[Federal Register: June 5, 2008 (Volume 73, Number 109)]
[Rules and Regulations]
[Page 32087-32220]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn08-6]
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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;
Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 418
[CMS-3844-F]
RIN 0938-AH27
Medicare and Medicaid Programs: Hospice Conditions of
Participation
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule revises the existing conditions of
participation that hospices must meet to participate in the Medicare
and Medicaid programs. The final conditions address the comments that
we received on the proposed rule published on May 27, 2005. This final
rule focuses on the care delivered to patients and their families by
hospices and the outcome of that care. The final requirements continue
to reflect the unique 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 and our efforts to improve
the quality of care furnished through the Medicare and Medicaid
programs.
EFFECTIVE DATE: These regulations are effective on December 2, 2008.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of December 2, 2008.
FOR FURTHER INFORMATION CONTACT: Steve Miller, (410) 786-6656; Mary
Rossi-Coajou, (410) 786-6051; Danielle Shearer, (410) 786-6617; or
Jeannie Miller, (410) 786-3164.
SUPPLEMENTARY INFORMATION:
I. Background
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 an approach
that improves the quality of life of patients and their families facing
the problems associated with life-threatening illness through the
prevention and relief of suffering by means of early identification,
assessment and treatment of pain and other issues. Hospice care allows
the patient to remain at home as long as possible by providing support
to the patient and family, and by 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 conditions are 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. To implement this
requirement, State survey agencies conduct surveys of hospices to
assess their compliance with the CoPs.
The hospice CoPs were originally published 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.
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.
In order to take advantage of continuing advances in the health
care delivery field, incorporate changes made to the Act, and
incorporate recommendations made by various government agencies we are
revising the Medicare hospice CoPs, which are also used by Medicaid.
The revised CoPs focus on a patient-centered, outcome-oriented, and
transparent process that promotes quality patient care for every
patient every time.
We have developed a set of core requirements for hospice services
that encompass the following: Patient rights, comprehensive assessment,
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.
We are revising the CoPs based on four main considerations. First,
we considered the recommendations 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 Committee recommended that we clarify the relationship between
nursing facilities and hospices (found in our final rule at Sec.
418.112); change the requirements for 24-hour nursing services for
hospices providing respite care (Sec. 418.108 of the final rule); and
clarify that all qualified individuals, including nurses, are permitted
to furnish dietary counseling (Sec. 418.64(d)(2) of the final rule).
Second, we considered the Balanced Budget Act of 1997 (Pub. L. 105-
33) because it made changes to the hospice statute that must now be
incorporated into the CoPs. Specifically, the Balanced Budget Act of
1997 (BBA) permitted hospices to provide physician services, including
those of a medical director, under contract (Sec. 418.64 and Sec.
418.102 of the final rule). It also allowed hospices located in non-
urbanized areas to receive a waiver of the requirement that physical
therapy, occupational therapy, speech-language pathology, and dietary
counseling be available on a 24-hour as needed basis (Sec. 418.74 of
the final rule). Additionally, the
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legislation allowed hospices located in non-urbanized areas to receive
a waiver of the requirement that dietary therapy be provided by hospice
employees (Sec. 418.74 of the final rule).
Third, we considered section 946 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173).
Section 946 of the MMA amended section 1861(dd) of the Act, to permit a
hospice to enter into an arrangement with another hospice to provide
core hospice services or to provide the highly specialized services of
a registered professional nurse, in certain circumstances (Sec. 418.64
of the final rule).
Finally, this revision is part of a larger effort to bring about
improvements in the quality of care furnished to hospice patients and
their families through an outcome-oriented approach to patient care.
The revised CoPs focus on the core elements of hospice care that are
necessary to achieve positive patient outcomes to meet the growing
challenges associated with the changing hospice care environment such
as increasingly diverse patient populations and care settings.
Before developing the proposed CoPs for hospices, published in the
Federal Register on May 27, 2005, we analyzed our hospice survey data,
and 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
the data and suggestions, we 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; and
Use performance measurement systems to evaluate and
improve care.
Based on these principles and the public comments that were
submitted regarding the May 2005 proposed rule, we are setting forth
this final rule.
II. Provisions of the Proposed Regulations and the Analysis and
Responses to Public Comments
On May 27, 2005, we set forth proposed rules for hospices that
choose to participate in Medicare and Medicaid. We proposed to revise
all of the existing conditions of participation (CoPs), and to add
several new CoPs to address aspects of hospice care that we believe
need attention. This section will briefly describe the content of each
CoP in the proposed rule.
We proposed no changes to Subparts B (Eligibility, Election and
Duration of Benefits), G (Payment for Hospice Care), or H (Coinsurance)
of 42 CFR part 418.
We received 205 timely items of correspondence that raised numerous
issues. These comments, detailed below, came from accrediting bodies,
consumer advocacy organizations, hospices, individuals, national health
care provider organizations, State agencies, and State health care
provider organizations.
1. Scope of the Part (Sec. 418.2)
We proposed to revise Sec. 418.2 to reflect the reorganization of
the part and to include an introductory statement describing the
purpose of the part. We did not receive any comments on this section.
Therefore, we are adopting the provisions as proposed.
2. Definitions (Sec. 418.3)
We proposed to remove, revise, and add numerous definitions to this
section in order to clarify the meaning of the proposed rule. We
proposed to move the definitions of ``physician'' and ``social worker''
from the definitions section to the personnel requirements section at
Sec. 418.114 because the definitions set forth the standards that
these individuals must meet in order to function in a hospice. In
addition, as it is not a condition of participation, and is only used
for hospice payment purposes, we proposed to maintain the existing
definition of the term ``cap period.''
We proposed to revise the definitions of the terms ``attending
physician'', ``bereavement counseling'', ``employee'', ``hospice'',
``representative'', and ``terminally ill''. Finally, we proposed to add
definitions for the following terms: ``clinical note'', ``drug
restraint'', ``hospice care'', ``licensed professional'', ``palliative
care'', ``physical restraint'', ``progress note'', ``restraint'',
``satellite location'', and ``seclusion''.
We proposed to add nurse practitioners to the definition of
``attending physician'' because section 408 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
changed the statutory definition of ``attending physician'' to include
nurse practitioners with respect to some (but not all) aspects of
hospice services.
The terms ``drug restraint'', ``physical restraint'', and
``seclusion'' were presented for the first time in the proposed rule.
Seclusion and restraint requirements were proposed because anecdotal
evidence suggested that there are occasions when hospice inpatient
facilities must use seclusion and/or restraints for patient and/or
staff safety. Moreover, Section 591 of the Public Health Service (PHS)
Act, as added by the Children's Health Act (Pub. L. 106-310), prohibits
the use of restraint and seclusion, except under specific
circumstances, in any health care facility, that receives support in
any form from any program supported in whole or in part with funds
appropriated to any Federal department or agency.
We proposed to define the term ``satellite location'' to codify
long-standing Medicare survey and certification policies that permit
hospices to operate multiple locations under a single provider number.
Multiple locations were not an issue when the hospice CoPs were
originally implemented, and, as such, were not addressed. We believed
that the proposed definition would help hospices determine when they do
or do not need to obtain Medicare approval for a new location and what
criteria would be used by Medicare in approving or denying a multiple
location application.
Comment: Many commenters requested that changes be made to the
proposed definition of ``attending physician.'' Some of these
commenters requested that, in addition to ``nurse practitioner,'' we
also add ``advanced practice nurse,'' ``clinical nurse specialist,''
and ``physician's assistant'' to the definition of ``attending
physician'' in order to broaden the category of individuals who could
receive payment in that capacity. A single commenter suggested that we
defer to the States to determine training, education and experience
requirements for nurse practitioners. Another commenter suggested that
the definition of ``attending physician'' should be divided into two
definitions, one for physicians and one for nurse practitioners. Still
another commenter requested that we delete the
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requirement that an attending physician must be legally authorized to
practice surgery by the State in which he or she performs that function
because surgery is not a specialty necessary to be considered qualified
as an attending physician. Several other commenters requested that we
specify in the definition of ``attending physician'' that a patient's
attending physician may be a hospice employee. Another commenter
suggested that we add a statement that a nurse practitioner may cover
for an attending physician in the attending physician's absence.
Response: Section 408(a) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (MMA)
amended the term ``attending physician'' at section 1861(dd)(3)(B) of
the Act specifically for hospices to allow nurse practitioners to
function as a patient's attending physician if the patient identifies
the nurse practitioner as such. Following publication of the proposed
rule, CMS published two final rules (70 FR 45144 and 72 FR 50214) on
other matters that, among other things, modified the definition of the
term ``attending physician'' to incorporate changes made by the MMA. We
are deferring to these final rules. Furthermore, Section 1861(r)(1) of
the Act specifically defines a physician as ``a doctor of medicine or
osteopathy legally authorized to practice medicine and surgery by the
State in which he performs such function or action.'' We believe that
this statutory definition is appropriate for hospice providers, as well
as for the many other health care providers for which it is used. We do
not have the authority to delete the term ``and surgery'' from this
definition.
We do not believe that it is necessary to state in the definition
that an attending physician may be an employee of the hospice. The
decision as to who is or is not the attending physician belongs to the
patient regardless of that individual's employment relationship (or
lack thereof) with the hospice. We do not prohibit attending physicians
from being hospice employees as long as it is the patient's choice to
decide whether or not to have an attending physician and who that
attending physician will be during the patient's hospice care. In
addition to consulting with the hospice interdisciplinary group (IDG)
regarding the patient's hospice care, the attending physician retains
responsibility for meeting the patient's needs that are not related to
the terminal illness and that terminal illness's related conditions.
The attending physician is typically someone with whom the patient had
a relationship before electing to receive hospice care. The role of the
attending physician is to provide a long term perspective on the
patient and family that takes into account their medical and personal
history. The attending physician is not typically an individual
provided by the hospice to fill this role because a patient does not
have an attending physician, although we recognize that this does occur
at times.
We also do not believe that it is necessary to state that a nurse
practitioner may act on behalf of the attending physician in the
attending physician's absence. If the attending physician is unable to
fulfill his or her duties, then the hospice physicians are responsible
for fulfilling the attending physician's duties in his or her absence
in accordance with Sec. 418.64(a)(3) of the final rule. Therefore,
there is no need for the attending physician to designate another
individual to cover his or her hospice patients. The role and function
of the nurse practitioner is also addressed in CMS hospice payment
policies (see, for example, 42 CFR 418.304(e)).
Comment: A commenter requested that we revise the definition of
``bereavement counseling'' to reflect the fact that bereavement
counseling begins before the patient dies. The commenter noted that the
proposed rule even required the initial step of bereavement counseling
to begin before the patient's death by requiring that the initial
bereavement assessment be completed at the time of the comprehensive
assessment. Another commenter questioned the qualifications of persons
providing bereavement counseling and indicated that we should consider
adding language to address this question within the definition of
``bereavement counseling.'' Another commenter requested that we
specify, in the definition of bereavement counseling, that the
counseling only applies to the patient's immediate family members as
set out in the Act.
Response: We agree that effective bereavement counseling must begin
before the patient's death and that the proposed rule and this final
rule reflect this practice by requiring a bereavement assessment early
in the patient's hospice stay. To clarify our intent, at section Sec.
