Notice2024-06144
Medicare Program; Application by the Utilization Review Accreditation Commission (URAC) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program
Primary source
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Published
March 22, 2024
Effective
March 27, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 57 (Friday, March 22, 2024)</title>
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[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Pages 20479-20481]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Be under the care of an applicable provider (that is,
physician, nurse practitioner, or physician assistant); and
<bullet> 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:
<bullet> The ability of the accrediting organization to conduct
timely reviews of HIT accreditation applications.
[[Page 20480]]
<bullet> 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).
<bullet> Whether the accrediting organization has established
reasonable fees to be charged to HIT suppliers applying for
accreditation.
<bullet> 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:
<bullet> 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.
<bullet> The equivalency of URAC's standards for HIT as compared
with CMS' HIT conditions for participation.
<bullet> 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).
<bullet> The adequacy of URAC's staff and other resources, and its
financial viability.
<bullet> URAC's agreement or policies for voluntary and involuntary
termination of suppliers.
<bullet> 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.
<bullet> Section 486.520(a), to address the requirement of all
patients must be under the care of an applicable provider.
<bullet> 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.
<bullet> Section 486.520(c), to address the requirement that the
plan of care must be periodically reviewed by the physician.
<bullet> 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.
<bullet> Section 486.525(a)(1), to provide professional services,
including nursing services.
<bullet> 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.
<bullet> Section 486.525(a)(3), to address the requirement of
remote monitoring for the provision of HIT and home infusion drugs.
<bullet> Section 486.525(b), to address the requirement of all home
infusion therapy suppliers must provide home
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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]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on March 22, 2024.
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