Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 97619 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING) 

PICOTS KQ1 KQ2 

Population ............................ Adults 18+ years of age with Down syndrome. 

Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic 

status. 

Adults 18+ years of age with Down syndrome 

Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic 

status. 

Intervention .......................... Screening/diagnostic tests for co-occurring medical 

conditions in adults with Down syndrome. 

Treatment interventions for co-occurring medical conditions in adults with Down syndrome. 

Comparator .......................... Alternative test for screening/diagnosis or no screening. For all conditions, compared with usual care or alternative intervention for treatment. 

Outcome ............................... Benefits: accurate diagnosis, time to diagnosis or intervention/treatment. 

Health and quality of life outcomes. 

Harms: adverse events related to screening/diagnosis 

(mortality, medical trauma, unnecessary testing, etc.). 

Intermediate outcomes: 

Treatment adherence. 

Lab values. 

Healthcare utilization. 

Final outcomes: 

Change in standardized symptom measures. 

Morbidity/mortality. 

Quality of life. 

Functional outcomes (e.g., activities of daily living, assisted living/nursing home status). 

Caregiver or family outcomes (including caregiver 

health and quality of life). 

Harm outcomes: 

Adverse treatment effects. 

Timing .................................. All duration and follow up. All duration and follow up. 

Setting .................................. US and non-US settings. 

All healthcare settings (e.g., primary care, specialty 

care, specialized clinics, etc.) 

US and non-US settings. 

All healthcare settings (e.g., primary care, specialty 

care, specialized clinics, etc.). 

Abbreviations: KQ = key question. 

Dated: December 3, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–28830 Filed 12–6–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–319, CMS–2088– 

17, CMS–224–14 and CMS–R–297/CMS– 

L564] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

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 January 8, 2025. 

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-andGuidance/Legislation/Paperwork

ReductionActof1995/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: Reinstatement without change 

of a previously approved collection; 

Use: Title XIX and title XXI State 

agencies are required to submit the 

MEQC pilot planning document in 

accordance with § 431.814(b), and the 

MEQC case level and CAP reports based 

on pilot findings in accordance with 

§§ 431.816 and 431.820, respectively. 


ddrumheller on DSK120RN23PROD with NOTICES1
97620 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 

The primary users of this information 

are State Medicaid (and where 

applicable CHIP) agencies and CMS. 

State agencies are expected to use the 

information collected for continuous 

quality improvement purposes. They 

will identify patterns of error in their 

eligibility processing operations and 

systems and take corrective actions to 

address issues and improve the 

eligibility determination process. CMS 

will use the data collected to identify 

and help those States that are most in 

need of technical assistance. CMS will 

also use the data set to identify potential 

weaknesses in Federal regulations. It 

will propose regulatory modifications 

designed to ensure that there are more 

effective quality controls in the 

eligibility determination process.; Form 

Number: CMS–319 (OMB control 

number: 0938–0147); Frequency: 

Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 35; Number of 

Responses: 647; Total Annual Hours: 

9,840. (For policy questions regarding 

this collection contact Camiel Rowe at 

410–786–0069.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Community 

Mental Health Center Cost Report Use: 

CMS requires the Form CMS–2088–17 

to determine a provider’s reasonable 

cost incurred in furnishing medical 

services to Medicare beneficiaries and 

reimbursement due to or from a 

provider. In addition, CMHCs may 

receive reimbursement through the cost 

report for Medicare reimbursable bad 

debts. CMS uses the Form CMS–2088– 

17 for rate setting; payment refinement 

activities, including market basket 

analysis; Medicare Trust Fund 

projections; and to support program 

operations. The primary function of the 

cost report is to determine provider 

reimbursement for services rendered to 

Medicare beneficiaries. Each CMHC 

submits the cost report to its contractor 

for reimbursement determination. 

