[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
[[Page 32103]]
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
[[Page 32104]]
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 commenters
without separating these two key areas from the comprehensive
assessment.
Comment: Some commenters requested that the final sentence of the
introductory paragraph of standard (c) be revised. The commenters
stated that characterizing the comprehensive assessment as a
description does not fully capture the role of the comprehensive
assessment. Commenters suggested that we use either the phrase, ``[t]he
comprehensive assessment must take into consideration the following
factors,'' or the phrase, ``[f]actors that must be considered in
developing the individualized care plan interventions include'' in its
place.
Response: We agree that more expressive language is useful in
introducing the elements that the comprehensive assessment must
contain. Since both of the suggested phrases achieve the same goal, we
chose to incorporate the more concise statement because it will likely
lead to less confusion. Therefore, the final sentence of the
introductory paragraph at Sec. 418.54(c) states, ``[t]he comprehensive
assessment must take into consideration the following factors.''
Comment: Several commenters suggested that we should add a new
element to standard 418.54(c), ``Content of the comprehensive
assessment,'' which would address the issue of the patient's functional
status and the impact of that status on the patient's ability to
understand and participate in care planning and implementation.
Response: We agree that the functional status of the patient, both
physically and mentally, impacts the patient's ability to participate
in his or her own care and the hospice's ability to furnish that care.
Furthermore, we agree that this information should be collected as part
of the comprehensive assessment. Therefore, we have added a new element
at Sec. 418.54(c)(3) that requires hospices to assess the patient's
``[f]unctional status, including the patient's ability to understand
and participate in his or her own care.''
Comment: Several commenters suggested that we add a new element to
standard 418.54(c), ``Content of the comprehensive assessment,'' which
would address the issue of the imminence of death.
Response: We agree that assessing the imminence of the patient's
death is an important part of the comprehensive assessment. A certain
portion of hospice patients have extremely short hospice stays of three
days, and sometimes less
[[Page 32105]]
than that. The imminence of a patient's death will often drive the type
and frequency of services provided to a patient. Published studies and
reports (Medpac, ``Report to the Congress: Increasing the Value of
Medicare,'' Chapter 3, June 2006; Huskamp, H., Buntin, M.B., Wang, V.,
and Newhouse, J., ``Providing Care at the End of Life: Do Medicare
Rules Impede Good Care?'', Health Affairs, 2001) have noted that
hospice per-patient expenditures are highest in the last few days of
life. This indicates that the pattern of care for a patient in the last
days of life will likely be different than for a patient who is
expected to receive hospice services for several weeks or months.
Identifying the imminence of death as part of the comprehensive
assessment will allow hospices to more accurately tailor the plan of
care to the patient's status. We are adding this element as new Sec.
418.54(c)(4).
Comment: Numerous commenters suggested that we add a new element to
the comprehensive assessment standard (c), which would address severity
of symptoms.
Response: We agree that the severity of a patient's symptoms is an
important aspect of the comprehensive assessment that should be
assessed for all patients, and we have added this requirement as new
Sec. 418.54(c)(5). Gathering accurate information about symptom
severity will allow hospices to make more accurate care planning
decisions. We are not prescribing how hospices must assess symptom
severity. There are numerous pain and distress scales available for use
and we do not endorse one scale over another. Hospices have the
discretion to identify the manner in which they will assess and
document symptom severity for their patients. We anticipate, over time,
that useful tools for patient assessment will emerge, and that the
hospice industry will select the most effective and efficient
assessment tools to use as part of a standard patient assessment
practice. We may revisit the patient assessment requirements in the
future to ensure that the requirements reflect current standards of
practice.
Comment: Many commenters supported our proposed requirement that
hospices complete a medication review for each patient as part of the
comprehensive assessment. The commenters suggested that further
clarification was needed with regard to the requirement that hospices
include a review of a patient's prescription and over-the-counter
drugs. Commenters suggested that this review should include all drugs
and alternative therapies, even those unrelated to the terminal illness
and related conditions. Furthermore, some commenters suggested that
hospices should be required to differentiate in their documentation of
this review which drugs were and were not related to the terminal
illness and related conditions. Some commenters noted that hospices
should not be held responsible for not being aware of drugs that they
were not informed of by the patient, family, physician, or other health
care provider.
Response: We thank the commenters for their support and agree that
the drug profile review should include all drugs, herbal remedies and
other alternative treatments that could affect drug therapy, whether
those drugs and remedies are related to the terminal illness and
related conditions or not. This thorough review must document all
substances which the patient is using. While we understand that
patients and families may be unwilling to disclose the use of certain
substances, we expect hospices to use all available and appropriate
methods to develop a complete list. These efforts may include asking
the patient, family, attending physician, and any other health care
providers. Efforts may also include asking to look at all medications
in the home, being attentive to tell-tale odors, and looking for
medication-specific equipment in the home. Hospices may choose how to
document the drug profile review and the efforts made to complete it in
the manner that best suits their individual needs. While we agree that
it may be helpful for hospices to note the relationship of a drug and
therapy to the terminal illness and related conditions, we do not
believe that it is necessary to prescribe this level of documentation
detail in regulation.
Comment: A few commenters suggested that we restructure the
comprehensive assessment standard to de-emphasize the bereavement and
drug therapy sections of the comprehensive assessment. The commenters
acknowledged that these are important areas to assess; however, they
believe that their placement within the standard appeared to place more
value on these two elements than on the other elements of the standard.
Response: We agree that neither bereavement nor drug therapy should
appear to take precedence over the other comprehensive assessment
elements. The drug therapy requirements, now referred to as drug
profile requirements, are now codified at Sec. 418.54(c)(6) and the
bereavement requirements are now codified at Sec. 418.54(c)(7), on par
with the other elements of the standard.
Comment: Many commenters suggested that we should rephrase the
requirement that hospices identify ``ineffective drug therapy'' as a
requirement that hospices assess the ``effectiveness of drug therapy.''
A single commenter suggested that this requirement should be removed
because it is not within the nurse's scope of practice.
Response: We agree that the phrase ``effectiveness of drug
therapy'' is more inclusive and will help to capture the range of
effectiveness of different drugs and therapies. For example, rather
than noting that drug B is ineffective and remaining silent on the
effectiveness of drugs A and C, this new requirement will require
hospices to note for example, that drug A is fully effective, but only
for a few hours, drug B is completely ineffective, and drug C is
consistently minimally effective. The additional level of detail
required by this new provision will help hospices develop a more
complete overall assessment from which to make more accurate care
planning decisions. This new provision is located at Sec.
418.54(c)(6)(i). If a nurse is unable to complete this part of the
assessment, then it is appropriate for a hospice to use another
discipline to complete the drug profile assessment.
Comment: Some commenters suggested that we require hospices to
identify all drug side effects, rather than only those side effects
that are not wanted. In addition, the commenters suggested that we
delete the term ``toxic'' because the phrase ``drug side effects''
would include issues of toxicity.
Response: Our original intent was to ensure that bothersome side
effects were noted in the drug assessment so that they could be
addressed in the care planning process. However, as the commenters
noted, all side effects should be noted, even if they are desirable.
Identifying desirable, as well as undesirable, side effects will help
ensure that the desired side effects are not negatively impacted by
other drugs and their side effects. Additionally, as the commenters
noted, the term ``toxic'' is unnecessary. Any toxic effects would
already be recorded as side effects, rendering the term ``toxic''
duplicative. Therefore, we are deleting the terms ``unwanted'' and
``toxic'' from Sec. 418.54(c)(6)(ii), and are simply requiring that
the hospice review the patient's drug profile for side effects.
Comment: Several commenters suggested that we require hospices to
evaluate potential as well as actual drug interactions.
Response: We agree that more specificity is needed to clarify our
intent. We agree that hospices must identify drug interactions that
have
[[Page 32106]]
occurred in the past or are occurring at the time of the assessment if
at all possible, and must identify drug interactions that have the
potential to occur if the patient continues using the same drugs. The
lack of a drug interaction to date does not mean that an interaction
will never occur as long as the patient continues to use the
potentially interacting drugs. The individual completing the drug
profile must document the existence of the potential interaction so
that the entire IDG is made aware of the potential problem and can then
make an informed decision about the patient's drug regimen. For these
reasons, we are revising the drug profile requirement at Sec.
418.54(c)(6)(iii), to require the hospice to evaluate both actual and
potential drug interactions.
Comment: A commenter suggested that we require hospices to
determine whether the patient is using duplicate medications or
medications that require laboratory monitoring.
Response: We agree that adding these provisions will help hospices
gather more detailed information from which to make accurate care
decisions. Patients often come to hospice with a long list of
medications prescribed by several different doctors. It is very
possible that some of these medications have overlapping effects, in
which case one or more medications may be safely and appropriately
discontinued. Identifying unnecessary/duplicate drugs and subsequently
eliminating them will make it easier for patients to follow their drug
regimens. Identifying drugs that currently require laboratory
monitoring during the assessment will also help patients and hospices.
Some patients come to hospice with the explicit desire to forgo more
laboratory tests. It is imperative that hospices identify any drugs
that the patient is currently taking that may require these tests so
that patients know about the situation and the options available to
them to help achieve their goals. Identifying drugs that require
laboratory testing will enable patients to make informed decisions and
may lead patients to forgo the use of certain drugs. For these reasons,
we have incorporated these two suggestions at Sec. 418.54(c)(6)(iv)
and Sec. 418.54(c)(6)(v).
Comment: A commenter suggested that, as part of the drug review,
hospices should be required to identify:
Medications that are unnecessary or are not consistent with patient
therapy goals; Medications requiring dosage optimization; Medications
that are inappropriate according to evidence based guidelines; and
Missing medications that are necessary to prevent or address symptoms
experienced by the patient.
Response: The purpose of the drug profile assessment is to gather
the information necessary to enable the hospice to make appropriate
care decisions, and it is the role of the individual completing this
portion of the assessment to collect this information. Several of the
commenter's suggestions (1, 3 and 4) require the individual completing
the drug profile portion of the assessment to draw conclusions. We
believe that these conclusions should be made by the IDG during care
planning, rather than by a single member of the IDG who is completing
this portion of the assessment. Suggestion 2 is already captured by the
requirement that hospices review the effectiveness of drug therapy at
Sec. 418.54(c)(6)(i). If a drug dosage needs adjustment, then that
need will be reflected in its level of effectiveness. For these
reasons, we are not incorporating these suggestions.
Comment: Numerous commenters expressed concern about the role of
the initial bereavement assessment in the comprehensive assessment and
in the bereavement plan of care. In particular, commenters noted that
the information gathered in the initial bereavement assessment may not
remain accurate when the patient dies and may unintentionally result in
poor decision making in the final bereavement plan of care. For this
reason, some commenters requested clarification of the role that the
initial bereavement assessment plays in the final bereavement plan of
care. Other commenters suggested that we substitute the hospice plan of
care for the bereavement plan of care. This would require hospices to
use the information gathered in the initial bereavement assessment when
developing the plan of care, but not when developing the bereavement
plan of care. Still other commenters suggested that the initial
bereavement assessment be completely removed from the comprehensive
assessment.
Response: We appreciate the valuable insight that the commenters
provided about the role of the initial bereavement assessment in
hospice. The comments validated our understanding that hospices already
assess patients and families for actual and potential bereavement
issues before the patient's death rather than waiting until after death
to begin this process.
We also appreciate the suggestions to help clarify the role of the
bereavement assessment within the comprehensive assessment. We agree
that the information gained in the initial bereavement assessment
should be incorporated into the hospice plan of care. Issues identified
in the initial bereavement assessment such as anticipatory grief and
previous experiences with loss should inform care planning decisions
long before the patient dies. By requiring hospices to incorporate
bereavement assessment information into the plan of care, hospices will
be able to develop a more complete picture of the patient and family.
Likewise, we agree that feelings can change over time, rendering
the information gathered in the initial bereavement assessment moot at
the time of the patient's death. For this reason, we are no longer
requiring that information gathered from the initial bereavement
assessment be incorporated into the bereavement plan of care. Rather,
we are requiring that the information from the initial bereavement
assessment be considered in the bereavement plan of care. This change
still requires hospices to begin the bereavement assessment process
early in the patient's stay. However, the change reflects that fact
that the bereavement assessment will change as it is updated.
Furthermore, the change allows hospices to use the most accurate
bereavement assessment information, regardless of when it was obtained,
in developing the bereavement plan of care.
Comment: A single commenter suggested that we require, as part of
the comprehensive assessment, that hospices assess the family's needs
along with the patient's needs.
Response: One of the most unique aspects of hospice, and one of the
most valued, is that it treats the patient and family as a single unit
of care. Hospices recognize that patients do not live in a vacuum.
Rather, patients are continually affected by the well-being, or lack
thereof, of the people who surround and care for them. We in no way
want to discourage this holistic practice. However, comprehensively
assessing all of the needs of the patient's family, as we require for
the patient, is beyond the scope of the Medicare and Medicaid hospice
benefits. Therefore, we are not incorporating this suggestion.
Comment: A few commenters suggested that we should add the phrase
``consistent with patient self-determination'' to the description of
the elements that must be included in the comprehensive assessment. The
commenters expressed that adding this phrase would convey to hospices
that the comprehensive assessment is patient-driven.
Response: We agree that, within the broad outline provided in this
rule, the
[[Page 32107]]
comprehensive assessment is a patient-driven process. Hospice has a
long history of tailoring patient care, including assessments, to the
needs and desires of the patient. We do not believe that the new
comprehensive assessment requirement will alter this existing practice
because it provides broad outlines that allow hospices to continue
tailoring their care. Therefore, we do not believe that adding the
phrase ``consistent with patient self-determination'' is necessary.
Comment: A single commenter suggested that we should add a new
element to Standard (c), which would address the issue of the need for
hospices to assess pain and symptom management as well as emotional and
spiritual support.
Response: We agree that these are important areas to be assessed;
however, we do not agree that they need to be separated out as new
elements. Standard (c) already requires hospices to ``identify the
physical, psychosocial, emotional, and spiritual needs'' of the
patient. The specific issues of pain and symptom management and
emotional and spiritual support are addressed by these broader
categories, and therefore do not require separate elements in the
assessment. To do so would be duplicative.
Comment: A few commenters asked us to specify which disciplines and
providers within those disciplines must complete the comprehensive
assessment. For example, one commenter asked us to specify the type of
personnel who are qualified to provide a spiritual assessment. Many
other commenters wanted us to specify that only certified chaplains
should perform this function. Another commenter questioned whether MSWs
should be required to complete social work assessments and whether,
based on those assessments, patients could then be assigned to a
baccalaureate degree prepared social worker.
Response: A comprehensive assessment, in the context of this rule,
is not a single document that all hospice providers are required to
use. Instead, it is a flexible evaluative process that could be
different for each hospice based on the hospice's own needs. If a
hospice chooses to implement a policy that an MSW must assess the
status and needs of all patients, then we would expect the hospice to
follow its own policy. Likewise, if a hospice chooses to implement a
policy that certified chaplains must be used to assess all patients who
do not have existing spiritual support systems while community
religious leaders must be used to assess all patients who have existing
spiritual support systems, then we would expect the hospice to follow
its own policy. These examples illustrate the flexible nature of the
assessment requirement. To prescribe who may or may not complete
different elements of the comprehensive assessment, or even what areas
of care must be assessed, would remove this flexibility. We do not
believe that removing flexibility is in the best interest of patients
or hospices; therefore we are not adopting these suggestions.
Comment: A single commenter observed that the plan of care could
not be completed until the comprehensive assessment was completed.
Response: The commenter is correct; however, the initial assessment
would already have gathered the most critical clinical and psychosocial
information, which would enable the hospice to begin completing the
plan of care. Once the comprehensive assessment is complete, the
hospice must then finish the plan of care based on the needs identified
in the comprehensive assessment. Hospices may not wait until the
comprehensive assessment is complete to begin to formulate the plan of
care and provide services, as the commenter seemed to imply. Such
waiting, when the hospice has assumed responsibility for caring for the
patient and the patient has forgone all other services related to the
terminal illness, would be a disservice to the patient and would likely
lead to negative patient outcomes, patient and family complaints, and
numerous other undesirable effects.
Comment: Several commenters expressed confusion about who would be
responsible for completing the comprehensive assessment, how it would
have to be completed, and who would review its content. Specifically,
commenters suggested that the hospice registered nurse be required to
complete the comprehensive assessment and that the IDG be required to
review its content. Other commenters questioned whether all disciplines
were required to make in-person visits or whether phone contacts could
be used to complete the assessment.
Response: The comprehensive assessment is not a single static
document, a symptom and severity checklist, or a set of generic
questions that all patients are asked. It is a dynamic process that
needs to be documented in an accurate and consistent manner for all
patients. While the comprehensive assessment often begins with a
nursing assessment that is focused on the patient's physical status and
conducted by a registered nurse, it does not end there. The
comprehensive assessment must also focus on the patient's psychosocial
and emotional status and needs, and this piece is often assessed by a
social worker. In addition, the comprehensive assessment must address
the patient's spiritual status and needs, which is often the domain of
the pastoral or other counselor who is a member of the patient's IDG.
Furthermore, the comprehensive assessment must focus on identifying any
other needs that fall into the scope of the physical therapist, speech
language pathologist, occupational therapist, dietitian, or any number
of other disciplines that a hospice may provide. A nurse is not
qualified to provide detailed assessments in all of these areas;
therefore we cannot place the burden of completing the comprehensive
assessment on the nurse alone. The broad nature of the comprehensive
assessment requires the active involvement of all of the members of the
IDG in order to ensure that a complete and accurate picture of the
patient and family is obtained.
The active involvement can occur in any number of ways depending on
the patient's needs and preferences. Some families may need a face-to-
face visit from a social worker to help them sort through myriad
insurance papers or simply provide a supportive presence, while other
families may find it easier to discuss difficult issues by phone. If
families need or prefer in person visits, then those needs should be
met. If they prefer the limited anonymity afforded by the telephone,
then their preference should be accommodated. We cannot provide the
clear cut answer that commenters are seeking because each patient,
family, and situation is different. Decisions about who assesses and
how they assess need to be based on the needs of the patient and family
and the hospice's own policies and procedures.
Comment: A single commenter suggested that we should create a
separate standard for assessing patients with short lengths of stay.
The commenter stated that a separate standard would avoid overwhelming
patients and families.
Response: We agree that patients and families should not be
overwhelmed in the last days of life. However, we do not agree that a
separate short stay assessment standard is necessary. We are finalizing
a requirement that hospices complete an initial, abbreviated patient
assessment within 48 hours of the patient or representative electing
the hospice benefit. This assessment, conducted by the hospice
[[Page 32108]]
nurse in conjunction with other appropriate hospice staff, will provide
hospices with the essential information to formulate a plan of care to
address the patient's immediate care and support needs without
overwhelming the patient and family. We believe that patients who stay
for a short time in hospice will be well served by this initial
assessment. Length of stay should not be the determinant of the quality
of care that is to be furnished. For those patients who stay for a
longer period of time, we are requiring hospices to complete a
comprehensive assessment within five days of the patient or
representative electing the hospice benefit. We are not prescribing
what areas of hospice care must be assessed (that is, nursing, social
work, therapies, etc.) or who must complete those assessments. Allowing
hospices to make these choices allows them to strike a balance between
the need for assessment information and the desire to not overwhelm
patients and families. We believe that this built-in flexibility
accomplishes the commenter's goal without adding a separate short stay
assessment standard. Therefore, we are not adopting the comments as
suggested.
Comment: A commenter suggested that standard (d), ``Update of the
comprehensive assessment'' should be renamed ``Ongoing assessment'' to
clarify that the entire assessment does not need to be redone every 15
days.
Response: We do not believe that renaming the standard will
accomplish the stated goal. Renaming the standard as ``Ongoing
assessment'' would imply that every single change, regardless of how
minute it was, would need to be documented on the comprehensive
assessment, as these minute changes would be identified in the day-to-
day clinical assessments of the patient. We believe this would add an
unnecessary burden to hospice staff and would not advance patient care.
Comment: Many commenters supported the goal of requiring hospices
to regularly update the comprehensive assessment. Most of these
commenters suggested changes to the proposed 14-day timeframe for
updating the comprehensive assessment. Some commenters suggested that
we delete the timeframe completely, while other commenters suggested
that the timeframe be every two weeks or at the beginning of each new
benefit period.
Response: We appreciate the support for regularly updating the
comprehensive assessment, as this support generally reflects our
understanding that most hospices already update patient assessments in
accordance with some sort of self-imposed timeframe. We believe that
establishing a standard comprehensive assessment timeframe in this rule
will help those hospices ensure that their update timeframe is
consistent with patient needs and standards of practice. Deleting or
greatly extending the timeframe, as a few commenters suggested, would
be out of step with current standards of practice and would likely lead
to negative patient outcomes. Updating the comprehensive assessment at
reasonable regular intervals ensures that hospices have the most recent
information about the patient from which to make accurate care planning
decisions. Without the timely updated assessment information, care
planning decisions are likely to be inaccurate, inappropriate, and
possibly harmful to the patient. This is not an acceptable outcome.
We also appreciate the many timeframe suggestions that we received.
We agree that the proposed 14-day timeframe, while within reason and in
the realm of acceptable standards of practice, may not be the best
match between patient and hospice needs. Numerous commenters suggested
that updating the comprehensive assessment at least every 15 days was
the proper match, as the 15-day timeframe would correspond with the 60-
and 90-day Medicare Hospice Benefit election periods described in Sec.
418.21. Corresponding the update timeframe length to the benefit period
length would help hospices avoid completing separate assessments for
the routine comprehensive assessment update and the update to re-
certify that the patient is terminally ill. Two separate assessments
within a few days of each other would be overwhelming for the patient
and burdensome for the hospice. Thus, we agree that requiring hospices
to update the comprehensive assessment at least every 15 days is
preferable to the proposed 14-day timeframe. We believe that the new
15-day timeframe accomplishes the flexibility goals of those commenters
who suggested twice monthly, bi-weekly, and every 14- to 16-day updates
as well. We note that hospices are still required to complete the
comprehensive assessment update more frequently than every 15 days as
the patient's status changes. We also note that hospices are permitted
to update the assessment more frequently than every 15 days if the 15th
day falls on a holiday or if day-to-day hospice operations are
scheduled to be suspended for any reason on the 15th day.
Comment: Several commenters suggested that we should either delete
the requirement that hospices must update the comprehensive assessment
at the time of each recertification, or allow a grace period at the
time of each recertification to ensure that the assessment is not
unnecessarily updated twice within a few days to meet the every 14-day
and recertification timeframes.
Response: As discussed above, we replaced the 14-day timeframe with
a 15-day timeframe. The 15-day timeframe would coincide with the length
of the benefit periods and the recertification timeframes. Since the
assessment and recertification timeframes are now coordinated, we agree
that it is appropriate to delete the recertification assessment
requirement.
Comment: Several commenters expressed confusion about the nature of
the comprehensive assessment update. A few commenters wanted to know if
we expected hospices to complete an entire new set of comprehensive
assessment forms each time an update is due. Other commenters wanted to
know if the update of the comprehensive assessment referred to the
regularly scheduled IDG meetings. Another commenter noted that the
medical director should not be required to update the assessment.
Response: We understand that some hospices are confused by the
proposed requirement that patient-specific comprehensive assessments
should be updated at regular intervals. To clarify, we are requiring
hospices to update those sections of the comprehensive assessment that
require updating. As a patient's condition changes the comprehensive
assessment must be updated to reflect these changes. For example, if a
patient had a normal blood pressure reading at the time of the initial
assessment and at a nursing visit nine days later the patient's blood
pressure becomes elevated for a period of time, this new elevated blood
pressure must be documented. This becomes an update to the
comprehensive assessment. A significant change in the patient's
condition must be documented and the assessment must then be updated to
reflect the patient's revised status. As in the case of the
comprehensive assessment, hospices are not required to use specific
forms or formats. However, there have to be dedicated documents that
contain assessment information and that are easily identified. Hospices
are free to choose the method that best suits their needs when
documenting the comprehensive assessment and the updates to that
assessment. The purpose of updating the assessment is to ensure that
the hospice IDG has the most recent
[[Page 32109]]
accurate information about the patient in order to make accurate care
planning decisions. We are not requiring hospices to complete, in full,
those documents which they identified as comprising their comprehensive
assessment every 15 days, although hospices are free to do so if they
choose. Likewise, we are not requiring hospice medical directors to
assume total responsibility for updating the comprehensive assessment,
although we do expect to see the physician member of the IDG actively
involved in all aspects of furnishing care, including updating the
comprehensive assessment.
Comment: Many commenters expressed confusion about the role of
patient outcome measures in the comprehensive assessment. Some
commenters stated that data elements should be in the plan of care
rather than in the assessments. Others stated that including data
measures in the assessments may limit the amount of useful data
available for a hospice's quality assessment and performance
improvement (QAPI) program.
Response: In the QAPI CoP hospices are required to identify patient
outcome measures that they will apply to all patients. These measures
should help the hospice identify areas of strength and weakness in
patient and family care delivery. Once the measures are identified,
hospices must choose which data elements they will collect in order to
measure their performance. For example, a hospice may choose to focus
on pain control as one of its QAPI domains. Within the pain control
domain, that hospice may choose an outcome measure that identifies the
percentage of patients whose pain was controlled within 48 hours of
admission to hospice. In order to measure this outcome, that hospice
may choose to incorporate a data element in its initial assessment that
identifies those patients who are experiencing uncontrolled pain upon
admission as well as a data element in its comprehensive assessment to
identify patients who experienced uncontrolled pain upon admission and
had that pain controlled within 48 hours of admission. The information
gathered by these data elements during the comprehensive assessment can
then be collected, aggregated, and used to identify areas of strength
and weakness within the hospice's care delivery system. Without these
individual pieces of information gathered during the assessments, the
hospice does not have the information it needs to make effective
judgments of its quality and to make appropriate performance
improvement project decisions. Therefore, QAPI-related data elements
must be included in the patient assessments completed by the hospice.
At the same time, we do not expect hospices to limit their QAPI-
related data collection efforts to the data collected in the patient
assessments. Data collection must look beyond patient assessment data
to examine all facets of a hospices operation, from contract services
to volunteer retention rates to adverse events. Rather than limiting
the amount of useful data available to hospices, this requirement
simply ensures that patient level data are included as part of the
broader data collection program.
For additional discussion of public comments regarding patient
outcome measures and the proposed QAPI CoP, please refer to the quality
assessment and performance improvement section in the preamble of this
rule.
Comment: A commenter requested that we change the timing of the
medical director's certification of the terminal illness to coincide
with the completion of the comprehensive assessment.
Response: The commenter did not provide any particular rationale
for this request. The timing of the certification of the terminal
illness for Medicare beneficiaries is based on specific Medicare
payment requirements. Since payment requirements are not within the
scope of this rule, we are not accepting this suggestion.
Comment: Numerous commenters expressed varying levels of confusion
regarding the exact sequence and timing of the initial assessment,
comprehensive assessment, updated assessments, plan of care, and
updated plans of care. Commenters believed that some of these elements
would occur simultaneously while other elements, such as orienting
patients to hospices and evaluating patients for hospice
appropriateness do not appear in the regulation at all.
Response: We appreciate the opportunity to explain how the
finalized requirements will function in the hospice environment. First,
hospices will obtain a signed election statement in accordance with
Sec. 418.24. Next, the hospice registered nurse must complete an
initial assessment of the patient's physical, psychosocial and
emotional status related to the terminal illness and related conditions
in order to evaluate the patient's immediate care and support needs
within 48 hours of completing the election form. This assessment need
not go into great detail in each of these areas. Rather, it needs to
gather key information, as identified in the hospices policies and
procedures, about the patient that will enable the hospice IDG
accurately to determine what the patient immediately needs to begin or
continue feeling comfortable. The purpose of the initial assessment is
not to determine the patient's eligibility for the hospice benefit,
which is addressed in 418.22 and 418.24, or to orient the patient to
the hospice benefit and obtain the election statement. Additional
information regarding physician certification of the terminal illness
is available in the FY 2008 Hospice Wage Index, 72 FR 50214, 50223,
August 31, 2007. These tasks, which are often part of following-up on
referrals from other providers, must already have been completed before
the initial assessment is completed. This does not mean, however, that
we expect hospices to conduct multiple visits to complete the patient
admission and assessment. Once the initial assessment is complete, the
hospice develops and implements a plan of care to address the immediate
needs identified in the initial assessment.
Next, the hospice must complete a comprehensive assessment within
five days of completion of the election statement. The comprehensive
assessment is defined as 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 ability to
care for the patient. This comprehensive assessment is based on the
hospice's policies and procedures as well as the information gathered
in the initial assessment. For example, a hospice may have a policy
that all patients will receive a psychosocial assessment conducted by
an MSW. Therefore, we would expect that a patient's comprehensive
assessment in his or her clinical record would include the information
gathered by and the conclusions made by an MSW. The comprehensive
assessment requirement is flexible to adapt to the needs of individual
hospices and patients, and will help hospices gather the information
needed to develop accurate and appropriate plans of care.
Then, based on the information gathered in the comprehensive
assessment, the hospice IDG, in collaboration with the patient's
attending physician (if any), the patient or representative, and the
primary caregiver, must develop an individualized plan of care for each
patient. The plan of care must reflect patient and family goals, and
include all interventions needed to address the problems identified in
the initial and comprehensive assessments. The plan of care is where
information turns into
[[Page 32110]]
actions that will result in patient comfort and dignity, self-
determined life closure, and any other goals that the hospice, patient,
and family establish for the patient's hospice care.
Once the plan of care is established and all disciplines are aware
of their respective roles in caring for the patient, the hospice must
implement the plan of care. If the patient's status in one or more
areas changes, hospice staff must update the comprehensive assessment
to reflect the change(s). We do not expect hospices to complete an
entire comprehensive assessment each time a patient's status changes.
Rather, we expect that the updated assessment reflects status changes
so that other disciplines furnishing services are aware of them.
Updating the comprehensive assessment will ensure that all disciplines
are providing care based on the most recent information about the
patient. We require that these updates occur as frequently as that
patient's condition requires, but no less frequently than every 15
days. If a change in the patient's status will affect the kind of care
that needs to be furnished, then the plan of care needs to be modified.
For example, information from a comprehensive assessment could indicate
that a patient has a stage three pressure ulcer and the patient's plan
of care indicates that the hospice registered nurse will make three
visits a week, in part, for wound care. The wound care provided by the
registered nurse results in the pressure ulcer healing. This change in
status would be recorded as an update to the comprehensive assessment.
Based on this new information in the updated comprehensive assessment,
the hospice IDG may decide to reduce registered nursing visits to two
times per week because the patient's status and needs no longer
indicated that RN visits three times per week were necessary. The
hospice IDG would then update the patient's plan of care to reflect
that RN visits will be two times per week and that wound care was no
longer part of the treatment that the RN would provide. In this way,
the patient's assessment and plan of care are both updated to provide
accurate and timely information to all disciplines providing services
to the patient, and the hospice complies with our requirements to
update both the comprehensive assessment and the plan of care.
We believe that the timeline described above will help illuminate
the timeframe requirements for both the assessment and plan of care
requirements, as well as how these two requirements are related.
Comment: A few commenters explicitly thanked us for not requiring
hospices to use a standardized assessment form. Other commenters
expressed concern that the proposed assessment requirement would result
in CMS requiring hospices to use a specific assessment form. Several of
these commenters specifically stated that we should not require
hospices to use the OASIS data collection tool that is currently used
by home health agencies.
Response: We appreciate the support from commenters who recognized
that we are not requiring any type of assessment form, standardized or
otherwise. As we stated in the preamble to the proposed rule, and
restate here, we are not requiring hospices to use any particular form
or tool to document the completion of the initial assessment,
comprehensive assessment, or updated assessments at this time. Hospices
are permitted to use the written or electronic form or tool that best
suits their needs and their patients' needs, provided that the
information gathered in the assessments is complete and available in
each patient's clinical record. Hospices need to choose a form or tool
that gathers thorough information about the patient's physical,
psychosocial, emotional and spiritual status related to the terminal
illness and related conditions. This form or tool must allow hospices
to document information in a systematic and retrievable way for each
patient. Within the framework of these broad guidelines, it is within
each hospice's discretion to choose its own patient assessment
documentation form or tool.
Hospices may find it beneficial to examine the CARE (Continuity
Assessment Record and Evaluation) tool developed by CMS in choosing
their assessment forms/tools. Under the Deficit Reduction Act of 2005,
Section 5008, CMS was directed to develop a uniform patient assessment
instrument for use in a three year, post acute care-payment reform
demonstration, to begin in January 2008. This uniform assessment
instrument is now referred to as CARE. The purpose of the CARE tool is
to collect standardized data on Medicare beneficiaries' medical
conditions, functional and cognitive impairments, and social support
factors, affecting treatment and discharge, regardless of site of care.
During the demonstration CARE will be administered to Medicare
beneficiaries at time of hospital discharge, upon admission and
discharge from post acute care (PAC) providers, as well as at interim
points, if significant changes occur. CARE is comprised of a set of
common assessment items administered to all patients across all
settings, and a set of supplemental items only administered for
specific conditions or at particular times (i.e., PAC discharge only).
A master version of the CARE instrument and item matrix identifying
common assessment items and supplemental items is available for viewing
at http://www.cms.hhs.gov/PaperworkReductionActof1995/PRALSep2007/
itemdetail.asp?filterType=none&filterByDID=-
99&sortByDID=1&sortOrder=ascending&itemID=CMS1205047&intNumPerPage=10.
If, at some time in the future, we determine that it is necessary
to require hospices to use a standardized patient assessment tool, we
will follow the provisions of the Administrative Procedure Act, which
generally requires us to publish a notice of proposed rule making and
solicit public comment on the proposal.
4. Condition of Participation: Interdisciplinary Group Care Planning
and Coordination of Services (Proposed Sec. 418.56)
This proposed CoP elaborated on the existing Interdisciplinary
group CoP at Sec. 418.68 and combined it with elements of the Plan of
care CoP at Sec. 418.58. It contained five standards: ``(a) Approach
to service delivery,'' ``(b) Plan of care,'' ``(c) Content of the plan
of care,'' ``(d) Review of the plan of care,'' and ``(e) Coordination
of services.'' Together, these standards would have required a hospice,
through its IDG, to develop, implement, and update a comprehensive plan
of care for each patient and family that addresses their needs as
identified in the patient assessment.
Standard (a), ``Approach to service delivery,'' would require each
hospice to have an IDG that included at least the following: A doctor
of medicine or osteopathy who is not the patient's attending physician;
a registered nurse; a social worker; and a pastoral, clergy, or other
spiritual counselor. This IDG would be required to work together to
meet the physical, medical, social, emotional, and spiritual needs of
the patient and family. The IDG would also be required to designate a
qualified individual to coordinate implementation of the plan of care
and assessment of the patient. Paragraph 418.68(d) of the existing rule
required the IDG to designate a registered nurse to fulfill this role.
In the proposed rule, the IDG would be required to establish policies
governing the day-to-day provision of care and services. If a hospice
has more than one IDG, one
[[Page 32111]]
would be designated in advance to fulfill the policy role.
The next proposed standard, ``(b) Plan of care,'' would require
hospices to provide care to patients and families in accordance with a
written plan of care established by the IDG and the patient's attending
physician. This standard would also require hospices to ensure that
patients and families received appropriate education and training that
would enhance the implementation of the plan of care. Unlike the
existing requirement, this proposed standard would incorporate families
into the plan of care, recognizing that hospice care must reach beyond
the patient to support those who surround and care for the patient.
