[Federal Register Volume 64, Number 75 (Tuesday, April 20, 1999)]
[Notices]
[Pages 19376-19379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-2029-FN]
RIN 0938-AJ42
Medicare Program; Recognition of the Community Health
Accreditation Program, Inc. (CHAP) for Hospices
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final notice.
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SUMMARY: This notice recognizes the Community Health Accreditation
Program, Inc. (CHAP) as a national accreditation organization for
hospices that request participation in the Medicare program. We believe
that accreditation of hospices by CHAP demonstrates that all Medicare
hospice conditions of participation are met or exceeded. Thus, we grant
deemed status to those hospices accredited by CHAP. The proposed notice
included the application from the Joint Commission for Accreditation of
Healthcare Organizations (JCAHO). We have separated the final notices
to appropriately process each application and will issue a separate
final notice containing the decision for JCAHO under HCFA-2039-FN.
EFFECTIVE DATE: This final notice is effective April 20, 1999 through
November 20, 2003.
FOR FURTHER INFORMATION CONTACT: Joan C. Berry, (410) 786-7233.
SUPPLEMENTARY INFORMATION:
I. Background
A. Laws and Regulations
Under the Medicare program, eligible beneficiaries may receive
covered palliative services in a hospice provided certain requirements
are met. The regulations specifying the Medicare conditions of
participation for hospice care are located in 42 CFR part 418. These
conditions implement section 1861(dd) of the Social Security Act (the
Act), which specifies services covered as hospice care and the
conditions that a hospice program must meet in order to participate in
the Medicare program.
Generally, in order to enter into an agreement with Medicare, a
hospice must first be certified by a State survey agency as complying
with the conditions or standards set forth in part 418 of the
regulations. Then, the hospice is subject to routine surveys by a State
survey agency to determine whether it continues to meet Medicare
requirements. There is an alternative, however, to surveys by State
agencies.
Current section 1865(b)(1) of the Act permits ``accredited''
hospices to be exempt from routine surveys by State survey agencies to
determine compliance with Medicare conditions of participation.
Accreditation by an accreditation organization is voluntary and is not
required for Medicare certification. Section 1865(b)(1) of the Act
provides that, if a provider is accredited by a national accreditation
body that has standards that meet or exceed the Medicare conditions,
the Secretary can ``deem'' that hospice as having met the Medicare
requirements.
We have rules at part 488 that set forth the procedure we use to
review applications submitted by national accreditation organizations
requesting our approval. A national accreditation organization applying
for approval must furnish to us information and materials listed in the
regulations at Sec. 488.4. The regulations at Sec. 488.8 (``Federal
review of accreditation organizations'') detail the Federal review and
approval process of applications for recognition as an accrediting
organization. On April 26, 1996, however, new legislation entitled
``Omnibus Consolidated Rescissions and Appropriations Act of 1996''
(Pub. L. 104-134) was enacted.
Section 1865(b)(3)(A) of the Act, as amended by section 516 of Pub.
L. 104-134, requires us to publish a notice in the Federal Register
within 60 days after receiving an accreditation organization's written
request that we make a determination regarding whether its
accreditation requirements meet or exceed Medicare requirements.
Section 1865(b)(3)(A) of the Act also requires that we identify in the
notice the organization and the nature of the request and allow a 30-
day comment period. This section further requires that we publish a
notice of our approval or disapproval within 210 days after we receive
a complete package of information and the organization's application.
B. Proposed Notice
On September 11, 1998, we published a proposed notice (63 FR 48735)
announcing the requests of CHAP and JCAHO for our approval as national
accreditation organizations for hospices. In the notice, we detailed
the factors on which we would base our evaluation. (We inadvertently
gave the citation for the regulations governing our evaluation as
Sec. 488.8, ``Federal review of accreditation organizations,'' rather
than as Sec. 488.4, ``Application and reapplication procedures for
accreditation organizations.'') Under section 1865(b)(2) of the Act and
our regulations at Sec. 488.4, our review and evaluation of the CHAP
application were conducted in accordance with the following factors:
A determination that CHAP is a national accreditation
body, as required by the Act.
A determination of the equivalency of CHAP's requirements
for a hospice to our comparable hospice requirements.
A review of CHAP's survey processes to determine the
following:
--The comparability of CHAP's processes to those of State agencies,
including survey frequency; its ability to investigate and respond
[[Page 19377]]
appropriately to complaints against accredited facilities; whether
surveys are announced or unannounced; and the survey review and
decision-making process for accreditation.
--The adequacy of the guidance and instructions and survey forms CHAP
provides to surveyors.
