Medicare and Medicaid Programs: Hospice Conditions of Participation, 30840-30893 [05-9935]
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 418
[CMS–3844–P]
RIN 0938–AH27
Medicare and Medicaid Programs:
Hospice Conditions of Participation
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
SUMMARY: This proposed rule would
revise the existing conditions of
participation that hospices must meet to
participate in the Medicare and
Medicaid programs. The proposed
requirements focus on the care
delivered to patients and their families
by hospices and the outcomes of that
care. The proposed requirements
continue to reflect an interdisciplinary
view of patient care and allow hospices
flexibility in meeting quality standards.
These changes are an integral part of the
Administration’s efforts to achieve
broad-based improvements in the
quality of health care furnished through
the Medicare and Medicaid programs.
DATES: We will consider comments if
we receive them at the appropriate
address, as provided below, no later
than 5 p.m. on July 26, 2005.
ADDRESSES: In commenting, please refer
to file code CMS–3844–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
three ways (no duplicates, please):
1. Electronically. You may submit
electronic comments to https://
www.cms.hhs.gov/regulations/
ecomments (attachments should be in
Microsoft Word, WordPerfect, or Excel;
however, we prefer Microsoft Word).
2. By mail. You may mail written
comments (one original and two copies)
to the following address ONLY: Centers
for Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3844–P, P.O.
Box 8010, Baltimore, MD 21244–8010.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
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please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to leave their comments in
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a proof of filing by stamping in and
retaining an extra copy of the comments
being filed.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by mailing
your comments to the addresses
provided at the end of the ‘‘Collection
of Information Requirements’’ section in
this document.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Mary Rossi-Coajou, (410) 786–6051.
Danielle Shearer, (410) 786–6617.
Steve Miller, (410) 786–6656.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this rule to assist us in fully
considering issues and developing
policies. You can assist us by
referencing the file code CMS–3844–P
and the specific ‘‘issue identifier’’ that
precedes the section on which you
choose to comment.
Inspection of Public Comments:
Comments received timely will be
available for public inspection as they
are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Introduction
As the single largest payer for health
care services in the United States, the
Federal Government assumes a critical
responsibility for the delivery and
quality of care furnished under its
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programs. Historically, we have adopted
a quality assurance approach that has
been directed toward identifying health
care providers that furnish poor quality
care or fail to meet minimum Federal
standards. These problems would either
be corrected or would lead to the
exclusion of the provider from
participation in the Medicare or
Medicaid programs. However, we have
found that this problem-focused
approach has inherent limits. Ensuring
quality through the enforcement of
prescriptive health and safety standards,
rather than improving the quality of care
for all patients, has resulted in our
expending much of our resources on
dealing with marginal providers, rather
than on stimulating broad-based
improvements in quality of care.
Eliciting quality health care for
Federal beneficiaries from CMS-certified
providers and suppliers requires taking
advantage of continuing advances in the
health care delivery field. As a result,
we are revising the Medicare hospice
requirements, which are also used by
Medicaid, to focus on a patientcentered, outcome-oriented process that
promotes patient care foremost, rather
than penalizing unproductive providers.
We have developed a set of core
requirements for hospice services that
encompass the following: Patient rights,
comprehensive assessment, and patient
care planning and coordination by a
hospice interdisciplinary group (IDG).
Overarching these requirements is a
quality assessment and performance
improvement program that builds on the
philosophy that a provider’s own
quality management system is key to
improved patient care performance. The
objective is to achieve a balanced
regulatory approach by ensuring that a
hospice furnishes health care that meets
essential health and quality standards,
while ensuring that it monitors and
improves its own performance.
To achieve this objective, we are
working to revise not only the hospice
requirements but the requirements for
several other major health care provider
types, such as hospitals, home health
agencies, and end-stage renal disease
facilities, through separate rules. All of
the revised requirements are directed
towards improving patient outcomes of
care and satisfaction.
II. Background
A. The Medicare Hospice Benefit
Hospice care is an approach to caring
for the terminally ill individual that
provides palliative care rather than
traditional medical care and curative
treatment. Palliative care is treatment
for the relief of pain and other
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uncomfortable symptoms through the
appropriate coordination of all aspects
of care needed to maximize personal
comfort and relieve distress. Hospice
care allows the patient to remain at
home as long as possible by providing
support to the patient and family, and
keeping the patient as comfortable as
possible while maintaining his or her
dignity and quality of life. A hospice
uses an interdisciplinary approach to
deliver medical, social, physical,
emotional, and spiritual services
through the use of a broad spectrum of
caregivers.
Section 122 of the Tax Equity and
Fiscal Responsibility Act of 1982
(TEFRA), Public Law 97–248, added
section 1861(dd) to the Social Security
Act (the Act) to provide coverage for
hospice care to terminally ill Medicare
beneficiaries who elect to receive care
from a Medicare-participating hospice.
Under the authority of section
1861(dd) of the Act, the Secretary has
established the Conditions of
Participation (CoPs) that a hospice must
meet to participate in Medicare and/or
Medicaid, and these are currently set
forth at 42 CFR part 418. The CoPs
apply to a hospice as an entity as well
as to the services furnished to each
individual under hospice care. Under
section 1861(dd) of the Act, the
Secretary is responsible for ensuring
that the CoPs, and their enforcement,
are adequate to protect the health and
safety of individuals under hospice care
and to promote the effective and
efficient use of Medicare funds. To
implement this requirement, State
survey agencies conduct surveys of
hospices to assess their compliance with
the CoPs.
B. Why Revise the Conditions of
Participation?
The hospice CoPs were originally
promulgated on December 16, 1983 (48
FR 56008) and were amended on
December 11, 1990 (55 FR 50831)
largely to implement provisions of
section 6005(b) of the Omnibus Budget
Reconciliation Act of 1989 (Pub. L. 101–
239). However, many of the current
CoPs have remained unchanged since
their inception.
We are proposing changes to the
current CoPs based on four main
considerations. First, we considered the
suggestions that emerged from the
Secretary’s Advisory Committee on
Regulatory Reform. In an effort to make
regulations more predictable and
responsive to relevant stakeholders, the
Committee heard public testimony on a
variety of hospice related topics and
developed recommendations to address
key issues that were highlighted. The
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two largest changes that resulted from
the Committee’s recommendations are
the clarification of the relationship
between nursing facilities and hospices
at proposed § 418.112, and the changes
to the nursing services standard at
proposed § 418.110(b).
Our second consideration was the
Balanced Budget Act of 1997 (Pub. L.
105–33) because it made changes to the
hospice statute that need to be
incorporated into the CoPs.
Our third consideration was
prompted by sections 408 and 946 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (Pub. L. 108–173). Section 408
amended the Social Security Act to
permit a nurse practitioner to be
deemed a patient’s attending physician
when the patient elects hospice care.
Section 946 amended section 1861(dd),
Hospice Care: Hospice Program, of the
Act to permit a hospice to enter into an
arrangement with another hospice to
provide core hospice services, or to
provide highly specialized services of a
registered professional nurse, in certain
circumstances.
Finally, this revision is part of a larger
effort to bring about improvements in
the quality of care furnished to
Medicare and Medicaid beneficiaries
through an outcome-oriented approach
to quality of care responsibilities. The
existing hospice CoPs do not contain
patient-centered, outcome-oriented
standards, nor do they provide for the
operation of a quality assessment and
performance improvement program.
Historically, we have established
requirements for participation in the
Medicare program that address the
structure and process of health care.
These early requirements are the result
of professional consensus. Enforcing
structure and process requirements by
identifying deficient providers has not
been adequate to meet the growing
challenges associated with the changing
hospice care environment. For example,
rather than focusing on the relationship
between the needs of patients and the
staff available in an inpatient facility,
the current regulations require that a
registered nurse be present on every
shift. Hospices often contract with local
nursing facilities to provide inpatient
respite care, and these facilities are only
required to have a registered nurse on
duty for a single eight hour shift each
day. A hospice would have to
supplement the nursing facility’s staff
with its own, at a significant cost to the
hospice, even if the needs and acuity of
the patient do not require a registered
nurse. A hospice that did not
supplement the facility’s staff could be
cited for not meeting the requirements,
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even though the requirements had no
relevance to the needs of the patient.
Thus, revisions to the hospice CoPs are
essential.
C. Transforming the Hospice Conditions
of Participation
Before developing these proposed
CoPs for hospices, we received advice
and suggestions from the hospice
industry, professional associations,
practitioner communities, consumer
advocates, and State and other
governmental agencies with an interest
in, or responsibility for, hospice
regulation and oversight. Based on these
suggestions, we have developed the
following principles:
• Focus on the continuous, integrated
health care process that a patient/family
experiences across all aspects of hospice
care, and on activities that center
around patient assessment, care
planning, service delivery, and quality
assessment and performance
improvement.
• Use a patient-centered,
interdisciplinary approach that
recognizes the contributions of various
skilled professionals and other support
personnel and their interaction with
each other to meet the patient’s needs.
• Incorporate an outcome-oriented
quality assessment and performance
improvement program.
• Facilitate flexibility in how a
hospice meets performance
expectations.
• Require that patient rights are
ensured.
• Use performance measurement
systems to evaluate and improve care.
Based on these principles, we are
proposing to set forth four core
conditions of participation: Patient
Rights, Patient/Family Assessment,
Interdisciplinary Care Planning and
Coordination of Services, and Quality
Assessment and Performance
Improvement.
• The Patient Rights CoP emphasizes
a hospice’s responsibility to respect and
promote the rights of each hospice
patient.
• The comprehensive Patient/Family
Assessment CoP reflects the critical
nature of a comprehensive assessment
in determining appropriate treatments
and accomplishing desired health
outcomes.
• The Care Planning and
Coordination of Services CoP
incorporates the interdisciplinary team
approach to providing hospice care.
• The Quality Assessment and
Performance Improvement CoP charges
each hospice with the responsibility for
carrying out a performance effort to
effect continuing improvement in the
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quality of care it furnishes to its patients
and their families.
The last three requirements establish
a cycle of individual care and hospicewide performance improvement. First,
the patient’s needs are comprehensively
assessed and outcome measure data are
collected. Second, the interdisciplinary
group, in consultation with the patient’s
attending physician, establishes a plan
of care to address those needs. Third,
the plan of care is implemented and the
results of the care are evaluated through
updates of the comprehensive
assessment and plan of care. Fourth, the
outcome measure data collected during
the initial and updated comprehensive
assessments are analyzed to identify
practices that lead to positive outcomes
as well as opportunities for
improvement. Finally, the hospice uses
the results of such analyses to
implement performance improvement
activities. These activities will influence
the establishment of plans of care and
their implementation, thus creating a
continuous cycle of individual care and
an ongoing effort to improve the
hospice’s performance related to
identified outcomes of care for all
patients.
This cycle of care adapts to changing
standards of practice while addressing
issues that surveyors have identified.
Below is a list of the most cited
deficiencies found by surveyors (year
ending September 3, 2002):
1. Plan of care was not complete.
2. No written plan was established.
3. Plan was not reviewed at specific
intervals.
4. Plan did not include an assessment
of needs.
5. Plan was not established before
providing care.
6. RN supervisory visits were not
made for home health aide services.
7. No plan of care was included for
bereavement services.
8. Hospice did not conduct a selfassessment of quality and care provided.
9. Clinical record was not maintained
for every patient.
10. Interdisciplinary group did not
review and update the plan of care for
each patient.
We note that 8 of the 10 top
deficiencies are related to plan of care,
assessment, and quality assurance.
Based on industry comments and our
own surveys, we believe that the current
plan of care condition contained in
§ 418.58 must be strengthened. We did
this by creating a separate condition for
the assessment of individual needs and
for the time frames related to that
assessment. We also revised the quality
assurance requirement and strengthened
the plan of care requirement.
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These requirements would focus
provider and surveyor efforts on the
actual care delivered to the patient, the
performance of the hospice as an
organization, and the impact of the
medical, physical, social, emotional,
and spiritual care delivered to the
patient.
We are proposing to retain some of
the current process-oriented
requirements when they are likely to
produce desirable outcomes and/or
prevent harmful outcomes. These
proposed CoPs invest in hospices the
responsibility for improving patient care
performance, rather than relying on an
externally based approach where
prescriptive requirements are enforced
through the punitive aspects of the
survey process.
This change signals an opportunity
for CMS, hospices, and States to join in
a partnership for improvement. When
implemented, hospice programming
will reflect a patient-centered, outcomeoriented approach that will likely alter
the manner in which CMS and States
manage the survey process. We believe
that this approach will provide
opportunities for improvement in
patient care that have been lacking in
the past. The addition of a strong quality
assessment and performance
improvement requirement will
stimulate the hospice to continuously
monitor its performance and find
opportunities for improvement.
D. Development of Outcome-Based
Performance Measures for Hospices
[If you choose to comment on issues in
this section, please include the caption
‘‘OUTCOME-BASED PERFORMANCE
MEASURES’’ at the beginning of your
comments.]
We are proposing to require that
hospices implement an outcome-based
internal performance improvement
program that can be used to measure
individual patient outcomes. The
information a hospice gleans from its
own data analysis will serve as a
baseline for hospice quality
improvement. Measures quantify quality
and are tools for the hospice to use in
assessing and improving patient care,
outcomes, and satisfaction. An outcome
based performance program can help
hospices improve the effectiveness and
efficiency of their services, improve the
outcomes of care they provide, and
increase patient satisfaction with their
services.
Hospice outcome measures, data
elements, tools, and instructions for
using them have already been
developed by the industry. A Task Force
initiative was sponsored and convened
by the National Hospice Work Group
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(NHWG) and the National Hospice and
Palliative Care Organization (NHPCO) in
1999. We participated in the
development of the measures and
provided technical assistance for pilot
testing of the measures. The Task Force
was invited to present the results of the
measurement development work and
results of the pilot studies to us in
November 2000.
The work of the Task Force resulted
in four measures for the outcome
domains of self-determination, comfort,
safety, and effective grieving. The
hospice industry rapidly moved to
include these four measures in the data
set that they encourage member
hospices to use and report. The data
elements and instructions for using the
measures are publicly available on the
NHPCO Web site at https://
www.nhpco.org.
These outcome-based measures are
part of a national reporting process
created by the hospice industry. If a
hospice chooses to participate in the
NHCPO process, it submits its data to
the NHPCO (or its contractor). Reports
are then generated for a hospice to
compare its performance with other
hospices. The hospice may also choose
to send additional information for the
NHPCO reporting process in the areas of
pertinent utilization data,
appropriateness and effectiveness of
services, and patient/family satisfaction.
All hospices that participate in the
NHPCO reporting process must comply
with regulations mandated by the
Health Insurance Portability and
Accountability Act of 1996 (Pub.L. 104–
191, ‘‘HIPAA’’). Regulations
implementing HIPAA were published
on December 28, 2000 (65 FR 82462)
and were amended on August 14, 2002
(67 FR 53182).
We are not proposing to require that
hospices participate in the NHPCO
process described above, but hospices
may choose to use some of the measures
the NHPCO is already using as part of
its comprehensive assessment of the
patient, and as part of the organization’s
quality assessment and performance
improvement program. Hospices may
also develop their own data elements
and measurement processes.
Participating in the NHPCO outcome
measurement and reporting process
would assist hospices in meeting the
requirements of proposed § 418.54(e). At
this time, we are neither proposing that
hospices use any particular measures of
outcomes, nor that they report data to
us. However, we may consider doing so
in the future.
We invite comments from the public
on this aspect of the proposed rule.
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III. Provisions of the Proposed
Regulations
A. Overview
Under our proposal, the hospice
conditions of participation would
continue to be set forth in regulations
under 42 CFR part 418. However, since
many of the existing requirements in
part 418 would be revised, consolidated
with other requirements, or eliminated,
we are proposing changes to the existing
organizational scheme. A significant
change would be to group all CoPs
directly related to patient care and place
them together in a separate subpart.
CoPs concerning hospice organization
and administration would be contained
in another subpart. We believe that this
proposed organization better reflects a
patient/family-centered orientation and
helps illustrate that patient assessment,
care planning, and quality assessment
and improvement efforts are central to
the delivery of high quality care.
B. Subpart A, General Provisions
The revised conditions would begin
with existing § 418.2 that specifies the
statutory authority and scope of the part
for the ensuing regulations. Section
418.1 would remain unchanged.
1. Scope of the Part (Proposed § 418.2)
Section 418.2 would be revised to
reflect the reorganization of the part and
to include an introductory statement
describing the purpose of the part.
2. Definitions (Proposed § 418.3)
Existing § 418.3 sets forth definitions
for terms used in the hospice CoPs. This
section is being revised in order to
provide further clarification. We are
proposing to move existing definitions
of ‘‘physician’’ and ‘‘social worker’’ to
proposed § 418.114, personnel
requirements. We believe these
definitions better fit in this new
condition. We propose to include the
following definitions:
• Attending physician (revised)
• Bereavement counseling (revised)
• Cap Period (same)
• Clinical note (new)
• Drug restraint (new)
• Employee (revised)
• Hospice (revised)
• Hospice care (new)
• Licensed professional (new)
• Palliative care (new)
• Physical restraint (new)
• Progress note (new)
• Representative (revised)
• Restraint (new)
• Satellite location (new)
• Seclusion (new)
• Terminally ill (revised)
These definitions would be revised to
read as follows:
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Attending physician means a—
(a)(1) Doctor of medicine or
osteopathy legally authorized to practice
medicine and surgery by the State in
which he or she performs that function
or action; or (2) Nurse practitioner who
meets the training, education and
experience requirements as the
Secretary may prescribe; and
(b) Is identified by the individual, at
the time he or she elects to receive
hospice care, as having the most
significant role in the determination and
delivery of the individual’s medical
care.
Here after, except as indicated, the
term ‘‘attending physician’’ includes
nurse practitioners.
We modified this definition to
address changes made to the Act by
Congress in section 408 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108–
173) (‘‘MMA’’). Nurse practitioners are
often the primary medical health care
professionals for some patients,
particularly those residing in rural
areas. For example, a nurse practitioner
that works in conjunction with a doctor
may be the health care professional a
patient sees most often. The patient
would develop a relationship with the
nurse practitioner, and would like the
nurse practitioner to continue to be
involved in his or her care once he or
she elects the hospice benefit. Under the
current regulations, this is not allowed.
Under the proposed regulations, we
would permit a nurse practitioner to
continue serving his or her patient as
that patient’s attending physician once
that patient elects to receive hospice
care. We believe that this would ensure
the continuity of care and improve the
quality of care because the health care
professional most familiar with the
patient, his or her conditions, and his or
her personal situation would be
involved in developing the plan of care
and in making other important
decisions.
Within the provisions of section 408
of the MMA nurse practitioners are
prohibited from certifying or
recertifying a patient’s terminal illness.
CMS will publish additional
information regarding section 408 in a
forthcoming Federal Register document.
Bereavement counseling means
emotional, psychosocial, and spiritual
support and services provided after the
death of the patient to assist with issues
related to grief, loss, and adjusting.
Cap period means the 12-month
period ending October 31 used in the
application of the cap on overall
hospice reimbursement as specified in
§ 418.309.
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Clinical note means a notation of a
contact with the patient that is written
and dated by any person providing
services, and that describes signs and
symptoms, treatments and medications
administered, including the patient’s
reaction and/or response, and any
changes in physical or emotional
condition.
Drug restraint means a medication
used to control behavior or to restrict
the patient’s freedom of movement
which is not a standard treatment for a
patient’s medical or psychiatric
condition.
Employee means a person who works
for the hospice and for whom the
hospice is required to issue a W–2 form
on his or her behalf, or if the hospice is
a subdivision of an agency or
organization, an employee of the agency
or organization who is appropriately
trained and assigned to the hospice or
is a volunteer under the jurisdiction of
the hospice.
Hospice means a public agency or
private organization or subdivision of
either of these that is primarily engaged
in providing hospice care as defined in
this section.
Hospice care means a comprehensive
set of services described in 1861(dd)(1)
of the Act, identified and coordinated
by an interdisciplinary team to provide
for the physical, psychosocial, spiritual,
and emotional needs of a terminally ill
patient and/or family members, as
delineated in a specific patient plan of
care.
Licensed professional means a
licensed person sanctioned by the State
in which services are delivered,
furnishing services such as skilled
nursing care, physical therapy, speechlanguage pathology, occupational
therapy, and medical social services.
Palliative care means patient and
family-centered care that optimizes
quality of life by anticipating,
preventing, and treating suffering.
Palliative care throughout the
continuum of illness involves
addressing physical, intellectual,
emotional, social, and spiritual needs
and to facilitate patient autonomy,
access to information, and choice.
Physical restraint means any manual
method or physical or mechanical
device, material, or equipment attached
to the patient’s body that he or she
cannot easily remove that restricts
freedom of movement or normal access
to one’s body.
Progress note means a written
notation, dated and signed by any
person providing services, that
summarizes facts about the care
furnished and the patient’s response
during a given period of time.
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Representative means an individual
who has the authority under State law
(whether by statute or pursuant to an
appointment by the courts of the State)
to authorize or terminate medical care
or to elect or revoke the election of
hospice care on behalf of a terminally ill
patient who is mentally or physically
incapacitated. This may include a legal
guardian.
Restraint means either a physical
restraint or a drug used as a restraint.
Satellite location means a Medicareapproved location from which the
hospice provides hospice care and
services within a portion of the total
geographic area served by the hospice
provider issued the provider agreement
number. The satellite location is part of
the hospice and shares administration,
supervision, and services in a manner
that renders it unnecessary for the
satellite location to independently meet
the conditions of participation as a
hospice.
We are proposing to add this
definition to recognize long-standing
Medicare survey and certification
policies, which allow for the operation
of multiple locations by a single hospice
provider. We are proposing that a
hospice satellite location be approved
by CMS before it begins to furnish
service to patients. In the past, some
hospices were found to be furnishing
services from locations that had not
been shown to be in compliance with
applicable regulations. We envision the
approval process to be consistent with
determining that patients receive safe
services from the satellite location in
question. As is done for other
appropriate providers and suppliers, we
are accepting comment on applying the
Medicare Appeals Procedures that affect
participation in the Medicare program
(42 CFR 498.3). If a hospice, including
any or all satellite locations, is
accredited by an accrediting
organization such as JCAHO or CHAP,
the hospice and each satellite location
must still receive Medicare approval.
Seclusion means the confinement of a
person in a room or an area where a
person is isolated and physically
prevented from leaving.
Terminally ill means that a patient has
a medical prognosis that his or her life
expectancy is six months or less if the
illness runs its normal course.
C. Subpart B, Eligibility, Election and
Duration of Benefits
Subpart B concerns eligibility,
election, and duration of hospice
benefits. We are not proposing changes
to this subpart at this time.
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D. Subpart C, Conditions of
Participation—Patient Care
1. Patient’s Rights, Condition of
Participation (Proposed § 418.52)
[If you choose to comment on issues in
this section, please include the caption
‘‘PATIENTS RIGHTS’’ at the beginning
of your comments.]
This section would replace the
current condition of participation,
Informed consent, laid out at § 418.62.
This condition would set forth certain
rights to which hospice patients would
be entitled, and would require that
hospices inform each patient of these
rights and that hospice personnel ensure
and support these rights. Among these
rights would be the following, laid out
at proposed § 418.52: Being informed in
advance regarding the care to be
provided; having an opportunity to
participate in care planning; voicing
grievances; being assured of
confidentiality of records; having
personal property respected; being
informed whether services are covered
or not covered, and having information
provided in writing. We are proposing
to specify that the patient must also be
informed about factors that affect
palliation and comfort. We believe that
these revisions would act as an
additional safeguard of patient health
and safety. Open communication
between hospice staff and the patient,
and patient access to palliative
information is vital to enhancing the
patient’s participation in his or her
coordinated care planning. All hospices
must also comply with the Privacy Rule
published in the Federal Register on
December 28, 2000 (65 FR 82461) as
amended on August 14, 2002 (67 FR
53182) and contained in 45 CFR parts
160 and 164.
We are specifically soliciting public
comment on this proposed condition of
participation.
2. The Cycle of Care: Assessment,
Planning, and Delivery (Proposed
§ 418.54 Through § 418.62)
The patient care assessment,
planning, and palliative care process
represented by the next four CoPs
(§ 418.54 through § 418.62) can be seen
as a cycle. Through the use of a
comprehensive assessment, accurate
and timely patient information is made
available for use in the patient care
process. The palliative care process
consists of all hospice care and services
furnished to the patient and family. The
patient palliative care process results in
an effect on the patient’s condition,
whether it is positive or negative. The
assessment of the effectiveness of
palliative care then results in
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subsequent care decisions, and the cycle
begins anew. Through this cycle,
accurate patient and family information
obtained from each comprehensive
assessment should yield effective and
appropriate palliative care decisions,
thus generating a positive effect on
patient care and desired outcomes.
Condition of Participation:
Comprehensive Assessment of the
Patient (Proposed § 418.54)
The proposed comprehensive
assessment requirement reflects our
view that a patient-centered,
interdisciplinary, and systematic patient
assessment is essential to improving
patient quality of care and patient
outcomes.
In hospice care, the comprehensive
assessment of the patient contributes to
quality of care improvements in closely
linked stages. First, the information
generated from an interdisciplinary
comprehensive assessment is a vital tool
for developing a hospice patient’s plan
of care that will guide decisions on how
best to determine the individual care
and support needs of the patient.
Second, based on updates of the
comprehensive assessment, a hospice is
able to track the patient’s progress
towards achieving the desired care
outcomes, and where this does not
occur, make appropriate changes to the
patient’s plan of care. Finally, the
hospice is able to evaluate the results of
its care decisions, thus yielding
information to help form the hospice’s
future care planning process. We believe
this approach reflects contemporary
standard practice for many hospices,
and we are proposing to revise the CoPs
to support this outcome-oriented
approach.
The centerpiece of this outcomeoriented approach is that each patient
receives a patient-specific
comprehensive assessment that
identifies the patient’s need for medical,
nursing, psychosocial, emotional and
spiritual care. The care needs identified
in the assessment would include, but
not be limited to, those necessary for
palliation and management of the
terminal illness and related medical
conditions. The comprehensive
assessment would be completed by the
interdisciplinary group in consultation
with the individual’s attending
physician to ensure that each member of
the interdisciplinary group provided
input within the scope of that
individual’s practice. We believe that
the patient-specific comprehensive
assessment requirement we are
proposing is already recognized and
practiced by the hospice industry in
general.
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The existing CoPs contain few
requirements that address the need for
patient assessment; therefore, we are
emphasizing the importance of the
comprehensive assessment by
establishing it as a separate CoP. In
hospice surveys nationwide, we have
identified a pattern of healthcare related
deficiencies that indicate that the
current assessment requirements are not
sufficient. The fourth most frequently
cited deficiency is that the plan of care
did not include an assessment of the
patient’s needs. The frequency with
which this area is cited indicates that
there are a significant number of
hospices that are not doing enough to
properly assess their patients.
The expanded assessment condition
would guide these deficient hospices in
thoroughly assessing their patients by
identifying the general areas that should
be included in each assessment and by
identifying time frames for the
completion of assessments. We believe
that this proposed CoP would enable
hospices to specifically identify patient
care needs. Once a hospice has
completed a timely and thorough
assessment of the patient, it can develop
an accurate plan of care that reflects the
needs identified during the assessment.
The accuracy and timeliness of the plan
of care may lead to an improvement in
the quality of the hospice experience for
the patient and his or her family.
In addition, we believe that the broad
assessment outline we are proposing
will encourage hospices to exercise
flexibility in determining how best to
achieve positive outcomes. We believe
that this approach is consistent with
currently accepted practices in
hospices.
In § 418.54(a), Initial assessment, we
are proposing that a registered nurse
make the initial assessment visit to
determine the patient’s immediate care
and support needs within 24 hours after
the hospice receives a physician’s
admission order for care (unless another
date is specified by the physician). We
realize that some hospices meet with
patients and their families, at their
request, before the actual admission for
care orders are received, and this
regulation would not prevent this
practice. However, meeting with a
patient and his or her family before the
patient’s physician orders hospice care
would not satisfy the initial assessment
requirement.
In § 418.54(b), Time frame for
completion of the comprehensive
assessment, we are proposing that the
hospice interdisciplinary group, in
consultation with the hospice medical
director or physician designee and/or
the individual’s attending physician,
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complete the comprehensive assessment
in a timely manner consistent with the
patient’s immediate needs, but no later
than 4 calendar days after the patient
elects the hospice benefit. We believe
that most hospices already complete the
assessment within this time frame and,
due to the decreased length of stay, as
explained in the discussion of
§ 418.54(d), Update of the
comprehensive assessment, and the
potential severity of the patient’s
condition, we believe it is essential to
ensure that patients are assessed in a
timely manner.
Section § 418.54(c), Content of the
comprehensive assessment, would
describe the requirements for the
content of the comprehensive
assessment that we believe are critical to
quality hospice care. These content
requirements are at the core of hospice
care and are needed to evaluate the
patient’s need for physical, social,
emotional, medical, and spiritual care.
Under proposed § 418.54(c)(3)(ii),
Drug therapy, the patient’s
comprehensive assessment would have
to‘include a review of the patient’s
current medication. The review and
accompanying documentation would
include identification of the following
items:
• Ineffective drug therapy;
• Unwanted side and toxic effects;
and
• Drug interactions.
This review must be repeated as
necessary to ensure that the patient
continues to receive drug therapy that is
effective and appropriate for his or her
needs. A review of a patient’s drugs
would be included in the initial
assessment and in the development of
the plan of care. This review could
occur at any time, but specifically when
a patient is prescribed or begins to take
any new drug and/or when use of a drug
is discontinued.
In § 418.54(d), Update of the
comprehensive assessment, we are
proposing that the comprehensive
assessment be updated by the
interdisciplinary group as frequently as
the patient’s condition requires, but no
less frequently than every 14 days. We
believe that these frequent reviews are
necessary and predictive of quality
outcomes for two reasons:
(1) In the terminal stages of care,
patient status needs, circumstances, and
family expectations can change greatly,
affecting the type and frequency of
services that should be furnished.
Reassessments assist the hospice in
developing a more responsive care plan.
The interdisciplinary group would use
assessment information to guide
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necessary reviews and/or changes to the
patient’s plan of care.
(2) We are proposing that a hospice
medical director or physician designee
be required to recertify a patient for
hospice care at specific intervals as
stated in § 418.21. We believe
recertification, which occurs at the end
of the initial and subsequent 90-day
benefit periods (and at the end of the
remaining benefit periods as described
in § 418.21), serves as a logical point for
updating an assessment in addition to
the minimum 14 days and when the
patient’s condition changes.
We believe that to ensure quality and
timely care for our hospice
beneficiaries, timely completion of the
initial assessment requirement and the
comprehensive assessment update
requirement is necessary. In 2001 the
average length of enrollment in hospice
care was 51 days (2002 Nov. Medicare
National Summary for HHA, Hospice,
SNF, and outpatient CY 1999–2001,
https://www.cms.hhs.gov/statistics/
feeforservice/National Summary.pdf).
According to research by the NHPCO, in
2000 the average length of enrollment in
hospice care was 48 days (2000 NHPCO
National Data Set Summary Report,
2001 Nov.). There has been some
concern regarding short lengths of stay.
Hospices have been admitting patients
late in their terminal illness and those
patients need extensive hospice services
and resources initially, and right before
death. In order to ensure that patients
receive the necessary services and thus
begin to benefit from hospice care at the
earliest time possible, we believe that it
is important that the comprehensive
patient assessment be completed within
the time frame that we have proposed.
A delay in completing the initial
comprehensive assessment and the
updated assessments is ultimately not as
beneficial to the patient and family as if
the patient had entered hospice care and
received timely assessments to
determine the proper care to be
provided.
These requirements, though processoriented in part, are predictive of good
patient care and safety. Our rationale for
requiring the completion of the initial
comprehensive assessment is that a new
patient being referred to a hospice for
initiation of services is at a point of
immediate need and often in crisis.
Likewise, maintaining an ineffective
plan of care could jeopardize patient
health and safety. Regular assessment
updates would minimize this
possibility.
We believe that the comprehensive
assessment requirements pose little or
no burden for hospices because it is a
current standard of practice to
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comprehensively assess hospice
patients. However, we recognize that the
proposed 4-day timeframe for
completing the initial comprehensive
assessment as proposed in § 418.54(b)
and 14-day timeframe for updating the
comprehensive assessment as proposed
in § 418.54(d) may set higher
performance expectations for some
hospices then the self-imposed
standards they currently utilize. We
believe that if a hospice recognizes that
it is not capable of furnishing services
within these timeframes, new patients
should not be accepted for care.
We welcome public comments on the
review of our proposed timeframes for
the initial comprehensive assessment
and updated comprehensive
assessment. We believe the timeframes
are reasonable and consistent with
current hospice practice.
[If you choose to comment on issues in
this section, please include the caption
‘‘ASSESSMENT TIME FRAMES’’ at the
beginning of your comments.]
Under the proposed § 418.54(e),
Patient outcome measures, we are
proposing that a patient’s
comprehensive assessment include
measurement and documentation of
aspects of care that are essential
outcomes of optimal hospice care.
Documentation is carried out in the
same way for all patients through what
we refer to as data elements. The
hospice may develop its own data
elements or use existing, externally
developed data elements. However,
some of the data elements should be
related to the domains of selfdetermination, comfort, safety, and
effective grieving related to bereavement
services. If a hospice chooses to collect
information for the data elements
developed by the NHPCO, it may also
choose to submit this information to the
NHCPO. However, submission must be
in accordance with the HIPAA privacy
rule (45 CFR Parts 160 and 164). The
hospice may also choose to send
additional information for the NHPCO
reporting process in the areas of
pertinent utilization data,
appropriateness and effectiveness of
services, and patient/family satisfaction.
The data elements used by the
hospice must be an integral part of both
the initial comprehensive and updated
assessments. The application of these
data elements to the identified domains
must be documented in a systematic
and retrievable way for each patient, as
the outcome measurements will be used
in patient care planning and
coordinating services. Measurements
will also be used (in the aggregate) for
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the hospice quality assessment and
performance improvement program.
We want to emphasize that we are not
proposing that hospices use any specific
data elements to measure domain
outcomes. We are simply proposing that
hospices collect the data necessary to
evaluate the quality of care they are
providing and use this information in a
systematic and retrievable way.
Hospices may develop their own data
elements related to the aspects of care
related to hospice and palliation, such
as self-determination, comfort, safety,
and effective grieving, or may use the
data elements related to the seven
outcome measures in the NHPCO data
set (https://www.nhpco.org).
Currently, there is insufficient
evidence for a valid and reliable
common set of measures (that is, data
elements) for use in hospice care. We
are aware that the industry is studying
this area. We also know that there are
many measures that are currently used
to help gauge the processes of care for
hospice patients and to make
adjustments to care on their basis. For
example, there are multiple scales for
use in pain management, anxiety, and
depression, and there are several
quality-of-life scales appearing in the
relevant literature (https://
www.nhpco.org and https://
www.chcr.brown.edu/pcoc/toolkit.htm).
Some measurable outcomes can be
captured in single items while others
require multiple items to capture the
full range of measurement issues.
We welcome comments on our
‘‘outcome measures’’ approach to this
proposed regulation. We are particularly
interested in comments as to whether
this approach is necessary in
assessment, care planning, service
delivery, and most importantly, to the
hospice’s quality assessment and
performance improvement program.
[If you choose to comment on issues in
this section, please include the caption
‘‘OUTCOME MEASURES’’ at the
beginning of your comments.]
Condition of Participation:
Interdisciplinary Group Care Planning
and Coordination of Services (Proposed
§ 418.56)
[If you choose to comment on issues in
this section, please include the caption
‘‘PLAN OF CARE’’ or ‘‘COORDINATION
OF SERVICES’’ where appropriate, at
the beginning of your comments.]
The existing condition of
participation concerning the plan of
care is set forth at § 418.58. We are
proposing to revise the contents of this
section and place them in a new
condition, ‘‘Interdisciplinary group care
planning and coordination of services’’
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(proposed § 418.56). The proposed
condition would contain five standards
that reflect the interdisciplinary
approach to hospice care delivery.
As proposed, each patient and family
would have a written plan of care
developed by the hospice
interdisciplinary group in consultation
with the patient’s attending physician
that specifies the hospice care and
services necessary to meet the patient/
family-specific needs identified in the
comprehensive and updated
assessments. All hospice services
furnished to patients and their families
must follow this written plan of care.
Under proposed § 418.56(a),
Approach to service delivery, we are
proposing that the hospice designate an
interdisciplinary group or groups
composed of individuals who work
together to meet the physical, medical,
social, emotional, and spiritual needs of
the hospice patients and families facing
terminal illness and bereavement. We
believe that the role of the
interdisciplinary group is paramount in
directing and monitoring the patient
care and is one of the factors that makes
the hospice benefit unique. The hospice
would designate a qualified health care
professional who is a member of the
interdisciplinary group to provide
program coordination, ensure the
continuous assessment of each patient’s
and family’s needs, and ensure the
implementation and revision of the plan
of care.
The proposed standard at § 418.56(b),
Plan of care, is the same as the existing
standard at § 418.58(a), with one
addition. We are including a reference
to the patient’s family when establishing
the plan of care. We would require that
all hospice services furnished to
patients and their families follow a
written plan of care established by the
hospice interdisciplinary group in
collaboration with the attending
physician. Family plays an important
role in the care of a hospice patient, and
this change reflects that role.
Under the proposed standard at
§ 418.56(c), Content of the plan of care,
we would require that each patient’s
plan of care reflect interventions for
problems identified in the
comprehensive and updated
assessments. This requirement ensures
that care and services are appropriate to
the level of each patient’s and family’s
specific needs. The plan of care must
include the following:
• Interventions to facilitate the
management of pain and symptoms;
• A detailed statement of the scope
and frequency of services required to
meet the patient’s and family’s specific
needs;
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• Measurable outcomes anticipated
from implementing and coordinating
the plan of care;
• Drugs and treatment necessary to
meet the needs of the patient;
• Medical supplies and appliances
required to meet the needs of the
patient; and
• The interdisciplinary group’s
documentation in the clinical record
indicating the patient’s and family’s
understanding, involvement, and
agreement with the plan.
As we noted in the description of the
previous standard, we are proposing to
add a requirement that the plan address
the patient’s and family’s expectations,
understanding, agreement, and ability to
participate in the care as the patient and
family desire. Since family members
need to understand the importance of
their role in care of the hospice patient,
their input and agreement regarding
care is essential in developing a
productive relationship with the
hospice. We would expect a hospice to
document the patient’s and family’s
understanding of and agreement to the
plan of care in accordance with its own
policies. This could include an
attestation signed by the patient and
family, a note in the clinical record,
and/or another form of documentation
decided upon by the hospice governing
body.
Proposed standard § 418.56(d),
Review of the plan of care, would
require that a revised plan of care
include current information from the
patient’s updated comprehensive
assessment and information concerning
the patient’s progress toward achieving
outcomes specified in the plan of care.
The plan of care must be reviewed at
intervals specified in the plan but no
less frequently than every 14 calendar
days. We believe that it is essential to
include the requirement that actual care
provided also be changed as needed,
thus establishing the essential linkage
between assessment information,
evaluation of treatment results, and plan
of care modification.
We also propose to require that the
hospice take steps to involve the
patient’s attending physician in the
review of the patient’s plan of care. The
attending physician often has had a
lengthy relationship with the patient;
and his or her input into the review of
the plan of care can be invaluable. We
do not have the authority in the
Conditions of Participation governing
hospices to require that an attending
physician, an individual who is not an
employee of the hospice and thus not
governed by these hospice regulations,
participate in this process. However, we
can and are proposing that the hospice
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collaborate with the patient’s attending
physician to the extent possible when
reviewing the plan of care. We believe
that requiring hospices to involve
interested attending physicians will
benefit patients by helping to ensure
that the care described in the plan of
care reflects the needs and desires of
patients and their families.
We are proposing to add a new
standard, Coordination of services, at
§ 418.56(e). This standard would require
that the hospice maintain a system of
communication and integration to
enable the interdisciplinary group to
ensure the overall provision of care and
the efficient implementation of the dayto-day policies. These new standards
would also make it easier for the
hospice to ensure that the care and
services are provided in accordance
with the plan of care, and that all care
and services provided are based on the
comprehensive and updated
assessments of the patient’s and family’s
needs. An effective communication
system would also enable the hospice to
ensure ongoing liaison of all disciplines
providing care and services in the home,
outpatient, and inpatient settings,
notwithstanding the manner in which
the care and services are furnished.
