[Federal Register Volume 73, Number 109 (Thursday, June 5, 2008)]
[Rules and Regulations]
[Pages 32087-32220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1305]



[[Page 32087]]

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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 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

[[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. Hospices are to use 
facility staff in the same way that they would use home caregivers to 
implement the patient's plan of care. While facility staff presumably 
possess more sophisticated health care skills than home caregivers, 
they may not be used to perform functions more frequently, or with a 
greater degree of complexity, than the hospice would utilize home 
caregivers under similar circumstances.
    We understand that, in times of crisis, it may be necessary for a 
hospice to direct staff of the SNF/NF or ICF/MR to perform more 
sophisticated functions than caregivers would typically perform in 
order to ensure patient comfort while

[[Page 32155]]

the hospice staff are in route to the patient. A hospice should, in the 
contract between it and the facility, address potential crisis 
situations, and how they would be handled, with facility staff. 
Potential crisis situations specific to the circumstances of individual 
patients should also be included in individual plans of care. The 
temporary emergency measures should be undertaken at the direction of 
the hospice, which maintains responsibility for ensuring that all 
hospice care is provided in accordance with the patient's plan of care.
    We understand that this does not provide the exact specificity of 
what functions may or may not be performed by facility caregivers that 
some commenters sought. We cannot provide an absolute list because such 
a list is subject to many variables (for example, patient needs, 
provisions of the written agreement, staff skill levels, etc.).
    Comment: Some commenters supported, while others demurred, on our 
proposal, originally at Sec.  418.64(d), to require hospices to provide 
bereavement services to facility personnel when appropriate and 
identified in the patient's plan of care.
    Response: We appreciate the support that we received regarding 
bereavement services furnished to facility personnel. There are times 
when facility employees fulfill the role of a patient's family, 
providing caregiver services, being companions, and generally 
supporting the patient. In order to ensure that the needs of these 
individuals are met in a manner that accommodates the needs and 
responsibilities of the hospice and the SNF/NF or ICF/MR, we moved the 
requirements concerning bereavement care for staff from 418.64, ``Core 
services,'' to 418.112(c), which governs the written agreement between 
a hospice and a facility. The relocated requirement at 418.112(c)(9) 
requires the written agreement to include a provision delineating the 
responsibilities of the hospice and the facility with regard to 
providing bereavement services to facility staff that fulfill the role 
of a hospice patient's family.
    Comment: Numerous commenters suggested that the proposed written 
agreement requirements at Sec.  418.112(e) should be clarified. A 
primary concern of the commenters was the proposed requirement that the 
written agreement must include the written consent of the patient or 
the patient's representative that hospice services are desired. 
Commenters stated that this proposed requirement implies that a new 
written agreement must be developed for each resident who receives 
hospice services. Commenters then noted that, if a written agreement is 
necessary per patient, it may be difficult to secure the agreement 
before furnishing care to the patient.
    Response: We agree that the proposed requirement implied that a new 
written agreement must be developed for each resident who receives 
hospice services. We also agree that such a requirement would be 
difficult to fulfill before any hospice services are furnished to a 
specific patient. As a proxy for the written consent of the patient or 
representative, we will use the requirement at new Sec.  
418.112(e)(3)(ii), which requires hospices to provide SNFs/NFs, ICFs/
MR, and assisted living facilities with each patient's hospice election 
form, to ensure that each provider is aware of the patient's choice to 
