[Federal Register: May 27, 2005 (Volume 70, Number 102)]
[Proposed Rules]
[Page 30839-30893]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my05-30]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 418
Medicare and Medicaid Programs: Hospice Conditions of Participation;
Proposed Rule
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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.
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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 http://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
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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 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 http://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.
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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 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.
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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 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, http://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 (http://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 (http://www.nhpco.org and http://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
http://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 http://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 http://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
[[Page 30849]]
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 Sec.
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 Sec. 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 Sec. 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 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 Sec. 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 Sec. 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 Sec. 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 Sec. 418.100(a) that ``* * * each patient is to be
kept comfortable, clean, well groomed, and protected from accident,
injury, and infection.'' We are 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''
(http://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 Sec. 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
[[Page 30850]]
training is one way to assure staff understanding.
In Sec. 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 Sec. 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
Sec. 418.62)
Sections of current regulations at Sec. 418.82, Nursing services;
Sec. 418.84, Medical social services; and Sec. 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 Sec. 418.82, Sec. 418.84, and Sec.
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.
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, speech-language 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 Sec. 418.64 and the non-core
services condition at Sec. 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 Sec. 418.64)
The conditions of participation containing the current core
services requirements are in Sec. 418.80, Furnishing of core services;
Sec. 418.82, Nursing services; Sec. 418.84, Medical social services;
Sec. 418.86, Physician services; and Sec. 418.88, Counseling
services. We are proposing to combine these into a single condition. We
are also proposing to incorporate the requirement at existing Sec.
418.50(b)(3) that core services 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 non-
routine 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 short-term 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 Sec. 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
[[Page 30851]]
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 Sec. 418.64(c), we are proposing to maintain the
current medical social services requirement found at Sec. 418.84. This
standard would continue to require that medical social services be
provided by a qualified social worker under the direction of a
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 Sec. 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.
Condition of Participation: Nursing Services Waiver of Requirement That
Substantially All Nursing Services Be Routinely Provided Directly by a
Hospice (Proposed Sec. 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
Sec. 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
Sec. 418.70)
The current CoP governing the provision of other services is
contained in Sec. 418.90. The hospice must ensure that the services
described in Sec. 418.72 through Sec. 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 Sec. 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 Sec. 418.72)
Currently, the CoP concerning physical therapy, occupational
therapy, and speech language pathology is laid out at Sec. 418.92. We
are proposing to recodify this CoP at Sec. 418.72 without changes.
[[Page 30852]]
Condition of Participation: Waiver of Requirement--Physical Therapy,
Occupational Therapy, Speech-Language Pathology, and Dietary Counseling
(Proposed Sec. 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 24-hour 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 Sec. 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 Sec. 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 Sec. 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 Sec. 418.94. We are
proposing in Sec. 418.76 that a home health aide completes a State-
established or other training program, and in Sec. 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 Sec. 484.36.
For example, we would continue to permit a home health aide to meet
the proposed Sec. 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, Sec. 418.76(j), homemaker
qualifications, has been adapted from the existing Sec. 418.94. The
proposed standard clarifies that a qualified homemaker is a home health
aide as described in Sec. 418.76 or an individual who has met the
standards in Sec. 418.202(g) and has successfully completed hospice
orientation addressing the needs and concerns of patients and families
coping 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, Sec. 418.76(h), Supervision of home health aides, would be
revised from the current Sec. 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. On-site
supervisory visits will still be required every 14 days as in the
current rule at Sec. 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, Sec. 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 Sec. 418.78)
The current CoP for volunteers is located at Sec. 418.70. We are
proposing to recodify this CoP at Sec. 418.78 with minor changes. We
are removing the existing Sec. 418.70(f), regarding the availability
of clergy, because the role of the pastoral, clergy, or other spiritual
counselor is described in proposed Sec. 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 Sec. 418.100)
[If you choose to comment on issues in this section, please include the
caption ``ORGANIZATION AND
[[Page 30853]]
ADMINISTRATION'' at the beginning of your comments.]
We are proposing to revise existing regulations at Sec. 418.50,
General provisions, Sec. 418.52, Governing body, and Sec. 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 well-
managed 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, Sec. 418.100), we have taken the current CoPs and
proposed changing them to standards:
Governing body and administrator (existing Sec. 418.52).
Continuation of care (existing Sec. 418.60).
Professional management responsibility (existing Sec.
418.56).
In-service training (existing Sec. 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 in-service 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, Sec. 418.50(b)(3), Required services; Sec. 418.52,
Governing body; Sec. 418.82(c), Acceptable standards of practice;
Sec. 418.92(a), PT, OT and SLP; and Sec. 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 Sec. 418.58.
We have long used the term ``in accordance with accepted standards
of practice,'' in various provider and supplier requirements, (such as
in the existing Sec. 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 Sec. 418.82(c) into Sec. 418.64,
Core services and Sec. 418.70, Furnishing of non-core services.
In the proposed governing body and administrator standard at Sec.
