Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request, 80724-80725 [2023-25631]
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80724
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices
titled the ‘‘Hospice Item Set’’ (HIS)
V1.00.0. The HIS is used for the
collection of quality measure data
related to the Hospice Quality Reporting
Program (HQRP), and the HIS V1.00.0
specified the collection of data items
that supported seven Consensus Based
Entity (CBE) endorsed Quality Measures
(QMs) for hospice. On April 1, 2017,
hospices began using an updated HIS
V2.00.0, which includes the same items
from the HIS V1.00.0 along with the
addition of several new items for use in
new measures, measure refinement,
patient record matching, and future
public reporting. Data collected from the
HIS are used to calculate the seven CBEendorsed QMs and the CBE-endorsed
Hospice and Palliative Care Composite
Process Measure—Comprehensive
Assessment at Admission QM.
During the FY 2021 rule, the Hospice
Visits when Death is Imminent measure
pair was removed and replaced with the
claims-based Hospice Visits in Last
Days of Life (HVLDL) measure. The
reduction in provider burden and costs
occurred when CMS replaced the HISbased HVWDII quality measure via the
HIS information collection request that
OMB approved on February 16, 2021.
CMS is requesting to extend the
expiration date. The HIS V3.00.0
consists of data elements that are
designed to collect standardized,
patient-level data for the following
domains of care: pain, respiratory status,
medications, patient preferences and
beliefs and values. The HIS V3.00.0 was
developed specifically for use by
hospices and contains data elements
that we can use to collect patient-level
data to calculate eight CBE endorsed
quality measures. Form Number: CMS–
10390 (OMB control number: 0938–
1153); Frequency: On Occasion;
Affected Public: State, Local, or Tribal
Governments, Private Sector (not-forprofit institutions); individuals or
households; Number of Respondents:
5,640; Total Annual Responses:
2,763,850; Total Annual Hours:
1,323,883. (For policy questions
regarding this collection contact
Jermama Keys at (410) 786–7778.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Monoclonal
Antibodies Directed Against Amyloid
for the Treatment of Alzheimer’s
Disease; Use: On April 7, 2022, CMS
finalized the national coverage
determination (NCD) to cover FDA
approved monoclonal antibodies
(mAbs) directed against amyloid for the
treatment of Alzheimer’s disease (AD)
under coverage with evidence
development (CED) in patients who
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have a clinical diagnosis of mild
cognitive impairment (MCI) due to AD
or mild AD dementia, both with
confirmed presence of amyloid beta
pathology consistent with AD. For antiamyloid mAbs that have accelerated
approval, the mAb may be covered in a
randomized controlled trial conducted
under an investigational new drug (IND)
application or any NIH sponsored trial.
For antiamyloid mAbs that have
traditional FDA approval (as opposed to
accelerated approval), the NCD specifies
coverage under CED in CMS approved
prospective comparative studies, where
data may be collected in a registry. In
addition to satisfying the study criteria
specified in the NCD, CMS approved
studies for anti-amyloid mAbs that have
received traditional FDA approval must
address all of the questions below:
• Does the antiamyloid mAb
meaningfully improve health outcomes
(i.e., slow the decline of cognition and
function) for patients in broad
community practice?
• Do benefits, and harms such as
brain hemorrhage and edema, associated
with use of the antiamyloid mAb,
depend on characteristics of patients,
treating clinicians, and settings?
• How do the benefits and harms
change over time?
In order to remove the data collection
requirement under this coverage with
evidence development (CED) NCD or
make any other changes to the existing
policy, we must formally reopen and
reconsider the policy. CMS supported
development of a registry, the
‘‘Monoclonal Antibodies Directed
Against Amyloid for the Treatment of
Alzheimer’s Disease CED Study
Registry’’ (mAb Registry), to facilitate
coverage under the NCD. Additionally,
CMS is working with multiple
organizations preparing to open their
own registries. Once more registries are
available, they will also be listed at
https://www.cms.gov/medicare/
coverage-evidence-development/
monoclonalantibodies-directed-againstamyloid-treatment-alzheimers-diseasead, and clinicians will be able to choose
which registry to participate in.