receive hospice care. In this way, the election form is not linked to 
the content of the written agreement. We believe that this will help to 
clarify that the written agreement does not need to be completed for 
each and every patient who is a resident of an SNF/NF or ICF/MR. In 
addition, we believe that this will make it easier for hospices to 
secure agreements before furnishing care to the patient because they 
will be required to secure the agreements less often than was implied.
    We would like to clarify that the written agreement requirements 
only apply to hospice patients who are residents of SNFs/NFs and ICFs/
MR. The written agreement, and the remaining requirements of Sec.  
418.112, do not apply to hospice patients who are placed in SNFs/NFs 
for general inpatient or respite care by the hospice itself. Rather, 
the requirements for the written agreement between a hospice and a 
facility that furnishes general inpatient or respite care are described 
in Sec.  418.108(c).
    Comment: Several commenters suggested that we should add a 
provision requiring the written agreement to contain information about 
the services to be provided by the SNF/NF or ICF/MR.
    Response: The services provided by the SNF/NF or ICF/MR will vary 
based on the plan of care which will identify the resident's needs. The 
written agreement established between the hospice and the SNF/NF or 
ICF/MR is not the appropriate place for a list of the services to be 
provided by the SNF/NF or ICF/MR. The services provided by the facility 
are included in the plan of care and coordinated by the hospice and the 
facility in accordance with new Sec.  418.112(d).
    Comment: Some commenters expressed confusion about the proposed 
hospice plan of care requirements at proposed Sec.  418.112(f). 
Commenters questioned if the standard required hospices and SNFs/NFs 
and ICFs/MR to have a single plan of care that applied to both 
providers. If so, commenters stated that updating the plan of care 
every 14 days would be burdensome to long term care facilities that 
otherwise would be required to update the resident's plan of care only 
every three months.
    Response: Hospices and SNFs/NFs and ICFs/MR must have a single plan 
for each patient. We would expect the hospice and the facility to 
develop and update this plan in full consultation with each other. The 
hospice portion of the plan of care governs the actions of the hospice 
and describes the services that are needed to care for the patient. The 
patient's single, coordinated plan of care must identify which provider 
(hospice or facility) is responsible for performing a specific service. 
The plan of care may be divided into two portions, one of which is 
maintained by the long term care facility and the other of which is 
maintained by the hospice. These two sections must work together to 
ensure that the needs of the patient for both hospice care and long 
term care facility care are met at all times. The facility is required 
to update its portion of the plan of care in accordance with any 
Federal, State or local laws and regulations governing the particular 
facility just as hospices would need to update their plans of care 
according to Sec.  418.56(d) of these CoPs.
    Comment: As with the proposed update of the plan of care 
requirements in Sec.  418.56, many commenters suggested changes to the 
update timeframe for the hospice plan of care for residents of SNFs/NFs 
and ICFs/MR. Commenters suggested that the update timeframe be changed 
from ``at least every 14 days'' to ``at least every 15 days'' or ``at 
least twice a month.''
    Response: We agree that the update timeframe should be lengthened 
to at least every 15 days to correspond with the lengths of the 
Medicare hospice benefit periods. This change has been made by 
referencing the requirements of Sec.  418.56, which includes an every-
15-day update timeframe.
    Comment: A commenter suggested that we should clarify that the 
hospice plan of care must be based on a comprehensive assessment of the 
patient's needs.
    Response: We agree that the plan of care must address those needs 
identified in the comprehensive assessment of the patient. This 
requirement is included in Sec.  418.56, and the revised hospice plan 
of care standard at new Sec.  418.112(d) references the requirements of 
Sec.  418.56.

