[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76839-76841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21409]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3464-FN]


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), Health and 
Human Services (HHS).

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
National Association of Boards of Pharmacy (NABP) for continued 
recognition as a national accrediting organization that accredits 
suppliers of home infusion

[[Page 76840]]

therapy (HIT) services that wish to participate in the Medicare or 
Medicaid programs.

DATES: The approval announced in this final notice is effective 
September 26, 2024 through September 26, 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 for 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.
    <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 not 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 current term of approval for the National Association of Boards 
of Pharmacy (NABP) HIT accreditation program expires September 26, 
2024.

II. Approval of Deeming Organization

    Section 1834(u)(5) of the Act and Sec.  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 April 26, 2024 Federal Register (89 FR 32434), we published 
a proposed notice announcing NABP's request for continued recognition 
as a national accrediting organization for suppliers providing 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) the Act and in our regulations at Sec.  488.1010, we 
conducted a review of NABP'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 NABP'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 NABP's standards for HIT as compared 
with CMS' HIT conditions for participation.
    <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 HIT 
facilities and respond to the facility's evidence of standards 
compliance 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;
    ++ 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; and
    ++ 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 or NABP's 
evidence of standards compliance).
    <bullet> The adequacy of NABP's staff and other resources, and its 
financial viability.
    <bullet> NABP's agreement or policies for voluntary and involuntary 
termination of suppliers.
    <bullet> NABP's agreement or policies for voluntary and involuntary 
termination of the HIT AO program.
    <bullet> NABP's policies and procedures to avoid conflicts of 
interest, including the appearance of conflicts of interest, involving 
individuals who conduct surveys or participate in accreditation 
decisions.

IV. Analysis of and Responses to Public Comments on the Proposed Notice

    In accordance with section 1834(u)(5) of the Act, the April 26, 
2024, proposed

[[Page 76841]]

notice also solicited public comments regarding whether NABP'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 NABP's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared NABP'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 NABP'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, NABP 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 that 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 and that it prescribes 
the type, amount, and duration of the home infusion therapy services 
that are to be furnished.
    <bullet> Section 486.520(c), to address the requirement that the 
plan of care for each patient must be periodically reviewed by the 
physician.
    <bullet> Section 486.525(a), to address the requirement that the 
HIT supplier must provide the following services on a 7-day a week, 24 
hour-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 
training and education and not otherwise paid for as durable medical 
equipment.
    ++ Section 486.525(a)(3), to address the requirement of remote 
monitoring services for the provision of HIT services and home infusion 
drugs.
    Section 486.525(b), to address the requirement that all home 
infusion therapy suppliers must provide HIT 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 NABP's requirements for HIT 
meet or exceed our requirements. Therefore, we approve NABP as a 
national accreditation organization for HITs that request participation 
in the Medicare program, effective September 26, 2024 through September 
26, 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. 2024-21409 Filed 9-18-24; 8:45 am]
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