[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1415-1416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00344]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10286 and CMS-10325]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

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 March 14, 2022.

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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

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).


[[Page 1416]]


CMS-10286 Notice of Research Exception under the Genetic Information 
Nondiscrimination
CMS-10325 Disclosure and Recordkeeping Requirements for Grandfathered 
Health Plans under the Affordable Care Act

    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: Private Sector; State, Local or Tribal governments; Number of 
Respondents: 2; Total Annual 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 Information Collection: Disclosure and 
Recordkeeping Requirements for Grandfathered Health Plans under the 
Affordable Care Act; Use: Section 1251 of the Affordable Care Act 
provides that certain plans and health insurance coverage in existence 
as of March 23, 2010, known as grandfathered health plans, are not 
required to comply with certain statutory provisions in the Act. The 
final regulations titled ``Final Rules under the Affordable Care Act 
for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and 
Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient 
Protections'' (80 FR 72192, November 18, 2015) require that, to 
maintain its status as a grandfathered health plan, a plan must 
maintain records documenting the terms of the plan in effect on March 
23, 2010, and any other documents that are necessary to verify, explain 
or clarify status as a grandfathered health plan. The plan must make 
such records available for examination upon request by participants, 
beneficiaries, individual policy subscribers, or a state or federal 
agency official. A grandfathered health plan is also required to 
include a statement in any summary of benefits under the plan or health 
insurance coverage, that the plan or coverage believes it is a 
grandfathered health plan within the meaning of section 1251 of the 
Affordable Care Act, and providing contact information for participants 
to direct questions and complaints. In addition, a grandfathered group 
health plan that is changing health insurance issuers is required to 
provide the succeeding health insurance issuer (and the succeeding 
health insurance issuer must require) documentation of plan terms 
(including benefits, cost sharing, employer contributions, and annual 
limits) under the prior health insurance coverage sufficient to make a 
determination whether the standards of paragraph Sec.  147.140(g)(1) of 
the final regulations are exceeded. It is also required that, for an 
insured group health plan (or a multiemployer plan) that is a 
grandfathered plan, the relevant policies, certificates, or contracts 
of insurance, or plan documents must disclose in a prominent and 
effective manner that employers, employee organizations, or plan 
sponsors, as applicable, are required to notify the issuer (or 
multiemployer plan) if the contribution rate changes at any point 
during the plan year. Form Number: CMS-10325 (OMB control number: 0938-
1093); Frequency: Occasionally; Affected Public: Private Sector, State, 
Local or Tribal governments; Number of Respondents: 14,669; Total 
Annual Responses: 2,651,523; Total Annual Hours: 40. For policy 
questions regarding this collection contact Usree Bandyopadhyay at 410-
786-6650.

    Dated: January 6, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-00344 Filed 1-10-22; 8:45 am]
BILLING CODE 4120-01-P