418.3 of this final rule, we are revising the definition of
``bereavement counseling'' to specify that it occurs both before and
after the patient's death.
With respect to counseling immediate family members, current
practice in many hospices is expanding this activity. Many hospice
programs have extensive bereavement programs that extend beyond
immediate family members to embrace other caregivers, friends, and the
larger community. As the commenter pointed out, the statute at section
1861(dd)(2)(A)(i) of the Act mandates bereavement counseling for the
immediate family of the terminally ill individuals, but does not
explicitly limit counseling to only such family members. We believe
that limiting counseling to immediate family members would disregard
the work that many hospices do for other persons whose relationship
with the patient is important. To restrict bereavement counseling to a
select few would discourage hospices from providing this service, thus
harming the bereaved and the larger community. Therefore, we did not
insert language limiting the definition of ``bereavement counseling''
to immediate family members. Bereavement counseling is part of the
hospice's bundled daily payment rate.
In order to facilitate bereavement counseling services beginning at
an early time and being furnished to whomever the hospice assesses as
needing services, we believe that it is necessary to allow hospices
flexibility in deciding who is qualified to provide bereavement
services in accordance with their own policies, current standards of
practice, and other applicable Federal, State, and local laws and
regulations. In the proposed and final rule at Sec. 418.64(d), we
require that counseling services, including bereavement counseling, are
provided by or under the supervision of a qualified individual with
experience in grief or loss counseling. Some hospices may use a social
worker while other hospices may choose to use chaplains or volunteers
to provide this service. This flexibility allows hospices to meet the
needs of their patients and families in a manner that works best for
their needs and resources. Therefore, we are not prescribing who may or
may not furnish bereavement counseling services.
Thus, the revised definition for ``bereavement counseling'' is as
follows: ``Bereavement counseling means emotional, psychosocial, and
spiritual support and services provided before and after the death of
the patient to assist with issues related to grief, loss, and
adjustment.''
Comment: Numerous commenters indicated that the proposed
definitions for the terms ``clinical note'' and ``progress note'' were
either unnecessary or redundant. The commenters suggested that these
definitions either be deleted or further clarified to distinguish their
purpose. In addition, many commenters suggested that the terms
``psychosocial'' and ``spiritual note'' be added to the definition of
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``clinical note'' to reflect the fact that individuals who furnish
psychosocial and spiritual care such as social workers, counselors and
chaplains also write notations in the patient's clinical record.
Response: Notations in a patient's clinical record by individuals
furnishing services on behalf of a hospice are standard practice. They
are a primary and crucial means of communication between various care
providers who are in the patient's home at different times while
furnishing different services. Therefore, we believe that it is
important to acknowledge their use in the hospice environment by
requiring their presence in the patient's clinical record. At the same
time, we agree that having two separate definitions for notations is
not necessary and may even be confusing. Therefore, at Sec. 418.3, we
are using a single definition, ``clinical note,'' that addresses
notations regarding both the patient and the family. We also added the
terms ``psychosocial'' and ``spiritual'' to the definition to reflect
the need for this important information in the patient's clinical
record. The condensed and revised definition is as follows:
``Clinical note means a notation of a contact with the patient and/
or the family 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, emotional, psychosocial or
spiritual condition during a given period of time.''
We would like to point out that the term ``clinical note'' does not
limit the notations only to those individuals who are clinicians.
Clinical notes may be written by any individual furnishing care and
services to a patient, including volunteers, homemakers, vendors, etc.
Indeed, we would expect that clinical notes from all individuals would
be included in the clinical record because the goal of the clinical
note is to include as much information as possible to ensure that all
hospice care providers have complete and correct information to use in
making care decisions and furnishing care.
Comment: Many commenters were confused by the terms ``initial
assessment'' and ``comprehensive assessment'' as they are used in Sec.
418.54, ``Initial and Comprehensive assessment of the patient.'' The
commenters requested definitions for these terms in order to help
clarify the difference between the two assessment requirements to
ensure that the proper information was being gathered within the stated
timeframes.
Response: We agree that adding definitions of these two terms will
help ensure that patients are being assessed in a timely fashion. We
are clarifying that the initial assessment is to determine the
patient's immediate care needs. Hospices must complete this abbreviated
assessment in 48 hours. The comprehensive assessment must assess in-
depth all of the patient's areas of need and will ensure that hospices
are fully aware of the patient's current status. Hospices will be able
to use these assessments to establish an individualized hospice plan of
care that meets the patient's needs. We did not, as some commenters
suggested, specify which disciplines must complete the comprehensive
assessment. Hospices provide many different services and not every
patient will require an assessment by a provider of each of those
services. If, upon completion of the initial assessment, it is
determined that a patient may benefit from physical therapy services,
then we would expect a physical therapist to complete a physical
therapy assessment as part of the comprehensive assessment. However, if
there is no indication that the therapy services may benefit the
patient, then a therapy assessment by a therapist would be unnecessary.
The new definitions for ``initial assessment'' and ``comprehensive
assessment'' are added at Sec. 418.3 as follows:
``Initial assessment means an evaluation of the patient's physical,
psychosocial and emotional status related to the terminal illness and
related conditions to determine the patient's immediate care and
support needs.''
``Comprehensive assessment means a thorough evaluation of the
patient's physical, psychosocial, emotional and spiritual status
related to the terminal illness and related conditions. This includes a
thorough evaluation of the caregiver's and family's willingness and
capability to care for the patient.''
Comment: A number of commenters asked us to define the terms
``dietary counseling'' and/or ``dietitian'' to help clarify what type
of counseling hospices are required to provide to their patients, and
who may furnish this service. A few commenters further suggested that
we should differentiate between dietary counseling furnished by a
dietitian and dietary counseling furnished by a qualified individual
such as a nurse or nutritionist.
Response: Section 1861(dd)(1)(H) of the Social Security Act (the
Act) requires hospice facilities to provide ``counseling (including
dietary counseling) with respect to care of the terminally ill
individual and adjustment to his death.'' However, the term ``dietary
counseling'' has never been defined for hospices, and there is a great
deal of confusion in the hospice industry regarding exactly what
constitutes ``dietary counseling.'' Therefore, we agree that a
definition of ``dietary counseling'' is necessary. The definition at
Sec. 418.3 reads as follows:
``Dietary counseling means education and interventions provided to
the patient and family regarding appropriate nutritional intake as the
patient's condition progresses. Dietary counseling is provided by
qualified individuals, which may include a registered nurse, dietitian
or nutritionist, when identified in the patient's plan of care.''
We do not agree that we should prescribe what type of counseling
must be provided by a dietitian. We would expect that, based on an
assessment of the patient's dietary needs, a hospice would furnish
dietary counseling services through an individual whose skills best
meet the patient's identified needs. We believe that the needs of the
individual patient, rather than preset rules, should be the determining
factor relative to services and staff. We do not believe it is
appropriate to define the term ``dietitian'' or establish personnel
requirements for dietitians because we believe that hospices should
have the flexibility to employ an individual that would meet the needs
of their patients in accordance with all other applicable Federal,
State, and local laws and regulations.
Comment: A few commenters submitted suggestions for the proposed
definition of the term ``employee.'' A single commenter asked that we
replace the definition of the term ``employee'' with a definition of
the term ``staff.'' Another commenter suggested that, through the
definition of the term, hospice employees should be required to be
appropriately trained in death and dying.
Response: The term ``employee'' is singular and is used throughout
the regulation to refer to the direct relationship between the hospice
and the individual in terms of furnishing services (that is, a direct
employee), supervision, and lines of authority and responsibility. The
term ``staff,'' on the other hand, is plural and may include
individuals who are contracted through an outside entity, supervised by
that outside entity, and primarily responsible to that outside entity.
``Staff,'' as a broader term, is not an appropriate substitution for
the term ``employee'' in these definitions.
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Additionally, it is not appropriate to require in the definition of
the term ``employee'' that an employee must be trained in issues
related to death and dying. We agree that thorough training in issues
related to death and dying is necessary for all individuals furnishing
patient care services, including clinicians and patient care
volunteers. In final Sec. 418.100(g)(1) we now require hospices to
educate all hospice employees who have patient contact in the hospice
philosophy. Education in the hospice philosophy would, we believe,
encompass issues related to death and dying, as the commenter
suggested. It is not necessary for office employees with no patient
contact to be trained in issues relating to death and dying. To require
the training for all employees, regardless of their role within the
hospice organization, would unnecessarily burden hospices and divert
resources from more critical patient care activities. Therefore, we are
not requiring all hospice employees to receive such training.
Comment: A commenter suggested that, in the definition of ``hospice
care,'' we should specify that hospice care may be provided in the
home, the community, or a facility.
Response: Hospice care is currently being furnished in a variety of
settings, and we do not believe that it is necessary or appropriate to
specify in this rule where hospice care may be provided. To do so may
unintentionally preclude hospices from providing services in settings
that are appropriate but that are outside of an established definition.
Comment: Numerous commenters requested changes to the definition of
``licensed professional.'' Many of those commenters suggested that
dietary therapy should be added to the list of examples of services
that should be furnished by a licensed professional. Another commenter
suggested deleting the list of examples because the examples may
inadvertently limit the types of services that should be provided by
licensed professionals. Yet another commenter suggested that medical
social services should be deleted from the list of examples because not
all States license social workers. Therefore, in those States where no
State licensure for social workers exists, medical social services, CMS
presumes, that the commenter is advocating that such services be
furnished by a professional without a license.
Response: We agree that the proposed definition needs to be
clarified. While the commenters are correct in suggesting that dietary
therapy should be provided by a licensed professional, whether a nurse,
dietitian or nutritionist, we agree with the commenter who suggested
that the mere presence of the list of services is limiting. Therefore,
while we agree that dietary therapy should be provided by a licensed
professional, we are not adding dietary therapy to the list of
examples. Rather, at Sec. 418.3, we are deleting the entire list of
examples because they are unnecessary and may be confusing. Deleting
the list of examples also addresses the commenter's concern regarding
the licensure status of social workers. We recognize that some States
may not license social workers or other health care disciplines, and we
do not intend to imply that States must provide licensure for all
health care disciplines furnishing hospice services. Rather, our
intent, as proposed at Sec. 418.116(a) and finalized at Sec.
418.114(a) is that if a State licenses a particular health care
discipline, then any individual working within that discipline in the
hospice environment must obtain and maintain that State license. If no
State license exists for a particular discipline, and if that
individual meets all other personnel and training requirements as
required by this rule and any other applicable Federal, State, or local
laws, regulations, policies, and requirements, then it is acceptable
for that individual to furnish services to hospice patients absent a
State license.
Comment: Numerous commenters requested clarification on the
definition of the term ``satellite location.'' Specifically, hospices
requested that the definition include: Concrete criteria that hospices
must meet in order to be considered satellite locations, information
about the approval and survey process, and information about the type
of services furnished by satellite locations.
Response: The term ``satellite location'' is now referred to as
``multiple locations,'' and Sec. 418.3 has been modified to reflect
this change. We believe that this new terminology more accurately
describes those entities that furnish a full array of services from two
or more locations. We have also clarified our intent by stating that
multiple locations are those locations ``from which the hospice
provides the same full range of hospice care and services that is
required of the hospice issued the certification number.'' We note that
the term ``certification number'' is now used in place of the term
``provider number.'' This change reflects a change in the terminology
used by CMS to describe the number issued to a hospice to identify it
in certain Medicare systems.
