[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33944-33946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3381-PN]


Medicare Program; Application From The Joint Commission (TJC) for 
Initial CMS-Approval of Its Home Infusion Therapy (HIT) Accreditation 
Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from The Joint Commission (TJC) for initial recognition as 
a national accrediting organization providing home infusion therapy 
(HIT) 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) 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, no later than 5 p.m. on August 15, 2019.

ADDRESSES: In commenting, please refer to file code CMS-3381-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    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-3381-PN, P.O. Box 8016, 
Baltimore, MD 21244-8010.

[[Page 33945]]

    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-3381-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:

Christina Mister-Ward, (410) 786-2441
Shannon Freeland, (410) 786-4348
Lillian Williams, (410) 786-8636

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 added section 1861(iii) to 
the Social Security Act (the Act) establishing a new Medicare benefit 
for home infusion therapy services. Section 1861(iii)(1) of the Act 
defines ``home infusion therapy'' as the items and services described 
furnished by a qualified home infusion therapy supplier which are 
furnished in the individual's home. The individual must--
     Be under the care of an applicable provider; and
     Have a plan of care prescribing the type, amount, and 
duration of infusion therapy services that are to be furnished/
established for him/her and periodically reviewed by a physician, in 
coordination with the furnishing of home infusion drugs under Part B.
     An ``applicable provider'' would mean a physician, a nurse 
practitioner, and a physician assistant.
    Section 1861(iii)(3)(D)(III) of the Act, requires that a qualified 
home infusion therapy supplier be accredited by an 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 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 home infusion therapy suppliers furnishing 
home infusion therapy not later than January 1, 2021. Section 
1861(iii)(3)(D) of the Act defines ``qualified home infusion therapy 
suppliers'' as being accredited by a CMS-approved AO.
    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 
accrediting organizations that accredit home infusion therapy suppliers 
of an opportunity to submit applications to participate in the home 
infusion therapy supplier accreditation program. Complete applications 
will be considered for the January 1, 2021 designation deadline if 
received by February 1, 2020.
    Regulations for the approval and oversight of accrediting 
organizations for home infusion therapy organizations are located at 42 
CFR part 488, subpart L. The requirements for home infusion therapy 
suppliers are located at 42 CFR part 486, subpart I.

II. Approval of Accreditation Organizations

    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 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 of The 
Joint Commission's (TJC's) initial request for CMS approval of its HIT 
accreditation program. This notice also solicits public comment on 
whether TJC's requirements meet or exceed the Medicare conditions of 
participation for HIT services.

III. Evaluation of Deeming Authority Request

    TJC 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 May 19, 2019. Under section 1834(u)(5) of the Act and Sec.  488.1010 
(Application and re-application procedures for national home infusion 
therapy accrediting organizations), our review and evaluation of TJC 
will be conducted in accordance with, but not necessarily limited to, 
the following factors:
     The equivalency of TJC's standards for HIT as compared 
with CMS' HIT conditions for certification.
     TJC'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 TJC's to CMS standards and processes, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ TJC's processes and procedures for monitoring a HIT found out of 
compliance with TJC's program requirements.
    ++ TJC's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    ++ TJC'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 TJC's staff and other resources, and its 
financial viability.

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    ++ TJC's capacity to adequately fund required surveys.
    ++ TJC's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    ++ TJC'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).
     TJC's agreement or policies for voluntary and involuntary 
termination of suppliers.
     TJC 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 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. Chapter 35).

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.

    Dated: July 3, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-15127 Filed 7-15-19; 8:45 am]
BILLING CODE 4120-01-P