[Federal Register Volume 83, Number 227 (Monday, November 26, 2018)]
[Notices]
[Pages 60428-60429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10286, CMS-10440 and CMS-10507]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by January 25, 2019.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number__, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-1326.

SUPPLEMENTARY INFORMATION: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10286 Notice of Research Exception under the Genetic Information 
Nondiscrimination Act
CMS-10440 Data Collection to Support Eligibility Determinations for 
Insurance Affordability Programs and Enrollment through Affordable 
Insurance Exchanges, Medicaid and Children's Health Insurance Program 
Agencies (CMS-10440)
CMS-10507 State-based Exchange Annual Report Tool (SMART)

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Notice of 
Research Exception under the Genetic Information Nondiscrimination Act; 
Use: Under the Genetic Information Nondiscrimination Act of 2008 
(GINA), a plan or issuer may request (but not require) a genetic test 
in connection with certain research activities so long as such 
activities comply with specific requirements, including: (i) The 
research complies with 45 CFR part 46 or equivalent federal regulations 
and applicable State or local law or regulations for the protection of 
human subjects in research; (ii) the request for the participant or 
beneficiary (or in the case of a minor child, the legal guardian of 
such beneficiary) is made in writing and clearly indicates that 
compliance with the request is voluntary and that non-compliance will 
have no effect on eligibility for benefits or premium or contribution 
amounts; and (iii) no genetic information collected or acquired will be 
used for underwriting purposes. The Secretary of Labor or the Secretary 
of Health and Human Services is required to be notified if a group 
health plan or health insurance issuer intends to claim the research 
exception permitted under Title I of GINA. Nonfederal governmental 
group health plans and issuers solely in the individual health 
insurance market or Medigap market will be required to file with the 
Centers for Medicare & Medicaid Services (CMS). The Notice of Research 
Exception under the Genetic Information Nondiscrimination Act is a 
model notice that can be completed by group health plans and health 
insurance issuers and filed with either the Department of Labor or CMS 
to comply with the notification requirement. Form Number: CMS-10286 
(OMB control number 0938-1077); Frequency: Occasionally; Affected 
Public: State, Local or Tribal Governments; Private Sector; Number of 
Respondents: 2; Number of Responses: 2; Total Annual Hours: 0.5. (For 
policy questions regarding this collection contact Usree Bandyopadhyay 
at 410-786-6650.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of

[[Page 60429]]

Information Collection: Data Collection to Support Eligibility 
Determinations for Insurance Affordability Programs and Enrollment 
through Affordable Insurance Exchanges, Medicaid and Children's Health 
Insurance Program Agencies; Use: Information collected by the 
Marketplace, Medicaid or CHIP agency will be used to determine 
eligibility for coverage through the Marketplace and insurance 
affordability programs (i.e., Medicaid, CHIP, and advance payment of 
the premium tax credits), and assist consumers in enrolling in a QHP if 
eligible. Applicants include anyone who may be eligible for coverage 
through any of these programs.
    The Marketplace verifies the information provided on the 
application, communicates with the applicant or his/her authorized 
representative and subsequently provides the information to the health 
plan selected by the applicant so that it can enroll him/her in a QHP. 
The Marketplace also uses the information provided in support of its 
ongoing operations, including activities such as verifying continued 
eligibility for all programs, processing appeals, reporting on and 
managing the insurance affordability programs for eligible individuals, 
performing oversight and quality control activities, combatting fraud, 
and responding to any concerns about the security or confidentiality of 
the information. Form Number: CMS-10440 (OMB control number: 0938-
1191); Frequency: Annually; Affected Public: Private Sector (Business 
or other for-profits, Not-for-Profit Institutions); Number of 
Respondents: 4,662,000; Total Annual Responses: 4,662,000; Total Annual 
Hours: 946,386. (For policy questions regarding this collection contact 
Anne Pesto at 410-786-3492.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: State-based 
Exchange Annual Report Tool (SMART); Use: The annual report is the 
primary vehicle to insure comprehensive compliance with all reporting 
requirements contained in the Affordable Care Act (ACA). It is 
specifically called for in Section 1313(a)(1) of the Act which requires 
an State Based Exchange (SBEs) (including an Exchange using the Federal 
Platform) to keep an accurate accounting of all activities, receipts, 
and expenditures, and to submit a report annually to the Secretary 
concerning such accounting.
    CMS and other Federal agencies use the information collected from 
the SMART to determine if a state is maintaining a compliant, 
operational Exchange. It also provides a mechanism to collect 
innovative approaches to meeting challenges encountered by the SBEs 
during the preceding year, as well as to provide information to CMS 
regarding potential changes in priorities and approaches for the 
upcoming year. Form Number: CMS-10507 (OMB control number: 0938-1244); 
Frequency: Annually; Affected Public: State, Local, or Tribal 
governments; Number of Respondents: 17; Total Annual Responses: 17; 
Total Annual Hours: 3,415. (For policy questions regarding this 
collection contact Christy Woods at 301-492-5140.)

    Dated: November 20, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-25700 Filed 11-23-18; 8:45 am]
 BILLING CODE 4120-01-P