[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]
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