[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Notices]
[Pages 60793-60795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3396-FN]


Medicare Program; Approval of Application by National Association 
of Boards of Pharmacy 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 
National Association of Boards of Pharmacy 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 is effective 
September 26, 2020 through September 26, 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 
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

[[Page 60794]]

``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.
    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 April 28, 2020 Federal Register (85 FR 23519), we published 
a proposed notice announcing National Association of Boards of 
Pharmacy's (NABP'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 NABP'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 NABP'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 NABP to conduct timely review of 
accreditation applications.
     The ability of NABP to take into account the capacities of 
suppliers located in a rural area.
     The comparison of NABP's Medicare home infusion therapy 
accreditation program standards to our current Medicare home infusion 
therapy conditions for coverage (CfCs).
     NABP's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
NABP's ability to provide continuing surveyor training.
    ++ NABP's processes, including periodic resurvey and the ability to 
investigate and respond appropriately to complaints against accredited 
home infusion therapies.
    ++ Evaluate NABP's procedures for monitoring home infusion 
therapies it has found to be out of compliance with NABP's program 
requirements.
    ++ Assess NABP'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 NABP'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 NABP's staff and other resources.
    ++ Confirm NABP's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm NABP's policies with respect to surveys being 
unannounced.
    ++ Review NABP'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 NABP'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 April 28, 2020 proposed notice also solicited public comments 
regarding whether NABP'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 NABP's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared NABP'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 NABP'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, NABP has completed revising 
its standards and certification processes in order to meet the 
condition at:
     Sec.  486.520, to include the term ``qualified'' to meet 
the requirement for home infusion suppliers.
     Sec.  486.525(a), to include the language ``qualified'' to 
meet the requirement for home infusion suppliers.
     Sec.  486.525(b), to revise standard language removing the 
word ``shall'' from the home infusion standards.
     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)(i), to revise survey procedures for 
information gathering and investigation.
     Sec.  488.1010(a)(6)(v), to revise 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 NABP's procedures and 
timelines for monitoring the home infusion therapy supplier's 
correction of identified non-compliance with the accreditation 
program's standards.
     Sec.  488.1010(6)(ix), to revise procedures for immediate 
jeopardy.
     Sec.  489.13, to reflect our policies regarding when the 
effective period of an accreditation begins and ends.

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

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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 
NABP's requirements for HIT meet or exceed our requirements. Therefore, 
we approve NABP as a national accreditation organization for HITs that 
request participation in the Medicare program, effective September 26, 
2020 through September 26, 2024.

V. Collection of Information Requirements

    This document does not impose information collection 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. 2020-21261 Filed 9-25-20; 8:45 am]
BILLING CODE 4120-01-P