In proposed standard (c), ``Content of the plan of care,'' we would
require hospices to develop a plan of care based on the problems
identified in the patient's assessments. We proposed to require that
the plan of care include: Pain and symptom management interventions; a
detailed statement of the scope and frequency of services; patient
outcomes; any necessary drugs and treatments; any necessary medical
supplies and equipment; and documentation of the patient's and family's
understanding, involvement, and agreement with the plan of care. The
existing plan of care requirement at Sec. 418.58(c) mandated that the
hospice describe the scope and frequency of services. The remainder of
the elements were new in the proposed rule.
The fourth proposed standard, ``(d) Review of the plan of care,''
would require the hospice medical director or physician designee, along
with the IDG and the patient's attending physician, to review, revise,
and document the plan of care at intervals specified in the plan of
care. The review of the plan of care would be required to occur no less
frequently than every 14 calendar days. The revised plan of care would
be required to include information from the patient's updated
assessment, and the hospice would have to document any progress toward
the outcomes specified in the plan of care. This proposed requirement
directly linked the results of the updated assessment, including the
data elements, to the changes that would be made in the plan of care.
This would empower hospices to make care decisions based on evidence of
the successes and failures of past care decisions in achieving the
desired outcomes.
The final proposed standard, ``(e) Coordination of services,'' was
a new addition to the hospice CoPs. Hospice has always been based on an
interdisciplinary care model, which requires frequent communication
between care disciplines and settings, as well as between the hospice,
the patient and the family. This proposed standard would require the
hospice to maintain a system of communication and integration to enable
the IDG to ensure that care and services are provided in accordance
with the plan of care. This system would also be required to ensure the
ongoing liaison of all disciplines providing care and services in the
home, outpatient, and inpatient settings, notwithstanding the manner in
which the care and services are furnished (that is, directly or under
arrangement).
Comment: A commenter asked us to clarify the meaning of the
following sentence at Sec. 418.56, ``The plan of care must specify the
hospice care and services necessary to meet the patient and family-
specific needs identified in the comprehensive assessment and as it
relates to the terminal illness and related conditions.'' The commenter
believed that this statement was confusing.
Response: The intent of the sentence is to ensure that there is a
direct link between the needs identified in the patient assessment and
the plan of care developed by the hospice. The intent is also that
hospices are responsible for including those services and treatments in
the plan of care that are related to the terminal illness and related
conditions, even if the hospice identified other needs in the patient
assessment that are not related to the terminal illness and related
conditions. We agree that minor grammatical changes to the statement
are warranted to clarify our intent. Specifically, we are replacing the
singular term ``it'' with the plural phrase ``such needs'' to
correspond with the plural ``specific needs'' identified earlier in the
sentence. This grammatical change provides a direct link between the
needs identified in the comprehensive assessment and those specific
needs related to the terminal illness and related conditions that must
be addressed in the plan of care. The revised sentence at Sec. 418.56
now states, ``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.'' We have not attempted to
enumerate the conditions in which care outside the hospice would be
covered under Medicare because we recognize that there are many
illnesses which may occur when an individual is terminally ill which
are brought on by the underlying condition of the patient. For example,
it is not unusual for a terminally ill patient to develop pneumonia or
some other illness as a result of his or her weakend condition.
Treatment of such illnesses is considered a hospice service and payment
under other Medicare benefits would be waived by the hospice election.
We expect that the hospice interdisciplinary group will reasonably
determine the services that the individual requires for palliation and
management of his or her symptoms.
Comment: A commenter suggested that, when hospices are caring for
residents of long term care facilities, the long term care facility
medical director should be the individual responsible for designating
the members of the IDG to care for the patient.
Response: It is the hospice's responsibility to furnish hospice
care. While we agree that designated long term care facility staff
should actively participate in a patient's hospice IDG, it is the
hospice's responsibility to decide what care is provided, based on the
information gathered during the patient assessments. Hospices are not
permitted, and certainly should not be compelled, to delegate their
responsibilities to the long term care facility medical director and
staff.
Comment: Numerous commenters suggested that we include the term
``psychosocial'', rather than ``social'', in Sec. 418.56(a) when
detailing the types of patient and family needs that IDGs are required
to address during care planning. The commenters stated that the term
``psychosocial'' is more consistent with the terminology used
throughout the remainder of the rule.
Response: We agree that the word ``psychosocial'' is more
consistent with the terminology in the rest of the rule and we have
made this change.
Comment: Numerous commenters made suggestions to refine our
proposal at Sec. 418.56(a) that ``The hospice must designate a
qualified health care professional that is a member of the IDG to
provide coordination of care and to ensure continuous assessment of
each patient's and family's needs and implementation of the
interdisciplinary plan of care.'' A few commenters supported our
proposal to permit any qualified health care professional that is a
member of the IDG to fulfill the coordinator role, while many other
commenters suggested that only nurses and/or social workers should be
considered qualified for this role. One commenter suggested that the
coordinator should only be responsible for ensuring the assessment of
each patient's and family's specific hospice care, rather than being
personally responsible for assessing their needs.
[[Page 32112]]
Another commenter suggested that the individual responsible for
coordinating the plan of care be named the ``interdisciplinary group
coordinator.''
Response: We appreciate the many comments that were submitted. We
do not believe that the coordinator needs to be given a specific title
in this rule. Hospices are free to refer to the coordinator in a manner
that meets their needs, as long as there is an individual identified as
being responsible for coordinating and implementing each patient's plan
of care.
The majority of commenters noted the unique demands of the case
coordinator role and the many skills that are necessary to successfully
fulfill the role. Commenters described the need for the case
coordinator to have solid knowledge of the biological, psychological
and spiritual issues of terminally ill patients and their families.
They also described the need for the case coordinator to act as an
advocate, negotiator, and leader when dealing with the varied members
of the IDG, the patient, and the patient's family. We agree that the
specific demands of the case coordinator role, as described by the
commenters, warrant a more specific requirement regarding who is
qualified to fulfill this role. Therefore, we are requiring the
coordinator to be a registered nurse. A registered nurse has the
necessary medical and interpersonal background to meet the demands of
the coordinator position in a way that no other discipline does. Social
workers are not educated or trained to identify physical issues, just
as physical or occupational therapists are not educated or trained to
identify psychosocial issues. The unique skills of registered nurses,
who are educated to assess and manage the overall aspects of a
patient's physical and psychosocial care, can be used to oversee the
coordination and implementation of the care identified by the IDG.
Comment: The majority of commenters asked us to reconsider the
specification in proposed Sec. 418.56(a)(1)(i) that the physician
member of the IDG may not be the patient's attending physician. The
commenters stated that hospice physicians often have their own private
practice and may, at times, be in the position of caring for a private
practice patient who has chosen to receive hospice care from the
hospice the physician works with. Furthermore, the commenters stated
that this prohibition could create a barrier to accessing hospice for
those patients whose attending physicians also work with hospices. One
commenter suggested we should replace the general requirement that a
doctor of medicine or osteopathy be a member of the IDG with a
requirement that the hospice medical director or physician designee be
a member of the IDG.
Response: While it was not our intent, we agree that this
prohibition could negatively impact hospice access and treatment.
Therefore, we have removed the statement that the physician member of
the IDG may not be the patient's attending physician. In its place, we
have added a statement that the physician member of the IDG must be an
employee of or under contract with the hospice. While the physician
member could be the hospice medical director or physician designee,
this revised requirement does not mandate this. This new requirement
accomplishes our original intent of ensuring that hospice physicians
are actively involved in patient care through the IDG without the
unintended effect of limiting access that accompanied the original
proposal.
Comment: Numerous commenters suggested that we amend the language
discussing spiritual counselors in Sec. 418.56(a)(1)(iv). Some
commenters noted that the terms ``pastoral'' and ``clergy'' are Judeo-
Christian terms that do not encompass other faiths. These commenters
suggested that we require hospices to have a board certified chaplain
as a member of the IDG because board certified chaplains are routinely
educated and trained to work with individuals from various, non-Judeo-
Christian faiths. On the other hand, some commenters specifically
disagreed with the suggestion that a board certified chaplain be a
required member of the IDG. Still other commenters suggested that we
should use the language that appears in section 1861(dd)(2)(B)(i) of
the Act, which reads that a hospice must have ``at least one pastoral
or other counselor'' as a member of the IDG.
Response: Spiritual advisors play an important role in helping many
patients and families achieve their end-of-life goals. In the proposed
rule we sought to further assure the role of spiritual advisors in
hospice care by specifying that the counselor must be capable of
addressing a patient's spiritual needs. As some commenters stated, not
all patients need or desire the involvement of spiritual counselors in
their care. These patients, the commenters contended, should not be
compelled to accept the involvement, even if that involvement is only
through the spiritual counselor's participation in the IDG meetings. We
agree that spiritual counselors, whether they are certified chaplains,
clergy, pastoral counselors, or any other discipline, should not be
forced upon unwilling patients. Therefore, we have replaced the
proposed ``pastoral, clergy, or other spiritual counselor'' requirement
with the statutory requirement of ``pastoral or other counselor.'' This
revised requirement gives hospices the flexibility to use the counselor
that best meets the patient's needs.
Nothing in this requirement prohibits hospices from using certified
chaplains as the IDG member to fulfill this role. Indeed, some hospice
patients who receive the services of certified chaplains may have
better outcomes because certified chaplains are trained to work with
individuals from various faiths and backgrounds.
Comment: A few commenters suggested that we should require a
bereavement counselor as a member of the IDG. The commenters stated
that including the bereavement counselor in the IDG would help ensure
that the information gathered in the bereavement assessment, required
in final Sec. 418.54(c)(7), is included in the plan of care.
Response: We expect that all disciplines involved in caring for a
patient and family will have a voice in the IDG. This voice may be
reflected through reports given by the members of the patient's care
team who are not part of the official IDG to the individual who is
coordinating care plan implementation or through IDG members attending
IDG meetings in some manner. Including a bereavement counselor, whether
as an individual position or as a function of the counselor or social
worker, in the IDG would satisfy our expectations that all disciplines
communicate with each other and have a voice in IDG meetings and
decisions, and may result in better patient and family satisfaction and
outcomes. Nothing in this rule prevents hospices from involving a
bereavement counselor in the IDG. The core members of the IDG are
identified in section 1861(dd)(2)(B) of the Act. This section permits
the use of another type of counselor instead of, or in addition to, the
pastoral counselor. Hospices are free to use a bereavement counselor
when they believe the needs of the patient and family require it.
Comment: Many commenters took issue with the proposed requirement
in Sec. 418.56(a)(2) that, if a hospice has more than one IDG, it must
designate one IDG to establish policies governing the day-to-day
provision of hospice care and services. Some commenters sought minor
changes to the proposed requirement to allow hospices to create a
special IDG, culled from all of its
[[Page 32113]]
IDGs, for the job of establishing policies. Other commenters suggested
that the hospice's administrator, clinical leaders, or governing body
should be responsible for developing these policies.
Response: Section 1861(dd)(2)(B)(iii) of the Act requires a hospice
IDG to establish policies governing the provision of hospice care and
services. Therefore, we believe that it is appropriate to maintain the
IDG's responsibility for developing a hospice's policies. At the same
time, we agree that the IDG that is responsible for developing those
policies does not need to be the same group that works together to care
for patients. For example, a hospice may choose to have a policy IDG
comprised of the physician from IDG 1, the nurse from IDG 2, and the
social worker and pastoral counselor from IDG 3. In order to clarify
that an arrangement is acceptable, we have modified the requirement at
Sec. 418.56(a)(2) to read, ``[i]f the hospice has more than one
interdisciplinary group, it must identify a specifically designated
interdisciplinary group to establish policies governing the day-to-day
provision of hospice care and services.''
Comment: A commenter sought clarification of the phrase ``policies
governing day-to-day provision of hospice care and services'' as it was
used in proposed Sec. 418.56(a)(2).
Response: This phrase, which is also located in the previously
existing CoPs at Sec. 418.68(b)(4), refers to the hospice's
responsibility to establish its own policies and procedures to govern
its practices within the framework of the CoPs. We are not prescribing
the exact patient care, documentation, orientation and training, and
administration policies and procedures that each hospice will use in
its daily operations. Each hospice, through its designated IDG, will
establish these policies and procedures. The policies and procedures
established by the IDG must be in compliance with the CoPs and other
applicable Federal, State, and local laws and regulations.
Comment: In proposed Sec. 418.56(b), many commenters sought
clarification on the role of the patient's attending physician in the
IDG. Some commenters suggested that all mention of the attending
physician's involvement in the IDG should be deleted because not all
patients would have attending physicians. Other commenters suggested
that the involvement of the attending physician in the IDG should be
qualified by statements such as ``at his/her discretion'', or ``only to
the extent possible.'' Still other commenters suggested that the
patient's attending physician should actively develop the patient's
plan of care or even lead the IDG.
Response: The role of the patient's attending physician in the
patient's hospice care will vary from hospice to hospice, and from
patient to patient. This variability is reflected in the diverse
comments that we received on this subject. Some commenters suggested
that attending physicians should assume a leadership role in the IDG,
while other commenters suggested that the role of the attending
physician should be excluded altogether. To accept either of the
suggested extremes, that is, attending physician leadership or
exclusion, would most certainly not meet the needs of all hospices. To
meet these needs, we have chosen to qualify the role of the attending
physician in the IDG by adding the phrase ``if any'' to Sec.
418.56(b). This phrase recognizes that not all patients have attending
physicians. We expect hospices to document their efforts to involve the
attending physician in developing the hospice plan of care, as well as
the results of those efforts. Hospices may determine the best method
for this documentation in accordance with their own policies and
procedures.
Comment: A commenter suggested that hospices be required to make
efforts to include the patient and primary caregiver when establishing
the plan of care.
Response: We agree that involving the patient and primary caregiver
in developing the plan of care is an important step to ensuring that
the plan of care reflects the patient's goals. We have achieved this
goal by adding a provision to Sec. 418.56(b) that a patient or
representative, and primary caregiver should be included in developing
the plan of care if they so desire in accordance with the patient's
needs. If a patient, his or her representative, and/or primary
caregiver decline to participate in actively developing the plan of
care, then hospices would need to document this. We also added a
provision in the patient rights CoP at Sec. 418.52(c)(2) that patients
have the right to be involved in developing their plan of care. In
addition, we have added a requirement in Sec. 418.56(c) that the plan
of care must reflect the patient's and family's goals. These provisions
will, we believe, ensure that the patient's and family's goals are
reflected in the plan of care and that patients will have full and open
access to the care planning process if they so desire.
Comment: A commenter observed that the proposed rule did not
include a requirement that at least two members of the IDG establish
the initial plan of care. The commenter appreciated that this
requirement was not included in the proposed rule.
Response: The requirement that the commenter referred to is part of
the interpretive guidelines that were issued for the current hospice
regulations. While we did not include this requirement in the proposed
rule, we do not recommend that a single member of the IDG independently
develop the initial plan of care without input from other IDG members.
This would violate the intent of the hospice interdisciplinary care
model. Development of the plan of care is a collaborative effort
involving all members of the IDG. We will continue to include this
information in the new Interpretive Guidelines.
Comment: A commenter suggested that we should include timeframes
for completing the initial plan of care and the comprehensive plan of
care.
Response: We do not differentiate between the stages of the plan of
care. We expect the first stage of the plan of care to be completed
after the initial patient assessment has been completed. This
preliminary plan of care must address the immediate care needs
identified during the initial assessment. Once the comprehensive
assessment is complete, the hospice must then update the plan of care
to address the other care needs identified through the comprehensive
assessment. We believe that beginning and completing the first
iteration of the plan of care should be based on the needs of the
patient and family rather than specific timeframes. If a patient is in
crisis or is actively dying, then it stands to reason that the plan of
care must be developed by the IDG members rather quickly.
Comment: A commenter requested that, in Sec. 418.56(b), hospices
only be required to provide education and training to the patient and
primary caregiver. In addition, the commenter requested that hospices
be permitted to tailor the training and education provided to patients
and caregivers based on their responsibilities for care.
Response: We agree that requiring hospices to educate and train the
family, as we proposed, is unnecessary because not all family members
may participate in furnishing care to the patient. We also agree that
hospices should be permitted to tailor the education and training
provided to patients and caregivers based on the exact services that
patients and caregivers will be providing. For example, if a caregiver
is assessed as being competent and willing to care for a patient's
catheter, then we would expect the caregiver to be educated and trained
on proper catheter
[[Page 32114]]
care procedures. The relevant portion of section 418.56(b) now reads,
``The hospice must ensure that each patient and the primary
caregiver(s) receive education and training provided by the hospice as
appropriate to their responsibilities for the care and services
identified in the plan of care.''
Comment: A commenter suggested that Sec. 418.56(b) should
explicitly state that only one plan of care is required and that a
separate plan of care is not necessary for the family's needs.
Response: One of the most unique and valuable aspects of hospice
care is its treatment of the patient and his/her family as a single
unit of care. It is current hospice practice to address the needs of
the patient's family as part of the patient's plan of care. This
standard practice will not change based on the requirements of this
rule. We expect that this rule will reinforce this practice by
requiring that all services provided to both patients and their
families be included in the written plan of care. We note that the term
``plan of care'' is singular and in no way implies that there should be
more than one plan.
Comment: A few commenters suggested that we should clarify the
scope of the plan of care by stating that the plan of care must address
all of a patient's needs, rather than only those services that the
hospice is capable of providing. Another commenter suggested that we
should specify that the plan of care must be individualized for each
patient and that it must reflect the patient's hospice care goals.
Still other commenters suggested that the plan of care, including
drugs, durable medical equipment and supplies, should be limited to
addressing those needs related to the terminal illness and related
conditions. The commenters suggested that deleting the phrase ``but is
not limited to'' in proposed Sec. 418.56(c) would accomplish this
goal.
Response: The plan of care is one of the most important documents
in hospice care. It is the essential link between the needs of the
patient and the actions of the hospice. Therefore, we agree with the
commenters that the plan of care must be individualized to meet all of
the needs of the patient and family related to the terminal illness and
related conditions. In order to achieve this goal, we have clarified
the rule in several places. First, we have added the term
``individualized'' to both Sec. 418.56(b) and Sec. 418.56(c), to
require hospices to develop and follow an ``individualized written plan
of care.'' Second, we have revised the final sentence of the stem
statement in Sec. 418.56(c) from ``The plan of care must include but
not be limited to--'' to ``The plan of care must include all services
necessary for the palliation and management of the terminal illness and
related conditions, including * * *.'' This revised statement more
explicitly links the patient's needs, as identified in the assessments,
to the services furnished by the hospice. In addition, this revised
statement clarifies that hospices are only responsible for furnishing
services based on those needs identified in the assessments related to
the terminal and related conditions. Needs that are not related to the
terminal illness and related conditions are not the responsibility of
the hospice, although the hospice may choose to furnish services for
those needs regardless of responsibility.
If a hospice does not choose to furnish services for those needs
unrelated to the terminal illness and related conditions, we would
expect the hospice to communicate and coordinate with those health care
providers who are caring for the unrelated needs, as described in Sec.
418.56(e). In such situations where a hospice coordinates its care and
services for the terminal illness and related conditions with care and
services provided by other health care providers for unrelated
conditions, we believe that it is essential for the hospice to be aware
of their role within the larger comprehensive plan of care for that
patient. Furthermore, we believe that it is essential for the hospice
to be aware of any gaps in the overall comprehensive plan of care, and
the parties responsible for filling those gaps.
Comment: A commenter questioned what was meant by the phrase
``initial comprehensive and updated assessment'' as it was used in
proposed Sec. 418.56(c).
Response: Our intent was to require hospices to base the
interventions described in the plan of care on information gathered in
all of the assessments, that is, the initial, comprehensive, and
updated assessments. We have modified the language in Sec. 418.56(c)
to reflect this.
Comment: A commenter suggested that we should remove or define the
terms ``facilitate'', ``targeted'', and ``anticipated'' in Sec.
418.56(c). Another commenter suggested that we should replace the term
``measurable targeted outcomes'' with ``agreed-upon goals.''
Response: Section 418.56(c) describes the general areas that must
be included in each patient's individualized plan of care. We agree
that when describing the interventions necessary to manage a patient's
pain and symptoms in Sec. 418.56(c)(1), the language should be
simplified. We deleted the term ``facilitate'' in this statement and
further refined it to require that the plan of care include
``Interventions to manage pain and symptoms.'' We also agree that in
Sec. 418.56(c)(3) the language should be simplified. We removed the
term ``targeted'' from the statement, which now reads ``Measurable
outcomes anticipated from implementing and coordinating the plan of
care.'' We did not remove the term ``anticipated'' from this
requirement, because the term ``anticipated'' explicitly recognizes
that the measurable outcomes are goals and they may or may not be
achieved. For example, a hospice may not be able to control pain within
48 hours of admission. The hospice may have anticipated meeting that
goal and took all necessary steps. However, 100 percent success is not
always guaranteed. The term ``anticipated'' recognizes that fact.
We did not, as the other commenter suggested, replace ``measurable
outcomes'' with ``agreed-upon goals.'' Instead, we have added a
statement to Sec. 418.56(c) to state that, ``[t]he plan of care must
reflect patient and family goals and interventions based on the
problems identified.* * * '' We believe that this is an appropriate way
to include patient and family goals in the plan of care without
excluding measurable outcomes, which are part of the individual patient
care planning process and the hospice's overall QAPI program. We expect
the hospice plan of care to address all patient goals in some way. If a
patient has a goal that is not related to the terminal illness and
related conditions, and if the hospice does not intend to address this
goal, then the hospice plan of care should identify the party that is
responsible for meeting the unrelated goal. Furthermore, final Sec.
418.56(e) requires the hospice to actively communicate with the outside
party to ensure that the goal is addressed.
Comment: Some commenters questioned the term ``prescribed'' as it
is used in proposed Sec. 418.56(c). The commenters stated that the
term ``prescribed'' implied that we were requiring a specific
physician's order for each intervention included in the plan of care.
Response: We agree that the term ``prescribed'' implies that all
interventions require physician's orders. Requiring physician orders
for everything was not our intent. Therefore, we removed the term
``prescribed'' from this standard.
Comment: Some commenters suggested that we should delete the terms
``detailed'', ``scope'', and ``specific'' as related to the services
provided (Sec. 418.56(c)(2)).
[[Page 32115]]
Response: We did not delete these terms in this final rule. In
Sec. 418.58(c) of the existing hospice regulations, hospices are
required to ``state in detail the scope and frequency of services
needed to meet the patient's and family's needs.'' We note that the
proposed requirement that the plan of care include, ''[a] detailed
statement of the scope and frequency of services necessary to meet the
specific patient and family needs'' is very similar to the requirement
that has existed for the last two decades. We believe that hospices
have already determined, and will continue to determine, through their
own policies and procedures, how to meet this requirement. The level of
detail established by the hospice in the plan of care should be clear
enough to provide a complete picture of which disciplines will be
furnishing which services, how frequently that care will be furnished,
and what needs are being addressed by such care. The plan of care
serves as a primary means of communication between all hospice
disciplines, the patient, the primary care giver, and the family. It
must contain enough information so that all of these individuals know
exactly what is supposed to be done, by whom, at what time, and for
what purpose.
Comment: A commenter suggested that non-pharmacological
interventions should be included, in addition to drugs, in Sec.
418.56(c)(4).
Response: We agree that non-pharmacological interventions should be
included in the individualized hospice plan of care; however, we are
not specifically referencing them in Sec. 418.56(c)(4). We believe
that the provision of required non-pharmacological interventions are
already strongly implied in the stem statement of Sec. 418.56, and
also in Sec. 418.56(c)(1), which states that the plan of care must
include ``interventions to manage pain and symptoms,'' as well as in
Sec. 418.56(c)(5), which requires the plan of care to indicate the
medical supplies and appliances necessary to meet the needs of the
patient.
Comment: Numerous commenters expressed concern regarding our
proposal at Sec. 418.56(c)(6) that the hospice document the patient's
and family's understanding, involvement, and agreement with the content
of the plan of care. The commenters stated that there are times when
the patient may agree with the plan of care while members of his or her
family do not. Commenters suggested either removing the term
``agreement'' or replacing the term ``family'' with ``representative''
or ``primary caregiver'' to narrow the number of individuals who must
agree, and to ensure that the patient's needs and goals take primacy.
Commenters also suggested that, rather than requiring hospices to
document complete understanding, involvement and agreement on the part
of patients and families, which may not be attainable, we should
require hospices to document the level of understanding, involvement
and agreement attained by the patient and family.
Response: We understand that patients and families may sometimes be
in conflict regarding the content of the plan of care, and we agree
that it is the patient's understanding, involvement and agreement with
the plan of care that takes precedence. Therefore, we have removed the
term ``family'' from this requirement and replaced it with the term
``representative.'' As defined in Sec. 418.3, a representative is the
individual who makes decisions for a patient when a patient is unable
to do so. We believe that limiting this requirement to patients and
representatives will help ensure that the patient's needs and goals are
primary in the content of the plan of care. We continue to expect a
hospice to also address, to the extent possible, the goals of the
patient's family in the plan of care. We do not require the entire
family to agree to the patient's plan of care.
Furthermore, we agree that, rather than requiring hospices to
document complete understanding, involvement and agreement with the
plan of care, it is more appropriate to require hospices to document
the level of understanding, involvement and agreement attained by the
patient or representative. The terminal illness and numerous other
factors may affect a patient's or representative's ability to
participate in care planning or understand the content of the plan of
care. Requiring hospices to document a level of understanding,
involvement and agreement with the plan of care recognizes this fact.
Hospices will now be required to note whether impediments to
understanding are present and the degree to which those impediments
impact the patient's or representative's participation in care
planning. Documenting this information will help hospices tailor the
content of the plan of care and their patient communication process to
the needs of the patient, resulting in improved patient outcomes.
Comment: A few commenters questioned the type of documentation that
would be necessary in terms of a patient's or representative's
understanding, involvement and agreement with the plan of care.
Response: The documentation in the clinical record must be correct
and complete, as required by Sec. 418.104, and should provide
sufficient detail to fully describe the level of understanding,
involvement and agreement with the plan of care. Hospices may choose to
include a specific form for this documentation in each patient's
medical record, include the documentation in the clinical notes or use
any number of other documentation methods as those methods meet the
needs and circumstances of individual hospices.
Comment: A commenter suggested that we delete proposed Sec.
418.56(c)(6) because the plan of care is a process, not just a single
document.
Response: While we agree that the plan of care is an on-going
process with many updates along the way, we are retaining this
regulatory element. As the plan of care evolves through updates by the
IDG, patients and representatives should continue to be involved, and
hospices should continue to seek their understanding of and agreement
with the changes. This requirement will help to ensure that patients
and representatives are involved in the care planning process and that
hospices actively address the needs and goals of patients.
Comment: Some commenters sought clarification on the obligations of
the hospice when the family disagrees with the plan of care, even
though the patient agrees.
Response: As discussed previously, we have deleted the requirement
that hospices must obtain family agreement with the plan of care.
Although hospices are no longer required to obtain the family's
agreement, the plan of care must still address the family's goals and
will still require assistance from the family in its implementation.
For these reasons, it remains essential for hospices to actively
educate and involve family members to the extent possible.
Comment: A commenter agreed with our proposal in Sec. 418.56(d)
that the patient's attending physician should be involved, to the
extent possible, in updating the plan of care.
Response: Involving the attending physician to the extent possible
in the patient's care, including updating the plan of care, is an
important step to help ensure continuity of care. We are setting forth
this requirement at Sec. 418.56(d).
Comment: Many commenters requested that the specific reference to
the medical director or physician designee's role in updating the plan
of care be deleted or rearranged. Commenters stated that the medical
director or physician designee is often a member of the IDG and does
not need to be mentioned separately.
[[Page 32116]]
Response: We agree that it is not necessary to specifically require
the involvement of the medical director or physician designee in
updating the plan of care because each IDG must have a physician member
and that physician member provides adequate medical input in the
updates. Therefore, we deleted this proposed requirement.
Comment: We received numerous comments about the proposed
timeframes for updating the plan of care (Sec. 418.56(d)). Some
commenters requested that we delete the proposed requirement that the
plan of care be updated at least every 14 days. Others suggested that
the 14 day requirement be changed to every 14-16 days, every 15 days,
every 30 days, or twice per month.
Response: The plan of care is the map that the hospice will follow
when delivering care to a patient and family. It is essential that the
plan of care accurately reflect the services that must be delivered in
order to meet the needs of the patient and family. As the patient's
condition changes, the plan of care changes as well. In order to ensure
that these updates occur, we proposed timeframes for both updating the
comprehensive assessment and the plan of care. As previously discussed,
we changed the timeframe for updating the comprehensive assessment from
14 to 15 days. We also believe that it is necessary for the timeframes
for updating the plan of care and updating the comprehensive assessment
to coincide. This will help to ensure that there is a direct
correlation between the two. Therefore, we have also changed the update
timeframe for the plan of care from every 14 days to every 15 days.
Comment: Some commenters suggested that we should delete the
requirement in proposed Sec. 418.56(d) that hospices must update the
plan of care at intervals specified in the plan of care. Commenters
stated that the plan of care cannot project future changes in the
patient's needs. Commenters suggested that the plan of care should be
updated based on the updates to the comprehensive assessment instead.
Response: Our intent in the proposed rule was to tie the updates to
the plan of care directly to changes in the patient's condition.
Predicting changes in patient status and the related plan of care is
too difficult; therefore, we agree that this requirement should be
deleted. We have deleted this requirement that hospices must ``review,
revise and document the plan as necessary at intervals specified in the
plan'', and, in its place, require that hospices must ``review, revise
and document the individualized plan as frequently as the patient's
condition requires * * * .''
Comment: A commenter suggested that IDGs should be required to meet
once every 28 days with all team members and the patient and family.
The commenter also suggested that two or three members of the IDG
should meet once a week.
Response: We do not believe that mandating an IDG meeting schedule
would meet the needs of patients and families or would enhance overall
care planning. A large number of patients in hospices die before the
28th day (NHPCO Facts and Figures 2005). In addition, the proposed
smaller weekly meetings would lack the essential input of all
disciplines involved in the patient's care, potentially resulting in
patient and family needs being overlooked or inadequately addressed.
Section 418.56(e), Coordination of services, already requires an IDG
system of communication that enables frequent information sharing among
disciplines and across service locations.
Comment: Several commenters sought clarification regarding the
requirement in proposed Sec. 418.56(e) that hospices must have a
system of communication and integration. Commenters requested
clarification on how the system might be documented, how the system
would interact with contract providers, and how the system might be
implemented. Other commenters expressed support for the new requirement
and stated that the communication system outlined in the requirement is
already standard practice in hospice agencies.
Response: We appreciate the support for this standard, as it
validates our understanding that hospices have already established
robust communication systems. As an interdisciplinary care model,
hospice relies on communication between and integration of providers to
effectively plan and furnish care to patients and families. Through the
years, hospices have developed methods to ensure that all members of a
patient's care team receive timely information about patients. This
standard expands on the communication and integration systems that
hospices have developed for their own uses. This standard requires
hospices to communicate, not only with their employees, but also with
their contractors. It also requires hospices to integrate those same
contractors into the hospice team. Communication and integration with
service providers outside of the hospice's direct purview will help
hospices ensure that each patient receives appropriate, high quality
care in accordance with his or her plan of care, regardless of whether
that care is furnished by hospice employees or contractors. As always,
the hospice is ultimately responsible for the care furnished on its
behalf and must actively ensure that contractors are fulfilling their
patient care and communication contractual obligations.
The exact structure of the system of communication and integration
will vary depending on the unique needs of each hospice. Telephone, e-
mail, instant messaging, the postal service, and any other form of
communication may be used in accordance with a hospice's own policies
and procedures. Likewise, clinical notes, IDG meeting minutes, and any
other form of documentation associated with the patient's plan of care
may be used to demonstrate compliance with this requirement, in
accordance with a hospice's own policies and procedures. We believe
that allowing hospices to determine the structure of the system and the
documentation necessary to ensure that the system is used in the best
and most flexible method for ensuring that hospices are able to comply
with this provision.
Comment: A commenter suggested that we should delete the phrase
``through its designated professionals'' from Sec. 418.56(e)(1)
because the members of the IDG are already defined in Sec.
418.56(a)(1).
Response: We agree with the commenter that the above-referenced
phrase is not necessary, and we have deleted it.
Comment: A commenter suggested that the language in proposed Sec.
418.56(e)(4) be simplified by substituting the phrase ``all
facilities'' for the list of the various settings where hospice care
may be provided.
Response: We agree that adopting an all-inclusive term will make it
easier for hospices to understand their crosscutting communication
responsibilities. Since ``settings'' is a broader term than
``facilities'', as the commenter suggested, we are modifying the text
in Sec. 418.56(e)(4) to require that the system of communication
provides for and ensures the ongoing sharing of information between all
disciplines in all settings.
Comment: A commenter suggested that, in Sec. 418.56(e), hospices
should be required to share information with non-hospice providers who
are also caring for a patient.
Response: We agree with this suggestion. We believe that it will
enhance patient care in the unusual circumstances where patients with
multiple illnesses and conditions receive care from multiple providers.
This will ensure that hospices actively
[[Page 32117]]
coordinate the care that they are providing with the care being
furnished by other providers. The coordination will help hospices avoid
a duplication of services as well as potentially dangerous drug
prescribing and dosage problems. This new requirement is located at
Sec. 418.56(e)(5). As stated previously, when coordinating care with
other providers, it is essential that hospices are aware of their role
within the larger comprehensive plan of care, as well as any gaps in
the comprehensive plan of care and the parties responsible for filling
those gaps.
5. Condition of Participation: Quality Assessment and Performance
Improvement (Proposed Sec. 418.58)
The existing Sec. 418.66, ``Condition of participation-Quality
assurance,'' relies on a problem-oriented approach to identify and
resolve patient care issues. Failure to meet the quality assurance
condition is consistently one of the top 10 deficiencies cited by
Medicare surveyors nationwide. During the last decade the health care
industry, including the hospice industry, has moved beyond the problem-
oriented, after-the-fact corrective approach of quality assurance to an
approach that focuses on a preemptive plan that continuously addresses
QAPI. Hospice industry associations have indicated that the upgraded
QAPI approach used by many hospice providers is incompatible with the
existing quality assurance condition. On the other end of the spectrum
some providers do not have any quality program.
The proposed QAPI requirement would raise the performance
expectations for hospices seeking entrance into the Medicare and
Medicaid programs, as well the expectations of those currently
participating in Medicare and Medicaid. We proposed that each hospice
would develop, implement, and maintain an effective, continuous quality
assessment and performance improvement program that stimulates the
hospice to constantly monitor and improve its own performance, and to
be responsive to the needs, desires, and satisfaction levels of the
patients and families it serves. The desired overall outcome of this
proposed CoP would be that the hospice would drive its own quality
improvement activities and improve its provision of services. With an
effective quality assessment and performance improvement program in
place and operating properly, a hospice can better identify and
reinforce the activities it is doing well, identify its activities that
are leading to poor patient outcomes, and take actions to improve
performance. A hospice would be free to develop a program that meets
its needs. As proposed, a provider's QAPI program would not be judged
against a specific model.
The proposed QAPI CoP was divided into five standards. Under
standard Sec. 418.58(a), ``Program scope,'' a hospice's quality
assessment and performance improvement program would include, but not
be limited to, an ongoing program that would be able to show measurable
improvement in indicators that were linked to improving palliative
outcomes and end-of-life support services. We expect that a hospice
would use standards of care and the findings made available in current
literature to select indicators to monitor its program. The hospice
would measure, analyze, and track these quality indicators, including
areas such as adverse patient events and other aspects of performance
that assess processes of care, hospice services, and operations.