--CHAP's procedures for monitoring providers or suppliers found to be
out of compliance with program requirements. (These procedures are used
only when CHAP identifies noncompliance.)
The composition of CHAP's survey team, surveyor
qualifications, the content and frequency of the in-service training
provided, the evaluation systems used to assess the performance of
surveyors, and potential conflict-of-interest policies and procedures.
CHAP's data management system and reports used to assess
its surveys and accreditation decisions, and its ability to provide us
with electronic data.
CHAP's procedures for responding to complaints and for
coordinating these activities with appropriate licensing bodies and
ombudsmen programs.
CHAP's policies and procedures for withholding or removing
accreditation from a facility that fails to meet its standards or
requirements.
A review of all types of accreditation status CHAP offers
and an assessment of the appropriateness of those for which CHAP seeks
deemed status.
A review of the pattern of CHAP's deemed facilities (that
is, types and duration of accreditation and its schedule of all planned
full and partial surveys).
The adequacy of CHAP's staff and other resources to
perform the surveys, and its financial viability.
CHAP's written agreement to--
--Meet our requirements to provide to all relevant parties timely
notifications of changes to accreditation status or ownership, to
report to all relevant parties remedial actions or immediate jeopardy,
and to conform its requirements to changes in Medicare requirements;
and
--Permit its surveyors to serve as witnesses for us in adverse actions
against its accredited facilities.
We received no comments on our proposed notice.
II. Review and Evaluation
Our review and evaluation of the CHAP application, which were
conducted as detailed above, yielded the following information.
Differences between the Community Health Care Program, Inc. (CHAP) and
Medicare Conditions and Survey Requirements
We compared the standards contained in the CHAP 1997 ``Standards of
Excellence for Hospice Organizations'' with CHAP's survey process
outlined in its training materials and ``Hospice Surveyor Operations
Manual,'' which incorporates our 1994 guidelines to the Medicare
hospice conditions and survey procedures. In 13 areas CHAP has made the
following revisions or clarifications:
No surveys prior to enrollment form verification. State
survey agencies do not conduct health and safety inspections until a
hospice has submitted a ``Medicare and Other Federal Health Care
Program General Enrollment Health Care Provider/Supplier Application''
(Form HCFA-855) that the servicing fiscal intermediary has reviewed and
approved. CHAP has provided written assurance that ``It is CHAP's
policy not to conduct a deemed status accreditation survey until an
organization is properly enrolled in the Medicare program.'' In
addition, CHAP has added a blanket statement that an organization must
meet not only ``All state licensure laws, Certificate of Need (CON)
requirements or other state regulations and standards,'' but ``Federal
requirements'' as well.
Unannounced surveys (Reference Sec. 488.4(a)(3)(v)).
Current CHAP procedures contain the following statement regarding
unannounced surveys for Medicare-certified home health agencies: ``All
visits to Medicare home health agencies will be unannounced. The
specific timing of the visit is determined by the CHAP's Board of
Review and no one from the applicant organization will be informed of
the dates.'' We expect that a similar statement will be added for
Medicare-certified hospices that elect the deemed status option. CHAP
has agreed to add this language to its hospice procedures.
Core services. Medicare requires that substantially all
core services (nursing, medical social services, and counseling
services) be provided directly by hospice employees, the only exception
being during times of peak patient loads or under extraordinary
circumstances. CHAP responded by revising its standards to require that
a hospice program employ sufficient staff to provide all core services
or provide documentation describing unusual or extraordinary
circumstances necessitating the use of contracted staff for these
services.
Notification when required services are not provided.
Medicare-certified hospices are required by section 1861(dd)(1) of the
Act to provide routinely the following services: nursing care, medical
social services, and counseling. CHAP has agreed that when it becomes
aware that any Medicare-certified hospice is not providing one or more
of these core services, we shall be promptly notified.
Change of status notification. We require prompt
notification from the accreditation organizations regarding hospice
changes of ownership, hospice mergers, hospice site expansions,
withdrawals from accreditation, and involuntary terminations from
accreditation by the accreditation organization, because those actions
require certification and enrollment actions by us, the fiscal
intermediary, or the State survey agency. CHAP has stipulated in
writing that its ``home care policy and practice to provide prompt
notification to HCFA of changes in ownership, mergers, site expansion,
withdrawals or involuntary termination'' will be applied to the hospice
program.
Accreditation survey review and decision-making process
(Reference Sec. 488.4(a)(3)(iii)). CHAP has responded to two requests
we made for clarification regarding current CHAP terminology in its
accreditation application under the heading, ``CHAP Accreditation
Policies and Procedures'':
--Deferral of action. CHAP has confirmed that facilities in
deferral are not considered accredited.
