[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18245-18247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3384-FN]


Medicare and Medicaid Programs; Application From the Joint 
Commission (TJC) for Continued Approval of Its Home Health Agency 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve The Joint 
Commission (TJC) for continued recognition as a national accrediting 
organization for home health agencies (HHAs) that wish to participate 
in the Medicare or Medicaid programs. A HHA that participates in 
Medicaid must also meet the Medicare conditions of participation 
(CoPs).

DATES: The decision announced in this final notice is effective March 
31, 2020 through March 31, 2026.

FOR FURTHER INFORMATION CONTACT: 
    Sharon Lash (410) 786-9457.
    Caecilia Blondiaux (410) 786-2190.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a home health agency (HHA), provided that certain 
requirements are met. Sections 1861(m) and (o), 1891 and 1895 of the 
Social Security Act (the Act) establish distinct criteria for an entity 
seeking designation as an HHA. Regulations concerning provider 
agreements are at 42 CFR part 489 and those pertaining to activities 
relating to the survey and certification of facilities and other 
entities are at 42 CFR part 488. The regulations at 42 CFR parts 409 
and 484 specify the conditions that an HHA must meet to participate in 
the Medicare program, the scope of covered services and the conditions 
for Medicare payment for home health care.
    Generally, to enter into a provider agreement with the Medicare 
program, an HHA must first be certified by a state survey agency as 
complying with the conditions or requirements set forth in 42 CFR part 
484 of our regulations. Thereafter, the HHA is subject to regular 
surveys by a state survey agency to determine whether it continues to 
meet these requirements. However, there is an alternative to 
certification surveys by state agencies. Accreditation by a nationally 
recognized Medicare accreditation program approved by CMS may 
substitute for both initial and ongoing state review.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met our 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary of 
Health and Human Services as having standards for accreditation that 
meet or exceed Medicare requirements, any provider entity accredited by 
the national accrediting body's approved program would be deemed to 
meet the Medicare conditions. A national accrediting organization 
applying for CMS approval of their accreditation program under 42 CFR 
part 488, subpart A must provide CMS with reasonable assurance that the 
accrediting organization requires the accredited provider entities to 
meet requirements that are at least as stringent as the Medicare 
conditions. Our regulations concerning the approval of accrediting 
organizations are set forth at Sec.  488.5. Section 488.5(e)(2)(i) 
requires accrediting organizations to reapply for continued approval of 
its Medicare accreditation program every 6 years or sooner as 
determined by CMS.
    The Joint Commission's (TJC's) term of approval for their HHA 
accreditation program expires March 31, 2020.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-

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approval of an accreditation program is conducted in a timely manner. 
The Act provides us 210 days after the date of receipt of a complete 
application, with any documentation necessary to make the 
determination, to complete our survey activities and application 
process. Within 60 days after receiving a complete application, we must 
publish a notice in the Federal Register that identifies the national 
accrediting body making the request, describes the request, and 
provides no less than a 30-day public comment period. At the end of the 
210-day period, we must publish a notice in the Federal Register 
approving or denying the application.