We believe that clarifying that a multiple location provides the
same full array of services as the hospice location originally issued
the certification number will alleviate commenter concerns that
convenience sites where staff stop in to complete paperwork or check
messages, or warehouse sites where equipment is stored would need to be
approved by Medicare as multiple locations. We note that although we do
not require hospices to obtain approval for warehouse and other single
function sites, States may still require hospices to receive approval
from State or local authorities. The requirement that multiple
locations must share administration, supervision, and services with the
hospice that was issued the certification number is relocated from the
definition of the term at Sec. 418.3 to the paragraph addressing
multiple locations at Sec. 418.100(f)(1)(ii). We continue to believe
that it is the level of control and supervision exercised by the
hospice that was issued the certification number over the multiple
location, rather than mileage limitations or staffing levels, which
determines whether or not a site is a multiple location of an existing
hospice or a completely separate hospice.
We do not believe that it is appropriate to add specific criteria
or procedures for the approval of multiple locations in the regulatory
definition because this level of specificity may reduce our ability to
adapt to rapid changes in the hospice industry related to the use of
multiple locations. Rather, we will continue to address specific
criteria and procedures for multiple locations in sub-regulatory
guidance such as the State Operations Manual.
Comment: A commenter requested clarification about the definition
of ``palliative care'' and its relationship to the requirement that, in
order for a Medicare beneficiary to qualify for the Medicare hospice
benefit, the beneficiary must be certified as being terminally ill.
Specifically, the commenter asked if palliative care could be provided
by a hospice to individuals who are not terminally ill or who have not
elected the Medicare hospice benefit.
Response: Hospice care is a very specific type of care provided
within a defined timeframe at the end of life. Palliative care, on the
other hand, can be provided at any time of life when there is a need to
anticipate, prevent and treat suffering to optimize a patient's quality
of life. Hospices have a long history of providing palliative care and
are often in a position to provide
[[Page 32093]]
the care either on a direct or contract basis to patients who either do
not qualify for the Medicare hospice benefit (or another health care
insurer's hospice benefit) or who do not choose to forgo curative
treatment in order to elect the Medicare hospice benefit. We do not
prohibit hospices from providing these palliative care services to
patients that do not elect or qualify for hospice care, as long as the
hospices are primarily engaged in furnishing hospice care as required
by section 1861(dd) of the Act.
Comment: A few commenters requested that we define the term
``physician designee'' as it was proposed in Sec. 418.102, ``Medical
director.'' The commenters believed that a definition would help to
clarify this individual's role.
Response: We agree that defining this term will help clarify what
responsibilities this individual has as well as when those
responsibilities are assumed. The purpose of the physician designee
role is to ensure that, if the medical director is unavailable, there
is a predetermined, qualified individual who can assume all of the
medical director's responsibilities. Having a predetermined individual
who is ready and able to assume the medical director responsibilities
will help to ensure that patients receive high quality hospice care
even when the usual medical director is not available to perform his or
her duties. With this in mind, we are adding a definition for
``physician designee'' at Sec. 418.3 to read as follows:
``Physician designee means a doctor of medicine or osteopathy
designated by the hospice who assumes the same responsibilities and
obligations as the medical director when the medical director is not
available.''
Comment: Several commenters asked us to clarify the definition of
the term ``representative'' by recognizing case law, common law, and
health care powers of attorney in determining whether or not an
individual is a patient's representative.
Response: The proposed definition of ``representative'' states that
a representative is an individual who has the authority under State law
to authorize or terminate care on the patient's behalf. In the context
of this definition, we are deferring to State law in its entirety,
including statutes, agency regulations, and binding court rulings.
Since designations of health care powers of attorney are deemed to
appoint legal representatives by most, if not all states, our proposed
definition would include individuals granted health care powers of
attorney. Thus, case law, common law, and health care powers of
attorney are subsumed within the definition of the term
``representative'', and there is no need to amend it.
Comment: A majority of commenters requested that we revise the
proposed definition of ``drug restraint'' to remove the stigma
associated with the term ``drug.'' A minority of commenters requested
that we delete the definition of ``drug restraint'' completely, and
suggested that the hospice industry at large or hospices individually
should be allowed to determine a definition.
Response: Drugs have long played a prevalent role in hospice care.
They are used to relieve pain, calm anxiety, improve breathing and
support the patient. However, the idea of drugs used as restraints is
relatively new in hospice care and has provoked much anxiety in the
hospice industry. We understand that hospices are concerned about an
overly restrictive definition of the term ``drug restraint.'' We also
understand that hospices are concerned about State surveyors applying
the drug restraint regulations applicable to other health care
providers to hospices. We believe that these regulations clearly apply
only to hospice inpatient facilities (hospice programs do not have
outpatient facilities). Deleting the definition of ``drug restraint''
will not resolve providers' uncertainty, and will only leave hospices
and patients in the untenable position of not knowing what is and is
not a drug restraint; and simply renaming the definition as ``chemical
restraint'' will not resolve the ambiguity either. While we acknowledge
that the term ``drug'' may have a negative connotation among patients,
we are not requiring hospices to use this term when discussing
medications or chemicals with patients. Hospices are free to refer to
drugs used for any purpose within the hospice in a manner that suits
their patients and their representatives, families, other caregivers,
and the hospice. Moreover, section 591(d)(1)(B) of the PHS Act
prohibits the use of drugs ``used as a restraint to control behavior or
restrict the resident's freedom of movement that is not a standard
treatment for the resident's medical or psychiatric condition.'' This
provision of the Act applies to any health care facility that receives
any financial support from any program receiving Federal dollars.
Comment: Many commenters suggested that we narrow the definition of
``drug restraint'' to tailor it to the hospice environment.
Specifically, commenters requested that we indicate, in the definition,
that a drug is only considered a restraint if it is not an accepted
treatment within a hospice program. The commenters expressed concern
that drugs that may be considered restraints in other health care
settings (for example, long term care facilities) are not restraints in
hospice care because those drugs are used to treat distressing symptoms
(for example, terminal restlessness). A single commenter requested that
we not consider a drug to be a restraint if that drug is requested by
the patient or the patient's representative while another commenter
suggested that drugs should only be considered restraints if they are
used inappropriately.
Response: Narrowing the definition of ``drug restraint'' by
specifying that a drug is not a restraint if it is a ``standard
treatment within a hospice program'' may hinder hospices from adopting
new symptom management drugs in the future because they may have not
yet met the ``standard treatment within a hospice program'' criteria.
Our final language states that drugs used as a restraint are drugs that
are not standard treatment or dosage for the patient's condition, and
we believe that this will afford adequate protection to the hospice
patient population. Therefore, we are not adding this additional
limitation to the definition.
Similarly, narrowing the definition by adding a provision that a
drug is not a restraint if it is requested is not appropriate.
Requesting a drug does not alter its status as a restraint. In fact,
there are times when a patient, representative or family member may
request that a drug be administered to protect a patient from his or
her own behavior. The requestor would, in essence, be asking for a
restraint. Once the drug is administered, the patient would require the
increased level of supervision required by this rule in order to ensure
the patient's safety and well being at all times. Therefore, we are not
adding a provision to exclude drugs from the definition of ``drug
restraint'' if those drugs are requested by the patient or family.
Furthermore, narrowing the definition of ``drug restraint'' to
those drugs that are used inappropriately is not suitable. There are
drugs commonly used in the hospice environment for symptom management
that can also be used appropriately as drug restraints under limited
circumstances when warranted by the patient's condition and needs as
documented in the patient's clinical record.
Comment: A few commenters suggested that we should use the same
definition of ``chemical restraint'' for hospices as we do for other
provider types.
Response: We agree that using the same definition will help to
ensure that
[[Page 32094]]
hospice patients receive the same level of care and protection
regardless of where they receive health care services. In addition, we
agree that using the same definition will help to ensure that employees
moving from another provider type to the hospice setting will more
likely be familiar with the regulatory requirements. Therefore, at
Sec. 418.3, we are adopting the same definition and definitional
format for drug restraints as is used in the Hospital Conditions of
Participation. We are deleting the definitions of ``drug restraint''
and ``physical restraint'' in favor of a more expansive definition of
``restraint'' that encompasses both drug and physical restraints. We
believe that having a single definition, rather than three separate
definitions, will simplify the regulation and increase the public's
understanding of the requirements. The specific section of the new
``restraint'' definition that applies to drug restraints is as follows:
``A drug or medication when it is used as a restraint to manage the
patient's behavior or restrict the patient's freedom of movement and is
not a standard treatment or dosage for the patient's condition.''
Comment: Many commenters suggested changes for the definition of
``physical restraint'' ranging from a suggestion to delete the
definition to a suggestion that devices adjacent to the patient's body
also be considered physical restraints.
Response: As with ``drug restraints,'' we understand that there is
a great deal of apprehension and uncertainty regarding physical
restraints. In the preamble to the proposed rule we asked for public
comments regarding instances when physical restraints may or may not be
appropriate and necessary. We heard from a few commenters that bedrails
and positional devices are used for patient safety, and for assisting
patients in functioning independently. No commenters described a single
instance where physical restraints have been, or to their knowledge,
are now used, whether appropriately or inappropriately, for patient
safety, behavior management or any other purpose. The lack of specific
comments leads us to conclude that this is an issue that most hospices
choose not to discuss. Without this input, we are unable to gauge the
level of physical restraint utilization in the hospice industry or the
purposes of that utilization.
The Children's Health Act (CHA) requires us to promulgate
regulations concerning the use of restraints in hospices. Deleting the
definition of ``physical restraint'' would be in conflict with the
requirements of the CHA and will not alleviate the concern about the
safe and proper use of physical restraints. Indeed, deleting the
definition will only leave hospices wondering whether their practices
constitute physical restraint and what precautions should be taken to
ensure patient safety and well being. We do not believe that this is in
the best interest of patients or hospices; therefore we are including a
definition to address physical restraints. Moreover, section 591 of the
PHS Act sets forth a statutory definition, which is the basis for
enforcing regulations on the use of restraints.
At the same time, however, we are sensitive to commenters' concerns
that the definition of ``physical restraint,'' as was proposed, could
include bedrails and positional devices. Bedrails and positional
devices may have the effect of restraining one patient but not another,
depending on the individual patient's condition and circumstances. For
example, a partial bedrail may assist one patient to enter and exit the
bed independently while acting as a restraint for another patient.
Patients who attempt to exit a bed through, between, over, or around
bedrails are at risk of injury or death. The potential for serious
injury is more likely from a fall from a bed with raised bedrails than
from a fall from a bed where bedrails are not used. Bedrails also
potentially increase the likelihood that the patient will spend more
time in bed and fall when attempting to transfer from the bed. To
address these potential hazards, many long term care facilities have
replaced the use of bedrails with lower beds, perimeter mattresses,
alarms, and sitters for restless individuals. We encourage hospices to
have a dialogue with their long term care facility colleagues about the
safe and appropriate use of bedrails for hospice patients, as we
believe that both parties can learn from their successes. To reflect
the fact that it is the function and effect of a device, rather than a
device itself, that determines whether or not the device is a physical
restraint, we have revised the definition at Sec. 418.3 as follows:
``Restraint means: (a) Any manual method, physical or mechanical
device, material, or equipment that immobilizes or reduces the ability
of a patient to move his or her arms, legs, body, or head freely, not
including devices, such as orthopedically prescribed devices, surgical
dressings or bandages, protective helmets, or other methods that
involve the physical holding of a patient for the purpose of conducting
routine physical examinations or tests, or to protect the patient from
falling out of bed, or to permit the patient to participate in
activities without the risk of physical harm (this does not include a
physical escort).''
