[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54832-54835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25072]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2900-FN]
Medicare and Medicaid Programs; Conditional Approval of the
Community Health Accreditation Program for Continued Deeming Authority
for Hospices
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This notice announces our decision to conditionally approve,
with a 180-day probationary period, the Community Health Accreditation
Program's (CHAP's) request for continued recognition as a national
accreditation program for hospices seeking to participate in the
Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective November 20, 2009
through November 20, 2012, with a 180-day probationary period beginning
November 20, 2009 through May 19, 2010.
FOR FURTHER INFORMATION CONTACT: Aviva Walker-Sicard, (410) 786-8648.
Alexis Prete, (410) 786-0375. Patricia Chmielewski (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a hospice, provided certain requirements are met.
Section 1861(dd)(1) of the Social Security Act (the Act) establishes
distinct criteria for entities seeking designation as a hospice
program. Under this authority, 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 hospice care. Provider agreement
regulations are located in 42 CFR part 489 and regulations pertaining
to the survey and certification of facilities are located in 42 CFR
part 488.
Generally, in order to enter into an agreement, a hospice facility
must first be certified by a State survey agency as complying with
conditions or requirements set forth in part 418 of our regulations.
Then, the hospice 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
accreditation organization that all applicable Medicare conditions are
met or exceeded, we may deem those provider entities as having met the
requirements. Accreditation by an accreditation organization is
voluntary and is not required for Medicare participation.
If an accreditation organization is recognized by the Secretary as
having standards for accreditation that meet or
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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 accreditation organization applying
for approval of deeming authority under part 488, subpart A, must
provide us with reasonable assurance that the accreditation
organization requires the accredited provider entities to meet
requirements that are at least as stringent as the Medicare conditions.
Our regulations concerning reapproval of accrediting organizations are
set forth at Sec. 488.4 and Sec. 488.8(d)(3). The regulations at
Sec. 488.8(d)(3) require accreditation organizations to reapply for
continued approval of deeming authority every 6 years, or sooner as
determined by CMS. CHAP's term of approval as a recognized
accreditation program for hospices expires November 20, 2009.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of deeming applications is conducted in a timely
manner. The Act provides us with 210 calendar days after the date of
receipt of an application to complete our survey activities and
application review process. Within 60 days of receiving a completed
application, we must publish a notice in the Federal Register that
identifies the national accreditation 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 of our approval or denial of the
application.
III. Provisions of the Proposed Notice
On May 22, 2009, we published a proposed notice (74 FR 24015)
announcing CHAP's request for reapproval as a deeming organization for
hospices. In this notice, we specified in detail our evaluation
criteria. Under section 1865(a)(2) of the Act and in our regulations at
Sec. 488.4 (application and reapplication procedures for accreditation
organizations), we conducted a review of the CHAP application in
accordance with the criteria specified in our regulation, which
include, but are not limited to the following:
An onsite administrative review of CHAP's--(1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited facilities; and (5)
survey review and decision-making process for accreditation.
A comparison of CHAP's hospice accreditation standards to
our current Medicare conditions for participation (CoPs).
A documentation review of CHAP's survey processes to--
++ Determine the composition of the survey team, surveyor
qualifications, and the ability of CHAP to provide continuing surveyor
training.
++ Compare CHAP's processes to that of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ Evaluate CHAP's procedures for monitoring providers or suppliers
found to be out of compliance with CHAP program requirements. The
monitoring procedures are used only when the CHAP identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d).
++ Assess CHAP's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ Establish CHAP's ability to provide us with electronic data and
reports necessary for effective validation and assessment of CHAP's
survey process.
++ Determine the adequacy of staff and other resources.
++ Review CHAP's ability to provide adequate funding for performing
required surveys.
++ Confirm CHAP's policies with respect to whether surveys are
announced or unannounced.
++ Obtain CHAP's agreement to provide us 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 May 22,
2009 proposed notice also solicited public comments regarding whether
CHAP's requirements met or exceeded the Medicare CoPs for hospices. We
received no public comments in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between CHAP's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared the standards contained in CHAP's accreditation
requirements and survey process with the Medicare hospice CoPs and
survey process as outlined in the State Operations Manual (SOM). Our
review and evaluation of CHAP's deeming application, which were
conducted as described in section III of this final notice, yielded the
following:
CHAP modified its policies related to the accreditation
effective date in accordance with the requirements at Sec. 489.13.
CHAP amended its policies to include required timeframes
for investigation of complaints in accordance with the requirements at
section 5075.9 of the SOM.
