[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4818-4820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02673]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3364-FN]
Application From the Joint Commission (TJC) for Continued
Approval of Its Psychiatric Hospital 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 for continued recognition as a national accrediting
organization for psychiatric hospitals that wish to participate in the
Medicare or Medicaid programs.
DATES: The approval announced in this final notice is effective
February 25, 2019 through February 25, 2023.
FOR FURTHER INFORMATION CONTACT: Mary Ellen Palowitch (410) 786-4496,
Monda Shaver (410) 786-3410, Tara Lemons (410) 786-3030.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a psychiatric hospital provided certain
requirements are met. Section 1861(f) of the Social Security Act (the
Act) establishes distinct criteria for facilities seeking designation
as a psychiatric hospital. 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 482 subparts A, B, C and E specify the
minimum conditions that a psychiatric hospital must meet to participate
in the Medicare program, the scope of covered services and the
conditions for Medicare payment for psychiatric hospitals.
Generally, to enter into an agreement, a psychiatric hospital must
first be certified by a State Survey Agency as complying with the
conditions or requirements set forth in part 482 subpart A, B, C and E
of our regulations. Thereafter, the psychiatric hospital is subject to
regular surveys by a State Survey Agency to determine whether it
continues to meet these requirements. There is an alternative, however,
to surveys by State agencies.
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 may treat the provider entity as having met those
conditions, that is, we may ``deem'' the provider entity as having met
the 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
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
may be deemed to meet the Medicare conditions. A national accrediting
organization applying for approval of its accreditation program under
part 488, subpart A, must provide the Centers for Medicare & Medicaid
Services (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. The regulations at Sec. 488.5(e)(2)(i)
require accrediting organizations to reapply for continued approval of
its accreditation program every 6 years or sooner as determined by CMS.
The Joint Commission's current term of approval for their
psychiatric hospital accreditation program expires February 25, 2019.
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, 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
On August 15, 2018, we published a proposed notice in the Federal
Register (83 FR 40514), announcing the Joint Commission's (TJC's)
request for continued approval of its Medicare psychiatric hospital
accreditation
[[Page 4819]]
program. In the 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 psychiatric hospital
accreditation renewal 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 psychiatric hospital surveyors; (4) ability to
investigate and respond appropriately to complaints against accredited
psychiatric hospitals; and, (5) survey review and decision-making
process for accreditation.
A comparison of TJC's Medicare hospital accreditation
program standards to our current Medicare hospital Conditions of
Participation (CoPs) and psychiatric hospital special conditions.
A documentation review of TJC's psychiatric hospital's
survey process to:
++ Determine the composition of the survey team, surveyor
qualifications, and TJC's ability to provide continuing surveyor
training.
++ Compare TJC's processes to those CMS require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited psychiatric
hospitals.
++ Evaluate TJC's procedures for monitoring psychiatric hospitals
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
hospital and respond to the psychiatric hospital'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.
++ 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 August 15,
2018 proposed notice also solicited public comments regarding whether
TJC's requirements met or exceeded the Medicare CoPs for psychiatric
hospitals. We received no comments 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 psychiatric hospital accreditation program
requirements and survey process with the Medicare CoPs at part 482 and
the survey and certification process requirements of parts 488 and 489.
Our review and evaluation of TJC's psychiatric hospital 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 revised its standards and certification processes in order to meet
the requirements at:
Section 482.12(a)(10), to address that consultation will
occur directly with the individual assigned the responsibility for the
organization and conduct of the hospital's medical staff, or his/her
designee and the timeframe for which direct consultation must occur.
Section 482.41(b)(3), to provide information related to
our rule stating that Life Safety Code provisions do not apply in a
State where CMS finds that a fire and safety code imposed by State law
adequately protects patients in hospitals.
Section 482.41(b)(5), to address cooperation with local
firefighting authorities.
Section 482.41(b)(7), to address installing alcohol-based
hand rub dispensers in a manner that adequately protects against
inappropriate access.
Section 482.41(e), to address the omission of a standard
to correspond to references and documents in this CMS requirement.
Section 482.42(b)(1), to address and clarify that ``make
certain'' is defined as ``must.''
Section 482.42(b)(2), to address and clarify that ``make
certain'' is defined as ``must.''
Section 482.43(b)(2), to address who may develop or
supervise the development of the discharge evaluation.
Section 482.43(c)(1), to address who must develop or
supervise the development of a discharge plan if the discharge planning
evaluation indicates a need for a discharge plan.
Section 482.51(a)(3), to address that a qualified
registered nurse is immediately available to respond to emergencies.
Section 482.51(b)(3), to address and include the required
equipment that must be available to the operating room suites.
Section Sec. 488.5(a)(4)(i), to ensure that all surveys
are unannounced.
Section Sec. 488.5(a)(4)(ii), to ensure that its
surveyors are provided clear instruction for assessing only the
applicable CoPs for the psychiatric hospital accreditation program.
Section 488.5(a)(4)(iv), to ensure that TJC psychiatric
hospital surveyors document findings of noncompliance with
accreditation standards at the comparable Medicare CoP; and to ensure
that all findings of observed noncompliance noted on surveyor
worksheets are clearly and accurately reflected in the final survey
deficiency report.
Section 488.5(a)(4)(v), to ensure that a minimum sample of
patient records are reviewed for all elements required by the
regulations.
Sections 488.5(a)(11)(ii), to ensure that data submitted
to CMS is timely, complete and accurate.
Section 488.5(a)(12), to ensure that TJC has a clearly
defined complaint investigation process that is comparable to CMS; to
ensure that the process for protecting complainant anonymity does not
impede the required complaint investigation; to ensure that complaints
are investigated, based on the submitted allegations, irrespective of
receiving a ``waiver of anonymity'' from the complainant; to ensure
that complaints are reviewed and investigated within the comparable
timelines established by CMS; and to ensure that all complaints that
would result in condition-level non-compliance, based on allegations
described therein, are required to be investigated through an onsite
survey.
Section 488.5(a)(19)(ii), to ensure that TJC proposed
survey process and crosswalked standards will not be implemented
without prior written notice of approval from CMS.
Section 488.26, to ensure TJC's survey process meets or
exceeds the Medicare program requirements; and to ensure that surveyors
assess all required facility locations and services during the survey
process.
Section 489.13, to ensure that the granting of
accreditation and recommendations to CMS for Medicare participation
occurs only after the
[[Page 4820]]
facility has demonstrated full compliance with all requirements.
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 psychiatric hospitals that request participation in
the Medicare program, effective February 25, 2019 through February 25,
2023.
To verify TJC's continued compliance with the provisions of this
final notice, CMS expects to conduct a follow-up corporate on-site
visit and survey observation within 18 months of the publication date
of this notice.
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.).
Dated: February 7, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-02673 Filed 2-15-19; 8:45 am]
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