This language almost precisely tracks 591(d)(1)(A) of the PHS Act,
and matches the definition in the Hospital Conditions of Participation.
As a commenter suggested, physical restraint applies to any device that
has a restrictive effect, regardless of whether the device is attached
to or adjacent to a patient's body. It is the effect of the device,
rather than its location, that makes it a restraint. Using the same
definition for hospices as is used for other provider types will help
ensure that patients are consistently provided the same quality of care
and supervision when restraints are used, regardless of whether those
patients are in a hospital or a hospice inpatient facility. At the same
time, using the same definition will make staff transitions between
different provider types easier because the same set of restraint rules
will apply to some other provider types. This may be particularly
helpful to hospices that have occasion to furnish services under
contract where a nurse or other practitioner may be more familiar with
the rules governing restraints in hospitals. Having the same definition
will help to ensure that there is no conflict between the
practitioner's previous background and training and the applicable
hospice rules.
Comment: Several commenters noted that the proposed definition of
the term ``seclusion'' implies that any placement of patients in
private rooms would constitute seclusion. One commenter suggested that
the term should be completely removed.
Response: While it was not our intent, we agree that the proposed
definition of ``seclusion'' could embrace private rooms. Therefore, at
Sec. 418.3, we have revised the definition of ``seclusion'' by adding
the term ``involuntary.'' Patients who request private rooms do so
voluntarily, and therefore would not be in seclusion. However, if a
patient is placed alone in a private room against his or her will and
is not permitted visitors or egress from that room, then the patient
would be considered to be in seclusion. We also believe that it is
essential for the term ``seclusion'' to remain in this rule. Seclusion,
as defined in section 591(d)(2) of the PHS Act, may only be used under
circumstances described at 591(b). Deleting the term ``seclusion'' will
not assist hospices in complying with the statutory requirement, and
will only leave hospice facilities and patients in the untenable
position of not knowing
[[Page 32095]]
what situations do and do not qualify as ``seclusion'' and whether they
may be in violation of the Children's Health Act. We do not believe
that this is in the best interest of hospices or their patients.
Comment: A few commenters requested that we delete the definition
of the term ``terminally ill'' because it is a term that may discourage
patients from accepting hospice care.
Response: Section 1861(dd) of the Act establishes the Medicare
hospice benefit for beneficiaries who are terminally ill with a
prognosis of 6 months or less if the illness runs its normal course.
The definition that we proposed is the same definition that is used in
the Act. We believe that this is necessary to maintain the definition
in this rule because this term is used in the hospice payment rules.
Comment: A number of commenters requested that we define the term
``family'' using a very broad, patient-directed approach that allows
the patient to identify those who are considered to be his or her
``family.''
Response: We do not believe that a single definition of the term
``family'' would benefit beneficiaries or hospices. The meaning of
``family'' can change depending on circumstances and availability of
persons close to the patient. While allowing the patient to identify
his or her ``family'' would be ideal, this may not be possible for
patients who cannot communicate and who do not have written information
available for the hospice. We have decided that it would be most
appropriate to allow each hospice to establish its own policy on what
``family'' means in its community and with its own patients.
Comment: A single commenter requested that we add a definition for
the term ``unnecessary drugs'' to include drugs used in excessive
dosages, for excessive durations, without adequate monitoring, without
adequate indications for use, or in the presence of adverse events.
Response: The term ``unnecessary drugs'' did not appear within the
proposed rule. The concept is very interesting and may be useful to
hospices when assessing a patient's drug therapy regimen as required by
Sec. 418.54(c), Content of the comprehensive assessment. We have
incorporated some of the commenter's concerns in our final rule at
section 418.54(c)(6). This section requires hospices to review a
patient's prescription and over-the-counter drugs in use at the time of
the assessment, including, but not limited to, an identification of the
effectiveness of the drug therapy regimen, any potential or existing
drug side effects, any potential or existing drug interactions, any
duplicate drug therapies, and any drug therapy requiring laboratory
monitoring. Excessive dosages or durations, or inadequate monitoring
would likely lead to effectiveness and side effect issues that will be
assessed during the comprehensive assessment and subsequent updates.
The IDG, in conference with an individual who has specialized education
and training in drug management, such as a pharmacist, will be required
to address these issues in the patient's individualized hospice plan of
care.
Comment: A commenter suggested that we should define the term
``adverse event'' using the Joint Commission patient safety event
taxonomy. Another commenter suggested that we should define the term as
an, ``unanticipated, non-therapeutic response or injury''.
Response: While we agree that using the Joint Commission patient
safety taxonomy or suggested definition may be helpful for some
hospices, we do not believe that a single definition of ``adverse
event'' would meet the needs of all hospices at this time. In general,
an adverse event would be any action or inaction by a hospice that
causes harm to a hospice patient. We believe that hospices are capable
of determining what is or is not an adverse event based on the
characteristics and needs of their patient populations and staff. We
recognize that hospices are seeking further guidance on this issue, and
we plan to provide such guidance in future sub-regulatory guidance,
such as the State Operations Manual and Interpretive Guidelines.
Comment: A few commenters requested that we define the term
``homemaker services'' with specific references to the Medicaid
personal care benefit that many states offer to Medicaid beneficiaries.
Commenters asked for clarification about the role of homemakers in
hospice care, their relationship to Medicaid personal care aides, and
the qualifications for individuals who furnish homemaker services.
Response: Section 418.202(g) in subpart F of the current hospice
regulations states, ``[h]omemaker services may include assistance in
maintenance of a safe and healthy environment and services to enable
the individual to carry out the treatment plan.'' We believe that this
language adequately describes the role that homemakers play in hospice
care, and we are making no changes to it in this final rule.
Each State establishes its own Medicaid personal care aide benefit,
pursuant to our regulations at 42 CFR 440.167, including its own
eligibility criteria, scope of services to be provided, and personnel
qualifications. Medicaid regulations impose only minimal restrictions
on the state's discretion regarding these services. Hospice care is
meant to supplement the care provided by the patient's caregiver. If
the individual(s) furnishing Medicaid personal care services is
functioning as the patient's caregiver, then the hospice would not be
expected to replace the Medicaid personal care providers with its own
homemaker services on a round-the-clock basis. The Medicare hospice
benefit is not meant to be a caregiver benefit and should not be
expected to function as such. Hospices should work with their
respective State Medicaid agencies if they have questions about who
pays for services provided to patients eligible for both Medicare and
Medicaid.
With regard to who is qualified to furnish homemaker services on
behalf of a hospice, we proposed in Sec. 418.76(j) that a homemaker
must have either completed home health aide training requirements or
must have successfully completed a hospice's orientation addressing the
needs and concerns of patients and families coping with a terminal
illness. We continue to believe that either home health aide (now
referred to as a hospice aide) training or hospice orientation provides
sufficient knowledge for an individual to function as a homemaker under
the supervision of the IDG, and our final requirements at Sec.
418.76(j) and Sec. 418.76(k) reflect this.
Comment: Several commenters requested that we define the term
``nursing services.'' Most of these commenters defined the term to
include those services furnished by a registered nurse, licensed
practical nurse (LPN), licensed vocational nurse (LVN), nurse
practitioner or other advanced practice nurse. However, the commenters
were divided on whether or not services should be allowed to be
delegated by a nurse to a hospice aide and whether these delegated
services should be considered nursing services.
Response: The intent of section 1861(dd) of the Act has always been
to require hospices to furnish nursing services to their patients as
part of the Medicare hospice benefit. Hospices have complied with this
requirement for the past two decades using the services of a variety of
different categories of nurses ranging from nurse practitioners to
licensed vocational nurses to registered nurses. Hospices have not, to
our knowledge, had any difficulty in determining what constitutes
nursing services and we see no reason to
[[Page 32096]]
establish a definition for the term at this time.
It is important to point out that if we had included delegated
services in the definition of the term ``nursing services,'' then the
inclusion would effectively prohibit hospices from contracting for
hospice aide services. We believe that this de facto prohibition would
occur because those contracted hospice aides would routinely be
furnishing delegated nursing services, and section 1861(dd) of the Act
requires that substantially all nursing services should be furnished by
direct hospice employees. We do not think that the commenters intended
to establish this de facto prohibition on contracting for hospice aide
services.
Comment: A commenter asked us to define the term ``covering
physician'' as a physician acting on behalf of the attending physician.
Response: The term ``covering physician'' did not appear in the
proposed rule. If the patient's attending physician is not available to
care for his or her patients, then a hospice physician would assume
care responsibilities. In accordance with the proposed and final rule
at Sec. 418.64(a)(3), a hospice is responsible for providing an
alternate physician to meet the medical needs of the patient in the
attending physician's absence.
Comment: A few commenters asked us to add a definition for the term
``social worker.'' Some commenters proposed maintaining the current
definition as an individual with a Bachelors degree in Social Work from
an accredited university. Others suggested raising the requirement to a
Masters degree in Social Work from an accredited university.
Response: We believe that the commenters raise important issues,
which are discussed in a subsequent portion of the preamble. We are
relocating the credential requirements for social workers from the
definitions section to the new personnel requirements section (Sec.
418.114). We believe that this new, central location for all
credentialing requirements is the appropriate location for the social
work credentialing requirements as well. Therefore, we are addressing
these suggestions in the personnel qualifications section of this rule.
Comment: Several commenters asked us to add definitions for the
four levels of care provided in hospice (routine home care, continuous
home care, respite care, and general inpatient care). A few commenters
even provided their own definitions for these levels of care.
Response: These ``levels of care'' are payment rather than health
and safety issues, and therefore we are not addressing them in this
rule. These terms are used specifically in reference to our hospice
payment rules found at 42 CFR 418 Subpart F ``Covered Services'' and
Subpart G ``Payment for Hospice Care.'' In these two subparts, specific
criteria for these payment levels are detailed, and these criteria
constitute the definitions for these payment terms.
Comment: Some commenters asked us to define the term ``plan of
care,'' and suggested the plan of care should be defined as a written
document that addresses the patient and family needs identified in the
comprehensive assessment and is updated as needed.
Response: We agree with the commenters that the plan of care must
be a written document and that it must address the status of the
patient and family as identified in the comprehensive and updated
assessments. We also agree that the plan of care should be updated as
frequently as necessary based on changing status and needs. We do not
believe that it is necessary to define ``plan of care'' because
pertinent issues are being specified in this final rule at Sec.
418.56, ``Interdisciplinary group, care planning, and coordination of
services.'' Section 418.56 requires that a hospice IDG ``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 as such needs
relate to the terminal illness and related conditions.'' In addition,
Sec. 418.56(d) will require that the plan of care be updated by the
IDG ``as frequently as the patient's condition requires, but no less
frequently than every 15 calendar days.'' We believe that these
requirements adequately address the commenters' concerns.
