[Federal Register Volume 85, Number 82 (Tuesday, April 28, 2020)]
[Notices]
[Pages 23519-23521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3396-PN]


Medicare Program; Application From National Association of Boards 
of Pharmacy for Initial CMS-Approval of Its Home Infusion Therapy 
Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice with comment period.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from National Association of Boards of Pharmacy for initial 
recognition as a national accrediting organization for suppliers of 
home infusion therapy services that wish to participate in the Medicare 
program. The statute requires that within 60 days of receipt of an 
organization's complete application, the Centers for Medicare & 
Medicaid Services (CMS) publishes 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, no later than 5 p.m. on June 26, 2020.

ADDRESSES: In commenting, please refer to file code CMS-3396-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-3396-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-3396-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.

[[Page 23520]]


FOR FURTHER INFORMATION CONTACT: 
Christina Mister-Ward, (410) 786-2441.
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.

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. 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 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.
    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 Accreditation Organizations

    Section 1834(u)(5) of the Act and the regulations at Sec.  488.1010 
require that our findings concerning review and approval of a national 
AO's requirements consider, among other factors, the applying AO'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 regulations at 42 CFR 488.1020(a) requires 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. In accordance with Sec.  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 
National Association of Boards of Pharmacy's (NABP's) initial request 
for CMS's approval of its HIT accreditation program. This notice also 
solicits public comment on whether NABP's requirements meet or exceed 
the Medicare conditions of participation for HIT services.

III. Evaluation of Deeming Authority Request

    NABP submitted all the necessary materials to enable us to make a 
determination concerning its request for initial approval of its HIT 
accreditation program. This application was determined to be complete 
on February 28, 2020. Under section 1834(u)(5) of the Act and Sec.  
488.1010 (Application and re-application procedures for national HIT 
AOs), 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 conditions for certification.
     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 supplier 
and respond to the suppliers' 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 assure 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 agreement or policies for voluntary and involuntary 
termination of suppliers.

[[Page 23521]]

     NABP agreement or policies for voluntary and involuntary 
termination of the HIT AO program.
     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. Collection of Information Requirements

    This document does not impose information collection and 
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 Public 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.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Seema Verma, having reviewed and approved this document, 
authorizes Evell J. Barco Holland, who is the Federal Register Liaison, 
to electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: April 14, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-08990 Filed 4-27-20; 8:45 am]
 BILLING CODE 4120-01-P