[[Page 32156]]

    Comment: Numerous commenters suggested that the proposed 
requirement at Sec.  418.112(f)(4) should be clarified. Specifically, 
these commenters expressed concern about the proposed requirement that 
changes in the plan of care must be discussed ``among all caregivers.'' 
These commenters stated that the phrase ``among all caregivers'' was 
very broad, considering that multiple facility staff may act as 
caregivers for a resident on any given day. Some commenters suggested 
that ``between both providers'' or ``discussed by the IDG, facility 
representatives and the patient/family'' should replace the phrase 
``among all caregivers.''
    Response: We agree that discussing plan of care changes with ``all 
caregivers'' should be replaced by a more definite requirement. 
Therefore, the final rule at Sec.  418.112(d)(3) requires changes in 
the hospice portion of the plan of care to be ``discussed with the 
patient or representative, and SNF/NF or ICF/MR representatives* * *'' 
This revised requirement allows the facility to identify those with 
whom plan of care discussions must occur and provides hospices with a 
defined list of those individuals who must be consulted before a change 
in the hospice portion of the plan of care is implemented. The revised 
requirement still states that the hospice must approve any changes to 
the hospice portion of the plan of care before those changes are 
implemented. We believe that this enables hospices to maintain control 
over the hospice portion of the plan of care while allowing facilities 
to have their voices heard before final decisions are made about 
hospice care.
    Comment: A commenter wanted to know what forms of communication are 
acceptable between the hospice and the residential facility concerning 
care planning.
    Response: Hospices are free to use any form of communication that 
best suits their needs in accordance with their established system of 
communication as required by Sec.  418.56(e). In accordance with 
418.112(c)(1) of this final rule, hospices must document that this 
communication has occurred to ensure that the hospice has made all 
necessary efforts to consult facility representatives in hospice care 
planning activities.
    Comment: A large number of commenters requested clarification of 
the proposed medical director requirement at proposed Sec.  418.112(d). 
The overall response of commenters was that the proposed requirements 
were overly burdensome. Many of these commenters suggested that the 
medical director requirement should be entirely deleted. Others 
suggested that the communication responsibilities assigned to the 
hospice medical director would be more appropriately handled by all 
physicians in the hospice, the hospice IDG, or the RN member of the IDG 
who is assigned the care plan coordinator role. Still others expressed 
concern that the proposed medical director communication requirement 
would overwhelm SNF/NF and ICF/MR medical directors with information 
about the care of patients that they are not actively involved with.
    Response: Our intent in proposing the medical director requirement 
was to ensure that there was communication and agreement among the 
clinical leadership of both providers. The purpose of this 
communication was to ensure that these senior physicians did not issue 
incompatible care orders for the same patient or otherwise disagree on 
the approach to patient care. However, as some commenters noted, 
hospice and facility medical directors are not necessarily involved in 
actively caring for all patients and facility residents. Some hospices 
and facilities have multiple physicians, and one of these physicians, 
rather than the medical director, could potentially be the most 
knowledgeable with respect to the care of a particular patient or 
resident. For this reason, we agree that it is appropriate to remove 
