[Federal Register Volume 86, Number 58 (Monday, March 29, 2021)]
[Notices]
[Pages 16373-16375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3404-FN]


Medicare and Medicaid Programs; Application From the Joint 
Commission for Continued Approval of Its Hospice Accreditation Program

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

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve The Joint 
Commission for continued recognition as a national accrediting 
organization for hospices that wish to participate in the Medicare or 
Medicaid programs.

DATES: The decision announced in this notice is effective on June 18, 
2021 through June 18, 2025.

FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux, (410) 786-2190.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a hospice provided certain requirements are met. 
Section 1861(dd) of the Social Security Act (the Act) establish 
distinct criteria for facilities seeking designation as a hospice. 
Regulations concerning provider agreements are at 42 CFR part 489 and 
those pertaining to activities relating to the survey and certification 
of facilities are at 42 CFR part 488. The regulations at 42 CFR part 
418 specify the minimum conditions that a hospice must meet to 
participate in the Medicare program.
    Generally, to enter into an agreement, a hospice must first be 
certified by a state survey agency (SA) as complying with the 
conditions or requirements set forth in part 418 of our regulations. 
Thereafter, the hospice is subject to regular surveys by a SA to 
determine whether it continues to meet these requirements. There is an 
alternative; however, to surveys by SAs.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by Centers for Medicare & Medicaid 
Services (CMS)-approved national accrediting organization (AO) that all 
applicable Medicare requirements are met or exceeded, we will deem 
those provider entities as having met such requirements. Accreditation 
by an AO is voluntary and is not required for Medicare participation.
    If an AO is recognized by the Secretary of the Department 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 AO applying for approval of its 
accreditation program under part 488, must provide CMS with reasonable 
assurance that the AO requires the accredited provider entities to meet 
requirements that are at least as stringent as the Medicare conditions. 
Our regulations concerning the approval of AOs are set forth at 
Sec. Sec.  488.4 and 488.5. The regulations at Sec.  488.5(e)(2)(i) 
require AOs to reapply for continued approval of its accreditation 
program every 6 years or sooner, as determined by CMS.
    The Joint Commission's (TJC's) current term of approval for their 
hospice accreditation program expires June 18, 2021.

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-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, along 
with any documentation necessary to make our determination, to complete 
our survey and review activities. 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 
notice in the Federal Register of our decision to approve or deny the 
application.

III. Provisions of the Proposed Notice

    On November 9, 2020, we published a proposed notice in the Federal 
Register (85 FR 71343), announcing TJC's request for continued approval 
of its Medicare hospice accreditation program. In the November 9, 2020 
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 hospice 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 hospice surveyors; (4) ability to investigate and 
respond appropriately to complaints against accredited hospices; and 
(5) survey review and decision-making process for accreditation.
     The comparison of TJC's Medicare hospice accreditation 
program standards to our current Medicare hospice conditions of 
participation (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 SAs, including 
periodic resurvey and the ability to investigate and respond 
appropriately to complaints against TJC-accredited hospices.
    ++ Evaluate TJC's procedures for monitoring and follow up with its 
accredited hospices, which it has found to have deficiencies and are 
out of compliance with TJC's program requirements. (This pertains only 
to monitoring procedures when TJC

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identifies non-compliance. If noncompliance is identified by a SA 
through a validation survey, the SA monitors corrections as specified 
at Sec.  488.9(c)).
    ++ Assess TJC's ability to report deficiencies to the surveyed 
hospice and respond to the hospice's 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.

IV. Analysis of and Responses to Public Comments on the Proposed Notice

    In accordance with section 1865(a)(3)(A) of the Act, the November 
9, 2020 proposed notice also solicited public comments regarding 
whether TJC's requirements met or exceeded the Medicare CoPs for 
hospices. No comments were received in response to our proposed notice.