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 Sec. 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 Sec. 418.100(d), Continuation of care, the current standard is
at Sec. 418.60. We are proposing to recodify this section at Sec.
418.100(d) without change.
In Sec. 418.100(e), Professional management responsibility, we are
proposing to revise some of the current requirements found at Sec.
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 Sec. 418.100(f)(1), we are proposing a new standard to address
the issue of 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
[[Page 30854]]
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 Sec. 418.52 through Sec.
418.116.
Proposed Sec. 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 Sec. 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 Sec. 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 Sec. 418.22, and require
that the medical director or physician designee review the patient's
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, Sec. 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 Sec. 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 Sec. 418.21.
Within Sec. 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 Sec. 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 Sec. 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.
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 Sec. 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
Sec. 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
Sec. 418.22(c) and
[[Page 30855]]
described in proposed Sec. 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 Sec. 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
Sec. 418.74(b) as Sec. 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 Sec. 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 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 Sec. 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 Sec. 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 Sec.
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 Sec. 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 Sec.
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.]
This condition of participation revises the current requirement,
found at Sec. 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 Sec.
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 Sec. 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 Sec. 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
[[Page 30856]]
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.
Condition of Participation: Short-Term Inpatient Care (Proposed Sec.
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 Sec. 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 Sec. 418.98(a),
Short-term inpatient care, as Sec. 418.108(a), Inpatient care for
symptom management and pain control.
The references to the condition at Sec. 418.108(b), Inpatient care
for respite purposes, would no longer focus on process as in the
existing Sec. 418.98. Rather, the updated standards reflect expected
outcomes of care.
We would eliminate the existing requirement found at Sec.
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 attendance on a
particular shift to serve the patient will have no effect on the
patient's care.
Under proposed Sec. 418.108(c), Inpatient care provided under
arrangement, we would incorporate many of the existing requirements in
existing Sec. 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 Sec. 418.108(d), Inpatient care limitation, and
Sec. 418.108(e), Exemption from limitation, we are proposing to re-
codify the existing requirements at Sec. 418.98(c) and (d),
respectively, without changes.
Condition of Participation: Hospices That Provide Inpatient Care
Directly (Proposed Sec. 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 Sec. 418.110, we are proposing to revise the
existing requirements, currently located at Sec. 418.100, as follows:
Under Sec. 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 Sec. 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
Sec. 418.110(b), 24-hour nursing services, that the hospice facility
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, 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 Sec. 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 Sec. 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 Sec.
418.110(c)(1)(iii) we have retained the existing requirement at Sec.
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 Sec. 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
[[Page 30857]]
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 Sec. 418.110(d), Fire protection, we are proposing to recodify,
without change, the existing provisions in Sec. 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 Sec. 418.110(e), Patient areas, would be recodified from
Sec. 418.100(e) without change.
Proposed Sec. 418.110(f), Patient rooms, would be revised. We are
proposing in Sec. 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 (Sec. 418.100(f), with only minor
language changes that would not change the substantive requirements of
the regulation.
Proposed Sec. 418.110(g), Toilet/bathing facilities, is linked
with patient rooms in the current requirement found at Sec.
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 Sec. 418.100(g) bathroom
facilities, except to recodify it at Sec. 418.110(h) and rename it,
Plumbing facilities.
In Sec. 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 Sec.
418.100(h), Linen, as Sec. 418.110(k) without substantive change.
In proposed Sec. 418.110(l), Meal service and menu planning, we
are proposing to revise the existing Sec. 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 evening
and breakfast meals, and having a staff member trained in food
management or nutrition.
In Sec. 418.110(m), Pharmaceutical services, we are proposing to
re-codify the existing requirement found at Sec. 418.100(k) without
substantive change.
In Sec. 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 Sec. 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
[[Page 30858]]
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 Sec.
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 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 Sec. 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 Sec. 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 Sec. 418.20 to
Sec. 418.30), as a patient who resides in his or her home in the
community.
At proposed Sec. 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 Sec. 418.100. This standard reinforces our belief that continuity
of care is crucial for hospice care in any setting.
In proposed Sec. 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 delegate any of its standard hospice core services to the
nursing or residential facility staff.
In proposed Sec. 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 Sec. 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
[[Page 30859]]
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 Sec. 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 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 Sec. 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 Sec. 418.112(h), Transfer, revocation, or discharge
from hospice care, we would specify that the proposed requirement for
discharge or revocation found at Sec. 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 Sec. 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 Sec. 418.114)
[If you choose to comment on issues in this section, please include the
caption ``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 Sec. 418.114. We discuss the personnel qualifications in
detail below.
(1) General qualifications (proposed Sec. 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 Sec. 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 Sec. 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
[[Page 30860]]
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 speech-language 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 Sec. 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
Sec. 418.114(c). This category would consist of all current personnel
qualifications specified in proposed Sec. 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 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 full-time 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 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,
http://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 Sec. 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.