CHAP developed a policy to ensure facilities with
condition level non-compliance on a recertification survey submit an
acceptable plan of correction (PoC), and receive a follow-up focused
survey, in order to meet the requirements at Sec. 488.20(a) and Sec.
488.28(a).
CHAP modified its policies surrounding timeframes for
sending and receiving PoCs, and to ensure that approved PoCs contain
all required elements to meet Medicare requirements at section 2728 of
the SOM.
CHAP developed and incorporated measures to improve the
accuracy and consistency of data submissions to CMS, in order to meet
the requirements at Sec. 488.4(b).
CHAP developed an action plan to ensure that deemed status
survey files are complete, accurate, and consistent with the
requirements at Sec. 488.6(a).
CHAP developed an action plan to ensure recertification
surveys are conducted no later than 36 months after the date of the
previous standard survey, in order to meet the requirements at Sec.
488.20(a).
CHAP amended its policies by eliminating recommendations
from the written survey findings, in order to meet the requirements at
Sec. 488.28(a) and section 2726 of the SOM.
CHAP revised its standards to include the definitions used
in the revised Medicare hospice CoPs set out at Sec. 418.3.
CHAP revised its standard to address the requirement that
investigations and/or documentation of alleged violations must be
conducted in accordance with established procedures, in order to meet
the requirements at Sec. 418.52(b)(4)(ii).
CHAP revised its standards to include the requirement that
the hospice document the patient's need for psychosocial, emotional and
spiritual care as part of the comprehensive assessment, in order to
meet the requirements at Sec. 418.54.
[[Page 54834]]
CHAP revised its standard to include the word
``individualized'', to meet the requirements at Sec. 418.56(b).
CHAP revised it standards to address the requirement that
the Quality Assessment and Performance Improvement (QAPI) program be
capable of showing improvement in hospice services, in order to meet
the requirements at Sec. 418.58(a)(1).
CHAP revised its standards to address the requirement that
patient care quality data be included in the QAPI program, in order to
meet the requirements at Sec. 418.58(b)(1).
CHAP revised its standards to address the requirement that
the hospice's performance improvement activities must affect palliative
outcomes, patient safety, and quality of care, in order to meet the
requirements at Sec. 418.58(c)(1)(iii).
CHAP revised its standards to include the requirement that
the number of performance improvement projects must reflect the scope,
complexity and past performance of the hospices services and
operations, in order to meet the requirements at Sec. 418.58(d)(1).
CHAP revised its standards to include the requirement that
the hospice's infection control program protect patients, families,
visitors and hospice personnel by preventing and controlling infections
and communicable diseases, in order to meet the requirements at Sec.
418.60.
CHAP revised its standards to address the requirement that
the infection control program is an integral part of the QAPI program,
in order to meet the requirements at Sec. 418.60(b)(1).
CHAP revised its standards to address the requirement that
the hospice's infection control program include a method for
identifying infectious and communicable disease problems, in order to
meet the requirements at Sec. 418.60(b)(2)(i).
CHAP revised its standards to address the requirement that
the hospice's infection control program include a plan for implementing
the appropriate actions that are expected to result in improvement and
disease prevention, in order to meet the requirements at Sec.
418.60(b)(2)(ii).
CHAP revised its standards to include language to address
the CMS waiver requirements for physical therapy, occupational therapy,
speech-language pathology and dietary counseling in non-urbanized
areas, in order to meet the requirements at Sec. 418.74.
CHAP revised its standards to ensure that the hospice aide
training program addressed the requirements of reading, writing and
verbally reporting clinical information to patients, caregivers, and
other hospice staff, in order to meet the requirements at Sec.
418.76(b)(3)(i).
CHAP revised its standards to require the hospice aide
training program include instruction in appropriate and safe techniques
in performing personal hygiene and grooming tasks, in order to meet the
requirements at Sec. 418.76(b)(3)(ix)(A) through (F), and Sec.
418.76(b)(3)(x) through (xiii).
CHAP revised its standards to include the requirement that
hospice aide in-service training be supervised by a registered nurse,
in order to meet the requirements at Sec. 418.76(d)(1).
CHAP revised its standards to require a registered nurse,
who is a member of the interdisciplinary group, assign patients to
hospice aides, in order to meet the requirements at Sec. 418.76(g)(1).
CHAP revised its standards to address the requirement that
hospice aide assignment be ordered by the interdisciplinary group, in
order to meet the requirements at Sec. 418.76(g)(2)(i).