We believe that this standard is
appropriate for two reasons. First, a
hospice patient typically encounters
many services delivered at different
times by a variety of individuals with
different skills. An efficient method of
communication and integration of
observations among members of the
interdisciplinary group and others
providing care is essential to meet and
respond to the patient’s and family’s
needs in a timely manner. Second,
effective communication and
coordination of services will assist a
hospice in avoiding a duplication of
effort or a furnishing of conflicting
services.
We recognize the value of an
interdisciplinary approach to the
delivery of hospice services. This
approach to care reflects actual industry
practice, and as a result, we believe the
proposed requirement is in step with
the hospice industry.
We are specifically soliciting public
comment on the proposed requirements
for the content of the plan of care, the
time frames for review of the plan of
care, and the new coordination of
services standard.
Condition of Participation: Quality
Assessment and Performance
Improvement (Proposed § 418.58)
[If you choose to comments on issues in
this section, please include the caption
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‘‘QAPI’’ at the beginning of your
comments.]
The existing § 418.66, Condition of
participation—Quality assurance, relies
on a problem-oriented approach to
identify and resolve patient care issues.
Failure to meet the quality assurance
condition is consistently one of the top
10 deficiencies cited by surveyors
nationwide. According to the hospice
industry associations, hospices are no
longer using the quality assurance
model. During the last decade the health
care industry, including the hospice
industry, has moved beyond the
problem-oriented, after-the-fact
corrective approach of quality assurance
to an approach that focuses on a preemptive plan that continuously
addresses quality assessment and
performance improvement (QAPI).
Hospice industry associations have
indicated that their upgraded QAPI
systems are incompatible with the
existing quality assurance condition.
Therefore, the providers who have
moved beyond quality assurance in
order to make meaningful and sustained
quality improvements in their own
programs are actually in violation of the
outdated quality assurance condition.
On the other end of the spectrum are
providers who are truly deficient
because they do not have any quality
program. These providers would find
more guidance in the proposed
regulation. In the following section of
this preamble we will discuss two
publicly available resources for data
measures, an integral part of the
proposed QAPI requirement. In the
proposed regulation we have outlined
when those should be collected and
what role they play in the proposed
QAPI condition. In addition, we have
described the scope of the proposed
QAPI program requirement, the
guidelines for identifying performance
improvement activities, and the
individuals responsible for ensuring
that a hospice has a QAPI program. The
proposed regulations provide hospices
that are unsure of what is expected of
them with the guidelines to begin
tailoring a QAPI program that meets
their needs and circumstances.
Therefore, we believe that this
proposed condition will reduce the
number of deficient providers by
recognizing those who are practicing
QAPI and guiding reluctant providers to
meet current standards of practice. The
proposed QAPI requirement would raise
the performance expectations for
hospices seeking entrance into the
Medicare program, as well the
expectations of those currently
participating in Medicare. We are
proposing that each hospice develop,
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implement, and maintain an effective,
continuous quality assessment and
performance improvement program that
stimulates the hospice to constantly
monitor and improve its own
performance, and to be responsive to the
needs, desires, and satisfaction levels of
the patients and families it serves.
The desired overall outcome of this
proposed CoP is that the hospice will
drive its own quality improvement
activities and improve its provision of
services. With an effective quality
assessment and performance
improvement program in place and
operating properly, the hospice can
better identify and reinforce the
activities it is doing well, identify its
activities that are leading to poor patient
outcomes, and take actions to improve
performance.
This proposed condition requires the
hospice to develop, implement, and
maintain an effective data driven quality
assessment and performance
improvement program (QAPI). The
program establishes a planned approach
to quality improvement and takes into
account the complexity of the hospice’s
organization and services, including
those provided directly or under
arrangement. The hospice must take
whatever actions are necessary to
implement improvements in its
performance as identified by its quality
assessment and performance
improvement program. The hospice is
also responsible for ensuring that the
professional services it offers are carried
out within current clinical practice
guidelines as well as professional
practice standards applicable to hospice
care.
In the first proposed standard under
this condition at § 418.58(a), Standard:
Program scope, we are proposing that
the hospice’s quality assessment and
performance improvement program
must include, but not be limited to, an
ongoing program that is able to show
measurable improvement in indicators
that are linked to improving palliative
outcomes and end-of-life support
services. We expect that a hospice will
use standards of care and the findings
made available in current literature to
select indicators to monitor its program.
The hospice must measure, analyze, and
track these quality indicators, including
areas such as adverse patient events and
other aspects of performance that assess
processes of care, hospice services, and
operations. Adverse patient events, as
used in the field, are occurrences that
are harmful or contrary to the targeted
patient outcomes.
The second proposed standard under
§ 418.58(b) Program data, would require
the hospice program to incorporate
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quality indicator data, including patient
care data and other relevant data, into
its QAPI program. This would include
data that are received from or submitted
to hospice professional organizations. A
fundamental barrier in identifying
quality care at the end of life is the lack
of measurement tools. Measurement
tools can identify opportunities for
improving medical care and examining
the impact of interventions.
CMS does not currently require the
submission of data from hospices to
calculate quality measures but is
interested in the development of a set of
measures. Hospice measures were
submitted and discussed as part of the
recent National Quality Forum process
identifying home health measures but
were withdrawn and added to the more
focused end of life discussions. CMS
would be interested in comments
regarding clinical measures, patient
experience of care measures, and
systems measures (use of information
technology, staffing, follow up
mechanisms) specific to hospice care.
These comments should include
existing measures in use, measures to be
developed, data collection methods and
issues, and how measures are currently
being used. We are especially interested
in the feasibility, usability, if the
measures presented are proprietary or
publicly available, and burden of
collecting and reporting the measures.
An example of available measurement
tools would be the hospice outcome
measures, data elements, tools, and
instructions developed by a hospice
industry task force in which the CMS
participated as a stakeholder. A Task
Force initiative was sponsored and
convened by the National Hospice Work
Group (NHWG) and the National
Hospice and Palliative Care
Organization (NHPCO) in 1999. We
participated in developing the measures
and provided technical assistance for
pilot testing the measures. In addition to
the work that has already been done in
this area, we are committed to working
with all relevant interest groups and
associations as they develop and
provide hospices with model quality
assessment and performance
improvement programs and other
services.
The work of the Task Force resulted
in measures addressing the outcome
domains of self-determined life closure,
comfortable dying, safe dying, and
effective grieving. The hospice industry
moved to include these measures in the
data set that they encourage member
hospices to use and report. The data
elements, tools, and instructions for
using the measures are publicly
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available on the NHPCO website
https://www.nhpco.org.
If a hospice chooses to participate in
this voluntary process as described in
the NHPCO web site, it would collect
the specified data elements, analyze the
data to assess its performance, and
implement performance improvement
projects to address weaknesses while
reinforcing strengths. A hospice may
also choose to submit its data to the
NHPCO or its contractor. The national
reporting process includes pertinent
utilization data, appropriateness and
effectiveness of services, and patient
and family satisfaction. Reports are then
generated by the NHPCO for hospices to
compare their performance with other
hospices.
All hospices that choose to utilize the
NHPCO reporting process will need to
follow the HIPAA Privacy Rule. We
believe that participating in the NHPCO
reporting process in order to improve
the quality of care delivered to patients
would probably be deemed to be part of
the hospice’s health care operations
under the HIPAA Privacy Rule. The
NHPCO would be doing work on behalf
of the hospice. Therefore, it appears that
the hospice and the NHPCO would be
required to have a business associate
agreement, ensuring that the NHPCO
would protect the health information
submitted by the hospice. Sample
business associate language is available
at https://www.hhs.gov/ocr/hipaa/
contractprov.html. Hospices should
confer with their legal counsel to ensure
that their disclosures are in compliance
with the Department’s rules. Once the
business associate agreement was in
place and the hospice began to submit
its data, it would not need individual
authorization to disclose protected
health information to the NHPCO. In
addition, the hospice would not need to
account for the disclosures to the
NHPCO.
We are not proposing to require that
hospices use any particular process or
outcome measures. However, a hospice
that uses the available quality measures
may be able to expect an enhanced
degree of insight into the quality of its
services and patient satisfaction than if
it began the outcome-measure
development process anew. In addition
to the NHPCO measures, there are many
other resources available. One of these
resources, for example, is the ‘‘TIME:
Toolkit of Instruments to Measure End
of life care,’’ developed by Brown
University. It can be found at https://
www.chcr.brown.edu/pcoc/toolkit.htm.
This Toolkit takes steps toward crossing
the measurement barrier by creating
patient-focused, family-centered survey
instruments that address the needs and
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concerns of patients and their families,
as defined by them.
The hospice could also develop its
own data elements and measurement
process as part of its quality assessment
and performance improvement program.
A hospice is free to develop a program
that meets its needs. We recognize the
diversity of provider needs and
concerns with respect to QAPI
programs. As such, a provider’s QAPI
program will not be judged against a
specific model.
Under the proposed standard,
Program data, found at § 418.58(b), the
hospice is expected to monitor the
effectiveness of services and be able to
target areas for improvement. The main
goal of the quality assessment and
performance improvement standard is
to identify and correct ineffective and/
or unsafe care. We expect hospices to
assess their patient load and identify
circumstances that could lead to
significant patient care issues and
concentrate quality assessment and
performance improvement energies in
these areas. For example, patients with
minimal support care, those
experiencing frequent exacerbations of
symptoms, and those whose diagnosis
and care may be unique to the hospice,
may be the subject of more intense
quality assessment and performance
improvement activity. We expect a
hospice to be able to demonstrate
consistent performance progress in
successful quality assessment and
performance improvement
interventions.
The third standard under the quality
assessment and performance
improvement program at proposed
§ 418.58(c), Program activities, states
that the hospice must set priorities for
its performance improvement activities
that: focus on high risk, high volume
and problem-prone areas; consider the
prevalence and severity of identified
problems; and give priority to
improvement activities that affect
palliative, patient safety, and quality of
care outcomes. We expect that a hospice
would take immediate action to correct
any identified problems that directly or
potentially threatened the care and
safety of patients. Prioritizing areas of
improvement is essential for the hospice
to gain a strategic view of its operating
environment and to ensure the
consistent quality of care provided over
time.
In § 418.58(c) we are also proposing to
require the hospice to track adverse
patient events, analyze their causes, and
implement preventive actions that
include feedback and learning
throughout the hospice. The hospice’s
quality assessment and performance
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improvement program is expected to
view staff as full partners in quality
improvement. Because staff members
are in a unique position to provide the
hospice with structured feedback on its
performance and suggestions on how
performance can be improved, we
expect the hospice to demonstrate how
staff contribute to its quality
improvement program.
We are proposing at § 418.58(d),
Performance improvement projects, to
require that the number and scope of
improvement projects conducted
annually must reflect the scope,
complexity, and past performance of the
hospice’s services and operations. The
hospice must document what
improvement projects are being
conducted, the reasons for conducting
them, and the measurable progress
achieved on these projects. We believe
that giving hospices the flexibility to
review their own organization and
quality performance and improvement
program may improve the effectiveness
and efficiency of their services, improve
the outcomes of care they provide, and
potentially improve beneficiary
satisfaction with their services.
We are proposing at § 418.58(e),
Executive responsibilities, to require the
hospice’s governing body to be
responsible and accountable for
ensuring that the ongoing quality
improvement program is defined,
implemented, and maintained. The
governing body must ensure that the
program addresses priorities for
improved quality of care and patient
safety. The governing body must also
specify the frequency and detail of the
data collection and ensure that all
quality improvement actions are
evaluated for effectiveness. The
governing body’s most important role is
to ensure that staff are furnishing and
patients are receiving the most
appropriate level of care. Therefore, it is
incumbent on the governing body to
lend its full support to agency quality
improvement and performance
improvement efforts.
We are specifically soliciting public
comments on this proposed condition of
participation.
Condition of Participation: Infection
Control (Proposed § 418.60)
[If you choose to comments on issues in
this section, please include the caption
‘‘INFECTION CONTROL’’ at the
beginning of your comments.]
There is no current requirement for
infection control other than the
requirement at § 418.100(a) that ‘‘* * *
each patient is to be kept comfortable,
clean, well groomed, and protected from
accident, injury, and infection.’’ We are
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30849
now proposing a new CoP due to the
seriousness and hazards of infectious
and communicable diseases. There is a
substantial amount of research from
government agencies and private
organizations regarding the effect of
infections and communicable diseases
in the inpatient environment. This
research documents their widespread
prevalence. While there is less research
that examines infections and
communicable diseases in the home, the
effect of both on the health and safety
of patients and the cost of patient care
cannot be dismissed. In response, the
health care industry has developed
guidelines and recommendations for
managing preventative programs. For
example, the Association for
Professionals in Infection Control and
Epidemiology, Inc. have published
‘‘Requirements for infrastructure and
essential activities of infection control
and epidemiology in out-of-hospital
settings: A Consensus Panel report’’
(https://www.apic.org/pdf/cpinfra2.pdf).
The Joint Commission on Accreditation
of Healthcare Organizations (JCAHO)
responded to the issue by designing new
infection control standards for, among
others, home care providers. These
standards will become effective in 2005.
Due to the negative effects on patient
health and safety that are posed by
infections and communicable diseases,
and due to the significant amount of
public, industry, and government
attention that this issue has generated,
we believe that hospices need to address
infection control in a more complete
manner.
In this proposed CoP, we are requiring
hospices to take specific actions to
address the prevention and control of
infections and disease, and to educate
patients, staff, and caregivers on their
hazards, prevention, and control. It is
essential that agencies consider the
devastating effects of rampant
communicable disease as they carry out
their quality assessment and
performance improvement programs. As
a result, we expect the hospice to
maintain an effective and up-to-date
infection control program that may be
part of its overall quality assessment
and performance improvement program.
We recognize that a hospice cannot be
directly responsible for the maintenance
of an infection-free environment in an
individual’s home or inpatient setting.
We are proposing in § 418.60(a),
Prevention, that hospices follow
accepted infection control standards of
practice and ensure that all staff that
provide hospice services know and use
these current best prevention practices
to curb the spread of infection. Periodic
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training is one way to assure staff
understanding.
In § 418.60(b),Control, we are
proposing that the hospice engage in an
ongoing system-wide program that
focuses on the surveillance,
identification, prevention, control, and
investigation of infections and
communicable disease. We expect the
hospice to use best control practices in
this endeavor. We are also expecting
that each hospice educate its staff, as
well as patients, families, and other
caregivers in the ‘‘current best
practices’’ for controlling the spread of
infections within the home during the
course of the family/care givers’
interactions. Where infection and/or
communicable disease is identified, we
expect that this information is made
part of the hospice’s quality assessment
and performance improvement program.
In § 418.60(c), Education, we are
proposing a standard allowing the
hospice flexibility in meeting its
infection control, prevention and
education objectives. For example, the
amount of training in infection control
necessary for the hospice’s personnel
would depend on the patient mix and
experience of the staff. While we would
expect that established best practices be
adhered to, we are not proposing any
specific approaches to meeting this
requirement. However, all staff and
family will be educated on the use of
standard precautions for the safety of
the patient, family and caregivers. We
will expect to see clear evidence that the
hospice aggressively seeks to minimize
the spread of disease and infection
through the use of effective techniques
by its staff and through its efforts to help
families and care givers understand
what can and should be done to
minimize infection.
We are specifically soliciting public
comments on this proposed condition of
participation.
Condition of Participation: Licensed
Professional Services (Proposed
§ 418.62)
Sections of current regulations at
§ 418.82, Nursing services; § 418.84,
Medical social services; and § 418.92,
Physical therapy, occupational therapy
and speech-language pathology, identify
detailed tasks that must be performed by
agency staff.
We are proposing to delete § 418.82,
§ 418.84, and § 418.92, and replace them
with a more simplified condition,
licensed professional services. Instead
of identifying detailed tasks, we are
broadly describing the expected
contributions of the licensed
professionals who are furnishing
hospice services.
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We are proposing that licensed
professionals who provide services to
hospice patients either directly or under
arrangement must participate in
coordinating all aspects of care,
including updating the interdisciplinary
comprehensive assessments, developing
and evaluating plans of care,
participating in patient and family
counseling, participating in the quality
assessment and performance
improvement plan, and participating in
in-service training. The expected
outcome is the coordinated,
comprehensive, interdisciplinary
delivery of appropriate and effective
licensed professional services delivered
and supervised by health care
professionals who practice under State
licensure requirements and the
hospice’s policies and procedures.
Licensed professional services, for
purposes of this section, include skilled
nursing care, physical therapy, speechlanguage pathology, occupational
therapy, and medical social services.
The services of these licensed
professionals are described in more
detail under the core services condition
proposed at § 418.64 and the non-core
services condition at § 418.70.
Medicare makes a distinction between
providing services directly, as opposed
to providing services under
arrangement. The most common way
services are provided directly is through
the use of employees. The common law
definition of ‘‘employee’’ fundamentally
relates to whether a person is under
control by the entity or individual
providing the services. The ‘‘physician
referral provisions’’ at section 1877(h)(2)
of the Act references the Internal
Revenue Service (IRS) ‘‘employee’’
definition. Section 1877(h)(2) provides
that an individual is considered to be
‘‘employed by’’ or an ‘‘employee’’ of an
entity if the individual would be
considered to be an employee of the
entity under the usual common law
rules applicable in determining the
employer-employee relationship (as
applied for purposes of section
3121(d)(2) of the Internal Revenue Code
of 1986).
Condition of Participation: Core
Services (Proposed § 418.64)
The conditions of participation
containing the current core services
requirements are in § 418.80, Furnishing
of core services; § 418.82, Nursing
services; § 418.84, Medical social
services; § 418.86, Physician services;
and § 418.88, Counseling services. We
are proposing to combine these into a
single condition. We are also proposing
to incorporate the requirement at
existing § 418.50(b)(3) that core services
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be provided in a manner consistent with
accepted standards of practice.
This section has been revised to
reflect changes to the Act made by
section 946 of the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 (‘‘MMA’’). In accordance
with that provision, we are proposing to
allow a hospice (the primary hospice) to
enter into arrangements with another
Medicare certified hospice to obtain
core hospice services. This could be
done under extraordinary or other nonroutine circumstances. Pursuant to
Section 1861(dd)(5)(D) of the Act, as
added by section 946(a) of the MMA,
those circumstances are: Unanticipated
periods of high patient loads; staffing
shortages due to illness or other shortterm temporary situations that interrupt
patient care such as natural disasters;
and temporary travel of a patient
outside the hospice’s service area. We
believe that the new MMA provision
authorizes us to propose that hospices
may not routinely contract for a specific
level of care (e.g., continuous care) or
for specific hours of care (e.g., evenings
and week-ends), as these are regularly
occurring situations that hospices are
able to plan staffing for.
We propose to require that contractual
arrangements under the provision be set
forth in a legally binding written
agreement between the hospices. The
written agreement would ensure that
contracted staff meet all hospice
personnel qualifications and receive
necessary training. The primary hospice
would be responsible for enforcing the
contractual provisions. This would
ensure that the primary hospice
maintains professional management
responsibility for the service(s) being
provided and the individual(s)
providing such service(s), as described
in sections 418.62, Skilled professional
services and 418.100, Organization and
administration of services. These
sections require contracted services to
be provided according to professional
standards and practices. Finally,
contracted individuals would be
required to actively participate in the
coordination of care, including patient
assessment and care planning, and in
the primary hospice’s in-service training
and quality assessment and performance
improvement programs.
The physician services requirement
would be changed to allow the use of
contracted physicians, including the
medical director (see proposed 418.102).
In proposed § 418.64(b), Nursing
services, we would add specific
language to address the role of nurse
practitioners in providing hospice care.
The services provided by nurse
practitioners continue to be guided by
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Medicare statutory requirements.
Within these statutory requirements, we
propose to allow nurse practitioners to
perform many other hospice functions
that are in the scope of their practice
and license, as well as within the laws
of the State in which they practice.
In this standard we have also
proposed to allow hospices to provide
certain types of nursing services under
a legally binding written contract. This
change also results from section 946 of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, which added new 1861(dd)(5)(E)
to the Act. These nursing services must
be highly specialized and provided non
routinely and so infrequently that their
provision by hospice employees would
be impracticable and prohibitively
expensive. We recognize that it may be
cost-prohibitive for a hospice to employ
a nurse that possesses very highly
specialized skills when he or she may
only care for a few patients a year. By
allowing hospices to contract with
specialized nursing providers or others
to provide these highly specialized
nursing services to the few patients who
require them, hospices will be able to
better implement an efficient staffing
plan and ensure proficiency in the
skilled service being provided. Highly
specialized services, as described,
would not include continuous care
because, while time intensive, such care
does not require highly specialized
nursing skills.
As with all other contracting
arrangements, the hospice would be
required to maintain professional
management responsibility for the
service(s) being provided under
arrangement as well as the individual(s)
providing them. The responsibilities of
both the primary hospice and the
‘‘lending’’ nursing provider would need
to be outlined in the written agreement,
and there would have to be a
mechanism in place to ensure that the
terms of the agreement were met. To
that end, the contracted individual(s)
would have to provide care in
accordance with professional standards
of practice; actively participate in the
coordination of care, including the
comprehensive patient assessment and
the formulation of the plan of care; and
actively participate in the hospice’s
inservice training and quality
assessment and performance
improvement programs.
In proposed § 418.64(c), we are
proposing to maintain the current
medical social services requirement
found at § 418.84. This standard would
continue to require that medical social
services be provided by a qualified
social worker under the direction of a
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physician. This standard would also
require that medical social services,
when accepted by a patient and family,
be based on an assessment of that
patient’s psychosocial needs.
In proposed § 418.64(d), we address
the counseling services that would be
available to hospice patients. Those
services would be bereavement,
nutritional, and spiritual counseling. In
the bereavement counseling section, we
propose that a hospice would be
required to have an organized program
of bereavement services furnished under
the supervision of a qualified
professional with experience in grief/
loss counseling. These services would
be required to be made available to
individuals identified in the
bereavement plan of care up to one year
following the death of the patient and
would reflect the needs of those
individuals. When appropriate,
residents and staff of a SNF/NF, ICF/
MR, or other facility would be offered
bereavement services.
In the nutritional counseling section,
we propose to alter the standard to
allow qualified individuals such as
dietitians and nurses to furnish this
service, provided that it is within their
scope of practice and expertise
according to State law. We believe that
allowing other qualified individuals to
participate in nutritional counseling
will give hospices greater flexibility and
will help ensure that all hospice
patients have access to this service
when needed. This proposal for
increased flexibility is a result of
recommendations made by the
Secretary’s Advisory Committee on
Regulatory Reform.
In the spiritual counseling section we
propose that a hospice would be
required to assess the patient’s and
family’s spiritual needs and provide
spiritual counseling to meet those needs
in accordance with the patient’s and
family’s beliefs and desires. If a patient
and family do not desire spiritual
counseling, then they would not have to
be provided this service. If a patient and
family do desire spiritual counseling,
then a hospice would be expected to
facilitate visits by local clergy, pastoral
counselors, or others to the best of its
ability. We have examined the relevant
jurisprudence regarding the provision of
spiritual counseling by Medicare
certified hospices (Kong v. Scully et al.
341 F.3d 1132 (9th Cir. 2003) reh. den.
as amended, 357 F.3d 895 (9th Cir.
2004). We do not see any impediment
to requiring hospices to offer spiritual
services if a patient and family so
desire.
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30851
Condition of Participation: Nursing
Services Waiver of Requirement That
Substantially All Nursing Services Be
Routinely Provided Directly by a
Hospice (Proposed § 418.66)
[If you choose to comment on issues in
this section, please include the caption
‘‘STATUTORY NURSING WAIVER’’ at
the beginning of your comments.]
The requirements for obtaining a
nursing services waiver as provided by
section 1861(dd)(5) of the Act is
currently set forth in § 418.83, and
remains virtually unchanged in this
proposal. This condition provides
hospices the opportunity to obtain a
waiver from the requirement that
substantially all nursing services be
routinely provided directly by the
hospice. The Act specifies that to obtain
a waiver a hospice must be located in
an area that is not an urbanized area,
must have been in operation on or
before January 1, 1983, and must
demonstrate a good faith effort to hire a
sufficient number of nurse employees.
Section 1861(dd)(5)(B) of the Act
specifies that if a waiver is requested by
an organization that meets the statutory
requirements, and if it is submitted in
the form and contains the information
required by the Secretary, the waiver
will be deemed granted unless the
request is denied in 60 days after the
request is received by the Secretary.
This waiver, set in statute, may be
obsolete. We do not know how many
hospices meet the criteria for the
waiver, nor do we know if any hospices
actually use the waiver. We request
comments on the use of this waiver.
Condition of Participation: Furnishing
of Non-Core Services (Proposed
§ 418.70)
The current CoP governing the
provision of other services is contained
in § 418.90. The hospice must ensure
that the services described in § 418.72
through § 418.78 are provided directly
by employees of the hospice or by
others under an arrangement with the
hospice. This is discussed further in
proposed § 418.100. As with core
services, non-core services should be
provided in a manner consistent with
current standards of practice.
Condition of Participation: Physical
Therapy, Occupational Therapy, and
Speech-Language Pathology (Proposed
§ 418.72)
Currently, the CoP concerning
physical therapy, occupational therapy,
and speech language pathology is laid
out at § 418.92. We are proposing to
recodify this CoP at § 418.72 without
changes.
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Condition of Participation: Waiver of
Requirement—Physical Therapy,
Occupational Therapy, SpeechLanguage Pathology, and Dietary
Counseling (Proposed § 418.74)
We are proposing a new CoP that
provides for a waiver of the requirement
that physical therapy (PT), occupational
therapy (OT), speech-language
pathology (SLP) and dietary counseling
services be provided as needed on a 24hour basis. In addition, the waiver
allows the hospice to provide the above
services directly or under arrangements
made by the hospice, as specified in
current § 418.56.
We may approve a hospice’s request
for a waiver of the requirement that it
furnish PT, OT, SLP and/or dietary
counseling services if it is located in a
nonurbanized area and can demonstrate
that it has been unable, despite diligent
efforts, to recruit appropriate personnel.
Hospices will be required to submit
evidence of their efforts to hire. We will
apply similar requirements as are used
for the nursing services waiver requests
found in proposed § 418.66. As in the
case for a waiver of nursing services,
eligibility for a waiver is based on the
primary location of a hospice. For a
hospice that operates in several areas,
its primary location is considered to be
the location of its central office. The
hospice must provide evidence that it
made a good faith effort to hire a
sufficient number of PTs, SLPs, OTs,
and dietary counselors to provide
services directly through hospice
employees or under arrangement.
Condition of Participation: Home Health
Aide and Homemaker Services
(Proposed § 418.76)
Section 1861(dd)(1)(D) of the Act
requires Medicare covered home health
aide services to be furnished by an
individual who has successfully
completed training or a competency
evaluation program that meets the
requirements established by the
Secretary. This section also provides for
coverage of ‘‘homemaker’’ services.
Currently, the condition of
participation concerning home health
aide and homemaker services is set forth
at § 418.94. We are proposing in
§ 418.76 that a home health aide
completes a State-established or other
training program, and in § 418.76(b) we
outline requirements that this training
must meet. Except for minor
reorganization, these training
requirements are consistent with
existing home health aide requirements
in § 484.36.
For example, we would continue to
permit a home health aide to meet the
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proposed § 418.76(a), Home health aide
qualifications, requirement in one of
three ways: by completing a training
and competency evaluation program
that meets the proposed training
requirements, by completing a
competency evaluation program, or by
completing a State licensure program
that meets the proposed training
requirements. We propose to include
three separate ways to meet the
proposed requirement because we
understand that home health aides come
to hospices with various levels of
experience and qualifications. We
would expect that, if a State licenses
home health aides, then an aide would
meet those licensure requirements and
would, in fact, be licensed by that State.
If a State does not have licensure
requirements, then we would expect
that a home health aide who had not
previously participated in a training
program that meets the proposed
requirements would be trained in a
program that meets the proposed
requirements. In addition, we would
expect that, following such training, that
aide would be evaluated in a systematic
way to assess his or her skills and
competencies before performing patient
care. If, however, a home health aide
has already completed a training
program that meets the proposed
requirements while employed at another
provider, then we would only expect
the aide to complete a competency
evaluation program at his or her new
employer. We believe that this would
make it easier for aides to change
employers and faster for hospices to get
qualified new employees out in the
field. One of the skills a home health
aide would be required to master is the
ability to observe, report, and document
patient status and the care or service
furnished. We believe that clear and
effective communication between the
many providers of hospice care is an
important part of ensuring high quality
patient care. We believe that a home
health aide should be able to both
verbally report and document in writing
what he or she observes and does at a
patient’s home.
Three standards have been
particularly adapted for the hospice
conditions of participation. First,
§ 418.76(j), homemaker qualifications,
has been adapted from the existing
§ 418.94. The proposed standard
clarifies that a qualified homemaker is
a home health aide as described in
§ 418.76 or an individual who has met
the standards in § 418.202(g) and has
successfully completed hospice
orientation addressing the needs and
concerns of patients and families coping
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with a terminal illness. Homemaker
services may include assistance in
maintenance of a safe and healthy
environment to enable the patient to
benefit from care that is furnished.
Second, § 418.76(h), Supervision of
home health aides, would be revised
from the current § 484.36(d) to require
that a registered nurse or appropriate
qualified therapist conduct an on-site
supervisory visit every 28 days while
the home health aide is providing care.
Thorough supervision of home health
aides is crucial to ensuring that the
patient’s and family’s needs are being
met, and conducting supervisory visits
when the aide is present and performing
his or her duties is the only way to
provide such thorough supervision. Onsite supervisory visits will still be
required every 14 days as in the current
rule at § 484.36(d)(2), but the aide
would not be required to be present for
these visits. This supervision schedule
would allow hospices to maintain
control over the quality and continuity
of care being provided, and would help
ensure that all patients receiving home
health aide services are having their
needs met by such services.
Finally, § 418.76(k) would require a
member of the interdisciplinary group
to coordinate homemaker services, and
supply instructions for the homemaker
on duties to be performed. The
homemaker would be required to report
all concerns about the patient or family
to the member of the IDG who was
coordinating the homemaker services.
We have proposed these changes to
ensure proper training and supervision,
and to protect the quality of the
homemaker services provided.
Condition of Participation: Volunteers
(Proposed § 418.78)
The current CoP for volunteers is
located at § 418.70. We are proposing to
recodify this CoP at § 418.78 with minor
changes. We are removing the existing
§ 418.70(f), regarding the availability of
clergy, because the role of the pastoral,
clergy, or other spiritual counselor is
described in proposed § 418.56(a)(1)(iv),
Interdisciplinary group, care planning
and coordination of services. This
change does not preclude the hospice
from continuing to use or starting to use
clergy as volunteers.
Subpart D, Conditions of Participation,
Organizational Environment
Condition of Participation: Organization
and Administration of Services
(Proposed § 418.100)
[If you choose to comment on issues in
this section, please include the caption
‘‘ORGANIZATION AND
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ADMINISTRATION’’ at the beginning of
your comments.]
We are proposing to revise existing
regulations at § 418.50, General
provisions, § 418.52, Governing body,
and § 418.56, Professional management,
by creating a new condition. This new
condition would simplify the structure
of these current requirements and
clarify new performance expectations
for the governing body. We believe the
structure of the current requirements
does not establish clear performance
expectations for the operation of all
services. The overall goal of the revised
requirement would be to ensure a
management structure that is organized
and accountable. We believe that a wellmanaged hospice will be more likely to
allocate resources so that patients
maintain their highest functional
capacity.
In the proposed organization and
administration of services condition
(that is, § 418.100), we have taken the
current CoPs and proposed changing
them to standards:
• Governing body and administrator
(existing § 418.52).
• Continuation of care (existing
§ 418.60).
• Professional management
responsibility (existing § 418.56).
• In-service training (existing
§ 418.64).
We would also include a standard
clearly listing the services that the
statute requires hospices to furnish. We
are also proposing to add a new
standard for in-service training that
would require a hospice to provide inservice training to all individuals,
including volunteers, to address
identified skill and competency gaps.
The hospice would be required to have
written policies and procedures
describing its methods for assessing
skills and competency. It would also be
required to maintain a written
description of in-service trainings
offered during the previous 12 months.
Currently, § 418.50(b)(3), Required
services; § 418.52, Governing body;
§ 418.82(c), Acceptable standards of
practice; § 418.92(a), PT, OT and SLP;
and § 418.96(a), Administration of drugs
and biologics, all exist as separate
standards. To emphasize the importance
of continuity of care and the focus on
quality, regardless of the site of service,
we are proposing to move these existing
provisions and incorporate their
performance expectation into the
quality assessment and performance
improvement program that is proposed
at § 418.58.
We have long used the term ‘‘in
accordance with accepted standards of
practice,’’ in various provider and
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supplier requirements, (such as in the
existing § 418.82(c)) to set a
performance expectation and to be able
to employ regulatory authority to shed
light on inappropriate and/or dangerous
practices. We are proposing to retain
this authority and move the existing
§ 418.82(c) into § 418.64, Core services
and § 418.70, Furnishing of non-core
services.
In the proposed governing body and
administrator standard at § 418.100(b)
we emphasize the responsibility of the
hospice governing body (or designated
persons so functioning) for the
management and provision of all
hospice services including fiscal
operations, quality assessment,
performance improvement, and the
appointment of the administrator. The
actual approach to the administration of
the hospice is left to the discretion of
the governing body, thereby affording
the hospice management flexibility. The
proposed governing body standard
reflects our goal of promoting the
effective management and
administration of the hospice as an
organizational entity without dictating
prescriptive requirements for how a
hospice must meet that goal.
Section 418.100(c), Services, includes
nursing, medical social services,
physician services, counseling services,
home health aide and homemaker
services, therapy services, short-term
inpatient care and medical supplies.
The nursing services, physician
services, and drugs/biologicals as
specified in § 418.100(c)(2) must be
routinely available on a 24-hour basis.
All other covered services must be
available on a 24-hour basis when
reasonable and necessary to meet the
needs of the patient and family.
In § 418.100(d), Continuation of care,
the current standard is at § 418.60. We
are proposing to recodify this section at
§ 418.100(d) without change.
In § 418.100(e), Professional
management responsibility, we are
proposing to revise some of the current
requirements found at § 418.56(b) and
(c). This standard would require written
agreements for services furnished under
arrangement, and would require that the
hospice retain professional management
and supervisory and financial
responsibility for all services that are
provided to the patient and family. The
hospice would be required to ensure
that all services provided are authorized
by the hospice, are furnished in a safe
and effective manner by qualified
personnel, and that items and/or
services specified in the plan of care are
provided.
In § 418.100(f)(1), we are proposing a
new standard to address the issue of
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multiple service locations. Our goal is to
establish clear requirements in order to
ensure patient comfort, patient safety,
and the provision of a consistent level
of care throughout the hospice
organization. This provision is intended
to codify long-standing Medicare survey
and certification policy, which allows
for the operation of multiple locations
by a single hospice provider with a
single Medicare agreement.
We are adding the definition of a
hospice satellite location. The way in
which hospices are organized has
changed since the original regulations
were promulgated. Today, unlike small
community based hospices that were
operating when the Medicare hospice
benefit first began, it is common to find
large hospice organizations serving a
patient population widely dispersed
throughout a sizeable geographic area.
Some existing hospices operate from
multiple locations. We believe it is
appropriate to develop a basis in
regulation to better clarify this
organizational structure and we have
been asked by hospices to more fully
consider the nature of the relationship
between a hospice and a satellite
location.
We expect that any hospice that
requests to establish a satellite location
will be able to demonstrate how it is
able to manage and monitor all of the
services provided in its entire service
area, including services from a satellite
location. Patients who receive care and
services from a hospice satellite location
must receive the full range of services
that are documented in the plan of care.
We will consider the following factors
in our review of a hospice’s request to
establish a satellite location:
• The hospice’s ability to supervise
the satellite location to ensure the
timely provision of quality care for
patients and families receiving care.
• The hospice’s past compliance
history.
• Relevant State issues and
recommendations including a reciprocal
agreement between the States to assure
that at least one of the State agencies
assumes responsibility for any necessary
surveys of the satellite location in
situations in which a hospice provides
services in satellite locations across
state lines.
• The hospice’s assurance that each
patient receives care from an assigned
interdisciplinary group that works
effectively together to identify and meet
the physical, social, emotional, and
spiritual needs of the hospice patients
and families receiving care.
Before operating a satellite location, a
hospice must enroll with the fiscal
intermediary and notify the State agency
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and CMS of all currently approved
satellite locations at the time it requests
approval for any additional satellite
locations. If a hospice provides care and
services to Medicare beneficiaries at an
unapproved or disapproved satellite
location, such services may be
determined to be non-covered. At the
time of any satellite location closure the
hospice is expected to notify the fiscal
intermediary, State agency and CMS.
Hospice satellite locations are also
subject to survey by the State survey
agency or CMS regional office.
Deficiencies that are identified at any
satellite location will apply to the entire
hospice issued the provider agreement
number. Satellite locations must comply
with the hospice conditions of
participation at § 418.52 through
§ 418.116.
Proposed § 418.100(g), Inservice
training, applies to volunteers and
employees, including those employed
under arrangement or contract. We are
expecting a hospice to take steps to
develop appropriate inservice programs
or to arrange to acquire training from
others.
We are not dictating a specific
inservice training program, but rather
we expect each hospice to determine the
scope of its own program, including the
manner in which it chooses to assess
competence levels, determine training
content, and determine the duration and
frequency of training.
We are specifically soliciting public
comment on this proposed condition of
participation.
Condition of Participation: Medical
Director (Proposed § 418.102)
[If you choose to comment on issues in
this section, please include the caption
‘‘MEDICAL DIRECTOR’’ at the
beginning of your comments.]
We would revise the existing medical
director CoP at § 418.54 by
incorporating current requirements and
expanding it to illustrate the importance
of having a medical director or
physician designee coordinate the
activities of physicians and other health
care professionals to ensure that care is
appropriate and reflects the hospice
philosophy. To maintain patient care
and coordination of services, the
medical director or physician designee
appointed by the medical director, must
either be a hospice employee or under
contract with the hospice. A contractual
arrangement with another agency or
organization is not permitted.
Section 418.102(a), Initial certification
of terminal illness, would incorporate
the provisions of current § 418.22, and
require that the medical director or
physician designee review the patient’s
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clinical information and provide written
certification that the individual has a
medical prognosis that his/her life
expectancy is 6 months or less if the
illness runs its normal course. The
certification would have to be based on
the medical director’s or physician
designee’s clinical judgment regarding
the normal course of the individual’s
illness.
In the second standard, § 418.102(b),
Recertification of the terminal illness,
we would require that the medical
director or physician designee review
the clinical information and the patient
and family’s expectations and wishes
for hospice care on an ongoing basis and
before each updated assessment.
Assessments would be required to be
updated at least every 14 calendar days
according to § 418.54(d). In addition,
this standard would also require that the
assessment be updated at the time of
each recertification. The timeframes for
recertification are described in § 418.21.
Within § 418.102(c), Coordination of
medical care, we are proposing that the
medical director or physician designee
and the hospice interdisciplinary group
maintain responsibility for coordinating
a patient’s medical care in all settings,
even when multiple physicians are
participating in the care. This level of
coordination ensures that the patient
receives continuous medical care and
services that are consistent with the
hospice philosophy.
We are also proposing to require that
the medical director or physician
designee be responsible for the
hospice’s quality assessment and
performance improvement program.
This program and implementation of its
findings are critical to ensuring that
patients receive effective and
meaningful care.
We are specifically soliciting public
comment on this proposed condition.
Condition of Participation: Clinical
Records (Proposed § 418.104)
[If you choose to comment on issues in
this section, please include the caption
‘‘CLINICAL RECORDS’’ at the beginning
of your comments.]
The proposed condition of
participation, Clinical records, would
incorporate several of the existing
requirements in § 418.74 of the current
regulation, Central clinical records. We
are proposing to add a new requirement
that the clinical record contain accurate
clinical information that is available to
the physician and hospice staff.
The proposed condition continues to
require that all clinical records contain
past and current findings and that they
are maintained for each patient who is
admitted by the hospice.
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We are also providing an opportunity
for the hospice to choose to maintain
clinical records electronically if it
desires and recognize that some
hospices are beginning to maintain
electronic records. The use of electronic
health records (EHRs) has the potential
to improve patient care and improve
efficiency. We anticipate that the use of
electronic health records will become
widespread, and will be required in
future hospice conditions of
participation.
We also recognize that there may be
significant barriers for hospices that are
interested in maintaining electronic
health records (EHRs) for their patients.
We are interested in learning how the
final hospice CoPs and/or other future
regulations can reduce or eliminate
those barriers.
