified CMS that it has not enacted legislation to enforce or that it is not otherwise enforcing a provision (or provisions) of the group and individual market reforms with respect to health insurance issuers, or when CMS has determined that a state is not substantially enforcing one or more of those provisions. This collection of information includes requirements that are necessary for CMS to conduct compliance review activities.

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Authorizing Statute(s): PL: Pub.L. 105 - 277 Title IX Name of Law: The Women's Health and Cancer Rights Act of 1998
   PL: Pub.L. 111 - 148 Title I Name of Law: Affordable Care Act
   US Code: 42 USC 300gg-23 Name of Law: Individual and Group Market Reforms
   US Code: 42 USC 241 Name of Law: Research and investigations generally
   PL: Pub.L. 104 - 204 Title VI Name of Law: Newborns' and Mothers' Health Protection Act of 1996
   PL: Pub.L. 104 - 191 Title I Name of Law: Health Insurance Portability and Accountability Act of 1996 (HIPAA)
   PL: Pub.L. 110 - 343 Title V Name of Law: Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008
   PL: Pub.L. 110 - 223 Title I Name of Law: Genetic Information Nondiscrimination Act of 2008
   US Code: 42 USC 300gg-61 Name of Law: Individual Market Rules
  

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:
	80 FR 75463	12/02/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 10627	03/01/2016
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
Information Collection Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health Service Act	CMS-10430	Model Notice to Enrollees

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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	100,758	39,831,442	0	-39,730,684	0	0
Annual Time Burden (Hours)	2,555	3,760,421	0	-3,757,866	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: Miscellaneous Actions

Short Statement: There are program burden changes in this collection. As indicated in the Background section, this revised burden is a result of new statutory requirements under title XXVII of the PHS Act. With respect to health insurance issuer burden in a state in which CMS is enforcing any of the requirements under title XXVII of the PHS Act, we revised the burden estimate to reflect that CMS is currently enforcing these requirements in 5 states. We also revised the burden estimates for other requirements since they are now applicable to issuers in the U.S. territories or expatriate plans only. One requirement is being discontinued. Therefore, the total burden is now revised from 3,760,421 hours to 2,555 hours, a total reduction of 3,757,866 hours.

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Annual Cost to Federal Government: $3,700,000

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]? Yes

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: 03/23/2016

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