[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
[Notices]
[Pages 26477-26479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09393]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3386-PN2]
Medicare Program; Application From The Compliance Team for
Initial CMS Approval of its Home Infusion Therapy Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Notice with request for comment.
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SUMMARY: This proposed notice acknowledges the receipt of an
application from The Compliance Team (TCT) 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, we publish a notice that identifies the
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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 3, 2020.
ADDRESSES: In commenting, please refer to file code CMS-3386-PN2.
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-3386-PN2, P.O. Box 8016,
Baltimore, MD 21244-8016.
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-3386-PN2, 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.
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 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, under section 1834(u)(5) of the Act.
On March 1, 2019, we published a solicitation notice entitled,
``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 us with the necessary data.
Section 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
Compliance Team's (TCT's) initial request for our approval of its HIT
accreditation program. This notice also solicits public comment on
whether TCT's requirements meet or exceed the Medicare conditions of
participation for HIT services.
III. Evaluation of Deeming Authority Request
TCT 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 March 4, 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 TCT will be conducted in accordance
with, but not necessarily limited to, the following factors:
The equivalency of TCT's standards for HIT as compared
with CMS' HIT conditions for certification.
TCT's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and
the
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ability of the organization to provide continuing surveyor training.
++ The comparability of TCT's to our standards and processes,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ TCT's processes and procedures for monitoring a HIT supplier
found out of compliance with TCT's program requirements.
++ TCT's capacity to report deficiencies to the surveyed supplier
and respond to the suppliers' plan of correction in a timely manner.
++ TCT's capacity to provide us with electronic data and reports
necessary for effective assessment and interpretation of the
organization's survey process.
++ The adequacy of TCT's staff and other resources, and its
financial viability.
++ TCT's capacity to adequately fund required surveys.
++ TCT's policies with respect to whether surveys are announced or
unannounced, to assure that surveys are unannounced.
++ TCT's agreement to provide us with a copy of the most current
accreditation survey together with any other information related to the
survey as we may require (including corrective action plans).
TCT's agreement or policies for voluntary and involuntary
termination of suppliers.
TCT agreement or policies for voluntary and involuntary
termination of the HIT AO program.
TCT'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 21, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-09393 Filed 5-1-20; 8:45 am]
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