[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Notices]
[Pages 64902-64904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25429]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3379-FN]
Medicare and Medicaid Programs; Continued Approval of the
Accreditation Commission for Health Care Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve the
Accreditation Commission for Health Care (ACHC) for continued
recognition as a national accrediting organization for hospices that
wish to participate in the Medicare or Medicaid programs. A hospice
that participates in Medicaid must also meet the Medicare conditions
for participation.
DATES: This final notice is effective November 27, 2019 through
November 27, 2025.
FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636, or
Joann Fitzell, (410) 786-4280.
SUPPLEMENTARY INFORMATION:
[[Page 64903]]
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a hospice provided certain requirements are met by
the hospice. Section 1861(dd) of the Social Security Act (the Act)
establishes 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 conditions that a hospice must meet in
order to participate in the Medicare program, the scope of covered
services and the conditions for Medicare payment for hospices.
Generally, to enter into an agreement, a hospice must first be
certified as complying with the conditions set forth in part 418 and
recommended to the Center for Medicare & Medicaid (CMS) for
participation by a state survey agency. Thereafter, the hospice 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, CMS
may treat the provider entity as having met those conditions, that is,
may ``deem'' the provider entity to be in compliance. Accreditation by
an accrediting organization is voluntary and is not required for
Medicare participation.
If an accrediting organization is recognized by the Secretary as
having standards for accreditation that meet or exceed Medicare
requirements, any provider entity accredited by the national
accrediting organization's approved program may 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 Accreditation Commission for Health Care
(ACHC'S) term of approval as a recognized accreditation program for its
hospice accreditation program expires November 27, 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 to
publish notice in the Federal Register of approval or denial of the
application. The Act also states 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.
III. Provisions of the Proposed Notice
In the June 28, 2019 Federal Register (84 FR 31068), we published a
proposed notice announcing ACHC's request for continued approval of its
Medicare hospice accreditation program. In the June 28, 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 ACHC'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 ACHC'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 ACHC's Medicare hospice accreditation
program standards to CMS's current Medicare hospice conditions of
participation.
A documentation review of ACHC's survey process to--
++ Determine the composition of the survey team, surveyor
qualifications, and ACHC's ability to provide continuing surveyor
training.
++ Compare ACHC'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 hospices.
++ Evaluate ACHC's procedures for monitoring hospices it has found
to be out of compliance with ACHC's program requirements. (This
pertains only to monitoring procedures when ACHC 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 ACHC's ability to report deficiencies to the surveyed
hospice and respond to the hospice's plan of correction in a timely
manner.
++ Establish ACHC'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 ACHC's staff and other resources.
++ Confirm ACHC's ability to provide adequate funding for
performing required surveys.
++ Confirm ACHC's policies with respect to surveys being
unannounced.
++ ACHC'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 ACHC'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 June 28,
2019 proposed notice also solicited public comments regarding whether
ACHC's requirements met or exceeded the Medicare CoPs for hospices. No
comments were received in response to the proposed notice.
IV. Provisions of the Final Notice
A. Differences Between ACHC's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared ACHC's hospice accreditation requirements and survey
process with the Medicare CoPs of part 418, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of ACHC'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, ACHC has completed revising
its standards and certification processes in order to meet the
requirements at:
[[Page 64904]]
Sec. 418.56(c)(2), to address the requirement the
frequency of services necessary to meet the specific patient and family
needs.
Sec. 418.110(c)(1), to require an inpatient hospice to
address real or potential threats to the health and safety of the
patients, others, and property.
Sec. 418.110)(d)(1)(i), to address the requirement that
hospice must meet applicable provisions and must proceed in accordance
with the Life Safety Code (National Fire Protection Association (NFPA)
101 and Tentative Interim amendments TIA 12-1, TIA 12-2, TIA 12-3 and
TIA 12-4.)
Sec. 418.110(d)(5), to address the requirement when a
sprinkler system is shut down for more than 10 hours.
Sec. 418.110(d)(5)(i), to address the requirement to
evacuate the building or portion of the building affected by the system
outage until the system is back in service.
Sec. 418.110(d)(5)(ii), to address the requirement to
establish a fire watch until the system is back in service.
Sec. 418.110(d)(6), to require both existing and new
buildings to have an outside window or door in every sleeping room and,
for any building constructed after July 5, 2016, to require that the
sill height must not exceed 36 inches above the floor.
Sec. 418.110(e), to address the requirement that except
as otherwise provided in this section, the hospice must meet the
applicable provisions and must proceed in accordance with the Health
Care Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-
2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6).
Sec. 418.11(e)(1), to address the requirement that
Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do
not apply to a hospice.
Sec. 418.110(e)(2), to address the requirement that if
application of the Health Care Facilities Code required under paragraph
(e) of this section would result in unreasonable hardship for hospice,
CMS may waive specific provisions of the Health Care Facilities Code,
but only if the waiver does not adversely affect the health and safety
of patients.
Sec. 418.110(q) through Sec. 418.110(q)(1)(xi), address
the requirement that the standards incorporated by reference in this
section are approved for incorporation by reference by the Director of
the Office of the Federal Register in accordance with 5 U.S.C 552(a)
and 1 CFR part 51.
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we approve ACHC as a national accreditation
organization for hospices that request participation in the Medicare
program, effective November 27, 2019 through November 27, 2025.
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. 35 et seq.).
Dated: November 5, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-25429 Filed 11-22-19; 8:45 am]
BILLING CODE 4120-01-P