V. 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 hospice accreditation requirements and survey 
process with the Medicare CoPs in part 418, and the survey and 
certification process requirements in parts 488 and 489. Our review and 
evaluation of TJC's hospice 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--
     Meet the standard requirements in all the following 
regulations:
    ++ Section 418.52(b)(2), to include language in TJC's comparable 
standard to specify that if a patient has been adjudged incompetent 
under state law by a court of proper jurisdiction, as part of the 
conditions of participation (CoP) relating to patient's rights, the 
rights of the patient are exercised by the person appointed to act on 
their behalf.
    ++ Section 418.52(b)(3), to revise existing language related to the 
patient's rights CoP; TJC's documentation also refers to a surrogate-
decision maker, which may have different implications than the term 
``legal representative'' used in regulations.
    ++ Section 418.52(b)(4)(i) and (ii), to require that the hospice 
must immediately investigate all alleged violations involving anyone 
furnishing services on behalf of the hospice, and to include language 
related to mistreatment (verbal or mental) and misappropriation of 
patient property and the need to immediately take action to prevent 
further potential violations while the alleged violation is being 
verified.
    ++ Section 418.54, to include language related to all aspects of 
the required patient-specific comprehensive assessment, including 
emotional/psychosocial assessment in addition to the pain/symptom 
assessment; functional status; and general physical assessment, to be 
included in writing in the initial and comprehensive assessment, to 
more closely align with the regulatory language.
    ++ Section 418.56(e), to incorporate language requiring that 
hospices must develop and maintain a system of communication and 
integration, in accordance with the hospice's own policies and 
procedures that reflects its responsibility to direct and coordinate 
care.
    ++ Section 418.58(d), to include that hospices must have developed, 
implemented, and evaluate performance improvement projects.
    ++ Section 418.60, to include language requiring the hospice to 
maintain and document an effective infection control program that 
protects patients, families, visitors, and hospice personnel by 
preventing and controlling infections and communicable diseases.
    ++ Section 418.62(c), to add participation in hospice sponsored in-
service training under the requirement applicable to licensed 
professionals.
    ++ Section 418.64(b)(1), to include comparable language that 
nursing services must ensure that the nursing needs of the patient are 
met as identified in the patient's initial assessment, comprehensive 
assessment, and updated assessments.
    ++ Sections 418.66(a) and 418.74, to clarify its discussion of the 
applicable requirements by including specific language related to 
hospices operating in non-urbanized areas, specifically in regard to 
physical therapy, occupational therapy, speech-language pathology, and 
dietary counseling waivers, and the process of submission of such 
waivers for CMS approval.
    ++ Section 418.76(c)(5), to include that hospices must maintain 
documentation demonstrating that hospice aide services are provided by 
competent individuals.
    ++ Section 418.76(h)(1), to remove language suggesting that ``If 
nursing services are not provided, a physical or occupational therapist 
or speech-language pathologist can supervise the hospice aide'' and to 
reflect the fact that ``the supervising individual'' must be a 
Registered Nurse, and is required to make an onsite visit to hospice 
patients.
    ++ Sections 418.78(b) and (e) and 418.100(b), to specify the 
requirements related to daily activities of volunteers.
    ++ Section 418.100(e) and (g)(3), to specify relevant requirements 
relating to professional management and training, including adding key 
terminology relating to financial management and qualified personnel to 
align with the requirements for organization and administration of 
services.
    ++ Section 418.106(d)(1), to include reference to the 
interdisciplinary group.
    ++ Section 418.110(f) and (g)(1), to include the term dignity as it 
relates to the atmosphere set in patient care areas.
    ++ Section 418.110(m)(1), to appropriately reference the plan of 
care within TJC's comparable standard.
    In addition to the standards review, CMS also reviewed TJC's 
comparable survey processes, which were conducted as described in 
section III of this final notice, and yielded the following areas 
where, as of the date of this notice, TJC has completed revising its 
survey processes in order to demonstrate that it uses survey processes 
comparable to SA processes by taking the following steps:
    ++ Removing language in award letters or communications with TJC's 
accredited hospices, which referenced ``lengthen the duration of the 
cycle'' beyond the allowable 36-month period, which is inconsistent 
with the regulatory requirements at Sec.  488.5(a)(4)(i).
    ++ Providing additional training to surveyors on citing the 
appropriate levels of noncompliance, as it relates to the scope, manner 
and degree of deficiencies (condition level versus standard level 
deficiencies), in the initial comprehensive assessment.
    ++ Providing additional surveyor training and tools under TJC's 
Surveyor Technology to ensure surveyors properly document reviews of 
personnel

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files and credentialing as part of the survey process.

B. Term of Approval

    Based on our review and observations described in sections III and 
V of this final notice, we approve TJC as a national accreditation 
organization for hospices that request participation in the Medicare 
program. The decision announced in this final notice is effective June 
18, 2021 through June 18, 2025 (4 years). Due to travel restrictions 
and the reprioritization of survey activities brought on by the 2019 
Novel Coronavirus Disease (COVID-19) Public Health Emergency (PHE), CMS 
was unable to observe a hospice survey completed by TJC surveyors as 
part of the application review process, which is one component of the 
comparability evaluation. Therefore, we are providing TJC with a 
shorter period of approval. Based on our discussions with TJC and the 
information provided in its application, we are confident that TJC will 
continue to ensure that its accredited hospices will continue to meet 
or exceed Medicare standards. While TJC has taken actions based on the 
findings annotated in section V.A. of this final notice, (Differences 
Between TJC's Standards and Requirements for Accreditation and Medicare 
Conditions and Survey Requirements) as authorized under Sec.  488.8, we 
will continue ongoing review of TJC's hospice survey processes and will 
conduct a survey observation once the COVID-19 PHE has expired.

VI. Collection of Information

    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 Acting Administrator of the Centers for Medicare & Medicaid 
Services (CMS), Elizabeth Richter, 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: March 24, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-06413 Filed 3-24-21; 4:15 pm]
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