(``Adverse patient events,'' as used in the field, generally refer to
occurrences that are harmful or contrary to the targeted patient
outcomes.)
The second proposed standard at Sec. 418.58(b), ``Program data,''
would require the hospice program to incorporate quality indicator
data, including patient care, administrative, and other relevant data,
into its QAPI program. This would include data that were received from
or submitted to hospice professional organizations. We did not propose
to require that hospices use any particular process or outcome
measures. However, a hospice that would choose to use the available
quality measures would be able to expect an enhanced degree of insight
into the quality of its services and patient satisfaction, compared to
beginning the outcome-measure development process anew because
currently existing measures have already been tested to some degree for
reliability and validity.
Proposed standard (b) also would require that data collected by the
hospice, regardless of the source of the data elements, would be
collected in accordance with the detail and frequency specifications
established by the hospice's governing body. Once collected, hospices
would use the data to monitor the effectiveness and safety of services,
and to identify opportunities for improvement.
The third standard under the quality assessment and performance
improvement program at proposed Sec. 418.58(c), ``Program
activities,'' stated that the hospice would set priorities for its
performance improvement activities that focused on high risk, high
volume and problem-prone areas, considered the prevalence and severity
of identified problems' and gave priority to improvement activities
that affected palliative care, patient safety, and quality of care
outcomes. In Sec. 418.58(c) we also proposed to require the hospice to
track adverse patient events, analyze their causes, and implement
preventive actions that would include feedback and learning throughout
the hospice.
We proposed at Sec. 418.58(d), ``Performance improvement
projects,'' that the number and scope of improvement projects conducted
annually would reflect the scope, complexity, and past performance of
the hospice's services and operations. The hospice would document what
improvement projects were being conducted, the reasons for conducting
them, and the measurable progress achieved on them.
In the final proposed standard at Sec. 418.58(e), ``Executive
responsibilities,'' a hospice's governing body would be responsible and
accountable for ensuring that the ongoing quality improvement program
was defined, implemented, and maintained. The governing body would
ensure that the program addressed priorities for improved quality of
care and patient safety. The governing body would also specify the
frequency and detail of the data collection and ensure that all quality
improvement actions were evaluated for effectiveness. The governing
body's most important role would be to ensure that staff were
furnishing, and patients were receiving, safe, effective, quality care.
Therefore, it would be incumbent on the governing body to lend its full
support to agency quality assessment and performance improvement
efforts.
Comment: A few commenters stated that the phrases ``measurable
improvement,'' ``palliative outcomes,'' ``end of life support
systems,'' and ``quality indicators'' as they were used in the QAPI
CoP, were vague.
Response: We agree that the phrase ``end of life support systems''
is vague, and we have removed it in the opening paragraph and standard
(a) because it is duplicative of the requirement that a hospice's QAPI
program must involve all hospice services, including those services
furnished under contract or arrangement. In Sec. 418.58(a)(1) we have
replaced the term ``end of life support systems'' with ``hospice
services'' to correspond with the ``hospice services'' described in the
opening paragraph. We do not agree that the phrase ``palliative
outcomes'' is vague. Outcomes are the results of care provided;
therefore palliative outcomes are the results of
[[Page 32118]]
palliative care provided. Since hospices primarily furnish palliative
care to patients and respond to the results of the care furnished, we
believe that it is reasonable to expect hospices to include palliative
outcomes, gathered as part of the comprehensive and updated
comprehensive assessments in accordance with final Sec. 418.54(e), as
part of their QAPI programs. We replaced the phrase ``indicators for
which there is evidence that improvement in those indicators will
improve palliative outcomes'' in Sec. 418.58(a)(1) with the phrase
``indicators related to palliative outcomes.'' We believe that this
revised language is clearer and more precise. Therefore, revised Sec.
418.58(a)(1) now reads, ``[t]he program must at least be capable of
showing measurable improvement in indicators related to improved
palliative outcomes and hospice services.'' We do not agree that the
phrase ``measurable improvement'' is vague. Hospices are required to
have data-driven QAPI programs. Through these data, hospices measure
their current performance, implement performance improvement projects,
and measure their changes in performance after implementing the
performance improvement project. Based on an analysis of the data, we
believe that hospices will be able to measure the amount of
improvement, stagnation, or decline in their performance and adjust
their activities accordingly.
Comment: Numerous commenters asked for more clarification of the
term ``adverse event'' as it is used in Sec. 418.58(a) and Sec.
418.58(c) of this Condition of Participation. Other commenters asked
for a delay in the proposed requirement that hospices must collect and
analyze adverse event data.
Response: We do not define the term ``adverse event'' because we
believe that, as part of their QAPI programs, hospices should be free
to define and implement the term in the manner that fits their needs.
Hospices may choose to develop their own definition or use a definition
developed by an accrediting body or industry organization. Once a
hospice has identified the definition of an adverse event, it is
responsible for adhering to the definition when tracking and analyzing
these events and when implementing preventive actions. In general, an
adverse event would be any action or inaction by a hospice that caused
harm to a hospice patient. However, hospices are not bound to use this
generic description.
We believe that it is essential to a hospice's QAPI program to
begin tracking and analyzing adverse events at the same time that it
begins collecting patient level outcome measure data elements and
hospice-wide measures. Since adverse events generally result in harm to
a patient, they serve as important indicators of areas for potential
improvement. If hospices do not collect adverse event information, they
may be missing important data from which to assess their performance.
Therefore, we are not delaying the adverse event requirements in this
final rule.
Comment: Many commenters submitted suggestions for what hospices
may want to consider when selecting the elements of their QAPI program.
Commenters suggested that hospices may want to examine such issues as
pharmacy services, bar coding, electronic prescribing, clinical
decision support programs, adverse event reporting systems, provider
education efforts, patient and family education efforts, pain, nausea,
shortness of breath, skin integrity, constipation, the appropriateness
of emotional and spiritual interventions, and the timeliness of meeting
patient needs at the start of care.
Response: We appreciate all of the suggested areas that hospices
may choose to examine when developing their QAPI programs. In addition
to these suggested domains, hospices may also want to consider issues
surrounding patient transitions. Transitions from one care setting/
provider to a hospice, or from a hospice to another care setting/
provider, are an opportunity for hospices to improve their
relationships with their referral sources while improving patient care
and safety. Hospices may want to consider the use of shared protocols,
agreements to honor advance directives, medication reconciliation
processes, caregiver training and support systems, communication
arrangements, and feedback systems, all related to patient transitions,
as areas to examine in their QAPI programs. We are not requiring
hospices to use any of the suggested domains identified above at this
time because there is no currently available set of standardized
measures.
Comment: A few commenters requested clarification about when and
where patient care measures will be documented.
Response: Different patient care measures require different data
collection timeframes. While some measures may require data collection
only once, other measures may require data collection every few days or
weeks. The nature of the patient care measure will determine the
timeframe for collecting and updating. We expect hospices to establish
their data collection timeframes within the specific context of the
measures used, the available literature, any nationwide data collection
projects they may participate in, their own data collection needs and
goals, as well as the needs of their patients.
We require in Sec. 418.104(a)(4) that the patient care outcome
measure data be included in the patient's clinical record because
hospices must use such data for individual care planning and
coordination of services (Sec. 418.54(e)(2)). Hospices are free to
document the patient care measure data in other locations as well in
order to meet their needs. All documentation must be in accordance with
the data collection policies and procedures established by the hospice
to ensure consistency and retrievability.
Comment: Many commenters requested clarification on the role of
national standardized patient outcome measures and their relationship
to standardized benchmarks. Specifically, commenters noted that, while
some national measures are currently available, there is still work to
be done in this area. A commenter suggested that any measures developed
should relate to providing physical and emotional support, promoting
shared decision-making, individualizing care, and attending to the
needs of families. In addition, commenters expressed uncertainty about
how national benchmarks may be used to measure patient outcomes. Some
commenters suggested that we should work with the hospice industry and
quality improvement organizations (QIOs) to establish such benchmarks
while other commenters stated that benchmarking is not necessary
because the variances between hospices put the validity of the
benchmarks into question.
Response: We agree that more work is needed to establish a wide
variety of valid patient outcome measures that hospices may choose
from. We commissioned a special study, the PEACE project, conducted by
the North and South Carolina QIO. This study created a quality-focused
self-audit tool for hospices to use, and identified quality measures
that focus on the quality of clinical care furnished to hospice
patients. Results of the study are available at http://medqic.org/dcs/
ContentServer?pagename=Medqic/MQPage/Homepage.
In addition, the National Hospice and Palliative Care Organization
launched a National Quality Initiative and Quality Collaborative to
improve hospice and palliative care outcomes. This initiative is
helping hospices develop functional
[[Page 32119]]
QAPI programs, including patient outcome measures.
Furthermore, the National Quality Forum has issued voluntary
consensus standards for end-of-life care of cancer patients, who
comprise approximately 50 percent of the hospice patient population
(National Voluntary Consensus Standards for Symptom Management and End-
of-Life Care in Cancer Patients, December 2006, www.qualityforum.org/
publications/reports/palliative.asp).
The National Quality Forum also issued the ``National Framework and
Preferred Practices for Palliative and Hospice Care Quality'' (2006,
www.qualityforum.org). This report identified eight domains of quality
care as follows: Structures and processes of care; physical aspects of
care; psychological and psychiatric aspects of care; social aspects of
care; spiritual, religious, and existential aspects of care; cultural
aspects of care; care of the imminently dying patient; and ethical and
legal aspects of care. Using the structure of these domains, the report
identifies 38 preferred practices that have been endorsed as suitable
for implementation in hospice programs.
Furthermore, the agency for Healthcare Quality and Research (AHRQ)
issued an evidence-based review of end-of-life care and outcomes
(www.ahrq.gov/clinic/epcsums/eolsums.htm) that may also assist
hospices.
We believe that these efforts, combined with the measures already
identified by the NHPCO and Brown University (Time Toolkit,
www.chcr.brown.edu/pcoc/toolkit.htm), are sufficient to provide
hospices with patient outcome measure options that suit their needs.
Some of the measures that already have been or are being developed
relate to comfortable dying, self-determined life closure, and family
satisfaction with care.
We do not believe that these efforts are sufficient to establish
nationwide benchmarks that are appropriate for inclusion in this rule.
More time is needed to test, refine, and collect further data related
to any specific measure before we could establish a nationwide
benchmark that all hospices should be required to meet. The necessary
information is simply not available at this time to establish mandatory
benchmarks, although hospices are free to use existing benchmarks to
measure their own performance against that of other similar hospices
who use the same measures.
In order to further the process of establishing widely-accepted,
valid, benchmarked quality measures, CMS is actively pursuing
additional research on selected quality measures. This research will
help identify and refine measures that are valid, meaningful, and
reliable for hospices. It will also help establish benchmarks for
hospices to attain.
Following publication of this final rule, CMS will issue further
sub-regulatory guidance on QAPI.
Comment: A few commenters questioned the ability or appropriateness
of using the same outcome measures for each patient within a hospice.
Some commenters noted that not all measures may apply to all patients.
Likewise, the commenters noted that certain patients may need
individualized measures unique to the patient's needs and goals. Other
commenters noted that measures may be different based on the location
in which care is provided (that is, in the patient's home or in an in-
patient facility). Still other commenters noted that outcome measure
data may not be statistically significant when the data are collected
from extremely small samples due to a low patient census.
Response: A variety of hospice-specific patient outcome measures
are currently available. Many of these measures capture data about
universal issues such as patient pain or discomfort. We believe that
these universal measures can be successfully applied to all of a
hospice's patients, regardless of their diagnosis or care location. At
the same time, we agree that hospices may need to add specific outcome
measures for specific patients in order to gather data related to the
individual's needs and goals. Hospices may add patient-specific
measures to the core set of standard measures that they choose to
collect data on for all patients. As with the core set of standardized
patient data, patient-specific data must be gathered and documented in
a consistent, systematic and retrievable manner.
When analyzing data on a patient level, sample size does not
matter. To use the patient outcome measure of pain controlled within 48
hours of admission discussed above in the patient assessment section, a
hospice would need to document for a patient the presence or absence of
uncontrolled pain upon the patient's admission to hospice. If a patient
has uncontrolled pain, the hospice would then reassess his or her pain
48 hours after the patient's admission to hospice and document the
presence or absence of uncontrolled pain at that time. This does not
mean that the hospice does not assess the patient's pain between the
initial pain assessment and the 48 hour pain assessment. Indeed, the
hospice may need to assess the patient's pain far more frequently in
order to adjust the treatments being provided to control the patient's
pain. In completing a patient-level analysis of the patient's data, the
hospice would be able to judge the effectiveness of the initial care
furnished in controlling the patient's pain.
In completing the hospice-wide analysis, this patient's pain
control data would be aggregated with the pain control data of the
other patients that the hospice cared for. This aggregated data would
allow the hospice to look for patterns such as a high level of pain
control success for patients with cancer diagnoses and lesser levels of
success for congestive heart failure patients. Identifying patterns,
areas of strength, and areas of weakness allows the hospice to reaffirm
promising practices that lead to positive patient outcomes and re-
examine practices that lead to inadequate or negative patient outcomes.
Aggregation of data must be done in accordance with the policies
and procedures established by the hospice. If a hospice has an
extremely small average monthly census, then it may make sense for that
hospice to aggregate several months of data. Likewise, if a hospice has
an extremely large average monthly census, then it may make sense for
them to aggregate the data more frequently to ensure that the amount of
data does not become overwhelming to those analyzing it. The flexible
nature of the patient outcome measure standard and the quality
assessment and performance improvement CoP allow hospices to adapt data
collection and analysis to their needs and goals.
Comment: A few commenters expressed enthusiastic support for the
requirement that hospices collect patient outcome measure data, noting
that other health care providers have been collecting this data for
several years. Other commenters, while expressing support for the
overall goals of data collection and QAPI, expressed concern about the
potential costs. Commenters cited the potential cost and availability
of software to aid in data collection as the single largest concern.
Response: We appreciate the overall support for data collection and
QAPI. At the same time, we understand the concerns that some hospices
have about implementing these new requirements. We note that the new
regulation does not require hospices to use electronic health records
or any specific software for data collection. Hospices are free to
choose the data collection methods and tools that best suit their
needs. We do not believe that this rule is imposing a
[[Page 32120]]
burden on hospices by requiring them to obtain sophisticated data
collection and analysis computer programs. Analysis of patient outcome
measures, as well as administrative data, will allow hospices to
determine objectively what care results in the best outcomes for a
particular patient or subset of patients. This will help hospices
identify best practices and avoid ineffective practices, which may
reduce hospice expenditures in the future. We believe these benefits
will outweigh any costs associated with the process.
Comment: A commenter suggested that, in Sec. 418.58(b)(2)(ii),
hospices should be required to use quality indicator data that they
collected to identify priorities, as well as opportunities, for
improvement.
Response: We agree that hospices should use data to prioritize
their areas for improvement, and we have incorporated this suggestion
into the final rule. Section 418.58(b)(2)(ii) now reads, ``[i]dentify
opportunities and priorities for improvement.''
Comment: In proposed Sec. 418.58(b)(3), a commenter suggested that
the governing body should approve, rather than specify, the frequency
and detail of data collection.
Response: We agree that the governing body's general QAPI oversight
responsibility would be more appropriately described by the term
``approved'' than the proposed term ``specified,'' and we have made
this change.
Comment: Some commenters suggested that the requirement for
hospices to conduct performance improvement projects should be phased
in.
Response: In accordance with this rule, hospices are required to
identify opportunities and priorities for improvement based on the data
that they have collected. We agree that it would be appropriate to
delay implementation of the performance improvement projects
requirement to allow hospices time to develop and implement a data
collection program, and actually amass several months of data. For this
reason, we have added a 240 day phase-in period. This phase-in period
will allow hospices to gather several months of data before being
required to develop and implement their data-driven performance
improvement projects. Once the 240 day phase-in period is complete, we
expect hospices to begin developing and implementing their data-driven
performance improvement projects, with evaluation of those performance
improvement projects to follow thereafter.
Comment: A commenter asked us to specify, in Sec. 418.58(d)(1),
that the number and scope of performance improvement projects that a
hospice undertakes should be based on the needs of the hospice's
population and its own internal organizational needs. Another commenter
asked us to clarify our proposed requirement that performance
improvement projects must reflect a hospice's past performance.
Response: While we understand that some hospices may want
additional guidance on the number and scope of projects that must be
undertaken, we believe that a hospice's performance improvement
projects should be required to reflect the needs of its patient
population as well as its own needs, and this requirement is included
in the final rule. We also believe that hospices must examine their
past performance when developing performance improvement projects. If a
hospice is aware that it had issues in a particular area in the past,
then we believe that it is appropriate to re-examine that issue to
assure that it has been remedied. Hospices should conduct these
performance improvement projects that focus on previously existing
concerns in concert with performance improvement projects that focus on
more recently occurring issues, to ensure that they are consistently
furnishing quality services to patients. Revised Sec. 418.58(d)(1)
reads, ``The number and scope of distinct performance improvement
projects conducted annually, based on the needs of the hospice's
population and internal organizational needs, must reflect the scope,
complexity, and past performance of the hospice's services and
operations.''
Comment: A commenter suggested that, in Sec. 418.58(d)(2),
hospices should be specifically required to document any national
quality improvement projects they are participating in. Other
commenters questioned whether or not participation in national quality
improvement projects would satisfy the QAPI requirement.
Response: Section 418.58(d)(2) requires hospices to document all
performance improvement projects they are conducting, including
national performance improvement projects. There is no need to single
out national performance improvement projects as needing to be
documented separately because they are one part of a hospice's larger
performance improvement project plan, which must be documented.
Hospices are free to participate in such national projects. We would
caution however, that participation in such projects does not guarantee
that hospices are in compliance with this requirement. As required by
Sec. 418.58(b)(2)(ii), hospices must use the quality indicator data
that they have gathered to identify and prioritize opportunities for
improvement. In addition, Sec. 418.58(a)(1) requires a hospice's QAPI
program to be able to show measurable improvement in areas related to
improved palliative outcomes and hospice services. Furthermore, Sec.
418.58(d)(1) requires that the scope and number of a hospice's
performance improvement projects are to be based on the needs of the
hospice and its patient population. Read together, these requirements
require hospices to develop, implement, and assess performance
improvement projects that reflect their areas of weakness, as
identified through the data that they have collected, and the needs of
their organizations. If a hospice participates in a national
performance improvement project that does not address one or more of
its areas of weakness, or if that performance improvement project will
not enable the hospices to demonstrate measurable improvement in areas
identified as needing to be addressed, then participation in the
national performance improvement project would not meet the QAPI
requirements of this rule.
Comment: Numerous commenters stated that the proposed QAPI
requirement at Sec. 418.58(e) assigned a hospice's governing body too
much responsibility for the hospice's QAPI program. Commenters believed
that the hospice IDG or a professional advisory committee would better
fulfill the executive responsibilities described in this paragraph. One
commenter suggested that the role of the governing body should be
augmented by requiring it to monitor the QAPI program rather than
simply ensuring that is it functioning. Another commenter suggested
that the role of the governing body should be further clarified by
adapting leadership standards for home care agencies established by the
Joint Commission.
Response: Section 418.100(b) of this rule requires the hospice's
governing body to assume full legal authority and responsibility for
the management of the hospice, including its QAPI program. Section
418.58(e) of the proposed rule specified the QAPI responsibilities of
the governing body. It would require the hospice's governing body to
ensure that a QAPI program is defined, implemented, and maintained. In
addition, the rule proposed that the governing body must ensure that
the QAPI program addresses the hospice's quality priorities and that
its
[[Page 32121]]
effectiveness is evaluated. As the entity that is legally responsible
for the hospice, we believe that it is essential that the hospice
governing body ensures that the hospice's QAPI program is meeting the
requirements of this rule.
We believe that our governing body requirements meet the intent of
the Joint Commission leadership standards. Therefore we are setting
forth this requirement as final. The governing body may assume hands-on
control of the QAPI program to ensure that the program is in compliance
with this rule, or it may choose to appoint one or more individuals to
handle the structure and administration of the QAPI program while the
governing body retains ultimate responsibility for the actions of the
designated individual(s).
As many commenters noted, the individuals who compose the governing
body may not have significant experience in a hospice QAPI program and
would therefore not be the best candidates to actively supervise or
direct its activities. For this reason, it may not be appropriate to
require the governing body to actively monitor the QAPI program if this
function can be managed by others more knowledgeable in clinical and/or
related fields of endeavor. A new provision has been added at Sec.
418.58(e)(3) explicitly requiring the governing body to appoint QAPI
leaders.
Comment: A commenter asked us to delete the proposed Sec.
418.58(e)(3) which required the governing body to ensure that clear
expectations for patient safety are established. The commenter stated
that patient safety is already addressed throughout the regulations,
and that it is redundant to include this requirement in the QAPI CoP.
Response: We agree that patient safety is already addressed
throughout the rule and does not need to be separately included in the
QAPI section.
Comment: The majority of commenters that submitted comments on the
proposed quality assessment and performance improvement CoP supported
its overall goals. The commenters appreciated our recognition of the
role that QAPI now plays in the hospice industry as well as its current
limitations. The commenters requested assistance from CMS in
implementing some aspects of the proposed QAPI requirement. Commenters
sought additional CMS involvement in developing measures that hospices
may choose to use. Commenters also sought assistance from the QIOs that
CMS contracts with to provide quality assistance for other provider
types.
Response: In August 2006 CMS contracted with the North and South
Carolina QIO to conduct a special study on hospice quality measures.
This study created a quality-focused self-audit tool for hospices to
use and identified quality measures that focus on the quality of
clinical care furnished to hospice patients. Results of the study are
available at http://medqic.org/dcs/ContentServer?pagename=Medqic/
MQPage/Homepage.
In addition to this completed project, CMS plans to sponsor
additional research that will examine the validity, reliability,
appropriateness, and usefulness of select quality measures.
Furthermore, CMS plans to sponsor work that will develop a method for
QIOs to actively assist interested hospices in developing and
implementing QAPI programs.
Comment: Many commenters made general statements in support of the
broad framework adopted by the proposed QAPI requirement. These
commenters liked the fact that we did not propose that hospices use any
specific quality measures, data elements or benchmarks. Commenters
voiced approval that they would be permitted to identify their own
quality goals, measures and elements, and that they would be permitted
to identify how many performance improvement projects they undertook
and what those projects would focus upon. Conversely, other commenters
specifically asked for the regulation to detail the quality measures
and data elements that must be collected, the number and topics of
performance improvement projects that must be undertaken, and the exact
benchmarks or results that must be achieved.
Response: The two diametrically opposed viewpoints expressed by
commenters are difficult to reconcile. Our intent in developing the
QAPI CoP was to ensure that hospices would develop a data-driven
program for continuous quality improvement that reflects the needs of
patients and hospices alike. We believe that prescribing specific data
measures and improvement projects is not appropriate at this time
because there is no currently available, valid, reliable, widely
applied set of clinical and/or administrative quality measures. As
hospice quality measurement and best practices continue to evolve, we
believe that a set of measures and practices may be identified, and
that such measures and practices may be appropriate for inclusion in
the hospice rules.
At the same time, we are sensitive to the concerns of hospice
providers who are wary of the new and unknown. As described above, we
conducted a special study through the Carolina QIO to identify hospice
measures focusing on the quality of clinical care furnished to hospice
patients. These measures are publicly available at no cost to hospice
providers. In addition, the largest hospice industry group, the
National Hospice and Palliative Care Organization, has launched a major
quality initiative to provide hospices with the tools they need to
begin collecting and analyzing QAPI data and to develop, implement, and
analyze performance improvement projects. Furthermore, Brown University
has made available the TIME Toolkit, which contains quality measures
and related data elements that hospices may use in their QAPI programs.
We are confident that these efforts, and others that may arise in the
future, will help hospices transition from the quality assurance
approach to the QAPI approach. For additional discussion of the former
quality assurance requirements and the new QAPI requirements, see pages
30847-30849 of the May 27, 2005 hospice proposed rule (70 FR 30840).
Comment: Many commenters expressed general concern about the cost
of implementing a QAPI program. Several of these commenters suggested
that implementing a QAPI program will require more staff hours and
money than estimated in the impact analysis section of the proposed
rule.
Response: We recognize that moving from the basic QA approach to a
QAPI approach will require some hospices to reallocate funds to expand
and evolve their existing quality programs. However, an effective QAPI
program will allow hospices to identify areas for improvement. The
analysis of patient care and administrative data for the QAPI program
may help hospices identify ineffective therapies, opportunities for
staff improvement, low performing contracts for services, etc., and
allow hospices the chance to improve services and efficiency. A
vigorous QAPI program will benefit hospices and patients, and will help
ensure that hospice resources are being used in the most effective and
efficient manner possible. While we have adjusted the cost estimate for
this CoP in the impact analysis section, we have not factored in the
cost savings that hospices may achieve.
Comment: Several commenters stressed the importance of ensuring
that all hospice employees are involved in the QAPI program. Of these
commenters, a few highlighted the need for board certified chaplain
involvement in QAPI.
Response: We agree that it is important to involve employees, both
paid and volunteer, as well as
[[Page 32122]]
individuals furnishing services under contract, in the hospice's QAPI
program. In order to ensure such involvement, we require in Sec.
418.62, that all licensed professionals furnishing services on behalf
of the hospice must actively participate in the hospice's QAPI program.
Hospices have the flexibility, within the licensed professional
requirement, to determine which individuals will lead QAPI efforts
based on their own needs and goals. Hospices may choose to use the
services of board certified chaplains in developing and implementing
their QAPI program.
Comment: A few commenters suggested that we should require hospices
to publicly report the results of their data collection, while other
commenters expressed concern that we may require hospices to use a data
collection tool such as OASIS, which would enable public reporting of
hospice data. Similarly, commenters expressed concern that we would
expect hospices to use computerized systems in implementing the QAPI
requirement.
Response: Quality assessment and performance improvement is a fast
growing approach to quality improvement in the hospice industry.
However, there is no nationally standardized and accepted set of
measures that could be used at this time to develop an OASIS-like tool
that would enable public reporting. The intent of this rule is to
establish the framework of QAPI in hospice, not to prescribe specific
measures or tools. As such, we are not requiring hospices to use
specific outcome or process measures, data elements, forms, or computer
systems. These decisions are at the discretion of each hospice based on
its own needs and goals. We caution that we cannot, at this time,
predict with any certainty the future of hospice data collection and
its relationship to the public reporting of data.
Comment: Many commenters asked for more information about how State
surveyors will survey hospices for compliance with the QAPI
requirements. Commenters sought more information about how hospice
surveyors will use hospice data and how they will determine a QAPI
program's scope, complexity and adequacy of improvement projects.
Response: Hospices are required to collect and analyze patient care
and administrative quality data and to use that data to identify,
prioritize, implement, and evaluate performance improvement projects to
improve the quality of services furnished to hospice patients. In order
to assess compliance with the QAPI requirements, hospice surveyors will
need to access, upon request, a hospice's aggregated data and its
analysis of that data. Surveyors will also need access to the hospice's
QAPI plan, any meeting minutes or notes for meetings concerning the
development and implementation of the hospice's QAPI program, those
individuals responsible for the QAPI program, and any other necessary
resources needed to assess a hospice's compliance. This information
will allow surveyors to match the data provided by the hospice with the
actual experiences of hospice employees and patients to ensure that the
QAPI program is prevalent throughout the hospice's operations and
services, and that it is positively influencing patient care.
Furthermore, this information will enable surveyors to assess the
adequacy and appropriateness of a hospice's QAPI program. Surveyors
will focus on areas such as how and why a hospice chose its quality
measures, how it ensures consistent data collection, how it uses data
in patient care planning, how it aggregates and analyzes data, how it
uses the data analysis to select performance improvement projects, how
it implements such projects, and its use of data to evaluate the
effectiveness of those projects. We will include more detailed
information about the QAPI survey process and goals in future sub-
regulatory guidance such as the State Operations Manual and
Interpretive Guidelines.
We note that hospitals are currently required to comply with a very
similar performance improvement project regulation and have
successfully determined their performance improvement project needs and
goals without prescribed minimums. Likewise, hospital surveyors have
successfully assessed hospital compliance with the performance
improvement project regulation without such minimums. We will use the
knowledge gained through the hospital survey process to guide our
understanding and implementation of surveys for hospices complying with
this performance improvement project regulation.
6. Condition of Participation: Infection Control (Sec. 418.60)
There are no current requirements for infection control other than
the requirements at Sec. 418.100(a) that read in part, ``each patient
is to be kept comfortable, clean, well groomed, and protected from
accident, injury, and infection,'' and the requirement at Sec.
418.100(e) regarding isolation areas. We proposed a new CoP to help
manage the seriousness and hazards of infectious and communicable
diseases.
We recognize that a hospice cannot be directly responsible for the
maintenance of an infection-free environment in every setting. We
proposed in Sec. 418.60(a), ``Prevention,'' that hospices follow
accepted infection control standards of practice and ensure that all
staff that provide hospice services know and use these current best
prevention practices to curb the spread of infection. Periodic training
is one way to assure that staff take all appropriate infection
prevention and control precautions. Hospices may also consider
immunizing their patient care staff for influenza as part of their
infection control programs. Hospice staff may transmit influenza to
patients, compromising their quality of life at this important time,
and to caregivers, compromising their ability to effectively care for
the patient. Furthermore, infected staff may create a staffing
shortage, compromising the entire hospice's ability to safely and
effectively deliver care to all hospice patients and their families.
In Sec. 418.60(b), ``Control,'' we proposed that the hospice be
required to engage in an ongoing system-wide program that focuses on
the surveillance, identification, prevention, control, and
investigation of infections and communicable disease. Where infection
and/or communicable disease are identified, we expect that this
information would be made part of the hospice's quality assessment and
performance improvement program.
As proposed in Sec. 418.60(c), ``Education,'' each hospice would
be expected to educate its staff, as well as patients, families, and
other caregivers in the ``current best practices'' for controlling the
spread of infections within the home during the course of the family/
caregiver's interactions. We did not propose any specific approaches
that a hospice would be required to adhere to. A hospice would be
expected to aggressively seek to minimize the spread of disease and
infection through its efforts to help families and caregivers
understand what can and should be done to minimize infection.
Comment: Several commenters thanked us and supported the
incorporation of this new requirement.
Response: We appreciate the support from the commenters on this
proposal. We believe that this requirement is necessary to ensure that
patients receive quality care from hospices, regardless of the
patient's setting. Due to the potential negative effects on health and
safety that are posed by infection and communicable diseases, we
believe hospices need to address infection standards of practice and
ensure all staff that provide hospice services know and
[[Page 32123]]
use the current best prevention practices to curb the spread of
infection.
Comment: One commenter requested that we add the word ``visitor''
to the list of those protected by the infection control program.
Response: We agree, and the word ``visitor'' has been added to the
opening paragraph. The final language at Sec. 418.60 reads, ``[t]he
hospice must maintain and document an effective infection control
program that protects, patients, families, visitors and hospice
personnel by preventing and controlling infections and communicable
diseases.''
Comment: One commenter recommended that the disease prevention plan
in Sec. 418.60(b)(2)(ii), should ensure the comfort of the patient.
Response: We strongly agree. The comfort, safety and well-being of
the patient must always be the main objective when providing care and
services. Section 418.100(a), ``Serving the hospice patient and
family,'' already requires hospices to furnish all care, including care
related to infection control, in a manner that optimizes patient
comfort.
Comment: A few commenters expressed concern about our proposed
requirement at Sec. 418.60(c) that hospices must provide infection
control education to staff, patients, family and other caregivers. One
commenter expressed concern that the tracking of infection in hospice
patients, especially in the home setting, is difficult and that in many
cases infection is a natural progression of the disease and is not
unexpected.
Response: We acknowledge the limitations hospices may encounter
regarding infections in patients, and in determining the outcomes for
patients that are terminally ill, immune-suppressed and that may have
other co-morbidities. However, we believe that this should not affect
the need to apprise family and caregivers about infection control. The
education standard in Sec. 418.60(c) allows the hospice flexibility in
meeting infection control, prevention and education objectives. While
we would expect the hospice to adhere to best practices, we are not
requiring any specific approaches. Due to the negative effects of
infections on the health and safety of patients and staff and the
potential financial burden on the hospice, we believe that it is in the
best interest of hospices and the patients they serve to focus on
controlling the spread of infections in the home.
Comment: A few commenters asked how hospices should handle
extremely short lengths of stays, where there may not be an opportunity
to educate the caregivers on infection control procedures.
Response: We certainly appreciate that hospices may encounter
patients that elect the benefit in the last 24-72 hours of life. We
agree that, due to the short timeframe, there may not be time to
educate the patient, family and caregiver on myriad infection control
procedures, nor given the circumstances, may it be appropriate.
Nonetheless, we believe that the demonstration of best practices by the
hospice staff while caring for the patient and the ability of the staff
to talk to the patient and family regarding basic precautions such as
hand washing while providing care would be sufficient. This information
will be included in future sub-regulatory guidance.
7. Condition of Participation: Licensed Professional Services (Sec.
418.62)
Sections of current regulations at Sec. 418.82, ``Nursing
services;'' Sec. 418.84, ``Medical social services;'' and Sec.
418.92, ``Physical therapy, occupational therapy and speech-language
pathology,'' identify detailed tasks that must be performed by agency
staff. We proposed to remove Sec. 418.82, Sec. 418.84, and Sec.
418.92, and replace them with a more simplified condition, ``Licensed
professional services.'' Instead of identifying detailed tasks, we
broadly described the expected contributions of the licensed
professionals who are furnishing hospice services. Licensed
professional services, for purposes of this section, would include, but
not be limited to, skilled nursing care, physical therapy, speech
language pathology, occupational therapy, and medical social services.
We proposed that licensed professionals who provide services to hospice
patients either directly or under arrangement would participate in
coordinating all aspects of care, including updating the
interdisciplinary comprehensive assessments, developing and evaluating
plans of care, participating in patient and family counseling,
participating in the quality assessment and performance improvement
plan, and participating in in-service training.
Comment: Several commenters suggested that we amend the language in
proposed Sec. 418.62(b) to apply to the coordination of the patient's
hospice care. One commenter stated that we should limit the hospice's
responsibility to coordination of hospice care, since the hospice
cannot control other aspects of patient care that are unrelated to the
terminal illness and related conditions.
Response: We appreciate the comments and are accepting the
suggested changes. Although we expect that the hospice will actively
participate in the coordination of hospice care, it is unrealistic and
beyond the scope of the hospice regulations to require hospices to
coordinate all aspects of a patient's care. Therefore, we have amended
this provision and the final language at Sec. 418.62(b) now reads,
``[l]icensed professionals must actively participate in the
coordination of all aspects of the patient's hospice care * * *.'' As
previously noted, if a hospice does not coordinate all aspects of a
patient's care, it is incumbent upon the hospice to know who is
performing this function, and to actively communicate and coordinate
with other providers to ensure that the patient's needs and goals are
met.
Comment: One commenter asked that we not require contracted staff
to participate in the hospice's QAPI program. The commenter suggested
that we amend this language so that contracted licensed professionals
are encouraged to participate whenever possible.
Response: For QAPI to work effectively for the hospice, all
professionals must be involved in the quality process. This would
include contracted licensed professionals. We expect all hospices to
provide high quality care for all of the patients they serve, and
believe that the care should be ``seamless,'' meaning that, whether the
individual providing services is an employee or contracted licensed
professional, the care provided to patients and their families must be
provided at the same high level of quality.
