Notice2023-19211
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 7, 2023
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 (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.
Full Text
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<title>Federal Register, Volume 88 Issue 172 (Thursday, September 7, 2023)</title>
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[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61593-61595]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19211]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10390 and CMS-10865]
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 November 6, 2023.
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
[[Page 61594]]
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-10390 Hospice Quality Reporting Program
CMS-10865 Monoclonal Antibodies Directed Against Amyloid for the
Treatment of Alzheimer's Disease
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: Hospice Quality
Reporting Program; Use: On July 1, 2014, hospices began using a newly
created data collection instrument, 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 CBE-endorsed 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 HIS-based 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-for-profit 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 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 anti-amyloid 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:
<bullet> Does the antiamyloid mAb meaningfully improve health
outcomes (i.e., slow the decline of cognition and function) for
patients in broad community practice?
<bullet> 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?
<bullet> 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 <a href="https://www.cms.gov/medicare/coverage-evidence-development/monoclonalantibodies-directed-against-amyloid-treatment-alzheimers-disease-ad">https://www.cms.gov/medicare/coverage-evidence-development/monoclonalantibodies-directed-against-amyloid-treatment-alzheimers-disease-ad</a>, 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 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;
[[Page 61595]]
Total Annual Hours: 3,320. (For policy questions regarding this
collection, contact Lori Ashby at 410-786-6322.)
Dated: August 31, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-19211 Filed 9-6-23; 8:45 am]
BILLING CODE 4120-01-P
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