We are interested in public comments
on the following areas:
1. What are the components of an
electronic health record (EHR)? What
are the advantages and disadvantages of
using an EHR in a hospice setting?
2. Should an EHR include a personal
health record which is accessible to the
patient? What are the positive and
negative consequences (e.g. caregivers
less likely to record certain procedures
or observations) of personal health
records?
3. What are the barriers (e.g. technical,
clinical) to implementing an EHR
system in a hospice?
It is obvious that there are many
different issues regarding the
institutionalization of EHRs. We are
aware that some hospices have already
chosen to pursue this option to one
degree or another. We are interested in
knowing what their experience has been
thus far. How have electronic health
records impacted the way they allocate
and deliver patient care, and how has
this, in turn, impacted patient
outcomes?
At § 418.104(a), Content, we would
retain the requirement that the record
include all assessments (including the
initial assessment and all updated
assessments), plan of care, consent and
election forms, and clinical and progress
notes. We are proposing the following
requirements for the content of the
clinical record—
• Advance directive information as
described in proposed § 418.52(a)(3);
• Informed consent, authorization
and election forms;
• Responses to medications, symptom
management, treatments and services;
• Patient process and outcome
measures as they relate to the plan of
care; and
• Physician certification of terminal
illness as required in § 418.22(c) and
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described in proposed § 418.102(a) and
(b).
We recognize that there has been
some confusion between the meaning of
clinical note and progress note. To
eliminate this confusion, we have
defined ‘‘clinical note’’ and ‘‘progress
note’’ in the definitions section. The key
differences between clinical and
progress notes are that:
1. Clinical notes summarize an actual
patient encounter (as this term is used
in the field) while progress notes do not
necessarily have to; and
2. Clinical notes comprehensively
describe the care provided during that
encounter while progress notes briefly
summarize care furnished (which could
cover a span of time) and the patient’s
response. We believe that these
definitions, adopted from the current
conditions of participation for home
health agencies (42 CFR part 484) will
provide needed clarity and will ensure
that the records contain information
necessary to provide high quality
patient care.
We are proposing to add a new
standard at § 418.104(b),
Authentication, that requires
authentication of clinical records. All
entries must be legible, clear, complete,
and appropriately authenticated and
dated. Authentication would include
verification of handwritten and/or
electronic signatures by signature logs
or a computer secure entry of a unique
identifier for a primary author who has
reviewed and approved the entry. This
new standard addresses technological
changes in information management
such as the computerization of records
as well as electronic signatures. A
similar requirement is in the conditions
of participation for hospitals.
We are proposing to re-codify the
existing requirement found in
§ 418.74(b) as § 418.104(c), Protection of
information. This re-codified provision
would require that all patient
information, including the clinical
record and its contents, be safeguarded
against loss or unauthorized use. The
text would also be revised to reflect that
all hospices must also comply with the
Privacy Rule published in the Federal
Register on December 28, 2000 (65 FR
82461) as amended on August 14, 2002
(67 FR 53182) and contained in 45 CFR
parts 160 and 164.
Under § 418.104(d), Retention of
records, we propose to ensure
protection of the patients information by
adding a new requirement that patient
records be retained for 5 years after the
death or discharge of the patient, unless
State law stipulates a longer period of
time. If the hospice discontinues
operation, hospice policies would be
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required to provide for the retention and
storage of clinical records. The hospice
would be required to notify the State
agency and its CMS regional office
where the clinical records would be
stored.
Under proposed § 418.104(e)(1),
Discharge or transfer of care, we have
proposed a new requirement that
Medicare/ Medicaid-approved hospice
facilities forward a copy of the patient’s
clinical record and hospice discharge
summary to the facility to which the
patient is being transferred. This would
help to ensure that the information flow
between the hospice and the transfer
facility is smooth, so that the level of
care will continue without being
compromised.
Under § 418.104(e)(2), we would add
a new requirement that the hospice
provide a copy of the patient’s clinical
record and hospice discharge summary
to the attending physician if the patient
revoked the election of hospice care or
was discharged from hospice because
eligibility criteria were no longer met.
This requirement was added to ensure
that the patient’s attending physician
would be aware of the most current
clinical information.
The hospice discharge summary
requirement proposed at § 418.104(e)(3)
would be a new requirement and would
detail what would be required to be
contained in the discharge summary.
The purpose of the discharge summary
is to provide important clinical
information to those medical and other
health professionals who will be
assuming the care of the patient upon
discharge from the hospice. At a
minimum, the discharge summary
would contain information that
accurately describes the patient’s stay,
current plan of care, recent treatment,
symptom, and pain management
information, most recent physician
orders, and any other documentation
that would assist in post-discharge
continuity of care.
Under § 418.104(f), Retrieval of
clinical records, we would require that
clinical records, whether in hard copy
or electronic form, be made readily
available to, and retrievable by, an
appropriate authority.
We are specifically soliciting public
comment on this proposed condition of
participation.
Condition of Participation: Drugs,
Controlled Drugs, Biologicals, Medical
Supplies, and Durable Medical
Equipment (Proposed § 418.106)
[If you choose to comment on issues in
this section, please include the caption
‘‘DRUGS, SUPPLIES, and DME’’ at the
beginning of your comments.]
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This condition of participation revises
the current requirement, found at
§ 418.96, and would clarify that durable
medical equipment, supplies,
appliances, and drugs and biologicals
related to the palliation and
management of the terminal illness and
related conditions, as identified in the
plan of care, must be provided by the
hospice while the patient is under
hospice care.
In addition, restrictions regarding the
use of controlled substances in the
patient’s home would be conveyed more
clearly. We believe that the hospice, as
well as the patient and family, need to
share in the responsibility and
accountability for maintaining
controlled substances in the home.
Primary responsibility rests with the
hospice, and the hospice must assume
responsibility to educate the family
about the proper use and disposal of
drugs and biologicals and the
consequences of misuse.
Section 418.106(a)(1), Administration
of drugs and biologicals, would require
that all drugs and biologicals be
administered in accordance with
accepted hospice and palliative care
standards of practice and according to
the patient’s plan of care. In
§ 418.106(a)(2) we are proposing to add
a new requirement that the
interdisciplinary group be responsible
for periodically reviewing the plan of
care to determine whether the patient
and/or family continues to have the
ability to safely administer drugs and
biologicals.
Under proposed § 418.106(b),
Controlled drugs in the patient’s home,
the hospice would ensure the safe
delivery and accountability of
controlled drugs in the patient’s home.
The hospice would have to have a
policy for the tracking, collecting, and
disposing of controlled drugs
maintained in the patient’s home.
During the initial assessment, the
hospice policy regarding the use and
disposal of controlled drugs would be
required to be discussed with the
patient and family, and the hospice
nurse would be required to document
that the policy had been discussed with
the patient and family. Because
controlled drugs can pose significant
danger to patients if improperly
ingested or abused, educating patients
and families may prevent unwanted
complications.
In § 418.106(c), Use and maintenance
of equipment and supplies, a hospice
would be responsible for overseeing the
use of durable medical equipment and
supplies in the patient’s home. Through
the Medicare survey process and
beneficiary complaints, we have found
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that equipment that is not properly
maintained does not perform properly
and may harm the patient. Under this
proposal, the hospice would be
responsible for making certain that
equipment being furnished under the
plan of care is operating safely. The
hospice may carry out this
responsibility through a contractual
arrangement with others, but would
continue to maintain primary
responsibility.
Stressing the importance of providing
families with information and levels of
comfort relative to the care being
furnished to family members, we are
proposing a new medical equipment
and supplies requirement. The hospice
would be required to take action to
ensure that the family received
instruction in the safe use of equipment
and supplies. In order for the family to
participate in providing quality care to
the patient, the family members would
need to understand how and when to
use equipment and supplies.
We are specifically soliciting public
comment on this proposed condition of
participation.
attendance on a particular shift to serve
the patient will have no effect on the
patient’s care.
Under proposed § 418.108(c),
Inpatient care provided under
arrangement, we would incorporate
many of the existing requirements in
existing § 418.56(e). In particular, we
would require that a hospice train the
personnel who would be providing
patient care in an inpatient facility. The
hospice model of patient care is very
different from the curative model of
patient care that medical personnel are
trained in. Therefore, in order to ensure
that patients in inpatient facilities
continue to receive care that is
consistent with the hospice philosophy
(i.e., proactive pain management,
interdisciplinary care), it is important
that inpatient facility personnel be
trained to understand the hospice
philosophy and model of care.
Under proposed § 418.108(d),
Inpatient care limitation, and
§ 418.108(e), Exemption from limitation,
we are proposing to re-codify the
existing requirements at § 418.98(c) and
(d), respectively, without changes.
Condition of Participation: Short-Term
Inpatient Care (Proposed § 418.108)
[If you choose to comment on issues in
this section, please include the caption
‘‘SHORT TERM INPATIENT CARE’’ at
the beginning of your comments.]
Under proposed § 418.108, we would
retain the requirement that hospices
make inpatient care available for pain
control, symptom management, and
respite purposes, and that care be
provided either in the hospice or in a
participating Medicare or Medicaid
facility.
We would recodify the current
requirement found at § 418.98(a), Shortterm inpatient care, as § 418.108(a),
Inpatient care for symptom management
and pain control.
The references to the condition at
§ 418.108(b), Inpatient care for respite
purposes, would no longer focus on
process as in the existing § 418.98.
Rather, the updated standards reflect
expected outcomes of care.
We would eliminate the existing
requirement found at § 418.100(a)(2),
requiring a registered nurse to provide
direct patient care on each shift. We
believe that the patient’s plan of care
and the patient’s condition should
determine the amount and skill level of
nursing care required, as well as the
skill level and State licensing
requirements of the staff to provide
requisite care. If the patient does not
need care by a registered nurse,
imposing a requirement on a hospice
that mandates a registered nurse to be in
Condition of Participation: Hospices
That Provide Inpatient Care Directly
(Proposed § 418.110)
[If you choose to comment on issues in
this section, please include the caption
‘‘INPATIENT CARE’’ at the beginning of
your comments.]
Under proposed § 418.110, we are
proposing to revise the existing
requirements, currently located at
§ 418.100, as follows:
Under § 418.110(a), Staffing, we
would include the expectation that
staffing for all services provided by the
hospice reflect the volume of patients,
patient acuity, and the level of intensity
of the services as reflected in the plan
of care to ensure that expected outcomes
of care are achieved and negative
outcomes are avoided. We also would
eliminate our requirement that a
registered nurse provide direct patient
care each shift when the condition of
the patient does not require the care of
a registered nurse on each shift. This
change would reduce the staffing
burden for hospices and is a result of
recommendations made by the
Secretary’s Advisory Committee on
Regulatory Reform.We are proposing to
remove the requirement in the existing
§ 418.100(a)(2) that each shift include a
registered nurse that provides direct
patient care for those patients who are
receiving short-term inpatient care for
symptom management. We are
proposing in § 418.110(b), 24-hour
nursing services, that the hospice
facility provide 24-hour nursing services
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that meet the nursing needs of all
patients and are furnished in
accordance with each patient’s plan of
care, as well as the skill level of the staff
that provides care, in accordance with
State licensing requirements. We would
require that each patient be kept
comfortable, clean, well-groomed and
protected from accident, injury, and
infection.
When assessing a facility’s
compliance with this proposed
regulation, we would expect to see that
the staffing level met the needs of the
patients. For example, if a patient
experiences unexpected break-through
pain and needs additional pain
management, we would expect that a
staff member with the appropriate skills
be available to care for that patient. If a
staff member with the appropriate skills,
and knowledge is not available to care
for that patient and assure that his or
her pain is effectively managed, then the
hospice would be considered to be out
of compliance with this proposed
regulation.
In § 418.110(c), Physical environment,
we are proposing that the hospice
maintain a safe physical environment
that is free of hazards for patients, staff,
and visitors. In § 418.110(c)(1), Safety
management, in paragraphs (c)(1)(i) and
(c)(1)(ii), we are proposing that the
hospice prevent situations that pose a
threat to the health and safety of the
patients, others, or property whenever
possible. The hospice would be required
to promptly report and investigate all
incidents that involve injury to patients,
staff or visitors, or that involve damage
to property. The hospice would be
required to report such incidents to the
appropriate State and local bodies
having regulatory jurisdiction. The
hospice would also be required to take
action to correct the problems promptly.
The hospice would be required to take
steps to prevent equipment failures and
correct and report any equipment
failures promptly. In § 418.110(c)(1)(iii)
we have retained the existing
requirement at § 418.100(b) that the
hospice periodically rehearse with staff
a disaster preparedness plan for
managing the consequences of natural
disasters and other emergencies that
affect the hospice’s ability to provide
care. We believe that special emphasis
should be placed on carrying out the
procedures necessary to protect the
patients and others.
In § 418.110(c)(2), Physical plant and
equipment, paragraphs (c)(2)(i) through
(c)(2)(iv), we are proposing that there be
procedures for the management of light,
temperature, and ventilation controls
throughout the hospice (including air
exchange) for patient care. The hospice
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would be required to make battery
lamps and flashlights available in all
areas not served by an emergency
electrical supply source. The hospice
would be required to make available an
emergency gas and water supply. All
equipment would be required to be
properly maintained.
In § 418.110(d), Fire protection, we
are proposing to recodify, without
change, the existing provisions in
§ 418.100(d). These provisions were
amended on January 10, 2003 (68 FR
1374) to adopt the year 2000 version of
the Life Safety Code. They were also
amended on August 11, 2004 to clarify
the effective date of the roller latch
prohibition (69 FR 49266). In addition,
they were amended on March 25, 2005
(70 FR 15229) to address the use and
placement of alcohol-based hand rubs.
Proposed § 418.110(e), Patient areas,
would be recodified from § 418.100(e)
without change.
Proposed § 418.110(f), Patient rooms,
would be revised. We are proposing in
§ 418.110(f)(3)(iv) that each room
accommodate no more than two
patients. We are proposing the two
patients per room requirement in
recognition of the fact that hospice
patients in the inpatient setting are
critically ill and may be actively dying.
These patients and their families need
the additional privacy that a two patient
room affords them in order to help
preserve the patient’s comfort and
dignity during the dying process. We
believe this is the standard
accommodation in most facilities.
Due to the potentially high cost of
retrofitting older buildings, the
proposed rule would allow existing
hospice facilities with more than two
patients in each room to receive a
waiver of this requirement. This waiver
would be based on whether or not the
hospice was already providing direct
inpatient care when this regulation
would become effective. That is, if a
hospice is providing direct inpatient
care in a building on the day before the
effective date of a final rule, and they
had more than two patients in each
room, then the hospice would qualify
for a waiver of the proposed
requirement. If a hospice chose to begin
operating its own inpatient unit after the
effective date of a final rule, then it
would not qualify for the proposed
waiver, and would thus be required to
have no more than two patients per
room.
The remaining paragraphs in this
standard would be virtually the same as
in the current requirement (§ 418.100(f),
with only minor language changes that
would not change the substantive
requirements of the regulation.
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Proposed § 418.110(g), Toilet/bathing
facilities, is linked with patient rooms
in the current requirement found at
§ 418.100(f). We are proposing to revise
this requirement as a stand-alone
standard. As such, it would highlight
our concern for the adequacy of toilet
and bathing facilities, and would
provide more flexibility for State agency
surveyors in evaluating the
appropriateness of these facilities. We
believe it is important for the privacy
and comfort of the patient and family to
have toilet and bathing facilities in each
patient room, or conveniently located
near the patient’s room.
We are proposing no changes to
existing § 418.100(g) bathroom facilities,
except to recodify it at § 418.110(h) and
rename it, Plumbing facilities.
In § 418.110(i), Infection control, we
are proposing to revise infection control
standards to conform to those required
of other provider types, such as home
health agencies and hospitals. We
would require a hospice to establish an
infection control program that protects
patients, families, and staff against
communicable diseases and would
prevent and control the spread of
infections. The infection control
program would be required to follow
national infection control standards and
be part of the hospice’s overall quality
assurance and performance
improvement and education program.
We also propose to retain the
requirement that hospices provide a
sanitary environment by following
accepted standards of practice.
We are not proposing any specific
approaches to meeting the infection
control requirement, but we would
expect to see clear evidence that the
hospice aggressively sought to minimize
the spread of infection through the use
of infection control techniques, such as
standard precautions by its staff, and
through the efforts made by the hospice
to help families and caregivers
minimize the spread of infection.
We are proposing to re-codify the
current requirement § 418.100(h), Linen,
as § 418.110(k) without substantive
change.
In proposed § 418.110(l), Meal service
and menu planning, we are proposing to
revise the existing § 418.100(j). We
would make this standard less
restrictive, and would emphasize the
need for a hospice to focus more on
outcomes rather than process.
Specifically, we believe that a hospice
should focus on meeting the patient’s
nutritional and plan of care needs. We
would eliminate several structural
requirements, such as serving at least
three meals at regular times, with no
more than 14 hours between substantial
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evening and breakfast meals, and having
a staff member trained in food
management or nutrition.
In § 418.110(m), Pharmaceutical
services, we are proposing to re-codify
the existing requirement found at
§ 418.100(k) without substantive
change.
In § 418.110(n), Pharmacist, we would
assign this requirement a higher level of
importance by making it a standard.
However, we would retain the essential
elements of the current requirement.
[If you choose to comment on the issues
contained in paragraph (o) of this
section, please include the caption
‘‘SECLUSION AND RESTRAINT’’ at the
beginning of your comments.]
Section 418.110(o), Seclusion and
restraint, would be a new standard. A
number of accidental injuries and
deaths across inpatient providers due to
the use of seclusion and restraints have
been documented. Therefore, we
discourage the use of seclusion and
restraints, but are aware that their
application may be warranted for brief
periods or in rare instances. In response
to the accidental deaths and injuries, we
published (in 1999) a new condition in
the hospital CoPs that included a new
standard at § 482.13(f), Standard:
Seclusion and restraint for behavior
management.
The hospital seclusion and restraint
CoP was the basis for the proposed
hospice seclusion and restraint CoP. We
also considered the seclusion and
restraint language in section 3207 of the
Children’s Health Act (CHA), Public
Law 106–310, codified at section 591 of
the Public Health Service Act (42 U.S.C.
290ii). The CHA provision requires that
any health care facility that receives
Federal funds, including Medicare
approved hospices, protect and promote
every patient’s right to be free from ‘‘any
restraints or involuntary seclusions
imposed for purposes of discipline or
convenience.’’ The CHA clearly
described the circumstances in which
restraints or seclusion may be
appropriate. The proposed seclusion
and restraint requirement for hospices
would codify the changes made to the
Act by the CHA. We believe that adding
this new requirement to the hospice
CoPs may promote safe use of seclusion
and restraints and may prevent
accidental injury or death while a
patient is receiving care as an inpatient
in a hospice.
We have focused this standard on the
proper use of seclusion and restraints,
the need for hospice personnel to
receive training and education in the
proper use of seclusion and restraint
application and techniques, and the
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need for hospice personnel to receive
training and education in alternative
methods for handling situations that
arise. We emphasize that seclusion and
restraint may only be used if needed to
improve the resident’s well-being or
protect him or her or others from harm,
and only when less restrictive
interventions have been determined
ineffective. We encourage the public to
comment on this standard, especially
with respect to instances where
seclusion and restraint are appropriate
and inappropriate.
Condition of Participation: Hospices
That Provide Hospice Care to Residents
of a SNF/NF, ICF/MR, or Other
Facilities (Proposed § 418.112)
[If you choose to comment on issues in
this section, please include the caption
‘‘RESIDENTS RESIDING IN A
FACILITY’’ at the beginning of your
comments.]
Hospice care is an approach to
treatment that recognizes that the
impending death of an individual
warrants a change in the focus from
curative care to palliative care (relief of
pain and other uncomfortable
symptoms). The goal of hospice care is
to help terminally ill individuals to
continue life with minimal disruption to
normal activities while remaining
primarily in the home environment.
A participating hospice may provide
care to an eligible patient in an
environment that the patient chooses to
be his or her home. This includes
hospice care provided to residents who
choose to live in skilled nursing
facilities, nursing facilities, intermediate
care facilities, mental retardation
facilities, and other facilities.
The provision of hospice care to
residents of those facilities has come
under scrutiny as a result of Operation
Restore Trust (ORT) activities and
Inspector General (OIG) reports from
1996, 1997, and 1998. An OIG report
released in 1997 found that ‘‘contractual
arrangements between hospices and
nursing homes present vulnerabilities
for inappropriate use of excessive
Medicare and Medicaid payments being
made to hospices or to nursing homes’’
(U.S. D.H.H.S. OIG, Hospice and
Nursing Home Contractual
Relationships, Nov. 1997, OEI–05–95–
00251. See also, OIG Special Fraud
Alert, Fraud and Abuse, Nursing Home
Arrangements with Hospices, Mar.
1998). In addition, in 2000 the Assistant
Secretary for Planning and Evaluation
(ASPE) Office of Disability, Aging and
Long-Term Care Policy and the Urban
Institute published a report entitled
‘‘Synthesis and Analysis of Medicare
Hospice Benefit Executive Summary
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and Recommendations’’ (Harvell,
Jennie; Jackson, Beth; Gage, Barbara;
Miller, Susan; and Mor, Vincent, 2000
March). This report made several
recommendations, some of which
related to training and hospice care
outcome measurement.
The relationship between hospices
and nursing facilities was also
addressed by the Secretary’s Advisory
Committee on Regulatory Reform. The
committee focused on clarifying the
responsibilities of each provider and on
the patients accessing the hospice
benefit while they are facility residents.
Based on the recommendations of the
committee, as well as the reports from
Operation Restore Trust, the Office of
Inspector General, and the Assistant
Secretary for Planning and Evaluation,
we would add this new condition of
participation. We are preparing a
separate regulatory document to address
long-term care facility obligations
regarding residents receiving hospice
services.
To ensure that quality hospice care is
provided to eligible patients, we are
proposing a new condition at § 418.112,
Hospices that provide care to residents
of a SNF/NF, ICF/MR or other facility.
Regardless of where the hospice patient
resides, the responsibility for
developing and implementing an
appropriate plan of care rests with the
hospice.
Under proposed § 418.112(a),
Resident eligibility, election and
duration of benefits, we would specify
that it is incumbent upon the hospice to
ensure that the resident meets all the
same Medicare eligibility requirements
for hospice care (found at § 418.20 to
§ 418.30), as a patient who resides in his
or her home in the community.
At proposed § 418.112(b), Professional
management, the hospice would be
expected to assume full responsibility
for all of the hospice care provided to
the resident. This would include
making arrangements for any inpatient
care that the patient would require in
accordance with § 418.100. This
standard reinforces our belief that
continuity of care is crucial for hospice
care in any setting.
In proposed § 418.112(c), Core
services, (and in accordance with
sections 1861(dd)(1) and (2)(A) of the
Act), the hospice would be required to
provide all necessary core services to its
patients in the same manner that it
would provide core services to a patient
residing in a home in the community.
The plan of care would have to identify
the care and services that were needed
and specify which provider would be
responsible for providing that care. It is
not reasonable to expect the hospice to
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delegate any of its standard hospice core
services to the nursing or residential
facility staff.
In proposed § 418.112(d), Medical
director, a hospice medical director
would be expected to play an integral
role in providing medical supervision to
the hospice interdisciplinary group and
in providing overall coordination of the
patient’s plan of care. The medical
director’s expertise in managing pain
and symptoms associated with the
patient’s terminal disease is necessary,
regardless of the setting in which the
patient is receiving hospice services to
ensure that the hospice patient has
access to quality hospice care.
Therefore, the medical director must
communicate with all facility
physicians and the attending physician
and other professionals involved in
developing and/or implementing the
patient’s plan of care.
Under proposed § 418.112(e), Written
agreement, we are proposing that a
comprehensive and legally binding
written agreement be developed
between the hospice and facility and
that it be in effect before any hospice
care is provided to a facility resident.
The purpose of the written agreement
would be to ensure that the duties and
responsibilities of the hospice and
facility are clearly articulated and
executed in a manner that ensures that
the resident will receive quality hospice
care. The written agreement would be
required to include the following:
(1) Written consent and
documentation of the patient or the
patient’s representative that hospice
services were desired;
(2) Identification of the services that
the hospice and the facility would
provide;
(3) The manner in which the facility
and the hospice would communicate to
ensure that the needs of the patient were
addressed and met 24 hours a day; and
(4) A requirement that the facility
immediately notify the hospice when—
(i) A significant change in the
patient’s physical, mental, social or
emotional status occurred;
(ii) Clinical complications appeared
that suggested a need to alter the plan
of care;
(iii) A life threatening condition(s)
appeared;
(iv) A need to transfer the patient
from the facility arose; and
(v) The patient died.
As the primary entity responsible for
the patient’s care, the hospice should
assume responsibility for determining
the appropriate course of care and the
decision to change the level of services
provided. The hospice would make
arrangements for, and remain
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responsible for, any necessary
continuous care or necessary inpatient
care related to the terminal illness.
We would require that the agreement
delineate the facility’s responsibilities,
including room and board and other
services and treatment, support or
otherwise. We would also require a
delineation of the hospice’s
responsibilities including medical
direction and management of the
patient, as well as nursing, counseling
(including spiritual and dietary
counseling), social work, bereavement
counseling for family members, the
provision of medical supplies and
durable medical equipment, and the
provision of drugs necessary for the
palliation of pain and symptoms
associated with the terminal illness. The
hospice would be required to provide
directly substantially all of the services
necessary for the care of the patient’s
terminal illness.
The hospice would be able to utilize
the facility’s nursing personnel (where
permitted by the facility and by law), for
the administration of prescribed
therapies included in the plan of care,
but only to the extent that the hospice
would routinely use the services of a
hospice patient’s family in
implementing the plan of care.
These would be mandatory agreement
provisions, but would not limit the
scope of the relationship between the
hospice and the facility. Additional
provisions could be added subject to
mutual agreement.
Under proposed § 418.112(f), Hospice
plan of care, just as required for hospice
services furnished to patients not
residing in an inpatient facility, we are
proposing that a written plan of care
would be required to be established and
maintained for each facility patient. The
plan of care would be required to be
coordinated with and developed by the
hospice interdisciplinary group and
SNF/NF, ICF/MR, or other facility in
collaboration with the attending
physician. The care provided would
have to be in accordance with the plan.
The plan would have to reflect the
hospice philosophy in all aspects and be
based on an assessment of the patient’s
needs and unique living situation in the
facility. The plan would have to address
the patient’s current medical, physical,
social, emotional, and spiritual needs
based on the problems identified in the
initial comprehensive and updated
comprehensive assessments, and other
assessments. Directives for the
management of pain would have to be
addressed and updated as necessary to
reflect the patient’s status.
We are proposing that the plan of care
identify the care and services that
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would be needed and specifically
identify which provider would be
responsible for performing the
respective functions that were agreed
upon and included in the plan of care.
The performance of the functions
should reflect the participation of the
hospice, SNF/NF, ICF/MR, or other
facility, and the patient and family to
the extent possible. The plan of care
would need to be reviewed at least
every 14 days and as needed to reflect
changes in the patient’s condition. In
conjunction with members of the
facility’s team, the hospice and the
attending physician would have to
discuss any changes in the plan of care,
and these changes would have to be
approved by the hospice before
implementation.
At proposed § 418.112(g),
Coordination of services, we are
proposing that the hospice designate a
member of the interdisciplinary group
to coordinate the implementation of the
plan. The hospice would provide the
facility with the plan of care, hospice
consent form, contact information for
hospice personnel involved in the care
of the resident, instructions on
accessing the hospice 24-hour on-call
system, medication information specific
to the patient, physician orders, and any
advance directives. We believe that
these requirements would ensure
effective communication between the
hospice and the facility.
Under proposed § 418.112(h),
Transfer, revocation, or discharge from
hospice care, we would specify that the
proposed requirement for discharge or
revocation found at § 418.104(e) applies.
In addition, we would specify that
discharge or revocation of the hospice
care would not impact the eligibility to
continue to reside in a SNF/NF, ICF/
MR, or other facility.
At proposed § 418.112(i), Orientation
and training of staff, we would specify
that the hospice staff would be required
to train facility staff who provide care to
hospice patients on aspects of the
hospice philosophy and unique program
features, including policies and
procedures, methods of comfort, pain
control and symptom management,
general principles about death and
dying and individual responses, patient
rights, appropriate forms, and record
keeping requirements.
We are specifically soliciting public
comment on this proposed condition of
participation.
Condition of Participation: Personnel
Qualifications for Licensed
Professionals (Proposed § 418.114)
[If you choose to comment on issues in
this section, please include the caption
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30859
‘‘PERSONNEL QUALIFICATIONS’’ at
the beginning of your comments.]
We are proposing significant revisions
to the personnel qualifications for
hospice employees. Specifically, we
would provide that in cases where
personnel requirements are not
statutory, or do not relate to a specific
payment provision, we would require
personnel to meet State certification or
licensure requirements. Under our
proposal, the personnel qualifications
would fall into three basic categories
that include: (1) General qualifications,
(2) personnel qualifications for
physicians, speech-language
pathologists, and home health aides,
and (3) personnel qualifications when
no State licensing laws or State
certification or registration requirements
exist. Under our proposed
reorganization of part 418, the personnel
qualifications would be located at
§ 418.114. We discuss the personnel
qualifications in detail below.
(1) General qualifications (proposed
§ 418.114(a)).
This category would encompass
licensed professionals who provide
hospice services directly, either as
employees or under individual contract,
or under arrangement with a hospice.
These professionals must be licensed, or
certified or registered to practice by the
State in which they perform the
functions, as applicable. All personnel
who fall into this category must act
exclusively within the scope of the State
license, certification or registration.
Examples of personnel who fall into this
category are registered nurses, licensed
practical nurses, physical therapists,
and physical therapist assistants; all
States currently have licensing or
certification requirements for these
caregivers.
(2) Personnel qualifications for
physicians, speech-language
pathologists, and home health aides
(proposed § 418.114(b)).
Section 1861(r) of the Act defines a
physician as a doctor of medicine,
osteopathy, or podiatry legally
authorized to practice medicine and/or
surgery by the State in which that
function or action is performed. We
would refer to this definition at
§ 418.114(b)(1). Sections 1861(ll)(1) and
(3)(A) of the Act define a qualified
speech-language pathologist as an
individual with a master’s or doctoral
degree in speech-language pathology
who is licensed as a speech-language
pathologist by the State in which the
individual furnishes those services. In
the case of an individual who furnishes
services in a State that does not license
speech-language pathologists, the
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individual must have successfully
completed 350 clock hours of
supervised clinical practicum (or is in
the process of accumulating the
supervised clinical experience),
performed not less than 9 months of
supervised full-time speech-language
pathology services after obtaining a
master’s or doctoral degree in speechlanguage pathology or a related field,
and successfully completed a national
examination in speech-language
pathology approved by the Secretary.
Section 1891(a) of the Act also defines
the qualifications for home health aides.
However, we believe that the
description of qualifications for home
health aides would be more
appropriately located under the home
health aide services CoP. Thus, the
requirement would be cross-referenced
at proposed § 418.76(a).
(3) Personnel qualifications when no
State licensing laws or State
certification or registration requirements
exist.
When a State does not have a
licensure, certification, or registration
requirement, the hospice would apply
the qualifications in § 418.114(c). This
category would consist of all current
personnel qualifications specified in
proposed § 418.3, Definitions. We
understand that portion of these
qualifications may seem outdated.
However, we believe that there may still
be individuals who met the
requirements of the 1960s and 1970s
and who are still practicing in their
chosen field today. Therefore, we
propose to include these personnel
qualifications. We welcome comments
on these revisions.
[If you choose to comment on issues
related to the qualification standards for
social workers, please include the
caption ‘‘SOCIAL WORK’’ at the
beginning of your comments.]
We are specifically requesting
comment on the qualifications for a
social worker. Hospice care marks the
passage from life to death. The services
furnished by a hospice takes on a higher
level of importance that greatly affects a
patient’s physical and emotional
comfort, and which will be remembered
by family members forever. The social
worker plays an important role in
providing these services to patients and
their families. Patients often enter
hospice care in a time of crisis and they
along with their families sometimes
require intense interventions that are
handled by a social worker. Patients and
their families rely on social workers for
emotional support and guidance during
the patient’s care.
Later, the social worker’s goal is to
help family members during the
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bereavement process through in-depth
counseling. Bereavement counseling can
take many forms, depending on the
individuals who will be receiving it. For
example, one patient’s family may
require intimate counseling sessions for
the patient’s children while a large
group session may be more appropriate
for nursing facility staff and residents.
Determining the exact needs of these
individuals and meeting those needs
through counseling sessions and other
support mechanisms requires the
expertise of a qualified social worker.
At present, a social worker is required
to possess a bachelor’s degree in social
work from an accredited school. There
is no consensus regarding the optimum
qualifications that a social worker must
possess when furnishing services to a
hospice patient. However, there is
strong anecdotal evidence that a social
worker who possess a Master’s of Social
Work (MSW) degree from an accredited
institution and who has at least one year
of health care experience would provide
a higher level patient care. Anecdotal
evidence also exists that suggests that
patients and families that receive
services from a Master’s of social work
are more satisfied with the care they
receive.
In addition to the patient care
advantages that MSWs offer, a hospice
may anticipate a reduction in overall
and per patient costs when utilizing
MSWs who have at least one year of
experience. A study conducted by the
National Hospice and Palliative Care
Organization (NHPCO) found that an
increase in social work experience after
academic training resulted in decreased
overall care costs, including nights of
continuous care. The study concludes
that, ‘‘[h]ospice programs will benefit by
hiring the best qualified and most
experienced social workers available.’’
(Reese, Dana J.; Raymer, Mary; and
Richardson, Joan, National Hospice
Social Work Survey, 2000 March).
Two issues may contribute to limiting
any change in the social work
qualification requirement— the
availability of personnel to work full
time, and the availability of personnel to
serve rural areas. Some hospices may
not be able to employ an MSW on a fulltime basis. Even if CMS were to increase
the education requirement to an MSW
level, hospices would still be allowed to
employ individuals with a bachelor’s
degree in some circumstances. These
individuals would be able to work
under the supervision of an MSW and
would be identified as social work
assistants. A social work assistant
would be defined as an individual who
has a bachelor’s degree from a school
accredited by the Council on Social
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Work Education, or a bachelor’s degree
in psychology, sociology or another
field related to social work.
In 2001, 4,087 MSWs were employed
by the nation’s 2,316 hospices (National
Association for Homecare, 2002 Hospice
Industry Report, https://www.nahc.org/
Consumer/hpcstats.html). We recognize
that MSWs may not be available in all
areas. If a hospice chooses to also utilize
the services of a social work assistant,
then the MSW would only have to be
employed part-time to supervise the
services. According to the NHPCO
study, ‘‘[a]ppropriate clinical
supervision is essential for social
workers. Like any other profession,
social workers require supervision by
seasoned social work practitioners to
continue to grow into high quality
skilled professionals.’’
We are specifically soliciting
comments about whether the care
furnished by an MSW should be
considered the standard of care for
hospice patients. Would an MSW
provide a higher level of care than a
social worker with a bachelor’s degree?
Should CMS require that any social
worker, regardless of the degree, have at
least one year of experience in a health
care setting? Should CMS allow social
work assistants with bachelor’s degrees
to function under the supervision of an
MSW? Would increasing the
qualifications for social workers to an
MSW while retaining social work
assistants with bachelor’s degrees
impact patient access to social work
services? Would employing both social
workers and social work assistants
ensure that hospices have the flexibility
to meet the needs of patients and their
families?
Please note that the policy regarding
credentialing would not apply under
Medicare Part B, when a specific level
or education or training is specified as
a precondition for reimbursement. For
example, Part B payment may be made
for the services of clinical social
workers, and the law specifically
defines a clinical social worker in
section 1861(hh) of the Act. Thus, the
definitions contained in this section
generally would apply for hospice
certification purposes only in States
where there were no State licensure
requirements.
In § 418.114(d), we are proposing a
new requirement that a hospice be
required to obtain a criminal
background check for all hospice and
contract employees before employment
at the hospice. We believe that this is an
important safety measure to protect both
patients and the hospice. We are
soliciting public comment on this
proposed standard.
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Condition of Participation: Compliance
With Federal State and Local Laws and
Regulations Related to Health and
Safety of Patients (Proposed § 418.116)
The provisions concerning licensure
requirements for hospices are currently
located at § 418.72, Condition of
participation: Licensure. We are
proposing to expand this condition in
the following manner:
We would make a minor revision to
the language at existing § 418.72(a),
which would require the hospice and its
staff to operate and furnish services in
compliance with all Federal, State, and
local laws and regulations applicable to
hospices related to health and safety of
patients. The State agency and CMS
would exercise discretion in
determining whether a violation of an
applicable Federal, State, or local law or
regulation related to health and safety
would be cited as a violation under the
Medicare CoPs. We would not cite a
hospice whose problem was remedied.
We will cite hospices when violations of
Federal, State, and local laws and
regulations affect the health and safety
of patients; the ability of hospices to
deliver quality services; the rights and
well-being of patients; and/or the
management of the hospice and its
ability to recruit qualified staff.
Under § 418.116(b), Multiple
locations, we would continue to require
that the hospice comply with the
requirements of § 420.206 regarding
disclosure of ownership and control
information. We would also provide
that the hospice and any other satellite
locations operated under the same
provider number be licensed in
accordance with applicable State
licensure laws before the hospice could
be reimbursed for Medicare services.
This provision seeks to ensure that
hospice patients receive the same level
of quality care from the appropriate
personnel at all sites of service. The
requirement that hospices comply with
State licensure laws before providing
services to Medicare beneficiaries
would apply to the hospice as an entity
as well as to any personnel furnishing
services to hospice patients.
We are proposing to recodify the
current requirements at § 418.92(b),
regarding laboratory services, at
§ 418.116(c).
IV. Hospice Crosswalk (Cross Refers
Existing Requirements to Proposed
Requirements)
The following table shows the
relationship of the former sections to the
current ones.
DERIVATION TABLE
Current conditions
(Part 418, subpart C, D, E)
Citation
existing
section
Scope of Subpart
Definitions ...................................................................................
General provisions .....................................................................
(a) Compliance ....................................................................
418.3
418.50
....................
(b) Required services ..........................................................
....................
(c)(1) 24 hour nursing, physician services, and drugs and
biologics.
(2) Other 24 hour services.
(3) Utilize accepted standards of practice .................................
....................
(d) Disclosure of information ...............................................
Medical director: The medical director is: A hospice employee, a
doctor of medicine or osteopathy, responsible for the medical
component of the hospice’s patient care program.
Professional management .................................................................
(a) Continuity of care .................................................................
(b) Written agreement:
(1) Identification of services to be provided .......................
418.3
Organization and Administration
of Services.
Organization and Administration
of Services.
Organization and Administration
of Services.
418.100(c)(2)
418.64 and 418.72
....................
418.54
Core Services and Furnishing of
Non-core Services.
Deleted.
Medical Director ..........................
418.56
....................
Deleted.
....................
....................
418.100(e)
....................
Short term inpatient care ............
418.108(c)(1)
....................
Short term inpatient care ............
418.108(c)(2)
....................
Short term inpatient care ............
418.108(c)(3)
....................
Short term inpatient care ............
418.108(c)(4)
(c) Professional management ....................................................
....................
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418.102
Organization and administration
of services.
Organization and administration
of services.
Organization and administration
of services.
....................
Jkt 205001
418.100(c)(1)
418.56(c)
(6) Personnel qualifications ................................................
16:47 May 26, 2005
418.100(c)(2)
Interdisciplinary
Group
Care
Planning and Coordination of
services.
Organization and Administration
of Services.
Organization and Administration
of Services.
Deleted
....................
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Citation
Definitions ....................................
(2) Express authorization of the hospice required for all
services.
(3) Coordination, supervision, and evaluation of contracted services.
(4) Roles of hospice and contractor in admission, assessment, and interdisciplinary group.
(5) Documentation of services furnished by contractor ......
(d) Financial responsibility.
(e) Inpatient care:
(1) Copy of the patient plan of care specifying the services to be provided is given to inpatient provider.
(2) Inpatient provider abides by hospice patient care protocols and maintains compatible policies.
(3) Medical record provided to hospice upon request.
Must include all inpatient services and events and a
copy of the discharge summary.
(4) Responsibility for implementing agreement provisions
Proposed condition
....................
....................
....................
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418.100(e)(1)
418.100(e)
418.100(e)(2)
418.100(e)
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules
DERIVATION TABLE—Continued
Citation
existing
section
Current conditions
(Part 418, subpart C, D, E)
(5) Hospice responsible for training all care providers .......