8. Condition of Participation: Core Services (Sec. 418.64)
The conditions of participation containing the current core
services requirements are in Sec. 418.80, ``Furnishing of core
services;'' Sec. 418.82, ``Nursing services;'' Sec. 418.84, ``Medical
social services;'' Sec. 418.86, ``Physician services;'' and Sec.
418.88, ``Counseling services.'' We proposed to combine these into a
single condition. We also proposed to incorporate the requirement at
existing Sec. 418.50(b)(3) which required that core services would be
provided in a manner consistent with accepted standards of practice.
This section was revised to reflect changes to the Act made by section
946 of the MMA. In accordance with section 946 of the MMA, we proposed
to allow a hospice (the primary hospice) to enter into arrangements
with another Medicare-certified hospice to obtain core hospice
services. The Act provided that this could be done under extraordinary
or
[[Page 32124]]
other nonroutine circumstances. Pursuant to section 1861(dd)(5)(D) of
the Act (as amended by section 946(a) of the MMA) those circumstances
are: unanticipated periods of high patient loads; staffing shortages
due to illness or other short-term temporary situations that interrupt
patient care such as natural disasters; and temporary travel of a
patient outside the hospice's service area.
In the first proposed standard, ``(a) Physician services,'' we
incorporated the existing requirements of Sec. 418.86. The existing
and proposed requirement states that hospice physicians, in conjunction
with the patient's attending physician, are responsible for the
palliation and management of the terminal illness, conditions related
to the terminal illness, and the general medical needs of the patient.
As a result of changes made to the Act by the BBA, we also proposed to
add a provision to the CoPs permitting hospices to contract for
physician services. This proposed provision would align the CoPs with
current CMS policy permitting hospices to contract for physician
services.
The second proposed standard, ``(b) Nursing services,''
incorporated the requirements of Sec. 418.82 of the existing CoPs. We
also proposed to add specific language to address the role of nurse
practitioners in providing hospice care. The services provided by nurse
practitioners continue to be guided by Medicare statutory requirements.
Within these statutory requirements, we propose to allow nurse
practitioners to perform hospice functions that are within the scope of
their practice and license, as well as within the laws of the State in
which they practice.
We also proposed in Sec. 418.64(b) to allow hospices to provide
certain types of nursing services under contract. This proposed change
also resulted from section 946 of the MMA, which amended the Act by
adding section 1861(dd)(5)(E). As amended, the Act provides that these
nursing services must be highly specialized and provided non-routinely
and so infrequently that their provision by hospice employees would be
impracticable and prohibitively expensive. We recognize that it may be
cost-prohibitive for a hospice to employ a nurse that possesses very
highly specialized skills when he or she may only care for a few
patients a year. By allowing hospices to contract with specialized
nursing providers or others to provide these highly specialized nursing
services to the few patients who require them, hospices would be able
to better implement an efficient staffing plan and ensure proficiency
in the skilled services being provided.
In standard ``(c) Medical social services,'' we proposed to
maintain the requirements of the current medical social services
requirement at Sec. 418.84. This standard would continue to require
that medical social services be provided by a qualified social worker
under the direction of a physician. This standard would also require
that medical social services, when accepted by a patient and family, be
based on an assessment of that patient's psychosocial needs. In
proposed standard Sec. 418.64(d), we addressed the counseling services
that would be available to hospice patients and their families. Those
services would be bereavement, nutritional, and spiritual counseling.
In the bereavement counseling section, we proposed that a hospice would
be required to have an organized program of bereavement services
furnished under the supervision of a qualified professional with
experience in grief/loss counseling. These services would be required
to be made available to individuals identified in the bereavement plan
of care up to one year following the death of the patient, and would
reflect the needs of those individuals. When appropriate, residents and
staff of a SNF/NF, ICF/MR, or other facility would be offered
bereavement services.
In the nutritional counseling section, we proposed to allow
qualified individuals, such as dietitians and nurses to furnish this
service, provided that it was within their scope of practice and
expertise according to State law. We believed that allowing other
qualified individuals to participate in nutritional counseling would
give hospices greater flexibility and would help ensure that all
hospice patients had access to this service when needed. This proposal
conformed to a recommendation made by the Secretary's Advisory
Committee on Regulatory Reform.
In the spiritual counseling section, we proposed that a hospice
would be required to assess the patient's and family's spiritual needs
and provide spiritual counseling to meet those needs, in accordance
with the patient's and family's beliefs and desires. If a patient and
family did not desire spiritual counseling, then they would not have to
be provided this service. If a patient and family did desire spiritual
counseling, then a hospice would be expected to facilitate visits by
local clergy, pastoral counselors, or others to the best of its
ability.
Comment: Numerous commenters requested that the regulations permit
hospices to contract for core services with various entities and for
various reasons. Some of these commenters believed that hospices should
be permitted to contract with hospice and non-hospice agencies on a
routine basis for the provision of core services to hospice patients.
Other commenters believed that, in extraordinary circumstances,
hospices should be allowed to contract with non-hospice agencies in
addition to contracting with other Medicare-certified hospice agencies,
as we proposed. Still other commenters stated that hospices should be
permitted to use contracted staff when they are providing continuous
care to one or more patients, either because continuous care increases
the amount of hours of patient care, which results in a period of peak
patient loads, or because providing continuous care requires highly
specialized nursing skills.
Response: Section 1861(dd) of the Act requires hospices to provide
substantially all core services directly (see section
1861(dd)(2)(A)(ii)(I) of the Act). Thus, in accordance with the Act,
hospices are prohibited from contracting with other hospices and non-
hospice agencies on a routine basis for the provision of core services
to hospice patients. The Act specifically states ``substantially all''
in recognition of the fact that there are times when hospices must
contract for core services. The Act identifies the circumstances in
which hospices are permitted to contract for core services as those
that are ``extraordinary'' or otherwise ``non-routine'' such as
unanticipated periods of high patient loads, temporary staffing
shortages, and travel of a patient outside of the hospice's service
area. We agree that hospices should be permitted to contract with non-
hospice providers as well as other Medicare certified hospices in order
to meet patient needs in extraordinary circumstances, and we have
amended the final rule as such.
We also agree that simultaneously providing continuous home care to
multiple patients may result in an unanticipated period of high patient
load that would warrant contracting for core services through the
extraordinary circumstance exception. If a hospice chooses to contract
with another Medicare-certified hospice or a non-hospice entity, the
contracting hospice must maintain professional management
responsibility for the services provided, in accordance with this final
rule at Sec. 418.100(e). In addition, all licensed professionals who
provide services to hospice patients under contract must actively
participate in the coordination of all aspects of the patient's hospice
care, including patient assessments; care planning development,
delivery, and
[[Page 32125]]
evaluation; patient and family counseling and education; in-service
training; and the hospice's quality assessment and performance
improvement program, to the extent applicable, in accordance with Sec.
418.62.
Comment: A commenter suggested that, in order to ensure the quality
of nurses providing care under contract, CMS should survey nurse
staffing agencies.
Response: Medicare does not currently have the authority to survey
nurse staffing agencies because they are not themselves providers under
Medicare. We expect hospices that use the services of a nurse staffing
agency to ensure that the nurses provided by such agency are qualified
to furnish nursing care to hospice patients. In addition, we expect
hospices to exercise full professional management responsibility for
the services provided by contractors to ensure that those services are
appropriate and are of high quality.
Comment: Many commenters submitted suggestions to refine the
proposed ``Physician services'' standard at Sec. 418.64(a). One of
these commenters suggested that this standard should be removed,
because having a standard for physician services separates physician
services from the rest of the IDG. Another commenter suggested that
this standard should explicitly state that the hospice medical director
would not be required personally to provide direct physician services
to every patient. Still another commenter suggested that the role of
physician assistants should be included in this standard. Several other
commenters suggested that we remove the proposed requirement that
hospice physicians be responsible for the general medical needs of the
patient, because this responsibility would create a conflict with the
role of the attending physician and/or the physicians of a SNF/NF.
Response: We believe that including a standard for physician
services under the umbrella of the core services CoP, highlights the
fact that physician services are one piece in the larger
interdisciplinary services model of hospice care. Physician services
are, in this rule, treated as equal to nursing services, medical social
services, and counseling services. These four disciplines are required
to work together as the core members of the IDG, and we believe that it
is appropriate to group them together under a single CoP.
We do not believe that it is appropriate or necessary to state that
medical directors are not required to furnish hands-on services to each
patient. Elements of the proposed rule, such as the proposed
requirement that the hospice medical director communicate with the
medical director of a SNF/NF in proposed Sec. 418.112(d), may have
incorrectly implied that the hospice medical director would be expected
to furnish direct care to every patient. We have removed or revised
these elements to reflect the fact that the hospice IDG, including its
physician member, is required to fulfill the role originally designated
for the hospice medical director. Now that these implications have been
removed, it is not necessary to explicitly state that the hospice
medical director is not required to furnish care to each patient.
We proposed the provisions governing the role of nurse
practitioners in hospice because the use of nurse practitioner services
is prevalent in the hospice industry, and we have received numerous
requests for this guidance for several years. Conversely, we are not
aware of any need to address the role of physician assistants in
hospice because, to our knowledge, physician assistant services are
rarely used in hospices and are not recognized under the Medicare
hospice benefit. We believe that there is no need to regulate services
that are not used.
We agree that we need to revise the proposed rule requiring hospice
physicians to assume responsibility for the general medical needs of
the patient. This responsibility could well be beyond the scope of
hospice physician services and could conflict with the responsibilities
of other physicians furnishing services for needs unrelated to the
patient's terminal illness and related conditions. Therefore, this
proposed requirement has been removed. We have retained the requirement
that, when the patient's attending physician is not available, a
hospice physician is responsible for meeting the patient's medical
needs. We do not believe that this requirement creates a conflict
because it only applies when the attending physician is not available
to perform his or her duties.
Comment: Several commenters suggested that requirements for nurse
practitioner services should be included in the same standard as those
for physician services. Some of these commenters also suggested that
the ``Physician services'' standard should be renamed ``Medical
services.'' In addition, some of these commenters suggested that the
requirements for nurse practitioner services, as included under the
physician services heading, should be expanded to govern the role of
all advanced practice nurses.
Response: Section 1861(dd) of the Act clearly delineates those
services provided by physicians from those provided by nurses. We
believe that the services of nurse practitioners fall squarely into the
nursing services category, because they are services provided by
nurses. We also believe that, as such, it is not appropriate to
relocate the regulation governing the services of nurse practitioners
from the nursing services standard to the physician services standard.
Since we are not placing nurse practitioner services into the same
standard as physician services, it is not necessary to rename the
standard. We agree that it is appropriate to replace the term ``nurse
practitioner'' as used in proposed Sec. 418.64(b), ``Nursing
services,'' and we have replaced it with the broader term ``registered
nurse.'' If a registered nurse, including a nurse practitioner,
advanced practice nurse, etc., is permitted by State law and regulation
to see, treat, and write orders, then they may perform this function
while providing nursing services for hospice patients. Hospices are
free to use the services of all types of advanced practice nurses
within their respective scopes of practice to enhance the nursing care
furnished to patients. The Medicare Hospice per diem payment includes
nursing costs. A Nurse practitioners cannot bill separately for care
provided to Medicare hospice patients, except under very limited
circumstances. Please refer to the Hospice chapter of the Medicare
Benefit Policy Manual for additional instructions regarding coverage
and payment policy.
Comment: A commenter suggested that we remove the proposed
requirement that the patient's plan of care describe the role and scope
of services provided by nurse practitioners.
Response: We agree that it is not necessary to describe the role
and scope of services provided by nurse practitioners separately from
the role and scope of general nursing services in the patient's plan of
care. Therefore, we have removed this proposed requirement. We continue
to expect that the role and scope of nursing services, including those
provided by nurse practitioners and other advanced practice nurses,
will be specified in each patient's plan of care in accordance with
final Sec. 418.56(c)(2).
Comment: A few commenters suggested that we should revise the
requirements of proposed Sec. 418.64(b)(3). Some of these commenters
suggested that we should delete the requirement that, in order to
contract for highly specialized nursing services, those services must
be provided infrequently. The commenters believed that the term
``infrequently'' was not specific. Other
[[Page 32126]]
commenters suggested that we should clarify that the contract for
highly specialized nursing services is not required to be with another
Medicare-certified hospice in order to differentiate this contracting
requirement from the general core services contracting requirement.
Response: Section 946(a) of the MMA amended 1861(dd)(5) of the Act
by adding a new subparagraph (E). That subparagraph states, ``A hospice
program may provide services described in paragraph (1)(A) other than
directly by the program if services are highly specialized services of
a registered professional nurse and are provided non-routinely and so
infrequently so that the provision of such services directly would be
impracticable and prohibitively expensive.'' We believe that this
criterion, established by the MMA, is sufficient for hospices to assess
whether or not they may contract for a highly specialized nursing
service. If providing the nursing service through direct hospice
employees is impossible and cost-prohibitive because the service is
provided infrequently, and if the service requires highly specialized
nursing skills, then the hospice may contract for the service.
We do not believe that it is necessary to state that the contract
for highly specialized nursing services need not be with another
Medicare-certified hospice because we have revised the requirements for
the general core services contract to permit hospices to contract with
Medicare-certified hospices and non-hospice providers for core services
under certain circumstances. Since hospices may contract with hospice
and non-hospice providers for the general core services contract and
for the highly specialized nursing skills contract, there is no need to
differentiate between the two contracts.
Comment: Several commenters suggested that we should revise
proposed Sec. 418.64(c), ``Medical social services.'' Many of these
commenters suggested that we should remove the requirement that medical
social services be provided under the supervision of a physician.
Others suggested that medical social services should be provided under
the direction of the hospice medical director or the IDG. Another
commenter suggested that this standard should require social workers to
have an MSW from an institution of higher learning that is accredited
by the Council on Social Work Education. Still another commenter
suggested that the scope of medical social services should be
broadened.
Response: Effective supervision of medical social services is
essential for ensuring high quality care. Section 1861(dd)(1)(C) of the
Act requires hospices to provide ``medical social services under the
direction of a physician.'' Since the Act specifically requires a
physician to supervise medical social services, it is not appropriate
to assign supervisory responsibility for medical social services to the
IDG. It is also not appropriate to assign supervisory responsibility to
the medical director because he or she may not necessarily be the
physician member of the IDG assigned to the patient. The medical
director, if he or she is not the physician member of the patient's
IDG, may not have sufficient knowledge about the patient's care to
effectively supervise the medical social services provided to that
patient.
In addition to effective supervision, it is essential that the
individuals providing medical social services to hospice patients be
qualified to provide these services. Section 418.114 addresses the
personnel qualifications that social workers must meet in order to
provide services to hospice patients. We have addressed the commenter's
suggestion of requiring an MSW for social workers in the section
addressing Sec. 418.114 in the preamble of this final rule.
Supervision and qualifications both affect the scope of medical
social services that are provided to patients. These services are
required to be based on the needs of patients and families as those
needs are identified through a thorough psychosocial assessment. Since
the scope of services provided is directly tied to the needs of the
patient and family, it is not possible to generically broaden their
scope. Some patients and families may have limited social work needs,
and should not be compelled to accept broader social work services that
do not meet their needs.
Comment: A commenter suggested that medical social services should
be included in the counseling services standard because social workers
perform counseling functions in hospices.
Response: While social workers do perform counseling functions in
hospices, their duties and responsibilities go beyond counseling.
Therefore, it is not appropriate to place the requirements for social
workers under the counseling services heading.
Comment: Many commenters requested that we broaden the definition
of ``counseling services'' to address the purpose of counseling
services rather than naming precisely which types of counseling
services are included in hospice.
Response: ``Counseling services'' is a broad category of services
that has undergone a change from the traditional physical and
psychological interventions and now includes the use of alternative
therapies (for example, art therapy, yoga therapy, massage therapy, and
light therapy). These therapies are now frequently used to benefit
hospice patients and their families. We encourage hospices to continue
to explore and employ alternative counseling services. We have adopted
the suggestion and have incorporated a broader description into the
requirements for counseling services at Sec. 418.64(d). In the
proposed rule we stated, ``Counseling services for adjustment to death
and dying must be available to both the patient and the family.'' This
final rule now states, ``Counseling services must be available to the
patient and family to assist the patient and family in minimizing the
stress and problems that arise from the terminal illness, related
conditions, and the dying process.'' We believe that this revised
language reflects the broad nature of counseling services described by
the commenters.
Comment: Many commenters suggested that hospices should be
permitted to provide certain specialized counseling services under
contract, either by inserting a provision to allow such contracting or
by relocating the counseling requirements to Sec. 418.70, ``Furnishing
of non-core services.'' Commenters suggested that the contract services
include dietary counseling provided by dietitians, art therapy and
music therapy, to name a few.
Response: Section 1861(dd)(2)(A)(ii)(I) of the Act requires
hospices to routinely provide substantially all core services,
including counseling services to care for the terminally ill patient
and to assist the patient in adjusting to his or her condition. The Act
permits hospices to contract for counseling services as well as other
core services, only under extraordinary or otherwise non-routine
circumstances such as short-term staffing shortages, periods of peak
patient loads, and travel of a patient outside of a hospice's service
area. Therefore, it is not appropriate to permit hospices to routinely
contract for counseling services.
Comment: Numerous commenters suggested changes to the proposed
bereavement counseling requirement at Sec. 418.64(d)(1). One of these
commenters suggested that hospices should be required to incorporate
bereavement services into their daily patient care
[[Page 32127]]
services. Another commenter suggested that either education or
experience in grief/loss counseling should be an appropriate
qualification for the individual supervising the bereavement services
program. Other commenters pointed out a distinction between offering
and providing bereavement services. They suggested that hospices should
only be required to offer bereavement services because they cannot
provide such services to individuals who are unwilling to receive them.
Response: We appreciate the general support received for the
bereavement services requirement. We agree that bereavement counseling
must be a daily hospice activity for each patient and family. To that
end, we have revised the definition of the term ``bereavement
counseling'' at final Sec. 418.3 to require the services to be
provided before and after the death of the patient. We also require
hospices to complete an initial bereavement assessment as part of the
comprehensive assessment, which must be completed within five days of
the completion of the hospice election statement and certification
form. Furthermore, as part of the comprehensive assessment, the
bereavement assessment must be updated in accordance with Sec.
418.56(d). We believe that these requirements will ensure that
bereavement counseling is incorporated into patient care throughout the
patient's hospice stay.
We also believe that it is necessary to ensure that the individual
supervising this thorough bereavement program is appropriately
qualified. We agree that, in addition to experience, education in
grief/loss counseling is an appropriate qualification for the program
supervisor. We have made this change in Sec. 418.64(d)(1)(i).
We also appreciate the support that we received regarding
bereavement services furnished within a SNF/NF or ICF/MR. As we stated
in the proposed rule preamble, there are times when facility staff and
residents fulfill the role of a patient's family, providing caregiver
services, being companions, and generally supporting the patient. We
believe it is appropriate for a hospice to consider the bereavement
needs of these individuals. However, we agree with commenters that
requiring a hospice to offer bereavement services to facility staff may
create a conflict between the hospice and the facility, which bears
ultimate responsibility for its staff. Therefore, we have separated
this requirement into two parts. A hospice may offer bereavement
services to facility residents as identified in the patient's plan of
care. Additionally, a hospice must include a provision in its contract
with a facility that addresses the offering of bereavement counseling
to facility staff. Through this contractual provision, hospices and
facilities can mutually agree upon a plan that meets the needs of the
hospice, the facility, and the staff (see Sec. 418.112(c)(9)).
Additionally, we believe that the offer of bereavement services, as
opposed to providing them, is the appropriate requirement for hospices
to meet. Hospices cannot force bereavement services upon unwilling
recipients; therefore, the bereavement plan of care is only able to
state what services will be offered because it cannot predict what
services will actually be accepted and provided. As such, we have
revised Sec. 418.64(d)(1)(iv) to state that the hospice is to,
``[d]evelop a bereavement plan of care that notes the kind of
bereavement services to be offered and the frequency of service
delivery * * *.''
Comment: One commenter stated that the reference to ``dietary
counseling'' in proposed Sec. 418.74 is confusing because we use the
term ``nutritional counseling'' in the proposed ``Core services''
requirement at Sec. 418.64.
Response: We agree with the commenter. Therefore to be consistent,
we have amended the language at Sec. 418.64(d)(2) to require hospices
to furnish ``dietary counseling.''
Comment: The majority of commenters that submitted comments
concerning our proposed requirements for nutritional counseling
supported the provision allowing nurses to furnish such counseling if
appropriate. However, a small number of commenters suggested that
hospices should be required to employ a registered dietitian to furnish
this counseling.
Response: In Sec. 418.64(d)(2) hospices are required to assure
that the dietary needs of the patient are met. If a nurse is capable of
meeting the patient's needs, then we believe that it is appropriate to
permit the nurse to fulfill this task. However, if the needs of the
patient exceed the knowledge and expertise of a nurse, we expect the
hospice to have available an appropriately educated and trained
individual, such as a registered dietitian or nutritionist, to meet the
needs of the patient. We believe that this needs-based requirement,
rather than a prescriptive requirement dictating the individuals that a
hospice must employ for this service, will assure that patient needs
are met and that hospices have the flexibility to structure their staff
in the manner that meets their needs.
Comment: While commenters generally supported the proposed
requirement at Sec. 418.64(d)(3) that hospices must assess a patient's
and family's spiritual needs, and provide care to meet those needs in
accordance with the patient's and family's acceptance of the hospice's
service, commenters expressed confusion regarding the statement that
hospices are not required to go to extraordinary lengths to facilitate
visits by individuals who can support the patient's needs. Some of
these commenters noted that spiritual counseling is often extremely
important to patients and families and that hospices should try very
hard to facilitate outside spiritual support. Other commenters stated
that the phrase ``extraordinary lengths'' is unclear and should be
removed or replaced. Some of these commenters suggested that the
requirement should read, ``[t]he hospice must make all reasonable
efforts to facilitate visits by local clergy, pastoral counselors * *
*'' or ``[t]he hospice must facilitate visits by local clergy, pastoral
counselors, or other individuals who can support the patient's
spiritual needs consistent with the patient's and family's wishes and
the willingness of the designated counselors to respond.''
Response: We agree that spiritual counseling is an essential
hospice service for many patients and families, and that hospices
should strive to facilitate visits and contacts by those spiritual
supporters that the patient and family need. However, we realize that
there is a limit to what hospices should be expected to do in order to
facilitate such visits, as reflected by the proposed requirement that
hospices are not required to go to extraordinary lengths. We replaced
the proposed ``extraordinary lengths'' requirement with a requirement
that reasonable efforts must be made. This change continues to reflect
the value of spiritual counseling without burdening hospices with
unrealistic expectations.
9. Condition of Participation: Nursing Services Waiver of Requirement
That Substantially All Nursing Services Be Routinely Provided Directly
by a Hospice (Sec. 418.66)
The requirements for obtaining a nursing services waiver as
provided by section 1861(dd)(5) of the Act is currently set forth in
Sec. 418.83, and remained virtually unchanged in the proposed rule.
This condition provides hospices the opportunity to obtain a waiver
from the requirement that substantially all nursing services be
routinely provided directly by the hospice. The Act specifies that to
obtain a waiver a hospice must be located in
[[Page 32128]]
an area that is not an urbanized area, must have been in operation on
or before January 1, 1983, and must demonstrate a good faith effort to
hire a sufficient number of nurse employees. Section 1861(dd)(5)(B) of
the Act also specifies that if a waiver is requested by an organization
that meets the statutory requirements and other provisions required by
the Secretary, then the waiver will be deemed granted unless the
request is denied within 60 days after the request is received by the
Secretary. We proposed to maintain the existing requirement, as well as
the regulatory timeframe that provides that waivers are effective for 1
year at a time, and that CMS may approve a maximum of two 1-year
extensions for each initial waiver.
Comment: A few commenters asked us to define ``urban area.''
Response: The statute at section 8161(dd)(5)(a)(i) of the Act
specifically references urbanized areas as defined by the Bureau of the
Census. We refer the commenters to the Web site at HYPERLINK ``http://
www.census.gov''. In addition, hospices may contact their fiscal
intermediary or check the hospice wage index, which is updated and
published yearly.
Comment: Several commenters requested that the waiver language
requiring a hospice to be in operation on or before 1983 be amended by
requiring that hospices to be in operation a specific number of years
in order to qualify. Commenters also asked that urban as well as rural
hospices be eligible for the nursing waiver.
Response: The nursing waiver language at Sec. 418.66 tracks the
statutory language and cannot be significantly changed absent a change
in the statute. Therefore, we are unable to promulgate a regulation
that would modify the requirements of this statutory provision.
Comment: A few commenters stated that the waiver process described
in proposed Sec. 418.66 is complex, cumbersome and time-consuming.
Other commenters urged CMS to streamline and simplify the process. One
commenter asked that the waiver be deemed granted unless the request is
denied within 30 days after it is received. Other commenters asked if
it is CMS' intent to limit the waiver for individual hospice programs
to only 3 years.
Response: While we understand the waiver process may be at times a
lengthy process, CMS is unable to change most of these statutorily
based requirements. Changing the current 60-day timeframe to a 30-day
timeframe would not allow the CMS Regional Office time to sufficiently
review the waiver request. In the proposed rule, we specifically
requested information on how frequently this waiver was being used. We
heard back from very few hospices or other entities. All of those
responding stated that they were not using this waiver. At the request
of those commenters that requested clarification on the restriction of
only two 1-year extensions, CMS has removed the first sentence in the
requirement at Sec. 418.66(d). We are not restricting the number of
extensions a hospice can receive on its original waiver request. We
believe that this will reduce the burden of requesting a waiver because
hospices will no longer be required to submit a new waiver request
every three years (original request + two 1-year extensions). Instead,
a hospice can submit a single waiver request and an unlimited number of
extensions as long as it continues to meet the waiver requirements.
Comment: One commenter requested the waiver not impede a hospice
from contracting with non-Medicare-certified hospices. Other commenters
requested that CMS allow hospices to contract for continuous nursing
care.
Response: The proposed language at Sec. 418.66 does not specify
with whom a hospice can contract, nor does it specify the level of
nursing care for which contracts can be written. The purpose of the
waiver was to allow hospices in rural areas, which were having
difficulty hiring nurses, to have the ability to contract for overall
nursing services. For a discussion of contracting for continuous
nursing care, see the preamble language relating to core services at
Sec. 418.64 and existing regulations at 418.204 and 418.302.
Comment: Some commenters confused the proposed Sec. 418.66 with
the nursing shortage exemption, which was implemented on October 14,
2004 and renewed on September 14, 2006 by CMS (S&C-05-02,
www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter06-
28.pdf). Other commenters stated that the proposed rule fails to
recognize the national nursing shortage.
Response: We understand that there may be some confusion about this
nursing waiver at Sec. 418.66, which is currently in regulations at
Sec. 418.83, and the nursing shortage exemption that has been in
effect the past several years. The nursing waiver at Sec. 418.66 is
statutory and allows rural hospices in operation before 1983 the
opportunity to obtain a waiver from the statutory requirement that
substantially all nursing services be routinely provided directly by
the hospice, thereby permitting such hospices to contract for nursing
services if they meet the statutory requirements. The nursing shortage
exemption implemented in 2004, and renewed in 2006, permits all
hospices that are having difficulty hiring nurses to apply for an
exemption that allows the hospice to contract for nursing services.
These two waivers are completely separate from one another. As noted,
the nursing waiver is statutory and applicable only to hospices located
in a nonurbanized area and in operation since 1983. By contrast, the
nursing shortage exemption provides short-term relief to all hospices
who qualify during this nursing shortage.
Comment: One commenter requested that this waiver not be available
to for-profit hospices, stating that ``for-profit hospices are the
fastest growing sector in the hospice industry, and there is no
evidence that they need this waiver.''
Response: The statute does not differentiate between for-profit or
not-for-profit hospices. Therefore, this waiver applies to any hospice
meeting the waiver requirements. We note that hospices must clearly
demonstrate that they have made a good-faith effort to hire nurse
employees before seeking a waiver.
10. Condition of Participation: Furnishing of Noncore Services (Sec.
418.70)
The current CoP governing non-core services is contained in Sec.
418.90. We proposed to re-number the CoP and maintain its requirements,
with slight language modifications. We also proposed to amend this CoP
by adding language contained in Sec. 418.50(b)(3) of the current rule,
which states that non-core services must be provided in a manner
consistent with current standards of practice.
There were no comments received on this condition of participation.
Therefore, we are finalizing it as proposed.
11. Condition of Participation: Physical Therapy, Occupational Therapy,
and Speech-Language Pathology (Sec. 418.72)
Currently, the CoP concerning physical therapy, occupational
therapy, and speech-language pathology is found at Sec. 418.92(a). We
proposed to recodify this CoP at Sec. 418.72 without changes. This CoP
requires hospices to make physical therapy, occupational therapy, and
speech-language pathology services available to patients, and to ensure
that these services are provided in a manner consistent with current
standards of practice.
Comment: Several commenters requested that we add dietary
counseling provided by dietitians to the
[[Page 32129]]
list of non-core services (that is, physical therapy, occupational
therapy, and speech-language pathology) included in proposed Sec.
418.72.
Response: Dietary counseling is seen as a core service, and
therefore falls under the regulatory requirements proposed at Sec.
418.64. Within Sec. 418.64 we have proposed that qualified
individuals, including dietitians and nurses, may furnish dietary
counseling, provided that it is within their scope of practice and
expertise according to State law. Also within Sec. 418.64, we allow
hospices to contract with other Medicare-certified hospices and
contracting agencies for core services under specific circumstances,
such as extraordinary or other non-routine circumstances, unanticipated
periods of high loads, and staffing shortages due to illness or other
short-term temporary situations that interrupt patient care.
Additionally, in Sec. 418.74, we allow hospices located in non-
urbanized areas to receive a waiver of the requirement that dietary
counseling be provided directly pursuant to statutory authorization at
1861(dd)(5)(C). We believe that the staffing flexibility and waivers
give hospices the flexibility to provide dietary counseling to all
patients who require the service.
12. Condition of Participation: Waiver of Requirement--Physical
Therapy, Occupational Therapy, Speech-Language Pathology and Dietary
Counseling (Sec. 418.74)
We proposed a new CoP that would provide for a waiver of certain
requirements. This CoP would establish authority to waive the
requirement that eligible hospices must provide physical therapy (PT),
occupational therapy (OT), and/or speech-language pathology (SLP)
services as needed on a 24-hour basis as otherwise required by section
1861(dd)(2)(A)(i). This CoP would also establish authority to waive the
requirement that eligible hospices must provide dietary counseling
services on a 24-hour basis and/or that eligible hospices must
routinely provide dietary counseling services directly through hospice
employees.
As in the case for a waiver of nursing services (proposed Sec.
418.66), eligibility for a waiver is based on the primary location of a
hospice. For a hospice that operates in multiple locations, its primary
location is considered to be the location of its central office. This
central office must be located in a non-urbanized area as determined by
the Bureau of the Census. The hospice must provide evidence that it
made a good faith effort (for example, copies of advertisements in
local newspapers, documentation of competitive salaries and benefits,
and evidence of recruiting activities) to hire a sufficient number of
PTs, SLPs, OTs, and dietary counselors to provide services directly
through hospice employees or under arrangement on a 24-hour as needed
basis.
Comment: Several commenters supported the optional waiver for PT,
OT, SLP and dietary services, but one commenter stated that these
services are so critical that it seemed inappropriate to provide a
waiver.
Response: We agree that these can be very valuable services for the
care of the hospice patient. However, we do not believe that these
services need to be offered as needed on a 24-hour basis if the 24-hour
requirement places an undue burden on rural hospices. Because of the
scarcity of those professionals in non-urbanized areas, we believe the
option for a waiver is appropriate. We also note that the waiver
conditions are statutory.
Comment: A few commenters requested that we consider allowing
hospices located in urban areas the waiver option as well.
Response: As noted above, this waiver language, like the nursing
waiver option at proposed Sec. 418.66, is statutory. We are unable to
promulgate a regulation that would contravene the statutory provision.
Comment: One commenter asked if it is our intent to limit the
waiver for individual hospice programs to only three years.
Response: As proposed, a hospice would have been required to submit
an original waiver request. The hospice could then request up to two
extensions on the original request. Once those two extensions expired,
the hospice would have been required to submit another original waiver
request. Thus, while the proposed requirement did not limit a hospice
to receiving a waiver for three years in total, it did require a
hospice to submit substantially more paperwork once every three years
in the form of an original waiver request. We believe that it is not
necessary to require an original waiver request every three years.
Therefore, we have removed the first sentence in the proposed
requirement at Sec. 418.74(d). We are not restricting the amount of
extensions a hospice may receive to the original waiver request.
Comment: One commenter requested that this waiver not be available
to for-profit hospices, stating that ``for-profit hospices are the
fastest growing sector in the hospice industry, and there is no
evidence that they need this waiver.''
Response: The statute does not differentiate between for-profit or
not-for-profit hospices. Therefore, this waiver applies to any hospice
meeting the waiver requirements. We believe that the criteria set out
at 1861(dd)(5)(C)(ii) of the Act will ensure that waivers are granted
only on an as-needed basis.
13. Condition of Participation: Hospice Aide and Homemaker Services
(Sec. 418.76)
Section 1861(dd)(1)(D) of the Act requires Medicare covered home
health aide services to be furnished by an individual who has
successfully completed training or a competency evaluation program that
meets the requirements established by the Secretary. This section also
provides for coverage of homemaker services. Currently, the condition
of participation concerning home health aide and homemaker services is
set forth at Sec. 418.94, which incorporates by reference the home
health aide requirements of the home health agency CoPs at Sec.
484.36. We proposed in Sec. 418.76 to use most of the substance of the
requirements of Sec. 484.36. The home health aide CoP establishes that
a home health aide must complete a State-established or other training
program, and in Sec. 418.76(b) we outline the requirements that this
training must meet, which are similar, but not identical to, the
provisions of Sec. 484.36. In Sec. 418.76(e) and Sec. 418.76(f) we
outline requirements for the individuals and organizations eligible to
provide the aide training.
We proposed that three standards be particularly adapted for the
hospice conditions of participation. First, Sec. 418.76(h),
``Supervision of home health aides,'' would be revised from the current
Sec. 484.36(d), to require that a registered nurse or appropriate
qualified therapist conduct an on-site supervisory visit no less
frequently than every 28 days while the home health aide is providing
care. This in-person supervisory visit would need to be conducted with
at least one patient to whom the aide is providing services at the
time. Thorough supervision of home health aides is crucial to ensuring
that the patient's and family's needs are being met, and conducting
supervisory visits when the aide is performing his or her duties is a
key way to provide thorough supervision. Onsite supervisory visits will
still be required every 14 days, as in the current rule at Sec.
484.36(d)(2), but the aide would not be required to be present for
these visits. This supervision schedule would allow hospices to
maintain control over the quality and continuity of care being
provided, and would help ensure that
[[Page 32130]]
all patients receiving home health aide services were having their
needs met by these services.
Second, proposed Sec. 418.76(j), ``Homemaker qualifications,'' was
adapted from the existing Sec. 418.94. The proposed standard would
define a qualified homemaker as a home health aide, as described in
Sec. 418.76, or an individual who met the standards in Sec.
418.202(g) and has successfully completed hospice orientation
addressing the needs and concerns of patients and families coping with
a terminal illness. Homemaker services, as noted in Sec. 418.202(g),
may include assistance in maintenance of a safe and healthy environment
to enable the patient to benefit from care that is furnished.
