[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80723-80724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10390 and CMS-10865]


Agency Information Collection Activities: Submission for OMB 
Review; 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 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.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by December 20, 2023.

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/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: 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: 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,

[[Page 80724]]

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; 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