[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68459-68460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3381-FN]


Medicare Program; Application From the Joint Commission 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 Joint 
Commission (TJC) for initial recognition as a national accrediting 
organization for home infusion therapy (HIT) suppliers that wish to 
participate in the Medicare program. An HIT supplier that participates 
must meet the Medicare conditions for coverage (CfCs).

DATES: The approval announced in this final notice is effective 
December 15, 2019 through December 15, 2023.

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

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 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. HIT 
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)(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 
HIT 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 part 488, subpart L. The requirements for 
HIT suppliers are located at part 486, subpart I.

II. Approval of Accreditation Organizations

    Section 1834(u)(5) of the Act and the regulations at 42 CFR 
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.
    Our regulations at Sec.  488.1020(a) require 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.

III. Provisions of the Proposed Notice

    In the July 16, 2019 Federal Register (84 FR 33944), we published a 
proposed notice announcing TJC's request for initial approval of its 
Medicare HIT accreditation program. In the July 16, 2019 proposed 
notice, we detailed our evaluation criteria. Under section of 
1834(u)(5) the Act and in our regulations at Sec.  488.1010, we 
conducted a review of TJC Medicare home infusion accreditation 
application in accordance with the criteria specified by our 
regulations, which included, but are not limited to the following:
     An onsite administrative review of TJC's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its HIT surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited HITs; and (5) survey 
review and decision-making process for accreditation.
     The ability for TJC to conduct timely review of 
accreditation applications.

[[Page 68460]]

     The ability of TJC to take into account the capacities of 
suppliers located in a rural area.
     The comparison of TJC's Medicare HIT accreditation program 
standards to our current Medicare HIT CfCs.
     A documentation review of TJC's survey process to--
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TJC's ability to provide continuing surveyor 
training.
    ++ Compare TJC's processes, including periodic resurvey and the 
ability to investigate and respond appropriately to complaints against 
accredited HITs.
    ++ Evaluate TJC's procedures for monitoring HITs it has found to be 
out of compliance with TJC's program requirements.
    ++ Assess TJC's ability to report deficiencies to the surveyed HIT 
and respond to the HIT's plan of correction in a timely manner.
    ++ Establish TJC's ability to provide us with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of TJC's staff and other resources.
    ++ Confirm TJC's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TJC's policies for surveys being unannounced.
    ++ TJC'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 TJC'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.
    In accordance with section 1834(u)(5) of the Act, the July 16, 2019 
proposed notice also solicited public comments regarding whether TJC's 
requirements met or exceeded the Medicare CfCs for HIT. No comments 
were received in response to our proposed notice.

IV. Provisions of the Final Notice

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

    We compared TJC's HIT accreditation requirements and survey process 
with the Medicare CfCs of 42 CFR part 486, and the survey and 
certification process requirements of part 488. Our review and 
evaluation of TJC's HIT application, which were conducted as described 
in section III. of this final notice, yielded the following areas 
where, as of the date of this notice, TJC has completed revising its 
standards and certification processes to meet the conditions at:
     Sec.  486.520 (b), to address the requirement that the 
plan of care must be established by a physician prescribing the type, 
amount and duration for HIT.
     Sec.  486.520 (c), to address the requirement that the 
plan of care must be periodically reviewed by the physician.
     Sec.  486.525 (a), to address the requirement that the HIT 
suppliers to be available 7 days a week, 24 hours a day.
     Sec.  486.525 (a)(1), to address the requirement of all 
professional services, including nursing services, to be available to 
the home infusion patient.
     Sec.  486.525 (a)(2), to address the requirement for 
patient education and training to be available for patients on a 7 day 
a week, 24 hour a day basis.
     Sec.  486.525 (a)(3), to address the requirement of remote 
monitoring for the provision of HIT.
     Sec.  488.1010 (a)(6)(ii), to ensure surveyors are 
educated on TJC survey policies and survey process for patient and 
record selection.

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that TJC's requirements for HITs 
meet or exceed our requirements. Therefore, we approve TJC as a 
national accreditation organization for HITs that request participation 
in the Medicare program, effective December 15, 2019 through December 
15, 2023.

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).

    Dated: December 2, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-26954 Filed 12-13-19; 8:45 am]
BILLING CODE 4120-01-P