Notice2024-30502
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
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Published
December 23, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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, 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.
Full Text
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<title>Federal Register, Volume 89 Issue 246 (Monday, December 23, 2024)</title>
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[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Notices]
[Pages 104547-104549]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30502]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-52]
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, 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 February 21, 2025.
[[Page 104548]]
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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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-R-52 End Stage Renal Disease (ESRD) Conditions for Coverage and
Supporting Regulations
CMS-10901 Expanding Access to Women's Health Grant
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 with
change of a previously approved collection; Title of Information
Collection: End Stage Renal Disease (ESRD) Conditions for Coverage and
Supporting Regulations; Use: The Centers for Medicare and Medicaid
Services (CMS) is requesting reinstatement of OMB Control number 0938-
0386 (CMS-R-52) in compliance with the Paperwork Reduction Act (PRA).
This package applies to existing Medicare End-stage Renal Disease
(ESRD) conditions for coverage (CfCs) at 42 CFR 494. Section 299I of
the Social Security Amendments of 1972 (Pub. L. 92-603) originally
extended Medicare coverage to insured individuals, their spouses, and
their dependent children with ESRD who require dialysis or
transplantation. Subsequently, the ESRD Amendments of 1978 (Pub. L. 95-
292) amended title XVIII of the Social Security Act (the Act) by adding
section 1881. Section 1881(b)(1) of the Act authorizes the Secretary to
prescribe health and safety requirements (known as conditions for
coverage) that a facility providing dialysis and transplantation
services to patients must meet to qualify for Medicare reimbursement.
Final regulations were published June 3, 1976. Subsequent to the
publication of the final regulations, the ESRD Amendments of 1978 were
enacted to amend title XVIII of the Act to include section 1881(c).
This section establishes ESRD network areas and Network organizations
to assure the effective and efficient administration of ESRD program
benefits. The requirements from section 1881(b) and (c) are implemented
in regulations at 42 CFR part 405, subpart U, Conditions for Coverage
for dialysis facilities.
On April 7, 1986, the Consolidated Omnibus Budget Reconciliation
Act of 1975 (COBRA) (Pub. L. 99-272) was enacted which requires the
Secretary to maintain renal disease Network organizations as authorized
under section 1881(c) of the Act, and not merge the Network
organizations into other organizations or entities. On April 15, 1986,
we published a notice of proposed rulemaking to implement section 9214
of Public Law 99-272. A final rule (HSQ-115) was published August 26,
1986 which included information collection requirements at Sec.
405.2112(e). This rule revised the requirements in regulations
pertaining to the ESRD networks and organizations and establishes new,
more efficient Network organizations.
Revisions resulting from two additional rules: HSQ-137--ESRD:
Responsibilities of Network Organizations, published January 21, 1988;
and BERC-434--Medicare Program: Standards for the Reuse of Hemodialyzer
Filters and Other Dialysis Supplies, published October 2, 1987, are
also included. HSQ-137-ESRD approved information collection
requirements at Sec. Sec. 405.2112(f) and (j). BERC-434 approved
information collection requirements stemming from the following
historical sections of the CFR including Sec. Sec. 405.2136(b),
405.2138(a), 405.2139(a), and 405.2140(b) and (c).
Major revisions to the CFR established new ESRD CfCs at 42 CFR 494
issued in a final rule, ``Medicare and Medicaid Programs; Conditions
for Coverage for End-Stage Renal Disease Facilities,'' published on
April 15, 2008 (CMS-3818-F). This rule modified, removed, added, and
redesigned CfCs that dialysis facilities must meet to be certified
under the Medicare program. This rule approved information collection
requirements at Sec. Sec. 494.30, 494.40, 494.50, 494.60, 494.70,
494.80, 494.90, 494.100, 494.110, 494.120, 494.150, 494.170, and
494.180.
An additional revision to the ESRD CfCs at 42 CFR 494 was
precipitated by CMS-3818-F at 414.330(a)(2)(iii)(C). The burden to ESRD
home dialysis suppliers associated with this requirement would be the
time and effort necessary to collect all data for each patient
receiving home dialysis care with respect to services and items
furnished. However, the payment method that covered these suppliers was
eliminated in 2011 and there are no longer any such entities. See 42
CFR parts 410, 413 and 414 Medicare Program; End-Stage Renal Disease
Prospective Payment System; Final Rule and Proposed Rule at the
following link Federal Register <a href="https://www.govinfo.gov/content/pkg/FR-2010-08-12/pdf/2010-18466.pdf">https://www.govinfo.gov/content/pkg/FR-2010-08-12/pdf/2010-18466.pdf</a>.
Therefore, there are no actual costs associated with this
requirement; we removed it from this package.
An additional revision to the ESRD CfCs at 42 CFR part 494 was
precipitated by interim final rule, ``Medicare Program; Conditions for
Coverage for End-Stage Renal Disease Facilities-Third Party Payment,''
published on December 14, 2016 (CMS-3337-IFC). This rule established
new requirements for Medicare-certified dialysis facilities that make
payments of premiums for individual market health plans. This interim
final rule
[[Page 104549]]
established additional burden associated with Sec. Sec. 494.70(c) and
494.180(k); these were quantified in the preceding information
collection which expired in 2024 (OMB Control Number 0938-0386). Since
these regulations were not finalized due to litigation, they are no
longer in effect. Therefore, we took out these sections from this
package as they do not impose any burden.
