[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Pages 20479-20481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS 3452-FN]


Medicare Program; Application by the Utilization Review 
Accreditation Commission (URAC) 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: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
Utilization Review Accreditation Commission (URAC) 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 March 
27, 2024 through March 27, 2030.

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) of 
the Act 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.

[[Page 20480]]

     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 no 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 Utilization Review Accreditation Commission's (URAC's) current 
term of approval for their Home Infusion Therapy accreditation program 
expires March 27, 2024.

II. Approval of Deeming Organization

    Section 1834(u)(5) of the Act and regulations at 42 CFR 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, 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 November 9, 2023 Federal Register (88 FR 77321), we 
published a proposed notice announcing the URAC's request for continued 
recognition as a national accrediting organization for suppliers 
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) of the Act 
and in our regulations at 42 CFR 488.1010, we conducted a review of 
URAC's Medicare HIT accreditation application in accordance with the 
criteria specified by our regulations, which include, but are not 
limited to, the following:
     An administrative review of URAC'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 URAC's standards for HIT as compared 
with CMS' HIT conditions for participation.
     URAC'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 URAC's to CMS' standards and processes, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities;
    ++ URAC's processes and procedures for monitoring a HIT supplier 
found out of compliance with URAC's program requirements;
    ++ URAC's capacity to report deficiencies to the surveyed HIT 
facilities and respond to the facility's evidence of standards 
compliance in a timely manner;
    ++ URAC's capacity to provide CMS with electronic data and reports 
necessary for effective assessment and interpretation of the 
organization's survey process;
    ++ URAC's capacity to adequately fund required surveys;
    ++ URAC's policies with respect to whether surveys are announced or 
unannounced, to ensure that surveys are unannounced; and
    ++ URAC'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 URAC's 
evidence of standards compliance).
     The adequacy of URAC's staff and other resources, and its 
financial viability.
     URAC's agreement or policies for voluntary and involuntary 
termination of suppliers.
     URAC'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 November 9, 
2023, proposed notice also solicited public comments regarding whether 
URAC's requirements met or exceeded the Medicare conditions for 
participation for HIT. No comments were received in response to our 
proposed notice.

V. Provisions of the Final Notice

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

    We compared URAC's HIT accreditation requirements and survey 
process with the Medicare Conditions for Coverage of 42 CFR part 486, 
and the survey and certification process requirements of part 488. Our 
review and evaluation of URAC'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, URAC has 
completed revising its standards and certification processes to meet 
the conditions at Sec. Sec.  486.500 to 486.525.
     Section 486.520(a), to address the requirement of all 
patients must be under the care of an applicable provider.
     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 basis in 
accordance with the plan of care.
     Section 486.525(a)(1), to provide professional services, 
including nursing services.
     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.
     Section 486.525(b), to address the requirement of all home 
infusion therapy suppliers must provide home

[[Page 20481]]

infusion therapy services in accordance with nationally recognized 
standards of practice, and in accordance with all applicable State and 
Federal laws and regulations.

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that URAC's requirements for HITs 
meet or exceed our requirements. Therefore, we approve URAC as a 
national accreditation organization for HITs that request participation 
in the Medicare program, effective March 27, 2024 through March 27, 
2030.

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. 2024-06144 Filed 3-21-24; 8:45 am]
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