76116 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 

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.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–21055 Filed 9–16–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3465–PN] 

Medicare and Medicaid Programs; 

Application From the Accreditation 

Commission for Health Care, Inc. 

(ACHC) for Continued Approval of Its 

Home Health Agency Accreditation 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Health and 

Human Services (HHS). 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the Accreditation 

Commission for Health Care, Inc. 

(ACHC) for continued recognition as a 

national accrediting organization for 

home health agencies (HHAs) that wish 

to participate in the Medicare or 

Medicaid programs. The statute requires 

that within 60 days of receipt of an 

organization’s complete application, the 

Centers for Medicare & Medicaid 

Services (CMS) must publish a notice 

that identifies the national accrediting 

body making the request, describes the 

nature of the request, and provides at 

least a 30-day public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on October 17, 2024. 

ADDRESSES: In commenting, refer to file 

code CMS–3465–PN. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3465– 

PN, P.O. Box 8013, Baltimore, MD 

21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3465– 

PN, Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Erin Imhoff (410) 786–2337. 

Lillian Williams (410) 786–8636. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. CMS will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

commenter will take actions to harm an 

individual. CMS continues to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a home health agency 

(HHA), provided certain requirements 

are met. Sections 1861(m) and (o), 1891 

and 1895 of the Social Security Act (the 

Act) establish distinct criteria for an 

entity seeking designation as an HHA. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

and other entities are at 42 CFR part 

488. The regulations at 42 CFR parts 409 

and 484 specify the conditions that an 

HHA must meet to participate in the 

Medicare program, the scope of covered 

services, and the conditions for 

Medicare payment for home health care. 

Generally, to enter into a provider 

agreement with the Medicare program, 

an HHA must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

42 CFR part 484 of our regulations. 

Thereafter, the HHA is subject to regular 

surveys by a state survey agency to 

determine whether it continues to meet 

these requirements. 

However, there is an alternative to 

surveys by state agencies. Section 

1865(a)(1) of the Act provides that, if a 

provider entity demonstrates through 

accreditation by an approved national 

accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by the Secretary of Health 

and Human Services as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

CMS approval of their accreditation 

program under 42 CFR part 488, subpart 

A, must provide CMS with reasonable 

assurance that the accrediting 

organization requires the accredited 

provider entities to meet requirements 

that are at least as stringent as the 

Medicare conditions. Our regulations 

concerning the approval of accrediting 

organizations are set forth at § 488.5. 

The regulations at § 488.5(e)(2)(i) 

require accrediting organizations to 

reapply for continued approval of their 

accreditation program every 6 years or 

sooner as determined by CMS. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 76117 

Accreditation Commission for Health 

Care, Incorporated’s (ACHC’s) term of 

approval for their HHA accreditation 

program expires February 24, 2025. 

II. Approval of Deeming Organizations 

Section 1865(a)(2) of the Act and our 

regulations at § 488.5 require that our 

findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’s requirements 

for accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide us with the necessary 

data for validation. 

Section 1865(a)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, a description 

of the nature of the request, and 

provision of at least a 30-day public 

comment period. We have 210 days 

from the receipt of a complete 

application to publish notice of 

approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of ACHC’s 

request for continued CMS approval of 

its HHA accreditation program. This 

notice also solicits public comment on 

whether ACHC’s requirements meet or 

exceed the Medicare conditions of 

participation (CoPs) for HHAs. 

III. Evaluation of Deeming Authority 

Request 

ACHC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its HHA 

accreditation program. This application 

was determined to be complete on July 

29, 2024. Under section 1865(a)(2) of the 

Act and our regulations at § 488.5 

(Application and re-application 

procedures for national accrediting 

organizations), our review and 

evaluation of ACHC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of ACHC’s 

standards for HHAs as compared with 

CMS’ HHA CoPs. 

• ACHC’s survey process to 

determine the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of ACHC’s 

processes to those of state agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited HHAs. 

++ ACHC’s processes and procedures 

for monitoring HHAs found out of 

compliance with ACHC’s program 

requirements. These monitoring 

procedures are used only when ACHC 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the state survey agency 

monitors corrections as specified at 

§ 488.9(c). 

++ ACHC’s capacity to report 

deficiencies to the surveyed HHAs and 

respond to the HHA’s plan of correction 

in a timely manner. 

++ ACHC’s capacity to provide us 

with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of ACHC’s staff and 

other resources, and its financial 

viability. 

++ ACHC’s capacity to adequately 

fund required surveys. 

++ ACHC’s policies with respect to 

whether surveys are announced or 

unannounced, to ensure that surveys are 

unannounced. 

++ ACHC’s policies and procedures 

to avoid conflicts of interest, including 

the appearance of conflicts of interest, 

involving individuals who conduct 

surveys or participate in accreditation 

decisions. 

++ ACHC’s agreement to provide us 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require (including corrective 

action plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is reporting, recordkeeping or thirdparty disclosure requirements. 

Consequently, there is no need for 

review by the Office Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35). 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this notice. Upon completion of our 

evaluation, including evaluation of 

comments received because of this 

notice, we will publish a final notice in 

the Federal Register summarizing our 

response to comments and announcing 

the result of our evaluation. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2024–21014 Filed 9–16–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1492] 

Chemistry, Manufacturing, and 

Controls Technical Section Filing 

Strategies; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry (GFI) #227 

entitled ‘‘Chemistry, Manufacturing, 

and Controls (CMC) Technical Section 

Filing Strategies.’’ This draft guidance 

provides recommendations to sponsors 

submitting CMC data submissions to 

new animal drug applications. This 

guidance describes the options for 

soliciting early input from the Center for 

Veterinary Medicine (CVM) and the 

process for submission of components 

of the CMC technical section. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 18, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 


ddrumheller on DSK120RN23PROD with NOTICES1