[[Page 30861]]
Condition of Participation: Compliance With Federal State and Local
Laws and Regulations Related to Health and Safety of Patients (Proposed
Sec. 418.116)
The provisions concerning licensure requirements for hospices are
currently located at Sec. 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 Sec.
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 Sec. 418.116(b), Multiple locations, we would continue to
require that the hospice comply with the requirements of Sec. 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 Sec.
418.92(b), regarding laboratory services, at Sec. 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
----------------------------------------------------------------------------------------------------------------
Citation
Current conditions (Part 418, subpart C, existing Proposed condition Citation
D, E) section
----------------------------------------------------------------------------------------------------------------
Scope of Subpart
Definitions........................... 418.3 Definitions........... 418.3
General provisions.................... 418.50
(a) Compliance.................... ........... Organization and 418.100(c)(2)
Administration of
Services.
(b) Required services............. ........... Organization and 418.100(c)(2)
Administration of
Services.
(c)(1) 24 hour nursing, physician ........... Organization and 418.100(c)(1)
services, and drugs and biologics. Administration of
Services.
(2) Other 24 hour services.
(3) Utilize accepted standards of ........... Core Services and 418.64 and 418.72
practice. Furnishing of Non-
core Services.
(d) Disclosure of information..... ........... Deleted...............
Medical director: The medical director is: 418.54 Medical Director...... 418.102
A hospice employee, a doctor of medicine
or osteopathy, responsible for the
medical component of the hospice's
patient care program.
Professional management................... 418.56
(a) Continuity of care................ ........... Deleted.
(b) Written agreement:
(1) Identification of services to ........... Interdisciplinary 418.56(c)
be provided. Group Care Planning
and Coordination of
services.
(2) Express authorization of the ........... Organization and 418.100(e)(1)
hospice required for all services. Administration of
Services.
(3) Coordination, supervision, and ........... Organization and 418.100(e)
evaluation of contracted services. Administration of
Services.
(4) Roles of hospice and ........... Deleted
contractor in admission,
assessment, and interdisciplinary
group.
(5) Documentation of services ........... Organization and 418.100(e)
furnished by contractor. administration of
services.
(6) Personnel qualifications...... ........... Organization and 418.100(e)(2)
administration of
services.
(c) Professional management........... ........... Organization and 418.100(e)
administration of
services.
(d) Financial responsibility.
(e) Inpatient care:
(1) Copy of the patient plan of ........... Short term inpatient 418.108(c)(1)
care specifying the services to care.
be provided is given to inpatient
provider.
(2) Inpatient provider abides by ........... Short term inpatient 418.108(c)(2)
hospice patient care protocols care.
and maintains compatible policies.
(3) Medical record provided to ........... Short term inpatient 418.108(c)(3)
hospice upon request. Must care.
include all inpatient services
and events and a copy of the
discharge summary.
(4) Responsibility for ........... Short term inpatient 418.108(c)(4)
implementing agreement provisions. care.
[[Page 30862]]
(5) Hospice responsible for ........... Short term inpatient 418.108(c)(5)
training all care providers. care.
NEW Comprehensive 418.54
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
Plan of Care.............................. 418.58
A written plan of care must be established ........... Interdisciplinary 418.56
and maintained for each individual Group Care Planning
admitted to a hospice program and the and Coordination of
care provided to an individual must be in Services.
accordance with the plan.
(a) Plan established by attending ........... Interdisciplinary 418.56(b)
physician, medical director or Group Care planning
physician designee and and Coordination of
interdisciplinary group prior to Service.
providing care.
(b) Plan reviewed, updated, and ........... Interdisciplinary 418.56(d)
documented at specified intervals by Group Care Planning
attending physician, medical director and Coordination of
or physician designee and the Services.
interdisciplinary group.
(c) Plan includes assessment of needs ........... Interdisciplinary 418.56(c)
and identification of services. It Group Care Planning
state in the scope and frequency of and Coordination of
services needed. Services.
Continuation of care: No discontinuation 418.60 Organization and 418.100(d)
or diminishment of care due to the Administration of
Medicare beneficiary's inability to pay Services.
for that care.
Informed Consent: The Informed consent 418.62 Patient Rights........ 418.52(a)
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 418.64 Organization and 418.100(g)
an ongoing program for the training of Administration of
its employees. services.
Quality assurance: A hospice must conduct 418.66 Quality Assessment and 418.60
an ongoing, comprehensive, intetrated, performance
self-assessment of the quality and Improvement.
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 ........... Quality Assessment and 418.60(d)
and mechanisms for monitoring the performance
quality of patient care. Improvement.
(b) Identify and resolve problems..... ........... Deleted.
(c) Make suggesitons for improving ........... Quality Assessment 418.60(c)(3)
patient care. performance
Improvement.
Interdisciplinary group: The hospice must 418.68 IDG Group Care 418.56(a)
designate an interdisciplinary group(s) Planning and
composed of individuals who provide or Coordination of
supervise care and services offered by Services.
the hospice.