Comment: A commenter requested that we define the term ``spiritual
assessment'' to ensure that these assessments address more than a
person's religious affiliation.
Response: Our inclusion of ``spiritual assessments'' in hospices
should not be solely related to religious affiliation (or lack
thereof). These assessments might focus on a patient's sense of peace,
purpose, beliefs, etc., but may not be warranted for all patients,
particularly if they already have an available spiritual/emotional
support system. Therefore, we do not believe that it is in the best
interest of hospice patients and hospice providers to prescribe exactly
what constitutes a spiritual assessment. A definition may
unintentionally interfere with the individualized, patient-centered
hospice care that we require hospices to furnish. We do not intend for
this regulation to suggest that any spiritual counseling or services be
provided to a hospice patient or family against their wishes.
Comment: Many commenters asked us to define the phrase ``patient's
home'' or ``patient's residence'' as a house, apartment, SNF/NF, ICF/
MR, assisted living facility, adult home, shelter, foster home or any
other place where a patient lives.
Response: We are unable to develop a single definition of the terms
``home'' or ``residence'' at this time. We will consider these
suggestions for future rulemaking.
Comment: Many commenters requested a definition of the term
``facility'' as it is used in proposed and final Sec. 418.112.
Response: The general term ``facility'' has been removed from this
condition of participation (CoP) in favor of a more specific list of
the facility types to which Sec. 418.112 applies. As the general term
no longer appears in the rule in the context of Sec. 418.112, it is no
longer necessary to define it.
Comment: A commenter suggested that we define the term ``hospice
patient'' as a patient who has been certified as being terminally ill
and who has accepted the care of a hospice agency.
Response: There is no single definition of ``hospice patient'' that
can encompass all types of patients treated by a hospice and all
eligibility criteria for all payment sources. Certifying a patient's
terminally ill status is a Medicare and Medicaid payment requirement
that does not necessarily apply to other health insurance or private
pay patients. To say that un-certified patients are not ``hospice
patients'' by excluding them from the definition would be
inappropriate. However, ``hospice patients'' for Medicare payment
purposes are those Medicare beneficiaries certified under Sec. 418.22
and electing hospice services under Sec. 418.24. Furthermore, we note
that the term ``hospice patient'' does not appear in statute or
regulation, and, as such, we do not believe that it requires a
definition in this rule.
3. Condition of Participation: Patient's Rights (Proposed Sec. 418.52)
We proposed to replace the existing CoP, Informed consent, at Sec.
418.62, with a new patient rights CoP. The proposed patient rights CoP
was divided into five standards. The first standard, ``(a) Notice of
rights,'' would have required hospices to develop a notice of rights,
including information about advance directives and the hospice's
controlled
[[Page 32097]]
drug policies. Under the proposed requirement, hospices would have been
required to present the notice of rights verbally (meaning spoken) and
in writing to patients and families in a language and manner that they
are able to understand. This would have occurred before the hospice
furnished care to a patient and family. Hospices would also have been
required to document the patient's or representative's understanding of
the notice of rights.
In standard (b), ``Exercise of rights and respect for property and
person,'' we proposed that the patient would be able to exercise his or
her rights, be respected, voice grievances, and not be subjected to
discrimination or reprisal. We also proposed that hospices would
investigate and report all alleged violations of patient rights, and
take appropriate corrective action where necessary.
The third standard, ``(c) Pain management and symptom control,''
proposed that patients would have the right to receive effective pain
management and symptom control from the hospice.
Standard (d), ``Confidentiality of clinical records,'' proposed
that hospices would be required to maintain the confidentiality of
clinical records in accordance 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 set out at 45 CFR parts 160 and 164.
Finally, the fifth standard, ``(e) Patient liability,'' proposed
that patients would be informed about the extent to which payment may
be expected from the patient, Medicare or Medicaid, third-party payers,
or other sources, verbally and in writing in a language that the
patient was able to understand. This standard proposed that this
information would be provided to patients before care was furnished.
The intent of this standard was to ensure that patients were aware of
their potential out-of-pocket costs for hospice care, such as co-
payments, so that they would not be surprised by financial concerns at
this stressful time.
Comment: A majority of commenters on this issue expressed concern
about the proposed requirement that hospices provide a notice of the
patient's rights and responsibilities verbally, as well as in writing,
in a language and manner that the patient would understand. Many of
these commenters requested that hospices not be required to furnish
written notices in obscure or otherwise uncommon languages. Other
commenters requested that the choice of language(s) used to communicate
be left to the discretion of each hospice or that the communication be
done in accordance with guidance issued by the Department of Health and
Human Services (HHS) related to Title VI of the Civil Rights Act of
1964, Prohibition Against National Origin Discrimination Affecting
Limited English Proficient Persons. Still other commenters requested
that we specifically recognize in the regulation that interpreters,
family or otherwise, be permitted to facilitate communication of the
notice of rights to patients and families.
Response: We recognize that this is an area of concern for
hospices, as it may be challenging for hospices to communicate with
patients who speak languages other than English. However, ensuring that
patients are aware of their rights and how to exercise them are vital
components of improving overall hospice quality and patient
satisfaction. If patients are unaware of their rights or the methods
and protections available for exercising those rights, then hospices
cannot expect to receive valid feedback from patients on ways to
improve their services. Without the valid feedback, true quality
measurement and improvement cannot exist. Therefore, we believe it is
in the interest of patients and hospices to ensure that all patients,
regardless of their communication needs, are informed of their patient
rights.
Even so, we are sensitive to the concerns of hospice providers. The
HHS guidance on Title VI (August 8, 2003, 68 FR 47311) applies to those
entities that receive federal financial assistance from HHS, including
hospices. This guidance presents four areas for hospices to consider
when developing and implementing strategies to meet the needs of
limited English proficient persons. The guidance recognizes the role of
professional translation services, as well as family and friends of the
patient, in communicating important information to patients, including
the notice of rights. Hospices are already expected to comply with the
HHS guidance, and doing so will enable them to comply with the
requirements of the proposed rule.
Using family and friends as translators should not be the
communication plan of choice for the hospice for its patients who do
not speak English, unless the patient specifically requests this
approach. Hospices should make all reasonable efforts to secure a
professional, objective translator for hospice-patient communications,
including those involving the notice of patient rights. Furthermore,
hospices should make all reasonable efforts to have written copies of
the notice of rights available in the language(s) that are commonly
spoken in the hospice's service area. For those patients who speak
uncommon languages in areas where professional translators for those
languages are not readily available, using family and friends of the
patient is an acceptable option.
Comment: A commenter asked that we explicitly specify in Sec.
418.52(a)(2) that patients have the right to refuse to formulate
advance directives.
Response: Under this final rule, hospices are required to comply
with 42 CFR part 489 Subpart I, ``Advance directives.'' Patients may
choose to develop advance directives in accordance with applicable
State requirements. Likewise, they may choose to not formulate advance
directives. We believe that 42 CFR part 489 adequately addresses all
aspects of advance directives, including patient choice. Therefore, we
are not adding the commenter's suggestion.
Comment: Some commenters asked that we clarify what type of
documentation would be necessary to demonstrate that the hospice
provided patients with a notice of rights and that the patient or
representative demonstrated an understanding of the rights. A majority
of commenters noted that language in the proposed rule, ``demonstrated
an understanding of,'' was imprecise and difficult to measure.
Additional commenters suggested that language from the home health
agency CoPs at 42 CFR 484.10 should be used in the hospice CoPs.
Section 484.10 states that ``the HHA must maintain documentation that
it has complied with the requirements of this section.'' This language,
commenters noted, would allow hospices to determine in their own
policies how the documentation would be handled. Several other
commenters suggested that hospices be required to obtain the patient's
or family's signature, confirming that they received the notice of
rights.
Response: We agree that a more precise requirement will help
hospices ensure that patients and families are fully informed about the
notice of rights. Furthermore, we agree that more precise language will
help hospices ensure that they are in compliance with our documentation
requirements. Therefore, this final rule at Sec. 418.52(a)(3) states,
``The hospice must obtain the patient's or representative's signature
confirming that he or she has received a copy of the notice of rights
and responsibilities.''
Comment: Some commenters noted that State practices and laws may
[[Page 32098]]
govern a legal representative's exercise of a patient's rights as
described in Sec. 418.52(b)(3). The commenters requested that we add
the phrase ``and practice'' at the end of this requirement so it would
read: ``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 and practice.''
Response: Without more specific information from the commenters
regarding what practices states may unofficially have in place, we do
not believe that it is appropriate for us to add the phrase ``and
practice'' to the requirement at this time. If more specific
information is made available at a future time, we will reconsider this
suggestion.
Comment: Many commenters had concerns about the scope of the
responsibilities of hospices when investigating and reporting
violations of patient rights by hospice staff. In addition, the
commenters had concerns about the proposed timeframes for investigating
and reporting alleged violations to local authorities and State survey
agencies. Specifically, the commenters noted that it would not be
necessary to notify State and local bodies having jurisdiction about
unverified violations. The commenters also noted that alleged
violations may occur several days before the hospice becomes aware of
them, and indicated that the reporting timeframe should not begin
before a hospice even becomes aware of the alleged violation. Numerous
commenters suggested that the patient rights requirement in the home
health agency regulations at Sec. 484.10 might be more appropriate,
while others suggested that the investigation and reporting
requirements be deleted in their entirety.
Response: Requiring hospices to investigate potential violations of
patient rights by hospice staff (including contracted or arranged
services) will protect patients and their families. Reporting
violations (when verified in accordance with hospice policies and
procedures and any applicable State and local laws and regulation) is
an integral part of improving the quality of hospice care provided to
Medicare beneficiaries. At the same time, adopting regulations more in
line with those currently in the home health agency rules would not, we
believe, be appropriate for the hospice industry because hospices
typically care for more fragile patients and families in a wider
variety of patient care settings, such as private homes, long term care
facilities, and hospice inpatient units. The home health agency
requirements are narrower than what we are requiring. We believe that a
broader framework in these hospice regulations, coupled with a
hospice's own policies and procedures, will allow hospices to adapt the
requirements to the particular needs and concerns of their patient
populations now and in the future.
However, we agree that further clarifications are warranted to
ensure that a hospice assumes full responsibility for its staff, while
not overwhelming the hospice with responsibilities beyond its control.
To that end, we are requiring hospice staff that discover alleged
violations to immediately report such allegations involving anyone
furnishing services on behalf of the hospice, including contracted and
arranged services, to the hospice's administrator. The hospice
administrator must investigate violations involving anyone furnishing
services on behalf of the hospice and, if verified, the hospice must
report the violation to State and local bodies having jurisdiction
within 5 working days of any member of the hospice staff (including
those furnishing contracted or arranged services) becoming aware of the
violation in accordance with the hospice's own policies and procedures.
We would expect that significant violations, such as illegal actions by
hospice staff, would be reported to State and local bodies. We believe
that these modifications will ensure that violations are fully
addressed while not overburdening hospices.
Comment: A single commenter requested that we defer to State
requirements for violation reporting.