....................
NEW
418.108(c)(5)
418.54
Interdisciplinary
Group
Care
Planning and Coordination of
Services.
Interdisciplinary
Group
Care
planning and Coordination of
Service.
Interdisciplinary
Group
Care
Planning and Coordination of
Services.
Interdisciplinary
Group
Care
Planning and Coordination of
Services.
Organization and Administration
of Services.
Patient Rights ..............................
418.56
Organization and Administration
of services.
Quality Assessment and performance Improvement.
418.100(g)
Quality Assessment and performance Improvement.
Deleted.
Quality Assessment performance
Improvement.
IDG Group Care Planning and
Coordination of Services.
418.60(d)
....................
IDG Care Planning and Coordination of Services
418.56(a)
....................
IDG Care Planning and
nation of Services.
IDG Care Planning and
nation of Services.
IDG Care Planning and
nation of Services.
IDG Care Planning and
nation of Services.
Deleted.
Coordi-
418.56(b)
Coordi-
418.56(a)(1)(3)
Coordi-
418.56(d)
Coordi-
418.56(a)(2)
418.56(a)(1)
418.70
IDG Care Planning and Coordination of Services.
Volunteers ...................................
....................
Volunteers ...................................
418.78(a)
....................
Volunteers ...................................
418.78(b)
....................
....................
....................
Plan of Care ......................................................................................
A written plan of care must be established and maintained for
each individual admitted to a hospice program and the care provided to an individual must be in accordance with the plan.
(a) Plan established by attending physician, medical director
or physician designee and interdisciplinary group prior to
providing care.
(b) Plan reviewed, updated, and documented at specified intervals by attending physician, medical director or physician
designee and the interdisciplinary group.
(c) Plan includes assessment of needs and identification of
services. It state in the scope and frequency of services
needed.
Continuation of care: No discontinuation or diminishment of care
due to the Medicare beneficiary’s inability to pay for that care.
Informed Consent: The Informed consent form specifies the type
of care and services that may be provided during the course of
the illness, and it must be completed for every individual, either
from the individual or representative as defined in 418.3.
Inservice training: A hospice must provide an ongoing program for
the training of its employees.
Quality assurance: A hospice must conduct an ongoing, comprehensive, intetrated, self-assessment of the quality and appropriateness of all care provided. The findings are used to correct
problems and revise hospice policies. Those responsible for the
quality assurance program must.
(a) Implement and report on activities and mechanisms for
monitoring the quality of patient care.
(b) Identify and resolve problems ..............................................
(c) Make suggesitons for improving patient care ......................
418.58
....................
Interdisciplinary group: The hospice must designate an interdisciplinary group(s) composed of individuals who provide or supervise care and services offered by the hospice.
(a) The interdisciplinary group(s) must include certain specialists.
(b) The interdisciplinary group is responsible for—
(1) Participation in the establishment of the plan of care ..
418.68
(3) Periodic review and updating of the plan of care for
each individual receiving hospice care; and.
(4) Establishment of policies governing the day-to-day
provision of hospice care and services.
Only one interdisciplinary group chosen in advance may execute the functions described in the paragraph (b)(4) of this
section.
(d) Designating a registered nurse to coordinate the implementation of the plan of care for each patient.
Volunteers: The hospice in accordance with the numerical standards, specified in paragraph (e) of this section, uses volunteers,
in defined roles, under the supervision of a designated hospice
employee.
(a) The hospice must provide appropriate orientation and
training.
(b) Volunteers must be used in direct patient care or administrative roles.
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Short term inpatient care ............
Comprehensive Assessment of
the Patient Initial assessment.
(a) Time frame for the completion
of the comprehensive assessment
(b) Content of the comprehensive
assessment
(c) Update of the comprehensive
assessment
(d) Outcome measures on the
patient
....................
(2) Provision of supervision of hospice care and services
Proposed condition
....................
....................
....................
418.60
418.62
418.64
418.66
....................
....................
....................
....................
....................
....................
....................
....................
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418.56(b)
418.56(d)
418.56(c)
418.100(d)
418.52(a)
418.60
418.60(c)(3)
418.56(a)
418.78
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DERIVATION TABLE—Continued
Current conditions
(Part 418, subpart C, D, E)
Citation
existing
section
Proposed condition
(c) The hospice must document active and ongoing efforts to
recruit and retain volunteers.
(d) The hospice must document the cost savings achieved
through volunteer use. Documentation must include—
(1) Necessary positions which are occupied by volunteers.
(2) The work time spent by volunteers occupying those
positions; and
(3) Estimates of the dollar costs of paying employees to
occupy the positions identified in (d)(1) for the time
specified in (d)(2).
(e) Volunteer staff providing direct patient care and administrative support must equal at least 5 percent of the total patient care hours of all paid hospice employees and contract
staff. Any expansion of care and services achieved by using
volunteers, including the type of services and time worked,
must be recorded.
(f) Reasonable efforts made to arrange for visits of members
of religious organizations to patients who request such visits
and must advise patients of this opportunity.
Licensure: The hospice and all its employees must be licensed in
accordance with applicable Federal, State, and local laws and
regulations.
(a) The hospice must be licensed if State or local law provides
for licensure.
....................
Volunteers ...................................
418.78(c)
....................
Volunteers ...................................
418.78(d)
....................
Volunteers ...................................
418.78(e)
....................
Deleted.
(b) Employees who provide services must be licensed, certified or registered in accordance with applicable Federal or
State laws.
Central Clinical Records: Establishment and maintenance of a clinical record for every patient. The record must be complete,
promptly and accurately documented, readily accessible and
systematically organized to facilitate retrieval.
(a) Clinical record is comprehensive. Entries are made and
signed for all services provided whether furnished directly or
under arrangements made by the hospice. Each individual’s
record contains—.
(1) Initial and subsequent assessments .............................
(2) Plan of care ...................................................................
(3) Identification data ..........................................................
(4) Consent and authorization and election forms .............
(5) Pertinent medical history ...............................................
(6) Complete documentation of all services and events ....
(b) Protection of information. The hospice must safeguard the
clinical record against loss, destruction, and unauthorized
use.
Subpart D—Condition of Participation: Core Services:
Furnishing of Core Services: Hospice employees must routinely
provide all core services. Contracted staff may supplement hospice employees to meet patient needs during peak periods or
under extraordinary circumstances. The hospice must maintain
professional, financial, and administrative responsibility for contracted services and must assure that the qualifications of staff
and services provided meet specified requirements. See exception in 418.83.
Nursing services: Nursing care and services provided by or under
the supervision of a registered nurse.
(a) The nursing needs of the patients must be met ..................
(b) Patient care responsibility of nursing personnel must be
specified.
(c) Services are provided in accordance with recognized
standards of practice.
Waiver of all requirements that substantially all nursing services be
routinely services be routinely provided directly by a hospice.
(a) Waiver if located in non-urbanized area, operational on or
before January 1, 1983, and good faith effort made to fulfill
staffing needs.
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418.72
Citation
Compliance with Federal, State &
local laws & regulations related
to health & safety of patients.
Personnel
Qualifications
for
Skilled
Professionals;
and
Compliance with Federal, State
& local laws & regulations related to health & safety of patients.
418.114 and
418.116(a)
418.74
Clinical Records ..........................
418.104
....................
Clinical Records ..........................
418.104(a)
....................
....................
....................
....................
....................
....................
....................
Clinical Records
Clinical Records
Deleted.
Clinical Records
Deleted.
Clinical Records
Clinical Records
..........................
..........................
418.104(a)(1)
418.104(a)(1)
..........................
418.104(a)(2)
..........................
..........................
418.104(a)(1)
418.104(c)
....................
418.116
418.80
Core services ..............................
418.64
418.82
Core services ..............................
418.64(b)
....................
....................
Core services ..............................
Deleted.
418.64(b)
....................
Core services ..............................
418.66
418.83
Nursing service waver (re-codified).
418.66
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules
DERIVATION TABLE—Continued
Citation
existing
section
Current conditions
(Part 418, subpart C, D, E)
(b) Any waiver request is deemed to be granted unless it is
denied within 60 days after it is received.
(c) Waivers will remain effective for one year at a time.
(d) HCFAa may approve a maximum of two one-year extensions for each initial waiver.
Medical social services: Medical social services must be provided
by a qualified social worker, under the direction of a physician.
Physician services: In addition to palliation and management of
terminal illness and related conditions, physician employees of
the hospice must also meet the general medical needs of the
patient.
Counseling services: Counseling services, including bereavement,
dietary, and spiritual counseling, must be available to both the
individual and the family.
(a) Organized program for the provision of bereavement services under the supervision of a qualified professional. A
special coverage is specified in 418.204(c).
(b) Provision of dietary counseling
(c) Spiritual counseling must include notice to patients as to
the availability of the clergy as provided in 418.70(f).
(d) Counseling may be provided by others ...............................
Subpart E—Condition of Participation: Other services:
Furnishing other services: The services described in this subpart
must be provided directly by hospice employees or under arrangements made by the hospice as specified in 418.56.
Physical therapy, occupational therapy and speech language pathology.
(a) Physical therapy, occupational therapy, and speech-language pathology services must be available and provided
under acceptable standards of practice.
(b)(1) Laboratory testing services must be in compliance with
all applicable requirements of part 493 of this chapter.
....................
(2) All referral laboratories must be certified in the appropriate
specialties and subspecialties of services. See part 493 of
this chapter.
....................
Home health aide and homemaker service: Home health aide and
homemaker must be services available and adequate in frequency to meet the needs of the patients. A home health aide is
a person who meets the training, attitude and skill requirements
specified in 484.36 of this chapter.
(a) Standard: A registered nurse visits the home site at least
every two weeks when aide services arebeing provided,
and conducts an assessment of the aide services.
(b) Standard: A registered nurse prepares written instructions
for patient care. Duties include, but may not be limited to,
the duties specified in 484.36(c) of this chapter.
Medical supplies: Medical supplies, appliances, drugs and
biologicals must be provided for the palliation and management
of the terminal illness and related conditions.
418.94
Proposed condition
Citation
418.84
Core services ..............................
418.64(c)
418.86
Core services ..............................
418.64(a)
418.88
Core services ..............................
418.64(d)
....................
Core services ..............................
418.64(d)(1)
....................
....................
Core services ..............................
Core services ..............................
418.64(d)(2)
418.64(d)(3)
....................
Deleted.
418.90
Furnishing of non core services ..
418.92(a)
....................
418.70
418.70, 418.72
Physical therapy, occupational
therapy and speech language
pathology and dietary counseling, Non-core services.
Compliance with Federal, State &
local laws & regulations related
to the health & safety of patients.
Compliance with Federal, State &
local laws & regulations & related to the health & safety of
patients.
Home Health Aide and homemaker services.
418.70, 418.72
....................
Home health aide and homemaker services (revised).
418.76(h)(1)
....................
Home health aide and homemaker services.
418.76(g)(1)
418.96
418.106
418.116(c)(1)
418.116(c)(2)
418.76
(a) All drugs and biologicals must be administered in accordance with accepted standards of practice.
....................
(b) The hospice must have a policy for the disposal of extraneous controlled drugs maintained in the patient’s home.
....................
(c) Only certain individuals may administer drugs and
biologicals.
Short term inpatient care: Inpatient care must be available for pain
control, symptom management and respite purposes, and must
be provided in a participating Medicare or Medicaid facility.
(a) Inpatient care for pain control and symptom management
must be provided in one of the following:
....................
Drugs, controlled drugs, and
biologicals, medical supplies
and durable medical equipment.
Drugs, controlled drugs, and
biologicals, medical supplies
and durable medical equipment.
Drugs, controlled drugs, and
biologicals, medical supplies
and durable medical equipment.
Deleted.
....................
Short term inpatient care ............
418.108
....................
Short term inpatient care ............
418.108(a)
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418.106(a)
418.106(b)
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules
DERIVATION TABLE—Continued
Citation
existing
section
Proposed condition
(1) A hospice that meets the standards for providing inpatient care directly specified in 418.100.
(2) A hospice or skilled nursing facility that also meets the
standards of 418.100(a) and (e).
(b) Inpatient care for respite purposes must be provided by: ...
(1) A provider specified in paragraph (a) of this section ....
(2) An intermediate care facility (ICF) meeting the standards in 418.100 (a) and (e).
....................
Short term inpatient care ............
418.108(a)(1)
....................
Short term inpatient care ............
418.108(a)(2)
....................
....................
....................
418.108(b)
418.108(b)(1)
418.108(b)(2)
(c) Inpatient care for Medicare beneficiaries may not exceed
20 percent of the total number of days for this beneficiary
group.
(d) Exemption from limitation in paragraph (c) ..........................
Hospices that provide inpatient care directly: A hospice that provides inpatient care directly must comply with all of the following
standards.
(a) Twenty-four hour nursing services:
(1) The facility provides 24-hour nursing services in accordance with patient plan of care sufficient to meet
total nursing needs.
(2) Each shift includes a direct care registered nurse .......
(b) The hospice has an acceptable written plan, periodically
rehearsed with staff, with internal and external disaster procedures.
(c) The hospice must meet all Federal, State and local laws,
regulations, and codes pertaining to health and safety.
....................
Short term inpatient care ............
Short term inpatient care ............
Short term inpatient care (delete
ICF and replace with nursing
facility (NF)).
Short term inpatient care ............
....................
418.100
Short term inpatient care ............
Hospices that provide inpatient
care directly.
418.108(e)
418.110
....................
Hospices that provide inpatient
care directly.
418.110(b)
....................
....................
Deleted.
Hospices that provide inpatient
care directly.
418.110(c)(1)(iii)
....................
418.116
(d) Fire protection .......................................................................
....................
Compliance with Federal, State &
local laws and regulations related to health and safety of
patients.
Hospices that provide inpatient
care directly.
(1) Hospices must comply with the 1985 edition of the
Life Safety Code of the NFPA. See exceptions in (d)(2)
and (3).
(2) Waiver for specific provisions of Life Safety Code.
(3) 1981 edition compliance by May 9, 1988 will be considered as meeting this standard.
(4) Restrictions on facilities of two or more stories not of
fire resistive construction.
(e) Patient areas. .......................................................................
....................
Hospices that provide inpatient
care directly.
418.110(e)
(1) Design and equipment of patient/family areas.
(2) Specifications for patient/family accommodations
(3) Visitor specifications.
(f) Patient rooms and toilet facilities. .........................................
....................
Hospices that provide inpatient
care directly.
418.110(f)
(1) Specifications for equipment, size, and location of patient rooms and toilet.
(2) Waiver of space and occupancy requirements for unreasonable hardships.
(g) Requirements for bathroom facilities ....................................
....................
(h) Requirements for linens .......................................................
....................
418.110(g),
418.110(h)
418.110(k)
(i) Isolating areas for patients with infectious diseases .............
....................
(j) Meal service and menu planning ..........................................
....................
(1) Three meals a day served at regular times; no more
than 14 hours between substantial evening meal and
breakfast.
(2) Procure, store, prepare, distribute, and serve all food
under sanitary conditions.
(3) Have a staff member trained or experienced in food
management or nutrition.
(4) A professionally qualified dietitian must plan and supervise a menu for patients requiring special diets.
(k) Pharmaceutical services. The hospice provides appropriate
methods and procedures for the dispensing and administering of drugs and biologicals.
418.100
Hospices that
care directly.
Hospices that
care directly.
Hospices that
care directly.
Hospices that
care directly.
Deleted.
Current conditions
(Part 418, subpart C, D, E)
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provide inpatient
provide inpatient
provide inpatient
provide inpatient
....................
Hospices that provide inpatient
care directly.
418.108(d)
418.110(d)(1)
418.110(j),
418.110(i)
418.110(l)
Deleted.
....................
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules
DERIVATION TABLE—Continued
Citation
existing
section
Proposed condition
(1) Licensed pharmacist The hospice must— ....................
....................
Hospices that provide inpatient
care.
418.110(n)
(i) employ a licensed pharmacist; or
(ii) have a formal agreement with a licensed pharmacist to advise the hospice on ordering, storage,
administration, disposal and record keeping of
drugs and biologicals.
(2) Orders for medications. .................................................
....................
Hospices that provide inpatient
care directly.
418.110(n)
NEW
Hospices that provide inpatient
care directly: Seclusion and
Restraint.
Waiver of Physical therapy, occupational therapy and speech
language pathology and dietary counseling.
Hospices that provide hospices
care to residents of a SNF/NF,
ICF/MR or other facility In addition to meeting the conditions
of participation at 418.10
through 418.116, a hospice
that provides hospice care to
residents of a SNF/NF, ICF/
MR, or other residential facility
abide by the following additional standards.
(a) Standard: Resident eligibility,
election, and duration of benefits.
(b) Standard: Professional management.
(c) Standard: Core services ........
(d) Standard: Medical director .....
(e) Standard: Written agreement
(f) Standard: Hospice plan of
care.
(g) Standard: Coordination of
services.
(h) Standard: Transfer, revocation, or discharge from hospice.
418.110(o)
Current conditions
(Part 418, subpart C, D, E)
Citation
(i) Physician orders all patient medications.
(ii) Verbal medication order:
(A) Only given to a registered nurse, pharmacist,
or physician.
(B) the individual receiving the order must record
and sign it immediately and have the prescribing physician sign it in a manner consistent with good medical practice.
(3) Medications are administered only by one of the individuals specified.
(4) The pharmaceutical service has procedures for control
and accountability of all drugs and biological throughout
the facility, including record keeping and reconciliation
procedures.
(5) The labeling of drugs and biologicals is based on currently accepted professional principles, and includes
the appropriate accessory and cautionary instructions,
as well as the expiration date when applicable.
(6) All drugs and biologicals are stored and locked in
compartments under proper temperature controls and
only authorized personnel have access to the keys.
Separately locked compartments are provided for
schedule II and other drugs subject to abuse, except
under single unit package drug distribution systems. An
emergency medication kit is kept readily available.
(7) Extraneous controlled drugs are disposed of in compliance with State requirements. When none apply, the
pharmacist and a registered nurse must dispose of the
drugs and prepare a record of the disposal.
NEW
NEW
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418.74
418.112
418.112(a)
418.112(b)
418.112(c)
418.112(d)
418.112(e)
418.112(f)
418.112(g)
418.112(h)
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DERIVATION TABLE—Continued
Citation
existing
section
Current conditions
(Part 418, subpart C, D, E)
Proposed condition
(i)
Standard: Orientation and
training of staff.
Personnel qualifications ..............
(a) General qualification requirements.
(b) Federally defined qualifications.
(c) Personnel qualifications when
no States licensing laws, certification or registration requirements exist.
Criminal background checks .......
Compliance with Federal, State,
& local laws and regulations
related to health and safety of
patients The hospice and its
staff must operate and furnish
services in compliance with all
applicable Federal, State, &
local laws & regulations related
to the health & safety of patients. If State and local law
provides for licensing of hospices, the hospice must be licensed.
(a) Standard: Licensure of staff ..
(b) Standard: Multiple locations ..
(c) Standard: Laboratory services
NEW
NEW
V. Collection of Information
Requirements
Section 418.52 Condition of
Participation: Patient’s Rights
Under the Paperwork Reduction Act
(PRA) of 1995, we are required to
provide 60-day notice in the Federal
Register and solicit public comment
before a collection of information is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the PRA requires that
we solicit comment on the following
issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment on
each of these issues for the information
collection requirements discussed
below. The following information
collection requirements in this proposed
rule and the associated burdens are
subject to PRA.
Paragraph (a) of this section would
require that the hospice provide each
patient with: a verbal and written notice
of the patient’s rights and
responsibilities during the initial
evaluation visit, in advance of
furnishing care; written information
concerning its policies on advance
directives, including a description of
applicable State law; and written or
verbal information regarding the
hospice’s drug policies and procedures,
including the tracking and disposing of
controlled substances. The hospice
would also be required to maintain
documentation showing that it
complied with the requirements of this
section and that the patient or
representative demonstrated an
understanding of these rights.
The burden associated with these
requirements would be the time
associated with disclosing the
information and documenting that the
hospice did disclose the information.
We estimate that this would take
approximately 5 minutes per patient or
24.58 hours per hospice, for an annual
total of 59,417 hours.
Paragraph (b) of this section would
require a hospice to document a patient/
representative complaint, and the steps
taken by the hospice to resolve it.
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Citation
418.112(i)
418.114
418.114(a)
418.114(b)
418.114(c)
418.114(d)
418.116
418.116(a)
418.116(b)
418.116(c)
The burden associated with this
requirement would be the time it took
to document the necessary aspects of
the issues. We anticipate 15 complaints
per year per hospice and 15 minutes to
document the complaint and resolution
activities, for a total of 9,045 hours
annually.
Paragraph (e) of this section would
require the patient to be informed of the
extent to which payment may be
expected from the patient, Medicare or
Medicaid, third-party payers, or other
resources of funding known to the
hospice, verbally and in writing, and in
a language that he or she can
understand, before care is initiated. The
burden associated with this requirement
would be the time it would take to
notify patients. We estimate that it
would take no more than 5 minutes per
patient, for a total of 24.58 hours per
hospice and 59,417 hours nationally.
Section 418.54 Condition of
Participation: Comprehensive
Assessment of the Patient
This section would require each
hospice to conduct and document in
writing a comprehensive patientspecific assessment, and maintain
documentation of the assessment and
any updates.
The burden associated with this
requirement would be the time it would
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take to record the assessment and any
changes/updates to it. We believe that
documenting a patient assessment is a
usual and customary business practice
and as such the burden is not subject to
the PRA.
Section 418.56 Condition of
Participation: Interdisciplinary Group
Care Planning and Coordination of
Services
This section would require all hospice
care and services furnished to patients
and their families to follow a written
plan of care established by the hospice
interdisciplinary group in collaboration
with the attending physician. The
hospice would be required to ensure
that each patient/family and primary
caregiver(s) receive education and
training provided by the hospice as
appropriate to the care and services
identified in the plan of care. The
section would specify the minimum
elements the plan of care must include.
In addition, the medical director or
physician designee and the hospice
interdisciplinary team, in collaboration
with the individual’s attending
physician, would be required to review,
revise and document the plan as
necessary at intervals specified in the
plan, but no less than every 14 calendar
days. A revised plan of care would have
to include information from the
patient’s updated comprehensive
assessment, and would have to
document the patient’s progress toward
the outcomes specified in the plan of
care.
These requirements are subject to the
PRA; however, they are currently
approved under OMB control number
0938–0302 with a current expiration
date of September 30, 2006.
The burden associated with these
requirements would be the time it
would take to document the plan of care
(10 minutes) and any revisions to it (15
minutes) in the clinical record. We
estimate that it would take 25 minutes
to comply with these requirements per
patient, for a total of 123 hours on
average per hospice, and 297,083 hours
nationally.
Section 418.58 Condition of
Participation: Quality Assessment and
Performance Improvement
This section would require a hospice
to develop, implement, and maintain an
effective ongoing hospice-wide datadriven quality assessment and
performance improvement (QAPI)
program. The hospice’s governing body
would have to ensure that the program
reflected the complexity of its
organization and services; involved all
hospice services, including those
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services furnished under contract or
arrangement; focused on indicators
related to improved palliative outcomes
and end-of-life support services
provided; and took actions to
demonstrate improvement in hospice
performance. The hospice would be
required to maintain and demonstrate
evidence of its quality assessment and
performance improvement program and
be able to demonstrate its operation to
the CMS.
The hospice would be required to take
actions aimed at performance
improvement and, after implementing
those actions, the hospice must measure
its success and track its performance to
ensure that improvements were
sustained.
The hospice would be required to
document what quality improvement
projects were being conducted, the
reasons for conducting these projects,
and the measurable progress achieved
on these projects.
The burden associated with this
requirement would be the time it would
take to document the development of
the quality assessment and performance
improvement and associated activities.
We estimate that it would take each
hospice an average of 24 hours per year
to comply with these requirements for a
total of 57,888 hours annually.
enter into a written agreement for the
provision of certain nursing services by
an outside body. The burden associated
with this requirement would be the time
required to negotiate, draft and sign an
agreement. We believe that this
requirement is a customary and usual
business practice. Thus, the burden
would not be subject to the PRA.
Under the counseling standard for
this condition, the hospice would be
required to advise the patient/family
that the hospice would facilitate visits
by local clergy, pastoral counselor, or
other individuals who could support the
patient’s spiritual needs. We believe
that this requirement is a customary and
usual hospice practice, and is therefore
not subject to the PRA.
Section 418.60 Condition of
Participation: Infection Control
The hospice would be required to
maintain and document a coordinated
infection control program that protected
patients, families and hospice personnel
by preventing and controlling infections
and communicable diseases.
The burden associated with this
requirement would be the time it would
take to document the program. We
believe that this proposed requirement
reflects usual and customary medical
and business practice; thus the burden
is not subject to the PRA.
Section 418.66 Condition of
Participation: Nursing Services Waiver
of Requirement That Substantially all
Nursing Services Be Routinely Provided
Directly by a Hospice
Under this section, if a hospice
wanted a waiver from the requirement
that substantially all nursing services be
routinely provided by the hospice, it
would be required to provide evidence
that it made a good faith effort to hire
a sufficient number of nurses to provide
services. To extend the waiver, the
hospice would be required to submit a
request to CMS attesting that the
conditions under which it originally
requested the initial waiver had not
changed since the initial waiver was
granted.
The burden associated with this
requirement would be the time it would
take to provide the necessary
documentation, and the time it would
take to request an extension. We
estimate that there will be no more than
5 hospices providing the information
and requesting extensions. Under
section 1320.3, this requirement would
not be subject to the PRA as it would
affect fewer than 10 entities.
Section 418.64 Condition of
Participation: Core Services
We are proposing that a hospice could
choose to enter into an arrangement
with another hospice to obtain
personnel to furnish core hospice
services under certain circumstances.
Such an arrangement would have to be
supported by a legally binding written
agreement. The burden associated with
this requirement would be the time
required to negotiate, draft and sign an
agreement. We believe that this
requirement is a customary and usual
business practice. Thus, the burden
would not be subject to the PRA.
Under the nursing services standard
for this condition, the hospice could
Section 418.74 Condition of
Participation: Waiver of RequirementPhysical Therapy, Occupational
Therapy, Speech-Language Pathology,
and Dietary Counseling
A hospice located in a non-urbanized
area would be able to submit a written
request for a waiver of the requirement
that the hospice directly provide
physical therapy, occupational therapy,
speech-language pathology, and dietary
counseling services. The hospice would
be able to seek a waiver of the
requirement that it make physical
therapy, occupational therapy, speechlanguage pathology, and dietary
counseling services (as needed)
available on a 24-hour basis. The
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hospice would also be able to seek a
waiver of the requirement that it
provide dietary counseling directly. The
hospice would have to provide evidence
that it had made a good faith effort to
meet the requirements for these services
before it sought such a waiver. To
extend the waiver, the hospice would be
required to submit a request to CMS
recertifying that the conditions under
which it originally requested the initial
waiver had not changed since the initial
waiver was granted.
The burden associated with this
requirement would be the time it would
take to provide the necessary
documentation and the time it would
take to request an extension. We
estimate that there would be no more
than 5 hospices providing the
information and requesting extensions.
Under section 1320.3, this requirement
would not be subject to the PRA, since
it would affect fewer than 10 entities.
Section 418.76 Condition of
Participation: Home Health Aide and
Homemaker Services
Under this section, the hospice would
be required to maintain documentation
that it met the requirements of the
standard concerning the content and
duration of home health aide classroom
and supervised practical training,
competency evaluation, and in-service
training.
We estimate that it would take
approximately 5 minutes per home
health aide to document meeting this
standard and that 2,412 home health
aides would be trained each year
nationally, for a total of 201 hours
annually.
Under this section, written patient
care instructions would have to be
prepared by a registered nurse or other
licensed professional.
We believe that this requirement
reflects a usual and customary business
practice and the burden would not be
subject to the PRA.
Home health aides would be required
to report changes in the patient’s
medical, nursing, rehabilitative, and
social needs to a registered nurse or
other appropriate licensed professional,
and complete appropriate records in
compliance with the hospice’s policies
and procedures. In addition, as
members of the interdisciplinary team,
home health aides would be required to
report any change in a patient’s
condition as the change related to the
plan of care and quality assessment and
performance improvement activities.
Under this section as well,
homemakers would be required to
report all concerns about the patient or
family to the member of the
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interdisciplinary group who was
coordinating homemaker services.
We believe that reporting and
documenting this is a usual and
customary business practice and, as
such, the burden would not be subject
to the PRA.
Section 418.78 Conditions of
Participation—Volunteers
Under this section, the hospice would
be required to maintain, document and
provide volunteer orientation and
training that was consistent with
hospice industry standards.
We estimate that on average a hospice
would provide orientation and training
6 times per year and that it would take
no more than five minutes to document
each orientation session, for a total of 30
minutes per year, and a national total of
1,206 hours.
Under this section, the hospice would
be required to document savings
achieved through the use of volunteers.
We estimate that this activity would
take approximately 3 hours per hospice
per year, or 7,236 hours nationally.
The hospice would also be required to
record examples of patient care tasks
and administrative services performed
by volunteers, including the type of
services and time worked.
We estimate that recording these
examples would take approximately 600
hours per year per hospice, or 1,447,200
hours nationally.
Section 418.100 Condition of
Participation: Organization and
Administration of Services
Under paragraph (e) of this section,
arranged services would be required to
be supported by written agreements that
would have to require specified
activities.
Written agreements are a necessary
part of usual and customary business
practice; thus, the burden would be
exempt from the PRA under section
1320.3(b)(2).
Under paragraph (g), the hospice
would be required to have written
policies and procedures describing its
method(s) of assessing competency and
would be required to maintain a written
description of the in-service training
provided during the previous 12
months.
Written policies and procedures are a
necessary part of usual and customary
business practice; thus, we believe that
the burden would be exempt from the
PRA under section 1320.3(b)(2).
Section 418.102 Condition of
Participation: Medical Director
This section would require the
medical director or physician designee
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to review the clinical information for
each hospice patient and provide
written certification that it was
anticipated that the patient’s life
expectancy was 6 months or less if the
illness were to run its normal course.
The burden associated with this
would be the review time and the
written certification. We estimate that it
would take approximately 10 minutes
per patient, for a total of 49 hours per
hospice annually and 118,833
nationally.
Section 418.104 Condition of
Participation: Clinical Records
Under this section the hospice would
be required to maintain on each patient
a clinical record that contained accurate
clinical information and was available
to the patient’s attending physician and
hospice staff.
The burden associated with this
requirement would be the time it would
take to maintain a record on each
patient. We believe that the requirement
reflects usual and customary medical
practices and, as such, the burden
would not be subject to the PRA.
Paragraph (e) of this section would
require that, if the care of a patient were
transferred to another Medicare/
Medicaid-approved facility, the hospice
would be required to forward a copy of
the patient’s clinical record and the
hospice discharge summary to that
facility. If a patient revoked the election
of hospice care, or was discharged from
hospice because eligibility criteria were
no longer met, the hospice would have
to provide a copy of the clinical record
and the hospice discharge summary of
this section to the patient’s attending
physician.
The burden associated with this
requirement would be the time it took
to forward the clinical record and
discharge summary. This is a usual and
customary business practice, and as
such the burden would not be subject to
the PRA.
Section 418.106 Condition of
Participation: Drugs, Controlled Drugs
and Biologicals, Medical Supplies, and
Durable Medical Equipment
Under paragraph (b), the hospice
would be required to have a written
policy for tracking, collecting, and
disposing of controlled drugs
maintained in the patient’s home.
The burden associated with this
requirement would be the time it would
require to put the policy in writing.
Written policies are a necessary part of
usual and customary business practice;
thus, we believe that the burden would
be exempt from the PRA under section
1320.3(b)(2).
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Under paragraph (b) of this section,
during the initial hospice assessment,
the use and disposal of controlled
substances would be required to be
discussed with the patient and family to
ensure the patient and family were
educated regarding the use and
potential danger of controlled
substances. The hospice nurse would be
required to document that the policy
was discussed with the patient and
family.
We anticipate that the discussion and
documentation of the discussion would
take approximately 5 minutes per
patient, and 24.58 hours per hospice, for
a total of 59,417 hours annually for all
patients.
Under paragraph (c) of this section, if,
for a piece of equipment, there were no
manufacturer recommendations for
repair and routine maintenance, the
hospice would be required to develop in
writing its own repair and routine
maintenance policy.
The burden associated with this
requirement would be the time required
to put the policy in writing. Written
policies are a necessary part of usual
and customary business practice; thus,
we believe that the burden would be
exempt from the PRA under section
1320.3(b)(2).
Section 418.108 Condition of
Participation—Short-Term Inpatient
Care
If the hospice had an arrangement
with a facility to provide for short-term
inpatient care, the arrangement would
have to be described in a legally binding
written agreement that at a minimum
contained specified elements.
The burden associated with this
requirement would be the time it took
to negotiate, draft, and sign the
agreement. Having written agreements is
a usual and customary business practice
and, as such, we believe that the burden
would not be subject to the PRA.
Section 418.110 Condition of
Participation: Hospices That Provide
Inpatient Care Directly
Under paragraph (c)(1)(i) of this
section, we would require a hospice to
report breaches of safety and equipment
failures to the appropriate State and
local bodies having regulatory
jurisdiction.
The reporting burden associated with
this requirement would be the time
required to report such safety and
equipment breaches. We estimate that
there would be approximately 110
safety and equipment breaches annually
nationwide. Filing a report regarding
these events would take approximately
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30 minutes per event for a total of 55
hours annually nationwide.
Under paragraph (c)(1)(iii) of this
section, the hospice would be required
to have a written disaster preparedness
plan in effect for managing the
consequences of power failures, natural
disasters, and other emergencies that
might affect the hospice’s ability to
provide care.
The burden associated with this
requirement would be the time it took
to write the disaster preparedness plan.
We believe that hospices will each
spend 1 hour developing a disaster plan
for a total of 2,412 hours on a one time
basis.
Under paragraph (m) of this section,
under the direction of a qualified
pharmacist, the hospice would be
required to provide pharmaceutical
services such as drugs and biologicals
and have a written protocol in place that
would ensure dispensing accuracy.
The burden associated with this
requirement would be the time it took
to devise and write down the protocol.
We believe that having such a protocol
in writing is a usual and customary
business practice, and, as such, we
believe that the burden would be
exempt from the PRA.
Paragraph (n) of this section would
require a physician to order all
medications for a patient; all drugs and
biologicals to be labeled in accordance
with accepted professional practice,
containing specified information; and
would require the hospice to keep
current and accurate records of the
receipt and disposition of all controlled
drugs. Any discrepancies in the
acquisition, storage, use, disposal, or
return of controlled drugs would have to
be investigated immediately by the
pharmacist and hospice administrator
and, where required, reported to the
appropriate State agency; a written
account of the investigation would be
required to be made available to State
and Federal officials.
The burden associated with these
requirements would be the time
required to (1) document orders, label
drugs, and maintain current and
accurate records of the receipt and
disposition of all controlled drugs; and
(2) document, investigate, and report
drug discrepancies. We believe that the
first requirement, concerning ongoing
documentation, reflects customary and
usual medical and business practices
and the burden would therefore be
exempt under the PRA. For the
documentation, investigation and
reporting of drug discrepancies, we
estimate that there are 55 events
annually that would require such
documentation, and that each event
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would require one hour of labor to meet
the proposed requirements for a total of
55 hours nationally annually.
Paragraph (o) of this section would
require orders for a physical restraint or
seclusion to be written, and that
physical restraint or seclusion be
supported by a documented order and
the patient’s response or outcome and
documented in the patient’s clinical
record. In addition, the hospice must
report any death that occurs while the
patient is restrained or in seclusion.
We estimate that there would be
approximately 7,130 incidents of
physical restraint or seclusion and that
it would take approximately 4 minutes
to write the orders and to document the
incident, for an annual national total of
475 hours. Additionally, it would take
six hours for a hospice to develop a
customized pre-printed seclusion and
restraint order, totaling 14,472 hours
nationwide on a one-time basis.
We have no concrete estimate of the
number of deaths that would occur per
year that occurred while the patient was
restrained or secluded. We believe that
the number of deaths is less than 10 per
year, and we would expect that number
to decrease as hospices implement the
proposed new seclusion and restraint
requirements. Therefore, under section
1320.3, this requirement is not subject
to the PRA, as it would affect fewer than
10 entities.
Section 418.112 Condition of
Participation: Hospices That Provide
Hospice Care to Residents of a SNF/NF,
ICF/MR, or Other Facility
Paragraph (e) of this section would
require the hospice and the other
facility to have a written agreement that
would specify the terms under which
the hospice would provide hospice
services in the facility, and would
require the agreement to be signed by
authorized representatives of the
hospice and the facility, before the
hospice could provide such hospice
services. The written agreement would
have to include specified information
and documents.
The burden associated with this
requirement would be the time required
to draft and sign an agreement and to
gather the information to be sent on
each patient. Both of these requirements
can be considered customary and usual
medical and business practices. Thus,
the burden would not be subject to the
PRA.
Paragraph (f) of this section would
require a written plan of care to be
established and maintained for each
facility patient, developed by and
coordinated with the hospice
interdisciplinary group in consultation
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with facility representatives, and in
collaboration with the individual’s
attending physician. The plan of care
would be required to include specified
information.
This proposed burden is included
with the burden discussed under
section 418.56.
Under paragraph (g) of this section we
would require a hospice to provide the
facility with the following information
specified in this paragraph.
The burden associated with this
requirement would be the time required
by staff to compile the information.
However, we believe that such
information compilation is a usual and
customary medical and business
practice. Thus, the burden would not be
subject to the PRA.
Section 418.114 Condition of
Participation: Personnel Qualifications
for Skilled Professionals
Paragraph (d) of this section would
require each hospice to obtain a
criminal background check on each
employee, including but not limited to
those employees who have hands-on
patient contact, those who are employed
in an administrative or maintenance
capacity, those who are volunteers, and
those who provide services under
contract. The background check would
be required to be obtained before the
hospice would employ that person.
In 2002, 39 states required criminal
background checks for hospice
employees. In these states
approximately 70,395 hospice
employees have already received a
criminal background check, thus greatly
reducing the overall burden. We
estimate that hospices that have not
previously performed background
checks, accounting for 19,876 hospice
employees, would each obtain 39
criminal background checks initially.
Each background check request form
would take 6 minutes to prepare and
send, for a total of 4 hours per hospice
the first year. For each year thereafter all
hospices would complete background
checks on approximately 8 new
employees per year for a total of 48
minutes per hospice per year and 1,852
hours nationally per year.
The total burden of these
requirements would be 2,117,529 hours
annually and 16,888 hours on a onetime basis.
To comment on these information
collection and record keeping
requirements, please mail copies
directly to the following:
Centers for Medicare & Medicaid
Services, Office of Strategic
Operations and Regulatory Affairs,
Regulations Development and
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Issuances Group, Attn: William
Parham, Room C5–14–03, 7500
Security Boulevard, Baltimore, MD
21244–1850.
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Room 10235, New Executive
Office Building, Washington, DC
20503, Attn: Christopher Martin, CMS
Desk Officer, (CMS–3844–P),
Christopher_Martin@omb.eop.gov.
Fax: (202) 395–6974.
VI. Impact Analysis
A. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 (September 1993, Regulatory
Planning and Review), the Regulatory
Flexibility Act (RFA) (September 16,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), and Executive Order 13132.
Executive Order 12866 (as amended
by Executive Order 13258, which
merely reassigns responsibility of
duties) directs agencies to assess all
costs and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
($110 million or more in any 1 year).
This is not a major rule, since the
overall economic impact for all
proposed new Conditions of
Participation is estimated to be $13.7
million annually.
The RFA requires agencies to analyze
options for regulatory relief of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and
government agencies. Individuals and
States are not included in the definition
of a small entity. For purposes of the
RFA, most hospices (approximately
73% of Medicare certified facilities) are
considered to be small entities, either by
virtue of their nonprofit or government
status or by having revenues of $6
million to $29 million in any one year
(for details, see the Small Business
Administration’s regulation that sets
forth size standards for health care
industries at 65 FR 69432). We estimate
there are approximately 2,412 hospices
with average admissions of
approximately 295 patients per hospice
(based on the number of patients in
2003 divided by the number of hospices
in 2003). The National Hospice and
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Palliative Care Organization estimates
that 79 percent of hospice patients are
Medicare beneficiaries, thus we have
not considered other sources of revenue
in this analysis.