(a) The interdisciplinary group(s) ........... IDG Care Planning and 418.56(a)
must include certain specialists. Coordination of
Services
(b) The interdisciplinary group is
responsible for--
(1) Participation in the ........... IDG Care Planning and 418.56(b)
establishment of the plan of care. Coordination of
Services.
(2) Provision of supervision of ........... IDG Care Planning and 418.56(a)(1)(3)
hospice care and services. Coordination of
Services.
(3) Periodic review and updating ........... IDG Care Planning and 418.56(d)
of the plan of care for each Coordination of
individual receiving hospice Services.
care; and.
(4) Establishment of policies ........... IDG Care Planning and 418.56(a)(2)
governing the day-to-day Coordination of
provision of hospice care and Services.
services.
Only one interdisciplinary group ........... Deleted...............
chosen in advance may execute the
functions described in the paragraph
(b)(4) of this section.
(d) Designating a registered nurse to ........... IDG Care Planning and 418.56(a)(1)
coordinate the implementation of the Coordination of
plan of care for each patient. Services.
Volunteers: The hospice in accordance with 418.70 Volunteers............ 418.78
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 ........... Volunteers............ 418.78(a)
appropriate orientation and training.
(b) Volunteers must be used in direct ........... Volunteers............ 418.78(b)
patient care or administrative roles.
[[Page 30863]]
(c) The hospice must document active ........... Volunteers............ 418.78(c)
and ongoing efforts to recruit and
retain volunteers.
(d) The hospice must document the cost ........... Volunteers............ 418.78(d)
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 ........... Volunteers............ 418.78(e)
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 ........... Deleted.
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 418.72 Compliance with 418.116
employees must be licensed in accordance Federal, State &
with applicable Federal, State, and local local laws &
laws and regulations. regulations related
to health & safety of
patients.
(a) The hospice must be licensed if ........... Personnel 418.114 and
State or local law provides for Qualifications for 418.116(a)
licensure. Skilled
Professionals; and
Compliance with
Federal, State &
local laws &
regulations related
to health & safety of
patients.
(b) Employees who provide services ...............................
must be licensed, certified or
registered in accordance with
applicable Federal or State laws.
Central Clinical Records: Establishment 418.74 Clinical Records...... 418.104
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. ........... Clinical Records...... 418.104(a)
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 ........... Clinical Records...... 418.104(a)(1)
assessments.
(2) Plan of care.................. ........... Clinical Records...... 418.104(a)(1)
(3) Identification data........... ........... Deleted. ...............................
(4) Consent and authorization and ........... Clinical Records...... 418.104(a)(2)
election forms.
(5) Pertinent medical history..... ........... Deleted. ...............................
(6) Complete documentation of all ........... Clinical Records...... 418.104(a)(1)
services and events.
(b) Protection of information. The ........... Clinical Records...... 418.104(c)
hospice must safeguard the clinical
record against loss, destruction, and
unauthorized use.
Subpart D--Condition of Participation:
Core Services:
Furnishing of Core Services: Hospice 418.80 Core services......... 418.64
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 418.82 Core services......... 418.64(b)
services provided by or under the
supervision of a registered nurse.
(a) The nursing needs of the patients ........... Core services......... 418.64(b)
must be met.
(b) Patient care responsibility of ........... Deleted. ...............................
nursing personnel must be specified.
(c) Services are provided in ........... Core services......... 418.66
accordance with recognized standards
of practice.
Waiver of all requirements that 418.83 Nursing service waver 418.66
substantially all nursing services be (re-codified).
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.
[[Page 30864]]
(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 418.84 Core services......... 418.64(c)
services must be provided by a qualified
social worker, under the direction of a
physician.
Physician services: In addition to 418.86 Core services......... 418.64(a)
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, 418.88 Core services......... 418.64(d)
including bereavement, dietary, and
spiritual counseling, must be available
to both the individual and the family.
(a) Organized program for the ........... Core services......... 418.64(d)(1)
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 ........... Core services......... 418.64(d)(2)
(c) Spiritual counseling must include ........... Core services......... 418.64(d)(3)
notice to patients as to the
availability of the clergy as
provided in 418.70(f).
(d) Counseling may be provided by ........... Deleted.
others.
Subpart E--Condition of Participation:
Other services:
Furnishing other services: The services 418.90 Furnishing of non core 418.70
described in this subpart must be services.
provided directly by hospice employees or
under arrangements made by the hospice as
specified in 418.56.
Physical therapy, occupational therapy and 418.92(a) 418.70, 418.72
speech language pathology.
(a) Physical therapy, occupational ........... Physical therapy, 418.70, 418.72
therapy, and speech-language occupational therapy
pathology services must be available and speech language
and provided under acceptable pathology and dietary
standards of practice. counseling, Non-core
services.
(b)(1) Laboratory testing services ........... Compliance with 418.116(c)(1)
must be in compliance with all Federal, State &
applicable requirements of part 493 local laws &
of this chapter. regulations related
to the health &
safety of patients.