Section 1874A of the Act describes the 

functions of the contractor. CMHCs 

must follow the principles of cost 

reimbursement, which require they 

maintain sufficient financial records 

and statistical data for proper 

determination of costs. The S series of 

worksheets collects the provider’s 

location, CBSA, date of certification, 

operations, and unduplicated census 

days. The A series of worksheets 

collects the provider’s trial balance of 

expenses for overhead costs, direct 

patient care services, and non-revenue 

generating cost centers. The B series of 

worksheets allocates the overhead costs 

to the direct patient care and nonrevenue generating cost centers using 

functional statistical bases. The 

Worksheet C computes the 

apportionment of costs between 

Medicare beneficiaries and other 

patients. The D series of worksheets are 

Medicare specific and calculate the 

reimbursement settlement for services 

rendered to Medicare beneficiaries. The 

Worksheet F collects the provider’s 

revenues and expenses data from the 

provider’s income statement. Form 

Number: CMS–2088–17 (OMB control 

number: 0938–0378); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other for-profits, 

Not-for-profits institutions; Number of 

Respondents: 191; Total Annual 

Responses: 191; Total Annual Hours: 

17,190. (For policy questions regarding 

this collection contact Jill Keplinger at 

410–786–4550.) 

3. Type of Information Collection 

Request: Extension of a previously 

approved collection; Title of 

Information Collection: Federally 

Qualified Health Center Cost Report 

Form; Use: The Form CMS–224–14 cost 

report is needed to determine a 

provider’s reasonable cost incurred in 

furnishing medical services to Medicare 

beneficiaries and to calculate the FQHC 

settlement amount. These providers, 

paid under the FQHC prospective 

payment system (PPS), may receive 

reimbursement outside of the PPS for 

Medicare reimbursable bad debts, 

pneumococcal, influenza, and COVID– 

19 vaccines, and monoclonal antibody 

products. CMS uses the Form CMS– 

224–14 for rate setting; payment 

refinement activities, including 

developing a FQHC market basket; 

Medicare Trust Fund projections; and to 

support program operations. 

Additionally, the Medicare Payment 

Advisory Commission (MedPAC) uses 

the FQHC Medicare cost report data to 

calculate Medicare margins; to 

formulate recommendations to Congress 

regarding the FQHC PPS; and to 

conduct additional analysis of the 

FQHC PPS. Form Number: CMS–224–14 

(OMB control number: 0938–1298); 

Frequency: Yearly; Affected Public: 

Private Sector, State, Local, or Tribal 

Governments, Federal Government, 

Business or other for-profits, Not-forProfit Institutions; Number of 

Respondents: 2,967; Total Annual 

Responses: 2,967; Total Annual Hours: 

172,086. (For policy questions regarding 

this collection contact LuAnn Piccione 

at 410–786–5423.) 

4. Type of Information Collection 

Request: Extension of a currently 

approved information collection; Title 

of Information Collection: Medicare 

Request for Employment Information; 

Use: Section 1837(i) of the Social 

Security Act (the Act) provides for a 

SEP for individuals who delay enrolling 

in Medicare Part B because they are 

covered by a group health plan based on 

their own or a spouse’s current 

employment status. Disabled 

individuals with Medicare may also 

delay enrollment because they have 

large group health plan coverage based 

on their own or a family member’s 

current employment status. When these 

individuals apply for Medicare Part B, 

they must provide proof that the group 

health plan coverage is (or was) based 

on current employment status. Form 

CMS L564 provides this proof so that 

SSA can determine eligibility for the 

SEP. Individuals eligible for the SEP can 

enroll in Part B without incurring a late 

enrollment penalty (LEP). Individuals 

may also use this form to prove that 

their group health plan coverage is 

based on current employment status and 

to have the assessed Medicare LEP 

reduced. Form Number: CMS–R–297/ 

CMS–L564 (OMB control number: 

0938–0787); Frequency: Annually; 

Affected Public: Individuals or 

households, Business or other for-profits 

and Not-for-profit institutions; Number 

of Respondents: 594,998; Total Annual 

Responses: 594,998; Total Annual 

Hours: 243,949. (For policy questions 

regarding this collection contact 

Candace Carter at 410–786–8466 or 

Candace.Carter@cms.hhs.gov). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–28857 Filed 12–6–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget for Review and Approval; 

‘‘State SNAP Agency NDNH Matching 

Program Performance Report’’ (Office 

of Management Budget #: 0970–0464) 

AGENCY: Office of Child Support 

Services, Administration for Children 

and Families, U.S. Department of Health 

and Human Services. 

ACTION: Request for public comments. 

SUMMARY: OCSS is requesting the Office 

of Management and Budget (OMB) to 

approve the ‘‘State SNAP Agency NDNH 

Matching Program Performance Report,’’ 


ddrumheller on DSK120RN23PROD with NOTICES1