Finally, Sec. 418.76(k) would require a member of the IDG to
coordinate homemaker services, and supply instructions for the
homemaker on duties to be performed. The homemaker would be required to
report all concerns about the patient or family to the member of the
IDG who was coordinating the homemaker services. We have proposed these
changes to ensure proper training and supervision, and to protect the
quality of the homemaker services provided.
Comment: Numerous commenters suggested that we should change the
term that we use to refer to aides who furnish hospice care. Commenters
suggested that the phrase ``nursing aide'', ``certified nursing
assistant'', or ``hospice aide'' be used instead of the phrase ``home
health aide.''
Response: We agree that it is appropriate to re-name aides who
furnish hospice care in order to differentiate them from aides who
furnish care in other environments. Therefore we have adopted the term
``hospice aide'' as best describing that role.
Comment: A commenter suggested that all of the hospice aide
requirements (that is, training, education, and supervision) should be
replaced by those for nurse aides, as described in 42 CFR part 483,
which sets out standards for long term care facilities.
Response: We agree that nurse aide training and education in
accordance with Sec. 483.151 through Sec. 483.154 is an appropriate
qualification for hospice aides, and we have incorporated these
provisions at new Sec. 418.76(a)(1)(iii). However, we do not believe
that the supervision requirements for nurse aides in long term care
facilities meet the needs of hospices, whose hospice aides furnish care
in the community rather than in a self-contained facility. Therefore,
we are not adopting the supervision requirements from part 483.
Comment: Many commenters suggested that, in order to adapt the
requirements of the home health aide regulations to the hospice
regulations, we should replace all references to home health agencies
with references to hospice agencies. Several commenters singled out the
reference to home health agencies in proposed Sec. 418.76(f),
``Eligible training organizations,'' which prohibits certain home
health agencies from training aides, as a place where a reference to
hospice agencies should be substituted.
Response: We agree that, throughout most of this CoP, references to
home health agencies should be replaced with references to hospice
agencies, and we have made these changes. However, in Sec. 418.76(f),
we are unable to substitute hospices for home health agencies. The
provisions of standard (f) come directly from Section 1891(a)(3) of the
Act. Therefore, certain home health agencies must be prohibited from
providing aide training. Hospices, however, are not prohibited from
providing aide training, even if they meet the exclusion criteria
established for home health agencies. Although hospices are not
excluded from providing training, we caution all hospices to ensure
that training furnished by other providers meets all of the
requirements of this rule and is of the highest quality. It is
essential that aides be well trained to perform their patient care
duties.
Comment: A commenter suggested that hospice aides should be
required to be certified in hospice and palliative nursing assistant
care.
Response: Hospices are free to require their hospice aides to be
certified in hospice and palliative care. However, this certification
goes beyond the standards of aide education and training that are
currently in place for other provider types and is uncommon within the
hospice industry. Requiring such certification for all hospice aides
nationwide would likely result in a shortage of qualified aides, which
would negatively impact patient care and outcomes. For these reasons,
we are not adding this suggested requirement.
Comment: A commenter suggested that, in the first sentence of Sec.
418.76(c), we should add the word ``aide'' to state that ``an
individual may furnish home health aide services on behalf of a hospice
* * *.''
Response: We agree that adding the term ``aide'' will clarify our
intent, and we have made this change. In this section, the term ``home
health aide'' has been replaced by the term ``hospice aide''.
Comment: Many commenters suggested changes to our proposal at Sec.
418.76(e) that would require the registered nurse who provides or
supervises hospice aide training to have at least two years of nursing
experience, one of which must be in home health care. The commenters
suggested that the term ``home health'' be replaced with the term
``hospice''.
Response: We agree that experience in hospice care is an
appropriate source of knowledge for a registered nurse to perform or
supervise practical training for hospice aides. We replaced the term
``home health'' with the term ``home care,'' which is used broadly in
this standard and encompasses both home health care and hospice care.
We believe that this fulfills the commenters' request without limiting
the opportunity for the registered nurse to gain the necessary
experience.
Comment: Numerous commenters made suggestions regarding the
proposed requirement at Sec. 418.76(g)(2) that aide services must be
ordered by a physician or nurse practitioner and included in the plan
of care. Specifically, some commenters suggested that the IDG as a
whole, of which the physician is a member, should be allowed to order
hospice aide services. Other commenters supported our proposal to allow
both nurse practitioners and physicians to order hospice aide services.
Still other commenters suggested that the frequency and scope of aide
services should not need to be detailed, as is required of all other
services contained in the plan of care. A single commenter suggested
that the proposed provisions regarding hospice aide assignments and
duties should only apply in the absence of State requirements.
Response: While we appreciate the support for our proposal that a
nurse practitioner or physician must order hospice aide services, we
agree that the IDG as a whole may order hospice aide services because
physicians and nurse practitioners are already active members of the
IDG. When ordering hospice aide services, we believe that it is
necessary to detail the scope and frequency of such services. The
purpose of the order, as included in the plan of care, is to provide a
comprehensive map of which disciplines are providing which services at
which time(s). Without such detailed information there is a lack of
clarity that may compromise patient and family care. Therefore, we are
keeping the detailed scope and frequency requirements.
Comment: Many commenters requested clarification about what duties
hospice aides are permitted to
[[Page 32131]]
perform. The commenters were particularly interested in proposed Sec.
418.76(g)(3)(iv), which would permit hospice aides to provide
assistance in administering medications that are ordinarily self-
administered. Some commenters wanted to know how to determine which
medications are ordinarily self-administered, while other commenters
noted that the hospice aide training requirement at proposed Sec.
418.76(b) does not require aides to be trained in medication
administration. Related to these comments on aide training are
commenters who sought clarification on the proposed requirements of
Sec. 418.76(g)(2)(iv), which stated that aides may only furnish
services that are consistent with their aide training. Still other
commenters suggested that medication administration requirements should
defer to State laws.
Response: Section 418.106 of this rule requires hospices to
evaluate a patient's and family's ability to safely administer
medications. This requirement is present because various factors may
interfere with a patient's ability to safely adhere to a medication
regimen. Allowing hospice aides to help administer those medications
that patients are typically allowed to administer to themselves, if
they are competent to do so, allows hospices to meet the medication
needs of patients and caregivers who are not capable of safely self-
administering medications. Assistance in medication administration may
consist of helping a patient with hand tremors apply or remove a
medication patch or any number of other similar tasks. Allowing aides
to fulfill this role may decrease the demand for nursing visits for the
purpose of medication maintenance, thus allowing nurses to provided
services where needed.
Determining those medications that are appropriate for aides to
help administer is the decision of the IDG, based on the needs of the
patient and family, the training of the aide, the policies of the
hospice, and any applicable State and local laws and regulations. We do
not require all hospice aides to be trained in medication
administration because not all hospices will choose to have aides
perform this task. Section 418.116 of this rule requires hospices to
comply with all health and safety related State and local laws and
regulations. State or local rules may very well prohibit hospice aides
from administering medication. However, if medication administration is
within the bounds of State and local rules, and if hospices do choose
to have aides perform this task, Sec. 418.76(b)(3)(xiii) requires
those hospices to provide aide training for any other task that an aide
is expected to perform, which would include medication administration.
This, in conjunction with the requirement at Sec. 418.76(g)(2)(iv),
that aide services furnished must be consistent with hospice aide
training, effectively requires medication administration training for
those aides who are charged with assisting patients in administering
medications that are ordinarily self-administered.
Comment: Some commenters suggested that we should replace the
proposed hospice aide supervision requirements with the supervisory
requirements for home health aides found in the home health regulations
at Sec. 484.36. Commenters also suggested that we should replace the
every-14-day supervisory visit requirement, which was designed to
ensure the adequacy and appropriateness of aide services for each
hospice patient, with a requirement that the RN should review the
patient's plan of care with the aide at least every 60 days, and as
needed. These commenters stated that supervising the aide every 14
days, as is currently required in the existing hospice regulations, is
overly burdensome. Other commenters explicitly supported the 14 day
supervision requirement.
Response: We appreciate the support for this requirement among some
commenters. We believe that supervising the aide every 14 days to
ensure that aide services are adequate and appropriate for each hospice
patient is appropriate, given the length of time that most hospice
patients receive hospice services. Many hospice patients die within a
few weeks of beginning hospice services. If we were to extend the
supervision timeframe, the extension would likely result in no
supervisory visits occurring between the time the patient begins
receiving hospice care and the time the patient passes away (for
example, a hospice patient begins receiving aide services on day three
and passes away on day 24, without ever receiving an aide supervisory
visit to assess the adequacy and appropriateness of the aide care
provided). This lack of supervision would in no way benefit patients
and families. In addition, this lack of supervision would likely not
help hospices because they would remain completely unaware of the
quality and adequacy of the aide services they were providing. This
could lead to an over-or under-use of aide services, low quality aide
services, patient and family dissatisfaction, and a wide variety of
other negative outcomes that hospices wish to avoid. In short, we
believe that adequate frequent supervision benefits patient and
hospices alike, and the requirement remains in this final rule.
Comment: A commenter suggested that all hospice aide supervision
requirements should be removed in favor of outcome and patient
satisfaction measures and performance improvement projects when
measures indicate inadequate performance in aide services. Another
commenter suggested that all hospice aide supervision requirements
should be removed because hospices are already required by Sec.
418.76(b) and Sec. 418.76(c) to ensure that hospice aides are trained
and that competency evaluations are completed.
Response: We are not deleting these requirements for two reasons.
First, while hospice aide training and competency evaluations ensure
that aide skills are adequate upon hiring or initial training, they do
not ensure that those same skills remain adequate as time passes. We
believe that aide skills should be continuously reexamined to ensure
competency at all times. Second, hospice quality and outcome measures
have not yet reached the point where there is consensus on a single set
of measures that have been thoroughly tested and determined to be
valid, reliable, and widely applicable. As quality and outcome measures
continue to evolve we will consider this suggestion. Nonetheless,
hospices may use an outcome measure that targets aide services as part
of their QAPI program, however the measure could not replace aide
supervision. Outcome measures and supervision can and should work
together, rather than replace each other, in order to enhance the
quality of the service provided, patient outcomes, and patient
satisfaction.
Comment: A few commenters requested clarification about the nursing
personnel who may function as hospice aide supervisors. One commenter
suggested that licensed vocational nurses (LVNs) and licensed practical
nurses (LPNs) should be permitted to supervise hospice aides. Another
commenter suggested that any nurse should be permitted to supervise a
hospice aide, rather than having a designated nurse supervise a
specific hospice aide's care of a patient.
Response: Registered nurses (RNs) have the education and training
to adequately supervise hospice aide services. In addition to ensuring
that hospice aides furnish the care identified in the plan of care,
nurse supervisors must be able to assess the adequacy of the aide
services in relationship to the
[[Page 32132]]
needs of the patient and family. Registered nurses possess the
assessment skills necessary to fulfill this function to a greater
degree than LVNs and LPNs, which makes registered nurses uniquely
qualified to fulfill the hospice aide supervisory position.
In addition to having the necessary assessment skills, it is
important that registered nurses have a relationship both with the aide
being supervised and the patient receiving the aide's services.
Ideally, the RN responsible for supervising the aide is the RN chiefly
responsible for the patient's nursing care. This allows the RN to
develop a complete picture of the patient and family and of the aide's
services. For this reason, we believe that it is necessary for hospices
to identify a specific RN who will serve as the aide's supervisor
during the care of a specific patient. We understand that, at times, it
is necessary to use other RNs to fill-in and supervise aide services.
If a substitute supervising RN is used, this should be noted.
Comment: A large number of commenters expressed concern about our
proposal in Sec. 418.76(h) to allow therapists to supervise hospice
aides. Some commenters sought clarification regarding the exact meaning
of the term ``qualified therapist.'' Other commenters suggested that
therapists should only be allowed to supervise hospice aides when aides
are furnishing delegated therapy services. Still others suggested that
only nurses be allowed to supervise hospice aides.
Response: We proposed to allow hospices to use therapists to
supervise home health aides in order to provide more flexibility in
meeting the every-28-day in-person supervisory visit requirement
discussed later. We have changed the 28-day timeframe, thereby
alleviating many of the related supervisory demands. For this reason,
we believe that it is no longer necessary to allow therapists, who are
not routinely involved in the care of most hospice patients, to
supervise hospice aides. Thus, the term ``therapist'' has been deleted
from this standard, as well as this CoP.
Comment: A commenter suggested that the every-14-day supervisory
visit could be conducted through a telephone contact with the patient
or family, rather than through a visit to the patient's home.
Response: In-person visits by the supervising nurse to the
patient's home allow the nurse directly to observe the patient and the
results of the aide's care. Telephone contacts do not allow the nurse
to see if the patient has been bathed, and patients may be hesitant to
report these failures of duty to nurses for any number of reasons. In-
person home visits simply provide nurse supervisors with more
information than telephone contacts do.
Comment: A commenter suggested that we should clarify the purpose
of the every-14-day supervisory visit required by Sec. 418.76(h), to
state that the visit is designed ``to assess the quality of care and
services provided'' by the aide.
Response: We agree that clarifying the intent of the every-14-day
supervisory visit will be helpful to hospices. We have added language
at Sec. 418.76(h)(1)(i) to reflect the intent of the suggestion. In
addition, we have added a statement that the every-14-day supervisory
visit is also meant to ensure that the services ordered by the hospice
are sufficient to meet the patient's needs.
Comment: Numerous commenters submitted suggestions on the proposed
every-28-day timeframe for in-person supervision of hospice aides at
Sec. 418.76(h). Although some commenters expressed support for the 28-
day supervision requirement, most suggested that the 28-day timeframe
be changed to every 60 days, every quarter, every 6 months, every 12
months, or even every 24 months. Some commenters also suggested that
the in-person supervision requirement be deleted in its entirety.
Response: We believe that all hospice employees, including hospice
aides, must be supervised. To ensure that aides are adequately
supervised, we proposed that each aide would be supervised while he or
she is furnishing care to a patient for the purpose of observing the
aide's skills. In addition, we proposed that this in-person supervision
would occur at least every 28 days. After reviewing the comments that
we received, we agree that assuring aide skill competency 12 times per
year is not necessary. In keeping with our desire to maintain
consistency with the aide requirements in the home health regulations,
we have changed the in-person supervisory visit timeframe from once
every 28 days to once annually per aide.
At the same time, we have added a new requirement at Sec.
418.76(h)(1)(ii) that requires hospices to conduct in-person
supervisory visits to observe and assess aide skills if a potential
deficiency in care furnished by the aide is noted in the regular 14-day
supervisory visit (during which the aide is not required to be
present). We believe that linking more frequent in-person supervisory
visits to the actual performance of the aides will ensure that aides
furnish quality care and that hospices have the flexibility to
supervise their staff in a manner that meets their needs.
Comment: A few commenters suggested that the aide in-person
supervision visit (proposed as occurring every 28 days and finalized as
occurring annually) should be documented in the aide's personnel
record, rather than in the patient's clinical record.
Response: We agree that the aide's personnel record is an
appropriate place to document the annual in-person supervisory visit.
Hospices may determine the appropriate location to document the annual
aide evaluation in accordance with their own policies and procedures.
Comment: Many commenters expressed confusion about the in-person
supervisory visit to observe the aide furnishing care. Commenters
wanted to know whether the observation visit needed to be conducted
with each patient that the aide is caring for, or whether the
observation visit only needed to be conducted with a single patient
that the aide is caring for. The commenters noted that conducting an
observation visit with each patient that the aide is caring for would
be difficult to schedule and cost-prohibitive.
Response: The intent of the proposed rule was to require an
observation once every 28 days with a single patient that the aide was
caring for at the time of the visit. In response to public comments, we
changed the timeframe for the observation visit from once every 28 days
to once annually. In addition, we have changed the phrasing of this
requirement to more clearly state our intent for only a visit to a
single patient's home. The revised requirement at Sec. 418.76(h)(2)
states, ``A registered nurse must make an annual on-site visit to the
location where a patient is receiving care in order to observe and
assess each aide while he or she is performing care.'' We believe that
``a patient'' is clearer than the language we originally proposed,
``the patient.'' We are not requiring that the aide be supervised with
each patient annually to evaluate the aide's proficiency.
Comment: Many commenters addressed the relationship between hospice
aide services, hospice homemaker services, and Medicaid personal care
benefits. Specifically, commenters suggested that we should state in
the regulation text that hospice aide and homemaker services are not
24-hour-a-day primary caregiver services and are not meant to replace
personal care aide services covered under Medicaid or other insurers.
Commenters also suggested that we should clarify the relationship
between the hospice and personal care aides by
[[Page 32133]]
stating that hospices may use the personal aides in implementing the
plan of care only to the extent that the hospices would routinely use
the services of a patient's family in implementing the plan of care.
Furthermore, commenters suggested that hospices should be required to
coordinate their services with those furnished by personal care aides.
Response: We understand that there may be confusion relative to the
interaction between the Medicaid personal care aide benefit and the
hospice benefit. The Medicaid personal care benefit is designed to
assist eligible Medicaid beneficiaries with daily personal care tasks
such as household chores and personal hygiene. The hospice aide and
homemaker services covered under the Medicare hospice benefit cover
many of the same tasks. However, hospice aide and homemaker services
are not necessarily meant to be daily services, and are certainly not
meant to be 24-hour daily services. Hospices are neither expected to
nor prohibited from fulfilling the caregiver role for a patient.
Rather, hospice aide and homemaker services are provided to supplement
the primary caregiver(s).
Since there may be occasions where a patient receives services
through a personal care aide benefit while receiving hospice services,
we agree with the commenters that this rule should address the
responsibilities of the hospice for coordinating the care provided by
hospice personnel and the Medicaid personal care aide. We have added
new elements to address this, Sec. 418.76(i)(2) and Sec.
418.76(i)(3). Section 418.76(i)(2) provides that services furnished by
the Medicaid personal care benefit may be used to the extent that the
hospice would routinely use the services of a hospice patient's family
in implementing a patient's plan of care. Section 418.76(i)(3) requires
that a hospice coordinate hospice aide and homemaker services with the
services furnished by the Medicaid personal care aide benefit to ensure
that patients receive all the services that they require.
Comment: Numerous commenters requested clarification of the
requirements at proposed Sec. 418.76(j), Homemaker qualifications. The
commenters interpreted the proposed standard to mean that only those
individuals who have completed hospice aide training are considered
qualified to function as homemakers. The commenters disagreed with this
policy and stated that orientation to hospice care should be sufficient
for homemakers.
Response: In Sec. 418.76(j) we proposed that a homemaker be either
an individual who has completed aide training or an individual who has
successfully completed hospice orientation addressing the needs and
concerns of patients and families coping with a terminal illness. We
believe that the commenters misinterpreted this requirement, and that
the misinterpretation led to a great deal of confusion. We agree with
the commenters that homemakers do not need to complete hospice aide
training in order to be qualified, which is why we proposed that
hospice orientation is sufficient. We do not agree that hospice aide
training should be completely removed from this standard. If an
individual has completed hospice aide training, he or she should not be
prevented from serving as a homemaker. Indeed, hospice aide training
provides an extra level of education and training that would go above
and beyond hospice orientation. In order to clarify our intent in this
standard, we have reformatted it to place hospice orientation as the
first option for homemaker qualifications and hospice aide training as
the second option for homemaker qualifications. We believe that this
reformatting will make it clearer that either qualification is
acceptable.
Comment: A commenter asked whether or not hospices are permitted to
contract for homemaker services.
Response: Section 1861(dd)(2)(A)(ii)(I) of the Act requires
hospices to provide substantially all nursing, medical social, and
counseling services through direct employees. Homemaker services do not
fall into any of these categories; therefore hospices may contract for
homemaker services. If hospices choose to contract for homemaker
services, then the professional management responsibility requirements
of Sec. 418.100(e) will apply. We believe that this question may have
been prompted by a requirement in proposed Sec. 418.76(h)(4) regarding
contracting for hospice aide services. The inclusion of specific
requirements for aide contracting, and the omission of requirements for
homemaker contracting, seemed to imply that homemaker contracting would
not be allowed. We have removed the aide contracting provision at Sec.
418.76(h)(4) in order to remove any implication that homemaker services
may not be contracted.
Comment: A commenter suggested that we should explicitly state that
homemakers can be volunteers.
Response: Volunteers are permitted to fulfill many roles in hospice
care, including providing homemaker services, provided that the
volunteers meet all qualifications and personnel requirements
established by this rule. We do not believe that it is necessary to
explicitly state in this standard that volunteers may function as
homemakers. We believe that making this statement may unintentionally
imply that volunteers may not function in other capacities within a
hospice program. The implication would negatively impact the role of
volunteers in hospice and may affect the level of volunteer services
that hospices furnish.
Comment: A commenter sought clarification about who is responsible
for supervising homemaker services.
Response: We agree that this rule should explicitly require such
supervision. We have added a provision at Sec. 418.76(k)(1), stating
that the member of the patient's IDG group who is responsible for
coordinating homemaker services must also be responsible for
supervising those services.
14. Condition of Participation: Volunteers (Sec. 418.78)
The current CoP for volunteers is located at Sec. 418.70. We
proposed to recodify this CoP at Sec. 418.78 with minor changes. We
proposed to remove the existing Sec. 418.70(f), regarding the
availability of clergy, because the role of the pastoral, clergy, or
other spiritual counselor would be described as part of the IDG at
proposed Sec. 418.56(a)(1)(iv). This change would not preclude the
hospice from continuing to use or starting to use clergy as volunteers.
We did not propose any changes to the requirements to document cost
savings and to maintain a sufficient level of volunteer activity.
Comment: A few commenters suggested that we should remove the term
``day to day'' from the proposed Sec. 418.78(b). The commenters stated
that removing the phrase would permit hospices to use volunteers for
special events that occur infrequently.
Response: The phrase ``day-to-day,'' as used, requires hospices to
incorporate volunteer services into their daily patient care and
operations routine in order to retain the volunteer-based essence of
hospice as it originated in the United States. The phrase does not
preclude hospices from using volunteer services for special events or
non-routine occurrences. Hospices must use volunteers for day-to-day
services, and may use volunteers for other services as well.
Comment: Some commenters asked us to clarify that volunteer time
spent in training, orientation, travel, direct patient care, and
administrative services may be included when documenting the
[[Page 32134]]
cost savings that the hospice achieves through the use of volunteers.
Response: Section 1861(dd)(2)(E)(ii) of the Act requires hospices
to maintain records on the cost savings achieved through the use of
volunteers. That is, hospices must document those hours that volunteers
furnished care and services for which a hospice would otherwise have
been required to pay its employees to furnish such care and services.
If a hospice is training and orienting volunteers, it is most likely
using its paid employees to do so. Therefore, no cost savings is
achieved. However, if a hospice does pay an employee for time spent
traveling for direct patient care and administrative purposes, and does
not compensate a volunteer for the time, then it may include the
volunteer's travel time, direct patient care and administrative
services in its documentation of the cost savings it achieves.
Likewise, hospices may document the time that volunteers actually spend
providing direct patient care and administrative services, because
hospices would compensate paid employees for the time spent performing
these duties. We note that travel time is not the same as direct
patient care. Following publication of this final rule, we will issue
further sub-regulatory guidance addressing the manner in which the cost
savings needs to be calculated and documented.
Comment: Several commenters requested clarification about what
volunteer hours may be included in calculating the level of volunteer
activity within a hospice, as required by proposed Sec. 418.78(e).
Commenters specifically suggested that time spent traveling, providing
care or services, documenting, and phoning patients should be included
in the level of volunteer activity calculation.
Response: We understand that traveling, providing care or services,
documenting information, and calling patients all consume volunteer
time, and we agree that the time may be used in calculating the level
of volunteer activity in a hospice. If a hospice chooses to include any
of these areas that are directly related to providing direct patient
care or administrative services in its percentage calculation of
volunteer hours, it must ensure that the time spent by its paid
employees and contractors for the same activity is also included in the
calculation. That is, if a hospice chooses to count the hours spent by
volunteers traveling to and from patient homes in its calculation of
the numerator, it must count the hours spent by its paid employees and
contractors in traveling to and from patient homes in its calculation
of the denominator. In this way, hospices will be able to accurately
assess the proportion of volunteer hours to paid staff and contractor
hours. Upon issuance of this final rule, we will issue sub-regulatory
guidance to reflect the potential inclusion of certain volunteer hours
in the overall calculation.
Comment: Some commenters suggested that hospices should only be
required to provide volunteer hours equal to five percent of the
routine home care level of care hours furnished to patients. Commenters
stated that this would be easier for hospices to comply with because
providing direct inpatient, respite, or continuous home care accounts
for a substantial number of paid staff hours. Eliminating the hours
spent providing direct inpatient, respite, or continuous home care
would decrease the number of hours in the denominator, thereby altering
the ratio of volunteer hours to paid hours. Other commenters suggested
that the five percent goal should be completely eliminated.
Response: Section 1861(dd)(2)(E)(i) of the Act requires the
Secretary to ensure a continuing level of effort to use volunteers in
providing care and services to hospice patients. In addition to serving
as companions, homemakers and administrative staff, volunteers often
serve as medical directors, nurses, alternative counselors, and
spiritual advisors. All of these services, when provided by volunteers,
count toward the five percent goal. Since we permit hospices the
flexibility to use volunteers to function in such a wide variety of
roles within hospices, we do not believe that it is necessary to
artificially lower the standard for achieving continual volunteer use
in hospice by eliminating the hours spent by hospices furnishing direct
inpatient, respite, or continuous home care. Additionally, we note that
hospices have not historically failed to meet the five percent
requirement, as this is not a frequently cited deficiency during
hospice surveys conducted by the State survey agencies.
Comment: A commenter asked us to define the role of a hospice
volunteer.
Response: Hospice volunteers are permitted to fill any role within
the hospice, provided that the volunteer filling the role meets the
appropriate qualifications of this rule and any other applicable State
and local requirements (for example, State licensure). Since volunteers
may be used in any role, there is no one volunteer role that can be
defined in this rule. Any definition may unintentionally limit a
hospice's use of volunteer services, thus compromising its ability to
comply with the requirements of this rule.
Comment: Some commenters suggested that board certified chaplains
should be required to train and supervise hospice volunteers.
Response: Hospices are responsible for ensuring that volunteers are
trained, oriented, and supervised. While a designated employee must
supervise volunteers, their training and orientation may be conducted
by a person(s) of the hospice's choosing. We believe that it is
inappropriate to prescribe the qualifications for the person(s)
responsible for training and supervising volunteers because hospices
need the flexibility to make the staffing decisions based on their
individual needs. If hospices choose to use board certified chaplains
to train and/or supervise volunteers, they are free to do so.
15. Condition of Participation: Organization and Administration of
services (Sec. 418.100)
We proposed to combine several conditions of the existing CoPs into
a single new CoP. The proposed CoP included the requirements of current
Sec. 418.50, ``General provisions,'' Sec. 418.52, ``Governing body,''
Sec. 418.56, ``Professional management,'' Sec. 418.60, ``Continuation
of care,'' and Sec. 418.64, ``In-service training.'' We believe that
the proposed CoP simplifies the structure of the requirements, making
them easier to understand. We also proposed to condense the list of all
services that hospices are required to furnish into a single standard.
We believe that this single list will emphasize hospice's holistic
approach to patient and family care.
We made minor changes to the ``General provisions,'' ``Governing
body,'' ``In-service training,'' and ``Continuation of care''
requirements. In Sec. 418.100(e), ``Professional management
responsibility,'' we proposed to revise some of the current
requirements found at Sec. 418.56(b) and Sec. 418.56(c). This
proposed standard would require written agreements for services
furnished under arrangement, and would require that the hospice retain
professional management, supervisory, and financial responsibility for
all services that are provided to the patient and family. The hospice
would be required to ensure that it authorizes all services that it
provides, that they are furnished in a safe and effective manner by
qualified personnel, and that items and/or services specified in the
plan of care are provided.
We proposed to add a new standard to address the issue of multiple
service locations. This provision was intended to codify long-standing
Medicare survey
[[Page 32135]]
and certification policy, which allows for the operation of multiple
locations by a single hospice provider with a single Medicare
agreement. We expect that any hospice that requests to establish a
satellite location (now referred to as a multiple location) will be
able to demonstrate how it is able to manage and monitor all of the
services provided in its entire service area, including services from a
multiple location. Patients who receive care and services from a
hospice multiple location must receive the full range of services that
are documented in the plan of care.
Before operating a multiple location, also known as a practice
location on CMS form 855, a hospice must enroll with the fiscal
intermediary and notify the State agency and CMS of all currently
approved multiple locations at the time it requests approval for any
additional multiple locations. If a hospice provides care and services
to Medicare beneficiaries from an unapproved or disapproved multiple
location, these services may be determined to be non-covered. At the
time of any multiple location closure the hospice is expected to notify
the fiscal intermediary, State agency and CMS. Hospice multiple
locations are also subject to survey by the State survey agency or CMS
regional office. Deficiencies that are identified at any multiple
location will apply to the entire hospice issued the provider agreement
number. Multiple locations must comply with the hospice conditions of
participation at Sec. 418.52 through Sec. 418.116.
Comment: A few commenters suggested that we restate the
requirements in proposed Sec. 418.100(a)(1) to clarify that hospices
are responsible for providing care that meets the patient's needs for
comfort and dignity, but are not responsible for ensuring that
patient's actually experience such care because patient perceptions are
outside of the hospice's control. A commenter suggested that this
requirement should be further qualified by adding a statement that
hospices should only be responsible for providing such care to the
extent that it is possible within the context in which the patient is
living.
Response: We agree that hospices are responsible for providing care
rather than ensuring experiences. We also believe that the term
``optimizes'' already reflects the fact that hospices must work within
the context of the patient's living situation to address the patient's
unique needs and goals. Rather than holding hospices responsible for
actually assuring comfort and dignity, we are requiring hospices to
optimize, or take all appropriate steps, to provide care that promotes
comfort and dignity. The revised requirement reads, ``[t]he hospice
must provide hospice care that [optimizes] comfort and dignity.''
Comment: Many commenters suggested that we should reexamine the
proposed requirement at Sec. 418.100(a)(2) which would require that
the hospice must ensure ``[t]hat each patient experiences hospice care
that is consistent with patient and family needs and desires.'' The
commenters stated that hospices are not necessarily able to ensure that
patients experience care that is consistent with their needs and
desires. Rather, hospices are able to, through their actions, promote
care that is consistent with patient needs. Furthermore, commenters
stated that the term ``desires'' was too broad to be successfully met
by hospices. The commenters suggested that it be deleted; qualified by
phrases such as ``consistent with hospice practice'' or ``that are
reasonable and necessary''; or replaced by ``goals.'' In addition, the
commenters expressed concern about the requirement to meet family
desires when those desires are in conflict with each other or those of
the patient.
Response: We agree with the commenters that hospices should be
required to provide care consistent with patient and family needs
rather than requiring hospices to ensure that patients and families
experience care that is consistent with their needs and desires. Using
the term ``provide'' holds hospices responsible for those things that
are within their control in contrast to the term ``experience,'' which
is subjective and out of a hospice's control. We also agree that the
term ``desires'' is too broad and subjective, even when qualified by
the suggested phrases. We believe that the term ``goals'' is more
objective, and it corresponds with the requirement at Sec. 418.56(c)
that the hospice plan of care must reflect patient and family goals.
Therefore, we have replaced the term ``desires'' with ``goals'' in this
requirement. Furthermore, we have added a statement in Sec.
418.100(a)(2) affirming that the patient's needs and goals are the
hospice's primary consideration in care planning and delivery. While
hospice treats the patient and family as a single unit of care, this
new statement recognizes that not all members of a family may agree
about the patient's hospice care. In situations where agreement cannot
be reached regarding the goals of hospice care, the patient's needs and
goals must take precedence.
Comment: A commenter suggested that the requirement for the
governing body to assume full responsibility for management of the
hospice may be in conflict with State laws regarding management of
entities. The commenter stated that Boards of Directors generally do
not perform hands-on management of the entity.
Response: We believe that the commenter may have misunderstood our
intent in this section. We are not requiring the governing body to
actually perform day-to-day management functions. We clarified in
proposed and final Sec. 418.100(b) that the administrator, who is
appointed by the governing body, is responsible for the 24-hour
operation of the hospice. If the administrator is not available to
fulfill his or her assigned duties and responsibilities, the hospice
must identify another individual to assume those assigned duties and
responsibilities in accordance with the hospice's established policies
and procedures. The governing body must assume responsibility for
ensuring that the hospice is managed by the administrator and any
managers that the administrator appoints.
Comment: A commenter requested that we provide a definition for the
term ``administrator'' at Sec. 418.100(b).
Response: At Sec. 418.100(b) we are requiring hospices to have an
administrator who reports to the governing body and who is responsible
for the day-to-day operations of the hospice. We have added a new
requirement that the administrator be appointed by the governing body,
to further clarify the relationship between the two parties. We are
requiring that the administrator be a hospice employee who possesses
the education and experience determined to be necessary by the
governing body. We intentionally are not including specific personnel
requirements or a job description for the administrator because this
leadership position varies from hospice to hospice, based on the unique
needs of each hospice. A hospice's governing body, with knowledge of
its operations and needs, is far better suited for making administrator
personnel and job description decisions.
Comment: A commenter suggested that we should add requirements
related to advanced beneficiary notices and expedited determination
notices to proposed Sec. 418.100(d), which states that hospices may
not discontinue or reduce care provided to a Medicare or Medicaid
beneficiary because of the beneficiary's inability to pay for that
care.
Response: It is not appropriate to add information about advanced
beneficiary
[[Page 32136]]
notices and expedited determination notices to this rule because these
notices are not within the scope of this rulemaking.
Comment: Many commenters expressed concern about our proposed
requirement at Sec. 418.100(e) that hospices must retain supervisory
responsibility for services furnished under arrangement. The commenters
stated that the word ``supervision'' implies that hospices are
responsible for providing personnel supervision for those individuals
furnishing services. Personnel supervision, the commenters further
stated, is the role of the entity with which the hospice has an
arrangement. The hospice should be responsible for ensuring that such
supervision occurs. Commenters suggested that the word ``supervision''
be deleted and replaced with ``oversight'', ``supervisory
responsibility'', or ``continually monitor and manage.''
Response: It was not our intent to imply that hospices must provide
personnel supervision for contracted staff. We agree that the term
``supervision,'' as used in the proposed regulatory standard, implies
much more than was intended. Therefore, we are deleting the term
``supervision'' and replacing it with the term ``oversight'' to clarify
that the hospice must be responsible for the services furnished rather
than the individuals furnishing the services.
Comment: Numerous commenters suggested that the proposed
requirement at Sec. 418.100(e)(2) regarding the qualifications of
contracted personnel be clarified. The commenters suggested that the
phrase ``qualified personnel'' replace the phrase ``personnel having at
least the same qualifications as hospice employees.'' The commenters
stated that for some contracted services, for example, durable medical
equipment, there are no equivalent positions between the hospice and
the contractor. Therefore, it would not be possible for the
contractor's employees to have at least the same qualifications as
hospice employees.
Response: Our intent was to ensure that hospice patients receive
the same quality service regardless of whether that service is provided
by hospice employees or contracted staff. We believe that the
commenters' suggestion is appropriate and we revised the requirement
found at Sec. 418.100(e)(2). This revised element requires contracted
staff to be ``qualified,'' meaning that they must meet the personnel
qualifications of whatever profession or job description they are in,
as well as any regulatory requirements particular to that profession or
job description.