The data collected and analyzed in
the CMS-supported mAb Registry and
potential CMS-approved registries will
be used by to determine if monoclonal
antibodies directed against amyloid for
the treatment of Alzheimer’s Disease
(AD) is reasonable and necessary (e.g.,
improves health outcomes) for Medicare
beneficiaries under section
1862(a)(1)(A) of the Act. CMS is
collecting information to learn more
about which individuals benefit the
most from this drug. CMS refers to this
as coverage with evidence development
PO 00000
Frm 00038
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or CED. The information being collected
via registry will be analyzed to assist
clinicians and patients make informed
treatment decisions. Furthermore, data
from the mAb Registry will assist the
pharmaceutical industry and the Food
and Drug Administration (FDA) in
surveillance of the quality, safety and
efficacy of these types of drugs. Form
Number: CMS–10865 (OMB control
number: 0938–NEW); Frequency:
Annually; Affected Public: Business or
other for-profits and Not-for-profit
institutions; Number of Respondents:
40,000; Number of Responses: 40,000;
Total Annual Hours: 3,320. (For policy
questions regarding this collection,
contact Lori Ashby at 410–786–6322.)
Dated: November 15, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–25601 Filed 11–17–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10398 #37]
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
On May 28, 2010, the Office
of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA)
guidance related to the ‘‘generic’’
clearance process. Generally, this is an
expedited process by which agencies
may obtain OMB’s approval of
collection of information requests that
are ‘‘usually voluntary, low-burden, and
uncontroversial collections,’’ do not
raise any substantive or policy issues,
and do not require policy or
methodological review. The process
requires the submission of an
overarching plan that defines the scope
of the individual collections that would
fall under its umbrella. On October 23,
2011, OMB approved our initial request
to use the generic clearance process
under control number 0938–1148
(CMS–10398). It was last approved on
April 26, 2021, via the standard PRA
process which included the publication
of 60- and 30-day Federal Register
SUMMARY:
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices
notices. The scope of the April 2021
umbrella accounts for Medicaid and
CHIP State plan amendments, waivers,
demonstrations, and reporting. This
Federal Register notice seeks public
comment on one or more of our
collection of information requests that
we believe are generic and fall within
the scope of the umbrella. Interested
persons are invited to submit 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
December 4, 2023.
ADDRESSES: When commenting, please
reference the applicable form number
(see below) and the OMB control
number (0938–1148). 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: CMS–10398 (#37)/OMB
control number: 0938–1148, 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: Following
is a summary of the use and burden
associated with the subject information
collection(s). More detailed information
can be found in the collection’s
supporting statement and associated
materials (see ADDRESSES).
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Generic Information Collections
1. Title of Information Collection:
Managed Care Rate Setting Guidance;
Type of Information Collection Request:
Revision of an active collection of
information request; Use: In accordance
with 42 CFR 438.7, states must submit
to CMS for review and approval all rate
certifications for managed care
organizations (MCOs), prepaid inpatient
health plans (PIHPs), and prepaid
ambulatory health plans (PAHPs). The
rate certification itself is prepared by a
state’s actuary who certifies the
managed care program’s capitation rates
as actuarially sound for a specific time
period, and documents the rate
development process and final certified
capitation rates.
Our Medicaid Managed Care Rate
Development Guide (otherwise referred
to as the ‘‘rate guide’’) outlines the rate
development standards and CMS’
expectations for documentation
included in rate certifications such as
descriptions of base data used, trend
factors to base data, projected benefit
and non-benefit costs, and any other
considerations or adjustments used
when setting capitation rates. The
information outlined in the rate guide
must be included within the rate
certification in adequate detail to allow
CMS to determine compliance with
applicable provisions of 42 CFR part
438, including that the data,
assumptions, and methodologies used
for rate development are consistent with
generally accepted actuarial principles
and practices and that the capitation
rates are appropriate for the populations
and services to be covered. There is no
required template that states’ actuaries
must utilize for the rate certification, but
the guidance outlined in the rate guide
serves as a resource for states and their
actuaries. Adherence by states and their
actuaries to the rate development
standards and documentation
expectations outlined in the rate guide,
will aid in ensuring compliance with
the regulations and support CMS’s
review and approval of actuarially
sound capitation rates and associated
federal financial participation. Form
Number: CMS–10398 (#37) (OMB
control number: 0938–1148); Frequency:
Annual; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 47; Total Annual
Responses: 137; Total Annual Hours:
753. For policy questions regarding this
collection contact Rebecca Burch-Mack
at 303–844–7355.