--Warnings. CHAP has confirmed that it issues a warning to an
accredited entity that ``has made limited progress regarding required
actions and recommendations or has demonstrated a decline in meeting
CHAP standards since the last appraisal based on a site visit or
progress report.'' We have also received assurance that the time frames
for reaching a decision on whether or not to withdraw accreditation for
these entities are comparable to those we use for State-surveyed
facilities.
Contracted services.
--Some of the requirements in Sec. 418.56 did not appear to be included
in CHAP standards. CHAP provided clarifying cross references and
revised pages, demonstrating that its standards do incorporate all of
the requested requirements.
--The requirement for retaining fiscal responsibility needed to be
included for all contracted services, not just inpatient care
contracts. CHAP revised its standard to read, ``the hospice program
retains professional
[[Page 19378]]
management and fiscal responsibilities for patient care when services
are provided under arrangement with contractors.''
Millennium updates. CHAP has provided us with its plans to
ensure that deemed hospices maintain equipment and systems to sustain
the quality of patient care through the millennium updates.
Data exchange. CHAP has assured us that it has the ability
to provide us with timely electronic survey data and validation of
survey findings for all Medicare-certified hospices that have elected
the deemed status option.
Qualified social worker. Medicare requires that medical
social services be provided by a qualified social worker under the
direction of a physician. Medicare defines a hospice social worker at
Sec. 418.3 as ``a person who has at least a bachelor's degree from a
school accredited or approved by the Council on Social Work
Education.'' CHAP's standard required that social work services be
provided by a qualified social worker or social worker assistant. CHAP
has provided revised language for its related standard to require that
``social work services are provided under the direction of a physician
by a person who has at least a bachelor's degree from a school
accredited or approved by the Council on Social Work Education'' and
that the services are in agreement with the patient's plan of care.
Home health aide supervision. Medicare requires at
Sec. 418.94(a) that a registered nurse visit the home site at least
every 2 weeks when aide services are being provided and that the visit
include an assessment of the aide services. In addition, Medicare
requires that a registered nurse provide written instructions for
patient care. CHAP's standard required that nursing and home health
aide services always be provided under the supervision of a qualified
registered nurse, available at all times, but made no reference to
biweekly, direct (in-person) supervision and assessment. CHAP responded
by clarifying how these requirements were covered at HIII.1d4(c) in its
``Standards of Excellence for Hospice Organizations'': ``Written
instructions prepared by an RN are provided to paraprofessional staff
for care plan compliance.'' CHAP further stipulates at HIII.1d4(b) that
a home health aide's performance is evaluated by a registered nurse
every 2 weeks.
Inpatient care.
--The Medicare standard requires at Sec. 418.98(c) that the total
number of inpatient care days used by Medicare beneficiaries not exceed
20 percent of the total number of hospice days for this group of
beneficiaries in any 12-month period preceding a certification survey.
We could not find this standard in the application. CHAP responded by
clarifying how this requirement was covered at HII6.a1 in its
``Standards for Excellence for Hospice Organizations'': ``The hospice
program reviews total inpatient days routinely in any 12 month period
to prevent Medicare clients from exceeding 20% of the total number of
hospice days.''
--Another Medicare standard requires at Sec. 418.100(a) that hospices
providing inpatient care directly provide 24-hour nursing services that
are sufficient to meet total nursing needs and that are in accordance
with the patient's plan of skilled care. We asked CHAP to provide
evidence that this standard was included in its requirements. CHAP
responded by clarifying how this requirement was covered at Item 17 of
HIII.1i in its ``Standards for Excellence for Hospice Organizations'':
``Inpatient facilities provide 24 hour nursing services, including a
registered nurse on each shift, which are sufficient to meet total
nursing needs and which are in accordance with the patient plan of
care.''
Storage of drugs. Medicare standards require at
Sec. 418.100(k)(6) that separately locked compartments be provided for
storage of Schedule II drugs and other drugs subject to abuse. CHAP's
standard did not include ``other drugs subject to abuse'' in the list
of drugs to be stored in separately locked compartments. CHAP revised
its standard by adding ``Separately locked compartment for Schedule II
drugs and other drugs subject to abuse (multidose containers)'' at
H.III.4 in CHAP's ``Standards of Excellence for Hospice
Organizations.''
In addition to these changes, CHAP provided a revised crosswalk
(table showing the match between CHAP's standards and ours)
incorporating all the changes necessitated by our requests.
