Medicare and Medicaid Programs: Hospice Conditions of Participation, 32088-32220 [08-1305]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 109 (Thursday, June 5, 2008)]
[Rules and Regulations]
[Pages 32088-32220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1305]



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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

Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Rules 
and Regulations

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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 identifi