CHAP revised its standards to ensure that the supervising
registered nurse assesses an aide's ability to comply with infection
control policies and procedures, in order to meet the requirements at
Sec. 418.76(h)(3)(iv).
CHAP revised its standards to ensure the supervising
registered nurse assess an aide's ability to report changes in the
patient's condition, in order to meet the requirements at Sec.
418.76(h)(3)(v).
CHAP revised its standards to ensure that the hospice
continually monitors and manages all services provided at all locations
so that each patient and family receives the necessary care and
services, in order to meet the requirements at Sec. 418.100(f)(2).
CHAP developed a surveyor tool that includes the
requirement to review three new hires for documentation of training and
competency on the use of restraints and seclusions, in order to meet
the requirements at Sec. 418.110(n)(4).
CHAP revised its standards to ensure all entries in the
medical record are legible and appropriately authenticated, in order to
meet the requirements at Sec. 418.104(b).
CHAP revised its standards to ensure necessary medical
appliances and durable medical equipment are provided by the hospice,
in order to meet the requirements at Sec. 418.106.
CHAP revised its standards to address the hospices'
responsibility to provide adequate staffing to ensure the plan of care
outcomes are achieved and negative outcomes are avoided, in order to
meet the requirements at Sec. 418.110(a).
CHAP added new standards to address CMS' ability to waive
space and occupancy requirements for facilities occupied by Medicare
participating hospices on December 2, 2008, in order to meet the
requirements at Sec. 418.110(f)(4)(i) through (ii).
CHAP revised its accreditation decision letters to ensure
they are accurate and contain all the required elements necessary for
the CMS Regional Office to render a decision regarding deemed status of
a hospice.
To verify CHAP's continued compliance with the provisions of this
final notice, we will conduct a follow-up corporate onsite visit within
6 months of the date of publication of this notice.
Our review of CHAP's renewal application for hospice deeming
authority revealed that CHAP has ongoing, serious, widespread areas of
noncompliance, specifically CHAP's inability to provide us with
accurate and timely data on deemed providers, lack of complete and
accurate deemed facility survey files, and failure to ensure that
recertification surveys are conducted on an interval not exceeding 36
months. Due to the significant number of areas of noncompliance
identified during the review of CHAP's renewal application for hospice
deeming authority, we have concerns that CHAP's accreditation program
for hospices may no longer provide reasonable assurance that its
accredited entities meet the Medicare requirements.
In accordance with Sec. 488.8(d)(3), every 6 years, or sooner as
determined by CMS, an approved accreditation organization must reapply
for continued approval of deeming authority. CMS notifies the
organization of the materials the organization must submit as part of
the reapplication procedure. An accreditation organization that is not
meeting the requirements of this subpart, as determined through a
comparability review, must furnish CMS, upon request and at any time,
with the reapplication materials CMS requests. CMS will establish a
deadline by which the materials are to be submitted.
In accordance with Sec. 488.8(f)(3)(i), if we determine that an
accreditation organization has failed to adopt requirements comparable
to CMS requirements, we may grant a conditional approval of the
accreditation organization's deeming authority for a period of up to 1
year to adopt comparable requirements; in this
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case, we are providing CHAP with a probationary period of 180 days.
Within 60 days after the end of CHAP's probationary period, we will
make a final determination as to whether or not CHAP's hospice
accreditation requirements are comparable to CMS requirements and issue
an appropriate notice that includes reasons for our determination, no
later than July 18, 2010. If CHAP has not made improvements acceptable
to CMS during the 180-day probationary period, we may remove
recognition of deemed authority for its hospice program effective 30
days after the date we provide written notice to CHAP that its hospice
deeming authority will be removed. In addition, due to the significant
number of areas of noncompliance, we will conduct a follow-up corporate
onsite visit to validate compliance with the provisions of this final
notice.
B. Term of Approval
Based on the review and observations described in section III of
this final notice, we have determined that CHAP's accreditation program
for hospices requires further revision and subsequent review. We
believe that with additional time, CHAP will be able to make the
necessary revisions to ensure that CHAP's accreditation program for
hospices meets or exceeds the Medicare requirements as stated in Part
418. Therefore, we conditionally approve CHAP as a national
accreditation organization for hospices that request participation in
the Medicare program, effective November 20, 2009 through November 20,
2012, with a 180-day probationary period beginning November 20, 2009
through May 19, 2010. As stated above, we will publish a final
determination giving final approval or revoking such approval no later
than July 18, 2010.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplementary Medical Insurance Program)
Dated: September 24, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-25072 Filed 10-22-09; 8:45 am]
BILLING CODE 4120-01-P