III. Provisions of the Proposed Notice

    In the October 24, 2019 Federal Register (84 FR 57026), we 
published a proposed notice announcing TJC's request for continued 
approval of its Medicare HHA accreditation program. In the October 24, 
2019 proposed notice, we detailed our evaluation criteria. Under 
section 1865(a)(2) of the Act and in our regulations at Sec.  488.5, we 
conducted a review of TJC's Medicare HHA accreditation application in 
accordance with the criteria specified by our regulations, which 
include, 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 HHA surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited HHAs; and (5) survey 
review and decision-making process for accreditation.
     The comparison of TJC's Medicare HHA accreditation program 
standards to our current Medicare HHA CoPs.
     A documentation review of TJC's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TJC's ability to provide continuing surveyor 
training.
    ++ Compare TJC's processes to those we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited HHAs.
    ++ Evaluate TJC's procedures for monitoring HHAs it has found to be 
out of compliance with TJC's program requirements. (This pertains only 
to monitoring procedures when TJC identifies non-compliance. If 
noncompliance is identified by a state survey agency through a 
validation survey, the state survey agency monitors corrections as 
specified at Sec.  488.9(c)).
    ++ Assess TJC's ability to report deficiencies to the surveyed HHAs 
and respond to the HHAs plan of correction in a timely manner.
    ++ Establish TJC'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 TJC's staff and other resources.
    ++ Confirm TJC's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TJC's policies with respect to surveys being 
unannounced.
    ++ Confirm 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 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.
    In accordance with section 1865(a)(3)(A) of the Act, the October 
24, 2019 proposed notice also solicited public comments regarding 
whether TJC's requirements met or exceeded the Medicare CoPs for HHA. 
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 HHA accreditation requirements and survey process 
with the Medicare CoPs of parts 409 and 484, and the survey and 
certification process requirements of parts 488 and 489. Our review and 
evaluation of TJC's HHA 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 in order to do all of the 
following:
     Meet the requirements of all of the following regulations:
    ++ Section 484.45 to address that HHAs must electronically report 
all OASIS data collected in accordance with Sec.  484.55.
    ++ Section 484.50 to include language referencing patient 
representatives, to be included within the ``Patient Rights'' condition 
of participation.
    ++ Section 484.50(a)(1)(i) to incorporate language related to the 
right of persons who have limited English proficiency and individuals 
with disabilities to receive understandable, accessible communications.
    ++ Section 484.50(c)(11) to include the patient's rights to voice 
grievances to an outside entity.
    ++ Section 484.50(d)(1) to address safe and appropriate transfer of 
patients.
    ++ Section 484.50(e)(2) to include reporting of injuries of unknown 
source, or misappropriation of patient property.
    ++ Section 484.60 to address ``individualized'' and ``patient-
specific'' plans of care, specifically that the individualized plan of 
care must specify the care and services necessary to meet the patient-
specific needs as identified in the comprehensive assessment, including 
identification of the responsible discipline(s), and the measurable 
outcomes that the HHA anticipates will occur as a result of 
implementing and coordinating the plan of care.
    ++ Section 484.60(b)(4) to address that stamped signatures are not 
acceptable unless used in a case of an author with a physical 
disability that can provide proof to a CMS contractor of his/her 
inability to sign their signature due to their disability 
(Rehabilitation Act of 1973).
    ++ Section 484.80(g)(1) to include professions of physical 
therapist, speech-language pathologist, or occupational therapist 
professions in any of their standards where ``appropriate skilled 
professional'' is found in the regulatory language.
    ++ Section 484.105(h)(2)(i) and 484.105(h)(2)(ii)(B) to include 
that transactions that are separated in time, but are components of an 
overall plan or patient care objective, are viewed in their entirety 
without regard to their timing and to include section 1122 of the Act 
(42 U.S.C. 1320a-1) and implementing regulations.
    ++ Section 484.115(a)(1) to address citable standards to this CoP 
regarding HHA administrators.
     Provide clarifications and training to surveyors related 
to the verification of written documentation of the facility's 
emergency preparedness program as required under Sec.  484.102.
     Provide training to TJC surveyors related to report 
gathering, specifically the requirements for CASPER and OASIS reports.
     Make changes to the amount of detail provided to the 
facility during TJC's daily briefing to ensure tracer methodology does 
not change the integrity of the survey process.
     Remove previous references to the educational and 
consultative nature of TJC's services when TJC is conducting

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surveys, particularly during communications with the facility. 
Accrediting organization survey processes should emphasize facility 
compliance with Medicare's health and safety standards, rather than any 
educational function.

B. Term of Approval

    Based on our review and observations described in section III. of 
this final notice, we approve TJC as a national accreditation 
organization for HHAs that request participation in the Medicare 
program. The decision announced in this final notice is effective March 
31, 2020 through March 31, 2026.

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. 3501 et seq.).
    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. 2020-06792 Filed 3-31-20; 8:45 am]
 BILLING CODE 4120-01-P