[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32434-32435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09044]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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-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: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. We will not post on Regulations.gov 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:
     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

[[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:
     The equivalency of NABP's standards for HIT as compared 
with CMS' HIT requirements for participation in the Medicare program.
     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