the medical director requirement. We also agree that it is appropriate 
to reassign communication responsibilities to the IDG responsible for 
caring for the resident of a SNF/NF or ICF/MR. New Sec.  418.112(e) 
requires the hospice IDG to designate one of its members to coordinate 
the patient's hospice care with representatives of the SNF/NF or ICF/
MR. The designated IDG member must also communicate with 
representatives of the SNF/NF or ICF/MR and any other health care 
providers to ensure quality care for the patient.
    Additionally, the designated IDG member must ensure that the 
hospice IDG communicates with the SNF/NF or ICF/MR medical director, 
the patient's attending physician, and any other physicians caring for 
the patient as needed to coordinate the patient's hospice care with the 
care provided by other entities. We believe that this new requirement 
will alleviate the demand on the hospice and facility medical directors 
while actively involving all members of the patient's care team, both 
within the hospice and the facility, in care planning and delivery.
    Comment: Commenters expressed general support for the coordination 
of services requirement at proposed Sec.  418.112(g), stating that it 
would have the greatest potential for strengthening the partnerships 
between hospices and SNFs/NFs and ICFs/MR. Several commenters suggested 
that we specify that the hospice provide the SNF/NF or ICF/MR with a 
copy of the hospice plan of care.
    The commenters believe that requiring this would reinforce the fact 
that the hospice and the facility have separate, but coordinated plans 
of care for each patient. Other commenters suggested that, in addition 
to the original hospice plan of care, facilities should also be 
provided with updated plans of care. Still other commenters suggested 
that hospices should provide SNFs/NFs and ICFs/MR copies of each 
patient's initial certification and recertification of terminal illness 
forms.
    Response: We appreciate the general support of this requirement. We 
agree that this standard, now at Sec.  418.112(e), should specify that 
hospices provide facilities with the most recent hospice plan of care. 
This will ensure that facilities have the most current plan for what 
services the hospice is providing as well as what services they are 
committed to providing. We also agree that it is helpful for the 
hospice to provide the facility with a patient's certification and 
recertification forms. Having these forms on file will serve as a 
reminder to the facility that the patient is terminally ill and that he 
or she is a Medicare hospice beneficiary.
    Comment: A few commenters sought clarification about what kind of 
physician orders hospices would provide to facilities. Other commenters 
suggested that we should take action to require SNFs/NFs and ICFs/MR to 
accept hospice physician orders.
    Response: Although a large amount of the care decided upon by the 
hospice IDG does not require specific physician orders, certain 
elements of the plan of care, such as medications and laboratory work, 
do require physician orders. Whenever physician orders are issued, 
whether by the hospice physician or the attending physician in 
coordination with the hospice, a copy of those orders must be provided 
to the SNF/NF or ICF/MR in a timely manner. Providing a copy of 
physician orders to the SNF/NF or ICF/MR allows the staff of the 
facility to implement any portions of the order for which they may be 
responsible. Providing a copy of orders is simply another way in which 
the hospice keeps the SNF/NF or ICF/MR abreast of its hospice care 
activities. In the final rule at Sec.  418.112(e)(3)(vii) we clarified 
that the ``physician orders'' supplied by the hospice are those issued 
by the hospice physician(s) and the patient's attending physician (if 
any). The acceptance of hospice physician orders by residential