Comment: A large number of commenters expressed support for, or
requested clarification regarding, our proposal at 418.100(f),
``Hospice satellite locations.'' Commenters appreciated our inclusion
of regulations on this fast growing part of hospice care and our
exclusion of mileage restrictions. Some commenters sought specific
criteria that hospices must meet in order to open a multiple location,
while other commenters requested more detailed information on the
Medicare approval process, including what would constitute an ``initial
determination'' under Sec. 498.3, regarding such locations. A few
commenters suggested that the entire proposed multiple location
requirement be deleted.
Response: We appreciate the support from commenters on this
proposal. We believe that this proposed requirement is necessary to
ensure that patients receive quality care from hospices, regardless of
whether those services are being provided by the hospice location
originally issued the certification number or by a multiple location of
the hospice. (As noted in the discussion of public comments in Sec.
418.3, the term ``multiple location'' is more current and appropriate
than the term ``satellite location.'') We also believe that the
proposed requirement at Sec. 418.100(f), coupled with the definition
of ``multiple locations'' at Sec. 418.3, will provide much-needed
guidance for hospices considering operating one or more ``multiple
locations.''
As previously stated, we relocated the requirement that hospices
must exercise supervision and management over multiple locations from
the definition of the term ``multiple location'' at Sec. 418.3 to
Sec. 418.100(f)(1)(ii). Furthermore, we reorganized Sec. 418.100(f)
to group all requirements related to Medicare approval of multiple
locations under a single regulatory element, Sec. 418.100(f)(1),
``Medicare approval.'' We believe that grouping these elements will
clarify our expectations for hospices seeking to operate multiple
locations. Revised Sec. 418.100(f)(1)(iii) now requires that the lines
of authority, and professional and administrative control be clearly
delineated in the hospice's organizational structure and in practice.
It also requires that the lines of authority be traceable between the
hospice location issued the certification number and all multiple
locations. This new requirement further clarifies how a hospice must
demonstrate supervision and management of the multiple location by the
hospice issued the provider number. Revised Sec. 418.100(f)(1)(iv)
also includes a provision that a determination of whether or not a
location qualifies as a multiple location in accordance with the
considerations described above is an ``initial determination'' under
Sec. 498.3. An ``initial determination'' is an administrative action
made by CMS, and is subject to appeal. Section 498.5 sets out the
procedures for appellate review of CMS administrative actions that
qualify as initial determinations. Therefore, hospices may appeal an
unfavorable multiple location determination in accordance with the
procedures of Sec. 498.5.
In the preamble to the proposed rule, we described some of the
factors that are currently examined when hospices apply to their CMS
regional office for Medicare approval of a multiple location. The
factors further explain what evidence must be presented by a hospice to
CMS to demonstrate that the requirements of Sec. 418.100(f)(1), such
as supervision and management by the hospice issued the certification
number, are met by the hospice. The factors, which will be updated in
sub-regulatory guidance [(Pub. 100-7, Chapter 2, section 2081)] for
this final rule, include, but are not limited to, the following:
The hospice's ability to supervise the multiple location to assure
the provision of quality care for the patients and families served by
the multiple location;
The hospice's past compliance history;
Relevant state issues and recommendations, such as a reciprocal
agreement between states to assure that at least one of the state
agencies assumes responsibility for any necessary surveys of multiple
locations in situations in which a hospice provides services across
State lines, certificate of need requirements, State licensure
requirements, etc.; and
The ability of the hospice to ensure that each patient receives
care from an assigned IDG that effectively works together to identify
and meet the needs of the hospice patient and family.
Once a hospice has received approval from Medicare and the State
(where applicable) to operate multiple locations, Sec. 418.100(f)(2)
requires that supervision and management of the multiple locations must
continually ensure that services delivered through the multiple
locations are delivered in a safe and effective manner, and that the
care of each patient and family is provided in accordance with the plan
of care. All care and services provided by multiple locations must be
in accordance with all hospice conditions of participation at all
times. Deficiencies
[[Continued on page 32137]]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
]
[[pp. 32137-32186]] Medicare and Medicaid Programs: Hospice Conditions of
Participation
[[Continued from page 32136]]
[[Page 32137]]
identified at any multiple location will apply to all locations
operating under the CMS-issued certification number.
Comment: A few commenters suggested that existing multiple
locations should not be required to have individual Medicare approval.
Other commenters suggested that multiple locations, whether existing or
new, should not be required to have Medicare approval.
Response: Hospices have been required through a CMS policy
memorandum from the Director of the Office of Chronic Care and
Insurance Policy and the Deputy Director for Survey and Certification
to all Regional Administrators on the subject of the Hospice Conditions
of Participation (June 27, 1997) to obtain Medicare approval for
multiple locations since 1997. Thus, there is no need to exclude
existing multiple locations from obtaining Medicare approval because
they should have already received such approval. Furthermore, we
believe that Medicare approval is essential for ensuring that hospice
services furnished from multiple locations are in accordance with all
Medicare conditions of participation and that hospice services meet the
needs of the patients and families being served.
Comment: Some commenters suggested that we should require hospices
to orient each hospice employee to specific job duties that the
employee is expected to perform and to the fundamentals of hospice
philosophy.
Response: We agree that employees and contracted staff furnishing
patient care should be oriented in hospice philosophy, and this
requirement has been added to 418.100(g)(1). We do not believe that it
is necessary for employees and staff that do not have patient contact
to be knowledgeable in hospice philosophy, and requiring them to be
oriented as such would be an unwise use of hospice resources. We also
agree that hospice employees should be oriented to their specific job
duties, and this requirement has been added to Sec. 418.100(g)(2). If
hospice employees provide hospice care to patients who reside in
regulated facilities (for example, a nursing facility), we believe that
it would be beneficial to educate hospice employees regarding the
regulatory requirements that the facility and its staff are required to
meet. Such education may help improve hospice-facility understanding
and cooperation to ensure consistent, high quality care for hospice
patients residing in facilities.
Comment: A commenter requested that we add a provision to this
standard stating that board[pi]certified chaplains who furnish hospice
care must maintain national standards of practice and serve as teachers
to other disciplines on the topics of patient rights, advance
directives, ethics, and cultural and spiritual needs.
Response: Hospices are permitted to use certified chaplains in the
manner that best meets their needs. If a hospice chooses to use the
services of certified chaplains, then we would expect the chaplains to
maintain national standards of practice just as all other disciplines
are expected to do.
16. Condition of Participation: Medical Director (Sec. 418.102)
We proposed to revise the existing medical director requirements at
Sec. 418.54 in several ways. First, we proposed that the medical
director could provide services under contract to the hospice. This
proposal would have prohibited general contracts with agencies or
organizations for medical director services, and reflected existing CMS
policy, as permitted by section 4445 of the BBA 1997. Second, we
proposed that another physician would be identified by the medical
director to assume the role of the medical director in the medical
director's absence. We believe that having another physician prepared
to assume the medical director role would ensure continuity of care for
the hospice's patients, even when the regular medical director was
unavailable.
Third, in standard (a) and (b), we proposed to add further guidance
on the factors that would need to be considered when certifying and
recertifying the terminal illness. We believe that these factors, such
as related diagnoses, current medication and treatment orders, and the
patient's desire to continue hospice care, are already routinely
considered by most medical directors when certifying and recertifying
the terminal illness. Fourth, we proposed to further define the role of
the medical director. We proposed that the medical director coordinate
with other physicians and health care professionals to ensure that
patients receive care that is consistent with hospice policy.
Additionally, we proposed that the medical director, in tandem with the
IDG, be responsible for patient medical care in its entirety. Finally,
we proposed that the medical director be responsible for directing the
hospice's QAPI program. We believed that these medical director
responsibilities would ensure that the medical director was an active
leader and participant in all aspects of the hospice's operations and
services. We believe active participation would lead to better quality
care and patient outcomes.
Comment: While several commenters expressed general support for our
proposed medical director requirements, calling them ``appropriate''
and ``much needed,'' many commenters expressed concern that the medical
director's role appeared to supersede the role of the IDG.
Specifically, commenters stated that the proposed requirement at Sec.
418.102 that, ``[t]he medical director and physician designee
coordinate with other physicians and health care professionals to
ensure that each patient experiences medical care that reflects hospice
policy'' seemed to elevate the medical director above the other members
of the IDG. In addition, the commenters stated that making the medical
director and physician designee responsible for this coordination would
be burdensome for volunteer medical directors. Some commenters also
stated that a patient's hospice care should reflect the hospice
philosophy rather than hospice policy.
Response: Our intent in this proposed standard was to ensure that
medical directors are actively involved in patient care. However, after
considering commenter concerns, we agree that this level of involvement
is not always necessary. Some larger hospices have several physicians
who may serve on IDGs, and it is the physician member of the IDG,
whether he or she is the medical director or not, who shares the
responsibility with the rest of the IDG for communicating with other
physicians and health care providers and for ensuring that the care
furnished by the hospice reflects hospice policy. Since the medical
director may not be the physician member of the IDG, we agree that this
requirement should be removed. Hospices will still be required to have
a communication system in place to ensure the ongoing sharing of
information, both between all disciplines providing care and services
in all settings, and with other non-hospice health care providers
furnishing services to the patient in accordance with final Sec.
418.56(e). In addition, hospices will still be required to develop and
implement an individualized plan of care for each patient that
addresses the patient's and family's hospice care needs and goals in
accordance with Sec. 418.56(c). The individualized plan of care and
the services furnished to execute the plan should be in accordance with
hospice policies, which should, in turn, reflect the individual
hospice's philosophy of care.
[[Page 32138]]
Comment: A few commenters wanted to know if a medical director
could be a volunteer.
Response: Medical directors may be volunteers, and we did not
intend to imply otherwise. We believe that this question arose from the
phrasing in the proposed rule that was used to describe the employment
status of the medical director. In Sec. 418.102 of the proposed rule,
we stated that the medical director could be ``employed by, or [be]
under contract with,'' the hospice. Additionally, in Sec. 418.3 we
define the term ``employee'' to include volunteers. Since the proposed
phrasing did not explicitly use the term ``employee'', we believe that
commenters were confused about our intent. We have clarified in this
final rule that the medical director may be an ``employee'' of the
hospice, which includes volunteers.
Comment: Many commenters suggested that the hospice, rather than
the medical director, should be responsible for identifying the
physician designee who fulfills the role of the medical director in the
medical director's absence. A few commenters suggested that hospices
should be allowed to contract with physician groups, without
designating a specific physician, for medical director services, while
still other commenters suggested that hospices should not be required
to have physician designees at all.
Response: We agree that the hospice is better suited than the
medical director exclusively to choose the physician designee, and we
have incorporated this suggestion in Sec. 418.102. We are requiring
hospices to employ or contract with physician designees because, in
many hospices, the medical director may be the only physician employee
or contractor in the entire hospice. It is essential that another
physician be available to assume the medical director's role when the
medical director is absent to ensure continuous quality care for the
hospice's patients. Likewise, it is essential that there be a specific
individual identified to be the physician designee. Allowing numerous
physicians to fulfill the medical director role would likely result in
inconsistent care and decreased accountability.
Comment: Numerous commenters requested that hospices be allowed to
contract with physicians employed by a professional entity or a
physicians'' group. The commenters explained that, for tax and
paperwork purposes, it is often easier for the hospice and the
physician to arrange the contract for a particular physician's medical
director services through the physician's practice or professional
organization. In such a case, a specific physician would fulfill the
medical director position at the hospice, but the hospice's contract
for that particular physician's services would be with the physicians''
group or professional organization.
Response: Our intent in this standard is to ensure that there is a
specific physician who fulfills and is held accountable for the medical
director's responsibilities. We agree that there may be times when it
is beneficial for hospices and physicians to handle contracts through
established entities, rather than through direct individual contracts.
For this reason, we have added a new standard at Sec. 418.102(a),
``Medical director contract,'' which permits hospices to contract with
a self-employed physician or a physician employed by a professional
entity or physicians'' group. The new standard at Sec. 418.102(a)
establishes that, when contracting for medical director services, the
contract must specify the name of the physician who assumes the
responsibilities and obligations of the medical director.
Comment: A commenter suggested that we should add attending
physicians to proposed Sec. 418.102(a), which requires the medical
director or physician designee to review clinical information for each
patient and provide written certification of the patient's terminal
illness.
Response: The attending physician is a participant in the
certification process pursuant to Sec. 418.22(c)(1)(ii). Although
regulating the actions of the attending physician is not within the
scope to this rule, we agree that attending physicians should consider
the same clinical information as the medical director or physician
designee to help ensure that all physicians make certification
decisions based on the same information.
Comment: Many commenters sought clarification on our proposal at
Sec. 418.102(a) that the medical director must consider certain
factors when initially certifying that it is anticipated that a
patient's life expectancy is 6 months or less if the illness runs its
normal course.
Response: We proposed that the medical director must consider the
primary terminal condition, related diagnoses, current subjective and
objective medical findings, current medication and treatment orders,
and information about unrelated conditions when considering the initial
certification of the terminal illness. In the proposed rule, we called
these areas ``criteria'', and we believe that this term may have been
the source of commenter concern. Our intent was to ensure that medical
directors carefully examine all relevant information that is gathered
about the patient before making this determination in accordance with
the requirements for establishing eligibility for the Medicare hospice
benefit found at 418.22 and 418.25. The interdisciplinary group may
consider the information gathered during the certification in and
developing the patient specific plan of care. We have removed the term
``criteria'' in order to remove any implication that there are specific
CMS clinical benchmarks in this rule that must be met in order to
certify terminal illness.
We believe the requirements in this final rule compliment and
encompass the existing Medicare hospice certification requirements and
may enhance the health and safety of patients by ensuring that hospices
have all relevant information about a patient in the patient's record.
Comment: Several commenters suggested that the IDG as a whole,
rather than the medical director or physician designee individually as
we proposed, be responsible for reviewing the patient's clinical
information in preparation for recertifying the terminal illness. One
commenter wanted to know if a review of the patient's clinical
information would include a review of the plan of care.
Response: Certifying and recertifying the terminal illness is the
function of the medical director or physician member of the IDG, and
the patient's attending physician, if any, (in accordance with Sec.
418.22(c)), not the entire IDG. The contributions of the other members
of the IDG should be considered when making the recertification
decision. Section 418.102(c) of the final rule requires that the
patient's clinical information be reviewed before recertification.
During this review the physicians would consider all of the patient's
clinical information from all disciplines providing services to the
patient. The review would, by definition, include the patient's plan of
care since we would deem the plan of care to be ``clinical
information.'' The plan of care is required to be updated at least
every 15 days, and the 90- and 30-day benefit periods that require
recertification would coincide with the plan of care updates. We
believe that this review will allow the collection of the necessary
information from which to make a determination.
Comment: Many commenters asked for clarification of the proposed
requirement at Sec. 418.102(b)(2) that provides for review of the
patient's and family's expectations and wishes for the continuation of
hospice care. Some
[[Page 32139]]
commenters suggested that the review should focus on the patient's or
representative's expectations and wishes, rather than the family's.
Others suggested that a review of the patient's goals would be more
appropriate. Some of these commenters contended that, because hospice
is an elected benefit and patients are free to revoke their election at
any time, this requirement is unnecessary. In addition, commenters
expressed concern that reviewing the patient's and family's desire for
hospice care may appear to patients and families as though they are
being pressured to change their minds about hospice care.
Response: We agree that the proposed requirement is not necessary
because patients may choose to leave hospice at any time. Therefore, we
are not finalizing this requirement.
Comment: Numerous commenters expressed concern regarding the
proposed requirement at Sec. 418.102(c) that the medical director or
physician designee and the other members of the IDG have joint
responsibility for coordinating the patient's medical care in its
entirety. Some of the commenters believed that the proposed standard
unnecessarily separated the medical director or physician designee from
the rest of the IDG, thereby downplaying the interdisciplinary nature
of hospice care. Other commenters believed that the hospice should only
be responsible for coordinating the patient's hospice care, because
other care being furnished to a hospice patient for unrelated
conditions is not within the hospice's control. Still other commenters
believe that the patient's attending physician (if any) or the
physician of the long term care facility where the patient resides (if
applicable) would be the appropriate provider to coordinate the
patient's medical care in its entirety.
Response: We agree that it is inappropriate to create an
environment which separates the medical director or physician designee
from the IDG. We expect that all members of the IDG, including the
physician, will actively work together to ensure that a patient's care
is coordinated. We believe that this IDG approach to care is already
reflected in final Sec. 418.56. Section 418.56(e) of this final rule
requires hospices to have a communication system that allows for the
sharing of information with health care providers who are furnishing
care to hospice patients for unrelated conditions. In addition, Sec.
418.56(a)(1) of this final rule requires hospices to designate a
registered nurse who is a member of the IDG to coordinate
implementation of the plan of care, which is required to address all of
a patient's hospice needs. Since these provisions adequately ensure
that each patient's hospice care is coordinated both within the hospice
and with other health care providers, we have removed the language in
question.
Comment: The majority of commenters expressed support for involving
medical directors in a hospice's quality assessment and performance
improvement program, but expressed concern about holding medical
directors responsible for directing the QAPI program. Commenters stated
that medical directors may not be the individuals who are most
qualified to direct QAPI programs. Commenters also stated that these
medical director responsibilities would be burdensome, particularly for
part-time and volunteer medical directors. Some commenters suggested
that the IDG designated as being responsible for establishing a
hospice's day-to-day policies should have the responsibility for
directing the QAPI program, while others suggested that the governing
body or a professional advisory committee should have this
responsibility.
Response: We agree that the medical director may not be the
individual who is most qualified to direct a hospice's QAPI program;
therefore, we have removed this requirement. As licensed professionals,
Sec. 418.62(c) requires medical directors to actively participate in a
hospice's QAPI program. We believe that this requirement is sufficient
to ensure that QAPI programs benefit from the expertise of medical
directors. We considered commenter suggestions for reassigning
responsibility for directing the QAPI program. The final rule at Sec.
418.58(e)(3) requires the governing body to designate individuals to be
responsible for directing the hospice's QAPI program.
Comment: A commenter suggested maintaining the existing requirement
at Sec. 418.54 that the medical director must be a hospice employee
who is a doctor of medicine or osteopathy who assumes overall
responsibility for the medical component of the hospice's patient care
program.
Response: We do not believe that the medical director requirement
in the current regulation is sufficient, because it does not address
the issues of contracting for medical director services, physician
designees, or the role of the medical director in certifying and
recertifying terminal illness status. These are important areas to
address, as they impact a hospice's ability to obtain medical director
services as well as patient care and patient eligibility. At the same
time, we agree that it continues to be appropriate to require the
hospice medical director to assume overall responsibility for the
medical component of the hospice's patient care program. We have
incorporated this requirement into the final rule at new Sec.
418.102(d).
Comment: A commenter suggested that we should incorporate the
definition of the term ``medical director'' from the American Academy
of Hospice and Palliative Care into the final rule.
Response: No publication or policy of the American Academy of
Hospice and Palliative Care defines the term ``medical director'';
therefore, we cannot incorporate this suggestion into the final rule.
Comment: One commenter stated that the ``Medical director''
condition of participation should be deleted because the requirements
can be incorporated into the physician services requirement at Sec.
418.64(a).
Response: The hospice medical director's role is above and beyond
that of general physician services because, in addition to furnishing
physician services and being a member of the IDG, the medical director
also is responsible for providing overall medical leadership in the
hospice. We believe that this additional level of responsibility,
coupled with the medical director's supervisory role of other hospice
physicians, warrants a separate condition of participation.
Comment: Some commenters suggested that we should require hospice
medical directors to have additional education, experience, and/or
training in palliative and end-of-life care.
Response: We agree that hospices should choose a medical director
with an appropriate set of knowledge and skills to meet the needs of
patients and the hospice. We do not believe that a single set of
personnel requirements for medical directors would achieve this goal.
Hospices need the flexibility to determine the qualifications of the
medical director based on the role of the medical director in that
particular hospice. That is, a medical director who is the only
physician in the hospice, and who is thus expected to provide direct
patient care to each patient needs a very different set of skills and
knowledge than the medical director of a large hospice whose job it is
to manage numerous hospice physicians and perform various other
administrative-type tasks.
17. Condition of Participation: Clinical Records (Sec. 418.104)
The proposed condition of participation, ``Clinical records,''
would
[[Page 32140]]
incorporate several of the existing requirements in Sec. 418.74 of the
current regulation, ``Central clinical records'' (for example, that
clinical records contain past and current findings, be maintained for
each patient who is admitted by the hospice, be protected from loss or
unauthorized use, and be readily accessible). We proposed to add a new
requirement that the clinical record contain accurate clinical
information that would be available to the physician and hospice staff.
At Sec. 418.104(a), ``Content,'' we proposed to retain the
requirement that the clinical record include all assessments (including
the initial assessment and all updated assessments), plans of care,
consent and election forms, and clinical and progress notes. We
proposed the following additional requirements for the content of the
clinical record--
Advance directive information as described in proposed
Sec. 418.52(a)(3);
Authorization forms;
Responses to medications, symptom management, treatments
and services;
Patient process and outcome measures as they relate to the
plan of care; and
Physician certification of terminal illness as required in
Sec. 418.22(c) and described in proposed Sec. 418.102(a) and (b) (now
(b) and (c) in the final rule).
We proposed to add a new standard at Sec. 418.104(b),
``Authentication,'' to require authentication of clinical records. This
proposed standard was similar to a requirement in the conditions of
participation for hospitals. We proposed that all entries be legible,
clear, complete, and appropriately authenticated and dated.
Authentication would include verification of handwritten and/or
electronic signatures by signature logs or a computer secure entry of a
unique identifier for a primary author who has reviewed and approved
the entry. This new standard would address technological changes in
information management, such as the computerization of records and
electronic signatures.
Under Sec. 418.104(d), ``Retention of records,'' we proposed to
ensure protection of patient information by adding a new requirement
that patient records be retained for five years after the death or
discharge of the patient, unless State law stipulated a longer period
of time.
Under Sec. 418.104(e), ``Discharge or transfer of care,'' we
proposed a new requirement that Medicare/Medicaid-approved hospice
facilities forward a copy of the patient's clinical record and hospice
discharge summary to the facility or provider to which the patient was
being transferred. We believe that this would help to ensure that the
information flow between the hospice and the transfer facility/provider
would be smooth, and that appropriate care would continue without being
compromised. Furthermore, we proposed that the hospice discharge
summary would include information that accurately described the
patient's stay; current plan of care; recent treatment, symptom, and
pain management information; most recent physician orders; and any
other documentation that would assist in post-discharge continuity of
care.
Comment: One commenter requested that we clarify the term
``accurate'' as it pertained to the information contained in the
clinical record.
Response: CMS expects that the hospice will ensure that information
placed into the clinical record is correct and we have replaced the
term ``accurate'' with the term ``correct'' to reflect this
expectation. This would include providing correct information in
appropriate sections of the clinical record in accordance with accepted
hospice documentation policies.
Comment: One commenter suggested that updated plans of care as well
as assessments should be included in the clinical record requirement
because updated plans of care are better to use than progress notes.
Response: We agree with the commenter's suggestion and have amended
the language at Sec. 418.104(a)(1) to indicate that the patient's
clinical record must include, ``the initial plan of care, updated plans
of care, initial assessment, comprehensive assessment, updated
comprehensive assessments, and clinical notes.''
Comment: Several commenters asked CMS to clarify what is meant by
the term ``authorization'' in proposed 418.104(a)(2). Another commenter
asked that we amend the language to read ``election statement, which is
required to include consent to start hospice services as well as
patient rights.''
Response: We agree that the word ``authorization'' was confusing in
this context. We also agree that ``election statement'' should be added
to this section. Therefore we have removed ``authorization'' and have
added ``election statement'' to the regulatory text. The election
statement must be completed in accordance with the requirements of
Sec. 418.24, which is not a part of these conditions of participation.
The new Sec. 418.104(a)(2) now requires the patient's clinical record
to include signed copies of the notice of patient rights and election
statement.
Comment: The majority of commenters believed that proposed Sec.
418.104(b) was too broad and held hospices to a higher standard than
home health agencies. They recommended that we consider using the
language in the home health CoPs regarding authentication issues.
Another commenter recommended that we mirror the home health
requirements by not having a signature requirement. The commenter
stated that making a home health agency and a hospice conform to the
same requirements would offer entities that have both a hospice and a
home health agency an administrative advantage. For example clinical
record software could be utilized by both entities. One commenter
believed that the proposed language looked too much like the hospital
conditions of participation. The majority of commenters strongly
recommended that this section be excluded from the hospice conditions
of participation.
Response: We do not believe it is the best interest of the hospice
to exclude this requirement, nor do we believe the clinical record
requirement of the home health agency conditions of participation meets
the needs of hospices. We agree that the proposed language could be
difficult for the hospice to comply with; therefore we have amended the
language to allow greater flexibility. We believe that a hospice should
have the authority to create its own policy on authentication of
clinical records. We have modified the proposed rule to reflect this
change. Hospices will follow State laws regarding authentication of
clinical records, and, within this context, alter their policies as
often as necessary to adapt to changing technologies and practices.
Comment: One commenter asked if a unique user name and password
that would allow access to, and creation of, an electronic health
record would constitute authentication. One commenter stated that
electronic medical records already have multiple protections in place,
such as frequently changed passwords, making the proposed signature
requirement duplicative and unnecessary. Some commenters stated that
hospices have no mechanism to authenticate a signature of a covering
physician beyond the initial verbal order taken by the registered
nurse. Another commenter suggested that we require authentication of
documents, not signatures. One commenter asked if authentication
requirements apply to consulting physicians and covering physicians.
Another asked whether they would be required to maintain a sample
[[Page 32141]]
signature on file as proof of the legitimacy of an authentication. An
additional commenter suggested that hospices should only be required to
authenticate handwritten and electronic signatures made by hospice
employees.
Response: It will be up to the individual hospice to decide how it
will handle authentication of entries made by employees, contracted
staff, attending physicians, and any other individuals who input
information in a patient's clinical record. Hospices must first decide
on who is permitted to enter information into a clinical record. If the
hospice is using electronic medical records, electronic authentication
must have a user ID and frequently changed passwords. Every entry, both
written and electronic must be signed and dated. Hospices must continue
to comply with any applicable State laws regarding record
authentication.
Comment: Many commenters asked what we meant by ``primary author''
in proposed 418.104(b). Commenters asked whether faxed signatures would
meet the authentication requirement, and who (if anyone) would be
required to authenticate a faxed signature. Commenters also asked if we
were requiring hospices to be held accountable for signature logs for
attending physicians not employed by the hospice, or whether we were
requiring a signature log for everyone. Finally, they asked whether
this standard would apply to contracted entities.
Response: ``Primary author,'' a term that has been removed from
this final rule, referred to the person who wrote the entry. For
information that is transcribed, we would require both the physician's
and transcriber's signatures. Faxed signatures supporting orders and
documentation, or care and services delivered would be acceptable, and
we will provide sub-regulatory guidance to that effect. The hospice
would need to make its own decision as to how it wanted to approach
authentication; it will be up to the hospice to make decisions
regarding signature logs.
Comment: Several commenters noted that there were differences
between the hospice proposed record retention standard and Health
Insurance Portability and Accountability Act (HIPAA) requirements as
set out at 45 CFR 164.530(j)(2).
Response: We thank the commenters for pointing out the different
timeframe requirements under HIPAA. It was an oversight by us. To
ensure consistency between these two regulations, we have changed the
language at Sec. 418.104 (d) to read: ``Patient clinical records must
be retained for 6 years after the death or discharge of the patient,
unless State law stipulates a longer period of time.''
Comment: Several commenters requested that we amend the discharge
summary language by stating that we prefer the use of electronic
methods for sending discharge summaries and/or clinical records when a
patient is discharged.
Response: We believe that when electronic clinical records are
available, sharing of discharge summaries and/or clinical record
information through an electronic format would be acceptable if agreed
upon by both the sender and the receiver. Electronic sharing of
information may include access to a record through a secure internet
access portal. We understand that many hospices may not have this
capability. We are not mandating this as a requirement. Paper copies of
the discharge summary and clinical record are acceptable.
Comment: One commenter requested that we amend the language at
Sec. 418.104(e) so that it does not apply to patients discharged as a
result of their death.
Response: We have amended the regulatory text to indicate that a
discharge summary is only necessary for patients discharged under Sec.
418.26. We agree with the commenter that a discharge summary need not
be completed for deceased patients; we do not deem a patient's death to
be a discharge within the meaning of Sec. 418.26.
Comment: Several commenters requested language changes under Sec.
418.104(e); for example, commenters requested that ``Medicare/Medicaid
approved'' be changed to ``Medicare/Medicaid certified''; that we add
the phrase ``as requested'' to the end of proposed Sec.
418.104(e)(3)(iv); and that we add the phrase ``patient's written
consent'' to the same element. Others commented on the unnecessary
requirement that both the clinical record and discharge summary be
sent. Many commenters believed that the discharge summary contains
enough information to maintain continuity of care, and believed that a
copy of the clinical record should only be sent upon request of the
receiving entity. One commenter questioned whether sending the
discharge summary would violate the HIPAA ``minimum necessary''
standards.
Response: In response to these suggestions we have decided to amend
the language under Sec. 418.104(e). We have changed ``Medicare/
Medicaid approved'' to ``Medicare/Medicaid certified,'' and have added
the term ``if requested'' when forwarding the clinical record. Pursuant
to the HHS privacy rule at 45 CFR 164.502(a)(1)(i), 164.502(b)(2), and
164.506 the ``minimum necessary'' standard does not apply to
disclosures to or requests by a health care provider for treatment. The
transfer of patient information is permitted when the patient transfers
from one provider to another.
In the reorganization of Sec. 418.104(e) we believe we captured
the commenters' concerns in the area of discharge summary. We recognize
that the discharge summary and clinical record are very important, and
have amended the language to specify that the discharge summary will be
sent automatically, but that a copy of the patient's entire clinical
record will only be sent if requested. When patients transition from a
hospice to another provider, it is important for hospices to establish
communication channels with receiving providers. The communication
channels give hospices to opportunity to receive feedback from
receiving providers regarding the adequacy and appropriateness of the
hospice's discharge process. This feedback, which can be incorporated
into a hospice's QAPI program, gives hospices the opportunity to
improve patient transitions to ensure that patients receive safe and
effective care at all times during the transfer process.
Comment: A commenter asked us to elaborate on the proposed
requirement at Sec. 418.104(f), ``Retrieval of clinical records.''
Response: Clinical records, either in electronic or hard copy form,
must be made available to the appropriate requestor, such as the State
survey agency or and accrediting body, within a reasonable amount of
time. Access needs to be granted to any and all patient related
documentation that the hospice maintains. If the hospice maintains
electronic clinical records, equipment must be available to allow
access to the clinical record information.
Comment: Many commenters responded to our request for information
and input on the use of electronic health records. The overwhelming
consensus at this time was that electronic health records (EHR) would
be burdensome and cost prohibitive, especially for smaller hospices. A
few commenters stated that financial assistance may be necessary to
achieve EHR standards, and one commenter suggested that at the very
least, EHR standards would need to be phased in.
Response: Given the potential financial constraints, we are not
amending the final rule to mandate
[[Page 32142]]
EHRs. Hospices may use EHRs if they choose, and would need to ensure
trouble-free record retrieval.
Comment: A few commenters requested that Federal regulations as a
whole need to address the development of EHRs that can be accessed and
used in multiple care sites, including the patient's home. One
commenter included the specific pieces of information that should be in
the EHR. Some commenters commented on the advantages of the EHR, such
as: improved coordination of care, increased communication, increased
accuracy, accessibility from any computer, easy portability and
legibility, with documentation available to others much more rapidly.
Response: We acknowledge and appreciate the comments. The overall
goal of the EHR is to achieve and improve collaborative practice among
all care providers and to ensure continuity of care as patients move
across the care continuum.
Promoting the use of health information technology (HIT) is a major
health initiative of the President and the Secretary of the Department
of Health and Human Services (HHS). The President has made
implementation of interoperable HIT a national priority and has
expressed a goal that most Americans have an electronic health record
(EHR) by 2014. While this rule does not require hospice providers to
use specific health information technology solutions, including EHRs,
we encourage hospice providers to become knowledgeable about ongoing
HHS activities and actively participate in efforts to develop and
implement cost-effective HIT. For example, one activity recently
undertaken by the Secretary has been the formation of the American
Health Information Community (AHIC), a public-private sector federal
advisory body charged with providing advice on accelerating the
adoption of interoperable EHRs. In another effort, the Health
Information Technology Standards Panel (HITSP) has identified widely
accepted, consensus-based HIT standards to enable and support the
development and use of interoperable HIT products in several healthcare
domains. While HITSP did not focus on the quality measures that are
typically important to hospice providers, several of the identified
standards could be used to support the development of interoperable
quality measurement and reporting HIT products needed by hospice
providers.
Comment: Some commenters noted the disadvantages of EHRs. For
example, software requirements to meet regulatory requirements and
quality initiatives have not been finalized, EHRs may be less flexible
that paper records, EHRs can be time consuming to computer challenged
staff, and EHR systems may be more prone to failures. Commenters
believed that one of the biggest barriers to the EHR was the potential
to allow personal health records to automatically be left available to
the patient/caregiver. The commenters stated that clear safeguards need
to be in place to ensure the security and appropriate use of personal
health records in the home. A commenter believed that caregivers might
be less likely to record certain procedures or observations because of
open access in the EHR.
Response: We acknowledge the disadvantages the commenters listed.
Because of these and other issues, we are not abandoning the
traditional clinical record keeping process in favor of the EHR at this
time.
18. Condition of Participation: Drugs and Biologicals, Medical
Supplies, and Durable Medical Equipment (Sec. 418.106)
This proposed condition of participation would revise the current
general requirement, found at Sec. 418.96, that durable medical
equipment, supplies, appliances, and drugs and biologicals related to
the palliation and management of the terminal illness and related
conditions, as identified in the hospice plan of care, must be provided
by the hospice while the patient is under hospice care.
Section 418.106(a)(1), ``Administration of drugs and biologicals,''
would have required that all drugs and biologicals be administered in
accordance with accepted hospice and palliative care standards of
practice and according to the patient's plan of care. In Sec.
418.106(a)(2) we proposed to add a new requirement that the IDG be
responsible for reviewing the plan of care to determine whether the
patient and/or family has and continues to have the ability to safely
administer drugs and biologicals.
In Sec. 418.106(b), we proposed that the hospice would have a
written policy for tracking, collecting and disposing of controlled
drugs that are maintained in a patient's home. We proposed that this
policy would be discussed with patients and their families during the
initial assessment to ensure that patients and families were educated
about the uses and potential dangers of controlled drugs. We believe
that the hospice's policy, coupled with patient and family education,
would result in shared responsibility for these beneficial, but
potentially dangerous, drugs.
Standard 418.106(c) proposed that hospices assume responsibility
for the use and maintenance of durable medical equipment and supplies.
This standard proposed that hospices, either directly or under
contract, would be responsible for ensuring the maintenance and repair
of durable medical equipment in a manner that conformed to manufacturer
recommendations. If no manufacturer recommendations existed for a piece
of equipment, then repair and routine maintenance policies and
procedures would have to be established. This standard also proposed
that the hospice ensure that the patient, family, and all other
caregivers receive instruction in the safe use of equipment and
supplies. Likewise, the hospice would have to ensure that the patient,
family, and other caregivers could demonstrate the safe use of such
equipment and supplies to the satisfaction of hospice staff. We believe
that proper maintenance and education are essential to ensuring the
patients benefit from fully functional equipment and supplies that they
are able to use in a safe and effective manner.
Comment: A commenter asked us to define the term ``controlled
drugs.''