(2) All referral laboratories must be ........... Compliance with 418.116(c)(2)
certified in the appropriate Federal, State &
specialties and subspecialties of local laws &
services. See part 493 of this regulations & related
chapter. to the health &
safety of patients.
Home health aide and homemaker service: 418.94 Home Health Aide and 418.76
Home health aide and homemaker must be homemaker services.
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 ........... Home health aide and 418.76(h)(1)
visits the home site at least every homemaker services
two weeks when aide services arebeing (revised).
provided, and conducts an assessment
of the aide services.
(b) Standard: A registered nurse ........... Home health aide and 418.76(g)(1)
prepares written instructions for homemaker services.
patient care. Duties include, but may
not be limited to, the duties
specified in 484.36(c) of this
chapter.
Medical supplies: Medical supplies, 418.96 Drugs, controlled 418.106
appliances, drugs and biologicals must be drugs, and
provided for the palliation and biologicals, medical
management of the terminal illness and supplies and durable
related conditions. medical equipment.
(a) All drugs and biologicals must be ........... Drugs, controlled 418.106(a)
administered in accordance with drugs, and
accepted standards of practice. biologicals, medical
supplies and durable
medical equipment.
(b) The hospice must have a policy for ........... Drugs, controlled 418.106(b)
the disposal of extraneous controlled drugs, and
drugs maintained in the patient's biologicals, medical
home. supplies and durable
medical equipment.
(c) Only certain individuals may ........... Deleted.
administer drugs and biologicals.
Short term inpatient care: Inpatient care ........... Short term inpatient 418.108
must be available for pain control, care.
symptom management and respite purposes,
and must be provided in a participating
Medicare or Medicaid facility.
(a) Inpatient care for pain control ........... Short term inpatient 418.108(a)
and symptom management must be care.
provided in one of the following:
[[Page 30865]]
(1) A hospice that meets the ........... Short term inpatient 418.108(a)(1)
standards for providing inpatient care.
care directly specified in
418.100.
(2) A hospice or skilled nursing ........... Short term inpatient 418.108(a)(2)
facility that also meets the care.
standards of 418.100(a) and (e).
(b) Inpatient care for respite ........... Short term inpatient 418.108(b)
purposes must be provided by:. care.
(1) A provider specified in ........... Short term inpatient 418.108(b)(1)
paragraph (a) of this section. care.
(2) An intermediate care facility ........... Short term inpatient 418.108(b)(2)
(ICF) meeting the standards in care (delete ICF and
418.100 (a) and (e). replace with nursing
facility (NF)).
(c) Inpatient care for Medicare ........... Short term inpatient 418.108(d)
beneficiaries may not exceed 20 care.
percent of the total number of days
for this beneficiary group.
(d) Exemption from limitation in ........... Short term inpatient 418.108(e)
paragraph (c). care.
Hospices that provide inpatient care 418.100 Hospices that provide 418.110
directly: A hospice that provides inpatient care
inpatient care directly must comply with directly.
all of the following standards.
(a) Twenty-four hour nursing services:
(1) The facility provides 24-hour ........... Hospices that provide 418.110(b)
nursing services in accordance inpatient care
with patient plan of care directly.
sufficient to meet total nursing
needs.
(2) Each shift includes a direct ........... Deleted...............
care registered nurse.
(b) The hospice has an acceptable ........... Hospices that provide 418.110(c)(1)(iii)
written plan, periodically rehearsed inpatient care
with staff, with internal and directly.
external disaster procedures.
(c) The hospice must meet all Federal, ........... Compliance with 418.116
State and local laws, regulations, Federal, State &
and codes pertaining to health and local laws and
safety. regulations related
to health and safety
of patients.
(d) Fire protection................... ........... Hospices that provide 418.110(d)(1)
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 418.110(e)
inpatient care
directly.
(1) Design and equipment of
patient/family areas.
(2) Specifications for patient/
family accommodations
(3) Visitor specifications.
(f) Patient rooms and toilet ........... Hospices that provide 418.110(f)
facilities.. inpatient care
directly.
(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 ........... Hospices that provide 418.110(g),
facilities. inpatient care 418.110(h)
directly.
(h) Requirements for linens........... ........... Hospices that provide 418.110(k)
inpatient care
directly.
(i) Isolating areas for patients with ........... Hospices that provide 418.110(j),
infectious diseases. inpatient care 418.110(i)
directly.
(j) Meal service and menu planning.... ........... Hospices that provide 418.110(l)
inpatient care
directly.
(1) Three meals a day served at 418.100 Deleted. ...............................
regular times; no more than 14
hours between substantial evening
meal and breakfast.
(2) Procure, store, prepare, ........... Deleted. ...............................
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 ........... Hospices that provide 418.110(m)
hospice provides appropriate methods inpatient care
and procedures for the dispensing and directly.
administering of drugs and
biologicals.
[[Page 30866]]
(1) Licensed pharmacist The ........... Hospices that provide 418.110(n)
hospice must--. inpatient care.
(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 418.110(n)
inpatient care
directly.