PO 00000
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80725
Dated: November 15, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–25631 Filed 11–17–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Financing for Early Care and
Education: Quality and Access for All
(New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, United States
Department of Health and Human
Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families (ACF) at the U.S.
Department of Health and Human
Services seeks approval to collect
information to explore the role of Head
Start in the early care and education
(ECE) financing landscape, as well as
how the use of multiple funding sources
within a single Head Start program may
be associated with the provision of Head
Start’s comprehensive services and with
state-level differences in ECE funding.
Survey data will be collected from Head
Start program directors and state
government administrators.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
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. You can also obtain
copies of the proposed collection of
information by emailing
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: The proposed data
collection seeks to better understand
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80724-80725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25631]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10398 #37]
Medicaid and Children's Health Insurance Program (CHIP) Generic
Information Collection Activities: Proposed Collection; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On May 28, 2010, the Office of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA) guidance related to the
``generic'' clearance process. Generally, this is an expedited process
by which agencies may obtain OMB's approval of collection of
information requests that are ``usually voluntary, low-burden, and
uncontroversial collections,'' do not raise any substantive or policy
issues, and do not require policy or methodological review. The process
requires the submission of an overarching plan that defines the scope
of the individual collections that would fall under its umbrella. On
October 23, 2011, OMB approved our initial request to use the generic
clearance process under control number 0938-1148 (CMS-10398). It was
last approved on April 26, 2021, via the standard PRA process which
included the publication of 60- and 30-day Federal Register
[[Page 80725]]
notices. The scope of the April 2021 umbrella accounts for Medicaid and
CHIP State plan amendments, waivers, demonstrations, and reporting.
This Federal Register notice seeks public comment on one or more of our
collection of information requests that we believe are generic and fall
within the scope of the umbrella. Interested persons are invited to
submit 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 December 4, 2023.
ADDRESSES: When commenting, please reference the applicable form number
(see below) and the OMB control number (0938-1148). 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: CMS-10398 (#37)/OMB
control number: 0938-1148, 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: Following is a summary of the use and burden
associated with the subject information collection(s). More detailed
information can be found in the collection's supporting statement and
associated materials (see ADDRESSES).
Generic Information Collections
1. Title of Information Collection: Managed Care Rate Setting
Guidance; Type of Information Collection Request: Revision of an active
collection of information request; Use: In accordance with 42 CFR
438.7, states must submit to CMS for review and approval all rate
certifications for managed care organizations (MCOs), prepaid inpatient
health plans (PIHPs), and prepaid ambulatory health plans (PAHPs). The
rate certification itself is prepared by a state's actuary who
certifies the managed care program's capitation rates as actuarially
sound for a specific time period, and documents the rate development
process and final certified capitation rates.
Our Medicaid Managed Care Rate Development Guide (otherwise
referred to as the ``rate guide'') outlines the rate development
standards and CMS' expectations for documentation included in rate
certifications such as descriptions of base data used, trend factors to
base data, projected benefit and non-benefit costs, and any other
considerations or adjustments used when setting capitation rates. The
information outlined in the rate guide must be included within the rate
certification in adequate detail to allow CMS to determine compliance
with applicable provisions of 42 CFR part 438, including that the data,
assumptions, and methodologies used for rate development are consistent
with generally accepted actuarial principles and practices and that the
capitation rates are appropriate for the populations and services to be
covered. There is no required template that states' actuaries must
utilize for the rate certification, but the guidance outlined in the
rate guide serves as a resource for states and their actuaries.
Adherence by states and their actuaries to the rate development
standards and documentation expectations outlined in the rate guide,
will aid in ensuring compliance with the regulations and support CMS's
review and approval of actuarially sound capitation rates and
associated federal financial participation. Form Number: CMS-10398
(#37) (OMB control number: 0938-1148); Frequency: Annual; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 47;
Total Annual Responses: 137; Total Annual Hours: 753. For policy
questions regarding this collection contact Rebecca Burch-Mack at 303-
844-7355.
Dated: November 15, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-25631 Filed 11-17-23; 8:45 am]
BILLING CODE 4120-01-P