[[Page 32157]]

facility staff is not within the purview of this rule. In its contract 
with the residential facility, the hospice is responsible for ensuring 
that the management of the residential facility communicates with its 
staff regarding the acceptability of hospice physician orders.
    Comment: A majority of commenters who submitted recommendations on 
this CoP recommended that we revise the proposed requirement at Sec.  
418.112(i) regarding the training of staff of a SNF/NF or ICF/MR in 
hospice philosophy. Most of these commenters noted that a SNF/NF or 
ICF/MR may work with several different hospices and that facility staff 
should not be required to be oriented to hospice philosophy by every 
hospice. The commenters suggested that hospices be required to assure 
that the staff of the SNF/NF or ICF/MR has received the required 
training, rather than requiring each hospice to provide the training. 
One commenter suggested that the responsibility for orienting facility 
staff in hospice philosophy should fall to the facility, rather than 
the hospice.
    Response: The intent of this proposed standard was to ensure that 
facility staff who furnish care to patients are provided information on 
the hospice philosophy and approach to care, much in the same way that 
home caregivers are routinely provided information on the hospice 
philosophy and approach to care. We agree that facility staff should 
not be oriented multiple times using the same basic information. 
Therefore, we have amended this requirement at new Sec.  418.112(f) of 
the final rule to state that hospices must assure the orientation of 
facility staff.
    At the same time, we note that the entire purpose for using outside 
hospices to furnish hospice care to facility residents is to fulfill a 
need that the facility is not able to fulfill on its own. If a facility 
is unable to provide hospice care because it lacks the capability to do 
so, then the facility is certainly not qualified to orient its staff in 
hospice philosophy. Furthermore, the facility would not be qualified to 
orient its staff in a particular hospice's policies and procedures, 
patient rights, forms, and record keeping requirements. In that case, 
the hospice working with the facility needs to provide information, 
guidance and/or staff to assure orientation of the facility staff.
    Comment: Several commenters asked how frequently hospices are to be 
involved in offering training to facility staff, considering the high 
staff turnover rates of some facilities. Commenters also questioned who 
might be in the best position to coordinate the training sessions.
    Response: It is the hospice's responsibility to coordinate the 
trainings with representatives of the facility. It is also the 
hospice's responsibility to determine how frequently training needs to 
be offered in order to ensure that the staff furnishing care to hospice 
patients are oriented to the philosophy of hospice care. Facility staff 
turnover rates should certainly be a consideration in determining 
training frequency.
    Comment: A commenter disagreed with our proposed requirement that 
facility staff should be trained by hospices in hospice philosophy and 
care. The commenter stated that there is a ``spillover effect,'' 
whereby the training received by staff affects the care furnished to 
non-hospice patients as well as hospice patients. The commenter further 
stated that this ``spillover effect'' may not be desirable for those 
patients who do not choose to receive hospice care.
    Response: While there may be a ``spillover effect'' when facility 
staff are oriented to hospice philosophy, we do not believe that the 
effect is inherently negative. The hospice philosophy focuses on using 
multiple treatment modes to make patients physically, emotionally, and 
spiritually comfortable. Providing comfort to residents, regardless of 
whether those residents receive hospice care or not, would positively 
impact their well-being. Therefore, we do not view a ``spillover 
effect'' as a problem that would warrant removal of the proposed 
facility staff orientation requirements.
    Comment: A commenter suggested that hospices be required to educate 
the facility staff regarding the individualized plan of care for each 
hospice patient who resides in the facility.
    Response: We agree with this suggestion. Section 418.56(b) of this 
rule, ``Plan of care,'' requires hospices to ensure that each patient 
and his or her primary caregiver(s) receives education and training 
provided by the hospice as appropriate to their responsibilities for 
the care and services identified in the plan of care. Facility staff 
members acting as the patient's primary caregivers are expected to 
receive education specific to each patient's hospice plan of care and 
the caregiver's role in implementing the content of the hospice portion 
of the plan of care.
    Comment: A commenter suggested that hospices should be required to 
orient facility administrative staff as well as the staff who furnish 
care to hospice patients that reside in the facility.
    Response: With the facility's consent, hospices may orient facility 
administrative staff as well as hands-on care staff. However, we do not 
believe that this orientation should be required because it is unlikely 
to improve patient care or outcomes.
    Comment: A commenter asked for a definition of the term ``nursing 
facility.''
    Response: Our use of the abbreviation ``SNF/NF'' refers to the long 
term care facilities referenced at 42 CFR part 483, where skilled 
nursing facilities (SNF) and nursing facilities (NF) are described.
    Comment: Many commenters stated that this section of the rule 
should require SNFs/NFs and ICFs/MR to contract with any hospice that a 
resident chooses. Many other commenters stated that hospices should be 
prohibited from contracting with SNFs/NFs and ICFs/MR that do not 
contract with all interested hospices.
    Response: As noted above, these CoPs regulate hospices, not SNFs/
NFs and ICFs/MR. We are not proposing mirroring requirements for 
Medicare/Medicaid facilities at this time. We also note that we do not 
have jurisdiction or authority to regulate facilities that do not 
participate in Medicare or Medicaid. In addition, even though these 
CoPs do regulate hospices, we do not believe that it is appropriate to 
preclude hospices from contracting with certain SNFs/NFs or ICFs/MR 
because the facility chooses to be selective in its contracting 
decisions. Indeed prohibiting hospices from contracting with selective 
SNFs/NFs and ICFs/MR could deny residents of those facilities any 
access to hospice care furnished by Medicare-approved hospices. We 
believe that this would be a disservice to those residents.
    Comment: Some commenters took issue with the requirement that, when 
hospice services are furnished to Medicaid eligible SNF/NF residents, 
the hospice receives payment from Medicaid for room and board care and 
is responsible for paying the SNF/NF for this service.
    Response: Payment and billing procedures are not within the scope 
of these CoPs. We have shared this comment with the appropriate 
officials within CMS, and it will be taken under advisement.
    Comment: A commenter suggested that hospices should be required to 
notify hospice patients who reside in a SNF/NF or ICF/MR that Medicare 
does not pay for room and board for a patient who is receiving the 
routine home care level of hospice care.