(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 Hospices that provide 418.110(o)
inpatient care
directly: Seclusion
and Restraint.
NEW Waiver of Physical 418.74
therapy, occupational
therapy and speech
language pathology
and dietary
counseling.
NEW Hospices that provide 418.112
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 418.112(a)
eligibility,
election, and
duration of benefits.
........... (b) Standard: 418.112(b)
Professional
management.
........... (c) Standard: Core 418.112(c)
services.
........... (d) Standard: Medical 418.112(d)
director.
........... (e) Standard: Written 418.112(e)
agreement.
........... (f) Standard: Hospice 418.112(f)
plan of care.
........... (g) Standard: 418.112(g)
Coordination of
services.
........... (h) Standard: 418.112(h)
Transfer, revocation,
or discharge from
hospice.
[[Page 30867]]
........... (i) Standard: 418.112(i)
Orientation and
training of staff.
NEW Personnel 418.114
qualifications.
........... (a) General 418.114(a)
qualification
requirements.
........... (b) Federally defined 418.114(b)
qualifications.
........... (c) Personnel 418.114(c)
qualifications when
no States licensing
laws, certification
or registration
requirements exist.
........... Criminal background 418.114(d)
checks.
NEW Compliance with 418.116
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: 418.116(a)
Licensure of staff.
........... (b) Standard: Multiple 418.116(b)
locations.
........... (c) Standard: 418.116(c)
Laboratory services.
----------------------------------------------------------------------------------------------------------------
V. Collection of Information Requirements
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.
Section 418.52 Condition of Participation: Patient's Rights
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.
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 patient-specific assessment, and maintain
documentation of the assessment and any updates.
The burden associated with this requirement would be the time it
would
[[Page 30868]]
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 data-driven 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 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.
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 418.64 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 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 418.66 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 418.74 Condition of Participation: Waiver of Requirement-
Physical 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, speech-language pathology, and dietary
counseling services (as needed) available on a 24-hour basis. The
[[Page 30869]]
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
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 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).
[[Page 30870]]
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 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 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
[[Page 30871]]
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 one-time 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
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 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
[[Page 30872]]
described in part B of this section. We estimate that t he 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 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....................... 2,412
Number of hospice patients nationwide........................ 713,000
Number of patients per average hospice....................... 295
Hourly rate of registered nurse.............................. $27
Hourly rate of office employee............................... $19
Hourly rate of administrator................................. $42
Hourly rate of home health aide.............................. $14
Hourly rate of pharmacist.................................... $45
Hourly rate of medical director.............................. $84
------------------------------------------------------------------------
Patient Rights (Sec. 418.52)
The proposed rule would expand on the informed consent section
(Sec. 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 x $42 an hour = $336
$27 hour/60 minutes = $0.45 minute x 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 x 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 x 713,000 patients = 1,497,300,
$2.10 per patient x 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 x 295 patients = 24.58 hours
5 minutes per patient x 713,000 patients = 59,417 hours
$27 hour/60 minutes = $0.45 minute x 5 minutes = $2.25
$2.25 per patient x 295 patients = $663.75
$2.25 per patient x 713,000 patients = $1,604,250
[[Page 30873]]
Table 2.--Patient Rights Burden Assessment
----------------------------------------------------------------------------------------------------------------
Time per Time per Cost per
Standard patient hospice Total time Cost per average Total cost
(minutes) (hours) (hours) patient hospice
----------------------------------------------------------------------------------------------------------------
Notice of rights................ 5 24.58 59,417 $2.25 $663.75 $1,604,250
Exercise of rights.............. 3 15 34,740 2.10 630 1,408,325
Notice of liability............. 5 24.58 59,417 2.25 663.75 1,604,250
--------------
Totals...................... 13 64.16 153,574 6.60 1,947 4,705,800
----------------------------------------------------------------------------------------------------------------
Comprehensive Patient Assessment (Sec. 418.54)
The existing rule (Sec. 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 pre-determined 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
(Sec. 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,
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 x 15 minutes = $6.75
$6.75 per patient x 295 patients = $1,991.25
$6.75 per patient x 713,000 patients = $4,812,750
Table 3.--Interdisciplinary Group, Care, Planning, and Coordination of Services Burden Assessment
----------------------------------------------------------------------------------------------------------------
Time per Time per Cost per
Standard patient hospice Total time Cost per average Total cost
(minutes) (hours) (hours) patient hospice
----------------------------------------------------------------------------------------------------------------
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 (Sec. 418.58)
The current rule requires a hospice to maintain a quality assurance
program that involves an ongoing, comprehensive, integrated self-
assessment by the hospice of the quality and appropriateness of care
(Sec. 418.66). The proposed rule would provide more guidance to
providers and would require approximately 24 hours a year to implement.
