[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18243-18245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3389-FN]


Medicare Program; Approval of Application by the Utilization 
Review Accreditation 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 
Utilization Review Accreditation Commission (URAC) 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 (CfCs).

DATES: The approval announced in this final notice is effective March 
27, 2020 through March 27, 2024.

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

[[Page 18244]]

I. Background

    Infusion therapy 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 (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
     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 
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 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.
    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 October 24, 2019 Federal Register (84 FR 57021), we 
published a proposed notice announcing URAC's request for initial 
approval of its Medicare HIT accreditation program. In the October 24, 
2019 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 URAC 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 URAC'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 URAC to conduct timely review of 
accreditation applications.
     The ability of URAC to take into account the capacities of 
suppliers located in a rural area.
     The comparison of URAC's Medicare home infusion therapy 
accreditation program standards to our current Medicare home infusion 
therapy CfCs.
     A documentation review of URAC's survey process to--
    ++ Determine the composition of the survey team, surveyor 
qualifications, and URAC's ability to provide continuing surveyor 
training.
    ++ Compare URAC's processes, including periodic resurvey and the 
ability to investigate and respond appropriately to complaints against 
accredited home infusion therapies.
    ++ Evaluate URAC's procedures for monitoring home infusion 
therapies it has found to be out of compliance with URAC's program 
requirements.
    ++ Assess URAC'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 URAC'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 URAC's staff and other resources.
    ++ Confirm URAC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm URAC's policies with respect to surveys being 
unannounced.
    ++ URAC'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 URAC'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 October 24, 2019 proposed notice also solicited public comments 
regarding whether URAC's requirements met or exceeded the Medicare CfCs 
for home infusion therapy. No comments were received in response to our 
proposed notice.

[[Page 18245]]

IV. Provisions of the Final Notice

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

    We compared URAC'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 URAC'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, URAC has completed revising 
its standards and certification processes in order to meet the 
condition at:
     Sec.  486.520(a), to address the requirement stating all 
patients must be under the care of an applicable provider.
     Sec.  488.1010(a)(5), to provide a detailed crosswalk 
identifying the exact language of the organization's comparable 
accreditation requirements and standards.
     Sec.  488.1010(a)(6)(ix), to revise URAC's procedures for 
``immediate jeopardy'' situations.
     Sec.  488.1010(a)(6)(iv), to revise URAC's survey 
procedures for surveys.
     Sec.  488.1010(a)(6)(v), to revise URAC's procedures and 
timelines for notifying a surveyed or audited home infusion therapy 
supplier of non-compliance with the home infusion therapy accreditation 
program's standards.
     Sec.  488.1010(a)(6)(vi), to revise URAC's procedures and 
timelines for monitoring the home infusion therapy supplier's 
correction of identified non-compliance with the accreditation 
program's standards.
     Sec.  489.13, to reflect our policies regarding when the 
effective period of an accreditation begins and ends

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that URAC's requirements for HITs 
meet or exceed our requirements. Therefore, we approve URAC as a 
national accreditation organization for HITs that request participation 
in the Medicare program, effective March 27, 2020 through March 27, 
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, is 
delegating the authority to electronically sign this document to Evell 
J. Barco Holland, who is the Federal Register Liaison, for purposes of 
publication in the Federal Register.

    Dated: March 26, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-06795 Filed 3-31-20; 8:45 am]
 BILLING CODE 4120-01-P