Agency Information Collection Activities: Proposed Collection; Comment Request, 104547-104549 [2024-30502]
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Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10913]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by January 22, 2025.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
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/PRAListing.
khammond on DSK9W7S144PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:03 Dec 20, 2024
Jkt 265001
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Medicare Part C
Utilization Management Annual Data
Submission and Audit Protocol Data
Request; Use: Section 1857(d) of the
Act, added by the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 and implementing
regulations at 42 CFR 422.503 and
422.504 state that CMS must oversee an
MA organization’s continued
compliance with the requirements for a
MA organization. Additionally, per
§ 422.516(a), MA organizations are
required to compile and report to CMS
information related to the utilization of
services, and other matters as CMS may
require.
The information gathered during this
annual data collection and audit will be
used by the Medicare Parts C and D
Oversight and Enforcement Group
(MOEG) within the Center for Medicare
(CM) to assess Sponsoring
organizations’ compliance with
Medicare UM requirements. CMS will
utilize the data submitted during the
annual data submission to assess the
number of items and services that have
associated internal coverage criteria,
and to develop a landscape of items and
services across the nation to assess
trends related to the development and
utilization of internal coverage criteria.
Additionally, CMS will use the annual
submission to select a number of
Sponsoring organizations to undergo
UM audits each year, and to select
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104547
specific items and services to audit.
Annual UM data submissions, for all
Sponsoring organizations, will be due to
CMS by January 31 of each calendar
year. Form Number: CMS–10913 (OMB
control number: 0938–new); Frequency:
Yearly; Affected Public: Private Sector,
Business or other for-profits, Not-forprofits institutions; Number of
Respondents: 179; Total Annual
Responses: 179; Total Annual Hours:
19,180. (For policy questions regarding
this collection contact Caroline Zeman
at 410–786–1564).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–30619 Filed 12–20–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–52]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
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104548
Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices
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 https://
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: lll, 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/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
khammond on DSK9W7S144PROD with NOTICES
ADDRESSES:
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
VerDate Sep<11>2014
17:03 Dec 20, 2024
Jkt 265001
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
§ 405.2112(e). This rule revised the
requirements in regulations pertaining
to the ESRD networks and organizations
PO 00000
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Fmt 4703
Sfmt 4703
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 §§ 405.2112(f) and (j).
BERC–434 approved information
collection requirements stemming from
the following historical sections of the
CFR including §§ 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 §§ 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 https://
www.govinfo.gov/content/pkg/FR-201008-12/pdf/2010-18466.pdf.
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
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khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices
established additional burden
associated with §§ 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 inperson visit to the dialysis facility to
perform the complete survey.
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17:03 Dec 20, 2024
Jkt 265001
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
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104549
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 James.Taing@cms.hhs.gov.)
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA), Center for Drug
Evaluation and Research (CDER), Office
of Medical Policy (OMP) has modified
their organizational structure. The new
organizational structure was approved
by the Secretary of Health and Human
Services on November 19, 2024.
FOR FURTHER INFORMATION CONTACT:
Jennifer Wade, Acting Director, Division
of Reorganizations and Delegations of
Authority, Office of Budget, Office of
Finance, Budget, and Acquisitions,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 240–731–0192.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
revised to reflect the FDA’s
reorganization of the CDER, OMP.
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]]>Agencies
[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Notices]
[Pages 104547-104549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30502]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
https://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-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 https://www.govinfo.gov/content/pkg/FR-2010-08-12/pdf/2010-18466.pdf.
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
[email protected].)
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]
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