Many providers are already using comprehensive quality assessment and
performance improvement programs for accreditation or
[[Page 30874]]
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 x 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
Standard hospice Total time Cost per Total cost
(hours) (hours) hospice
----------------------------------------------------------------------------------------------------------------
QAPI development............................................ 12 28,944 $504 $1,215,648
QAPI implementation......................................... 12 28,944 504 1,215,648
--------------
Total annually.......................................... 24 57,888 1,008 2,431,296
----------------------------------------------------------------------------------------------------------------
Infection Control (Sec. 418.60)
There is no specific existing requirement for infection control
other than what is briefly mentioned in the existing Sec. 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 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 (Sec. 418.64)
The proposed rule would allow core services to be provided under
contract with another Medicare certified hospice in certain
extraordinary or other non-routine 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 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 (Sec. 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
[[Page 30875]]
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 (Sec. 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 Sec. 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 above-mentioned
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 x 5 minutes to
document that requirements are met per home health aide = $1.60 x 1
document per year = $1.60 per hospice
$1.60 per hospice x 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 Time per Cost per
Standard aid hospice Total time Cost per average Total cost
(minutes) (minutes) (hours) aid hospice
----------------------------------------------------------------------------------------------------------------
Documentation (based on 1 new HHA 5 5 201 $1.60 $1.60 $3,859.20
per year) *......................
--------------
Totals........................ 5 5 201 1.60 1.60 3,859.20
----------------------------------------------------------------------------------------------------------------
Organization and Administration of Services (Sec. 418.100)
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 in-service 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 in
the industry and present no additional burden.
Medical Director (Sec. 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 appropriate, and reviewing relevant information prior to the
date that re-certification is necessary are all standard procedures.
Clinical Records (Sec. 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.
[[Page 30876]]
Drugs, Medical Supplies and Durable Medical Equipment (Sec. 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 x 5 minutes = $2.25
$2.25 per patient x 295 patients = $663.75
$2.25 per patient x 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 x 15 minutes per
patient= $3.45 per patient
$3.45 per patient x 295 patients = $1,017.75
$3.45 per patient x 713,000 patients = $2,459,850
Table 6.--Drugs, Medical Supplies and Durable Medical Equipment Burden Assessment
----------------------------------------------------------------------------------------------------------------
Time per Total
Time per average industry Cost per Cost per Total
Standard patient hospice time patient average industry
(minutes) (minutes) (hours) hospice cost
----------------------------------------------------------------------------------------------------------------
Drug Education.................... 5 24.58 59,417 $2.25 $663.75 $1,604,250
Equipment......................... 15 73.75 178,250 3.45 1,017.75 2,459,850
--------------
Totals........................ 20 98.33 237,667 5.70 1,681.50 4,064,100>
----------------------------------------------------------------------------------------------------------------
Short Term Inpatient Care (Sec. 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 (Sec. 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 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 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 x 30 minutes per report = 55 hours nationwide
$42 hour/60 minutes = $0.70 minute x 30 minutes = $21 per
report
$21 per report x 110 reports = $2,310
(i) Standard: Infection Control, contains a cross-reference to
standards contained in Sec. 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,
[[Page 30877]]
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 x 1 hour investigation =
$87 per investigation
$87 per investigation x 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 x 2,412 hospices = 14,472 hours to
develop form
6 hours per hospice x $42 hour = $252 to develop form
$252 to develop form x 2,412 hospices = $607,824
713,000 patients x 0.01 percent = 7,130 patients
nationwide requiring seclusion or restraint x 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 patients per hospice requiring seclusion
or restraint
$84 hour/60 minutes = $1.40 minute x 4 minutes per patient
to complete form = $5.60 per patient to complete form
$5.60 per patient x 3 patients per hospice requiring
seclusion or restraint = $16.80 per hospice
$5.60 per patient x 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost per
Standard Time per patient Time per hospice Total time Cost per average Total cost
(hours) patient hospice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical environment................ 1 second................ 5 minutes............... 55 $0.01 $1.00 $2,310
Pharmacist.......................... 1 second................ 5 minutes............... 55 0.01 2.06 4,785
Seclusion form development.......... 1 minute................ 6 hours................. 14,472 0.84 252 607,824
Seclusion form completion........... 4 minutes............... 12 minutes.............. 475 5.60 16.80 39,928
---------------------------
Totals.......................... 5 minutes............... 6.25 hours.............. 15,057 6.46 271.86 $654,847
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospices That Provide Hospice Care to Residents of a SNF/NF, ICF/MR or
Other Facility (Sec. 418.112)
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 and would not increase a hospice's regulatory burden.
Personnel Qualifications (Sec. 418.114)
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 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
[[Page 30878]]
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 x 39 states already requiring background
checks = 70,395 already required to have background checks
90,271 total employees x 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 x 6 minutes per check = 4 hours per hospice
19,876 employees x 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 x 39 employees requiring checks = $487.50
$12.50 per check x 19,876 employees requiring checks =
$248,250
Table 8.--Personnel Qualifications Burden Assessment
----------------------------------------------------------------------------------------------------------------
Time per check Time per average Total industry time Cost per Total cost per
(minutes) hospice (minutes) (hours) check average hospice Total industry cost
----------------------------------------------------------------------------------------------------------------
6................ 1st year--4 hours 1st year--1,988 $12.50 1st year--$487.50 1st year--$248,250
annually--48. hours annually-- annually--$100. annually--51,000.