We certify that this rule would not
have a significant impact on a
substantial number of small entities
because the cost of this rule is less than
1 percent of total hospice Medicare
revenue. According to the CMS 2003
national expenditure data, Medicare
paid $5.7 billion to providers for
hospice care in 2003. We estimate this
rule will cost hospices approximately
$16.9 million or approximately $7,389
per statistically average hospice
annually.
We understand that there are different
sizes of hospices and that the burden for
hospices of different sizes will vary.
Therefore, we have assessed the burden
for hospices that are smaller than the
statistically average hospice used for
calculations in part B of this section,
Anticipated effects on hospices. The
smaller hospices have been broken up
into three categories based on the
number of routine home care days, the
most common level of hospice care
provided. The categories are: group 1
hospices providing 0 to 1,754 routine
home care days; group 2 hospices
providing 1,755 to 4,373 routine home
care days; and group 3 hospices
providing 4,374 to 9,681 routine home
care days. Group 1 hospices, averaging
23 patients per year, would spend
approximately $1,845 to comply with
the proposed regulations. The average
hospice in this group received $101,181
from Medicare for routine home care
days under the 2002 hospice payment
rates. Group 2 hospices, averaging 77
patients per year would spend
approximately $2,936 to comply with
the proposed regulations. The average
hospice in this group received $325,533
from Medicare for routine home care
days under the 2002 rates. Group 3
hospices, averaging 173 patients per
year, will spend approximately $4,889
to comply with the proposed
regulations. The average hospice in this
group received $767,550 from Medicare
for routine home care days under the
2002 rates.
The time and cost burden for these
providers is significantly less than that
of the statistically average hospice used
in part B of this section because the
majority of the burden imposed by the
proposed regulations is directly tied to
patient care and the staff necessary to
provide care. Therefore, a reduced
patient census leads to reduced burden.
These figures do not, however, adjust
the estimated quality assessment and
performance improvement burden
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described in part B of this section. We
estimate that the financial burden for
group 1 hospices would be 1.75 percent
of the payment received for routine
home care days. For group 2 hospices
the financial burden would be less than
1 percent, and for group 3 hospices the
financial burden would be less than
0.75 percent of Medicare payments for
routine home care days. These
percentages do not include amounts
paid by Medicare for continuous home
care days, respite care days, and regular
inpatient care days. The percentages
also do not include amounts paid by
Medicaid, private insurers, and
individual patients, which account for
approximately 21 percent of hospice
revenue.
In addition, section 1102 (b) of the
Act requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. We believe that this rule
would not have a significant impact on
the operations of a substantial number
of small rural hospitals, since there are
few hospice programs in those facilities.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
proposed rule that may result in an
expenditure of $110 million or more in
any one year by a State, local, or tribal
government, in the aggregate, or by the
private sector. This rule has no impact
on the expenditures of State, local, or
tribal governments, and the impact on
the private sector is estimated to be far
less than $110 million.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
compliance costs on State or local
governments, preempts State law, or
otherwise has Federalism implications.
This rule has no Federalism
implications.
B. Anticipated Effects on Hospices
As described in the preamble, this
proposed regulation contains both new
provisions and provisions that are
carried over from the existing hospice
regulations. For purposes of this section,
we have assessed the impact of the new
provisions. The provisions contained in
the existing regulations are simply being
re-codified and therefore do not present
a new burden to hospices.
Within this section, we have made
several assumptions and estimates in
order to assess the time that it would
take for a hospice to comply with the
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provisions and the associated costs of
compliance. We have detailed these
assumptions and estimates in the table
below. We have also detailed many, but
not all, of the standards within each
CoP, and have noted whether or not
there is an impact for each. However,
the requirements contained in many
provisions are already standard medical
or business practices. These
requirements would, therefore, not
provide additional burden to hospice
providers.
TABLE 1.—ASSUMPTIONS AND ESTIMATES USED THROUGHOUT THE IMPACT ANALYSIS SECTION
Number of Medicare hospices nationwide .....................................
Number of hospice patients nationwide .....................................
Number of patients per average
hospice ......................................
Hourly rate of registered nurse ....
Hourly rate of office employee .....
Hourly rate of administrator ..........
Hourly rate of home health aide ...
Hourly rate of pharmacist .............
Hourly rate of medical director .....
2,412
713,000
295
$27
$19
$42
$14
$45
$84
Patient Rights (§ 418.52)
The proposed rule would expand on
the informed consent section (§ 418.62)
of the current rule, recognizing that
hospice patients are entitled to certain
rights that must be protected and
preserved, and that all patients must be
able to freely exercise those rights.
(a) Standard: Notice of Rights. A
hospice would be required to provide
patients or their representatives with
written and verbal notice of the patient’s
rights and responsibilities during the
initial evaluation and would have to
document this notification as well as
document that the patient/
representative understands their rights.
A hospice would also be required to
inform and distribute written
information regarding its policies on
advance directives, and it would have to
inform the patient, representative, and
family of its drug policies and
procedures. We estimate that it would
take eight hours on a one-time basis for
a hospice to develop a patient rights
form, at a cost of $336, based on the
assumption that an administrator will
develop the form. We estimate that it
would take approximately five minutes
per patient to incorporate this
information into the existing informed
consent process. At the average hourly
rate for a registered nurse, it would cost
$2.25 per patient to fulfill the
requirement.
• 8 hours × $42 an hour = $336
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• $27 hour/60 minutes = $0.45
minute × 5 minutes = $2.25
(b) Standard: Exercise of rights and
respect for property and person. A
hospice would be required to investigate
and document all allegations,
unexplained injuries, and
misappropriations. It would be required
to report such incidents to the hospice
administrator and appropriate State and
local bodies having jurisdiction, and
take action to correct problems once
they were identified.
We expect that a hospice
administrator would handle the
investigations. We estimate that as many
as 5% (15) of an average hospice’s
patients would require a one hour-long
investigational session, for a total of 15
hours per hospice. We estimate that
hospices will spend, on average, three
minutes per patient, at a cost of $2.10
per patient per year to comply with this
provision. The cost for the entire
hospice industry would be $1,497,300 a
year, while the cost for an average
hospice would be $619.50 a year.
• 15 hours × 60 minutes = 900
minutes, 900 minutes/295 patients = 3
minutes per patient
• $42 hour/60 minutes = $0.70 per
minute x 3 minutes per patient = $2.10
per patient
• $2.10 per patient × 713,000 patients
= 1,497,300,
• $2.10 per patient × 295 patients =
$619.50
(c) Standard: Pain management and
symptom control. There is no burden
associated with this standard.
(d) Standard: Confidentiality of
clinical records. There is no burden
associated with this standard.
(e) Standard: Patient liability. A
hospice would be required to inform a
patient verbally and in writing about his
or her payment liability. Developing a
form to notify patients is not a burden
because CMS has already developed this
form, CMS–R131, Advanced Beneficiary
Notice (ABN). Informing the patient
verbally and in writing would take five
minutes per patient to fulfill, or 24.58
hours per average hospice and 59,417
hours nationwide. The estimated cost
would be $2.25 per patient, $663.75 per
hospice, and $1,604,250 nationwide.
• 5 minutes per patient × 295 patients
= 24.58 hours
• 5 minutes per patient × 713,000
patients = 59,417 hours
• $27 hour/60 minutes = $0.45
minute × 5 minutes = $2.25
• $2.25 per patient × 295 patients =
$663.75
• $2.25 per patient × 713,000 patients
= $1,604,250
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TABLE 2.—PATIENT RIGHTS BURDEN ASSESSMENT
Time per
patient
(minutes)
Standard
Time per
hospice
(hours)
Total time
(hours)
Cost per
patient
Notice of rights .............................................................
Exercise of rights .........................................................
Notice of liability ...........................................................
5
3
5
24.58
15
24.58
59,417
34,740
59,417
$2.25
2.10
2.25
Totals ....................................................................
13
64.16
153,574
6.60
Comprehensive Patient Assessment
(§ 418.54)
The existing rule (§ 418.58(c)) requires
the hospice to assess the patient’s needs
and to state in detail the scope and
frequency of services needed. The
proposed rule would go beyond this by
specifying the time for completing the
assessment, the factors to be included in
the assessment, and the time for
updating the assessment. However, we
do not believe this will add any
additional burden, since this section of
the proposed rule reflects the
contemporary standard practice of
hospice programs.
Standard: Content of the
comprehensive assessment. The
assessment would be required to
identify the physical, psychosocial,
emotional, and spiritual needs related to
the terminal illness. Every assessment
would likely include factors such as the
patient’s physical and nutritional needs,
pain status, and psychological state.
This differs from the current rule in that
it describes what would be included in
the plan of care. The factors that are
described were identified by the
industry and reflect standard industry
practice.
Standard: Update of the
comprehensive assessment. Updates of
the patient’s comprehensive assessment
would have to be conducted at least
every 14 days and at the time of each
recertification. The current regulation
allows the plan of care to determine the
frequency of updates. However, due to
the rapidly changing status of hospice
patients it is standard practice for
hospices to update patient assessments
at least every 14 days, and often more
frequently; therefore, this proposed new
standard is simply codifying current
industry practice and should not
present a burden.
Standard: Patient outcome measures.
The comprehensive assessment would
have to include consistent predetermined data elements that allowed
for the measurement of outcomes. (Note:
There is no data reporting element.)
We believe this standard would pose
a burden on the hospice provider.
However, the burden of collecting
information related to these outcome
measures is calculated as part of a
hospice’s quality assessment and
performance improvement program. If a
hospice currently collects data and
calculates values for measures that are
reported to the NHPCO, it will meet the
requirement in the proposed rule.
Interdisciplinary Group, Care Planning
and Coordination of Services (§ 418.56)
The proposed rule makes several
changes to the existing rule to improve
patient care and lessen burden.
(a) Standard: Approach to service and
delivery. Unlike the existing
requirement that a registered nurse must
implement a patient’s plan of care, this
new rule would allow any qualified
member of the interdisciplinary group
to implement a patient’s plan of care,
Cost per
average
hospice
$663.75
630
663.75
1,947
Total cost
$1,604,250
1,408,325
1,604,250
4,705,800
lessening the burden on hospices and
the demand on registered nurses.
(c) Standard: Content of the plan of
care. This section goes into further
detail about the content of each patient’s
plan of care than the existing regulation
does. The burden of including these
items is accounted for in the
development of the plan of care, as
described in part 2 of this section. The
items that would be required under the
proposed rule are already included in
the standard industry patient plan of
care.
(d) Standard: Review of the plan of
care. The existing rule states that a
patient’s plan of care should be
reviewed at intervals specified in the
initial plan of care. The proposed rule
would require that it be reviewed at
least every two weeks. We estimate that
documenting the update of a patient’s
plan of care would take five minutes per
patient and that each patient’s plan of
care would be updated 3 times, based
on a an average 51 day length of stay
(2002 nov., Medicare National Summary
for HHA, Hospice, SNF, and outpatient
CY 1999–2001). This amounts to 15
minutes per patient, or 73.75 hours per
hospice, at a cost of $6.75 per patient for
a registered nurse to complete the
updates.
• $27 hour/60 minutes = $0.45
minute × 15 minutes = $6.75
• $6.75 per patient × 295 patients =
$1,991.25
• $6.75 per patient × 713,000 patients
= $4,812,750
TABLE 3.—INTERDISCIPLINARY GROUP, CARE, PLANNING, AND COORDINATION OF SERVICES BURDEN ASSESSMENT
Time per
patient
(minutes)
Standard
Time per
hospice
(hours)
Total time
(hours)
Cost per
patient
Cost per
average
hospice
Total cost
Update plan of care .........................................................
15
73.75
178,250
$6.75
$1,991.25
$4,812,750
Totals ........................................................................
15
73.75
178,250
6.75
1,991.25
4,812,750
Quality Assessment and Performance
Improvement (§ 418.58)
The current rule requires a hospice to
maintain a quality assurance program
that involves an ongoing,
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comprehensive, integrated selfassessment by the hospice of the quality
and appropriateness of care (§ 418.66).
The proposed rule would provide more
guidance to providers and would
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require approximately 24 hours a year to
implement. Many providers are already
using comprehensive quality assessment
and performance improvement
programs for accreditation or
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independent improvement purposes,
including one designed by the NHPCO.
For those providers who choose to
develop their own quality assessment
and performance improvement program,
we estimate that it would take 12 hours
to create a program. We also estimate
that hospices would spend 4 hours a
year collecting and analyzing data. In
addition, we estimate that hospices
would spend 3 hours a year training
their staff and 5 hours a year
implementing performance
improvement activities. Both the
program development and
implementation would most likely be
managed by that hospice’s
administration. Based on an
administrator’s hourly rate, the total
cost of the quality assessment and
performance improvement condition of
participation would be $1,008 per
hospice.
• $42 per hour × 24 hours = $1,008
Our hourly burden estimates are
based on the proportion of patients to
hours that is found in the CMS final
rule, Hospital Conditions of
Participation: Quality Assessment and
Performance Improvement at 68 FR
3435 (January 24, 2003). CMS estimated
that a hospital would spend 80 hours
collecting and analyzing data on 12
identified measures. According to 2002
CMS statistics, in 2000, 5,985 hospitals
discharged 11.8 million patients. This
means that the statistically average
hospital discharged approximately
2,000 patients that year. Therefore,
collecting and analyzing data for 2,000
patients would take 80 hours, for a ratio
of 80 hours/2,000 patients (or 4 hours/
100 patients). Based on this estimate, for
the average 295 patient hospice, we
believe that this ratio would be 12
hours/295 patients. However, we do not
expect hospices to collect information
on 12 measures, as hospitals are
required to do. Hospices that collect
information in the four suggested areas
(self-determination, comfort, safety, and
effective grieving) would have one third
the burden required to collect the 12
hospital measures, or 4 hours. This ratio
methodology is also used to assess the
burden in all other quality assessment
and performance improvement areas.
(a) Standard: Program scope. Under
the existing regulation, hospices must
assess the quality and appropriateness
of the care they provide. This new
standard would expand on the rule by
requiring that the existing assessment
become a formal quality assessment and
performance improvement program that
is capable of showing measurable
improvement through the use of quality
indicator data.
(b) Standard: Program data. The
proposed rule would require the use of
quality indicator data in a quality
assessment and performance
improvement program, but would not
require any specific data collection or
utilization, nor would it require
hospices to report the collected data.
This would give hospices flexibility and
minimize burden.
(c) Standard: Program activities. This
new standard would identify certain
areas that would be required to be
covered in a hospice’s customized
quality assessment and performance
improvement program. The categories
would be sufficiently broad to allow for
a vast range of acceptable compliance
methods. This would minimize burden.
TABLE 4.—QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT BURDEN ASSESSMENT
Time per
hospice
(hours)
Standard
Total time
(hours)
Cost per
hospice
Total cost
QAPI development ...........................................................................................................
QAPI implementation .......................................................................................................
12
12
28,944
28,944
$504
504
$1,215,648
1,215,648
Total annually ...........................................................................................................
24
57,888
1,008
2,431,296
Infection Control (§ 418.60)
There is no specific existing
requirement for infection control other
than what is briefly mentioned in the
existing § 418.100(i), Standard: Isolation
areas. However, we believe that hospice
clinicians such as nurses, physicians,
and therapists are already using
infection control practice as part of the
current requirement that hospice
clinicians provide services to patients in
accordance with accepted standards of
practice. It is an accepted standard of
practice to use infection control
methods when caring for patients. This
proposed regulation would reinforce
those positive infection control
practices and would address the serious
nature and potential hazards of
infectious and communicable diseases.
Infection control and standard
precautions are long-standing clinical
practices that are standard throughout
the medical industry. This proposed
CoP would require hospices to continue
to take specific and appropriate actions
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to address the prevention and control of
infections, and to educate the patients,
staff and caregivers on the hazards,
prevention and control of infections. We
acknowledge that this is a new focus;
however, we do not believe this would
add any regulatory burden, since this
section of the proposed rule reflects
contemporary standard practice in
hospice programs.
Core Services (§ 418.64)
The proposed rule would allow core
services to be provided under contract
with another Medicare certified hospice
in certain extraordinary or other nonroutine circumstances as described,
allowing hospices more flexibility. In
addition, it would allow hospices to
contract for highly specialized nursing
services, allowing for even more
flexibility. The option to contract out for
highly specialized nursing services
would allow hospices to provide such
highly specialized services at a lower
cost than if the hospice directly
employed individuals to perform such
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services. We are proposing that hospices
that choose to contract for core services
or highly specialized nursing services
must have a contract with the entity
providing the contracted services.
Negotiating, documenting and signing a
business contract is a standard business
practice and does not impose a burden.
The proposed rule also would require
that a psychosocial assessment of the
patient be undertaken by the social
worker providing medical social
services. There is no substantive change
to this regulatory burden.
Waiver of Requirement—Physical
Therapy, Occupational Therapy,
Speech-Language Pathology, and
Dietary Counseling (§ 418.74)
This proposed waiver, currently
implemented through a memorandum
from CMS’s Center for Medicaid and
State Operations, would reduce the
compliance burden on hospices located
in non-urbanized areas. If the hospice
program could demonstrate that
recruitment efforts were unsuccessful, it
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could request certain waivers with
respect to PT, OT, speech-language
pathology, and dietary counseling. Thus
far there have been less than five
applications for this waiver in the last
four years; therefore we believe that the
burden is negligible.
Home Health Aide and Homemaker
Services (§ 418.76)
Home health aide and homemaker
services are an integral part of hospice
care, yet they receive little attention in
the current regulation. These services
are briefly addressed in § 418.94 with a
standard regarding the supervision of
home health aide services and a
standard regarding written patient care
instructions. These two standards
appear in the proposed regulation, with
some minor alterations. The proposed
regulation also would add several new
requirements.
(b) Standard: Content and duration of
home health aide classroom and
supervised practical training; (c)
Standard: Competency evaluation; (d)
Standard: In-service training. These
three standards would describe the
ways in which a home health aide could
meet the proposed qualification
requirements. All of these standards
would require the hospice to maintain
documentation that each home health
aide met these qualifications. The
burden associated with these standards
is the time it would take to complete the
required documentation. We estimate
that it would take five minutes to
document the information and that an
office employee would complete this
task. In addition, we have calculated the
burden based on an assumed employee
turnover rate of 20%, meaning that we
expect that the average hospice would
replace 20% of its home health aides in
a given year, or roughly one home
health aide a year based on the
employment of 5 home health aides. We
believe that this is a reasonable
assumption. Based on the abovementioned estimates and assumptions,
we estimate that will cost an average
hospice $1.60 to document that its home
health aides meet the proposed
qualification requirements, for a total
cost of $3,859.20 nationwide.
• 19 an hour/60 minutes = $0.32
minute × 5 minutes to document that
requirements are met per home health
aide = $1.60 × 1 document per year =
$1.60 per hospice
• $1.60 per hospice × 2,412 hospices
= $3,859.20
(g) Standard: Home health aide
assignments and duties. The home
health aide would be required to report
changes in the patient’s needs to a
registered nurse, and complete
appropriate records in compliance with
the hospice’s policies and procedures.
This new requirement reflects the
standard industry practice of
maintaining communication between all
healthcare providers and maintaining a
complete patient record.
(h) Standard: Supervision of home
health aides. This standard would retain
the current rule’s requirement that a
registered nurse or qualified therapist
visit the patient’s home to assess home
health aide services every 14 days. It
also would add a requirement that a
registered nurse or qualified therapist
visit the patient’s home every 28 days
when the aide is providing services in
the home. We believe that thoroughly
supervising employees is standard
practice and does not increase burden.
(j) Standard: Homemaker
qualifications. The proposed regulation
would require homemakers to complete
a hospice orientation program
addressing the needs and concerns of
patients and families coping with a
terminal illness. We believe that this
standard would not impose any
additional regulatory burden because
hospices train all their employees,
including homemakers, to deal with the
realities of hospice care; this is already
accepted standard practice in the
industry.
(k) Standard: Homemaker supervision
and duties. The interdisciplinary group
would be required to develop written
instructions for the homemaker. We
believe that providing patient care
instructions is a usual and customary
medical practice; therefore, this
requirement would not impose any
additional regulatory burden.
TABLE 5.—HOME HEALTH AIDE AND HOMEMAKER SERVICES BURDEN ASSESSMENT
Time per
aid
(minutes)
Standard
Time per
hospice
(minutes)
Total time
(hours)
Cost per aid
Cost per
average
hospice
Total cost
Documentation (based on 1 new HHA per year) * ..........
5
5
201
$1.60
$1.60
$3,859.20
Totals ........................................................................
5
5
201
1.60
1.60
3,859.20
Organization and Administration of
Services (§ 418.100)
in the industry and present no
additional burden.
The proposed requirement is
essentially the same as the current
regarding the organization and
administration of services. However, the
proposed rule would add a specification
that a hospice’s satellite locations be
approved by CMS, a practice that is
currently mandated through a June 1997
memorandum from CMS’ Center for
Medicaid and State Operations. A
specification for the maintenance of inservice training records and a
requirement that education/training be
given to the patient, family and primary
caregiver would also be new
regulations. However, we believe all of
these additions reflect standard practice
Medical Director (§ 418.102)
The existing rule requires that the
medical director be an employee of the
hospice. The proposed rule would
permit the medical director to work
under a contractual arrangement; this
would reduce the program and hiring
burden on the hospice, particularly if
the hospice is in a rural area.
We believe that the proposed rule
would merely codify the current
standards of practice to which medical
directors adhere. For example,
coordinating with other physicians and
health care professionals, considering
broad criteria when making the
determination that hospice care is
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appropriate, and reviewing relevant
information prior to the date that recertification is necessary are all
standard procedures.
Clinical Records (§ 418.104)
The proposed rule would permit
hospices to maintain records
electronically. This would provide
flexibility and reduce burden. While the
proposed rule also would add
specificity in regard to content,
authentication, retrievability, retention,
and transfer of records, we believe that
these additions reflect standard industry
practice and would therefore add no
burden.
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Drugs, Medical Supplies and Durable
Medical Equipment (§ 418.106)
(a) Standard: Administration of drugs
and biologicals. The proposed rule
would require the interdisciplinary
group to periodically review the plan of
care to determine whether the patient
and/or family continued to have the
ability to safely administer drugs and
biologicals. This review, however,
would not burden hospices because it
would be part of the standard 14 day
review of the patient’s plan of care that
already would be performed by the
interdisciplinary group. The current
rule details persons permitted to
administer drugs. The proposed rule
would eliminate this level of specificity,
thus giving the hospice greater
flexibility. The proposed rule would
require only that drugs be administered
in accordance with standards of practice
and the patient’s plan of care.
(b) Standard: Controlled drugs in the
patient’s home. The current rule
requires that the hospice have a policy
for the disposal of controlled drugs
maintained in the patient’s home. The
proposed rule would add to the existing
rule a requirement that the hospice have
a policy for tracking and collecting these
drugs. The proposed rule would require
the use and disposal of controlled
substances to be discussed with the
family, and would require the hospice
nurse to document this discussion.
Developing written policies is part of
usual and customary medical and
business practices. Thus, this standard
would create no additional burden.
The second requirement, a
documented education session
regarding hospice drug policies would
require approximately five minutes
during the initial evaluation conducted
by a registered nurse. Fulfilling the
requirement would cost $2.25 per
patient based upon the average hourly
rate for a registered nurse.
• $27 hour/60 minutes = $0.45
minute × 5 minutes = $2.25
• $2.25 per patient × 295 patients =
$663.75
• $2.25 per patient × 713,000 patients
= $1,604,250
(c) Standard: Use and maintenance of
equipment and supplies. The existing
rule does not address the use of durable
medical equipment, but the proposed
regulation would do so. The proposed
rule would add a requirement that the
hospice ensure that there is a process for
routine and preventive maintenance of
equipment, that the family receives
instruction in regard to the use of
equipment and supplies, and that the
safe use of equipment and supplies be
demonstrated and monitored. This
requirement would be fulfilled by the
individual most frequently at the home,
usually a home health aide. Performing
these duties would take approximately
15 minutes per patient.
• $14 hour/60 minutes = $0.23
minute × 15 minutes per patient= $3.45
per patient
• $3.45 per patient × 295 patients =
$1,017.75
• $3.45 per patient × 713,000 patients
= $2,459,850
TABLE 6.—DRUGS, MEDICAL SUPPLIES AND DURABLE MEDICAL EQUIPMENT BURDEN ASSESSMENT
Time per
patient
(minutes)
Standard
Time per
average
hospice
(minutes)
Total industry time
(hours)
Cost per
patient
Cost per
average
hospice
Total industry cost
Drug Education ................................................................
Equipment ........................................................................
5
15
24.58
73.75
59,417
178,250
$2.25
3.45
$663.75
1,017.75
$1,604,250
2,459,850
Totals ........................................................................
20
98.33
237,667
5.70
1,681.50
4,064,100≤
Short Term Inpatient Care (§ 418.108)
The proposed rule would be more
specific than the current rule with
respect to the substance of the written
agreement, which we believe is a usual
and customary business practice. This
provision therefore would not increase
regulatory burden.
Hospices That Provide Inpatient Care
Directly (§ 418.110)
(a) Standard: Staffing. The existing
rule is highly prescriptive in requiring
a registered nurse to provide direct
patient care on each shift. We would
eliminate this requirement, to reflect the
proposed regulation’s focus on expected
outcomes of care. We believe that the
patient plan of care drives the amount
and skill level of the nursing care that
would be required and therefore would
help the hospice determine staffing
levels that would reflect the volume of
patients, patient acuity, and the level of
intensity of the nursing care required.
This approach would give the hospice
greater flexibility in staffing and
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therefore reduce the hospice’s
regulatory burden.
(c) Standard: Physical Environment.
In addition to the existing requirement
of having and practicing a disaster plan,
under the proposed regulations a
hospice would be required to report
safety breaches and equipment failures
to the appropriate State and local bodies
having jurisdiction. The entities to
which a hospice would report a breach
or failure would depend on the nature
of the breach or failure. Additional
guidance on this standard would be
included in another CMS document,
such as the State Operations Manual.
Complying with this standard would
require additional staff time. In 2001,
1,375 deficiencies were issued by State
surveyors for violations of the Medicare
hospice Conditions of Participation. At
least some of these deficiencies were
related to the physical environment of
inpatient hospices. We estimate that 110
of those deficiencies were related to the
safety of the physical environment and
equipment. Therefore, we believe that
approximately 110 safety breaches and
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equipment failures would need to be
reported annually by the hospice
industry.
We estimate that reporting safety
breaches and equipment failures would
take 30 minutes per episode to
complete. This task would be completed
by a hospice administrator. Each report,
therefore, would cost $21, for an
industry total of $2,310 annually.
• 110 reports × 30 minutes per report
= 55 hours nationwide
• $42 hour/60 minutes = $0.70
minute × 30 minutes = $21 per report
• $21 per report × 110 reports =
$2,310
(i) Standard: Infection Control,
contains a cross-reference to standards
contained in § 418.60. A discussion of
the burden of those requirements is
discussed in that section.
(l) Standard: Meal service and menu
planning. The existing rule is highly
prescriptive in terms of specifying the
number of meals, meal spacing, meal
planning, and menu planning. The
proposed rule would give these
hospices far greater flexibility by
requiring only that the food be sanitary,
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nutritious (including therapeutic diets
that are in the plan of care), fulfilling,
palatable and attractive. We believe that
this would reduce the hospice’s burden.
(n) Standard: Pharmacist. The
proposed rule would provide greater
flexibility in regard to administering
medication by permitting any health
care professional to carry out this
function, if it were in accordance with
his/her scope of practice. We believe
that this would reduce the hospice’s
regulatory burden.
The proposed rule also would require
hospices to investigate discrepancies
involving controlled drugs and to
document an account of the
investigation. Of the 1,375 deficiencies
issued by State surveyors in 2001, we
estimate that 55 were related to
controlled drug violations. We do not
expect a significant increase in
violations, and estimate that 55
investigations would be conducted and
documented throughout the hospice
industry.
The proposed rule would require the
hospice’s pharmacist and administrator
to conduct controlled drug
investigations. We estimate that a
thorough investigation, including an
examination of the records of incoming
and outgoing drugs and biologicals, and
report would require one additional
hour per incident. The entire industry
would thus spend 55 hours annually at
a cost of $4,785 to fulfill this
requirement. Maintaining inventory
records incoming and outgoing drugs
and biologicals is a usual and customary
business practice and is not a burden.
• $42 hour + $45 hour = $87 hour ×
1 hour investigation = $87 per
investigation
• $87 per investigation × 55
investigations = $4,785
(o) Standard: Seclusion and restraint.
The proposed rule would add
considerable detail in regard to
seclusion and restraint. This section
would be adapted from the language of
the Patient’s Rights Condition of
Participation for hospitals published as
an Interim Final Rule in the Federal
Register in July 1999, currently codified
at 42 CFR 482.13. The burden associated
with this standard would be the time it
would take to document the need for
seclusion and/or restraint, and the time
to write the order. We estimate that a
hospice would spend 6 hours to develop
this form, for a nationwide total of
14,472 hours. After this one-time
expenditure, it would take four minutes
per patient to meet this documentation
requirement for a total of 475 hours
nationwide, based on an estimate of the
use of seclusion and/or restraint on 1%
of the entire patient population. The
annual cost of this standard would
therefore be $39,928 nationwide.
• 6 hours per hospice × 2,412
hospices = 14,472 hours to develop form
• 6 hours per hospice × $42 hour =
$252 to develop form
• $252 to develop form × 2,412
hospices = $607,824
• 713,000 patients × 0.01 percent =
7,130 patients nationwide requiring
seclusion or restraint × 4 minutes per
patient to complete form = 475 hours
nationwide to complete form
• 7,130 patients nationwide requiring
seclusion or restraint/2,412 hospices = 3
30877
patients per hospice requiring seclusion
or restraint
• $84 hour/60 minutes = $1.40
minute × 4 minutes per patient to
complete form = $5.60 per patient to
complete form
• $5.60 per patient × 3 patients per
hospice requiring seclusion or restraint
= $16.80 per hospice
• $5.60 per patient × 7,130 patients =
$39,928
There would also be costs associated
with developing training programs for
staff regarding restraint and seclusion
use and alternative interventions;
however, we are not dictating how a
hospice meets this requirement.
Therefore, hospices would have the
flexibility to decide how to meet this
requirement. We believe that the
benefits associated with training staff
would far outweigh the costs involved,
since proper training would protect the
hospice from situations of inappropriate
restraint and seclusion use and
situations that could lead to patient
injuries and/or deaths.
Finally, hospices would have to
report to CMS, through the appropriate
CMS regional office, all deaths that
occur while a patient is restrained or in
seclusion. We have no concrete estimate
of the number of deaths that occur per
year. There could be a nominal cost
involved in making a telephone call to
the appropriate CMS regional office;
however, because we expect that this
regulation would reduce the number of
deaths from restraint and seclusion use,
we estimate that the number of reports
would average less than one call per
hospice per year. Therefore, we think
the cost will be negligible.
TABLE 7.—HOSPICES THAT PROVIDE INPATIENT CARE DIRECTLY BURDEN ASSESSMENT
Time per
patient
Standard
Physical environment ..................................
Pharmacist ..................................................
Seclusion form development ......................
Seclusion form completion .........................
Totals ...................................................
1
1
1
4
Time per
hospice
Total time
(hours)
55
55
14,472
475
$0.01
0.01
0.84
5.60
$1.00
2.06
252
16.80
$2,310
4,785
607,824
39,928
5 minutes ....
6.25 hours ...
15,057
6.46
271.86
$654,847
The proposed rule would specify the
minimum content of the written
agreement hospice providers and
facilities would be required to have and
would recodify existing regulations
concerning information sharing
practices. These requirements reflect
usual and customary business practices
The proposed rule’s personnel
qualification section would specify that
the current qualifications would apply
only where there were no State
licensing laws, or State certification or
registration requirements for the
profession. Additionally, the proposed
rule would require a background check
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Total cost
5 minutes ....
5 minutes ....
6 hours ........
12 minutes ..
and would not increase a hospice’s
regulatory burden.
16:47 May 26, 2005
Cost per average hospice
second .....
second .....
minute ......
minutes ....
Hospices That Provide Hospice Care to
Residents of a SNF/NF, ICF/MR or
Other Facility (§ 418.112)
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Cost per
patient
Personnel Qualifications (§ 418.114)
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for each employee involved in direct
patient care. In 2002, 39 states required
criminal background checks for hospice
employees. In these states,
approximately 70,411 hospice
employees already received a criminal
background check, thus greatly reducing
the overall potential burden. We
estimate that hospices that have not
previously performed background
checks, accounting for approximately
19,876 hospice employees, would each
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obtain 39 criminal background checks
initially. Each background check request
form would take 6 minutes to prepare
and send, for a total of 4 hours per
hospice the first year. For each year
thereafter, we estimate that all hospices
would complete background checks on
approximately 8 new employees per
year for a total of 48 minutes per
hospice per year and 408 hours
nationally per year.
• 90,271 employees in 2001
according to National Association for
Home Care 2002 Hospice Industry
Report/50 states = 1,805 average number
of employees per state × 39 states
already requiring background checks =
70,395 already required to have
background checks
• 90,271 total employees × 70,395
already required to have background
checks = 19,876 employees not already
required to have background checks
• 90,271 employees/2,316 hospices in
2001 = 39 employees per average
hospice
• 39 employees × 6 minutes per check
= 4 hours per hospice
• 19,876 employees × 6 minutes per
check = 1,988 hours nationwide
We estimate that the average cost for
an individual background check is
$12.50. We understand that some states
may charge more or less that this fee to
conduct a background check. In
addition, some hospices may choose to
conduct more extensive background
checks that may cost more. We are not
proposing to require that hospices
conduct a specific type of background
check or obtain such a check from a
specific source. The flexibility of the
proposed requirement would allow
hospices to identify the most cost
efficient method of meeting the
requirement.
• $12.50 per check × 39 employees
requiring checks = $487.50
• $12.50 per check × 19,876
employees requiring checks = $248,250
TABLE 8.—PERSONNEL QUALIFICATIONS BURDEN ASSESSMENT
Time per
check
(minutes)
6 .............
Time per average hospice
(minutes)
1st year—4 hours annually—48.
Total industry time
(hours)
Cost per
check
1st year—1,988 hours annually—408.
$12.50
Total cost per average hospice
1st year—$487.50 annually—$100.
Total industry cost
1st year—$248,250 annually—51,000.
TABLE 9.—TOTAL BURDEN ASSESSMENT PROPOSED REQUIREMENTS
[Total time and cost for all altered or new CoPs:]
Total time
per patient (minutes)
Total time per hospice
(hours)
Total industry time
(hours)
Total cost per patient
Total cost per hospice
Total industry cost
53 ...........
275
644,625
$25.51
$7,389
$16,920,902
2. Effects on other providers:
Effects on other providers: We do not
expect this regulation to affect any other
provider.
3. Effects on the Medicare and
Medicaid programs:
The costs to the Medicare and
Medicaid programs resulting from this
rule will be negligible.
C. Alternatives Considered
One alternative was to keep the
existing CoPs. We concluded this was
not a reasonable option because our
existing CoPs are problem-focused. As
discussed in the preamble, the problemfocused approach has inherent limits.
Trying to ensure quality through the
enforcement of prescriptive health and
safety standards, rather than trying to
improve quality of care for all patients,
would not contribute to hospice
improvement or stimulate broad-based
quality of care initiatives.
Revising the existing CoPs would take
advantage of continuing advances in the
health care delivery field. We believe it
is necessary to keep pace with growing
demands for services.
In addition, listed below are other
alternatives.
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Patient’s Rights (§ 418.52)
We considered including more
prescriptive rights regarding privacy of
a hospice patient’s medical information.
However, the privacy rule published in
the Federal Register on December 28,
2000 (65 FR 82461) as amended on
August 14, 2002 (67 FR 53182) and
contained in 45 CFR parts 160 and 164,
protects patient privacy adequately.
Comprehensive Assessment of the
Patient (§ 418.54)
We considered not proposing the
Comprehensive Assessment CoP.
However, because the third most cited
deficiency noted during hospice surveys
is the absence of the assessment of
needs, we believe it is essential to
address this area. We also heard from
hospice industry representatives, who
recommended that we include a
provision dealing with comprehensive
assessment. Our decision to propose a
general assessment requirement is based
on the knowledge that individual
hospices understand patient
assessments and why an assessment is
important to overall quality of care.
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Interdisciplinary Group Care Planning
and Coordination of Services (§ 418.56)
We considered leaving the current
CoPs as written. However, it was logical
to have the coordination of services, the
interdisciplinary group requirements,
and the care planning requirements in
one CoP. Since the interdisciplinary
approach to the delivery of hospice
services reflects actual practice for
hospices, we believe that this new
proposed regulation would support
current industry practice.
Quality Assessment and Performance
Improvement § 418.58
We discussed eliminating any
reference to the use of quality indicator
data, including patient care data, for
regulatory purposes. But, in light of the
existing hospital and home health
quality assessment and performance
improvement activities requirements,
we believe hospices must begin to build
a foundation where quality indicators
can be used to gather patient-related
information. The use of quality
indicator data would help in creating an
effective quality assessment and
performance improvement program. As
a result, the hospices would be able to
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better identify activities that lead to
poor patient outcomes, and would be
able to take corrective action to improve
performance.
Infection Control (§ 418.60)
We considered leaving the existing
CoP, which has very little reference to
infection control. We also considered
making infection control a standard
under proposed § 418.58, Quality
assessment and performance
improvement. However, we believe that
the serious nature and potential hazards
of infectious and communicable
diseases warrants a separate and
identifiable CoP. This new condition
would work in concert with the
hospice’s responsibility to carry out a
quality assessment and performance
improvement program that is geared to
patient health and safety.
Licensed Professionals (§ 418.62)
We considered rewriting each existing
CoP instead of combining all of them
into the proposed CoP, § 418.62.
However, we decided that the current
CoPs were outdated and too
prescriptive, and that a new condition
would offer hospices more flexibility.
Medical Director (§ 418.102)
We changed part of this CoP because
section 4445 of the Balanced Budget Act
of 1997 mandated that CMS give
hospices the option to utilize
contractual relationships between
hospices and physicians. Previously,
physicians could only furnish services
as direct hospice employees.
Clinical Records (§ 418.104)
We considered keeping the current
CoP as written, but opted to clarify some
of its standards to reflect current
hospice practice. For example, we
included the provision that hospices
may use electronic records.
Drugs, Controlled Drugs, Biologicals,
Medical Supplies, and Durable Medical
Equipment (§ 418.106)
We considered a wide range of
changes for this CoP. We enhanced the
requirement for controlled substances in
the home. We considered requiring the
hospice, patient, and family to account
for the controlled substance including
disposal of the substance. We also
considered requiring a pharmacist to
conduct drug reviews on each patient
record. However, we decided to discard
these suggestions because they could
place too much burden on hospices. We
believe that the current CoPs needed to
be strengthened and therefore, we opted
to require the hospice, patient, and
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family to share in the accountability of
controlled substances in the home.
Inpatient Care (Short-Term, Long-Term,
and ICFs/MR) (§ 418.108, § 418.112)
Consideration was given to
maintaining this CoP and revising the
Long Term Care CoPs. However, we
decided against relying on a future
change in the Long Term Care CoPs and
revised the hospice CoPs to the extent
possible, to clarify the roles of SNF/NFs
and hospices.
We also decided to separate out
hospice care provided to hospice
patients in SNF/NF, ICF/MR and other
facilities. Thus, instead of a single CoP
that addresses hospice care provided in
all inpatient facilities, we created a CoP
entitled Short Term Inpatient Care and
then a second CoP entitled Hospices
that Provide Care to Residents in a SNF/
NF, ICF/MR or Non certified facility. We
chose this alternative because the
concerns were related to coordination of
care issues expressed by hospice and
inpatient facility providers.
Personnel Qualifications (§ 418.114)
More prescriptive requirements
addressing personnel qualifications
were considered. As an example, we
considered utilizing only Federal
definitions for personnel qualifications
instead of deferring to State law.
However, we decided to defer to State
law for two reasons. First, we wanted to
be consistent with other health care
providers, and second, we believe a
State can best determine what
qualifications are needed to fit its
population’s needs. Each hospice has
the option to require more stringent
qualifications of its practitioners.
D. Conclusion
We are not preparing analyses for
either the RFA or section 1102(b) of the
Act because we have determined, and
we certify, that this proposed rule
would not have a significant economic
impact on a substantial number of small
entities or a significant impact on the
operations of a substantial number of
small rural hospitals.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
VII. Response to Comments
Because of the large number of items
of correspondence we normally receive
on Federal Register documents
published for comment, we are not able
to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
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30879
this preamble, and, if we proceed with
a subsequent document, we will
respond to the comments in the
preamble to that document.