Response: If State requirements for reporting violations are
stricter than our Federal requirements, then those stricter State
requirements would take precedence. Stricter State requirements may be
those that require violations to be reported regardless of whether they
are verified or not, or requirements that verified violations be
reported in less than 5 days. However, if State requirements are less
stringent than Federal requirements, then the Federal requirements will
take precedence. We believe that the scope and timeframes contained in
this final rule are the minimum health and safety requirements with
which facilities could reasonably be expected to comply.
Comment: Several commenters specifically focused their concerns on
the implementation of proposed Sec. 418.52(b)(4) in the context of the
dual and possibly overlapping responsibilities of hospices that provide
services to residents of long term care facilities. In particular,
commenters suggested that hospices should only be held responsible for
those individuals functioning on behalf of the hospice and that
concerns pertaining to individuals functioning on behalf of the long
term care facility should be the responsibility of that facility.
Response: We agree that hospices should only be held responsible
for investigating and reporting violations pertaining to their own
employees and contractors. To address this comment, at Sec.
418.112(c)(8), we are setting forth a requirement that the written
agreement between the hospice and the SNF/NF or ICF/MR must contain a
provision whereby the hospice must report all alleged violations
involving mistreatment, neglect, or verbal, mental, sexual, and
physical abuse, including injuries of unknown source, and
misappropriation of patient property by anyone unrelated to the hospice
to the facility administrator within 24 hours of the hospice becoming
aware of the alleged violation.
This requirement will assure that the SNF/NF or ICF/MR is made
aware of the alleged violation in a timely manner so that it can begin
its own investigation and implement its own intervention(s). A hospice
may also want to consider incorporating a provision in the contract to
require a SNF/NF or ICF/MR to notify the hospice if any of its staff
become aware of a potential patient rights violation involving hospice
staff. Such a provision may enhance hospice-facility communication and
cooperation. In addition, we will consider this issue when developing
complementary regulations for long term care facilities.
Comment: A few commenters asked that we define the term
``immediately'' as it applies to the timeframe for reporting alleged
violations to the hospice's administrator. The commenter recommended
that the timeframe for reporting alleged violations be based on an
assessment of the patient's needs.
Response: It is in the patient's best interest to involve the
hospice administrator at the time that the potential violation is noted
to assure that the situation is adequately and expeditiously dealt
with. Once notified, it is up to the hospice's policies and procedures
and the hospice administrator's judgment, in accordance with this rule,
to handle the allegation. The hospice administrator is the designated
leader of the hospice and assumes responsibility for the care and
services furnished by the hospice, whether directly or under contract.
This is a 24-hour a day responsibility, and it
[[Page 32099]]
applies to incidences of alleged violations.
Comment: Some of commenters expressed concern regarding the manner
in which the terms ``mistreatment'' and ``injury'' are used in the
proposed patient's rights CoP. They believe the terms to be vague and
too difficult to judge objectively.
Response: The terms ``mistreatment'' and ``injury'' encompass two
important areas that affect patient safety and satisfaction. While
other terms such as ``abuse'' and ``neglect'' imply actual harm to a
patient, ``mistreatment'' is a broader term that encompasses quality of
life issues that are crucial as patients and families cope with death
and dying. We understand that the broad nature of the term makes it
difficult to judge. This judgment difficulty is exactly why we are
requiring hospices to conduct their own internal investigation into the
potential patient rights violation. We are leaving these terms mostly
undefined so that hospices may determine whether ``mistreatment'' or
``injury'' have occurred on a case-by-case basis. State tort liability
laws may serve as a guide for hospices in determining whether
``mistreatment'' or ``injury'' have occurred. Through a thorough
investigation, hospices can determine, in accordance with their own
policies and procedures, whether mistreatment occurred and what steps
need to be taken to resolve the mistreatment and prevent future
occurrences.
The presence of the term ``injury'' is also important in this
standard because it addresses other issues that may not constitute
``abuse'' or ``neglect'' but that nonetheless impact a patient's well-
being. We understand that some relatively minor injuries such as skin
tears may be perceived as injuries. By maintaining the term ``injury''
in this standard, hospices are required to fully investigate incidents
of minor injuries (like skin tears) to determine if they constitute a
violation of a patient's rights. If the internal investigation reveals
that all appropriate steps were taken to prevent the minor injury, then
the hospice may determine that the injury is not a violation of a
patient's rights. However, if the investigation reveals that reasonable
precautions were not taken, then the hospice may determine that the
injury is a violation of patient rights. In setting forth a standard in
the final rule that requires hospices to report patient injuries to the
hospice administrator, hospices have the opportunity to conduct a self
assessment to determine if care processes need to be changed to improve
the consistent delivery of quality care.
Comment: Some commenters asked for clarification regarding proposed
Sec. 418.52(c), which reads, ``The patient has a right to receive
effective pain management and symptom control from the hospice.'' While
the commenters supported the intent of this standard, they questioned
its scope. One commenter wanted to know whether this standard would
require hospices to furnish continuous home care, while another
questioned if hospices were supposed to be responsible for pain and
symptom management unrelated to the terminal and related conditions.
Still another commenter suggested that hospices should be allowed to
refer patients to other providers for pain and symptom management.
Response: Effective pain and symptom management have long been the
hallmark of hospice care, and we appreciate that the commenters
recognized the importance of this patient right. We agree that hospices
are required to furnish pain and symptom management for the terminal
illness for which the patient is receiving hospice care and conditions
related to the terminal illness. We have revised this standard and
clarified this point at Sec. 418.52(c)(1). The continuous home care
level of care described in the payment and coverage sections at 42 CFR
418.204 and 418.302 may or may not be the most effective way to provide
effective pain management and symptom control while maintaining a
patient at home.
It is acceptable for hospices to refer pain and symptom control
issues unrelated to the terminal illness and related conditions to
other providers. If a hospice were to make a referral, we would expect
the hospice to coordinate its efforts with the other provider to avoid
duplicative or contradictory therapies in accordance with final Sec.
418.56(e)(5). The goal of this coordination is to ensure that the
patient's hospice plan of care is implemented, and that the hospice
care is furnished in concert with other care sources to ensure that all
patient needs are met. In accordance with Sec. 418.100(c) hospices are
responsible for pain and symptom management related to the terminal
illness and related conditions and should not refer patients to other
providers for these issues. If a hospice does not have the expertise to
handle pain and symptom management issues related to the terminal and
related conditions, it is responsible for procuring the expertise for
the patient as part of its regular hospice services.
Comment: Many commenters suggested that we should add provisions
stating that patients have the right to refuse treatment and the right
to be involved in developing their plans of care.
Response: We agree that these are important patient rights that
should be included in this final rule. We believe that including these
rights, at new Sec. 418.52(c)(2) and Sec. 418.52(c)(3) respectively,
will help to ensure that the patient's goals and needs are consistently
reflected in the hospice's plan of care and actions.
Comment: A few commenters requested that we add a provision
requiring hospices to provide patients with a written statement of the
scope of care and services that will and will not be provided. One
commenter requested that we add a provision stating that patients have
the right to receive information about the services covered under the
hospice benefit.
Response: We agree that providing a patient with general
information about his or her hospice benefit is an important step in
ensuring that hospice patients are educated about their rights.
Therefore, we are establishing section 418.52(c)(7), which requires
hospices to provide this general benefit information.
We also agree that providing a patient with general information
about the scope of services that the hospice provides, as well as any
limitations on those services, will further empower hospice patients
and their caregivers to take an active role in hospice care planning.
Providing the patient and family a list of services that the hospice
may provide gives the patient and family an opportunity to request
specific services that the IDG had not considered. Simply knowing that
help is available may lead patients and families to reach out for it.
For this reason, we are establishing section Sec. 418.52(c)(8), which
requires hospices to provide information about the scope of services
that the hospice will provide to its patients, and specific limitations
on those services.
Comment: A single commenter requested that we add a specific
provision stating that patients have the right to continue to maintain
a relationship with their attending physician once they elect the
hospice benefit.
Response: It is understood and widely accepted throughout the
health care community, including in the hospice industry, that patients
should be allowed, even encouraged, to continue to work with their
attending physicians as they transition from one health care provider
or setting to another. The goal of this practice is to enhance
continuity and quality of care by actively including the attending
physician, who knows
[[Page 32100]]
that patient's medical and family history, in planning and delivering
the patient's hospice care. We believe that this is in the best
interest of patients and providers. Explicitly identifying a patient's
right to choose his or her attending physician without undue influence
from a hospice will help ensure that hospices and patients continue to
benefit from the knowledge of attending physicians. Therefore, we have
added this patient right at Sec. 418.52(c)(4).
Comment: A commenter requested that we add a provision stating that
patients have the right to access, request amendments to, and receive
an accounting of disclosures regarding their health information.
Response: Patient rights regarding their health information are
explicitly addressed in the HIPAA regulations at 45 CFR
164.502(a)(2)(i) and 164.524. Hospices are already required to comply
with these extensive regulations, and we see no need to duplicate the
HIPAA patient rights requirements in this rule. Therefore, we are not
adding this suggested provision.
Comment: Many commenters expressed confusion and concern about our
proposed requirement that hospices notify patients of the extent to
which payment may be expected from the patient before care is
initiated. Commenters sought clarification on how this requirement
would dovetail with the Advanced Beneficiary Notice (ABN), long term
care facility payments, and private health insurance payment rules. In
addition, commenters wanted to know if, before care is initiated,
hospices would be required to advise patients of those services that
would not be covered by the hospice because those items would not be in
the plan of care, even though the plan of care had not yet been
formulated. Some commenters suggested that, rather than providing exact
dollar amounts for patient liability, we should require a more general
description about co-pays, Medicaid spend down requirements, etc. Other
commenters requested that this notice not be in writing or that it be
provided at the time of the initial assessment rather than before any
care is provided. A single commenter requested that the requirement be
phased in over a period of time.
Response: The original intent of this proposed standard was to
educate patients and families about their potential liability in
consideration of all available payment sources. Patients and families
often come to hospice after long illnesses with pressing financial
concerns. In requiring hospices to provide information when services
are first provided (particularly on Medicare's comprehensive benefit
with minimal co-pays) we sought to alleviate some of those financial
worries. However, as many commenters noted, hospices regularly provide
this payment overview as part of their patient intake process when
patients are choosing whether or not to elect the hospice benefit. We
encourage hospices to continue this practice. Furthermore, commenters
noted that financial liability for long term care facility residents
becomes very complicated and uncertain because of the patient's
residential status. Information provided before the start of care is
likely to be inaccurate because hospices do not control the resident's
long term care facility liability. The proposed timing of the
notification and its all-encompassing nature make it impractical for
hospices to implement and would likely not increase the benefit of
hospice services to patients and families. Therefore, we are deleting
this requirement. We believe that the existing ABN requirements at 42
CFR 411.404, which require hospices to notify patients should a
particular service or item potentially not be covered by Medicare,
provide the most timely and accurate information to patients and
families. The ABN should be delivered far enough in advance that the
patient or representative has time to consider the options and make an
informed choice. The ABN should be verbally reviewed with the patient
or representative and any questions raised during that review should be
answered before it is signed.
Comment: A commenter requested that we add a provision to the
patient's rights CoP stating that patients have the right to refuse to
participate in experimental research.