Response: In this regulation we intend controlled drugs to mean
those substances identified under schedules II, III, IV, and V of the
Federal Controlled Substances Act (Pub. L. 91-513) and FDA regulations
(see 21 CFR part 290) issued thereunder.
Comment: A few commenters suggested that we should require hospices
to use pharmacists to participate in the drug review. Other commenters
suggested that we should require a pharmacist as a member of the IDG to
help identify and prevent drug-related complications such as
duplication, improper dosing, and drug interactions. Still other
commenters suggested that the requirements for pharmacist and
pharmaceutical services at proposed Sec. 418.110(m) and Sec.
418.110(n) should apply to the entire hospice, rather than only to the
hospice inpatient facility. The commenters stated that, since drugs are
prescribed to virtually all hospice patients, these patients should
benefit from the expertise of a pharmacist and the additional level of
drug oversight required by these regulatory standards. One commenter
suggested that we should retain the existing requirements for drugs
found at Sec. 418.96(b), which requires the hospice to have a policy
for the disposal of controlled drugs maintained in the patient's home
when
[[Page 32143]]
those drugs are no longer needed by the patient.
Response: Many hospices, particularly those with hospice inpatient
facilities, have already realized the benefits of actively involving
pharmacists in patient care planning. Hospices are seeking to use drugs
more effectively and efficiently to improve patient outcomes and reduce
costs. In the last years of life, patients typically use five drugs or
more at any one time, increasing the risk of duplicative drug therapy,
drug interactions, or drug side effects, as well as the risk of
dispensing or dosing errors. (Steinman, M., Landefeld, C.S., Rosenthal,
G., Berthenthal, D., Sen, S., et al., ``Polypharmacy and prescribing
quality in older people,'' Journal of the American Geriatrics Society,
2006; Koh, N.Y., Koo, W.H., ``Polypharmacy in palliative care: Can it
be reduced,'' Singapore Medical Journal, 2002; Meredith, S., Feldman,
P., Frey, D., Hall, K., Arnold, K., et al., ``Possible medication
errors in home healthcare patients,'' Journal of the American
Geriatrics Society, 2001; Twycross, R., Bergl, S., John, S., and Lewis,
K., ``Monitoring drug use in palliative care,'' Palliative Medicine,
1994.) The need for the use of drugs in caring for hospice patients,
coupled with the risk of negative patient outcomes, warrants an
additional focus on drug management for all hospice patients,
regardless or whether they receive care in their place of residence or
in an inpatient facility. Therefore, we have moved and modified the
requirements of proposed Sec. 418.110(m) and Sec. 418.110(n) to Sec.
418.106 and have reorganized the requirements in standards (a) through
(e).
In new standard (a), ``Managing drugs and biologicals,'' we
combined some of the requirements of proposed Sec. 418.110(m) and
Sec. 418.110(n), such as the proposed requirement that a qualified
licensed pharmacist direct the inpatient hospice's pharmaceutical
services, including evaluation of a patient's response to drug therapy,
and identification of adverse drug reactions. New standard (a) requires
the hospice to ensure that the interdisciplinary group confers with an
individual with education and training in drug management as defined in
hospice policies and procedures and State law, who is an employee of or
under contract with the hospice to ensure that drugs and biologicals
meet each patient's needs.
Hospices may choose to use a licensed pharmacist, an individual who
has an extensive and up-to-date knowledge of drugs, to fulfill this
role. Approximately 1,600 hospices already contract with pharmacy
benefit management companies to provide drugs and pharmacist services
to each of their patients. Hospices may also choose to use other
individuals with specialized education and training in drug management,
including evaluating the effectiveness of drug therapies, identifying
drug side effects, identifying actual or potential drug interactions,
identifying redundant drugs, and taking appropriate corrective actions.
All hospices must be able to demonstrate an individual's knowledge,
skills, and abilities in managing the use of drugs in accordance with
accepted standards of practice and all applicable State and local
requirements, including State licensure requirements.
Standard (a)(2) also incorporates the proposed requirements of
Sec. 418.110(m) and Sec. 418.110(n) that a pharmacist must oversee an
inpatient hospice's pharmacy program. The provided pharmacist services
must include evaluation of a patient's response to medication therapy,
identification of potential adverse drug reactions, and recommended
appropriate corrective action. New standard (b), ``Ordering of drugs,''
relocates the requirements of proposed Sec. 418.110(n)(1). This new
standard indicates who may order drugs for a hospice patient and how
verbal or electronic drug orders should be documented. New standard
(c), ``Dispensing of drugs and biologicals,'' combines some of the
requirements of proposed Sec. 418.110(m), with proposed Sec.
418.110(n)(4)(ii). This new standard requires a hospice to have a
written policy that promotes dispensing accuracy, to maintain current
and accurate records of the receipt and disposition of all controlled
drugs, and to obtain drugs and biologicals from community or
institutional pharmacists or from its own stock. New standard (d),
``Administration of drugs and biologicals,'' combines the requirements
of proposed Sec. 418.106(a)(2) and Sec. 418.110(n)(2). The new
standard addresses drug administration in both the home and hospice
inpatient facility environments to ensure that drugs and biologicals
are administered to a patient by an individual who is competent to do
so, regardless of the patient's current environment.
New standard (e), ``Labeling, disposing, and storing of drugs and
biologicals,'' combines and revises the requirements of proposed Sec.
418.106(b) and Sec. 418.110(n)(3), (n)(4)(i), (n)(4)(iii), and (n)(5).
This new standard ensures that drugs are safely labeled, stored, and
disposed of in accordance with accepted standards of practice and
applicable Federal and State laws and regulations. It also ensures that
patients and families are properly educated about drug disposal.
We understand that the revised drug requirements may have some
financial impact on hospices. However the cost saving achieved through
a more efficient and effective use of drugs in the hospice, as well as
improved patient outcomes and satisfaction, will, we believe, offset a
portion of this financial impact. Additionally, we believe that the new
standards (for example, development of hospice-wide policies and
procedures, patient and family education) will help hospices create
partnerships with patients and families to ensure that controlled drugs
are used and disposed of in a safe manner.
Comment: Numerous commenters suggested that we should address the
issue of hospice patients bringing their own drugs from their homes
into a hospice inpatient facility.
Response: This rule does not prohibit patients from bringing their
own drugs into a hospice inpatient facility. If patients do so, the
transportation and use of these drugs must be in accordance with any
applicable Federal, State, and local laws and regulations, as well as
with the hospice's own policies and procedures.
Comment: A commenter suggested that we should delete the
requirement that drugs and biologicals must be obtained from a
community or institutional pharmacist or stocked by the hospice.
Response: We assume that the commenter seeks to obtain drugs and
biologicals from sources outside of the United States. Due to concerns
about the safety of drugs and biologicals obtained from sources that
are outside of the purview of the Food and Drug Administration, we
believe it it necessary to continue to require hospices to obtain drugs
and biologicals from a community or institutional pharmacist or from
its own stocks.
Comment: A commenter requested that the following statement be
added to proposed Sec. 418.106(a) (now located at Sec.
418.106(d)(1)):
``If the patient and/or family are determined to be unable to
safely administer drugs and biologicals, the patient and family will be
encouraged to relocate the patient to a setting where administration
assistance can be routinely offered. However, it is recognized that the
patient, if competent, and the patient's surrogate if the patient is
not competent, can refuse to relocate. Given patient rights and the
home setting, [the] hospice will be expected to provide reasonable
[[Page 32144]]
assistance. [The] hospice will not be expected to restrict the
provision of medications unless there is a blatant safety issue for
non-competent adults or children in the home.''
Response: If a patient and all family members are unable to safely
administer drugs themselves, then it is incumbent upon the hospice to
identify alternatives to ensure safe administration. Depending on the
circumstances, alternatives may include friends and neighbors of the
patient and family who are competent to administer medications with
appropriate training from the hospice, the hospice's own paid employees
and volunteers, paid caregivers, and, lastly, patient relocation. We do
not believe that it is necessary to include the suggested language
because the options mentioned above are already available to hospices.
Furthermore, we do not believe that it is necessary to establish in
this regulation criteria for restricting the placement of drugs in a
patient's home. We believe that hospices should be able to assume the
responsibility to determine when it is or is not appropriate to place
drugs in a patient's home.
Comment: A few commenters suggested changes regarding who is
permitted to administer medications to patients in a hospice inpatient
facility. One commenter suggested that licensed practical nurses (LPN)
and licensed vocational nurses (LVN) should be allowed to administer
medications, while other commenters suggested that the patient's family
or caregiver should be allowed to administer medications.
Response: In accordance with Sec. 418.106(d)(2) of this final
rule, licensed nurses are permitted to administer medications in
accordance with their scope of practice. If an LPN's or LVN's scope of
practice permits him or her to administer medications, then it is
appropriate to allow them to administer medications in accordance with
this rule. However, it is not appropriate to allow the family or
primary care giver of a patient to administer medications in an
inpatient facility. Patients enter hospice inpatient facilities for two
primary reasons, respite and general inpatient care. If a patient is in
an inpatient facility for respite care, it is because the family/care
giver needs a temporary break from care giving duties. It would not be
appropriate to expect the family/caregiver to administer medications to
the patient in the inpatient facility. If a patient is in an inpatient
facility for general inpatient care, it is because the patient is
experiencing pain or symptoms which cannot be managed in the patient's
home by the patient's caregivers in conjunction with the hospice staff,
in which case it is not appropriate to expect the family/caregiver to
handle the complex medication regimen the patient likely requires. This
is the job of the hospice inpatient staff.
Comment: Numerous commenters expressed concern regarding our
proposal in Sec. 418.52(a)(3) that hospices inform patients and
families about their drug policies before hospice care is furnished.
Commenters believed that providing the drug policy information at that
time would overwhelm patients and families with information that was
not urgent. Some commenters suggested that a hospice should be required
to provide information about its drug policy in the admission package
of information that is left with the patient. The content of the
admission package, including the drug policy, could be discussed with
the patient and family at some time during the comprehensive assessment
period. Other commenters suggested that hospices be required to discuss
their drug policies when patients are prescribed drugs to which the
hospice's policy applies. Other commenters requested clarification
regarding the form of the drug policy notice, noting the difficulties
involved in furnishing the notice in obscure or otherwise uncommon
languages. As with the general notice of patient rights in Sec.
418.52, many commenters requested that we explicitly allow the use of
translators when providing the drug policy notice. Additionally, as
with the general notice of patient rights, a few commenters requested
that we clarify how hospices should document the fact that patients and
families were informed of the hospice's drug policies.
Response: We agree that providing controlled drug policy
information before the start of care may not be appropriate in all
cases because not all patients are taking controlled drugs at the start
of care. We also agree that providing such information may
unnecessarily overwhelm patients and families. Therefore, we have
replaced the proposed requirement at Sec. 418.52(a)(3), with a
requirement set out at Sec. 418.106(e)(2) that, at the initial time
that controlled drugs are ordered by the hospice for the patient's use
at home, the hospice must provide a copy of its written policies and
procedures on the management and disposal of controlled drugs to the
patient or representative, and the family.
While we are requiring hospices to provide drug policy and
procedure information to patients and families, we are not prescribing
the manner in which they must document this information sharing. The
drug policy and procedure information, unlike the notice of patient
rights in Sec. 418.52, is more of an educational effort. The hospice's
drug policies and procedures will help patients learn how to safely use
controlled substances and avoid negative outcomes. The drug policies
and procedures will also help the hospice explain its own role in
controlled drug management. We do not believe that it is necessary to
dictate the method for educating patients and families about the
hospice's drug policies and procedures, nor is it necessary to
prescribe how hospices should document that patients and families have
received such education. Hospices should decide for themselves, in
their own policies and procedures, how staff will document the
discussion of the hospice's drug policies and procedures. Obtaining a
patient or family member signature would be appropriate, as would any
number of other documentation methods.
As previously discussed in the notice of patient rights section, it
is acceptable to use translators, either professional or family
members, to ensure that patients and families fully understand the
hospice's controlled drugs policies and procedures.
Comment: In Sec. 418.106(b) we proposed that hospices have a
written policy for tracking, collecting, and disposing of controlled
drugs maintained in the patient's home. The majority of commenters who
submitted comments on this CoP asked us to remove this requirement. The
commenters were concerned that the tracking requirement would require
hospice staff to conduct pill counts. They were also concerned that
these proposed requirements would compel hospice employees to remove
drugs from the patient's home, which employees are prohibited from
doing because the drugs are the patient's property.
Response: While it was not our intent to imply that hospices would
be required to conduct pill counts or remove drugs from patient homes,
we understand that the terms ``tracking'', ``collecting'' and
``disposing'' implied precisely that. Therefore, we have removed these
terms and replaced them with a requirement at new Sec. 418.106(e)(2)
that hospices have written policies and procedures for management and
disposal of controlled drugs maintained in the patient's home. The
intent of this revised requirement is to ensure that hospices have a
clear picture of what drugs have been prescribed and delivered to the
patient,
[[Page 32145]]
and are therefore present in the patient's home, at any time. Through
the written policies and procedures, hospices will have a plan
detailing how they can assist a family in safely disposing of
controlled drugs after a patient's death.
Comment: The majority of commenters who submitted comments on this
CoP asked us to replace the proposed requirement that hospices must
discuss the potential dangers of controlled drugs with a requirement
that hospices must discuss the ``safe use,'' ``appropriate use,'' or
``risks/benefits'' of controlled drugs.
Response: Our intent in the proposed standard was to ensure that
hospices educate patients and families on how controlled drugs are used
and the risks associated with abusing and/or improperly disposing of
them. We agree that requiring hospices to discuss the ``safe use'' of
controlled drugs accomplishes this intent without the negative
connotations that may be associated with the language of the proposed
rule. The safe disposal of controlled drugs should also be part of the
patient and family education effort. Therefore, we revised Sec.
418.106(e)(2)(B) to require that, when controlled drugs are first
ordered for use in the patient's home, the hospice must, ``[d]iscuss
the hospice policies and procedures for managing the safe use and
disposal of controlled drugs with the patient or representative and the
family in a language and manner that they understand to ensure that
these parties are educated regarding the safe use and disposal of
controlled drugs.''
Comment: A commenter suggested that we should require hospices to
educate patients and families about drug policies in a language and
manner that the patient and family understand.
Response: HHS guidance on Title VI, ``Guidance to Federal Financial
Assistance Recipients Regarding Title VI, Prohibition Against National
Origin Discrimination Affecting Limited English Proficient Persons,''
August 8, 2003 (68 FR 47311), related to limited English proficiency
persons, presents guidelines for developing and implementing
communication strategies in a variety of settings, including hospice.
Since hospices are already expected to meet these guidelines, we agree
that it is appropriate to re-enforce the existing guidance by requiring
the discussion of drug policies to occur in a language and manner that
the patient and family understand.
Comment: A few commenters wanted to know where drug discrepancy
investigation reports should be sent to. One of these commenters
suggested that sending drug discrepancy investigation reports to State
and Federal officials should be done only when required by law.
Response: We agree that such reports should only be sent to the
appropriate agencies when required by a specific Federal or State law
or regulation. These State specific laws and regulations may vary, and
describe the appropriate reporting mechanism, timeframe, and recipient.
We have added the phrase ``if required by law or regulation'' to the
end of the reporting requirement, which is now located at Sec.
418.106(e)(3)(ii).
Comment: A commenter asked us to clarify the relationship between
the requirement that hospices must provide drugs for patients and the
Medicare Part D benefit.
Response: Hospices are required by section 1861(dd)(1)(E) of the
Act to furnish all drugs and supplies related to the terminal illness
and related conditions. Hospices may not expect patients to obtain
drugs related to the terminal illness and related conditions through
the Medicare Part D benefit. If a patient requires drugs that are not
related to the terminal illness and related conditions, then it may be
possible for the patient to obtain those unrelated drugs through the
Medicare Part D benefit.
Comment: A commenter suggested that hospices should note in the
patient's clinical record any drugs that are prescribed for the patient
that are not standard treatment for that patient's symptoms. The
commenter further suggested that the patient's clinical record should
include an explanation for such unconventional use.
Response: Hospices are free to determine the type, dose and
administration methods for any drugs that they choose to prescribe. We
would expect hospices to confer with an individual with education and
training in drug management and use current practices to select the
most appropriate drugs for a particular patient, and to be able to
explain drug choices to those providing patient care, the patient or
representative, the family, and any authorities having jurisdiction, as
necessary. Hospices may find it appropriate to document those drugs
that are prescribed for uncommon or unconventional reasons, and the
rationale behind such decisions; however, we do not believe that it is
necessary to require such additional documentation.
Comment: Numerous commenters stated that, when durable medical
equipment (DME) is provided under contract, the contracted DME provider
is responsible for DME maintenance. As such, the commenters stated that
hospices should not be held responsible for DME maintenance when it is
provided under contract.
Response: We understand that the majority of hospices contract with
outside entities for DME equipment. We also understand that, as part of
that contract, most hospices require the DME company to provide
maintenance services. This is an acceptable arrangement. However,
requiring a DME company to maintain the equipment that it provides does
not absolve the hospice of its ultimate responsibility to ensure that
all services provided on its behalf, whether by its employees or
through a contract, are safe and effective. An improperly or
inadequately maintained piece of DME is neither safe nor effective.
Thus, it is the hospice's ultimate responsibility (as it is with
respect to all of its contracted services) to ensure that maintenance
is performed on DME equipment, regardless of the source of such
equipment. A written statement from the DME supplier and signed by a
person of authority stating that equipment has been serviced according
to manufacturer recommendations or other comparable standards would be
one way that the hospice could assure that the equipment is safe and
performs as required. If a hospice does not ensure that such
maintenance is performed, it is not in compliance with the requirement
that it must maintain professional management responsibility for all
services provided or this requirement at new Sec. 418.106(f)(1).
At the same time, we understand that the proposed requirements
should be clarified to ensure that hospices may provide DME maintenance
services under contract. We have revised new Sec. 418.106(f)(1) to
state that hospices must ensure that manufacturer maintenance
recommendations are followed. If there are no manufacturer
recommendations, hospices must ensure that maintenance policies are
developed. We believe that adding the term ``ensure'' will clarify that
hospices must make sure that such maintenance is complete, but that
hospices are not necessarily required to handle maintenance through
their employees.
Comment: Numerous commenters stated that the contracted entity that
supplies the DME is best suited to instruct the patient and family in
the safe use of the DME provided.
Response: In the proposed rule at Sec. 418.106(c)(2), we stated
that hospices must ensure that patients and families receive DME
instruction. Our intent was to allow hospices to provide such
instruction through a contracted DME supplier. We agree that this
intent
[[Page 32146]]
should be further clarified. We have added a provision to the final
rule at Sec. 418.106(f)(2) to clarify that, ``[t]he hospice may use
persons under contract to ensure patient and family instruction.''
Comment: A few commenters asked for clarification about the role of
the Medicare Supplier Standards and accreditation in contracting for
DME services. Some of these commenters suggested that any DME supplier
who furnished DME equipment as part of the Medicare hospice benefit be
required to meet the Medicare Supplier Standards and be accredited by a
national accrediting body. Another commenter suggested that by
contracting with a DME supplier that met the Medicare Supplier
Standards, hospices would have more assurance that the DME provider
would safely and effectively perform its maintenance and instruction
duties.
Response: We believe that Medicare beneficiaries should receive the
same high quality DME service whether they receive such DME through
Medicare Part B or through the Medicare hospice benefit. In order to
ensure continuous DME service quality, we agree that hospices should
contract with those DME suppliers who meet the Medicare Supplier
Quality and Accreditation Standards. A provision to this effect has
been added at new Sec. 418.106(f)(3).
Comment: A commenter suggested that the National Safety Council
should be involved in conducting site inspections of DME suppliers to
determine compliance with the Medicare Supplier Standards.
Response: As part of the effort to ensure quality DME services for
Medicare beneficiaries, the Medicare Supplier Quality and Accreditation
Standards require DME suppliers to be accredited by national
accrediting organizations. (See 42 CFR 424.58.) Accreditation requires
regular surveys by CMS-approved accrediting bodies. The existing DME
accreditation regulations, we believe, respond to the commenter's
concern.
Other Issues
We are aware that the appearance of a conflict of interest or an
actual conflict of interest could exist when a pharmacist or pharmacist
service under contract to the hospice recommends one brand name drug
over another, favors one drug in a therapeutic class over another, or
recommends an increase in the utilization of a specific drug. For
example, a conflict of interest exists when a pharmacist under contract
to the hospice is employed by the pharmacy that supplies drugs to the
hospice and that pharmacy accepts access/performance rebates or other
price concessions designed to or likely to influence or impact
utilization of drugs in the hospice. The term ``access/performance
rebates'' refers to rebates manufacturers provide to pharmacies that
are designed to prefer, protect, or maintain that manufacturer's
product selection by the pharmacy or to increase the volume of that
manufacturer's products that are dispensed by the pharmacy under its
formulary (referred to as ``moving market share''). If a conflict of
interest exists, it has the potential to compromise the judgment of the
pharmacist which could affect the care of a patient. The hospice IDG
retains responsibility for all patient care decisions independent of
others, and it is inappropriate for a pharmacist or any other member or
consultant of the IDG to drive patient care decisions based on
financial or business incentives. It is incumbent upon a hospice to
obtain assurance that a contracted pharmacist or pharmacist service is
free of any potential or real conflicts of interest or financial
incentives.
19. Condition of Participation: Short-Term Inpatient Care (Sec.
418.108)
Under Sec. 418.108, we proposed to retain the requirement that
hospices make inpatient care available for pain control, symptom
management, and respite purposes, and that care be provided either in
the hospice or in a participating Medicare or Medicaid facility. We
proposed to recodify the current standard found at Sec. 418.98(a),
``Inpatient care for symptom control,'' as Sec. 418.108(a),
``Inpatient care for symptom management and pain control.'' We proposed
to recodify the current standard found at Sec. 418.98(b), ``Inpatient
care for respite purpose'', as Sec. 418.108(b), with the same title
and only minor terminology changes.
We proposed to eliminate the existing requirement found at Sec.
418.100(a)(2), requiring that a registered nurse provide direct patient
care on each shift. In its place, we proposed that the patient's plan
of care and the patient's condition should determine the amount and
skill level of nursing care required, as well as the skill level and
State licensing requirements of the staff required to provide requisite
care.
Under proposed Sec. 418.108(c), ``Inpatient care provided under
arrangement,'' we proposed to incorporate the requirements of existing
standard 418.56(e), ``Inpatient care.'' In particular, we proposed to
require that, if a hospice chose to contract with another type of
facility to provide inpatient care, the hospice would have to include
in its contract a provision that it would train the personnel who would
be providing hospice patient care in the inpatient facility (currently
at Sec. 418.56(e)(5)). We believe the training is necessary because
the hospice palliative model of patient care is very different from the
curative model of patient care in which medical personnel are routinely
trained. We also proposed that, as part of the contract, a copy of the
inpatient clinical record and discharge summary would have to be
available to the hospice at the time of discharge from the inpatient
facility.
Under proposed Sec. 418.108(d), ``Inpatient care limitation,'' and
Sec. 418.108(e), ``Exemption from limitation,'' we proposed to re-
codify the existing parallel requirements at Sec. 418.98(c) and (d)
respectively, without changes, because these requirements are derived
directly from section 1861(dd) of the Act.
Comment: Many commenters believe that a reference to the
psychosocial/family crisis situations should be added to the opening
paragraph of the CoP as an additional reason to admit a patient to
inpatient care. Adding psychosocial and family crisis situations would,
according to the commenters, conform to the requirements of Chapter 9,
section 40.1.5 of the Medicare benefit policy manual. Another commenter
asked that we allow inpatient care to be used for acute caregiver
breakdown. One commenter stated that the hospice should have the option
of placing the patient in a general inpatient level of care for a short
period of time while developing a more appropriate plan of care.
Response: We believe that caregiver and family status should be
considered in the comprehensive assessment process. This allows
families and hospices time to develop back-up plans for any family or
caregiver breakdowns that may occur in the future. As this issue
primarily relates to Medicare payment rules, we refer readers to the FY
2008 hospice wage index (72 FR 50214, August 31, 2007) for additional
discussion of the appropriate use of the respite and general inpatient
levels of care in situations where a caregiver breakdown has occurred.
Comments: One commenter requested that we change the language in
proposed Sec. 418.108(b)(2) from ``Medicare/Medicaid approved'' to
``Medicare/Medicaid participating.'' Two commenters requested that we
use the phrase ``Medicare certified.''
Response: We have amended the language to read ``Medicare or
Medicaid-certified.''
[[Page 32147]]
Comment: One commenter asked for clarification of whether or not a
freestanding hospice inpatient facility operated by a Medicare-
certified hospice would qualify as a participating Medicare or Medicaid
facility.
Response: Yes, the facility would qualify if it met all applicable
requirements of the hospice regulations at 42 CFR part 418.
Comment: One commenter stated that a hospice should not be able to
send its own nursing staff to supplement contracted facility staff to
meet inpatient care staffing requirements.
Response: We understand the commenter's view; however, this issue
is related to a hospice's contractual agreement with its providers. A
hospice must set up its own polices and guidelines, as well as its own
written contract with an inpatient provider. We would not prohibit a
hospice from sending in its own staff to care for the hospice patient,
if it is permitted within the provisions of its contractual arrangement
and the statutory and regulatory requirements applicable to the
contracted inpatient provider.
Comment: One commenter requested that we allow up to four patients
per room for inpatient respite purposes.
Response: We do not agree with the commenter. The level of care
provided to the patient should not determine the level of patient and
family privacy. Therefore, we believe that no more than two patients
per room should be permitted.
Comment: Many commenters thanked us for proposing to remove the 24
hour nursing requirement for respite care. The commenters felt it was
not always necessary to have an RN on duty 24 hours a day for respite
care and that the proposed nurse staffing requirement allowed for
greater staffing flexibility and improved coordination of care between
hospices and nursing homes where respite care may be provided.
Response: We agree that it is not automatically necessary to have a
registered nurse on every shift to provide direct patient care if the
only hospice patients in a facility are receiving the respite level of
care. We believe that respite care is meant to give the family time to
rest and re-energize before the patient returns to the home. The care
needs of a respite patient are equivalent to those of the patient in
his or her home and therefore may not necessitate registered nursing
care on a 24-hour basis. Rather, staffing for a facility solely
providing the respite level of care to hospice patients should be based
on each patient's care needs. The requirements for nursing services for
respite care are now at Sec. 418.108(b)(2).
Comment: A few commenters requested that that we define nursing
services in inpatient facilities as care provided by an RN or LPN.
Response: Because Congress was not specific about what level of
nursing services were required, we believe that the intent of section
1861(dd) of the Act has always been for hospices to furnish nursing
services from a variety of different categories of nurses, ranging from
nurse practitioners to licensed vocational nurses to registered nurses.
Since hospices have not, to our knowledge, had any difficulty in
determining what constitutes nursing services, we see no reason to
establish a definition for the term at this time.
Comment: One commenter stated that the respite level of care should
be able to be provided in any facility that meets the general nursing
requirements that apply to all hospice care; that is, that the nursing
services provided must meet patient needs without CMS issuing specific
regulations prescribing the exact level of nursing services that must
be available at all times (such as 24-hour RN services). A few
commenters requested that assisted living facilities and licensed group
homes providing 24-hour care (but not necessarily nursing care) that
meet the needs of the patient should be authorized for inpatient
respite purposes.
Response: To meet each patient's nursing needs the facility would
need to be a Medicare/Medicaid certified nursing facility, a Medicare-
certified hospice or a Medicare-certified hospital or skilled nursing
facility because these facilities already maintain the requisite staff
to meet hospice patient's needs at the respite level of care.
While we understand that care of the respite patient is much
different than care of the general inpatient, we do not have regulatory
authority over assisted living facilities or group homes. Therefore, to
maintain continuity and safe care of the respite patient, we require
that all respite care be provided in Medicare or Medicaid certified
inpatient facilities. This in no way prohibits a hospice patient from
residing in an assisted living facility or licensed group home.
Comment: One commenter requested that we add language that states
that general inpatient care and respite care are coordinated by the
hospice in a Medicare or Medicaid facility.
Response: We agree with the commenter in that care of the general
inpatient and respite patient must be coordinated by the hospice. The
standard at Sec. 418.108(c), ``Inpatient care provided under
arrangements'' has been modified to read: ``If the hospice has an
arrangement with a facility to provide for short-term inpatient care,
the arrangement is described in a legally binding written agreement,
coordinated by the hospice * * *.''
Comment: A few commenters suggested that the inpatient clinical
record should be provided by the inpatient facility only if requested
by the hospice, and that a discharge summary would be routinely
provided to the hospice at the time of discharge.
Response: We agree with the commenters, and the amended language at
Sec. 418.108(c)(3) requires the written agreement to specify, ``[t]hat
the hospice patient's inpatient clinical record includes a record of
all inpatient services furnished and events regarding care that
occurred at the facility; that a copy of the discharge summary be
provided to the hospice at the time of discharge; and that a copy of
the inpatient clinical record is available to the hospice at the time
of discharge.''
Comment: One commenter requested that we replace the word
``individual'' with ``position'' in proposed Sec. 418.108(c)(4). This
would have the effect of permitting more than individual holding that
position to implement the provisions of the agreement.
Response: Identifying a single individual, rather than a position
that may be shared by more than one individual, in the inpatient
facility that is responsible for implementing the contract, ensures
that accountability is clearly assigned. Therefore, we are not
accepting the commenter's suggestion and are finalizing this
requirement as proposed.
Comment: A few commenters stated that, since inpatient facilities
provide services to more than one hospice, the hospice should retain
responsibility for ensuring the training of all personnel who will be
providing care to the patients in facilities for which it has
responsibility, rather than the hospice actually arranging such
training. In addition, a description of the training and the names of
those giving the training would be documented. Another commenter noted
that hospices have no control over the staff of facilities, and
therefore, requiring hospice responsibility for training will pose
problems for hospices.
Response: The training of personnel who will be furnishing care
must be specified in the contractual agreement. The hospice must ensure
that facility personnel are trained. Through the contractual agreement,
the hospice is responsible for ensuring that the facility makes its
staff available for these trainings. We agree with the
[[Page 32148]]
commenters that hospices are responsible for ensuring that training
occurs, but not necessarily arranging for or providing such training;
therefore, we are amending the language at Sec. 418.108(c)(5) and
Sec. 418.108(c)(6) to require the agreement between the hospice and
the inpatient facility to state: ``that the hospice retains
responsibility for ensuring that the training of personnel who will be
providing the patient's care in the inpatient facility has been
provided and that a description of the training and the names of those
giving the training is documented; and (6) A method for verifying that
the requirements in paragraphs (c)(1) through (c)(5) of this section
are met.''
Comment: A few comments were submitted regarding the proposed
requirement in Sec. 418.108(d), ``Inpatient care limitation.'' The
commenters stated that the 20 percent limitation is problematic because
patients who reside a great distance from the hospice must be admitted
to the hospice, making their entire hospice stay an inpatient stay.
Response: We believe that there may be some confusion about the
proposal in this section. Hospices are permitted to admit patients to
their own facilities if the patient lives a long distance from the
hospice, cannot stay at home, or for any number of other reasons.
However, if the patient is admitted for a reason other than the need
for short-term respite care, or for symptom management or pain ---
control, then the patient is not receiving an inpatient level of care
that counts toward the 20 percent inpatient cap. atients admitted for
reasons other than short-term respite care, symptom management, or pain
control receive the routine home care level of payment.
20. Condition of Participation: Hospices That Provide Inpatient Care
Directly (Sec. 418.110)
We proposed to recodify most of the requirements of existing Sec.
418.100 at Sec. 418.110, with some revisions. We proposed to recodify,
without change, the requirements of Sec. 418.100(d), ``Fire
protection,'' at Sec. 418.110(d); Sec. 418.100(e), ``Patient areas,''
at Sec. 418.110(e); Sec. 418.100(f), ''Patient rooms and toilet
facilities,'' at 418.110(f) and (g); Sec. 418.100(g), ``Bathroom
facilities,'' at Sec. 418.110(h); Sec. 418.100(h), ``Linen,'' at
Sec. 418.110(k); and Sec. 418.100(k), ``Pharmaceutical services,'' at
Sec. 418.110(m) and (n).
We proposed to replace existing Sec. 418.100(a) with Sec.
418.110(a), ``Staffing,'' and Sec. 418.110(b), ``24-hour nursing
services.'' The existing regulation requires that a registered nurse
must provide direct patient care on each shift. The two proposed
standards provide some flexibility and would require hospices that
provide inpatient care in their own inpatient facilities to ensure that
staffing for all services, including nursing services, is adequate,
based on the volume of patients, their acuity, and the level of
services they need. These standards further proposed that staffing must
meet the needs of patients to ensure that each patient's plan of care
is adhered to and that the outcomes described in each patient's plan of
care are achieved. Finally, these standards proposed that nursing
services must be adequate to ensure that each patient is kept
comfortable, clean, well-groomed, and protected from accident, injury,
and infection. We believe that this outcome-based approach meets the
needs of patients and hospices without using prescriptive requirements.
At Sec. 418.110(c), ``Physical environment,'' we proposed that the
hospice maintain a safe physical environment that was free of hazards
for patients, staff, and visitors. In Sec. 418.110(c)(1), ``Safety
management,'' we proposed that the hospice prevent situations that
posed a real or potential threat to the health and safety of the
patients, others, and property. The hospice would be required to
promptly investigate, correct, and report to appropriate State and
local bodies with jurisdiction all breaches of safety. The hospice
would be required to take steps to prevent equipment failures, and
correct and report any equipment failures promptly.
In addition, Sec. 418.110(c)(1)(iii) proposed to retain the
existing requirement at Sec. 418.100(b) that the hospice periodically
rehearse with staff a disaster preparedness plan for managing the
consequences of natural disasters and other emergencies that affect the
hospice's ability to provide care. In developing and rehearsing their
disaster preparedness plans, we believe that it is important for
hospices to be engaged with their local and state disaster preparedness
planning counterparts. Although this disaster preparedness requirement
applies only to hospice inpatient facilities, we encourage all hospices
to be aware of the need for disaster planning at the hospice, local,
and State levels, and to actively engage in the planning process. We
also proposed, at Sec. 418.110(c)(2), that the hospice develop
procedures for managing trash and medical waste disposal; light,
temperature and ventilation; emergency gas and water supplies; and
equipment maintenance and repairs. We believe that these basic
precautions and actions will help the hospice ensure that buildings, as
well as the equipment inside of them, are fully and safely functioning
at all times to ensure patient and family comfort and satisfaction.
Proposed Sec. 418.110(f), ``Patient rooms,'' would recodify and
revise the requirements of existing 418.100(f). We proposed in Sec.
418.110(f)(3)(iv) that each room accommodate no more than two patients
because we believe that hospice patients and families need the
additional privacy that a two-patient room affords them in order to
help preserve the patient's comfort and dignity during the dying
process. We believe this is the standard accommodation in most
facilities. We proposed to allow existing hospice facilities with more
than two patients in each room to receive a waiver of this requirement.
This waiver would be based on whether the hospice was already providing
direct inpatient care in a non-compliant facility when this regulation
became effective. That is, if a hospice was providing direct inpatient
care in a non-compliant building on the day before the effective date
of the final rule and could demonstrate that the imposition of a two-
patient-per-room requirement would result in unreasonable hardship or
jeopardize its ability to continue to participate in Medicare or
Medicaid, then the hospice operating in the non-compliant building
could qualify for a waiver of the proposed requirement. A hospice would
have to demonstrate to CMS that the waiver served the needs of its
patients and did not adversely affect their health and safety. If that
same hospice moved into a non-compliant building after the effective
date of this final rule, then the hospice would be deemed out of
compliance with our rules. If a hospice chose to begin operating its
own inpatient unit after the effective date of this final rule, then it
would not qualify for the proposed waiver, and would be required to
have no more than two patients per room. The remaining paragraphs in
this standard would be virtually the same as in the current
requirement, with only minor revisions to the language that would not
change the substantive requirements of the regulation.
