[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Notices]
[Pages 9799-9801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05037]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3370-FN]
Medicare and Medicaid Programs: Approval of an Application From
the Accreditation Association for Hospitals and Health Systems/
Healthcare Facilities Accreditation Program for Continued CMS Approval
of Its Hospital 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
Accreditation Association for Hospitals and Health Systems/Healthcare
Facilities Accreditation Program (AAHHS/HFAP) (formerly known as the
American Osteopathic Association/Healthcare Facilities Accreditation
Program (AOA/HFAP)) for continued recognition as a national accrediting
organization for hospitals that wish to participate in the Medicare or
Medicaid programs.
DATES: This final notice is effective September 25, 2019 through
September 25, 2023.
FOR FURTHER INFORMATION CONTACT: Tara Lemons (410) 786-3030, Mary Ellen
Palowitch (410) 786-4496, or Monda Shaver, (410) 786-3410.
SUPPLEMENTARY INFORMATION:
I. Background
A healthcare provider may enter into an agreement with Medicare to
participate in the program as a hospital provided certain requirements
are met. Section 1861(e) of the Social Security Act (the Act)
establishes criteria for providers seeking participation in Medicare as
a hospital. Regulations concerning Medicare provider agreements in
general are at 42 CFR part 489 and those pertaining to the survey and
certification for Medicare participation of providers and certain types
of suppliers are at 42 CFR part 488. The regulations at 42 CFR part 482
specify the specific conditions that a provider must meet to
participate in the Medicare program as a hospital. Hospitals that wish
to be paid under the Medicaid program must be approved to participate
in Medicare, in accordance with 42 CFR 440.10(a)(3)(iii).
Generally, to enter into a Medicare hospital provider agreement, a
facility must first be certified as complying with the conditions set
forth in part 482 and recommended to the Centers for Medicare &
Medicaid Services (CMS) for participation by a State survey agency.
Thereafter, the hospital is subject to periodic surveys by a State
survey agency to determine whether it continues to meet these
conditions. 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 the Secretary of
the Department of Health and Human Services (the Secretary) finds that
accreditation of a provider entity by an approved national accrediting
organization meets or exceeds all applicable Medicare conditions, we
may treat the provider entity as having met those conditions, that is,
we may ``deem'' the provider entity to be in compliance. Accreditation
by an accrediting organization is voluntary and is not required for
Medicare participation.
Part 488, subpart A, implements the provisions of section 1865 of
the Act and requires that a national accrediting organization applying
for approval of its Medicare accreditation program must provide CMS
with reasonable assurance that the accrediting organization requires
its 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.
[[Page 9800]]
488.5(e)(2)(i) require an accrediting organization to reapply for
continued approval of its Medicare accreditation program every 6 years
or sooner as determined by CMS. On January 14, 2019, CMS recognized the
change in ownership from American Osteopathic Association/Healthcare
Facilities Accreditation Program (AOA/HFAP) to the new owner,
Accreditation Association for Hospitals and Health Systems/Healthcare
Facilities Accreditation Program (AAHHS/HFAP). This recognition
included a transfer and continuation of CMS-approval for AAHHS/HFAP's
hospital accreditation program, as was published under the AOA/HFAP
approval on August 28, 2013. AAHHS/HFAP's term of approval as a
recognized Medicare accreditation program for hospitals expires
September 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 provide 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 October 17, 2018, we published a proposed notice in the Federal
Register (83 FR 52458) announcing AAHHS/HFAP's request for continued
approval of its Medicare hospital accreditation 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 AAHHS/HFAP's Medicare hospital 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 AAHHS/HFAP's: (1)
Corporate policies; (2) financial and human resources available to
accomplish the proposed surveys; (3) procedures for training,
monitoring, and evaluation of its hospital surveyors; (4) ability to
investigate and respond appropriately to complaints against accredited
hospitals; and, (5) survey review and decision-making process for
accreditation.
A comparison of AAHHS/HFAP's Medicare accreditation
program standards to our current Medicare hospital Conditions of
Participation (CoP).
A documentation review of AAHHS/HFAP's survey process to
do the following:
++ Determine the composition of the survey team, surveyor
qualifications, and AAHHS/HFAP's ability to provide continuing surveyor
training.
++ Compare AAHHS/HFAP'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
hospitals.
++ Evaluate AAHHS/HFAP's procedures for monitoring hospitals it has
found to be out of compliance with AAHHS/HFAP's program requirements.
(This pertains only to monitoring procedures when AAHHS/HFAP identifies
non-compliance. If non-compliance 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 AAHHS/HFAP's ability to report deficiencies to the
surveyed hospitals and respond to the hospital's plan of correction in
a timely manner.
