[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61593-61595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
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

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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-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:
     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-against-amyloid-treatment-alzheimers-disease-ad, 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;

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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