Medicare and Medicaid Programs; Application From the Accreditation Commission for Health Care, Inc. (ACHC) for Continued Approval of Its Home Health Agency Accreditation Program, 76116-76117 [2024-21014]

Download as PDF 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 Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Proposed notice. AGENCY: 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:12 Sep 16, 2024 Jkt 262001 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 https://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: https:// 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. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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. E:\FR\FM\17SEN1.SGM 17SEN1 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 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. ddrumheller on DSK120RN23PROD with NOTICES1 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. VerDate Sep<11>2014 17:12 Sep 16, 2024 Jkt 262001 ++ 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 76117 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. 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: SUMMARY: 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, E:\FR\FM\17SEN1.SGM 17SEN1

Agencies

[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76116-76117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21014]


-----------------------------------------------------------------------

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 https://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: https://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 Sec.  488.5. The regulations at Sec.  
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.

[[Page 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 Sec.  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 Sec.  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 
Sec.  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 third-party 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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.