An additional revision to the ESRD CfCs at 42 CFR 494 was
precipitated by final rule, ``Medicare and Medicaid Programs; Emergency
Preparedness Requirements for Medicare and Medicaid Participating
Providers and Suppliers,'' published September 16, 2016 (CMS-3178-F).
This rule established the creation and maintenance of an Emergency
Preparedness Plan at 494.62(a), an Emergency Preparedness Policies and
Procedures document at 494.62(b), an Emergency Preparedness
Communication Plan at 494.62(c), a training program 494.62(d), and
documentation of training exercises 494.62(e). These information
collections are in separate package, OMB Control number 0938-1325.
On July 5, 2024, revisions to the CfC were proposed in ``Medicare
Program; End-Stage Renal Disease Prospective Payment System, Payment
for Renal Dialysis Services Furnished to Individuals with Acute Kidney
Injury, Conditions for Coverage for End-Stage Renal Disease Facilities,
End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal
Disease Treatment Choices Model'', (CMS-1805-P). This rule proposed to
expand coverage of home dialysis services to patients with acute kidney
injury (AKI). Since the ESRD CfCs apply to dialysis facilities, not to
people with ESRD, this rule proposes to revise language in the CfCs to
allow beneficiaries with AKI to utilize home dialysis. Specifically, we
refer to facilities abiding by the ESRD CfCs as `dialysis facilities'
opposed to `ESRD facilities and all patients seeking services from
dialysis facilities as `patients' rather than `ESRD patients.' There is
no ICR burden associated with these changes however we made confirming
changes to the language in this package.
The CfCs are used by Federal (CMS), State surveyors (employed by
State survey agencies), or CMS authorized accrediting organizations as
a basis for determining whether a dialysis facility qualifies for
approval or re-approval under Medicare. Surveyors make an in-person
visit to the dialysis facility to perform the complete survey.
The preceding information collection, which expired on March 31,
2024, estimated the total annual hourly burden as 1,260,491 hours at a
cost of $64,839,657. We revise this to 800,621 hours at a cost of
$49,638,502. The reduction in hours and cost is largely due to removing
the burden estimates that no longer apply. Form Number: CMS-R-52 (OMB
Control Number: 0938-0386); Frequency: Annually; Affected Public:
Private sector--Business or other for-profit; Number of Respondents:
8,048; Total Annual Responses: 215,591; Total Annual Hours: 800,621
(For policy questions regarding this collection contact Claudia Molinar
at 410-786-8445.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of information Collection:
Expanding Access to Women's Health Grant; Use: On March 23, 2010,
President Obama signed into law the Patient Protection and Affordable
Care Act (PPACA), and on March 30, 2010, the Health Care and Education
Reconciliation Act of 2010 was also signed into law (collectively
referred to as the ``ACA''). The ACA includes a number of provisions
that reform the health insurance markets and provide Federal consumer
protections through amendments to title XXVII of the Public Health
Service Act (PHS Act) and corresponding amendments to the Employee
Retirement Income Security Act and the Internal Revenue Code. The ACA
also includes significant grant funding for States to work with the
Federal Government to implement the Federal market reforms and consumer
protections.
Section 1003 of the ACA adds a new section 2794 to the PHS Act
entitled, ``Ensuring That Consumers Get Value for Their Dollars.''
Specifically, section 2794(a) requires the Secretary of the Department
of Health and Human Services (the Secretary) (HHS), in conjunction with
the States, to establish a process for the annual review of health
insurance premiums to protect consumers from unreasonable rate
increases. Section 2794(c) directs the Secretary to carry out a program
to award grants to States. The data collection (quarterly and final
reports) are a source of information on the State's progress with
meeting CMS expectations for the Expanding Access to Women's Health
Grant. The reports describe significant advancements towards the
State's goal of enhancing and expanding access to reproductive and
maternal health coverage and services from the beginning of the grant
period through the completion of the grant period. The data collection
is imperative to CMS being able to assess the State's progress,
barriers, and updates on measurable objectives. Without the data
collection, CMS will be unable to efficiently monitor the State's
progress. It will also inhibit CMS' ability to support and share
opportunities of best practices with other States. Form Number: CMS-
10901 (OMB control number 0938-NEW); Frequency: Quarterly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 15;
Total Annual Responses: 68; Total Annual Hours: 840. (For policy
questions regarding this collection contact Jim Taing at
<a href="/cdn-cgi/l/email-protection#81cbe0ece4f2afd5e0e8efe6c1e2ecf2afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="bcf6ddd1d9cf92e8ddd5d2dbfcdfd1cf92d4d4cf92dbd3ca">[email protected]</span></a>.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-30502 Filed 12-20-24; 8:45 am]
BILLING CODE 4120-01-P
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