Response: Ethical research practices dictate that patients must
choose to participate in experimental research and that their
participation or lack thereof may not negatively impact their well-
being. In addition, although we acknowledge that it may occur at times,
experimental research in palliative care is not, to our knowledge, a
common occurrence. We believe that the existing patient opt-in research
standard, combined with the rarity of the situation, does not warrant
us issuing a new standard within this CoP.
Comment: A few commenters suggested that we should add a provision,
either in the ``Patient's rights'' requirement or other requirements,
that ensures that long term care facility residents are provided a
choice of which hospice furnishes their care.
Response: We are aware of concern within the hospice industry about
long term care facilities that choose to not contract with hospice
providers, or to only contract with a single hospice provider to
furnish hospice services to residents. However, authority to govern
long term care facilities' actions is not contained in the hospice
regulations found in 42 CFR part 418. Therefore, we are not adding the
suggested requirement. We will however, take these comments into
consideration as we review the long term care CoPs for possible future
revisions that would address this aspect of long term care facility
responsibility relative to the care of residents.
Comment: Some commenters requested that we require hospices to
recognize board-certified chaplains as advocates for patient rights in
hospices.
Response: We expect that all hospice employees and contractors
should be patient rights advocates with the best interest of the
patients in mind at all times. We are not requiring that hospices use
patient advocates. However, if hospices choose to designate specific
patient rights advocates, they are free to do so, and are free to
select those individuals who are best suited for the task. Board-
certified chaplains may serve well in the patient rights advocate
capacity, and hospices are free to explore this option.
Comment: Another commenter requested that we add a provision
stating that patients should not be denied hospice care based on the
cost of their reasonable and necessary palliative care.
Response: Decisions about admission to hospice fall outside of the
purview of this rule, which focuses on ensuring the safe and effective
provision of quality care to patients and their families once the
patient is admitted to a hospice. Although we take this issue very
seriously, we are not incorporating the suggested provision in this
rule. We note that providers, in general, cannot be required to provide
services to Medicare patients (see Section 1802(a) of the Social
Security Act).
Comment: A single commenter suggested that patients should be
required to demonstrate their willingness to comply with the plan of
care.
Response: We understand that patient noncompliance is occasionally
an obstacle for hospices in providing safe and effective hospice care.
However, we have no authority to mandate patient compliance. It is the
hospice's responsibility to fully educate the patient and family
regarding hospice care, as well as hospice policies and
[[Page 32101]]
procedures for handling plan of care disagreements, emergencies and
other situations that may prompt patient noncompliance. For these
reasons we are not adding a patient compliance provision.
Comment: A single commenter suggested that hospices be required to
comply with any additional State reporting requirements for elder
abuse.
Response: We agree that hospices should be required to comply with
all health and safety related Federal, State and local laws and
regulations, which would include reporting requirements for elder
abuse. This rule finalizes Sec. 418.116, ``Compliance with Federal,
State and local laws and regulations related to the health and safety
of patients,'' which requires hospices to comply with State elder abuse
reporting requirements.
4. Condition of Participation: Initial and Comprehensive Assessment of
the Patient (Proposed Sec. 418.54)
The proposed assessment requirement identified the general areas
that would be included in a patient assessment and the timeframes for
completing the assessments to help hospices ensure that they were
identifying needs in all areas in a timely fashion.
The proposed comprehensive assessment requirement was divided into
five standards. The first standard, (a), ``Initial assessment,'' would
require a registered nurse to make an initial assessment visit within
24 hours of receiving a physician's admission order for care, unless
ordered otherwise by the physician. The purpose of this initial
assessment was to determine the patient's immediate care and support
needs. In the proposed rule we differentiated this initial assessment
from the hospice's evaluation of a patient's appropriateness for
hospice care. We stated that visiting a patient to determine his or her
appropriateness for hospice care does not constitute an initial
assessment.
The second standard, (b), ``Timeframe for the completion of the
comprehensive assessment,'' proposed that the hospice IDG and the
patient's attending physician complete the comprehensive assessment no
later than four calendar days after the patient elected the hospice
benefit. The four day timeframe was proposed because many hospice
patients are admitted to hospice late in their terminal illness and
often require intensive hospice services at the beginning of their
hospice stay. A hospice must assess a patient to identify his or her
needs before it can develop and implement a plan of care to meet those
needs. Therefore, a timely assessment is necessary to properly care for
a patient.
In the third standard, (c), ``Content of the comprehensive
assessment,'' we proposed that hospices identify the physical,
psychosocial, emotional, and spiritual needs of the patient related to
the terminal illness and related conditions. As proposed, the
comprehensive assessment would include information about the terminal
condition, complications and risk factors, an initial bereavement
assessment, a drug profile review, and any further referrals or
evaluations, as appropriate. We did not propose that hospices use a
specific assessment form or tool.
Under proposed standard (d), ``Update of the comprehensive
assessment,'' the hospice IDG would be required to update each
patient's comprehensive assessment no less frequently than every 14
days and at the time of each recertification. The proposed
comprehensive assessment update would document changes that had
occurred since the last assessment, including the patient's progress
toward desired outcomes and the patient's response to the care
furnished by the hospice. We proposed these update timeframes because
the condition of a hospice patient is expected to change over the
course of hospice care, and often does so quite rapidly, considering
that the median length of a hospice stay is about 26 days.
The final standard in this proposed CoP, (e), ``Patient outcome
measures,'' would require hospices to include, as part of the
information gathered by the comprehensive assessment, data elements to
allow hospices to measure patient outcomes. This standard proposed that
the data elements would be collected and documented in the same manner
for all patients in order to ensure the accuracy and consistency of the
data. Hospices would be required to use the data in individual care
planning and the quality assessment and performance improvement program
described in proposed Sec. 418.58. We did not propose to require
hospices to use any specific patient outcome measures or data elements.
Comment: Many commenters requested that we clarify in the opening
paragraph of the CoP that hospices are not required to assess a
patient's condition beyond the patient's need for hospice care and
services related to the terminal illness and related conditions.
Commenters suggested that we delete the phrase ``but is not limited
to'' because it implies that hospices are required to assess and
address areas beyond the boundaries of the terminal illness and related
conditions.
Response: The Medicare hospice benefit covers all care provided by
hospices for the palliation and management of an individual's terminal
illness and related conditions. Hospices are required to furnish these
services; however, they are not required to furnish services for needs
unrelated to the terminal illness and related conditions. Our intent in
specifying that hospices are not limited to assessing the patient's
status and needs associated with the terminal and related conditions
was to explicitly permit hospices to look beyond the terminal and
related conditions to gain a complete picture of the patient. We did
not intend to imply that hospices would be required to provide care for
those issues that are outside of the scope of hospice care under the
hospice benefit. In order to clarify our intent in the second sentence
of the CoP, we have removed the phrase ``but is not limited to'' and we
have replaced the word ``care'' with ``assessment''. The final sentence
of the introductory paragraph at 418.54 now reads, ``This assessment
includes all areas of hospice care related to the palliation and
management of the terminal illness and related conditions.''
Modifying the requirement does not mean that hospices are
prohibited from identifying and/or addressing issues and areas of
patient need outside of the hospice benefit, even though hospices are
not responsible for providing services for these issues. Indeed, not
gathering the information may make it more difficult for hospices to
effectively plan to care for a patient because important information
would not be available when making care planning decisions.
Comment: The majority of commenters who submitted comments in this
section expressed concern about the timing of the initial assessment.
Commenters seemed unclear about the proposed requirement that hospices
would have 24 hours from the time that a physician order is received to
make the assessment. Additionally, commenters were concerned that the
proposed rule, as written, would not allow hospices to adjust the
initial assessment timeframe based upon patient and family wishes. Many
commenters specifically requested that we replace the term
``physician's order for care'' with ``physician's certification'',
which would require the assessment to be completed after the physician
has certified that the patient is terminally ill and thus an
appropriate candidate for hospice care. A few commenters explicitly
disagreed with
[[Page 32102]]
this suggestion. Several other commenters questioned the role that the
patient's election to receive hospice care played in determining when
to begin the timeframe for completing the assessment.
Response: We agree that a more definitive time point needs to be
established and that patient and family wishes should be taken into
account when establishing this timeframe. We recognize that some
patients are self-referred and therefore may not have a physician's
order for hospice care. These patients could create uncertainty in
hospices because hospices would not know when to begin the 24 hour
period for completion of the initial assessment. This uncertainty could
lead to situations of non-compliance that are out of the hospice's
control. We do not believe that this would be in the best interest of
patients or hospices; therefore, we are revising the timeframe language
as requested by many commenters.
In order to clarify the length of time that hospices have to
complete the initial assessment, we have referenced language used in
Subpart B, Eligibility, election and duration of benefits, of the
existing hospice regulations, into the initial assessment requirement
at Sec. 418.54(a). Once a hospice has obtained an election statement
for a particular Medicare or Medicaid patient in accordance with the
requirements of Subpart B, the hospice has 48 hours to complete the
initial assessment, unless the patient, his/her representative, and/or
physician request an expedited timeframe. Since election requirement is
particular to the Medicare and Medicaid hospice benefits, hospices are
free to establish a similar starting point for non-Medicare and
Medicaid patients in their own policies, based on the needs of the
hospice, its community, and any applicable State and local laws and
regulations.
We also agree that the needs of patients or their representatives
should be taken into consideration when completing the initial
assessment. There are times when patients or representatives may want
to expedite the initial assessment, and their wishes, along with the
health status of the patient, should be taken into account when
scheduling and completing the initial assessment. For example, a
patient's representative may request that the hospice complete the
initial assessment in a shortened timeframe because the patient is in
acute distress and requires immediate hospice assistance. We would
expect the hospice to consider the patient's or representative's
request for a change in the initial assessment timeframe when
scheduling the necessary visit(s) to complete the initial assessment.
Therefore, we have modified the language to state that the patient or
representative may request that the initial assessment be completed in
less than 48 hours.
If a patient or representative wishes to delay the completion of
the initial assessment, it would not be appropriate to have that
patient or representative elect the hospice benefit. When a patient
elects the hospice benefit she waives the right to receive all other
Medicare covered services for the terminal illness and related
conditions. If the patient may not receive all other Medicare covered
services for the terminal illness and related conditions, and that
patient cannot receive hospice services because she has not received an
initial assessment to determine her immediate care needs, then the
terminally ill patient is effectively without health care for the
intervening time period. We do not believe that this is an acceptable
situation.
Standard (a), ``Initial assessment,'' now states, ``The hospice
registered nurse must complete an initial assessment within 48 hours
after the election of hospice care in accordance with Sec. 418.24 is
complete (unless the physician, patient, or representative requests
that the initial assessment be completed in less than 48 hours).''
Comment: A few commenters expressed support for separating the
initial assessment from the comprehensive assessment.
Response: We agree that separating the assessment requirements will
enable hospices to quickly assess the most critical areas of need and
begin furnishing appropriate care while ensuring that all areas of need
are assessed by the appropriate disciplines in a timely manner.
Comment: Some commenters requested that we replace the requirement
that hospices complete initial assessments within 24 hours with a
requirement that hospices make or make available an initial patient
contact within 24 hours of receiving a referral. In addition,
commenters requested that any hospice employee, or at least an RN or
social worker, be permitted to make this initial contact.
