[Federal Register Volume 88, Number 239 (Thursday, December 14, 2023)]
[Notices]
[Pages 86654-86655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27469]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS 3444-FN]


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), Health and 
Human Services (HHS).

ACTION: Notice.

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SUMMARY: This final notice announces our decision to approve The Joint 
Commission (TJC) for continued recognition as a national accrediting 
organization that accredits suppliers of home infusion therapy (HIT) 
services that wish to participate in the Medicare or Medicaid programs.

DATES: The approval announced in this final notice is effective 
December 15, 2023 through December 15, 2029.

FOR FURTHER INFORMATION CONTACT: Shannon Freeland, (410) 786-4348.

SUPPLEMENTARY INFORMATION:

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. Sections 1861(iii)(A) and (B) 
require that the individual (patient) 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, which 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 
HIT AOs and in reviewing and modifying the list of designated HIT AOs. 
These statutory factors are as follows:
     The ability of the accrediting organization to conduct 
timely reviews of HIT accreditation applications.
     The ability of the accrediting organization to take into 
account the capacities of HIT suppliers located in a rural area (as 
defined in section 1886(d)(2)(D) of the Act).
     Whether the accrediting organization has established 
reasonable fees to be charged to HIT 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.
    The Joint Commission's (TJC's) current term of approval for their 
Home Infusion Therapy accreditation program expires December 15, 2023.

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) require that we publish, after 
receipt of an organization's complete application, a notice identifying 
the national accrediting body making the request,

[[Page 86655]]

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.

III. Provisions of the Proposed Notice

    In the July 18, 2023 Federal Register (88 FR 45907), we published a 
proposed notice announcing The Joint Commission's (TJC's) request for 
continued recognition as a national accrediting organization providing 
home infusion therapy (HIT) services that wish to participate in the 
Medicare or Medicaid programs. In that proposed notice, we detailed our 
evaluation criteria. Under section 1834(u)(5) the Act and in our 
regulations at Sec.  488.1010, we conducted a review of TJC's Medicare 
HIT accreditation application in accordance with the criteria specified 
by our regulations, which included, but are not limited to the 
following:
     An administrative review of TJC's:
    ++ Corporate policies;
    ++ Financial and human resources available to accomplish the 
proposed surveys;
    ++ Procedures for training, monitoring, and evaluation of its HIT 
surveyors;
    ++ Ability to investigate and respond appropriately to complaints 
against accredited HITs; and
    ++ Survey review and decision-making process for accreditation.
     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 supplier 
found out of compliance with TJC's program requirements.
    ++ TJC's capacity to report deficiencies to the surveyed HIT 
facilities and respond to the facility's evidence of standards 
compliance 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.
    ++ TJC's capacity to adequately fund required surveys.
    ++ TJC's policies with respect to whether surveys are announced or 
unannounced, to ensure that surveys are unannounced, and
    ++ 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 or TJC's 
evidence of standards compliance).
     The adequacy of TJC's staff and other resources, and its 
financial viability.
     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. Analysis of and Responses to Public Comments on the Proposed Notice

    In accordance with section 1834(u)(5) of the Act, the July 18, 
2023, proposed notice also solicited public comments regarding whether 
TJC's requirements met or exceeded the Medicare conditions for 
participation for HIT. We received one comment in response to our 
proposed notice. The comment and our response follows:
    Comment: The commenter believes that continued approval of home 
infusion therapy is one that greatly benefits those on Medicare and 
Medicaid. The commenter stated that it also provides many benefits to 
all including less travel, less staff needed, comfort of your home, and 
less exposure to others for the immune compromised.
    Response: We thank this commenter for their comment in support of 
the HIT program.

V. Provisions of the Final Notice

A. Differences Between TJC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared TJC's HIT accreditation requirements and survey process 
with the Medicare CfCs of 42 CFR part 486, and the survey and 
certification process requirements of part 488. Our review and 
evaluation of TJC's HIT application, which were conducted as described 
in section III. of this final notice, yielded the following areas 
where, as of the date of this notice, TJC has completed revising its 
standards and certification processes to meet the conditions at:
     Section 486.520 (b), to address the requirement that the 
plan of care must be established by a physician prescribing the type, 
amount, and duration for HIT.
     Section 486.520 (c), to address the requirement that the 
plan of care must be periodically reviewed by the physician.
     Section 486.525 (a), to address the requirement that the 
HIT suppliers to be available 7 days a week, 24 hours a day.
     Section 486.525 (a)(1), to address the requirement of all 
professional services, including nursing services, to be available to 
the home infusion patient.
     Section 486.525 (a)(2), to address the requirement for 
patient education and training to be available for patients on a 7 day 
a week, 24 hour a day basis in accordance with the plan of care.
     Section 486.525 (a)(3), to address the requirement of 
remote monitoring for the provision of HIT and home infusion drugs.

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that TJC's requirements for HITs 
meet or exceed our requirements. Therefore, we approve TJC as a 
national accreditation organization for HITs that request participation 
in the Medicare program, effective December 15, 2023 through December 
15, 2029.

VI. 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. chapter 35).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Trenesha Fultz-Mimms,
Federal Register Liaison,Centers for Medicare & Medicaid Services.
[FR Doc. 2023-27469 Filed 12-13-23; 8:45 am]
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