Notice2024-09044
Medicare Program; Application by the National Association of Boards of Pharmacy (NABP) for Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation Program
Primary source
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Published
April 26, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice acknowledges the receipt of an application from the National Association of Boards of Pharmacy (NABP) for continued approval by the Centers for Medicare & Medicaid Services (CMS) of NABP'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.
Full Text
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<title>Federal Register, Volume 89 Issue 82 (Friday, April 26, 2024)</title>
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[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32434-32435]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3464-PN]
Medicare Program; Application by the National Association of
Boards of Pharmacy (NABP) 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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SUMMARY: This notice acknowledges the receipt of an application from
the National Association of Boards of Pharmacy (NABP) for continued
approval by the Centers for Medicare & Medicaid Services (CMS) of
NABP'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 28, 2024.
ADDRESSES: In commenting, refer to file code CMS-3464-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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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-3464-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-3464-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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. We will not post on <a href="http://Regulations.gov">Regulations.gov</a> 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. HIT
must be furnished by a qualified HIT supplier and furnished in the
individual's home. The individual 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, 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:
<bullet> The ability of the organization to conduct timely reviews
of accreditation applications.
<bullet> 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).
<bullet> Whether the organization has established reasonable fees
to be charged to 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.
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
[[Page 32435]]
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
National Association of Boards of Pharmacy's (NABP's) request for CMS'
continued recognition of its HIT accreditation program. This notice
also solicits public comment on whether NABP's requirements meet or
exceed the Medicare requirements of participation for HIT services.
III. Evaluation of Deeming Authority Request
In the April 28, 2020 Federal Register, we published NABP's initial
application for recognition as an accreditation organization for HIT
(85 FR 23519). On September 28, 2020, we published notification of
their approval as such an organization, effective September 26, 2020
through September 26, 2024 (85 FR 60793). NABP 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 February 28, 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 NABP will be
conducted in accordance with, but not necessarily limited to, the
following factors:
<bullet> The equivalency of NABP's standards for HIT as compared
with CMS' HIT requirements for participation in the Medicare program.
<bullet> NABP'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 NABP's to CMS' standards and processes,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ NABP's processes and procedures for monitoring a HIT supplier
found out of compliance with NABP's program requirements.
++ NABP's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ NABP'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 NABP's staff and other resources, and its
financial viability.
++ NABP's capacity to adequately fund required surveys.
++ NABP's policies with respect to whether surveys are announced or
unannounced, to ensure that surveys are unannounced.
++ NABP'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).
++ NABP'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.
++ NABP's agreement or policies for voluntary and involuntary
termination of HIT suppliers.
++ NABP'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. 2024-09044 Filed 4-25-24; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on April 26, 2024.
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