Response: We understand there may be some confusion in the hospice
community about the purpose of the initial assessment. The purpose of
the initial assessment is to gather the critical information necessary
to treat the patient's immediate care needs. The initial assessment is
not a ``meet and greet'' visit whereby the hospice introduces itself to
the patient and begins to evaluate the patient's interest in and
appropriateness for hospice care. As the commenters stated, the initial
patient contact takes place before the hospice assumes responsibility
for the patient's care. Hospices may choose the timeframe and
appropriate individual for completing this initial contact.
It is not appropriate to substitute an initial contact for an
initial assessment. Merely requiring an initial contact within 24 hours
would not be sufficient to meet the needs of critical patients.
Patients often come to hospice in moments of crisis. An initial contact
when a patient is in need of timely assistance would be a disservice to
the patient and family and would not lead to effective, high quality
care. Hospices may choose to send a social worker or other discipline
to complete the initial assessment along with the RN, and this may lead
to better patient outcomes and satisfaction. Because other disciplines
do not have the skills necessary to independently complete the initial
assessment, we are not incorporating the commenters' suggestions.
Comment: Several commenters suggested that we change the phrase
``RN must make an initial assessment visit'' to ``RN must complete an
initial assessment.'' Similarly, another commenter suggested that we
require that ``the hospice registered nurse must perform and document
an initial assessment visit.'' The commenters stated that their
proposed revised language would clarify our intent that, rather than
simply making a visit to begin the initial assessment, the initial
assessment must be fully complete within the specified timeframe.
Response: The commenters are correct in their assertion that the
initial assessment must be completed, not just started, within the
timeframe. Completing the initial assessment, which means that it is
both performed and documented, enables the hospice to determine the
patient's immediate care and support needs in a timely manner. An
accurate determination of care and support needs cannot be made until
the initial assessment is complete; therefore, we agree that it is
necessary that it be completed within 48 hours. We have clarified the
requirement to read, ``The hospice registered nurse must complete an
initial assessment within 48 hours * * * .''
Comment: A few commenters questioned the role of the hospice
physician in completing the initial assessment.
Response: The initial assessment completed by hospice staff must
address the patient's critical physical, psychosocial and emotional
status
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related to the terminal and related conditions. It is likely not the
most efficient use of a physician's time to complete a task (the
initial assessment) that can be fully handled by a registered nurse.
Therefore, we continue to require that a registered nurse complete the
initial assessment. This requirement in no way prevents a hospice from
using the knowledge and skills of both a registered nurse and a
physician to complete the initial assessment. A physician who is
employed by or under contract with a Medicare hospice cannot bill
separately for the initial and comprehensive assessments.
Comment: Several commenters requested that we revise the timeframe
for completing the initial assessment. Suggestions included 48 hours,
72 hours, the close of the day following the day the patient is
referred, and 24 hours ``when reasonably possible.'' Other commenters
requested that the timeframe be deleted completely.
Response: Establishing a clear and consistent timeframe for
completing the initial assessment is essential to ensuring that
patients benefit from hospice care early in their stay. Completing the
initial assessment within 48 hours will help hospices gather the
essential information to begin a plan of care that addresses the
patient's needs before those needs escalate and become extremely
difficult to address.
Overall, many commenters stated that the 24 hour timeframe for the
initial assessment, as we proposed, was too restrictive. In this final
rule we have effectively increased the length of the timeframe by
changing its starting point from the time the physician's order is
received to the time that the election statement is complete in
accordance with the applicable requirement of Subpart B. Under the
proposed rule, hospices would have been required to complete the
initial assessment within 24 hours of the physician's order to begin
hospice care, even if the hospice was unable to schedule a visit with
the patient and family within that timeframe. Under the revised final
rule language, hospices have 48 hours after the patient elects the
hospice benefit to complete the initial assessment. At times, a
patient, representative, or physician may request that the
comprehensive assessment be completed in a timeframe less than 48
hours, and we expect hospices to accommodate such requests when they
are made.
Comment: Many commenters questioned the role of the patient's
attending physician in completing the comprehensive assessment. Some
commenters explicitly requested that hospices should not be required to
involve attending physicians. Other commenters requested that a
provision be added permitting attending physicians to ``opt out'' of
participating in the assessment. Still others indicated that we should
require attending physicians to approve, in writing, the content of the
comprehensive assessment.
Response: The scope of public comments submitted regarding the role
of the attending physician in hospice care suggested that there is no
single model that applies. Some commenters indicated that community-
based attending physicians provide a leading role in hospice care,
actively participating in the IDG, writing orders, and even making
visits. Some commenters, however, indicated that community-based
attending physicians preferred to step back once a patient has elected
hospice, typically transferring their patients to the hospice
physician's care. While we are pleased to know that there are many
attending physicians who wish to stay involved in caring for their
patients, these physicians should not assume that their attending
physician service role is part of the hospice benefit. Likewise, while
we are pleased to know that hospices are fully prepared to care for all
of their patients needs, including those needs unrelated to the
terminal illness and related conditions that the attending physician
would be responsible for, it would be inappropriate for a hospice to
influence a patient to relinquish his or her attending physician.
At the same time, we are sensitive to the concerns expressed by the
hospices. Some patients do not have attending physicians. Some patients
do not want to continue seeing their attending physicians. Some
attending physicians may be unresponsive to, or uncooperative with, the
hospice. We do not want to place patients in a position where they must
choose between receiving services from their attending physician and
their hospice, nor do we want to place hospices in a position where
they are forced to handle difficult attending physicians who disrupt
their operations.
In light of these considerations, we are maintaining the
requirement that hospices consult with the patient's attending
physician when completing the comprehensive assessment. Involving the
attending physician to the extent possible will allow hospices to gain
additional information about the patient. Attending physicians can
often provide a lengthy history of the patient's disease process and
family dynamics can help the hospice make better care planning
decisions that result in improved patient outcomes. In recognition of
the fact that not all patients have willing attending physicians, we
have added a caveat that this consultation need only occur if there is
an attending physician to consult with. In this way, attending
physicians may, with the patient's agreement, opt out of following the
patient's care through the patient's hospice stay. We are not, as some
commenters suggested, requiring that the attending physician sign a
document approving the content of the comprehensive assessment. Rather,
we leave it to hospices to define in their own policies and procedures
how they will document that they have conferred with the attending
physician. We believe that this will give hospices the ability to
structure their communication and coordination system in a way that
meets their needs for timely information sharing and documentation.
Comment: Several commenters wanted to know if the consultation with
the attending physician to complete the comprehensive assessment could
be accomplished over the telephone or through electronic communication
methods.
Response: A hospice would need to consult with willing attending
physicians in accordance with its own policies and procedures. If a
hospice's policies and procedures permitted it to consult with
attending physicians on the telephone or through electronic
communications, then that would be an acceptable practice. Rather than
dictate what is or is not an acceptable communication method, this rule
seeks to ensure that these communications occur. Effective
communication between the hospice and attending physician in completing
the comprehensive assessment will enable a hospice to develop a more
complete understanding of the patient and family in order to develop a
plan of care that addresses all areas of need related to the terminal
illness and related conditions.
Comment: A majority of commenters addressed the issue of the length
of time necessary to complete the comprehensive assessment. As with the
initial assessment, some commenters questioned the exact time that the
timeframe began. Some commenters expressed strong support for the
proposed four-day timeframe, with a few commenters even suggesting
that, in the future, we should move to a two- or three-day timeframe.
Other commenters suggested that the timeframe should be lengthened to
five, seven, eight, or even 14 days. Some suggested that no
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timeframe be established at all. Still other commenters suggested that
we should add a caveat that completion of the comprehensive assessment
should be dependent upon the patient's condition.
Response: Completing the comprehensive assessment is an integral
step in hospice care. The information gathered in the comprehensive
assessment is the basis for completing the plan of care. If the
information is not gathered in a timely manner, then completing the
plan of care is delayed. This results in patients and families not
receiving all of the services they need in order to maximize comfort
and dignity and achieve the patient's and family's hospice care goals.
Comprehensive assessment plays an important role in hospice care and a
reasonable time is needed for its completion. The timeframes suggested
by the commenters varied greatly, with some being so short as to
potentially preclude hospices from conducting a truly thorough
assessment and some being so long as to virtually ensure that hospices
would never be required to complete comprehensive assessments for more
than 30 percent of their patients. Neither extreme would successfully
meet the needs of patients and hospices.
In the middle are the commenters who suggested maintaining the
four-day requirement, lengthening it to five days, or lengthening it to
seven days. While we appreciate the support from commenters who agreed
with the proposed four-day timeframe, we agree with those commenters
who suggested that a longer timeframe would be more appropriate due to
the scheduling demands of hospice providers. We have lengthened the
timeframe from four days to five days. Allowing hospices another day to
complete the comprehensive assessment will allow more time to schedule
the necessary contacts.
While we have lengthened the timeframe, we note that it is a
maximum, a length of time that should not be exceeded. The timeframe
should not be misinterpreted to prevent hospices from completing the
comprehensive assessment earlier than five days after the patient or
representative elects the hospice benefit. Indeed, we encourage
hospices to complete comprehensive assessments in less than five days
if at all possible. This is particularly true for patients who enter
hospice in crisis. While the initial assessment will provide the
necessary information to begin the plan of care for these critical
patients, it is the comprehensive assessment that will fill in
important pieces of information to be used to maximize the patient and
family's physical, emotional and spiritual comfort. While we recognize
that a portion of patients enter hospice at the end stage of the
disease process and may die in less than five days after electing the
hospice benefit, their physical condition does not necessarily absolve
hospices of the responsibility to comprehensively assess these
patients. The hospice is still responsible for taking all appropriate
steps to complete the comprehensive assessment as that assessment is
tailored to the patient's areas of need. The ability of hospices to
tailor the exact content of the comprehensive assessment, and the
individuals who complete it, to the needs of patient and families
addresses concerns about extremely short stay patients who may not be
contacted by all disciplines before death. We do not expect or require
designated disciplines to complete assessments if those assessments are
not indicated as being necessary during the initial assessment and any
subsequent contacts.
Comment: A few commenters suggested that we eliminate certain areas
from the comprehensive assessment. In particular, commenters suggested
that we eliminate the requirement that hospices assess spiritual or
potential bereavement issues as part of the comprehensive assessment.
Commenters noted that eliminating either of these areas from the
comprehensive assessment would make it easier to complete the
comprehensive assessment within the required timeframe. The commenters
acknowledged that these areas would still need to be assessed, and
stated that completing the assessments by the time of the first IDG
meeting would be sufficient.
Response: As discussed above, we agree that fully assessing all
areas may require more than the four days we initially proposed for
this process. For this reason, we have extended the timeframe from four
days to five days. We believe that this approach, rather than carving
out certain sections of the comprehensive assessment, best meets the
flexibility needs of hospices and the care needs of patients. In
maintaining both the spiritual and bereavement assessment requirements,
hospices will be required to ensure that patient and family specific
information about these important areas is gathered in a timely manner
to inform the care planning decisions. At the same time, allowing
hospices more time to schedule the necessary contacts to gather this
information will ensure that hospices have the flexibility to
incorporate new patients into existing workloads and schedules. We
believe that this solution accommodates the concerns of the commenter