[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

[[Page 54833]]

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:
    <bullet> 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.
    <bullet> A comparison of CHAP's hospice accreditation standards to 
our current Medicare conditions for participation (CoPs).
    <bullet> 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:
    <bullet> CHAP modified its policies related to the accreditation 
effective date in accordance with the requirements at Sec.  489.13.
    <bullet> CHAP amended its policies to include required timeframes 
for investigation of complaints in accordance with the requirements at 
section 5075.9 of the SOM.
    <bullet> 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).
    <bullet> 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.
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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.
    <bullet> CHAP revised its standards to include the definitions used 
in the revised Medicare hospice CoPs set out at Sec.  418.3.
    <bullet> 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).
    <bullet> 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]]

    <bullet> CHAP revised its standard to include the word 
``individualized'', to meet the requirements at Sec.  418.56(b).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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.
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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.
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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.
    <bullet> 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).
    <bullet> 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).
    <bullet> 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

[[Page 54835]]

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