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 

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 

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 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 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 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: 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 

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) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, United States 

Department of Health and Human 

Services. 

ACTION: Request for public comments. 

SUMMARY: 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 


ddrumheller on DSK120RN23PROD with NOTICES1