List of Subjects in 42 CFR Part 418
Health facilities, Hospice care,
Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR part 418 as follows:
PART 418—HOSPICE CARE
1. The authority citation for part 418
continues to read as follows:
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
2. Section 418.2 is revised to read as
follows:
§ 418.2
Scope of the part.
This part establishes requirements
and the conditions of participation that
hospices must meet, and be in
compliance with, in order to participate
in the Medicare program. Subpart A of
this part sets forth the statutory basis
and scope and defines terms used in
this part. Subpart B of this part specifies
the eligibility requirements and the
benefit periods. Subpart C of this part
specifies the conditions of participation
that hospice providers must meet
regarding patient and family care.
Subpart D of this part specifies the
organizational environment that hospice
providers must meet as conditions of
participation. Subpart E is reserved for
future use. Subpart F specifies
coinsurance amounts applicable to
hospice care.
3. Section 418.3 is revised to read as
follows:
§ 418.3
Definitions
For the purposes of this part—
Attending physician means a—
(1)(i) Doctor of medicine or
osteopathy legally authorized to practice
medicine and surgery by the State in
which he or she performs that function
or action; or
(ii) Nurse practitioner who meets the
training, education and experience
requirements as the Secretary may
prescribe; and
(2) Is identified by the individual, at
the time he or she elects to receive
hospice care, as having the most
significant role in the determination and
delivery of the individual’s medical
care.
Bereavement counseling means
emotional, psychosocial, and spiritual
support and services provided after the
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death of the patient to assist with issues
related to grief, loss, and adjusting.
Cap period means the 12-month
period ending October 31 used in the
application of the cap on overall
hospice reimbursement specified in
§ 418.309.
Clinical note means a notation of a
contact with the patient that is written
and dated by any person providing
services and that describes signs and
symptoms, treatments and medications
administered, including the patient’s
reaction and/or response, and any
changes in physical or emotional
condition.
Drug restraint means a medication
used to control behavior or to restrict
the patient’s freedom of movement
which is not a standard treatment for a
patient’s medical or psychiatric
condition.
Employee means a person who works
for the hospice and for whom the
hospice is required to issue a W–2 form
on his or her behalf, or if the hospice is
a subdivision of an agency or
organization, an employee of the agency
or organization who is appropriately
trained and assigned to the hospice or
is a volunteer under the jurisdiction of
the hospice.
Hospice means a public agency or
private organization or subdivision of
either of these that is primarily engaged
in providing hospice care as defined in
this section.
Hospice care means a comprehensive
set of services described in 1861(dd)(1)
of the Act, identified and coordinated
by an interdisciplinary team to provide
for the physical, psychosocial, spiritual,
and emotional needs of a terminally ill
patient and/or family members, as
delineated in a specific patient plan of
care.
Licensed professional means a
licensed person sanctioned by the State
in which services are delivered,
furnishing services such as skilled
nursing care, physical therapy, speechlanguage pathology, occupational
therapy, and medical social services.
Palliative care means patient and
family-centered care that optimizes
quality of life by anticipating,
preventing, and treating suffering.
Palliative care throughout the
continuum of illness involves
addressing physical, intellectual,
emotional, social, and spiritual needs
and to facilitate patient autonomy,
access to information, and choice.
Physical restraint means any manual
method or physical or mechanical
device, material, or equipment attached
to the patient’s body that he or she
cannot easily remove that restricts
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freedom of movement or normal access
to one’s body.
Progress note means a written
notation, dated and signed by any
person providing services, that
summarizes facts about the care
furnished and the patient’s response
during a given period of time.
Representative means an individual
who has the authority under State law
(whether by statute or pursuant to an
appointment by the courts of the State)
to authorize or terminate medical care
or to elect or revoke the election of
hospice care on behalf of a terminally ill
patient who is mentally or physically
incapacitated. This may include a legal
guardian.
Restraint means either a physical
restraint or a drug used as a restraint.
Satellite location means a Medicareapproved location from which the
hospice provides hospice care and
services within a portion of the total
geographic area served by the hospice
location issued the provider agreement
number. The satellite location is part of
the hospice and shares administration,
supervision, and services in a manner
that renders it unnecessary for the
satellite location to independently meet
the conditions of participation as a
hospice.
Seclusion means the confinement of a
person in a room or an area where a
person is isolated and physically
prevented from leaving.
Terminally ill means that the patient
has a medical prognosis that his or her
life expectancy is 6 months or less if the
illness runs its normal course.
Subpart E—[Removed and Reserved]
4. Subpart E is removed and reserved.
5. Subparts C and D are revised to
read as follows:
Subpart C—Conditions of Participation:
Patient Care
Sec.
418.52 Condition of participation: Patient’s
rights.
418.54 Condition of participation:
Comprehensive assessment of the
patient.
418.56 Condition of participation:
Interdisciplinary group care planning
and coordination of services.
418.58 Condition of participation: Quality
assessment and performance
improvement.
418.60 Condition of participation: Infection
control.
418.62 Condition of participation: Licensed
professional services.
Core Services
418.64 Condition of participation: Core
services.
418.66 Condition of participation: Nursing
services—waiver of requirement that
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substantially all nursing services be
routinely provided directly by a hospice.
Noncore Services
418.70 Condition of participation:
Furnishing of noncore services.
418.72 Condition of participation: Physical
therapy, occupational therapy, and
speech-language pathology.
418.74 Waiver of requirement-Physical
therapy, occupational therapy, speechlanguage pathology and dietary
counseling.
418.76 Condition of participation: Home
health aide and homemaker services.
418.78 Condition of participation:
Volunteers.
Subpart D—Conditions of Participation:
Organizational Environment
418.100 Condition of participation:
Organization and administration of
services.
418.102 Condition of participation: Medical
director.
418.104 Conditions of participation:
Clinical records.
418.106 Condition of participation: Drugs,
controlled drugs and biologicals, medical
supplies, and durable medical
equipment.
418.108 Condition of participation: Shortterm inpatient care.
418.110 Condition of participation:
Hospices that provide inpatient care
directly.
418.112 Condition of participation:
Hospices that provide hospice care to
residents of a SNF/NF, ICF/MR, or other
facilities.
418.114 Condition of participation:
Personnel qualifications for licensed
professionals.
418.116 Condition of participation:
Compliance with Federal, State, and
local laws and regulations related to
health and safety of patients.
Subpart C—Conditions of
Participation: Patient Care
§ 418.52 Condition of participation:
Patient’s rights.
The patient has the right to be
informed of his or her rights, and the
hospice must protect and promote the
exercise of these rights.
(a) Standard: Notice of rights. (1) The
hospice must provide the patient or
representative with verbal and written
notice of the patient’s rights and
responsibilities in a language and
manner that the patient understands
during the initial evaluation visit in
advance of furnishing care.
(2) The hospice must comply with the
requirements of subpart I of part 489 of
this chapter regarding advance
directives. The hospice must inform and
distribute written information to the
patient concerning its policies on
advance directives, including a
description of applicable State law.
(3) The hospice must inform the
patient and family of the hospice’s drug
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policies and procedures, including the
policies and procedures regarding the
tracking and disposing of controlled
substances.
(4) The hospice must maintain
documentation showing that it has
complied with the requirements of this
section and that the patient or
representative has demonstrated an
understanding of these rights.
(b) Standard: Exercise of rights and
respect for property and person. (1) The
patient has the right—
(i) To exercise his or her rights as a
patient of the hospice;
(ii) To have his or her property and
person treated with respect; and
(iii) To voice grievances regarding
treatment or care that is (or fails to be)
furnished and the lack of respect for
property by anyone who is furnishing
services on behalf of the hospice; and
(iv) To not be subjected to
discrimination or reprisal for exercising
his or her rights.
(2) If a patient has been adjudged
incompetent under State law by a court
of proper jurisdiction, the rights of the
patient are exercised by the person
appointed pursuant to State law to act
on the patient’s behalf.
(3) If a State court has not adjudged
a patient incompetent, any legal
representative designated by the patient
in accordance with State law may
exercise the patient’s rights to the extent
allowed by State law.
(4) The hospice must—
(i) Ensure that all alleged violations
involving mistreatment, neglect, or
verbal, mental, sexual, and physical
abuse, including injuries of unknown
source, and misappropriation of patient
property are reported to State and local
bodies having jurisdiction (including to
the State survey and certification
agency) within at least 5 working days
of the incident, and immediately to the
hospice administrator. Investigations
and/or documentation of all alleged
violations must be conducted in
accordance with established
procedures.;
(ii) Immediately investigate all alleged
violations and immediately take action
to prevent further potential abuse while
the alleged violation is being verified;
(iii) Take appropriate corrective
action in accordance with State law if
the alleged violation is verified by the
hospice administration or an outside
body having jurisdiction, such as the
State survey agency or local law
enforcement agency; and
(iv) Investigate complaints made by a
patient or the patient’s family or
representative regarding treatment or
care that is (or fails to be) furnished,
lack of respect for the patient or the
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patient’s property by anyone furnishing
services on behalf of the hospice, and
document both the existence of the
complaint and the steps taken to resolve
the complaint.
(c) Standard: Pain management and
symptom control. The patient has a right
to receive effective pain management
and symptom control from the hospice.
(d) Standard: Confidentiality of
clinical records. The hospice must
maintain the confidentiality of clinical
records. Access to or release of patient
information and clinical records is
permitted in accordance with 45 CFR
parts 160 and 164.
(e) Standard: Patient liability. Before
care is initiated, the patient must be
informed, verbally and in writing, and
in a language that he or she can
understand, of the extent to which
payment may be expected from the
patient, Medicare or Medicaid, thirdparty payers, or other resources of
funding known to the hospice.
§ 418.54 Condition of participation:
Comprehensive assessment of the patient.
The hospice must conduct and
document in writing a patient-specific
comprehensive assessment that
identifies the patient’s need for hospice
care and services, and the patient’s need
for medical, nursing, psychosocial,
emotional, and spiritual care. This care
includes, but is not limited to, the
palliation and management of the
terminal illness and related medical
conditions.
(a) Standard: Initial assessment. The
hospice registered nurse must make an
initial assessment visit within 24 hours
after the hospice receives a physician’s
admission order for care (unless ordered
otherwise by the physician), to
determine the patient’s immediate care
and support needs.
(b) Standard: Time frame for
completion of the comprehensive
assessment. The hospice
interdisciplinary group in consultation
with the individual’s attending
physician, must complete the
comprehensive assessment no later than
4 calendar days after the patient elects
the hospice benefit.
(c) Standard: Content of the
comprehensive assessment. The
comprehensive assessment must
identify the physical, psychosocial,
emotional, and spiritual needs related to
the terminal illness that must be
addressed in order to promote the
hospice patient’s well-being, comfort,
and dignity throughout the dying
process. The comprehensive assessment
describes—
(1) The nature and condition causing
admission (including the presence or
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lack of objective data and subjective
complaints);
(2) Complications and risk factors that
affect care planning;
(3) Factors that must be considered in
developing individualized care plan
interventions, including—
(i) Bereavement. An initial
bereavement assessment of the needs of
the patient’s family and other
individuals focusing on the social,
spiritual, and cultural factors that may
impact their ability to cope with the
patient’s death. Information gathered
from the initial bereavement assessment
must be incorporated into the
bereavement plan of care.
(ii) Drug therapy. A review of the
patient’s prescription and over-thecounter drug profile, including but not
limited to identification of the
following—
(A) Ineffective drug therapy;
(B) Unwanted drug side and toxic
effects; and
(C) Drug interactions.
(4) The need for referrals and further
evaluation by appropriate health
professionals.
(d) Standard: Update of the
comprehensive assessment. The update
of the comprehensive assessment must
be accomplished by the hospice
interdisciplinary group and must
consider changes that have taken place
since the initial assessment. It must
include information on the patient’s
progress toward desired outcomes, as
well as a reassessment of the patient’s
response to care. The assessment update
must be accomplished—
(1) As frequently as the condition of
the patient requires, but no less
frequently than every 14 days; and
(2) At the time of each recertification.
(e) Standard: Patient outcome
measures. (1) The comprehensive
assessment must include data elements
that allow for measurement of
outcomes. The hospice must measure
and document data in the same way for
all patients. The data elements must
take into consideration aspects of care
related to hospice and palliation.
(2) The data elements must be an
integral part of the comprehensive
assessment and must be documented in
a systematic and retrievable way for
each patient. The data elements for each
patient must be used in individual
patient care planning and in the
coordination of services, and must be
used in the aggregate for the hospice’s
quality assessment and performance
improvement program.
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§ 418.56 Condition of participation:
Interdisciplinary group care planning and
coordination of services.
The hospice must designate an
interdisciplinary group or groups as
specified in paragraph (a) of this section
which, in consultation with the
patient’s attending physician, must
prepare a written plan of care for each
patient. The plan of care must specify
the hospice care and services necessary
to meet the patient and family-specific
needs identified in the comprehensive
assessment and as it relates to the
terminal illness and related conditions.
(a) Standard: Approach to service
delivery. (1) The hospice must designate
an interdisciplinary group or groups
composed of individuals who work
together to meet the physical, medical,
social, emotional, and spiritual needs of
the hospice patients and families facing
terminal illness and bereavement.
Interdisciplinary group members must
provide the care and services offered by
the hospice, and the group in its entirety
must supervise the care and services.
The hospice must designate a qualified
health care professional that is a
member of the interdisciplinary group
to provide coordination of care and to
ensure continuous assessment of each
patient’s and family’s needs and
implementation of the interdisciplinary
plan of care. The interdisciplinary group
must include, but is not limited to,
individuals who are qualified and
competent to practice in the following
professional roles:
(i) A doctor of medicine or osteopathy
(who is not the patient’s attending
physician).
(ii) A registered nurse.
(iii) A social worker.
(iv) A pastoral, clergy, or other
spiritual counselor.
(2) If the hospice has more than one
interdisciplinary group, it must
designate in advance only one of those
groups to establish policies governing
the day-to-day provision of hospice care
and services.
(b) Standard: Plan of care. All hospice
care and services furnished to patients
and their families must follow a written
plan of care established by the hospice
interdisciplinary group in collaboration
with the attending physician. The
hospice must ensure that each patient
and family and primary caregiver(s)
receive education and training provided
by the hospice as appropriate to the care
and services identified in the plan of
care.
(c) Standard: Content of the plan of
care. The hospice must develop a
written plan of care for each patient that
reflects prescribed interventions based
on the problems identified in the initial
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comprehensive and updated
comprehensive assessments, and other
assessments. The plan of care must
include but not be limited to—
(1) Interventions to facilitate the
management of pain and symptoms;
(2) A detailed statement of the scope
and frequency of services necessary to
meet the specific patient and family
needs;
(3) Measurable targeted outcomes
anticipated from implementing and
coordinating the plan of care;
(4) Drugs and treatment necessary to
meet the needs of the patient;
(5) Medical supplies and appliances
necessary to meet the needs of the
patient; and
(6) The interdisciplinary group’s
documentation of patient and family
understanding, involvement, and
agreement with the plan of care, in
accordance with the hospice’s own
policies, in the clinical record.
(d) Standard: Review of the plan of
care. The medical director or physician
designee, and the hospice
interdisciplinary team (in collaboration
with the individual’s attending
physician to the extent possible) must
review, revise and document the plan as
necessary at intervals specified in the
plan but no less than every 14 calendar
days. A revised plan of care must
include information from the patient’s
updated comprehensive assessment and
the patient’s progress toward outcomes
specified in the plan of care.
(e) Standard: Coordination of services.
The hospice must develop and maintain
a system of communication and
integration, in accordance with the
hospice’s own policies and procedures,
to—
(1) Ensure the interdisciplinary group,
through its designated professionals,
maintains responsibility for directing,
coordinating, and supervising the care
and services provided;
(2) Ensure that care and services are
provided in accordance with the plan of
care;
(3) Ensure that the care and services
provided are based on all assessments of
the patient and family needs; and
(4) Provide for and ensure the ongoing
sharing of information between all
disciplines providing care and services
in the home, in outpatient settings, and
in inpatient settings, irrespective
whether the care and services are
provided directly or under arrangement.
§ 418.58 Condition of participation: Quality
assessment and performance improvement.
The hospice must develop,
implement, and maintain an effective,
ongoing, hospice-wide data-driven
quality assessment and performance
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improvement program. The hospice’s
governing body must ensure that the
program: Reflects the complexity of its
organization and services; involves all
hospice services (including those
services furnished under contract or
arrangement); focuses on indicators
related to improved palliative outcomes;
focuses on the end-of-life support
services provided; and takes actions to
demonstrate improvement in hospice
performance. The hospice must
maintain documentary evidence of its
quality assessment and performance
improvement program and be able to
demonstrate its operation to CMS.
(a) Standard: Program scope. (1) The
program must at least be capable of
showing measurable improvement in
indicators for which there is evidence
that improvement in those indicators
will improve palliative outcomes and
end-of-life support services.
(2) The hospice must measure,
analyze, and track quality indicators,
including adverse patient events, and
other aspects of performance that enable
the hospice to assess processes of care,
hospice services, and operations.
(b) Standard: Program data. (1) The
program must utilize quality indicator
data, including patient care, and other
relevant data, in the design of its
program.
(2) The hospice must use the data
collected to—
(i) Monitor the effectiveness and
safety of services and quality of care;
and
(ii) Identify opportunities for
improvement.
(3) The frequency and detail of the
data collection must be specified by the
hospice’s governing body.
(c) Standard: Program activities. (1)
The hospice’s performance
improvement activities must—
(i) Focus on high risk, high volume,
or problem-prone areas;
(ii) Consider incidence, prevalence,
and severity of problems in those areas;
and
(iii) Affect palliative outcomes,
patient safety, and quality of care.
(2) Performance improvement
activities must track adverse patient
events, analyze their causes, and
implement preventive actions and
mechanisms that include feedback and
learning throughout the hospice.
(3) The hospice must take actions
aimed at performance improvement
and, after implementing those actions,
the hospice must measure its success
and track performance to ensure that
improvements are sustained.
(d) Standard: Performance
improvement projects. (1) The number
and scope of distinct improvement
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projects conducted annually must
reflect the scope, complexity, and past
performance of the hospice’s services
and operations.
(2) The hospice must document what
quality improvement projects are being
conducted, the reasons for conducting
these projects, and the measurable
progress achieved on these projects.
(e) Standard: Executive
responsibilities. The hospice’s
governing body is responsible for
ensuring the following:
(1) That an ongoing program for
quality improvement and patient safety
is defined, implemented and
maintained;
(2) That the hospice-wide quality
assessment and performance
improvement efforts address priorities
for improved quality of care and patient
safety, and that all improvement actions
are evaluated for effectiveness; and
(3) That clear expectations for patient
safety are established.
§ 418.60 Condition of participation:
Infection control.
The hospice must maintain and
document an effective infection control
program that protects patients, families
and hospice personnel by preventing
and controlling infections and
communicable diseases.
(a) Standard: Prevention. The hospice
must follow accepted standards of
practice to prevent the transmission of
infections and communicable diseases,
including the use of standard
precautions.
(b) Standard: Control. The hospice
must maintain a coordinated agencywide program for the surveillance,
identification, prevention, control, and
investigation of infectious and
communicable diseases that—
(1) Is an integral part of the hospice’s
quality assessment and performance
improvement program; and
(2) Includes:
(i) A method of identifying infectious;
and communicable disease problems;
and
(ii) A plan for the appropriate actions
that are expected to result in
improvement and disease prevention.
(c) Standard: Education. The hospice
must provide infection control
education to staff, patients, and family
members or other caregivers.
§ 418.62 Condition of participation:
Licensed professional services.
(a) Licensed professional services
provided directly or under arrangement
must be authorized, delivered, and
supervised only by health care
professionals who meet the appropriate
qualifications specified under 418.114
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and who practice under the hospice’s
policies and procedures.
(b) Licensed professionals must
actively participate in the coordination
of all aspects of the patient’s care, in
accordance with current professional
standards and practice, including
participating in ongoing
interdisciplinary comprehensive
assessments, developing and evaluating
the plan of care, and contributing to
patient and family counseling and
education; and
(c) Licensed professionals must
participate in the hospice’s quality
assessment and performance
improvement program and hospice
sponsored in-service training.
Core Services
§ 418.64 Condition of participation: Core
services.
A hospice must routinely provide
substantially all core services directly
by hospice employees. These services
must be provided in a manner
consistent with acceptable standards of
practice. These services include nursing
services, medical social services, and
counseling. The hospice may contract
for physician services as specified in
§ 418.64(a). A hospice may, under
extraordinary or other non-routine
circumstances, enter into a written
arrangement with another Medicare
certified hospice program for the
provision of core services to supplement
hospice employee/staff to meet the
needs of patients. Circumstances under
which a hospice may enter into a
written arrangement for the provision of
core services include: Unanticipated
periods of high patient loads, staffing
shortages due to illness or other shortterm temporary situations that interrupt
patient care; and temporary travel of a
patient outside of the hospice’s service
area.
(a) Standard: Physician services. The
hospice medical director, physician
employees, and contracted physician(s)
of the hospice, in conjunction with the
patient’s attending physician, are
responsible for the palliation and
management of the terminal illness,
conditions related to the terminal
illness, and the general medical needs of
the patient.
(1) All physician employees and those
under contract, must function under the
supervision of the hospice medical
director.
(2) All physician employees and those
under contract shall meet this
requirement by either providing the
services directly or through
coordinating patient care with the
attending physician.
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(3) If the attending physician is
unavailable, the medical director,
contracted physician, and/or hospice
physician employee is responsible for
meeting the medical needs of the
patient.
(b) Standard: Nursing services. (1)
The hospice must provide nursing care
and services by or under the supervision
of a registered nurse. Nursing services
must ensure that the nursing needs of
the patient are met as identified in the
patient’s initial comprehensive
assessment and updated assessments.
(2) If State law permits nurse
practitioners (NPs) to see, treat and
write orders for patients, then NPs may
provide services to beneficiaries
receiving hospice care. The role and
scope of the services provided by a NP
that is not the individual’s attending
physician must be specified in the
individual’s plan of care.
(3) Highly specialized nursing
services that are provided so
infrequently that the provision of such
services by direct hospice employees
would be impracticable and
prohibitively expensive, may be
provided under contract.
(c) Standard: Medical social services.
Medical social services must be
provided by a qualified social worker,
under the direction of a physician.
Social work services must be based on
the patient’s psychosocial assessment
and the patient’s and family’s needs and
acceptance of these services.
(d) Standard: Counseling services.
Counseling services for adjustment to
death and dying must be available to
both the patient and the family.
Counseling services must include but
are not limited to the following:
(1) Bereavement counseling. The
hospice must:
(i) Have an organized program for the
provision of bereavement services
furnished under the supervision of a
qualified professional with experience
in grief/loss counseling.
(ii) Make bereavement services
available to the family and other
individuals in the bereavement plan of
care up to one year following the death
of the patient. Bereavement counseling
also extends to residents and employees
of a SNF/NF, ICF/MR, or other facility
when appropriate and identified in the
bereavement plan of care.
(iii) Ensure that bereavement services
reflect the needs of the bereaved.
(iv) Develop a bereavement plan of
care that notes the kind of bereavement
services to be provided and the
frequency of service delivery. A special
coverage provision for bereavement
counseling is specified in § 418.204(c).
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(2) Nutritional counseling. Nutritional
counseling, when identified in the plan
of care, must be performed by a
qualified individual, which include
dietitians as well as nurses and other
individuals who are able to address and
assure that the dietary needs of the
patient are met.
(3) Spiritual counseling. The hospice
must:
(i) Provide an assessment of the
patient’s and family’s spiritual needs;
(ii) Provide spiritual counseling to
meet these needs in accordance with the
patient’s and family’s acceptance of this
service, and in a manner consistent with
patient and family beliefs and desires;
(iii) Facilitate visits by local clergy,
pastoral counselors, or other individuals
who can support the patient’s spiritual
needs to the best of its ability. The
hospice is not required to go to
extraordinary lengths to do so; and
(iv) Advise the patient and family of
this service.
§ 418.66 Condition of participation:
Nursing services—Waiver of requirement
that substantially all nursing services be
routinely provided directly by a hospice.
(a) CMS may waive the requirement
in § 418.64(b) that a hospice provide
nursing services directly, if the hospice
is located in a nonurbanized area. The
location of a hospice that operates in
several areas is considered to be the
location of its central office. The
hospice must provide evidence to CMS
that it has made a good faith effort to
hire a sufficient number of nurses to
provide services. CMS may waive the
requirement that nursing services be
furnished by employees based on the
following criteria:
(1) The location of the hospice’s
central office is in a nonurbanized area
as determined by the Bureau of the
Census.
(2) There is evidence that a hospice
was operational on or before January 1,
1983 including—
(i) Proof that the organization was
established to provide hospice services
on or before January 1, 1983;
(ii) Evidence that hospice-type
services were furnished to patients on or
before January 1, 1983; and
(iii) Evidence that hospice care was a
discrete activity rather than an aspect of
another type of provider’s patient care
program on or before January 1, 1983.
(3) By virtue of the following evidence
that a hospice made a good faith effort
to hire nurses:
(i) Copies of advertisements in local
newspapers that demonstrate
recruitment efforts;
(ii) Job descriptions for nurse
employees;
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(iii) Evidence that salary and benefits
are competitive for the area; and
(iv) Evidence of any other recruiting
activities (for example, recruiting efforts
at health fairs and contacts with nurses
at other providers in the area).
(b) Any waiver request is deemed to
be granted unless it is denied within 60
days after it is received.
(c) Waivers will remain effective for 1
year at a time from the date of the
request.
(d) CMS may approve a maximum of
two 1-year extensions for each initial
waiver. If a hospice wishes to receive a
1-year extension, it must submit a
request to CMS before the expiration of
the waiver period, and certify that the
conditions under which it originally
requested the initial waiver have not
changed since the initial waiver was
granted.
Non-Core Services
§ 418.70 Condition of participation:
Furnishing of non-core services.
A hospice must ensure that the
services described in § 418.72 through
§ 418.78 are provided directly by the
hospice or under arrangements made by
the hospice as specified in § 418.100.
These services must be provided in a
manner consistent with current
standards of practice.
§ 418.72 Condition of participation:
Physical therapy, occupational therapy, and
speech-language pathology.
Physical therapy services,
occupational therapy services, and
speech-language pathology services
must be available, and when provided,
offered in a manner consistent with
accepted standards of practice.
§ 418.74 Waiver of requirement—Physical
therapy, occupational therapy, speechlanguage pathology, and dietary
counseling.
(a) A hospice located in a nonurbanized area may submit a written
request for a waiver of the requirement
for providing physical therapy,
occupational therapy, speech-language
pathology, and dietary counseling
services. The hospice may seek a waiver
of the requirement that it make physical
therapy, occupational therapy, speechlanguage pathology, and dietary
counseling services (as needed)
available on a 24-hour basis. The
hospice may also seek a waiver of the
requirement that it provide dietary
counseling directly. The hospice must
provide evidence that it has made a
good faith effort to meet the
requirements for these services before it
seeks a waiver. CMS may approve a
waiver application on the basis of the
following criteria:
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(1) The hospice is located in a nonurbanized area as determined by the
Bureau of the Census.
(2) The hospice provides evidence
that it had made a good faith effort to
make available physical therapy,
occupational therapy, speech-language
pathology, and dietary counseling
services on a 24-hour basis and/or to
hire a dietary counselor to furnish
services directly. This evidence must
include—
(i) Copies of advertisements in local
newspapers that demonstrate
recruitment efforts;
(ii) Physical therapy, occupational
therapy, speech-language pathology,
and dietary counselor job descriptions;
(iii) Evidence that salary and benefits
are competitive for the area; and
(iv) Evidence of any other recruiting
activities (for example, recruiting efforts
at health fairs and contact discussions
with physical therapy, occupational
therapy, speech-language pathology,
and dietary counseling service providers
in the area).
(b) Any waiver request is deemed to
be granted unless it is denied within 60
days after it is received.
(c) An initial waiver will remain
effective for 1 year at a time from the
date of the request.
(d) CMS may approve a maximum of
two 1-year extensions for each initial
waiver. If a hospice wishes to receive a
1-year extension, it must submit a
request to CMS prior to the expiration
of the waiver period and certify that
conditions under which it originally
requested the waiver have not changed
since the initial waiver was granted.
§ 418.76 Condition of participation: Home
health aide and homemaker services.
All home health aide services must be
provided by individuals who meet the
personnel requirements specified in
paragraph (a) of this section.
Homemaker services must be provided
by individuals who meet the personnel
requirements specified in paragraph (j)
of this section.
(a) Standard: Home health aide
qualifications. (1) A qualified home
health aide is a person who has
successfully completed—
(i) A training program and
competency evaluation as specified in
paragraphs (b) and (c) of this section
respectively; or
(ii) A competency evaluation
program; or
(iii) A State licensure program that
meets the requirements of paragraphs
(b) and (c) of this section.
(2) A home health aide is not
considered to have completed a training
program, or a competency evaluation
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program if, since the individual’s most
recent completion of the program(s),
there has been a continuous period of 24
consecutive months during which none
of the services furnished by the
individual as described in § 409.40 of
this chapter were for compensation. If
there has been a 24-month lapse in
furnishing services, the individual must
complete another training and/or
competency evaluation program before
providing services, as specified in
paragraph (a)(1) of this section.
(b) Standard: Content and duration of
home health aide classroom and
supervised practical training. (1) Home
health aide training must include
classroom and supervised practical
classroom training in a practicum
laboratory or other setting in which the
trainee demonstrates knowledge while
performing tasks on an individual under
the direct supervision of a registered
nurse or licensed practical nurse, who is
under the supervision of a registered
nurse. Classroom and supervised
practical training combined must total
at least 75 hours.
(2) A minimum of 16 hours of
classroom training must precede a
minimum of 16 hours of supervised
practical training as part of the 75 hours.
(3) A home health aide training
program must address each of the
following subject areas:
(i) Communication skills, including
the ability to read, write, and verbally
report clinical information to patients,
care givers, and other hospice staff;
(ii) Observation, reporting, and
documentation of patient status and the
care or service furnished;
(iii) Reading and recording
temperature, pulse, and respiration;
(iv) Basic infection control
procedures;
(v) Basic elements of body functioning
and changes in body function that must
be reported to an aide’s supervisor;
(vi) Maintenance of a clean, safe, and
healthy environment;
(vii) Recognizing emergencies and the
knowledge of emergency procedures
and their application;
(viii) The physical, emotional, and
developmental needs of and ways to
work with the populations served by the
hospice, including the need for respect
for the patient, his or her privacy, and
his or her property;
(ix) Appropriate and safe techniques
in performing personal hygiene and
grooming tasks, including items on the
following basic checklist—
(A) Bed bath;
(B) Sponge, tub, and shower bath;
(C) Hair shampoo (sink, tub, and bed);
(D) Nail and skin care;
(E) Oral hygiene; and
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(F) Toileting and elimination;
(x) Safe transfer techniques and
ambulation.
(xi) Normal range of motion and
positioning.
(xii) Adequate nutrition and fluid
intake.
(xiii) Any other task that the hospice
may choose to have an aide perform.
The hospice is responsible for training
home health aides, as needed, for skills
not covered in the basic checklist, as
described in paragraph (b)(3)(ix) of this
section.
(4) The hospice must maintain
documentation that demonstrates that
the requirements of this standard are
met.
(c) Standard: Competency evaluation.
An individual may furnish home health
services on behalf of a hospice only after
that individual has successfully
completed a competency evaluation
program as described in this section.
(1) The competency evaluation must
address each of the subjects listed in
paragraphs (b)(1) through (b)(3) of this
section. Subject areas specified under
paragraphs (b)(3)(i), (b)(3)(iii), (b)(3)(ix),
(b)(3)(x) and (b)(3)(xi) of this section
must be evaluated by observing an
aide’s performance of the task with a
patient. The remaining subject areas
may be evaluated through written
examination, oral examination, or after
observation of a home health aide with
a patient.
(2) A home health aide competency
evaluation program may be offered by
any organization, except as specified in
paragraph (f) of this section.
(3) The competency evaluation must
be performed by a registered nurse in
consultation with other skilled
professionals, as appropriate.
(4) A home health aide is not
considered competent in any task for
which he or she is evaluated as
unsatisfactory. An aide must not
perform that task without direct
supervision by a registered nurse until
after he or she has received training in
the task for which he or she was
evaluated as ‘‘unsatisfactory,’’ and
successfully completes a subsequent
evaluation.
(5) The hospice must maintain
documentation that demonstrates the
requirements of this standard are being
met.
(d) Standard: In-service training. A
home health aide must receive at least
l2 hours of in-service training during
each 12-month period. In-service
training may occur while an aide is
furnishing care to a patient.
(1) In-service training may be offered
by any organization except one that is
excluded by paragraph (f) of this
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section, and must be supervised by a
registered nurse.
(2) The hospice must maintain
documentation that demonstrates the
requirements of this standard are met.
(e) Standard: Qualifications for
instructors conducting classroom
supervised practical training,
competency evaluations and in-service
training. Classroom supervised practical
training must be performed by or under
the supervision of a registered nurse
who possesses a minimum of two years
nursing experience, at least one year of
which must be in home health care.
Other individuals may provide
instruction under the general
supervision of a registered nurse.
(f) Standard: Eligible training
organizations. A home health aide
training program may be offered by any
organization except by a home health
agency that, within the previous 2
years—
(1) Was out of compliance with the
requirements of paragraphs (b) or (c) of
this section;
(2) Permitted an individual that does
not meet the definition of a ‘‘qualified
home health aide’’ as specified in
paragraph (a) of this section to furnish
home health aide services (with the
exception of licensed health
professionals and volunteers);
(3) Was subjected to an extended (or
partial extended) survey as a result of
having been found to have furnished
substandard care (or for other reasons at
the discretion of CMS or the State);
(4) Was assessed a civil monetary
penalty of $5,000 or more as an
intermediate sanction;
(5) Was found by CMS to have
compliance deficiencies that
endangered the health and safety of the
home health agency’s patients and had
temporary management appointed to
oversee the management of the home
health agency;
(6) Had all or part of its Medicare
payments suspended; or
(7) Was found by CMS or the State
under any Federal or State law to have:
(i) Had its participation in the
Medicare program terminated;
(ii) Been assessed a penalty of $5,000
or more for deficiencies in Federal or
State standards for home health
agencies;
(iii) Been subjected to a suspension of
Medicare payments to which it
otherwise would have been entitled;
(iv) Operated under temporary
management that was appointed by a
governmental authority to oversee the
operation of the home health agency
and to ensure the health and safety of
the home health agency’s patients; or
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(v) Been closed by CMS or the State,
or had its patients transferred by the
State.
(g) Standard: Home health aide
assignments and duties. A registered
nurse or the appropriate qualified
therapist that is a member of the
interdisciplinary team makes home
health aide assignments.
(l) Home health aides are assigned to
a specific patient by a registered nurse
or the appropriate qualified therapist.
Written patient care instructions for a
home health aide must be prepared by
a registered nurse or other appropriate
skilled professional (i.e., a physical
therapist, speech-language pathologist,
or occupational therapist) who is
responsible for the supervision of a
home health aide as specified under
paragraph (h) of this section.
(2) A home health aide provides
services that are:
(i) Ordered by the physician or nurse
practitioner;
(ii) Included in the plan of care;
(iii) Permitted to be performed under
State law by such home health aide; and
(iv) Consistent with the home health
aide training.
(3) The duties of a home health aide
include:
(i) The provision of hands-on personal
care;
(ii) The performance of simple
procedures as an extension of therapy or
nursing services;
(iii) Assistance in ambulation or
exercises; and
(iv) Assistance in administering
medications that are ordinarily selfadministered.
(4) Home health aides must report
changes in the patient’s medical,
nursing, rehabilitative, and social needs
to a registered nurse or other
appropriate licensed professional, as the
changes relate to the plan of care and
quality assessment and improvement
activities. Home health aides must also
complete appropriate records in
compliance with the hospice’s policies
and procedures.
(h) Standard: Supervision of home
health aides. (1) A registered nurse or
qualified therapist must make an onsite
visit to the patient’s home no less
frequently than every 14 days to assess
the home health aide’s services. The
home health aide does not have to be
present during this visit. A registered
nurse or qualified therapist must make
an onsite visit to the location where the
patient is receiving care in order to
observe and assess each aide while he
or she is performing care no less
frequently than every 28 days.
(2) The supervising nurse or therapist
must assess an aide’s ability to
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demonstrate initial and continued
satisfactory performance in meeting
outcome criteria that include, but is not
limited to—
(i) Following the patient’s plan of care
for completion of tasks assigned to the
home health aide by the registered nurse
or qualified therapist;
(ii) Creating successful interpersonal
relationships with the patient and
family;
(iii) Demonstrating competency with
assigned tasks;
(iv) Complying with infection control
policies and procedures; and
(v) Reporting changes in the patient’s
condition.
(3) If the hospice chooses to provide
home health aide services under
contract with another organization, the
hospice’s responsibilities include, but
are not limited to—
(i) Ensuring the overall quality of care
provided by an aide;
(ii) Supervising an aide’s services as
described in paragraphs (h)(1) and (h)(2)
of this section; and
(iii) Ensuring that home health aides
who provide services under
arrangement have met the training and/
or competency evaluation requirements
of this condition.
(i) Standard: Individuals furnishing
Medicaid personal care aide-only
services under a Medicaid personal care
benefit. An individual may furnish
personal care services, as defined in
§ 440.167 of the Code of Federal
Regulations, on behalf of a hospice or
home health agency. Before the
individual may furnish personal care
services, the individual must be found
competent by the State to furnish those
services. The individual only needs to
demonstrate competency in the services
the individual is required to furnish.
(j) Standard: Homemaker
qualifications. A qualified homemaker
is a home health aide as described in
§ 418.76 or an individual who meets the
standards in § 418.202(g) and has
successfully completed hospice
orientation addressing the needs and
concerns of patients and families coping
with a terminal illness.
(k) Standard: Homemaker supervision
and duties. (1) Homemaker services
must be coordinated by a member of the
interdisciplinary group.
(2) Instructions for homemaker duties
must be prepared by a member of the
interdisciplinary group.
(3) Homemakers must report all
concerns about the patient or family to
the member of the interdisciplinary
group who is coordinating homemaker
services.
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§ 418.78 Conditions of participation:
Volunteers.
The hospice must use volunteers to
the extent specified in paragraph (e) of
this section. These volunteers must be
used in defined roles and under the
supervision of a designated hospice
employee.
(a) Standard: Training. The hospice
must maintain, document and provide
volunteer orientation and training that
is consistent with hospice industry
standards.
(b) Standard: Role. Volunteers must
be used in day-to-day administrative
and/or direct patient care roles.
(c) Standard: Recruiting and
retaining. The hospice must document
and demonstrate viable and ongoing
efforts to recruit and retain volunteers.
(d) Standard: Cost saving. The
hospice must document the cost savings
achieved through the use of volunteers.
Documentation must include—
(1) The identification of each position
that is occupied by a volunteer;
(2) The work time spent by volunteers
occupying those positions; and
(3) Estimates of the dollar costs that
the hospice would have incurred if paid
employees occupied the positions
identified in paragraph (d)(1) of this
section for the amount of time specified
in paragraph (d)(2) of this section.
(e) Standard: Level of activity.
Volunteers must provide day-to-day
administrative and/or direct patient care
services in an amount that, at a
minimum, equals 5 percent of the total
patient care hours of all paid hospice
employees and contract staff. The
hospice must maintain records on the
use of volunteers for patient care and
administrative services, including the
type of services and time worked.
Subpart D—Conditions of
Participation: Organizational
Environment
§ 418.100 Condition of participation:
Organization and administration of
services.
The hospice must organize, manage,
and administer its resources to provide
the hospice care and services to
patients, caregivers and families
necessary for the palliation and
management of terminal illness.
(a) Standard: Serving the hospice
patient and family. The hospice must
ensure—
(1) That each patient receives and
experiences hospice care that optimizes
comfort and dignity; and
(2) That each patient experience
hospice care that is consistent with
patient and family needs and desires.
(b) Standard: Governing body and
administrator. A governing body (or
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designated persons so functioning)
assumes full legal authority and
responsibility for the management of the
hospice, the provision of all hospice
services, its fiscal operations, and
continuous quality assessment and
performance improvement. A qualified
administrator reports to the governing
body and is responsible for the day-today operation of the hospice. The
administrator must be a hospice
employee and possess education and
experience required by the hospice’s
governing body.
(c) Standard: Services. (1) A hospice
must be primarily engaged in providing
the following care and services and
must do so in a manner that is
consistent within accepted standards of
practice:
(i) Nursing services.