III. Results of Evaluation
We completed a standard-by-standard comparison of CHAP's conditions
or requirements for hospices to determine whether they met or exceeded
Medicare requirements. We found that, after requested revisions were
made, CHAP's requirements for hospices did meet or exceed our
requirements. In addition, we visited the corporate headquarters of
CHAP to validate the information it submitted and to verify that its
administrative systems could adequately monitor compliance with its
standards and survey processes and that its decision-making
documentation and processes met our standards. We also observed a
survey in real time to see that it met or exceeded our standards. As a
result of our review of the documents and observations, we requested
certain clarifications to CHAP's survey and communications processes.
These clarifications were provided as indicated above, and changes were
made to the documentation in the applications. Therefore, we recognize
CHAP as a national accreditation organization for hospices that request
participation in the Medicare program, effective April 20, 1999 through
November 20, 2003.
IV. Paperwork Reduction Act
This document does not impose any information collection and record
keeping requirements subject to the Paperwork Reduction Act (PRA).
Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB) under the authority of the PRA. The
requirements associated with granting and withdrawal of deeming
authority to national accreditation, codified in part 488, ``Survey,
Certification, and Enforcement Procedures,'' are currently approved by
OMB under OMB approval number 0938-0690, with an expiration date of
August 31, 1999.
V. Regulatory Impact Statement
We have examined the impacts of this notice as required by
Executive Order 12866 and the Regulatory Flexibility Act (RFA) (P.L.
96-354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects; distributive impacts; and equity). The RFA requires agencies
to analyze options for regulatory relief for small businesses. For
purposes of the RFA, States and individuals are not considered small
entities.
Also, section 1102(b) of the Act requires the Secretary to prepare
a regulatory impact analysis for any notice that may have a significant
impact on the operations of a substantial number of small rural
hospitals. Such an analysis must conform to the provisions of section
604 of the RFA. For purposes of section 1102(b) of the Act, we consider
a small rural hospital as a hospital that is located outside of
[[Page 19379]]
a Metropolitan Statistical Area and has fewer than 50 beds.
This notice merely recognizes CHAP as a national accreditation
organization for hospices that request participation in the Medicare
program. As evidenced by the following data for the cost of surveys,
there are neither significant costs nor savings for the program and
administrative budgets of Medicare. Therefore, this notice is not a
major rule as defined in Title 5, United States Code, section 804(2)
and is not an economically significant rule under Executive Order
12866.
Therefore, we have determined, and the Secretary certifies, that
this notice will not result in a significant impact on a substantial
number of small entities and will not have a significant effect on the
operations of a substantial number of small rural hospitals. Therefore,
we are not preparing analyses for either the RFA or section 1102(b) of
the Act.
In fiscal year 1996, there were 2,148 certified hospices
participating in the Medicare program. We conducted 258 initial
surveys, 322 recertification surveys (both at a cost of $634,904), and
145 complaint surveys.
In fiscal year 1997, there were 2,270 certified hospices. This was
an increase of 122 facilities. We conducted 180 initial surveys, 354
recertification surveys (both at a cost of $330,686), and 237 complaint
surveys.
In fiscal year 1998, there were 2,290 certified hospices. This was
an increase of 20 facilities. We conducted 126 initial surveys, 196
recertification surveys (both at a cost of $360,783), and 201 complaint
surveys.
As the data above indicate, the number of hospices and the cost for
conducting hospice surveys by State agencies are increasing. There was
a 6.6 percent increase in hospices within 3 years (fiscal years 1996
through 1998). The fiscal year 1999 appropriation for hospice survey
activities was not increased, and these surveys were included within
the lowest priority category. This appropriation does not allow
sufficient resources for some regions to meet the survey demand,
especially for resurvey activity, which remains a small proportion of
eligible facilities (less than 9 percent for a maximum resurvey once
every 12 years). Hospices accredited by CHAP would be surveyed every 3
years. The numbers of participating providers continue to increase. In
an effort to better assure the health, safety, and services of
beneficiaries in hospices already certified, as well as to provide
relief to State budgets in this time of tight fiscal constraints, we
deem hospices accredited by CHAP as meeting our Medicare requirements.
Thus, we continue our focus on assuring the health and safety of
services by providers and suppliers already certified for participation
in a cost-effective manner.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by OMB.
Authority: Section 1865(b)(3)(A) of the Social Security Act (42
U.S.C. 1395bb(b)(3)(A)).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance)
Dated: March 1, 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 99-9802 Filed 4-19-99; 8:45 am]
BILLING CODE 4120-01-P