[Federal Register Volume 90, Number 75 (Monday, April 21, 2025)]
[Notices]
[Pages 16685-16687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06760]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10198, CMS-10561, CMS-10572, CMS-10286, CMS-
10377 and CMS-460]
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 (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,
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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 June 20, 2025.
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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
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).
CMS-10198 Creditable Coverage Disclosure to CMS On-Line Form and
Instructions
CMS-10561 Essential Community Provider Data Collection to Support QHP
Certification
CMS-10572 Transparency in Coverage Reporting by Qualified Health Plan
Issuers
CMS-10286 Notice of Research Exception under the Genetic Information
Nondiscrimination Act
CMS-10377 Student Health Insurance Coverage
CMS-460 Medicare Participating Physician or Supplier Agreement
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 Collections
1. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Creditable Coverage Disclosure to CMS On-Line Form and
Instructions; Use: Section 1860D-13 of the Social Security Act, as
established by the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) and implementing regulations at 42 CFR
423.56(e), require that entities that offer prescription drug benefits
under any of the types of coverage described in 42 CFR 423.56(b)
provide a disclosure of creditable coverage to CMS. There are other
disclosure and notification requirements to Part D eligible individuals
in Sec. 423.56(c), (d), and (f); this PRA covers the requirement in
subsection (e). Entities required to make this disclosure state whether
their prescription drug coverage meets the actuarial requirements
defined in Sec. 423.56(a).
Disclosure of whether prescription drug coverage is creditable
provides Medicare with important information relating to whether
prescription drug benefits offered by an entity to Medicare Part D
eligible individuals is expected to pay at least as much as the
standard benefits under Medicare Part D. The form is used as a
reporting tool where entities offering prescription drug coverage
indicate whether the coverage being provided is considered creditable
or non-creditable. Form Number: CMS-10198 (OMB control number 0938-
1013); Frequency: Yearly; Affected Public: Individuals and Households,
Private Sector, State, Local, or Tribal Governments, Federal
Government, Business, and Not-for Profits; Number of Respondents:
141,400; Number of Responses: 141,400; Total Annual Hours: 11,786. (For
questions regarding this collection contact Tammie Wall at 410-786-
3317.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Supporting
Statement for Essential Community Provider Data Collection to Support
QHP Certification; Use: Standards for Essential Community Provider
(ECP) requirements are codified at 45 CFR 156.235. Issuers must
contract with a certain percentage, as determined by Health and Human
Services (HHS), of the available ECPs in the plan's service area. HHS
will continue to collect more complete data from such providers so that
all issuers are held to a more uniform ECP standard. HHS achieves this
outcome by soliciting qualified ECPs throughout the year to complete
and submit the ECP application in order to be added to the HHS ECP list
or update required data fields to remain on the list. In soliciting
updates directly from providers, HHS routinely performs research and
outreach to providers on the ECP List to verify information about ECPs
collected via the ECP application and annual renewal form. These
ongoing efforts will result in a more accurate listing of the universe
of available ECPs from which issuers select to satisfy the ECP
standard. Form Number: CMS-10561 (OMB control number: 0938-1295);
Frequency: Annually; Affected Public: Private Sector--Business or other
for-profits and Not-for-profits institutions; Number of Respondents:
19,020; Number of Responses: 19,020; Total Annual Hours 4,914. (For
questions regarding this collection, contact Samantha Nguyen Kella at
816-426-6339.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Transparency in
Coverage Reporting by Qualified Health Plan Issuers; Use: Sections
1311(e)(3)(A)-(C) of the ACA, as implemented at 45 CFR 155.1040(a)-(c)
and 156.220, establish standards for qualified health plan (QHP)
issuers to submit specific information related to transparency in
coverage. QHP issuers are required to post and make data related to
transparency in coverage available to the public in plain language and
submit this data to the Department of Health and Human Services (HHS),
the Exchange, and the state insurance commissioner. Section 2715A of
the Public Health Service (PHS) Act as
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added by the ACA largely extends the transparency provisions set forth
in section 1311(e)(3) to non-grandfathered group health plans and
health insurance issuers offering group and individual health insurance
coverage. Form Number: CMS-10572 (OMB control number: 0938-1310);
Frequency: Annually; Affected Public: Private Sector, Business, and
Not-for Profits; Number of Respondents: 400; Number of Responses: 400;
Total Annual Hours: 22,000. (For questions regarding this collection,
contact Jack Reeves at 301-492-5152.)
4. 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. Non-Federal 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: On Occasion; 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 Erik Gomez at
667-414-0682.)
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Student Health
Insurance Coverage; Use: Under the Student Health Insurance Coverage
Final Rule published March 21, 2012 (77 FR 16453), student health
insurance coverage is a type of individual health insurance coverage
provided pursuant to a written agreement between an institution of
higher education (as defined in the Higher Education Act of 1965) and a
health insurance issuer, and provided to students who are enrolled in
that institution and their dependents. The Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for
2017 Final Rule provided that, for policy years beginning on or after
July 1, 2016, student health insurance coverage is exempt from the
actuarial value (AV) requirements under section 1302(d) of the
Affordable Care Act, but must provide coverage with an AV of at least
60 percent. This provision also requires issuers of student health
insurance coverage to specify in any plan materials summarizing the
terms of the coverage the AV of the coverage and the metal level (or
the next lowest metal level) the coverage would otherwise satisfy under
Sec. 156.140. This disclosure will provide students with information
that allows them to compare the student health coverage with other
available coverage options. Form Number: CMS-10377 (OMB control number:
0938-1157); Frequency: Yearly; Affected Public: Private Sector; Number
of Respondents: 46; Total Annual Responses: 1,237,980; Total Annual
Hours: 46. (For policy questions regarding this collection contact
Russell Tipps at (667) 290-9640.)
6. Type of Information Collection Request: Extension of a currently
approved collection: Title of Information Collection: Medicare
Participating Physician or Supplier Agreement; Use: Form CMS-460 is the
agreement a physician, supplier, or their authorized official signs to
become a participating provider in Medicare Part B. By signing the
agreement to participate in Medicare, the physician, supplier, or their
authorized official agrees to accept the Medicare-determined payment
for Medicare covered services as payment in full and to charge the
Medicare Part B beneficiary no more than the applicable deductible or
coinsurance for the covered services. For purposes of this explanation,
the term ``supplier'' means certain other persons or entities, other
than physicians, that may bill Medicare for Part B services (e.g.,
suppliers of diagnostic tests, suppliers of radiology services, durable
medical suppliers (DME) suppliers, nurse practitioners, clinical social
workers, physician assistants). Institutions that render Part B
services in their outpatient department are not considered
``suppliers'' for purposes of this agreement. Form Number: CMS-460 (OMB
control number: 0938-0373); Frequency: Annually; Affected Public:
Private Sector, Business or other for-profits; Number of Respondents:
14,029; Number of Responses: 14,029; Total Annual Hours: 3,507. (For
questions regarding this collection contact Mark G. Baldwin at 410-786-
8139.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-06760 Filed 4-18-25; 8:45 am]
BILLING CODE 4120-01-P