[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 33946]]
++ 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