In Sec. 418.110(i), ``Infection control,'' we proposed to revise
the infection control standards to conform to those required of other
provider types, such as home health agencies and hospitals. We proposed
to require a hospice to establish an infection control program that
would protect patients, families, and staff against communicable
diseases and would prevent and control the
[[Page 32149]]
spread of infections. The infection control program would be required
to follow professionally established infection control standards and be
part of the hospice's overall quality assurance and performance
improvement and education program. We did not propose any specific
approaches to meeting the infection control requirement.
In Sec. 418.110(l), ``Meal service and menu planning,'' we
proposed to revise the existing Sec. 418.100(j). We proposed to make
this standard less restrictive by eliminating several structural
requirements, such as serving at least three meals at regular times,
with no more than 14 hours between substantial evening and breakfast
meals, and having a staff member trained in food management or
nutrition. In place of these prescriptive requirements, we proposed
that a hospice should focus on meeting the individual patient's
nutritional and plan of care needs.
We proposed a new standard at Sec. 418.110(o) to address the use
of seclusion and restraints in hospice inpatient facilities. Anecdotal
evidence indicates that seclusion and restraints are occasionally used
in hospice inpatient facilities ostensibly to protect patients,
visitors, and/or staff. The proposed requirements, modeled on those for
hospitals issued by CMS in 1999, and on the requirements of section
3207 of the Children's Health Act (Pub. L. 106-310), would ensure that,
when seclusion or restraints are used, they are used in a safe manner
for the shortest time necessary to ensure patient and staff safety.
The proposed standard, divided into seven elements, focused on the
proper use of seclusion and restraints, and on the need for hospice
personnel to receive training and education both in the proper use of
seclusion and restraint application and techniques, and in the use of
alternative methods for handling situations that arise. The standard
proposed specific requirements for physician orders for seclusion or
restraint (for example, consultation with the hospice medical director,
1 hour face-to-face evaluation of the patient, and time limits on the
length of orders). The proposed standard also included a requirement
that a hospice would have to report to its CMS regional office any
death that occurs while a patient is restrained or in seclusion, or
that occurred within 24 hours of a patient being removed from seclusion
or restraint.
Comment: A commenter asked us to clarify that the requirements in
Sec. 418.110 would apply only to facilities operated by the hospice
and not to nursing facilities or hospitals with which the hospice has a
contract for inpatient care.
Response: The commenter is correct that, with the exception of
Sec. 418.110(b) and Sec. 418.110(f), the requirements of this CoP
only apply to hospice operated inpatient facilities. These facilities
may be in a building owned wholly by the hospice, or may be in space
leased from a company or health care provider, such as a designated
hospice inpatient facility leasing and occupying a floor in a hospital.
In order to clarify our longstanding intent that this CoP only applies
to inpatient facilities operated by a hospice, we have added the term
``in its own facility'' to the stem statement, which now reads, ``[a]
hospice that provides inpatient care directly in its own facility must
demonstrate compliance with all of the following standards.'' We
believe that restricting the majority of the requirements of Sec.
418.110 to hospice-operated inpatient facilities, and permitting
contracted facilities to comply with their own applicable regulations,
will help avoid and potential regulatory conflicts between the hospice
regulations and the regulations pertaining to a contracted facility
(for example, a hospital or skilled nursing facility). A contracted
facility would nonetheless be required to comply with (b) and (f),
because these requirements are necessary to ensure appropriate staffing
levels to care for seriously ill patients receiving the general
inpatient level of hospice care and to ensure that hospice patients and
families receive the care in a comfortable environment.
Comment: A commenter suggested that we should define the term
``nursing services'' as it is used in proposed Sec. 418.110(b) to
include the services of licensed practical nurses within their scope of
practice.
Response: The nursing services, as well as all other services,
furnished by a hospice inpatient facility must meet the needs of the
patients in the facility. Hospices may choose to use registered nurses,
licensed practical nurses, licensed vocational nurses, and any other
level of nurse to meet the needs of their patients. We expect all
nurses, as well as other professionals, to always act within the scope
of their training and licensure. We do not believe that a statement to
this effect needs to be in regulation because we require in Sec.
418.114 that all professionals must obtain the license offered by their
State. In order to obtain and maintain the license, these providers are
required by their State to practice only within the scope of their
license.
Comment: The majority of commenters who submitted comments on this
CoP made suggestions regarding the 24-hour nursing services requirement
at proposed Sec. 418.110(b). An overwhelming number of commenters
suggested that, if a hospice is providing general inpatient care, the
hospice should be required to have a registered nurse (RN) on duty at
all times. These same commenters stated that it is not necessary to
have a registered nurse on duty at all times if the hospice is only
providing respite care. Other commenters agreed with our proposal to
require that the nursing services provided by the hospice must meet
patient needs rather than requiring hospices to have a registered nurse
on duty at all times. Still other commenters suggested that, if a
registered nurse is not present in the facility, one must be available
for on-call consultation and direct care, if needed.
Response: We proposed to eliminate the 24-hour registered nurse
requirement in order to make it easier for providers to care for
respite patients. We continue to believe that it is not necessary to
require a registered nurse on duty for all shifts if patients in the
facility are receiving respite care only, and we therefore did not
include a 24-hour RN requirement in Sec. 418.108(b)(2), which pertains
to nurse staffing levels in facilities that are only providing respite
level care to hospice patients. At the same time, we agree that the
needs of patients receiving general inpatient care, who are in distress
to such a degree that their pain and symptoms cannot be managed in
their homes, necessarily require care from a registered nurse on all
shifts. Therefore, we have incorporated a requirement for 24-hour RN
services at Sec. 418.110(b)(2), and have cross-referenced this
requirement at Sec. 418.108(a)(2). All facilities providing the
general inpatient level of care, whether operated by the hospice or
under arrangement with the hospice, must provide 24-hour RN care if at
least one hospice patient is receiving general inpatient care.
Comment: Numerous commenters asked us to define and provide
examples of the terms ``breach of safety'' and ``equipment failures''
as they are used in proposed Sec. 418.110(c)(1) (i) and (ii),
respectively. Commenters asked us to clarify the relationship between
the requirements for equipment failures and the requirements of the
Safe Medical Devices Act of 1990 (Pub. L. 101-629). Furthermore,
commenters asked us to clarify which State and local bodies should
receive reports of safety breaches and equipment failures.
[[Page 32150]]
Response: The intent of these proposed requirements was to ensure
that the proper authorities were alerted by hospices regarding
situations that may jeopardize patient health and safety. We agree that
this goal has already been accomplished both through the requirements
of the Safe Medical Devices Act, with which health care providers are
required to comply (21 U.S.C. Sec. 360L), and the requirements of
final Sec. 418.110(c)(2)(iv), which requires hospices to have
procedures for controlling the reliability and quality of their
emergency maintenance and repair program for their equipment.
Therefore, we have deleted the proposed requirements.
Comment: A commenter was confused about the requirements for
chapter 9 of the Life Safety Code, as included in proposed Sec.
418.110(d)(4).
Response: In January 2003 we published a final rule adopting the
2000 edition of the Life Safety Code. The 2000 edition of the Life
Safety Code requires health care facilities, including hospices, to
have emergency lighting systems meeting certain specifications. We
allowed hospices a 3-year phase-in period after the effective date of
the Life Safety Code rule to purchase and install their emergency
lighting systems. That phase-in period expired March 13, 2006.
Therefore all hospices must now have emergency lighting systems that
comply with the specifications of chapter 9 of the 2000 edition of the
Life Safety Code. Since the phase-in date has now passed, we have
removed the phase-in language in this final hospice rule. We believe
that removing the phase-in language will make it clearer that hospices
must comply with all of the requirements of the 2000 edition of the
Life Safety Code.
Comment: Some commenters suggested that we should define the terms
``home-like'' and ``equipped for nursing care'' as they are used in
proposed Sec. 418.110(e) and (f).
Response: Hospice inpatient facilities have been required, since
the inception of the Medicare hospice benefit, to have a home-like
environment for patients and families to enjoy. Hospices should take
all appropriate steps to minimize a cold, clinically sterile
environment by incorporating materials and items typically found in
private residences where appropriate. We understand that certain
standards of hygiene may preclude the use of certain materials or
objects. We also understand that certain machines and devices needed to
provide medical care to patients may need to be present and that such
machines and equipment may not appear ``home-like.'' We expect hospices
to take appropriate steps, where feasible, to create a soothing,
inviting atmosphere within the context of creating an environment where
nurses and other hospice staff are able to effectively provide care and
services.
Comment: Many commenters submitted comments regarding our proposal
at Sec. 418.110(f), ``Patient rooms.'' Some suggested that hospices
should be allowed to have more than two patients in a room during
community disasters or evacuations. Others suggested that patient rooms
should be required to accommodate families as well as patients. Still
others supported our proposal to waive the maximum two patients per
room requirement for existing hospice facilities.
Response: We appreciate the support and thoughtful comments that we
received in this area. We agree that the two-patient rooms should
accommodate patients and family members, and we have specified this in
revised Sec. 418.110(f)(3)(iv). We also agree that hospices should be
allowed to place more than two patients in a room during community
disasters or evacuations. This situation is already addressed through
separate waiver authority in section 1135 of the Act. Furthermore, we
agree that the two-patient-per-room waiver for existing facilities
should remain. Requiring a hospice to reduce the number of beds per
room without the opportunity for a waiver may reduce the number of
overall beds available and could create a hardship for affected
facilities and problems for patients requiring access to inpatient
care.
Comment: All commenters who submitted comments on proposed Sec.
418.110(l), ``Meal service and menu planning,'' supported our proposal
to replace prescriptive food planning and service requirements with
requirements based on patient needs and goals.
Response: We thank the commenters for their support of this change.
The final rule will require that food service in a hospice inpatient
facility be based on the needs and wants of the patient in the
facility, rather than on prescriptive regulatory requirements.
Comment: Numerous commenters who submitted comments on our proposed
seclusion and restraint requirements at Sec. 418.110(o) were confused
about the applicability of the proposed standard. Commenters seemed to
believe that the proposed standard would apply to patients in their
homes or to hospice patients who reside in long term care facilities.
Response: This standard is located in the CoP that governs hospice
inpatient facilities operated by the hospice. It only applies to care
furnished to hospice patients in the hospice's inpatient facility. This
requirement does not apply to care furnished to hospice patients
outside of the hospice's inpatient facility. If a hospice contracts
with another facility (for example, hospital, or SNF) for inpatient
care, we believe that it is preferable for the seclusion and restraint
requirements for that provider to apply to the hospice patient.
Comment: A single commenter suggested that we should convene an
expert task force to examine the use of drug restraints in hospice
care.
Response: Under the revised definition of ``drug restraints''
previously described, we believe that it will be a rare situation for a
hospice to use a drug restraint on a patient. Since the situation is
likely to be very rare, we do not believe that it is necessary to
convene an expert panel to examine the issue. Moreover, we are
following the statutory definition, which applies to hospices through
the Children's Health Act (42 U.S.C. 290ii(d)(1)(B)).
Comment: Many commenters made suggestions to modify proposed Sec.
418.110(o)(3)(ii) regarding orders for seclusion and restraint. One
commenter sought clarification about the prohibition on standing or as
needed orders for seclusion and restraint. Other commenters stated that
it would be difficult for a hospice physician to get to the inpatient
facility in time to complete the one-hour visit and evaluation of a
patient in seclusion or restraint. A commenter questioned the role and
responsibility of the attending physician ordering restraints or
seclusion. Other commenters suggested that orders be allowed to be
written for eight or even 24-hour periods, rather than only for four
hours as proposed. One commenter suggested that there should be no
maximum length of time for a seclusion or restraint order.
Response: An order for seclusion or restraint must be specific to
the patient, time, and place where the intervention will be used. A
physician may not order restraint for a patient unless the patient
requires such intervention at that very moment. In other words, orders
based on future contingencies are not acceptable.
Hospices may authorize their medical director, physician designee,
other hospice physician employees, and/or attending physicians to issue
restraint or seclusion orders. If an order for seclusion or restraint
is not ordered by the attending physician, medical director, or
physician designee, then the medical director or physician designee
must be consulted as soon as possible after the order is issued.
[[Page 32151]]
Once an order for seclusion or restraint is issued and implemented,
the patient must be seen within one hour to evaluate the need for
continuing the intervention. We agree that it may be difficult for a
hospice physician to arrive at the inpatient facility and actually see
the patient within this one-hour window. Therefore, we have added a
provision permitting a registered nurse trained in the proper use of
seclusion and restraint to conduct the one-hour face-to-face evaluation
of the patient.
In addition to the one-hour evaluation, we believe that it is
necessary to regularly re-evaluate the patient's status and need for
the ordered intervention. To ensure a thorough re-evaluation, we are
requiring orders for seclusion or restraint to last no more than four
hours each for a total of up to 24 hours. We believe that frequently
re-ordering the intervention will ensure that patients remain in
seclusion or restraint for the shortest time possible to control their
distress.
Comment: A commenter asked us to clarify the meaning of the term
``continually'' as it is used in proposed Sec. 418.110(o)(4)(i). The
commenter specifically asked if this term meant that patients would
need to be constantly monitored when restraint and seclusion are used
simultaneously.
Response: If restraint and seclusion are used simultaneously, the
patient must be continually monitored, face-to-face, by an assigned,
trained staff member or continually monitored by trained staff using
both video and audio equipment. This monitoring must be in close
proximity to the patient. For the purposes of this provision,
``continually'' means ongoing without interruption.
Comment: Some commenters expressed concern that the presence of
seclusion and restraint requirements would seem to discourage their
use, even when medically necessary and appropriate. Other commenters
suggested that the requirement proposed at Sec. 418.110(o)(7),
regarding the reporting of seclusion and/or restraint-related deaths,
would discourage the use of seclusion and/or restraint because hospices
would fear that the reports would result in State surveys. They
therefore suggested deleting the seclusion and restraint requirements
in their entirety, while other comments suggested that hospices should
only be required to report unexpected deaths or deaths that occur by
hanging due to physical restraints.
Response: Seclusion and restraint requirements are needed to
protect a patient from harm by ensuring that professionals will be able
to appropriately use seclusion and restraint methods. These regulations
also implement sections 591-593 of the Public Health Service Act, as
added by section 3207 of the Children's Health Act. In order to further
the goal of safe and appropriate implementation of seclusion and
restraint techniques, we clarified the training requirements for
hospice inpatient staff. Staff must be trained in techniques to
identify behaviors, events, and environmental factors that may trigger
the need for seclusion and restraint techniques. Staff must also be
trained in the following: using nonphysical intervention skills,
choosing the least restrictive intervention, safely implementing all
types of restraint and seclusion, recognizing and responding to
distress signs, identifying behavioral changes that indicate that
seclusion and restraint are no longer necessary, monitoring patient
well-being, and using first aid and cardiopulmonary resuscitation
techniques. We believe that this staff training will minimize the
likelihood of a patient death related to the use of seclusion or
restraint for a patient, and will thus minimize the number of deaths
that hospices must report. These regulations are similar to those that
we plan for other facility types, as required by section 593(b) of the
PHS Act.
Should a seclusion or restraint-related death occur, our intent is
to ensure that hospices fully investigate the death and notify CMS of
the death and the investigation findings. We have clarified that the
seclusion and restraint investigation and reporting requirements in
final standard Sec. 418.110(o), ``Death reporting requirements,'' only
apply to those patients who die unexpectedly.
Section 592 of the PHS Act requires facilities to report all deaths
within 24 hours after a patient is removed from restraint or seclusion,
or where it is reasonable to assume that a patient's death is a result
of such seclusion or restraint. Therefore, we have also clarified that
unexpected deaths occurring within 24 hours of a patient being removed
from seclusion and/or restraints would need to be investigated. We
believe that unexpected deaths require a full investigation by the
hospice to determine the presence or lack of a relationship between the
seclusion and/or restraint and the patient's death. We also believe
that CMS must be apprised of such situations because a patient death
related to seclusion and/or restraint use may indicate the presence of
patient safety issues within the hospice that require additional
guidance from the State or CMS. It is important to remember that we are
in no way seeking to discourage the use of seclusion and restraint if,
within these regulatory boundaries, their use will benefit a patient.
Our goal is to ensure that seclusion and restraint, when used, are used
in a safe manner for the shortest amount of time necessary, as required
by the PHS Act.
21. Condition of Participation: Hospices That Provide Hospice Care to
Residents of a SNF/NF or ICF/MR (Sec. 418.112)
We currently do not separately address the provision of hospice
care to a hospice-eligible resident of a facility. This includes
hospice care provided to residents who choose to live in skilled
nursing facilities, nursing facilities, intermediate care facilities,
and many other types of facilities. The provision of, and questions
related to, hospice care for residents of those facilities has come
under scrutiny as a result of a variety of report findings, including
Operation Restore Trust (ORT) activities, Inspector General (OIG)
reports from 1996, 1997, and 1998, and a 2000 report from the
Department's Assistant Secretary for Planning and Evaluation (ASPE)
Office of Disability, Aging and Long-Term Care Policy and the Urban
Institute. (U.S. D.H.H.S. OIG, ``Hospice and Nursing Home Contractual
Relationships,'' Nov. 1997, OEI-05-95-00251; OIG Special Fraud Alert,
``Fraud and Abuse, Nursing Home Arrangements with Hospices,'' Mar.
1998; ``Synthesis and Analysis of Medicare Hospice Benefit Executive
Summary and Recommendations.'' (Harvell, J.; Jackson, B.; Gage, B.;
Miller, S.; and Mor, V., Mar. 2000)). The relationship between hospices
and nursing facilities was also addressed by the Secretary's Advisory
Committee on Regulatory Reform. The committee focused on clarifying the
responsibilities of each provider and on patient access to the hospice
benefit while residing in a facility.
Based on the recommendations of the committee, as well as the
reports from Operation Restore Trust, the Office of the Inspector
General, and ASPE, we proposed to add a new condition at Sec. 418.112,
``Hospices that provide care to residents of a SNF/NF, ICF/MR, or other
facilities.'' We are also preparing a separate regulatory document to
address long-term care facility obligations regarding residents
receiving hospice services.
Under Sec. 418.112(a), ``Resident eligibility, election and
duration of benefits,'' we proposed that the hospice ensure that the
resident met all the same Medicare eligibility requirements for hospice
care (found at Sec. 418.20 to
[[Page 32152]]
Sec. 418.30), as a patient who resides in his or her home in the
community.
At Sec. 418.112(b), ``Professional management,'' we proposed that
the hospice assume full responsibility for all of the hospice care
provided to the patient. This would include making arrangements for any
inpatient care that the patient would require in accordance with Sec.
418.100. This standard would reinforce the necessity of continuity of
care for patients who reside in a SNF/NF, ICF/MR, or other facility. In
Sec. 418.112(c), ``Core services,'' (and in accordance with sections
1861(dd)(1) and (2)(A) of the Act), we proposed that the hospice be
required to provide all necessary core services to its patients
residing in a SNF/NF, ICF/MR, or other facility in the same manner that
it would provide such core services to a patient residing in a home in
the community. It is not reasonable for the hospice to delegate any of
its standard hospice core services to the nursing or residential
facility staff.
In Sec. 418.112(d), ``Medical director,'' we proposed that a
hospice medical director would be expected to communicate with all
facility physicians, including the facility's medical director, and the
attending physician and other professionals involved in developing and/
or implementing the patient's plan of care. This standard was designed
to ensure that all physicians, including those in leadership positions,
were in agreement regarding the patient's care to ensure that
duplicative and/or conflicting physician orders are not issued for
patient care.
Under Sec. 418.112(e), ``Written agreement,'' we proposed that a
comprehensive written agreement be developed between the hospice and
facility, and that it be in effect before any hospice care was provided
to a facility resident. The purpose of the written agreement would be
to ensure that the duties and responsibilities of the hospice and
facility were clearly articulated and executed in a manner that ensured
that the patient would receive quality hospice care. The written
agreement would be required to include the following:
(1) Written consent and documentation of the patient or the
representative's desire for hospice services.
(2) Identification of the services that the hospice and the
facility would provide.
(3) The manner in which the facility and the hospice would
communicate to ensure that the needs of the patient were addressed and
met 24 hours a day.
(4) A requirement that the facility immediately notify the hospice
when:
(A) A significant change in the patient's physical, mental, social
or emotional status occurred;
(B) Clinical complications appeared that suggested a need to alter
the plan of care;
(C) A life threatening condition(s) appeared;
(D) A need to transfer the patient from the facility arose; or
(E) The patient died.
(5) A provision stating that the hospice assumed responsibility for
determining the appropriate course of care, including the determination
to change the level of services provided. (An agreement that it was the
facility's primary responsibility to furnish room and board.)
(6) A delineation of the hospice's responsibilities, which would
include, but not be limited to, providing medical direction and
management of the patient, nursing, counseling (including spiritual and
dietary counseling), social work, bereavement counseling, provision of
medical supplies and durable medical equipment, provision of drugs
necessary for the palliation of pain and symptoms associated with the
terminal illness and related conditions, as well as all other hospice
services that might be necessary for the care of the resident's
terminal illness and related conditions.
(7) A provision that the hospice could use the facility's nursing
personnel where permitted by law and as specified by the facility to
assist in the administration of prescribed therapies included in the
plan of care, but only to the extent that the hospice would routinely
use the services of a hospice patient's family in implementing the plan
of care.
These would be mandatory agreement provisions, but would not
otherwise limit the scope or content of the relationship between the
hospice and the facility. Additional provisions could be added subject
to mutual agreement.
Under Sec. 418.112(f), ``Hospice plan of care,'' we proposed that
the content of the plan of care for a patient residing in a SNF/NF,
ICF/MR, or other residential facility would be similar to the content
of the plan of care for a patient residing in a home in the community.
The plan would have to reflect the hospice philosophy in all aspects,
be based on an assessment of the patient's needs and unique living
situation in the facility, and be updated at least every 14 calendar
days. In addition to the standard plan of care requirements, the plan
of care for a patient residing in a SNF/NF, ICF/MR, or other facility
would be required to be coordinated with and developed by the hospice
IDG and SNF/NF, ICF/MR, or other facility in collaboration with the
attending physician. Furthermore, the plan of care would have to
specify which provider would be responsible for providing a particular
form of care. The performance of the functions would reflect the
participation of the hospice, SNF/NF, ICF/MR, or other facility, and
the patient and family to the extent possible.
At Sec. 418.112(g), ``Coordination of services,'' we proposed that
the hospice designate a member of the IDG to coordinate the
implementation of the plan. The hospice would provide the residential
facility with the plan of care, hospice consent form, contact
information for hospice personnel involved in the care of the resident,
instructions on accessing the hospice 24-hour on-call system,
medication information specific to the patient, physician orders, and
any advance directives. We believe that these requirements would ensure
effective communication between the hospice and the facility.
Under Sec. 418.112(h), ``Transfer, revocation, or discharge from
hospice care,'' we proposed to cross-reference the proposed requirement
for discharge or revocation at Sec. 418.104(e). In addition, we
proposed that discharge or revocation of the hospice care would not
impact the eligibility to continue to reside in a SNF/NF, ICF/MR, or
other facility.
At Sec. 418.112(i), ``Orientation and training of staff,'' we
proposed that the hospice staff would be required to train facility
staff who provided care to hospice patients on aspects of the hospice
philosophy and unique program features, including policies and
procedures, methods of comfort, pain control and symptom management,
general principles about death and dying and individual responses,
patient rights, appropriate forms, and record keeping requirements.
Comment: Many commenters suggested that the phrase ``other
facilities'' be removed from the title and text of this CoP. The
commenters stated that this phrase was too broad and imprecise to
enable hospices to effectively determine when they would have to comply
with the additional requirements of this CoP. Some commenters suggested
that ``other facilities'' should only apply to those that were
Medicare-or Medicaid-approved, while others suggested that assisted
living facilities could be included as well.
[[Page 32153]]
Response: We agree that the phrase ``other facilities'' is
ambiguous and difficult to objectively determine. We also agree that
this requirement should be limited to those facilities that can be
Medicare-certified so as not to impose a de facto burden upon
facilities that do not receive Medicare funds. Therefore, this final
requirement applies only to those types of residential facilities that
are eligible to be Medicare-certified, that is SNFs, NFs, and ICFs/MR.
Hospices are permitted to use the structure and content of this section
when establishing and managing their relationships with other facility
types such as assisted living facilities.
Comment: A commenter asked us to clarify that the requirement of
proposed Sec. 418.112(a) regarding eligibility criteria would apply to
residents of ICFs/MR in addition to residents of SNFs and NFs.
Response: We agree that this clarification would be helpful, and we
have made the suggested change.
Comment: Many commenters asked us to specify in Sec. 418.112(b)
that hospices would only be responsible for making the necessary
arrangements for inpatient care related to a patient's hospice care
(that is, the terminal illness and related conditions).
Response: We agree that is it helpful to clarify that the hospice
is responsible for hospice-related inpatient care for the patient, and
we have made this change. In addition, we have clarified that the
arrangements for hospice inpatient care must be in accordance with the
requirements of Sec. 418.108, ``Short term inpatient care,'' as well
as the requirements of Sec. 418.100(e), ``Professional management
responsibility.'' We believe that the new reference to the requirements
of Sec. 418.108 will ensure that hospices make arrangements with the
appropriate facilities and ensure proper staffing to meet the needs of
the patient.
Comment: Numerous commenters sought clarification on proposed Sec.
418.112(b), ``Professional management.'' Commenters were confused by
the proposed requirement that the hospice must assume full
responsibility for professional management of the resident's hospice
care. They believed that this requirement could create conflicts with
long term care facility responsibilities. One commenter suggested that,
in order to further clarify the hospice's responsibility, we should add
a statement that the hospice is responsible for those services that are
included in the hospice plan of care. Another commenter suggested that
deleting the word ``full'' would clarify the scope of the hospice's
responsibility.
Response: We agree that further clarification is warranted in this
standard. Hospices are only responsible for furnishing and managing a
patient's hospice care related to the terminal illness and related
conditions. They are not responsible for managing all of a patient's
care. We believe that requiring hospices to take responsibility for the
care they furnish is not in conflict with the long term care facility
regulations at 42 CFR part 483. To ensure that our intent is clear in
the requirement, we have removed the word ``full'' and have added a
provision that the hospice is responsible for services provided in
accordance with the plan of care. Revised standard (b) now reads,
``[t]he hospice must assume responsibility for professional management
of the resident's hospice services provided, in accordance with the
hospice plan of care and the hospice conditions of participation, and
make any arrangements necessary for hospice-related inpatient care in a
participating Medicare/Medicaid facility according to Sec. 418.100 and
Sec. 418.108.''
Comment: A commenter sought additional clarification on the
distinction between coordination of care and responsibility for the
provision of care as the latter appears in the proposed rule at Sec.
418.112(b).
Response: Hospices are responsible for furnishing all care and
services related to the terminal illness and related conditions as
those services are identified in the plan of care, regardless of where
the patient resides. Hospices are required by section 1861(dd) of the
Act to provide some of these services directly, while other services
may be provided under arrangement. Regardless of whether the hospice
services are provided directly or under arrangement, hospices are
required to assume full professional management responsibility for
those services. In addition, hospices are required to designate a
registered nurse who is a member of the hospice's IDG to coordinate the
implementation of the patient's hospice care and services. Furthermore,
hospices are required to have a system of communication to ensure that
all disciplines furnishing hospice care to patients communicate with
each other about patient needs. This system of communication must also
include a sharing of information with health care providers that are
simultaneously caring for the same patients that the hospice is caring
for to ensure that the hospice is able to coordinate its care with that
being provided by others.
Through these mechanisms, the hospice maintains responsibility for
all of its care and services for all of its patients and ensures that
the care it is providing complements the care being provided by others.
In addition to these mechanisms used for all patients, hospices are
required to establish written agreements and communication systems with
SNFs, NFs, and ICFs/MR when hospices are furnishing hospice care to
residents of those facilities. Clear communication between the hospice
and the SNF/NF or ICF/MR will help hospices ensure that they are
meeting their responsibility to furnish the care necessary to meet the
needs of its patients.
Comment: Many commenters suggested that we should revise or remove
the proposed requirement at Sec. 418.112(e)(4)(iii) that the written
agreement between a hospice and a SNF/NF or ICF/MR must contain a
provision that the facility notifies the hospice if a life-threatening
condition appears in a hospice patient. Some commenters stated that
this should be clarified to state that the life-threatening condition
is only required to be reported if it is unrelated to the terminal
illness and related conditions. Other commenters stated that this
should be removed because the requirement at proposed Sec.
418.112(e)(4)(i), stating that the facility must notify the hospice if
a significant change in a patient's status occurs, would apply to life-
threatening conditions as well.
Response: We agree that proposed Sec. 418.112(e)(4)(i), now
located at 418.112(c)(2)(i), applies to life threatening conditions,
and, as a result, we have deleted the proposed requirement at Sec.
418.112(e)(4)(iii).
Comment: Many commenters asked us to clarify or remove the proposed
requirements of Sec. 418.112(e)(6), which would require the agreement
between the hospice and the residential facility to state that it would
be the residential facility's primary responsibility to furnish room
and board. Commenters stated that, although SNFs/NFs and ICFs/MR do
provide room and board, describing these functions as their primary
responsibility ignores the other functions that the facilities perform.
Commenters also stated that the services provided by the SNF/NF or ICF/
MR should not be assumed by the hospice. Rather, the commenters stated,
the SNF/NF or ICF/MR should furnish services in the role of the primary
caregiver at the same level that would have been provided if the
resident had not elected to receive hospice care.
Response: We agree that the term ``primary'' unnecessarily excludes
the other functions that SNFs/NFs and ICFs/MR perform for their
residents, and it has been deleted. Nonetheless,
[[Page 32154]]
the responsibility of room and board will be deemed to be that of the
residential facility. In addition, we have expanded this requirement to
clarify that hospices should not be expected to assume the functions of
the SNF/NF or ICF/MR. The revised requirement, located at new Sec.
418.112(c)(4), requires the agreement to state that ``it is the SNF/NF
or ICF/MR's responsibility to continue to furnish 24-hour room and
board care, meeting the personal care and nursing needs that would have
been provided by the primary caregiver at home at the same level of
care provided before hospice care was elected.'' This expanded
requirement clarifies that hospices are not required to assume the
functions that the SNF/NF or ICF/MR performed for the patient before
the patient elected to receive hospice care. This requirement is not,
however, meant to imply that the SNF/NF or ICF/MR is required to
automatically increase its level of services simply because the
resident has elected to receive hospice care. All Medicare and Medicaid
approved facilities, be they SNFs/NFs or ICFs/MR are responsible for
providing services to their residents in accordance with their
respective laws and regulations.
Comment: Numerous commenters suggested that the written agreement
between the hospice and the SNF/NF or ICF/MR should contain a provision
that the SNF/NF or ICF/MR will continue to provide services at the same
level as those services would have been provided before the patient
elected the hospice benefit.
Response: We agree that it is beneficial for hospice patients to
continue to receive the same level of services provided by the SNF/NF
or ICF/MR upon entry into the hospice program. These facilities often
function as a patient's family, and, just as hospices are not expected
to replace the role of the family in caring for hospice patients, we do
not expect hospices to replace the role of the SNF/NF or ICF/MR staff
in caring for hospice patients who reside in those facilities. We have
clarified proposed Sec. 418.112(e)(6) to this effect, and have
relocated the requirement to new Sec. 418.112(c)(4). To further
clarify this issue, we have also added a new requirement for the
written agreement, located at Sec. 418.112(c)(5), that it is the
hospice's responsibility to provide services to residents of a SNF/NF
or ICF/MR at the same level and to the same extent as those services
would be provided to patients residing in their own private homes.
Regardless of where a patient resides, a hospice is continually
responsible for furnishing core services, and may not delegate these
services to the staff of a SNF/NF or ICF/MR. We believe that this new
requirement will help to ensure consistent, high quality hospice care
for all hospice patients, regardless of their place of residence.
Comment: Numerous commenters sought clarification on our proposal
at Sec. 418.112(e)(8) that a hospice may use the nursing personnel of
the SNF/NF or ICF/MR, where permitted by law and as specified by the
facility, to assist in administering hospice care, to the extent that
the hospice would routinely use a patient's family to implement the
plan of care. Some commenters suggested that hospices should be allowed
to use the nursing personnel of SNFs/NFs or ICFs/MR to a greater extent
than family members would be used, because the nursing personnel have
more training and education in furnishing medical care than family
caregivers typically do. Other commenters wanted to know how this
provision would affect the long term care facility requirement that
long term care facility staff must provide care to residents as needed
to maintain resident well-being. Other commenters were concerned that
utilizing facility nursing personnel could be a ``slippery slope''
whereby hospices would delegate essential tasks to the facility's
personnel. Still other commenters sought clarification regarding which
laws would apply to hospices utilizing facility personnel to implement
the plan of care. These commenters suggested that State laws would most
appropriately apply. A single commenter suggested that the personnel of
the SNF/NF or ICF/MR should be expected to provide all nursing care
unless the facility specifically asks the hospice to perform a nursing
function.
Response: The utilization of SNF/NF or ICF/MR personnel in
implementing the hospice plan of care for a patient is difficult to
address because both hospices and these facilities provide varying
levels of care based on the needs of the patient/resident. We agree
that State laws are best suited to governing the use of facility
personnel by hospice staff, and we have specified this in the final
rule. This provision is not intended to preempt any State laws that may
apportion duties between hospice and residential facility staff.
We proposed that hospices may only use the staff of the SNF/NF or
ICF/MR as specified in the written agreement signed by the SNF/NF or
ICF/MR. This is being retained in the final rule at Sec.
418.112(c)(7). It recognizes that facilities must give consent for
their staff to be used in caring for the hospice patient and must
determine the extent of staff involvement. This consent allows
facilities and hospices to match their corresponding levels of
available personnel service to the needs of the patients being served.
As stated above, hospices are not responsible for assuming the
functions that the SNF/NF or ICF/MR performed for the patient before
the patient elected to receive hospice care. Likewise, SNFs/NFs and
ICFs/MR are not responsible for assuming the functions that the hospice
would provide for a patient residing in his or her own home.
The hospice benefit is not designed so that hospice personnel
routinely provide 24-hour care or serve as the patient's primary
caregiver. Hospice patients in their private homes have private
caregivers, be they family members, friends, hospice volunteers, paid
assistants, or any of a number of other combinations. These caregivers
are trained by the hospice to administer care in accordance with the
patient's plan of care. Caregivers may help patients with a variety of
duties, such as medication administration, bathing, and housekeeping.
Hospice patients in SNFs/NFs and ICFs/MR depend, at least in part,
on facility staff to provide caregiver services. As such, we believe
that it is reasonable to allow hospices to use facility staff who act
as caregivers in the same manner and to the same extent that hospices
would use family members, friends or other caregivers who care for
patients in their private residences. For example, hospices typically
instruct home caregivers in how and when to administer medications to
hospice patients. Therefore, it would be appropriate to instruct
facility staff caregivers in how and when to administer medications.
Hospices typically do not instruct home caregivers in how to draw blood
to monitor medication levels; thus it would not be appropriate to
expect facility staff to draw blood, even though some members of the
facility's staff may be competent to do so. Hospic