[[Page 32158]]

    Response: The commenter is correct that Medicare does not pay for 
room and board. We believe that Medicare coverage of services under the 
hospice benefit is already addressed by Sec.  418.52(c)(7), stating 
that patients have the right to ``[r]eceive information about the 
services covered under the hospice benefit.'' We do not believe that it 
is necessary to require hospices to provide a separate notice in 
writing regarding Medicare non-coverage of a patient's room and board 
in a SNF/NF or ICF/MR.
    Comment: Many commenters had questions about the proposed core 
services requirement at Sec.  418.112(c), which would have required 
hospices to routinely provide all core services to hospice patients who 
are residents of SNFs/NFs or ICFs/MR. Some commenters wanted to know if 
this requirement was the same as proposed Sec.  418.64, ``Core 
Services.'' If so, the commenters suggested that it should be deleted 
because it is duplicative and unnecessary. Other commenters asked if it 
would be permissible to use staff of the SNFs/NFs or ICFs/MR to furnish 
core services to hospice patients. A single commenter suggested that, 
for clarity, we should add the word ``work'' to the term ``medical 
social'' to clarify that hospices must provide medical social work 
services to patients who reside in SNFs, NFs, or ICFs/MR.
    Response: Hospices that furnish hospice services to residents of a 
SNF/NF or ICF/MR are required to furnish core services to those 
residents under the same requirements and in the same manner as those 
services are furnished to patients residing in their own homes. The 
core services requirement at Sec.  418.64 applies equally to both 
facility and community residents. We agree that it is not necessary to 
state the same requirements in both Sec.  418.64 and Sec.  418.112. 
Therefore, the core services standard in Sec.  418.112 has been 
removed.
    Since the core services requirement at Sec.  418.64 applies, 
regardless of where services are provided, hospices are not permitted 
to routinely delegate hospice services to the staff of a SNF/NF or ICF/
MR. Hospices are required to routinely provide substantially all core 
services directly. Hospices may only provide core services under 
arrangement if they meet the conditions for an extraordinary 
circumstance exemption described in Sec.  418.64, the nursing services 
waiver described in Sec.  418.66, or the nursing shortage waiver 
described in CMS S&C letter 05-02.
    Comment: Numerous commenters asked us to clarify or delete the 
proposed requirement at Sec.  418.112(h), ``Transfer, revocation, or 
discharge from hospice care.'' Most of these commenters stated that 
this requirement should be deleted because hospices have no authority 
to govern the discharge actions of SNFs/NFs and ICFs/MR, thereby making 
it very difficult for hospices to comply with the requirement. Some 
commenters suggested that the intent of the standard should be 
clarified. One commenter suggested that we should add the following 
statement to the end of the requirement: ``It is believed that patients 
should not experience the trauma of an external move because they 
perhaps have stabilized and may not continue to be eligible for 
hospice.''
    Response: We agree that resident eligibility is not within the 
control of the hospice, and this requirement has been removed. Absent 
this requirement, the discharge requirement set forth in Sec.  
418.104(e) continues to apply to any hospice patients who reside in a 
SNF/NF or ICF/MR. The requirements of Sec.  418.104(e) do not place any 
requirements on residential facilities serving as a patient's home.
    Comment: A large number of commenters stated that it would be 
difficult for hospices to implement the requirements of this CoP 
without the inclusion of complementary requirements in the long term 
care CoPs at 42 CFR part 483. Some commenters suggested that we should 
not issue this CoP until the complementary requirements are included in 
the long term care CoPs, while other commenters suggested that we 
should add a phase-in period for this CoP to allow the long term care 
CoPs to ``catch-up'' to this hospice CoP. Still other commenters 
suggested that this CoP should be issued as planned, but that survey 
enforcement of its requirements should understand that not all 
provisions can be adequately implemented until the long term care CoPs 
agree with those for hospices.
    Response: Upon issuance of this final rule we intend to issue a 
proposed rule to add a new requirement to the long term care CoPs at 
Sec.  483.75(r). This proposed rule would describe:
     The manner in which long term care facilities may furnish 
hospice services to their residents;
     The minimum content of the written agreement between the 
long term care facility and the hospice;
     The conditions under which the long term care facility 
must contact the hospice;
     The participation and coordination of the long term care 
facility in care planning and delivery; and
     The information that the long term care facility must 
obtain from the hospice.
    We agree that, without this requirement in the long term care 
facility regulations, it will be challenging for hospices to comply 
with the requirements of this CoP. We will work with the hospice and 
long term care industries to address any situations that may occur 
during the intervening time period.
    Comment: Several commenters sought clarification about how 
surveyors would determine accountability for negative patient outcomes 
when patients were both hospice patients and residents of a SNF/NF or 
ICF/MR.
    Response: Hospices are responsible for all hospice care and 
services provided to a patient, regardless of where that patient 
resides. Hospices are also responsible for coordinating the plan of 
care for a particular patient with representatives of the facility 
where the patient resides to ensure that both the hospice and facility 
are aware of their respective patient care responsibilities. 
Furthermore, hospices are responsible for ensuring that the terms of 
the arrangement established between the hospice and the facility are 
met to ensure patient care and safety at all times. We expect hospices 
to fulfill their responsibilities at all times and for all patients. If 
a hospice does not fulfill its responsibility and take all appropriate 
actions to ensure the health and safety of its patient in accordance 
with the requirements of this final rule, then that hospice will be 
held accountable for its actions. We note that these final provisions 
do not propose to judge hospices on ``negative patient outcomes'' 
except to the extent that those outcomes are connected with regulatory 
non-compliance.
    Comment: Several commenters noted that the interpretive guidelines 
that surveyors will use to ensure compliance with this CoP needs to 
provide further detail regarding provider responsibilities for 
individual aspects of hospice care.
    Response: We agree that additional detail is needed and we will 
take this suggestion under advisement as we develop interpretive 
guidelines for this regulation.
    Comment: A commenter suggested that frequent onsite verification of 
hospice agency compliance with this proposed CoP is the best way to 
ensure that hospices are fulfilling their regulatory obligations.
    Response: State surveyors are required to survey long term care 
facilities annually. These surveyors have already been directed to 
report issues involving long term care facility residents who are 
hospice patients to their hospice surveyor counterparts for

