[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]
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