[Federal Register Volume 88, Number 136 (Tuesday, July 18, 2023)]
[Notices]
[Pages 45907-45908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS 3444-PN]


Medicare Program; Application by The Joint Commission (TJC) for 
Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation 
Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with comment.

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SUMMARY: This notice acknowledges the receipt of an application from 
The Joint Commission (TJC) for continued recognition as a national 
accrediting organization providing home infusion therapy (HIT) services 
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) 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, by August 16, 2023.

ADDRESSES: In commenting, refer to file code CMS-3444-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-3444-PN, P.O. Box 8016, 
Baltimore, MD 21244-8010.
    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-3444-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: Shannon Freeland, (410) 786-4348.

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. We will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. We 
continue 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

    Home infusion therapy (HIT) is a treatment option for Medicare 
beneficiaries with a wide range of acute and chronic conditions. 
Section 5012 of the 21st Century Cures Act (Pub. L. 114-255, enacted 
December 13, 2016) added section 1861(iii) to the Social Security Act 
(the Act), establishing a new Medicare benefit for HIT services. 
Section 1861(iii)(1) of the Act defines ``home infusion therapy'' as 
professional services, including nursing services; training and 
education not otherwise covered under the Durable Medical Equipment 
(DME) benefit; remote monitoring; and other monitoring services. Home 
infusion therapy must be furnished by a qualified HIT supplier and 
furnished in the individual's home. The individual must:
     Be under the care of an applicable provider (that is, 
physician, nurse practitioner, or physician assistant); and
     Have a plan of care established and periodically reviewed 
by a physician in coordination with the furnishing of home infusion 
drugs under Part B, that prescribes the type, amount, and duration of 
infusion therapy services that are to be furnished.
    Section 1861(iii)(3)(D)(i)(III) of the Act requires that a 
qualified HIT supplier be accredited by an accrediting organization 
(AO) designated by the Secretary in accordance with section 1834(u)(5) 
of the Act. Section 1834(u)(5)(A) of the Act identifies factors for 
designating AOs and in reviewing and modifying the list of designated 
AOs. These statutory factors are as follows:

[[Page 45908]]

     The ability of the organization to conduct timely reviews 
of accreditation applications.
     The ability of the organization to take into account the 
capacities of suppliers located in a rural area (as defined in section 
1886(d)(2)(D) of the Act).
     Whether the organization has established reasonable fees 
to be charged to suppliers applying for accreditation.
     Such other factors as the Secretary determines 
appropriate.
    Section 1834(u)(5)(B) of the Act requires the Secretary to 
designate AOs to accredit HIT suppliers furnishing HIT not later than 
January 1, 2021. Section 1861(iii)(3)(D)(i)(III) of the Act requires a 
``qualified home infusion therapy supplier'' to be accredited by a CMS-
approved AO, pursuant to section 1834(u)(5) of the Act.
    On March 1, 2019, we published a solicitation notice entitled, 
``Medicare Program; Solicitation of Independent Accrediting 
Organizations To Participate in the Home Infusion Therapy Supplier 
Accreditation Program'' (84 FR 7057). This notice informed national AOs 
that accredit HIT suppliers of an opportunity to submit applications to 
participate in the HIT supplier accreditation program. We stated that 
complete applications would be considered for the January 1, 2021 
designation deadline if received by February 1, 2020. Regulations for 
the approval and oversight of AOs for HIT organizations are located at 
42 CFR part 488, subpart L. The requirements for HIT suppliers are 
located at 42 CFR part 486, subpart I.

II. Approval of Deeming Organization

    Section 1834(u)(5) of the Act and Sec.  488.1010 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 CMS with the 
necessary data.
    Our rules at 42 CFR 488.1020(a) requires that we publish, after 
receipt of an organization's complete application, a notice identifying 
the national accrediting body making the request, describing the nature 
of the request, and providing at least a 30-day public comment period. 
Pursuant to our rules at 42 CFR 488.1010(d), 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 The 
Joint Commission's (TJC's) request for CMS continued recognition of its 
HIT accreditation program. This notice also solicits public comment on 
whether TJC's requirements meet or exceed the Medicare conditions of 
participation for HIT services.

III. Evaluation of Deeming Authority Request

    In the July 16, 2019 Federal Register, we published TJC's initial 
application for recognition as an accreditation organization for HIT 
(84 FR 33944). On December 16, 2019, we published notification of their 
approval as such an organization, effective December 15, 2019 through 
December 15, 2023 (84 FR 68459). Last month, TJC submitted all the 
necessary materials to enable us to make a determination concerning its 
request for continued recognition of its HIT accreditation program. 
This application was determined to be complete on May 19, 2023. Under 
section 1834(u)(5) of the Act and Sec.  488.1010 (Application and re-
application procedures for national home infusion therapy accrediting 
organizations), our review and evaluation of TJC will be conducted in 
accordance with, but not necessarily limited to, the following factors:
     The equivalency of TJC's standards for HIT as compared 
with CMS' HIT conditions for certification.
     TJC'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 TJC's to CMS standards and processes, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
     TJC's processes and procedures for monitoring a HIT found 
out of compliance with TJC's program requirements.
     TJC's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
     TJC's capacity to provide CMS with electronic data and 
reports necessary for effective assessment and interpretation of the 
organization's survey process.
     The adequacy of TJC's staff and other resources, and its 
financial viability.
     TJC's capacity to adequately fund required surveys.
     TJC's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
     TJC's agreement to provide CMS with a copy of the most 
current accreditation survey together with any other information 
related to the survey as CMS may require (including corrective action 
plans).
     TJC's agreement or policies for voluntary and involuntary 
termination of suppliers.
     TJC's agreement or policies for voluntary and involuntary 
termination of the HIT AO program.

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 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

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 preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Evell J. Barco Holland, who is the Federal 
Register Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-15140 Filed 7-17-23; 8:45 am]
BILLING CODE 4120-01-P