(ii) Medical social services.
(iii) Physician services.
(iv) Counseling services, including
spiritual counseling, dietary counseling,
and bereavement counseling.
(v) Home health aide, volunteer, and
homemaker services.
(vi) Physical therapy, occupational
therapy and speech-language pathology
therapy services.
(vii) Short-term inpatient care.
(viii) Medical supplies (including
drugs and biologicals) and medical
appliances.
(2) Nursing services, physician
services, and drugs and biologicals (as
specified in § 418.106) must be made
routinely available on a 24-hour basis 7
days a week. Other covered services
must be available on a 24-hour basis
when reasonable and necessary to meet
the needs of the patient and family.
(d) Standard: Continuation of care. A
hospice may not discontinue or reduce
care provided to a Medicare or Medicaid
beneficiary because of the beneficiary’s
inability to pay for that care.
(e) Standard: Professional
management responsibility. A hospice
that has a written agreement with
another agency, individual, or
organization to furnish any services
under arrangement, must retain
administrative and financial
management, and supervision of staff
and services for all arranged services, to
ensure the provision of quality care.
Arranged services must be supported by
written agreements that require that all
services be—
(1) Authorized by the hospice;
(2) Furnished in a safe and effective
manner by personnel having at least the
same qualifications as hospice
employees; and
(3) Delivered in accordance with the
patient’s plan of care.
(f) Standard: Hospice satellite
locations. (1) All hospice satellite
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locations must be approved by CMS
before providing hospice care and
services to Medicare patients. The
determination that a satellite location
does or does not meet the definition of
a satellite location, as set forth in this
part, is an initial determination, as set
forth in § 498.3.
(2) The hospice must continually
monitor and manage all services
provided at all of its locations to ensure
that services are delivered in a safe and
effective manner and to ensure that each
patient and family receives the
necessary care and services outlined in
the plan of care.
(g) Standard: In-service training. A
hospice must assess the skills and
competence of all individuals
furnishing care, including volunteers
furnishing services, and, as necessary,
provide in-service training and
education programs where required.
The hospice must have written policies
and procedures describing its method(s)
of assessment of competency and
maintain a written description of the inservice training provided during the
previous 12 months.
§ 418.102 Condition of participation:
Medical director.
The hospice must designate a
physician to serve as medical director.
The medical director must be a doctor
of medicine or osteopathy who is either
employed by, or under contract with,
the hospice. When the medical director
is not available, a physician designated
by the medical director assumes the
same responsibilities and obligations as
the medical director. The medical
director and physician designee
coordinate with other physicians and
health care professionals to ensure that
each patient experiences medical care
that reflects hospice policy.
(a) Standard: Initial certification of
terminal illness. The medical director or
physician designee reviews the clinical
information for each hospice patient
and provides written certification that it
is anticipated that the patient’s life
expectancy is 6 months or less if the
illness runs its normal course. The
physician must consider the following
criteria when making this
determination:
(1) The primary terminal condition.
(2) Related diagnosis(es), if any.
(3) Current subjective and objective
medical findings.
(4) Current medication and treatment
orders.
(5) Information about the medical
management of any of the patient’s
conditions unrelated to the terminal
illness.
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(b) Standard: Recertification of the
terminal illness. Before the
recertification period for each patient, as
described in § 418.21(a), the medical
director or physician designee must
review:
(1) The patient’s clinical information;
and
(2) The patient’s and family’s
expectations and wishes for the
continuation of hospice care.
(c) Standard: Coordination of medical
care. The medical director or physician
designee, and the other members of the
interdisciplinary group are jointly
responsible for the coordination of the
patient’s medical care in its entirety.
The medical director or physician
designee is also responsible for directing
the hospice’s quality assessment and
performance improvement program.
§ 418.104 Condition of participation:
Clinical records.
A clinical record containing past and
current findings is maintained for each
hospice patient. The clinical record
must contain accurate clinical
information that is available to the
patient’s attending physician and
hospice staff. The clinical record may be
maintained electronically.
(a) Standard: Content. Each patient’s
record must include the following:
(1) The plan of care, initial
assessment, comprehensive assessment,
and updated comprehensive
assessments, clinical notes, and progress
notes.
(2) Informed consent, authorization,
and election forms.
(3) Responses to medications,
symptom management, treatments, and
services.
(4) Outcome measure data elements,
as described in § 418.54(e) of this
subpart.
(5) Physician certification and
recertification of terminal illness as
required in § 418.22 and described in
§ 418.102(a) and § 418.102(b)
respectively.
(6) Any advance directives as
described in § 418.52(a)(3).
(b) Standard: Authentication. All
entries must be legible, clear, complete,
and appropriately authenticated and
dated. All entries must be signed, and
the hospice must be able to authenticate
each handwritten and electronic
signature of a primary author who has
reviewed and approved the entry.
(c) Standard: Protection of
information. The clinical record, its
contents and the information contained
therein must be safeguarded against loss
or unauthorized use. The hospice must
be in compliance with the Department’s
rules regarding personal health
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information set out at 45 CFR parts 160
and 164.
(d) Standard: Retention of records.
Patient clinical records must be retained
for 5 years after the death or discharge
of the patient, unless State law
stipulates a longer period of time. If the
hospice discontinues operation, hospice
policies must provide for retention and
storage of clinical records. The hospice
must inform its State agency and its
CMS Regional office where such clinical
records will be stored and how they
may be accessed.
(e) Standard: Discharge or transfer of
care. (1) If the care of a patient is
transferred to another Medicare/
Medicaid-approved facility, the hospice
must forward a copy of the patient’s
clinical record and the hospice
discharge summary to that facility.
(2) If a patient revokes the election of
hospice care, or is discharged from
hospice because eligibility criteria are
no longer met, the hospice must provide
a copy of the clinical record and the
hospice discharge summary of this
section to the patient’s attending
physician.
(3) The hospice discharge summary
must include—
(i) A summary of the patient’s stay
including treatments, symptoms and
pain management;
(ii) The patient’s current plan of care;
(iii) The patient’s latest physician
orders; and
(iv) Any other documentation that
will assist in post-discharge continuity
of care.
(f) Standard: Retrieval of clinical
records. The clinical record, whether
hard copy or in electronic form, must be
made readily available on request by an
appropriate authority.
§ 418.106 Condition of participation:
Drugs, controlled drugs and biologicals,
medical supplies, and durable medical
equipment.
Medical supplies and appliances, as
described in § 410.36 of this chapter;
durable medical equipment, as
described in § 410.38 of this chapter;
and drugs and biologicals related to the
palliation and management of the
terminal illness and related conditions,
as identified in the hospice plan of care,
must be provided by the hospice while
the patient is under hospice care.
(a) Standard: Administration of drugs
and biologicals. (1) All drugs and
biologicals must be administered in
accordance with accepted hospice and
palliative care standards of practice and
according to the patient’s plan of care.
(2) The interdisciplinary group, as
part of the review of the plan of care,
must determine the ability of the patient
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and/or family to safely self-administer
drugs and biologicals.
(b) Standard: Controlled drugs in the
patient’s home. The hospice must have
a written policy for tracking, collecting,
and disposing of controlled drugs
maintained in the patient’s home.
During the initial hospice assessment,
the use and disposal of controlled
substances must be discussed with the
patient and family to ensure the patient
and family are educated regarding the
uses and potential dangers of controlled
substances. The hospice nurse must
document that the policy was discussed
with the patient and family.
(c) Standard: Use and maintenance of
equipment and supplies. (1) The
hospice must follow manufacturer
recommendations for performing
routine and preventive maintenance on
durable medical equipment. The
equipment must be safe and work as
intended for use in the patient’s
environment. Where there is no
manufacturer recommendation for a
piece of equipment, the hospice must
develop in writing its own repair and
routine maintenance policy. The
hospice may use persons under contract
to ensure the maintenance and repair of
durable medical equipment.
(2) The hospice must ensure that the
patient, where appropriate, as well as
the family and/or other caregiver(s),
receive instruction in the safe use of
durable medical equipment and
supplies. The patient, family, and/or
caregiver must be able to demonstrate
the appropriate use of durable medical
equipment to the satisfaction of the
hospice staff.
§ 418.108 Condition of participation:
Short-term inpatient care.
Inpatient care must be available for
pain control, symptom management,
and respite purposes, and must be
provided in a participating Medicare or
Medicaid facility.
(a) Standard: Inpatient care for
symptom management and pain
control. Inpatient care for pain control
and symptom management must be
provided in one of the following:
(1) A Medicare-approved hospice that
meets the conditions of participation for
providing inpatient care directly as
specified in § 418.110.
(2) A Medicare-participating hospital
or a skilled nursing facility that also
meets the standards specified in
§ 418.110(b) and (f) regarding 24-hour
nursing services and patient areas.
(b) Standard: Inpatient care for respite
purposes. Inpatient care for respite
purposes must be provided by one of
the following:
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(1) A provider specified in paragraph
(a) of this section.
(2) A Medicare/Medicaid approved
nursing facility that also meets the
standards specified in § 418.110(b) and
(f).
(c) Standard: Inpatient care provided
under arrangements. If the hospice has
an arrangement with a facility to
provide for short-term inpatient care,
the arrangement is described in a legally
binding written agreement that at a
minimum specifies—
(1) That the hospice supplies the
inpatient provider a copy of the
patient’s plan of care and specifies the
inpatient services to be furnished;
(2) That the inpatient provider has
established patient care policies
consistent with those of the hospice and
agrees to abide by the palliative care
protocols and plan of care established
by the hospice for its patients;
(3) That the hospice patient’s
inpatient clinical record includes a
record of all inpatient services
furnished, events regarding care that
occurred at the facility, and that a copy
of the inpatient clinical record and
discharge summary is available to the
hospice at the time of discharge;
(4) That the inpatient facility has
identified a individual within the
facility who is responsible for the
implementation of the provisions of the
agreement;
(5) That the hospice retains
responsibility for arranging the training
of personnel who will be providing the
patient’s care in the inpatient facility
and that a description of the training
and the names of those giving the
training is documented; and
(6) That a way to verify that
requirements in paragraphs (c)(1)
through (c)(5) of this section have been
met is established.
(d) Standard: Inpatient care
limitation. The total number of inpatient
days used by Medicare beneficiaries
who elected hospice coverage in a 12month period in a particular hospice
may not exceed 20 percent of the total
number of hospice days consumed in
total by this group of beneficiaries.
(e) Standard: Exemption from
limitation. Before October 1, 1986, any
hospice that began operation before
January 1, 1975, is not subject to the
limitation specified in paragraph (d) of
this section.
§ 418.110 Condition of participation:
Hospices that provide inpatient care
directly.
A hospice that provides inpatient care
directly must demonstrate compliance
with all of the following standards:
(a) Standard: Staffing. The hospice is
responsible for ensuring that staffing for
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all services reflects its volume of
patients, their acuity, and the level of
intensity of services needed to ensure
that plan of care outcomes are achieved
and negative outcomes are avoided.
(b) Standard: Twenty-four hour
nursing services. The hospice facility
must provide 24-hour nursing services
that meet the nursing needs of all
patients and are furnished in
accordance with each patient’s plan of
care. Each patient must receive all
nursing services as prescribed and must
be kept comfortable, clean, wellgroomed, and protected from accident,
injury, and infection.
(c) Standard: Physical environment.
The hospice must maintain a safe
physical environment free of hazards for
patients, staff, and visitors.
(1) Safety management. (i) The
hospice must address real or potential
threats to the health and safety of the
patients, others, and property. The
hospice must report a breach of safety
to appropriate State and local bodies
having regulatory jurisdiction and
correct it promptly.
(ii) The hospice must take steps to
prevent equipment failure and when a
failure occurs, report it appropriate
State and local bodies having regulatory
jurisdiction and correct it promptly.
(iii) The hospice must have a written
disaster preparedness plan in effect for
managing the consequences of power
failures, natural disasters, and other
emergencies that would affect the
hospice’s ability to provide care. The
plan must be periodically reviewed and
rehearsed with staff (including nonemployee staff) with special emphasis
placed on carrying out the procedures
necessary to protect patients and others.
(2) Physical plant and equipment. The
hospice must develop procedures for
managing the control, reliability, and
quality of—
(i) The routine storage and prompt
disposal of trash and medical waste;
(ii) Light, temperature, and
ventilation/air exchanges throughout
the hospice;
(iii) Emergency gas and water supply;
and
(iv) The scheduled and emergency
maintenance and repair of all
equipment.
(d) Standard: Fire protection. (1)
Except as otherwise provided in this
section—
(i) The hospice must meet the
provisions applicable to nursing homes
of the 2000 edition of the Life Safety
Code (LSC) of the National Fire
Protection Association The Director of
the Office of the Federal Register has
approved the NFPA 101 2000 edition of
the Life Safety Code, issued January 14,
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2000, for incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. A copy of the code is
available for inspection at the CMS
Information Resource Center, 7500
Security Boulevard, Baltimore, MD or at
the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/
federal register/code of federal
regulations/ibr locations.html. Copies
may be obtained from the National Fire
Protection Association, 1 Batterymarch
Park, Quincy, MA 02269. If any changes
in the edition of the Code are
incorporated by reference, CMS will
publish a notice in the Federal Register
to announce the changes.
(ii) Chapter 19.3.6.3.2, exception
number 2 of the adopted edition of the
LSC does not apply to hospice.
(2) In consideration of a
recommendation by the State survey
agency, CMS may waive, for periods
deemed appropriate, specific provisions
of the Life Safety Code which, if rigidly
applied would result in unreasonable
hardship for the hospice, but only if the
waiver would not adversely affect the
health and safety of patients.
(3) The provisions of the adopted
edition of the Life Safety Code do not
apply in a State if CMS finds that a fire
and safety code imposed by State law
adequately protects patients in hospices.
(4) Beginning March 13, 2006, a
hospice must be in compliance with
Chapter 9.2.9, Emergency lighting.
(5) Beginning March 13, 2006,
Chapter 19.3.6.3.2, exception number 2
does not apply to hospices.
(6) Notwithstanding any provisions of
the 2000 edition of the Life Safety Code
to the contrary, a hospice may place
alcohol-based hand rub dispensers in its
facility if—
(i) Use of alcohol-based hand rub
dispensers does not conflict with any
State or local codes that prohibit or
otherwise restrict the placement of
alcohol-based hand rub dispensers in
health care facilities;
(ii) The dispensers are installed in a
manner that minimizes leaks and spills
that could lead to falls;
(iii) The dispensers are installed in a
manner that adequately protects against
access by vulnerable populations; and
(iv) The dispensers are installed in
accordance with chapter 18.3.2.7 or
chapter 19.3.2.7 of the 2000 edition of
the Life Safety Code, as amended by
NFPA Temporary Interim Amendment
00–1(101), issued by the Standards
Council of the National Fire Protection
Association on April 15, 2004. The
Director of the Office of the Federal
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Register has approved NFPA Temporary
Interim Amendment 00–1(101) for
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. A copy of the amendment
is available for inspection at the CMS
Information Resource Center, 7500
Security Boulevard, Baltimore MD and
at the Office of the Federal Register, 800
North Capitol Street NW., Suite 700,
Washington, DC. Copies may be
obtained from the National Fire
Protection Association, 1 Batterymarch
Park, Quincy, MA 02269. If any
additional changes are made to this
amendment, CMS will publish notice in
the Federal Register to announce the
changes.
(e) Standard: Patient areas. The
hospice must provide a home-like
atmosphere and ensure that patient
areas are designed to preserve the
dignity, comfort, and privacy of
patients.
(1) The hospice must provide—
(i) Physical space for private patient
and family visiting;
(ii) Accommodations for family
members to remain with the patient
throughout the night; and
(iii) Physical space for family privacy
after a patient’s death.
(2) The hospice must provide the
opportunity for patients to receive
visitors at any hour, including infants
and small children.
(f) Standard: Patient rooms. (1) The
hospice must ensure that patient rooms
are designed and equipped for nursing
care, as well as the dignity, comfort, and
privacy of patients.
(2) The hospice must accommodate a
patient and family request for a single
room whenever possible.
(3) Each patient’s room must—
(i) Be at or above grade level;
(ii) Contain a suitable bed and other
appropriate furniture for each patient;
(iii) Have closet space that provides
security and privacy for clothing and
personal belongings;
(iv) Accommodate no more than two
patients;
(v) Provide at least 80 square feet for
each residing patient in a double room
and at least 100 square feet for each
patient residing in a single room; and
(vi) Be equipped with an easilyactivated, functioning device accessible
to the patient, that is used for calling for
assistance.
(4) For an existing building, CMS may
waive the space and occupancy
requirements of paragraphs (f)(2)(iv) and
(f)(2)(v) of this section for a period of
time if it determines that—
(i) Imposition of the requirements
would result in unreasonable hardship
on the hospice if strictly enforced; or
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jeopardize its ability to continue to
participate in the Medicare program;
and
(ii) The waiver serves the needs of the
patient and does not adversely affect
their health and safety.
(g) Standard: Toilet/bathing facilities.
Each patient room must be equipped
with, or conveniently located near,
toilet and bathing facilities.
(h) Standard: Plumbing facilities. The
hospice must—
(1) Have an adequate supply of hot
water at all times; and
(2) Have plumbing fixtures with
control valves that automatically
regulate the temperature of the hot
water used by patients.
(i) Standard: Infection control. The
hospice must maintain an infection
control program that protects patients,
staff and others by preventing and
controlling infections and
communicable disease as stipulated in
§ 418.60.
(j) Standard: Sanitary environment.
The hospice must provide a sanitary
environment by following current
standards of practice, including
nationally recognized infection control
precautions, and avoid sources and
transmission of infections and
communicable diseases.
(k) Standard: Linen. The hospice must
have available at all times a quantity of
clean linen in sufficient amounts for all
patient uses. Linens must be handled,
stored, processed, and transported in
such a manner as to prevent the spread
of contaminants.
(l) Standard: Meal service and menu
planning. The hospice must furnish
meals to each patient that are—
(1) Consistent with the patient’s plan
of care, nutritional needs, and
therapeutic diet;
(2) Palatable, attractive, and served at
the proper temperature; and
(3) Obtained, stored, prepared,
distributed, and served under sanitary
conditions.
(m) Standard: Pharmaceutical
services. Under the direction of a
qualified pharmacist, the hospice must
provide pharmaceutical services such as
drugs and biologicals and have a written
process in place that ensures dispensing
accuracy. The hospice will evaluate a
patient’s response to the medication
therapy, identify adverse drug reactions,
and take appropriate corrective action.
Drugs and biologicals must be obtained
from community or institutional
pharmacists or stocked by the hospice.
The hospice must furnish the drugs and
biologicals for each patient, as specified
in each patient’s plan care. The use of
drugs and biologicals must be provided
in accordance with accepted
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professional principles and appropriate
Federal, State, and local laws.
(n) Pharmacist. A licensed pharmacist
must provide consultation on all aspects
of the provision of pharmaceutical care
in the facility, including ordering,
storage, administration, disposal, and
record keeping of drugs and biologicals.
(1) Orders for medications. (i) A
physician as defined by section
1861(r)(1) of the Act, or a nurse
practitioner in accordance with the plan
of care and State law, must order all
medications for the patient.
(ii) If the medication order is verbal or
given by or through electronic
transmission—
(A) The physician must give it only to
a licensed nurse, nurse practitioner
(where appropriate), pharmacist, or
another physician; and
(B) The individual receiving the order
must record and sign it immediately and
have the prescribing physician sign it in
accordance with State and Federal
regulations.
(2) Administration of medications.
Medications must be administered by
only the following individuals:
(i) A licensed nurse, physician, or
other health care professional in
accordance with their scope of practice.
(ii) An employee who has completed
a State-approved training program in
medication administration.
(iii) The patient, upon approval by the
attending physician.
(3) Labeling of drugs and biologicals.
Drugs and biologicals must be labeled in
accordance with currently accepted
professional practice and must include
appropriate accessory and cautionary
instructions, as well as an expiration
date (if applicable).
(4) Drug management procedures. (i)
All drugs and biologicals must be stored
in secure areas. All drugs listed in
Schedules II, III, IV, and V of the
Comprehensive Drug Abuse Prevention
and Control Act of 1976 must be stored
in locked compartments within such
secure storage areas. Only personnel
authorized to administer controlled
medications may have access to the
locked compartments.
(ii) The hospice must keep current
and accurate records of the receipt and
disposition of all controlled drugs.
(iii) Any discrepancies in the
acquisition, storage, use, disposal, or
return of controlled drugs must be
investigated immediately by the
pharmacist and hospice administrator
and where required reported to the
appropriate State agency. A written
account of the investigation must be
made available to State and Federal
officials.
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(5) Drug disposal. Controlled drugs no
longer needed by a patient must be
disposed of in compliance with the
hospice policy and in accordance with
State and Federal requirements.
(o) Standard: Seclusion and restraint.
(1) The patient has the right to be free
from seclusion and restraint, of any
form, imposed as a means of coercion,
discipline, convenience, or retaliation
by staff. The term restraint includes
either a physical restraint or a drug that
is being used as a restraint. A physical
restraint is any manual method or
physical or mechanical device, material
or equipment attached or adjacent to the
patient’s body that he or she cannot
easily remove, that restricts free
movement of, normal function of, or
normal access to one’s body. A drug
used as a restraint is a medication used
to control behavior or to restrict the
patient’s freedom of movement and is
not a standard treatment for a patient’s
medical or psychiatric condition.
Seclusion is the confinement of a person
alone in a room or an area where a
person is physically prevented from
leaving.
(2) Seclusion and restraint can only be
used in emergency situations if needed
to ensure the patient’s or others’
physical safety, and only if less
restrictive interventions have been tried,
determined and documented to be
ineffective.
(3) The use of restraint and seclusion
must be—
(i) Selected only when less restrictive
measures have been found ineffective to
protect the patient or others from harm;
(ii) Carried out in accordance with the
order of a physician. The following will
be superseded by more restrictive State
laws:
(A) Orders for seclusion or restraints
must never be written as a standing
order or an as needed basis (that is,
PRN).
(B) The hospice medical director or
physician designee must be consulted as
soon as possible if restraint or seclusion
is not ordered by the hospice medical
director or physician designee.
(C) A hospice medical director or
physician designee must see the patient
and evaluate the need for restraint or
seclusion within 1 hour after initiation
of this intervention.
(D) Each order for a physical restraint
or seclusion must be in writing and
limited to 4 hours for adults; 2 hours for
children and adolescents ages 9 through
17; or 1 hour for patients under the age
of 9. The original order may only be
renewed in accordance with these limits
for up to a total of 24 hours. After the
original order expires, a physician must
reassess the patient’s need before
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issuing another seclusion and restraint
order.
(iii) In accordance with the
interdisciplinary group and a written
modification to the patient’s plan of
care;
(iv) Implemented in the least
restrictive manner possible not to
interfere with the palliative care being
provided;
(v) In accordance with safe,
appropriate restraining techniques;
(vi) Ended at the earliest possible
time; and
(vii) Supported by medical necessity
and the patient’s response or outcome,
and documented in the patient’s clinical
record.
(4) A restraint and seclusion may not
be used simultaneously unless the
patient is—
(i) Continually monitored face to face
by an assigned staff member; or
(ii) Continually monitored by staff
using video and audio equipment. Staff
must be in immediate response
proximity to the patient.
(5) The condition of the patient who
is in a restraint or in seclusion must
continually be assessed, monitored, and
reevaluated by an assigned staff
member.
(6) All staff who have direct patient
contact must have ongoing education
and training in the proper and safe use
of seclusion and restraint application
and techniques and alternative methods
for handling behavior, symptoms, and
situations that traditionally have been
treated through the use of restraints or
seclusion.
(7) The hospice must report to the
CMS regional office any death that
occurs while the patient is restrained or
in seclusion, within 24 hours after a
patient has been removed from restraint
or seclusion.
§ 418.112 Condition of participation:
Hospices that provide hospice care to
residents of a SNF/NF, ICF/MR, or other
facilities.
In addition to meeting the conditions
of participation at § 418.10 through
§ 418.116, a hospice that provides
hospice care to residents of a SNF/NF,
ICF/MR, or other residential facility
must abide by the following additional
standards.
(a) Standard: Resident eligibility,
election, and duration of benefits.
Medicare patients receiving hospice
services and residing in a SNF, NF, or
other facility must meet the Medicare
hospice eligibility criteria as identified
in § 418.20 through § 418.30.
(b) Standard: Professional
management. The hospice must assume
full responsibility for professional
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management of the resident’s hospice
care, in accordance with the hospice
conditions of participation and make
any arrangements necessary for
inpatient care in a participating
Medicare/Medicaid facility according to
§ 418.100.
(c) Standard: Core services. A hospice
must routinely provide all core services.
These services include nursing services,
medical social services, and counseling
services. The hospice may contract for
physician services as stated in
§ 418.64(a). A hospice may use
contracted staff provided by another
Medicare certified hospice to furnish
core services, if necessary, to
supplement hospice employees in order
to meet the needs of patients under
extraordinary or other non-routine
circumstances, as described in § 418.64.
(d) Standard: Medical director. The
medical director and physician designee
of the hospice must provide overall
coordination of the medical care of the
hospice resident that resides in an SNF,
NF, or other facility. The medical
director and physician designee must
communicate with the medical director
of the SNF/NF, the patient’s attending
physician, and other physicians
participating in the provision of care for
the terminal and related conditions to
ensure quality care for the patient and
family.
(e) Standard: Written agreement. The
hospice and the facility must have a
written agreement that specifies the
provision of hospice services in the
facility. The agreement must be signed
by authorized representatives of the
hospice and the facility before the
provision of hospice services. The
written agreement must include at least
the following:
(1) The written consent of the patient
or the patient’s representative that
hospice services are desired.
(2) The services that the hospice will
furnish and that the facility will furnish.
(3) The manner in which the facility
and the hospice are to communicate
with each other to ensure that the needs
of the patient are addressed and met 24
hours a day.
(4) A provision that the facility
immediately notifies the hospice if—
(i) A significant change in the
patient’s physical, mental, social, or
emotional status occurs;
(ii) Clinical complications appear that
suggest a need to alter the plan of care;
(iii) A life threatening condition
appears;
(iv) A need to transfer the patient
from the facility and the hospice makes
arrangements for, and remains
responsible for, any necessary
continuous care or inpatient care
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30891
necessary related to the terminal illness;
or
(v) The patient dies.
(5) A provision stating that the
hospice assumes responsibility for
determining the appropriate course of
care, including the determination to
change the level of services provided.
(6) An agreement that it is the
facility’s primary responsibility to
furnish room and board.
(7) A delineation of the hospice’s
responsibilities, which include, but are
not limited to, providing medical
direction and management of the
patient, nursing, counseling (including
spiritual and dietary counseling), social
work, bereavement counseling for
immediate family members, provision of
medical supplies and durable medical
equipment, and drugs necessary for the
palliation of pain and symptoms
associated with the terminal illness, as
well as all other hospice services that
are necessary for the care of the
resident’s terminal illness.
(8) A provision that the hospice may
use the facility’s nursing personnel
where permitted by law and as specified
by the facility to assist in the
administration of prescribed therapies
included in the plan of care only to the
extent that the hospice would routinely
utilize the services of a hospice
resident’s family in implementing the
plan of care.
(f) Standard: Hospice plan of care. A
written plan of care must be established
and maintained for each facility patient
and must be developed by and
coordinated with the hospice
interdisciplinary group in consultation
with facility representatives and in
collaboration with the attending
physician. All care provided must be in
accordance with this plan. The plan
must reflect the hospice’s policies and
procedures in all aspects and be based
on an assessment of the patient’s needs
and unique living situation in the
facility. It must include the patient’s
current medical, physical, social,
emotional, and spiritual needs.
Directives for management of pain and
other symptoms must be addressed and
updated as necessary to reflect the
patient’s status.
(1) The plan of care must identify the
care and services that are needed and
specifically identify which provider is
responsible for performing the
respective functions that have been
agreed upon and included in the plan of
care.
(2) The plan of care reflects the
participation of the hospice, the facility,
and the patient and family to the extent
possible.
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(3) In conjunction with
representatives of the facility, the plan
of care must be reviewed at intervals
specified in the plan but no less often
than every 14 calendar days.
(4) Any changes in the plan of care
must be discussed among all caregivers
and must be approved by the hospice
before implementation.
(g) Standard: Coordination of services.
The hospice must designate a member
of its interdisciplinary group to
coordinate the implementation of the
plan of care with the representatives of
the facility. The hospice must provide
the facility with the following
information:
(1) Plan of care.
(2) Patient or patient’s representative
hospice consent form and advance
directives.
(3) Names and contact information for
hospice personnel involved in hospice
care of the patient.
(4) Instructions on how to access the
hospice’s 24-hour on-call system.
(5) Medication information specific to
the patient
(6) Physician orders.
(h) Standard: Transfer, revocation, or
discharge from hospice care.
Requirements for discharge or
revocation from hospice care,
§ 418.104(e), apply. Discharge from or
revocation of hospice care does not
directly impact the eligibility to
continue to reside in an SNF, NF, ICF/
MR, or other facility.
(i) Standard: Orientation and training
of staff. Hospice staff must orient
facility staff furnishing care to hospice
patients in the hospice philosophy,
including hospice policies and
procedures regarding methods of
comfort, pain control, symptom
management, as well as principles about
death and dying, individual responses
to death, patient rights, appropriate
forms, and record keeping requirements.
§ 418.114 Condition of participation:
Personnel qualifications for licensed
professionals.
(a) General qualification
requirements. Except as specified in
paragraph (c) of this section, all
professionals who furnish services
directly, under an individual contract,
or under arrangements with a hospice,
must be legally authorized (licensed,
certified or registered) to practice by the
State in which he or she performs such
functions or actions, and must act only
within the scope of his or her State
license, or State certification, or
registration. All personnel qualifications
must be kept current at all times.
(b) Personnel qualifications for
physicians, speech-language
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pathologists, and home health aides.
The following qualifications must be
met:
(1) Physicians. Physicians must meet
the qualifications and conditions as
defined in section 1861(r) of the Act and
implemented at § 410.20 of this chapter.
(2) Speech language pathologists.
Speech language pathologists must meet
the qualifications specified in section
1861(ll)(1) of the Act. The individual
must have a master’s or doctoral degree
in speech-language pathology and
must—
(i) Be licensed as a speech-language
pathologist by the State in which the
individual furnishes such services, or,
(ii) In the case of an individual who
furnishes services in a State which does
not license speech-language
pathologists, must:
(A) Have successfully completed 350
clock hours of supervised clinical
practicum (or is in the process of
accumulating such supervised clinical
experience),
(B) Have performed not less than 9
months of supervised full-time speech
language pathology services after
obtaining a master’s or doctoral degree
in speech-language pathology or a
related field, and successfully
completed the Praxis National
Examination in Speech-Language
Pathology.
(3) Home health aides. Home health
aides must meet the qualifications
required by section 1891(a)(3) of the Act
and implemented at § 484.75.
(c) Personnel qualifications when no
State licensing, certification or
registration requirements exist. If no
State licensing laws, certification or
registration requirements exist for the
profession, the following requirements
must be met:
(1) Occupational therapist. An
occupational therapist must—
(i) Be a graduate of an occupational
therapy curriculum accredited by the
American Occupational Therapy
Association, and be eligible for the
National Registration Examination of
the American Occupational Therapy
Association; or
(ii) Have 2 years of appropriate
experience as an occupational therapist,
and have achieved a satisfactory grade
on a proficiency examination
conducted, approved, or sponsored by
the U.S. Public Health Service, except
that such determinations of proficiency
do not apply with respect to persons
initially licensed by a State or seeking
initial qualification as an occupational
therapist after December 31, 1977.
(2) Occupational therapy assistant.
An occupational therapy assistant
must—
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(i) Meet the requirements for
certification as an occupational therapy
assistant established by the American
Occupational Therapy Association; or
(ii) Have 2 years of appropriate
experience as an occupational therapy
assistant, and have achieved a
satisfactory grade on a proficiency
examination conducted, approved, or
sponsored by the U.S. Public Health
Service, except that such determinations
of proficiency do not apply with respect
to persons initially licensed by a State
or seeking initial qualification as an
occupational therapy assistant after
December 31, 1977.
(3) Physical therapist. A person
who—
(i) Has graduated from a physical
therapy curriculum approved by—
(A) The American Physical Therapy
Association;
(B) The Council on Medical Education
of the American Medical Association
and the American Physical Therapy
Association; or
(ii) Prior to January 1, 1966—
(A) Was admitted to membership by
the American Physical Therapy
Association;
(B) Was admitted to registration by
the American Registry of Physical
Therapists; or
(C) Has graduated from a physical
therapy curriculum in a 4-year college
or university approved by a State
department of education; or
(iii) Has 2 years of appropriate
experience as a physical therapist, and
has achieved a satisfactory grade on a
proficiency examination conducted,
approved, or sponsored by the U.S.
Public Health Service except that such
determinations of proficiency do not
apply with respect to persons initially
licensed by a State or seeking
qualification as a physical therapist after
December 31, 1977; or
(iv) Was licensed or registered prior to
January 1, 1966, and prior to January 1,
1970, had 15 years of full-time
experience in the treatment of illness or
injury through the practice of physical
therapy in which services were
rendered under the order and direction
of attending and referring doctors of
medicine or osteopathy; or
(v) If trained outside the United
States—
(A) Has graduated, since 1928, from a
physical therapy curriculum approved
in the country in which the curriculum
was located and in which there is a
member organization of the World
Confederation for Physical Therapy;
(B) Meets the requirements for
membership in a member organization
of the World Confederation for Physical
Therapy.
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(4) Physical therapist assistant. A
person who—
(i) Has graduated from a 2-year
college-level program approved by the
American Physical Therapy
Association; or
(ii) Has 2 years of appropriate
experience as a physical therapy
assistant, and has achieved a
satisfactory grade on a proficiency
examination conducted, approved, or
sponsored by the U.S. Public Health
Service, except that these
determinations of proficiency do not
apply with respect to persons initially
licensed by a State or seeking initial
qualification as a physical therapy
assistant after December 31, 1977.
(5) Registered nurse. A graduate of a
school of professional nursing.
(6) Licensed practical nurse. A person
who has completed a practical nursing
program.
(7) Social worker. A person who has
a baccalaureate degree from a school of
social work accredited by the Council
on Social Work Education.
(d) Standard: Criminal background
checks. The hospice must obtain a
criminal background check on each
hospice employee and contracted
employee before employment at the
hospice.
VerDate jul<14>2003
16:47 May 26, 2005
Jkt 205001
§ 418.116 Condition of participation:
Compliance with Federal, State, and local
laws and regulations related to health and
safety of patients.
The hospice and its staff must operate
and furnish services in compliance with
all applicable Federal, State, and local
laws and regulations related to the
health and safety of patients. If State or
local law provides for licensing of
hospices, the hospice must be licensed.
(a) Standard: Licensure of staff. Any
persons who provide hospice services
must be licensed, certified, or registered
in accordance with applicable Federal,
State and local laws.
(b) Standard: Multiple locations.
Every hospice must comply with the
requirements of § 420.206 of this
chapter regarding disclosure of
ownership and control information. All
hospice satellite locations must be
approved by CMS and licensed in
accordance with State licensure laws, if
applicable, before providing Medicare
reimbursed services.
(c) Standard: Laboratory services. (1)
If the hospice engages in laboratory
testing other than assisting a patient in
self-administering a test with an
appliance that has been approved for
that purpose by the FDA, the hospice
must be in compliance with all
applicable requirements of part 493 of
this chapter.
(2) If the hospice chooses to refer
specimens for laboratory testing to a
PO 00000
Frm 00055
Fmt 4701
Sfmt 4700
30893
reference laboratory, the reference
laboratory must be certified in the
appropriate specialties and
subspecialties of services in accordance
with the applicable requirements of part
493 of this chapter.
§ 418.200
[Amended]
6. Section 418.200 is amended by
revising the reference ‘‘§ 418.58’’ to read
‘‘§ 418.56’’.
§ 418.202
[Amended]
7. In § 418.202, paragraph (e) is
amended by revising the reference
‘‘§ 418.98(b)’’ to read ‘‘§ 418.108(b)’’ and
paragraph (g) is amended by revising the
reference ‘‘§ 418.94’’ to read ‘‘§ 418.76’’.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: February 7, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: February 7, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05–9935 Filed 5–26–05; 8:45 am]
BILLING CODE 4120–01–P
E:\FR\FM\27MYP2.SGM
27MYP2
Agencies
[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Proposed Rules]
[Pages 30840-30893]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9935]
[[Page 30839]]
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Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
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42 CFR Part 418
Medicare and Medicaid Programs: Hospice Conditions of Participation;
Proposed Rule
Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed
Rules
[[Page 30840]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 418
[CMS-3844-P]
RIN 0938-AH27
Medicare and Medicaid Programs: Hospice Conditions of
Participation
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would revise the existing conditions of
participation that hospices must meet to participate in the Medicare
and Medicaid programs. The proposed requirements focus on the care
delivered to patients and their families by hospices and the outcomes
of that care. The proposed requirements continue to reflect an
interdisciplinary view of patient care and allow hospices flexibility
in meeting quality standards. These changes are an integral part of the
Administration's efforts to achieve broad-based improvements in the
quality of health care furnished through the Medicare and Medicaid
programs.
DATES: We will consider comments if we receive them at the appropriate
address, as provided below, no later than 5 p.m. on July 26, 2005.
ADDRESSES: In commenting, please refer to file code CMS-3844-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments to https://
www.cms.hhs.gov/regulations/ecomments (attachments should be in
Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft
Word).
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-3844-
P, P.O. Box 8010, Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Mary Rossi-Coajou, (410) 786-6051.
Danielle Shearer, (410) 786-6617.
Steve Miller, (410) 786-6656.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-3844-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: Comments received timely will be
available for public inspection as they are received, generally
beginning approximately 3 weeks after publication of a document, at the
headquarters of the Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view
public comments, phone 1-800-743-3951.
I. Introduction
As the single largest payer for health care services in the United
States, the Federal Government assumes a critical responsibility for
the delivery and quality of care furnished under its programs.
Historically, we have adopted a quality assurance approach that has
been directed toward identifying health care providers that furnish
poor quality care or fail to meet minimum Federal standards. These
problems would either be corrected or would lead to the exclusion of
the provider from participation in the Medicare or Medicaid programs.
However, we have found that this problem-focused approach has inherent
limits. Ensuring quality through the enforcement of prescriptive health
and safety standards, rather than improving the quality of care for all
patients, has resulted in our expending much of our resources on
dealing with marginal providers, rather than on stimulating broad-based
improvements in quality of care.
Eliciting quality health care for Federal beneficiaries from CMS-
certified providers and suppliers requires taking advantage of
continuing advances in the health care delivery field. As a result, we
are revising the Medicare hospice requirements, which are also used by
Medicaid, to focus on a patient-centered, outcome-oriented process that
promotes patient care foremost, rather than penalizing unproductive
providers. We have developed a set of core requirements for hospice
services that encompass the following: Patient rights, comprehensive
assessment, and patient care planning and coordination by a hospice
interdisciplinary group (IDG). Overarching these requirements is a
quality assessment and performance improvement program that builds on
the philosophy that a provider's own quality management system is key
to improved patient care performance. The objective is to achieve a
balanced regulatory approach by ensuring that a hospice furnishes
health care that meets essential health and quality standards, while
ensuring that it monitors and improves its own performance.
To achieve this objective, we are working to revise not only the
hospice requirements but the requirements for several other major
health care provider types, such as hospitals, home health agencies,
and end-stage renal disease facilities, through separate rules. All of
the revised requirements are directed towards improving patient
outcomes of care and satisfaction.
II. Background
A. The Medicare Hospice Benefit
Hospice care is an approach to caring for the terminally ill
individual that provides palliative care rather than traditional
medical care and curative treatment. Palliative care is treatment for
the relief of pain and other
[[Page 30841]]
uncomfortable symptoms through the appropriate coordination of all
aspects of care needed to maximize personal comfort and relieve
distress. Hospice care allows the patient to remain at home as long as
possible by providing support to the patient and family, and keeping
the patient as comfortable as possible while maintaining his or her
dignity and quality of life. A hospice uses an interdisciplinary
approach to deliver medical, social, physical, emotional, and spiritual
services through the use of a broad spectrum of caregivers.
Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982
(TEFRA), Public Law 97-248, added section 1861(dd) to the Social
Security Act (the Act) to provide coverage for hospice care to
terminally ill Medicare beneficiaries who elect to receive care from a
Medicare-participating hospice.
