[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Pages 33354-33356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09172]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3462-PN]
Medicare Program; Application by The Compliance Team (TCT) for
Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with request for comment.
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[[Page 33355]]
SUMMARY: This notice acknowledges the receipt of an application from
The Compliance Team (TCT) for continued approval by the Centers for
Medicare & Medicaid Services (CMS) of TCT's national accrediting
organization program for suppliers providing home infusion therapy
(HIT) services and 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, CMS will 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 May 29, 2024.
ADDRESSES: In commenting, refer to file code CMS-3462-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-3462-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-3462-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: 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 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
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. HIT
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:
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 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.
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 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 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. 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
Compliance Team's (TCT's) request for CMS' continued recognition of its
HIT accreditation program. This notice also solicits public comment on
whether TCT's requirements meet or exceed the Medicare requirements of
participation for HIT services.
[[Page 33356]]
III. Evaluation of Deeming Authority Request
In the September 23, 2019 Federal Register, we published TCT's
initial application for recognition as an accreditation organization
for HIT (84 FR 49736). On September 28, 2020, we published notification
of their approval as such an organization, effective October 1, 2020
through October 1, 2024 (85 FR 60799). TCT has since 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 March 2, 2024. Under
section 1834(u)(5) of the Act and 42 CFR 488.1010 (Application and re-
application procedures for national home infusion therapy accrediting
organizations), our review and evaluation of TCT will be conducted in
accordance with, but not necessarily limited to, the following factors:
The equivalency of TCT's standards for HIT as compared
with CMS' HIT requirements for participation in the Medicare program.
TCT'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 TCT's to CMS' standards and processes,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ TCT's processes and procedures for monitoring a HIT supplier
found out of compliance with TCT's program requirements.
++ TCT's capacity to report deficiencies to the surveyed facilities
and respond to the facility's plan of correction in a timely manner.
++ TCT'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 TCT's staff and other resources, and its
financial viability.
++ TCT's capacity to adequately fund required surveys.
++ TCT's policies with respect to whether surveys are announced or
unannounced, to ensure that surveys are unannounced.
++ TCT'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).
++ TCT's policies and procedures to avoid conflicts of interest,
including the appearance of conflicts of interest, involving
individuals who conduct surveys, audits or participate in accreditation
decisions.
++ TCT's agreement or policies for voluntary and involuntary
termination of HIT suppliers.
++ TCT'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 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. 2024-09172 Filed 4-26-24; 8:45 am]
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