++ Establish AAHHS/HFAP'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 AAHHS/HFAP's staff and other
resources.
++ Confirm AAHHS/HFAP's ability to provide adequate funding for
performing required surveys.
++ Confirm AAHHS/HFAP's policies with respect to surveys being
unannounced.
++ Obtain AAHHS/HFAP'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
17, 2018 proposed notice also solicited public comments regarding
whether AAHHS/HFAP's requirements met or exceeded the Medicare CoP for
hospitals. There were no comments submitted.
IV. Provisions of the Final Notice
A. Differences Between AAHHS/HFAP's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared AAHHS/HFAP's hospital accreditation requirements and
survey process with the Medicare CoP at part 482, and the survey and
certification process requirements of parts 488 and 489. AAHHS/HFAP's
standards crosswalk, which maps AAHHS/HFAP's standards with the
corresponding requirements under the Medicare CoP, was also examined to
ensure that the appropriate CMS regulation was included in citations as
appropriate. We reviewed and evaluated AAHHS/HFAP's hospital
application, as described in section III of this final notice. This
review yielded the following areas where, as of the date of this
notice, AAHHS/HFAP has revised its standards and certification
processes:
Sec. 482.13(e), to ensure that AAHHS/HFAP's crosswalk
reflects the comparable restraint and seclusion requirements.
Sec. 482.13(h)(1) through Sec. 482.13(h)(4) regarding
patient visitation rights, to ensure that redundant language in its
standards is removed.
Sec. 482.15(d)(1)(i) regarding emergency preparedness
training, to ensure AAHHS/HFAP's standards require a comparable
standard to this CMS requirement.
Sec. 482.15(d)(1)(iii) regarding documentation of
emergency preparedness training, to ensure AAHHS/HFAP's standards
require compliance with this CMS requirement.
Sec. 482.15(d)(1)(iv) regarding demonstration of staff
knowledge of emergency preparedness procedures, to ensure AAHHS/HFAP's
standards require compliance with this CMS requirement.
Sec. 482.15(d)(2)(i) through Sec. 482.15(d)(2)(ii)(B),
to ensure AAHHS/HFAP's standards require compliance with these CMS
requirements regarding staff emergency preparedness testing.
Sec. 482.15(e)(3), to clarify its requirement related to
maintaining an emergency onsite fuel source.
[[Page 9801]]
Sec. 482.15(f)(4) through Sec. 482.15(f)(5), to address
these CMS requirements regarding emergency plans, policies and
procedures for integrated health care systems.
Sec. 482.21, to ensure that redundant language regarding
the Quality Assessment and Performance Improvement Condition of
participation is removed.
Sec. 482.23(b)(1) regarding nursing services, to ensure
that CMS references are accurately referenced.
Sec. 482.27(b)(11) regarding hepatitis C virus
notifications, to ensure that redundant language in its standard is
removed.
Sec. 482.41(a)(2), to ensure that the requirement for
emergency water supply for structures is adequately addressed.
Sec. 482.41(b)(1)(i) and Sec. 482.41(b)(2), to ensure
that the 2012 edition of the Life Safety Code is accurately referenced.
Sec. 482.41(b)(7), to clarify that Alcohol-Based Hand Rub
dispensers are permitted to be installed in areas other than exit
access corridors.
Sec. 482.41(b)(8)(ii), to ensure that fire watches are to
be maintained until the system is back in service.
Sec. 488.5(a)(4)(ii), to ensure that survey activities,
including the review of all records, are administered in a
comprehensive method comparable to CMS processes.
Sec. 488.5(a)(4)(iii), to ensure that patient sample
sizes are based on the hospital's average daily census and meets
minimum sample requirements; and to ensure compliance with AAHHS/HFAP's
policies related to documentation related to medical record review.
Sec. 488.5(a)(4)(iv), to ensure findings of non-
compliance are documented under all appropriate CMS standards where
non-compliance is found; and to ensure that all citations of
noncompliance accurately identify the appropriate CMS requirement.
Sec. 488.5(a)(12), to ensure that its complaint
investigations address the minimum patient sample size for review, as
applicable.
Sec. 488.26(b), to ensure that surveyor documentation is
reviewed for manner and degree of non-compliance and subsequently cited
at the appropriate level (that is, condition versus standard level).
Sec. 488.28(a), to ensure that facility plans of
correction contain all required elements to be considered comparable to
CMS.
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we have determined that AAHHS/HFAP's hospital
program requirements meet or exceed our requirements. Therefore, we
approve AAHHS/HFAP as a national accreditation organization for
hospitals that request participation in the Medicare program, effective
September 25, 2019 through September 25, 2023.
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: March 12, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-05037 Filed 3-15-19; 8:45 am]
BILLING CODE 4120-01-P