Under the authority of section 1861(dd) of the Act, the Secretary
has established the Conditions of Participation (CoPs) that a hospice
must meet to participate in Medicare and/or Medicaid, and these are
currently set forth at 42 CFR part 418. The CoPs apply to a hospice as
an entity as well as to the services furnished to each individual under
hospice care. Under section 1861(dd) of the Act, the Secretary is
responsible for ensuring that the CoPs, and their enforcement, are
adequate to protect the health and safety of individuals under hospice
care and to promote the effective and efficient use of Medicare funds.
To implement this requirement, State survey agencies conduct surveys of
hospices to assess their compliance with the CoPs.
B. Why Revise the Conditions of Participation?
The hospice CoPs were originally promulgated on December 16, 1983
(48 FR 56008) and were amended on December 11, 1990 (55 FR 50831)
largely to implement provisions of section 6005(b) of the Omnibus
Budget Reconciliation Act of 1989 (Pub. L. 101-239). However, many of
the current CoPs have remained unchanged since their inception.
We are proposing changes to the current CoPs based on four main
considerations. First, we considered the suggestions that emerged from
the Secretary's Advisory Committee on Regulatory Reform. In an effort
to make regulations more predictable and responsive to relevant
stakeholders, the Committee heard public testimony on a variety of
hospice related topics and developed recommendations to address key
issues that were highlighted. The two largest changes that resulted
from the Committee's recommendations are the clarification of the
relationship between nursing facilities and hospices at proposed Sec.
418.112, and the changes to the nursing services standard at proposed
Sec. 418.110(b).
Our second consideration was the Balanced Budget Act of 1997 (Pub.
L. 105-33) because it made changes to the hospice statute that need to
be incorporated into the CoPs.
Our third consideration was prompted by sections 408 and 946 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(Pub. L. 108-173). Section 408 amended the Social Security Act to
permit a nurse practitioner to be deemed a patient's attending
physician when the patient elects hospice care. Section 946 amended
section 1861(dd), Hospice Care: Hospice Program, of the Act to permit a
hospice to enter into an arrangement with another hospice to provide
core hospice services, or to provide highly specialized services of a
registered professional nurse, in certain circumstances.
Finally, this revision is part of a larger effort to bring about
improvements in the quality of care furnished to Medicare and Medicaid
beneficiaries through an outcome-oriented approach to quality of care
responsibilities. The existing hospice CoPs do not contain patient-
centered, outcome-oriented standards, nor do they provide for the
operation of a quality assessment and performance improvement program.
Historically, we have established requirements for participation in
the Medicare program that address the structure and process of health
care. These early requirements are the result of professional
consensus. Enforcing structure and process requirements by identifying
deficient providers has not been adequate to meet the growing
challenges associated with the changing hospice care environment. For
example, rather than focusing on the relationship between the needs of
patients and the staff available in an inpatient facility, the current
regulations require that a registered nurse be present on every shift.
Hospices often contract with local nursing facilities to provide
inpatient respite care, and these facilities are only required to have
a registered nurse on duty for a single eight hour shift each day. A
hospice would have to supplement the nursing facility's staff with its
own, at a significant cost to the hospice, even if the needs and acuity
of the patient do not require a registered nurse. A hospice that did
not supplement the facility's staff could be cited for not meeting the
requirements, even though the requirements had no relevance to the
needs of the patient. Thus, revisions to the hospice CoPs are
essential.
C. Transforming the Hospice Conditions of Participation
Before developing these proposed CoPs for hospices, we received
advice and suggestions from the hospice industry, professional
associations, practitioner communities, consumer advocates, and State
and other governmental agencies with an interest in, or responsibility
for, hospice regulation and oversight. Based on these suggestions, we
have developed the following principles:
Focus on the continuous, integrated health care process
that a patient/family experiences across all aspects of hospice care,
and on activities that center around patient assessment, care planning,
service delivery, and quality assessment and performance improvement.
Use a patient-centered, interdisciplinary approach that
recognizes the contributions of various skilled professionals and other
support personnel and their interaction with each other to meet the
patient's needs.
Incorporate an outcome-oriented quality assessment and
performance improvement program.
Facilitate flexibility in how a hospice meets performance
expectations.
Require that patient rights are ensured.
Use performance measurement systems to evaluate and
improve care.
Based on these principles, we are proposing to set forth four core
conditions of participation: Patient Rights, Patient/Family Assessment,
Interdisciplinary Care Planning and Coordination of Services, and
Quality Assessment and Performance Improvement.
The Patient Rights CoP emphasizes a hospice's
responsibility to respect and promote the rights of each hospice
patient.
The comprehensive Patient/Family Assessment CoP reflects
the critical nature of a comprehensive assessment in determining
appropriate treatments and accomplishing desired health outcomes.
The Care Planning and Coordination of Services CoP
incorporates the interdisciplinary team approach to providing hospice
care.
The Quality Assessment and Performance Improvement CoP
charges each hospice with the responsibility for carrying out a
performance effort to effect continuing improvement in the
[[Page 30842]]
quality of care it furnishes to its patients and their families.
The last three requirements establish a cycle of individual care
and hospice-wide performance improvement. First, the patient's needs
are comprehensively assessed and outcome measure data are collected.
Second, the interdisciplinary group, in consultation with the patient's
attending physician, establishes a plan of care to address those needs.
Third, the plan of care is implemented and the results of the care are
evaluated through updates of the comprehensive assessment and plan of
care. Fourth, the outcome measure data collected during the initial and
updated comprehensive assessments are analyzed to identify practices
that lead to positive outcomes as well as opportunities for
improvement. Finally, the hospice uses the results of such analyses to
implement performance improvement activities. These activities will
influence the establishment of plans of care and their implementation,
thus creating a continuous cycle of individual care and an ongoing
effort to improve the hospice's performance related to identified
outcomes of care for all patients.
This cycle of care adapts to changing standards of practice while
addressing issues that surveyors have identified. Below is a list of
the most cited deficiencies found by surveyors (year ending September
3, 2002):
1. Plan of care was not complete.
2. No written plan was established.
3. Plan was not reviewed at specific intervals.
4. Plan did not include an assessment of needs.
5. Plan was not established before providing care.
6. RN supervisory visits were not made for home health aide
services.
7. No plan of care was included for bereavement services.
8. Hospice did not conduct a self-assessment of quality and care
provided.
9. Clinical record was not maintained for every patient.
10. Interdisciplinary group did not review and update the plan of
care for each patient.
We note that 8 of the 10 top deficiencies are related to plan of
care, assessment, and quality assurance. Based on industry comments and
our own surveys, we believe that the current plan of care condition
contained in Sec. 418.58 must be strengthened. We did this by creating
a separate condition for the assessment of individual needs and for the
time frames related to that assessment. We also revised the quality
assurance requirement and strengthened the plan of care requirement.
These requirements would focus provider and surveyor efforts on the
actual care delivered to the patient, the performance of the hospice as
an organization, and the impact of the medical, physical, social,
emotional, and spiritual care delivered to the patient.
We are proposing to retain some of the current process-oriented
requirements when they are likely to produce desirable outcomes and/or
prevent harmful outcomes. These proposed CoPs invest in hospices the
responsibility for improving patient care performance, rather than
relying on an externally based approach where prescriptive requirements
are enforced through the punitive aspects of the survey process.
This change signals an opportunity for CMS, hospices, and States to
join in a partnership for improvement. When implemented, hospice
programming will reflect a patient-centered, outcome-oriented approach
that will likely alter the manner in which CMS and States manage the
survey process. We believe that this approach will provide
opportunities for improvement in patient care that have been lacking in
the past. The addition of a strong quality assessment and performance
improvement requirement will stimulate the hospice to continuously
monitor its performance and find opportunities for improvement.
D. Development of Outcome-Based Performance Measures for Hospices
[If you choose to comment on issues in this section, please include the
caption ``OUTCOME-BASED PERFORMANCE MEASURES'' at the beginning of your
comments.]
We are proposing to require that hospices implement an outcome-
based internal performance improvement program that can be used to
measure individual patient outcomes. The information a hospice gleans
from its own data analysis will serve as a baseline for hospice quality
improvement. Measures quantify quality and are tools for the hospice to
use in assessing and improving patient care, outcomes, and
satisfaction. An outcome based performance program can help hospices
improve the effectiveness and efficiency of their services, improve the
outcomes of care they provide, and increase patient satisfaction with
their services.
Hospice outcome measures, data elements, tools, and instructions
for using them have already been developed by the industry. A Task
Force initiative was sponsored and convened by the National Hospice
Work Group (NHWG) and the National Hospice and Palliative Care
Organization (NHPCO) in 1999. We participated in the development of the
measures and provided technical assistance for pilot testing of the
measures. The Task Force was invited to present the results of the
measurement development work and results of the pilot studies to us in
November 2000.
The work of the Task Force resulted in four measures for the
outcome domains of self-determination, comfort, safety, and effective
grieving. The hospice industry rapidly moved to include these four
measures in the data set that they encourage member hospices to use and
report. The data elements and instructions for using the measures are
publicly available on the NHPCO Web site at https://www.nhpco.org.
These outcome-based measures are part of a national reporting
process created by the hospice industry. If a hospice chooses to
participate in the NHCPO process, it submits its data to the NHPCO (or
its contractor). Reports are then generated for a hospice to compare
its performance with other hospices. The hospice may also choose to
send additional information for the NHPCO reporting process in the
areas of pertinent utilization data, appropriateness and effectiveness
of services, and patient/family satisfaction. All hospices that
participate in the NHPCO reporting process must comply with regulations
mandated by the Health Insurance Portability and Accountability Act of
1996 (Pub.L. 104-191, ``HIPAA''). Regulations implementing HIPAA were
published on December 28, 2000 (65 FR 82462) and were amended on August
14, 2002 (67 FR 53182).
We are not proposing to require that hospices participate in the
NHPCO process described above, but hospices may choose to use some of
the measures the NHPCO is already using as part of its comprehensive
assessment of the patient, and as part of the organization's quality
assessment and performance improvement program. Hospices may also
develop their own data elements and measurement processes.
Participating in the NHPCO outcome measurement and reporting process
would assist hospices in meeting the requirements of proposed Sec.
418.54(e). At this time, we are neither proposing that hospices use any
particular measures of outcomes, nor that they report data to us.
However, we may consider doing so in the future.
We invite comments from the public on this aspect of the proposed
rule.
[[Page 30843]]
III. Provisions of the Proposed Regulations
A. Overview
Under our proposal, the hospice conditions of participation would
continue to be set forth in regulations under 42 CFR part 418. However,
since many of the existing requirements in part 418 would be revised,
consolidated with other requirements, or eliminated, we are proposing
changes to the existing organizational scheme. A significant change
would be to group all CoPs directly related to patient care and place
them together in a separate subpart. CoPs concerning hospice
organization and administration would be contained in another subpart.
We believe that this proposed organization better reflects a patient/
family-centered orientation and helps illustrate that patient
assessment, care planning, and quality assessment and improvement
efforts are central to the delivery of high quality care.
B. Subpart A, General Provisions
The revised conditions would begin with existing Sec. 418.2 that
specifies the statutory authority and scope of the part for the ensuing
regulations. Section 418.1 would remain unchanged.
1. Scope of the Part (Proposed Sec. 418.2)
Section 418.2 would be revised to reflect the reorganization of the
part and to include an introductory statement describing the purpose of
the part.
2. Definitions (Proposed Sec. 418.3)
Existing Sec. 418.3 sets forth definitions for terms used in the
hospice CoPs. This section is being revised in order to provide further
clarification. We are proposing to move existing definitions of
``physician'' and ``social worker'' to proposed Sec. 418.114,
personnel requirements. We believe these definitions better fit in this
new condition. We propose to include the following definitions:
Attending physician (revised)
Bereavement counseling (revised)
Cap Period (same)
Clinical note (new)
Drug restraint (new)
Employee (revised)
Hospice (revised)
Hospice care (new)
Licensed professional (new)
Palliative care (new)
Physical restraint (new)
Progress note (new)
Representative (revised)
Restraint (new)
Satellite location (new)
Seclusion (new)
Terminally ill (revised)
These definitions would be revised to read as follows:
Attending physician means a--
(a)(1) Doctor of medicine or osteopathy legally authorized to
practice medicine and surgery by the State in which he or she performs
that function or action; or (2) Nurse practitioner who meets the
training, education and experience requirements as the Secretary may
prescribe; and
(b) Is identified by the individual, at the time he or she elects
to receive hospice care, as having the most significant role in the
determination and delivery of the individual's medical care.
Here after, except as indicated, the term ``attending physician''
includes nurse practitioners.
We modified this definition to address changes made to the Act by
Congress in section 408 of the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (Pub. L. 108-173) (``MMA''). Nurse
practitioners are often the primary medical health care professionals
for some patients, particularly those residing in rural areas. For
example, a nurse practitioner that works in conjunction with a doctor
may be the health care professional a patient sees most often. The
patient would develop a relationship with the nurse practitioner, and
would like the nurse practitioner to continue to be involved in his or
her care once he or she elects the hospice benefit. Under the current
regulations, this is not allowed. Under the proposed regulations, we
would permit a nurse practitioner to continue serving his or her
patient as that patient's attending physician once that patient elects
to receive hospice care. We believe that this would ensure the
continuity of care and improve the quality of care because the health
care professional most familiar with the patient, his or her
conditions, and his or her personal situation would be involved in
developing the plan of care and in making other important decisions.
Within the provisions of section 408 of the MMA nurse practitioners
are prohibited from certifying or recertifying a patient's terminal
illness. CMS will publish additional information regarding section 408
in a forthcoming Federal Register document.
Bereavement counseling means emotional, psychosocial, and spiritual
support and services provided after the death of the patient to assist
with issues related to grief, loss, and adjusting.
Cap period means the 12-month period ending October 31 used in the
application of the cap on overall hospice reimbursement as specified in
Sec. 418.309.
Clinical note means a notation of a contact with the patient that
is written and dated by any person providing services, and that
describes signs and symptoms, treatments and medications administered,
including the patient's reaction and/or response, and any changes in
physical or emotional condition.
Drug restraint means a medication used to control behavior or to
restrict the patient's freedom of movement which is not a standard
treatment for a patient's medical or psychiatric condition.
Employee means a person who works for the hospice and for whom the
hospice is required to issue a W-2 form on his or her behalf, or if the
hospice is a subdivision of an agency or organization, an employee of
the agency or organization who is appropriately trained and assigned to
the hospice or is a volunteer under the jurisdiction of the hospice.
Hospice means a public agency or private organization or
subdivision of either of these that is primarily engaged in providing
hospice care as defined in this section.
Hospice care means a comprehensive set of services described in
1861(dd)(1) of the Act, identified and coordinated by an
interdisciplinary team to provide for the physical, psychosocial,
spiritual, and emotional needs of a terminally ill patient and/or
family members, as delineated in a specific patient plan of care.
Licensed professional means a licensed person sanctioned by the
State in which services are delivered, furnishing services such as
skilled nursing care, physical therapy, speech-language pathology,
occupational therapy, and medical social services.
Palliative care means patient and family-centered care that
optimizes quality of life by anticipating, preventing, and treating
suffering. Palliative care throughout the continuum of illness involves
addressing physical, intellectual, emotional, social, and spiritual
needs and to facilitate patient autonomy, access to information, and
choice.
Physical restraint means any manual method or physical or
mechanical device, material, or equipment attached to the patient's
body that he or she cannot easily remove that restricts freedom of
movement or normal access to one's body.
Progress note means a written notation, dated and signed by any
person providing services, that summarizes facts about the care
furnished and the patient's response during a given period of time.
[[Page 30844]]
Representative means an individual who has the authority under
State law (whether by statute or pursuant to an appointment by the
courts of the State) to authorize or terminate medical care or to elect
or revoke the election of hospice care on behalf of a terminally ill
patient who is mentally or physically incapacitated. This may include a
legal guardian.
Restraint means either a physical restraint or a drug used as a
restraint.
Satellite location means a Medicare-approved location from which
the hospice provides hospice care and services within a portion of the
total geographic area served by the hospice provider issued the
provider agreement number. The satellite location is part of the
hospice and shares administration, supervision, and services in a
manner that renders it unnecessary for the satellite location to
independently meet the conditions of participation as a hospice.
We are proposing to add this definition to recognize long-standing
Medicare survey and certification policies, which allow for the
operation of multiple locations by a single hospice provider. We are
proposing that a hospice satellite location be approved by CMS before
it begins to furnish service to patients. In the past, some hospices
were found to be furnishing services from locations that had not been
shown to be in compliance with applicable regulations. We envision the
approval process to be consistent with determining that patients
receive safe services from the satellite location in question. As is
done for other appropriate providers and suppliers, we are accepting
comment on applying the Medicare Appeals Procedures that affect
participation in the Medicare program (42 CFR 498.3). If a hospice,
including any or all satellite locations, is accredited by an
accrediting organization such as JCAHO or CHAP, the hospice and each
satellite location must still receive Medicare approval.
Seclusion means the confinement of a person in a room or an area
where a person is isolated and physically prevented from leaving.
Terminally ill means that a patient has a medical prognosis that
his or her life expectancy is six months or less if the illness runs
its normal course.
C. Subpart B, Eligibility, Election and Duration of Benefits
Subpart B concerns eligibility, election, and duration of hospice
benefits. We are not proposing changes to this subpart at this time.
D. Subpart C, Conditions of Participation--Patient Care
1. Patient's Rights, Condition of Participation (Proposed Sec. 418.52)
[If you choose to comment on issues in this section, please include the
caption ``PATIENTS RIGHTS'' at the beginning of your comments.]
This section would replace the current condition of participation,
Informed consent, laid out at Sec. 418.62. This condition would set
forth certain rights to which hospice patients would be entitled, and
would require that hospices inform each patient of these rights and
that hospice personnel ensure and support these rights. Among these
rights would be the following, laid out at proposed Sec. 418.52: Being
informed in advance regarding the care to be provided; having an
opportunity to participate in care planning; voicing grievances; being
assured of confidentiality of records; having personal property
respected; being informed whether services are covered or not covered,
and having information provided in writing. We are proposing to specify
that the patient must also be informed about factors that affect
palliation and comfort. We believe that these revisions would act as an
additional safeguard of patient health and safety. Open communication
between hospice staff and the patient, and patient access to palliative
information is vital to enhancing the patient's participation in his or
her coordinated care planning. All hospices must also comply with the
Privacy Rule published in the Federal Register on December 28, 2000 (65
FR 82461) as amended on August 14, 2002 (67 FR 53182) and contained in
45 CFR parts 160 and 164.
We are specifically soliciting public comment on this proposed
condition of participation.
2. The Cycle of Care: Assessment, Planning, and Delivery (Proposed
Sec. 418.54 Through Sec. 418.62)
The patient care assessment, planning, and palliative care process
represented by the next four CoPs (Sec. 418.54 through Sec. 418.62)
can be seen as a cycle. Through the use of a comprehensive assessment,
accurate and timely patient information is made available for use in
the patient care process. The palliative care process consists of all
hospice care and services furnished to the patient and family. The
patient palliative care process results in an effect on the patient's
condition, whether it is positive or negative. The assessment of the
effectiveness of palliative care then results in subsequent care
decisions, and the cycle begins anew. Through this cycle, accurate
patient and family information obtained from each comprehensive
assessment should yield effective and appropriate palliative care
decisions, thus generating a positive effect on patient care and
desired outcomes.
Condition of Participation: Comprehensive Assessment of the Patient
(Proposed Sec. 418.54)
The proposed comprehensive assessment requirement reflects our view
that a patient-centered, interdisciplinary, and systematic patient
assessment is essential to improving patient quality of care and
patient outcomes.
In hospice care, the comprehensive assessment of the patient
contributes to quality of care improvements in closely linked stages.
First, the information generated from an interdisciplinary
comprehensive assessment is a vital tool for developing a hospice
patient's plan of care that will guide decisions on how best to
determine the individual care and support needs of the patient. Second,
based on updates of the comprehensive assessment, a hospice is able to
track the patient's progress towards achieving the desired care
outcomes, and where this does not occur, make appropriate changes to
the patient's plan of care. Finally, the hospice is able to evaluate
the results of its care decisions, thus yielding information to help
form the hospice's future care planning process. We believe this
approach reflects contemporary standard practice for many hospices, and
we are proposing to revise the CoPs to support this outcome-oriented
approach.
The centerpiece of this outcome-oriented approach is that each
patient receives a patient-specific comprehensive assessment that
identifies the patient's need for medical, nursing, psychosocial,
emotional and spiritual care. The care needs identified in the
assessment would include, but not be limited to, those necessary for
palliation and management of the terminal illness and related medical
conditions. The comprehensive assessment would be completed by the
interdisciplinary group in consultation with the individual's attending
physician to ensure that each member of the interdisciplinary group
provided input within the scope of that individual's practice. We
believe that the patient-specific comprehensive assessment requirement
we are proposing is already recognized and practiced by the hospice
industry in general.
[[Page 30845]]
The existing CoPs contain few requirements that address the need
for patient assessment; therefore, we are emphasizing the importance of
the comprehensive assessment by establishing it as a separate CoP. In
hospice surveys nationwide, we have identified a pattern of healthcare
related deficiencies that indicate that the current assessment
requirements are not sufficient. The fourth most frequently cited
deficiency is that the plan of care did not include an assessment of
the patient's needs. The frequency with which this area is cited
indicates that there are a significant number of hospices that are not
doing enough to properly assess their patients.
The expanded assessment condition would guide these deficient
hospices in thoroughly assessing their patients by identifying the
general areas that should be included in each assessment and by
identifying time frames for the completion of assessments. We believe
that this proposed CoP would enable hospices to specifically identify
patient care needs. Once a hospice has completed a timely and thorough
assessment of the patient, it can develop an accurate plan of care that
reflects the needs identified during the assessment. The accuracy and
timeliness of the plan of care may lead to an improvement in the
quality of the hospice experience for the patient and his or her
family.
In addition, we believe that the broad assessment outline we are
proposing will encourage hospices to exercise flexibility in
determining how best to achieve positive outcomes. We believe that this
approach is consistent with currently accepted practices in hospices.
In Sec. 418.54(a), Initial assessment, we are proposing that a
registered nurse make the initial assessment visit to determine the
patient's immediate care and support needs within 24 hours after the
hospice receives a physician's admission order for care (unless another
date is specified by the physician). We realize that some hospices meet
with patients and their families, at their request, before the actual
admission for care orders are received, and this regulation would not
prevent this practice. However, meeting with a patient and his or her
family before the patient's physician orders hospice care would not
satisfy the initial assessment requirement.
In Sec. 418.54(b), Time frame for completion of the comprehensive
assessment, we are proposing that the hospice interdisciplinary group,
in consultation with the hospice medical director or physician designee
and/or the individual's attending physician, complete the comprehensive
assessment in a timely manner consistent with the patient's immediate
needs, but no later than 4 calendar days after the patient elects the
hospice benefit. We believe that most hospices already complete the
assessment within this time frame and, due to the decreased length of
stay, as explained in the discussion of Sec. 418.54(d), Update of the
comprehensive assessment, and the potential severity of the patient's
condition, we believe it is essential to ensure that patients are
assessed in a timely manner.
Section Sec. 418.54(c), Content of the comprehensive assessment,
would describe the requirements for the content of the comprehensive
assessment that we believe are critical to quality hospice care. These
content requirements are at the core of hospice care and are needed to
evaluate the patient's need for physical, social, emotional, medical,
and spiritual care.
Under proposed Sec. 418.54(c)(3)(ii), Drug therapy, the patient's
comprehensive assessment would have to` include a review of the
patient's current medication. The review and accompanying documentation
would include identification of the following items:
Ineffective drug therapy;
Unwanted side and toxic effects; and
Drug interactions.
This review must be repeated as necessary to ensure that the
patient continues to receive drug therapy that is effective and
appropriate for his or her needs. A review of a patient's drugs would
be included in the initial assessment and in the development of the
plan of care. This review could occur at any time, but specifically
when a patient is prescribed or begins to take any new drug and/or when
use of a drug is discontinued.
In Sec. 418.54(d), Update of the comprehensive assessment, we are
proposing that the comprehensive assessment be updated by the
interdisciplinary group as frequently as the patient's condition
requires, but no less frequently than every 14 days. We believe that
these frequent reviews are necessary and predictive of quality outcomes
for two reasons:
(1) In the terminal stages of care, patient status needs,
circumstances, and family expectations can change greatly, affecting
the type and frequency of services that should be furnished.
Reassessments assist the hospice in developing a more responsive care
plan. The interdisciplinary group would use assessment information to
guide necessary reviews and/or changes to the patient's plan of care.
(2) We are proposing that a hospice medical director or physician
designee be required to recertify a patient for hospice care at
specific intervals as stated in Sec. 418.21. We believe
recertification, which occurs at the end of the initial and subsequent
90-day benefit periods (and at the end of the remaining benefit periods
as described in Sec. 418.21), serves as a logical point for updating
an assessment in addition to the minimum 14 days and when the patient's
condition changes.
We believe that to ensure quality and timely care for our hospice
beneficiaries, timely completion of the initial assessment requirement
and the comprehensive assessment update requirement is necessary. In
2001 the average length of enrollment in hospice care was 51 days (2002
Nov. Medicare National Summary for HHA, Hospice, SNF, and outpatient CY
1999-2001, https://www.cms.hhs.gov/statistics/feeforservice/National
Summary.pdf). According to research by the NHPCO, in 2000 the average
length of enrollment in hospice care was 48 days (2000 NHPCO National
Data Set Summary Report, 2001 Nov.). There has been some concern
regarding short lengths of stay. Hospices have been admitting patients
late in their terminal illness and those patients need extensive
hospice services and resources initially, and right before death. In
order to ensure that patients receive the necessary services and thus
begin to benefit from hospice care at the earliest time possible, we
believe that it is important that the comprehensive patient assessment
be completed within the time frame that we have proposed. A delay in
completing the initial comprehensive assessment and the updated
assessments is ultimately not as beneficial to the patient and family
as if the patient had entered hospice care and received timely
assessments to determine the proper care to be provided.
These requirements, though process-oriented in part, are predictive
of good patient care and safety. Our rationale for requiring the
completion of the initial comprehensive assessment is that a new
patient being referred to a hospice for initiation of services is at a
point of immediate need and often in crisis. Likewise, maintaining an
ineffective plan of care could jeopardize patient health and safety.
Regular assessment updates would minimize this possibility.
We believe that the comprehensive assessment requirements pose
little or no burden for hospices because it is a current standard of
practice to
[[Page 30846]]
comprehensively assess hospice patients. However, we recognize that the
proposed 4-day timeframe for completing the initial comprehensive
assessment as proposed in Sec. 418.54(b) and 14-day timeframe for
updating the comprehensive assessment as proposed in Sec. 418.54(d)
may set higher performance expectations for some hospices then the
self-imposed standards they currently utilize. We believe that if a
hospice recognizes that it is not capable of furnishing services within
these timeframes, new patients should not be accepted for care.
We welcome public comments on the review of our proposed timeframes
for the initial comprehensive assessment and updated comprehensive
assessment. We believe the timeframes are reasonable and consistent
with current hospice practice.
[If you choose to comment on issues in this section, please include the
caption ``ASSESSMENT TIME FRAMES'' at the beginning of your comments.]
Under the proposed Sec. 418.54(e), Patient outcome measures, we
are proposing that a patient's comprehensive assessment include
measurement and documentation of aspects of care that are essential
outcomes of optimal hospice care. Documentation is carried out in the
same way for all patients through what we refer to as data elements.
The hospice may develop its own data elements or use existing,
externally developed data elements. However, some of the data elements
should be related to the domains of self-determination, comfort,
safety, and effective grieving related to bereavement services. If a
hospice chooses to collect information for the data elements developed
by the NHPCO, it may also choose to submit this information to the
NHCPO. However, submission must be in accordance with the HIPAA privacy
rule (45 CFR Parts 160 and 164). The hospice may also choose to send
additional information for the NHPCO reporting process in the areas of
pertinent utilization data, appropriateness and effectiveness of
services, and patient/family satisfaction.
The data elements used by the hospice must be an integral part of
both the initial comprehensive and updated assessments. The application
of these data elements to the identified domains must be documented in
a systematic and retrievable way for each patient, as the outcome
measurements will be used in patient care planning and coordinating
services. Measurements will also be used (in the aggregate) for the
hospice quality assessment and performance improvement program.
We want to emphasize that we are not proposing that hospices use
any specific data elements to measure domain outcomes. We are simply
proposing that hospices collect the data necessary to evaluate the
quality of care they are providing and use this information in a
systematic and retrievable way. Hospices may develop their own data
elements related to the aspects of care related to hospice and
palliation, such as self-determination, comfort, safety, and effective
grieving, or may use the data elements related to the seven outcome
measures in the NHPCO data set (https://www.nhpco.org).
Currently, there is insufficient evidence for a valid and reliable
common set of measures (that is, data elements) for use in hospice
care. We are aware that the industry is studying this area. We also
know that there are many measures that are currently used to help gauge
the processes of care for hospice patients and to make adjustments to
care on their basis. For example, there are multiple scales for use in
pain management, anxiety, and depression, and there are several
quality-of-life scales appearing in the relevant literature (https://
www.nhpco.org and https://www.chcr.brown.edu/pcoc/toolkit.htm). Some
measurable outcomes can be captured in single items while others
require multiple items to capture the full range of measurement issues.
We welcome comments on our ``outcome measures'' approach to this
proposed regulation. We are particularly interested in comments as to
whether this approach is necessary in assessment, care planning,
service delivery, and most importantly, to the hospice's quality
assessment and performance improvement program.
[If you choose to comment on issues in this section, please include the
caption ``OUTCOME MEASURES'' at the beginning of your comments.]
Condition of Participation: Interdisciplinary Group Care Planning and
Coordination of Services (Proposed Sec. 418.56)
[If you choose to comment on issues in this section, please include the
caption ``PLAN OF CARE'' or ``COORDINATION OF SERVICES'' where
appropriate, at the beginning of your comments.]
The existing condition of participation concerning the plan of care
is set forth at Sec. 418.58. We are proposing to revise the contents
of this section and place them in a new condition, ``Interdisciplinary
group care planning and coordination of services'' (proposed Sec.
418.56). The proposed condition would contain five standards that
reflect the interdisciplinary approach to hospice care delivery.
As proposed, each patient and family would have a written plan of
care developed by the hospice interdisciplinary group in consultation
with the patient's attending physician that specifies the hospice care
and services necessary to meet the patient/family-specific needs
identified in the comprehensive and updated assessments. All hospice
services furnished to patients and their families must follow this
written plan of care.
Under proposed Sec. 418.56(a), Approach to service delivery, we
are proposing that the hospice designate an interdisciplinary group or
groups composed of individuals who work together to meet the physical,
medical, social, emotional, and spiritual needs of the hospice patients
and families facing terminal illness and bereavement. We believe that
the role of the interdisciplinary group is paramount in directing and
monitoring the patient care and is one of the factors that makes the
hospice benefit unique. The hospice would designate a qualified health
care professional who is a member of the interdisciplinary group to
provide program coordination, ensure the continuous assessment of each
patient's and family's needs, and ensure the implementation and
revision of the plan of care.
The proposed standard at Sec. 418.56(b), Plan of care, is the same
as the existing standard at Sec. 418.58(a), with one addition. We are
including a reference to the patient's family when establishing the
plan of care. We would require that all hospice services furnished to
patients and their families follow a written plan of care established
by the hospice interdisciplinary group in collaboration with the
attending physician. Family plays an important role in the care of a
hospice patient, and this change reflects that role.
Under the proposed standard at Sec. 418.56(c), Content of the plan
of care, we would require that each patient's plan of care reflect
interventions for problems identified in the comprehensive and updated
assessments. This requirement ensures that care and services are
appropriate to the level of each patient's and family's specific needs.
The plan of care must include the following:
Interventions to facilitate the management of pain and
symptoms;
A detailed statement of the scope and frequency of
services required to meet the patient's and family's specific needs;
[[Page 30847]]
Measurable outcomes anticipated from implementing and
coordinating the plan of care;
Drugs and treatment necessary to meet the needs of the
patient;
Medical supplies and appliances required to meet the needs
of the patient; and
The interdisciplinary group's documentation in the
clinical record indicating the patient's and family's understanding,
involvement, and agreement with the plan.
As we noted in the description of the previous standard, we are
proposing to add a requirement that the plan address the patient's and
family's expectations, understanding, agreement, and ability to
participate in the care as the patient and family desire. Since family
members need to understand the importance of their role in care of the
hospice patient, their input and agreement regarding care is essential
in developing a productive relationship with the hospice. We would
expect a hospice to document the patient's and family's understanding
of and agreement to the plan of care in accordance with its own
policies. This could include an attestation signed by the patient and
family, a note in the clinical record, and/or another form of
documentation decided upon by the hospice governing body.
Proposed standard Sec. 418.56(d), Review of the plan of care,
would require that a revised plan of care include current information
from the patient's updated comprehensive assessment and information
concerning the patient's progress toward achieving outcomes specified
in the plan of care. The plan of care must be reviewed at intervals
specified in the plan but no less frequently than every 14 calendar
days. We believe that it is essential to include the requirement that
actual care provided also be changed as needed, thus establishing the
essential linkage between assessment information, evaluation of
treatment results, and plan of care modification.
We also propose to require that the hospice take steps to involve
the patient's attending physician in the review of the patient's plan
of care. The attending physician often has had a lengthy relationship
with the patient; and his or her input into the review of the plan of
care can be invaluable. We do not have the authority in the Conditions
of Participation governing hospices to require that an attending
physician, an individual who is not an employee of the hospice and thus
not governed by these hospice regulations, participate in this process.
However, we can and are proposing that the hospice collaborate with the
patient's attending physician to the extent possible when reviewing the
plan of care. We believe that requiring hospices to involve interested
attending physicians will benefit patients by helping to ensure that
the care described in the plan of care reflects the needs and desires
of patients and their families.
We are proposing to add a new standard, Coordination of services,
at Sec. 418.56(e). This standard would require that the hospice
maintain a system of communication and integration to enable the
interdisciplinary group to ensure the overall provision of care and the
efficient implementation of the day-to-day policies. These new
standards would also make it easier for the hospice to ensure that the
care and services are provided in accordance with the plan of care, and
that all care and services provided are based on the comprehensive and
updated assessments of the patient's and family's needs. An effective
communication system would also enable the hospice to ensure ongoing
liaison of all disciplines providing care and services in the home,
outpatient, and inpatient settings, notwithstanding the manner in which
the care and services are furnished.
We believe that this standard is appropriate for two reasons.
First, a hospice patient typically encounters many services delivered
at different times by a variety of individuals with different skills.
An efficient method of communication and integration of observations
among members of the interdisciplinary group and others providing care
is essential to meet and respond to the patient's and family's needs in
a timely manner. Second, effective communication and coordination of
services will assist a hospice in avoiding a duplication of effort or a
furnishing of conflicting services.
We recognize the value of an interdisciplinary approach to the
delivery of hospice services. This approach to care reflects actual
industry practice, and as a result, we believe the proposed requirement
is in step with the hospice industry.
We are specifically soliciting public comment on the proposed
requirements for the content of the plan of care, the time frames for
review of the plan of care, and the new coordination of services
standard.
Condition of Participation: Quality Assessment and Performance
Improvement (Proposed Sec. 418.58)
[If you choose to comments on issues in this section, please include
the caption ``QAPI'' at the beginning of your comments.]
The existing Sec. 418.66, Condition of participation--Quality
assurance, relies on a problem-oriented approach to identify and
resolve patient care issues. Failure to meet the quality assurance
condition is consistently one of the top 10 deficiencies cited by
surveyors nationwide. According to the hospice industry associations,
hospices are no longer using the quality assurance model. During the
last decade the health care industry, including the hospice industry,
has moved beyond the problem-oriented, after-the-fact corrective
approach of quality assurance to an approach that focuses on a pre-
emptive plan that continuously addresses quality assessment and
performance improvement (QAPI). Hospice industry associations have
indicated that their upgraded QAPI systems are incompatible with the
existing quality assurance condition. Therefore, the providers who have
moved beyond quality assurance in order to make meaningful and
sustained quality improvements in their own programs are actually in
violation of the outdated quality assurance condition.
On the other end of the spectrum are providers who are truly
deficient because they do not have any quality program. These providers
would find more guidance in the proposed regulation. In the following
section of this preamble we will discuss two publicly available
resources for data measures, an integral part of the proposed QAPI
requirement. In the proposed regulation we have outlined when those
should be collected and what role they play in the proposed QAPI
condition. In addition, we have described the scope of the proposed
QAPI program requirement, the guidelines for identifying performance
improvement activities, and the individuals responsible for ensuring
that a hospice has a QAPI program. The proposed regulations provide
hospices that are unsure of what is expected of them with the
guidelines to begin tailoring a QAPI program that meets their needs and
circumstances.
Therefore, we believe that this proposed condition will reduce the
number of deficient providers by recognizing those who are practicing
QAPI and guiding reluctant providers to meet current standards of
practice. The proposed QAPI requirement would raise the performance
expectations for hospices seeking entrance into the Medicare program,
as well the expectations of those currently participating in Medicare.
We are proposing that each hospice develop,
[[Page 30848]]
implement, and maintain an effective, continuous quality assessment and
performance improvement program that stimulates the hospice to
constantly monitor and improve its own performance, and to be
responsive to the needs, desires, and satisfaction levels of the
patients and families it serves.
The desired overall outcome of this proposed CoP is that the
hospice will drive its own quality improvement activities and improve
its provision of services. With an effective quality assessment and
performance improvement program in place and operating properly, the
hospice can better identify and reinforce the activities it is doing
well, identify its activities that are leading to poor patient
outcomes, and take actions to improve performance.
This proposed condition requires the hospice to develop, implement,
and maintain an effective data driven quality assessment and
performance improvement program (QAPI). The program establishes a
planned approach to quality improvement and takes into account the
complexity of the hospice's organization and services, including those
provided directly or under arrangement. The hospice must take whatever
actions are necessary to implement improvements in its performance as
identified by its quality assessment and performance improvement
program. The hospice is also responsible for ensuring that the
professional services it offers are carried out within current clinical
practice guidelines as well as professional practice standards
applicable to hospice care.
In the first proposed standard under this condition at Sec.
418.58(a), Standard: Program scope, we are proposing that the hospice's
quality assessment and performance improvement program must include,
but not be limited to, an ongoing program that is able to show
measurable improvement in indicators that are linked to improving
palliative outcomes and end-of-life support services. We expect that a
hospice will use standards of care and the findings made available in
current literature to select indicators to monitor its program. The
hospice must measure, analyze, and track these quality indicators,
including areas such as adverse patient events and other aspects of
performance that assess processes of care, hospice services, and
operations. Adverse patient events, as used in the field, are
occurrences that are harmful or contrary to the targeted patient
outcomes.
The second proposed standard under Sec. 418.58(b) Program data,
would require the hospice program to incorporate quality indicator
data, including patient care data and other relevant data, into its
QAPI program. This would include data that are received from or
submitted to hospice professional organizations. A fundamental barrier
in identifying quality care at the end of life is the lack of
measurement tools. Measurement tools can identify opportunities for
improving medical care and examining the impact of interventions.
CMS does not currently require the submission of data from hospices
to calculate quality measures but is interested in the development of a
set of measures. Hospice measures were submitted and discussed as part
of the recent National Quality Forum process identifying home health
measures but were withdrawn and added to the more focused end of life
discussions. CMS would be interested in comments regarding clinical
measures, patient experience of care measures, and systems measures
(use of information technology, staffing, follow up mechanisms)
specific to hospice care. These comments should include existing
measures in use, measures to be developed, data collection methods and
issues, and how measures are currently being used. We are especially
interested in the feasibility, usability, if the measures presented are
proprietary or publicly available, and burden of collecting and
reporting the measures.
An example of available measurement tools would be the hospice
outcome measures, data elements, tools, and instructions developed by a
hospice industry task force in which the CMS participated as a
stakeholder. A Task Force initiative was sponsored and convened by the
National Hospice Work Group (NHWG) and the National Hospice and
Palliative Care Organization (NHPCO) in 1999. We participated in
developing the measures and provided technical assistance for pilot
testing the measures. In addition to the work that has already been
done in this area, we are committed to working with all relevant
interest groups and associations as they develop and provide hospices
with model quality assessment and performance improvement programs and
other services.
The work of the Task Force resulted in measures addressing the
outcome domains of self-determined life closure, comfortable dying,
safe dying, and effective grieving. The hospice industry moved to
include these measures in the data set that they encourage member
hospices to use and report. The data elements, tools, and instructions
for using the measures are publicly available on the NHPCO website