[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Notices]
[Pages 60799-60800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3386-FN]


Medicare Program; Approval of Application by The Compliance Team 
for Initial CMS-Approval of Its Home Infusion Therapy Accreditation 
Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve The 
Compliance Team for initial recognition as a national accrediting 
organization for home infusion therapy suppliers that wish to 
participate in the Medicare program. A home infusion therapy supplier 
that participates must meet the Medicare conditions for coverage.

DATES: The approval announced in this final notice takes effect October 
1, 2020 through October 1, 2024.

FOR FURTHER INFORMATION CONTACT: 
Christina Mister-Ward, (410) 786-2441.
Shannon Freeland, (410) 786-4348.
Lillian Williams, (410) 786-8636.

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 on 
December 13, 2016) added sections 1861(iii) and 1834(u) to the Social 
Security Act (the Act), establishing a new Medicare benefit for HIT 
services. Section 1861(iii)(1) of the Act defines HIT 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) of the Act defines ``qualified 
home infusion therapy suppliers'' as being accredited by a CMS-approved 
AO.
    In the March 1, 2019 Federal Register, 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. 
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 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

[[Page 60800]]

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.
    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 approve or deny the application.

III. Provisions of the Proposed Notice

    In the May 4, 2020 Federal Register (85 FR 26477), we published a 
proposed notice announcing The Compliance Team's (TCT's) request for 
initial approval of its Medicare HIT accreditation program. 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 TCT's Medicare HIT accreditation application in 
accordance with the criteria specified by our regulations, which 
included, but are not limited to the following:
     An administrative review of TCT's: (1) Corporate policies; 
(2) financial and human resources available to accomplish the proposed 
surveys; (3) procedures for training, monitoring, and evaluation of its 
home infusion therapy surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited home infusion therapies; 
and (5) survey review and decision-making process for accreditation.
     The ability for TCT to conduct timely review of 
accreditation applications.
     The ability of TCT to take into account the capacities of 
suppliers located in a rural area.
     The comparison of TCT's Medicare HIT accreditation program 
standards to our current Medicare home infusion therapy conditions for 
coverage (CfCs).
     A documentation review of TCT's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TCT's ability to provide continuing surveyor 
training.
    ++ Compare TCT's processes, including periodic resurvey and the 
ability to investigate and respond appropriately to complaints against 
accredited home infusion therapies.
    ++ Evaluate TCT's procedures for monitoring home infusion therapies 
it has found to be out of compliance with TCT's program requirements.
    ++ Assess TCT's ability to report deficiencies to the surveyed home 
infusion therapy and respond to the home infusion therapy's plan of 
correction in a timely manner.
    ++ Establish TCT's ability to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of TCT's staff and other resources.
    ++ Confirm TCT's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TCT's policies with respect to surveys being 
unannounced.
    ++ Review 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.
    ++ Obtain TCT's agreement to provide CMS 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.
    The May 4, 2020 proposed notice also solicited public comments 
regarding whether TCT's requirements met or exceeded the Medicare CfCs 
for home infusion therapy. No comments were received in response to our 
proposed notice.

IV. Provisions of the Final Notice

A. Differences Between TCT's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared TCT's HIT accreditation requirements and survey process 
with the Medicare CfCs of part 486, subpart I and the survey and 
certification process requirements of part 488, subpart L. Our review 
and evaluation of TCT's HIT application, which was conducted as 
described in section III. of this final notice, yielded the following 
areas where, as of the date of this notice, TCT has completed revising 
its standards and certification processes in order to meet the 
condition at:
     Sec.  486.520(b), to address the requirement of the plan 
of care must be established by a physician prescribing the type, amount 
and duration for home infusion therapy.
     Sec.  486.525(a), to include the language ``must'' and 
``qualified'' to meet the requirements for home infusion suppliers.
     Sec.  486.525(a)(1) through (3) and (b), to restructure 
and revise submitted standard language to meet the requirements for 
professional services, patient training and education, remote 
monitoring, and standards of practice.
     Sec.  488.1010(a)(6), to revise TCT's procedures for 
surveys.

B. Term of Approval

    As authorized under Sec.  488.1040(a), we reserve the right to 
conduct onsite observations of accrediting organization operations at 
any time as part of the ongoing review and continuing oversight of an 
accrediting organization's performance. Based on the review and 
observations described in section III. of this final notice, we have 
determined that TCT's requirements for HIT meet or exceed our 
requirements. Therefore, we approve TCT as a national accreditation 
organization for HITs that request participation in the Medicare 
program, effective October 1, 2020 through October 1, 2024.

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).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Seema Verma, having reviewed and approved this document, 
authorizes Lynette Wilson, who is the Federal Register Liaison, to 
electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: September 22, 2020.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid.
[FR Doc. 2020-21260 Filed 9-25-20; 8:45 am]
BILLING CODE 4120-01-P