408.
----------------------------------------------------------------------------------------------------------------
Table 9.--Total Burden Assessment Proposed Requirements
[Total time and cost for all altered or new CoPs:]
----------------------------------------------------------------------------------------------------------------
Total time per patient Total time per Total industry Total cost per Total cost per Total industry
(minutes) hospice (hours) time (hours) patient hospice 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 problem-focused 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.
Patient's Rights (Sec. 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 (Sec. 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.
Interdisciplinary Group Care Planning and Coordination of Services
(Sec. 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 Sec. 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
[[Page 30879]]
better identify activities that lead to poor patient outcomes, and
would be able to take corrective action to improve performance.
Infection Control (Sec. 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 Sec. 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 (Sec. 418.62)
We considered rewriting each existing CoP instead of combining all
of them into the proposed CoP, Sec. 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 (Sec. 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 (Sec. 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 (Sec. 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 family to share in the accountability
of controlled substances in the home.
Inpatient Care (Short-Term, Long-Term, and ICFs/MR) (Sec. 418.108,
Sec. 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 (Sec. 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 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:
Sec. 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:
Sec. 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
[[Page 30880]]
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
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.
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 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 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,
speech-language 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: Short-term 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
Sec. 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
[[Page 30881]]
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 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, third-party payers, or
other resources of funding known to the hospice.
Sec. 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 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-
the-counter 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.
[[Page 30882]]
Sec. 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
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.
Sec. 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
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
[[Page 30883]]
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.
Sec. 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
agency-wide 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.
Sec. 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 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
Sec. 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 Sec.
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 short-term 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.
(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 Sec. 418.204(c).
[[Page 30884]]
(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.
Sec. 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 Sec. 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;
(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
Sec. 418.70 Condition of participation: Furnishing of non-core
services.
A hospice must ensure that the services described in Sec. 418.72
through Sec. 418.78 are provided directly by the hospice or under
arrangements made by the hospice as specified in Sec. 418.100. These
services must be provided in a manner consistent with current standards
of practice.
Sec. 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.
Sec. 418.74 Waiver of requirement--Physical therapy, occupational
therapy, speech-language pathology, and dietary counseling.
(a) A hospice located in a non-urbanized 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, speech-language 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:
(1) The hospice is located in a non-urbanized 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.
Sec. 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
[[Page 30885]]
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 Sec. 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
(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 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
[[Page 30886]]
(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
self-administered.
(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 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 Sec. 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 Sec. 418.76 or an individual who
meets the standards in Sec. 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.
Sec. 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
Sec. 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
[[Page 30887]]
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-to-day
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 Sec. 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 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 Sec. 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 in-service
training provided during the previous 12 months.
Sec. 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.
(b) Standard: Recertification of the terminal illness. Before the
recertification period for each patient, as described in Sec.
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.
Sec. 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 Sec. 418.54(e)
of this subpart.
(5) Physician certification and recertification of terminal illness
as required in Sec. 418.22 and described in Sec. 418.102(a) and Sec.
418.102(b) respectively.
(6) Any advance directives as described in Sec. 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
[[Page 30888]]
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.
Sec. 418.106 Condition of participation: Drugs, controlled drugs and
biologicals, medical supplies, and durable medical equipment.
Medical supplies and appliances, as described in Sec. 410.36 of
this chapter; durable medical equipment, as described in Sec. 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 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.
Sec. 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
Sec. 418.110.
(2) A Medicare-participating hospital or a skilled nursing facility
that also meets the standards specified in Sec. 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:
(1) A provider specified in paragraph (a) of this section.
(2) A Medicare/Medicaid approved nursing facility that also meets
the standards specified in Sec. 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 12-month 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.
Sec. 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
[[Page 30889]]
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, well-groomed, 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 non-employee 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, 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: http://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 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 easily-activated, 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
[[Page 30890]]
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 Sec. 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 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.
(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
[[Page 30891]]
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.
Sec. 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 Sec.
418.10 through Sec. 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 Sec. 418.20 through Sec. 418.30.
(b) Standard: Professional management. The hospice must assume full
responsibility for professional 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 Sec. 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 Sec. 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 Sec. 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 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.
[[Page 30892]]
(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, Sec.
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.
Sec. 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
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
Sec. 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 Sec. 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--
(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.
[[Page 30893]]
(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.
Sec. 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 Sec. 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 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.
Sec. 418.200 [Amended]
6. Section 418.200 is amended by revising the reference ``Sec.
418.58'' to read ``Sec. 418.56''.
Sec. 418.202 [Amended]
7. In Sec. 418.202, paragraph (e) is amended by revising the
reference ``Sec. 418.98(b)'' to read ``Sec. 418.108(b)'' and
paragraph (g) is amended by revising the reference ``Sec. 418.94'' to
read ``Sec. 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