[[Page 32159]]

follow-up with the hospice. We believe that using hospice survey 
resources to focus on potential problems is preferable to randomly 
surveying hospices where issues involving long term care facility 
residents have not appeared.
    Comment: Several commenters suggested that we address the 
responsibilities of the attending physician in caring for residents of 
a SNF/NF or ICF/MR who receive hospice services. The commenters 
suggested that the attending physician be responsible for coordinating 
the patient's care and communicating with hospice and facility 
physicians.
    Response: We do not have the authority to regulate the actions of a 
patient's attending physician who is not an employee of or under 
contract with the hospice through this hospice rule. If a patient has 
an attending physician who is actively involved in his or her care, 
then the hospice is required to consult the attending physician in 
developing and updating the patient's hospice plan of care. The hospice 
may use this consultation with the attending physician to gather 
information about other care and services the patient is receiving from 
the facility where the patient resides and from any other health care 
providers. The hospice may not delegate its responsibility to 
coordinate the patient's hospice care to the attending physician.
    Comment: A commenter asked if the medical director of a SNF/NF or 
ICF/MR may also be the medical director of a hospice.
    Response: These regulations do not prohibit this arrangement.
    Comment: A commenter suggested that the interpretive guidelines 
should allow the medical director of the SNF/NF to relinquish or assume 
secondary professional responsibility for coordinating the medical care 
for residents who elect the hospice benefit.
    Response: As discussed above, we have deleted the proposed medical 
director requirement at proposed Sec.  418.112(d), including the 
requirement that the hospice medical director must provide overall 
coordination of the medical care of the hospice patient residing in a 
SNF/NF or ICF/MR. We have replaced it with the requirement of the final 
rule at Sec.  418.112(e)(1) that a member of the IDG coordinate the 
patient care and services with the facility.

22. Condition of Participation: Personnel Qualifications (Sec.  
418.114)

    We proposed significant revisions to the personnel qualifications 
for hospice employees. Specifically, we proposed to provide that in 
cases where personnel requirements are not statutory, or do not relate 
to a specific payment provision, personnel would only be required to 
meet State certification or licensure requirements.
    In Sec.  418.114(a), ``General qualifications,'' we proposed that 
licensed professionals who provide hospice services directly, either as 
employees or under individual contract, or under arrangement with a 
hospice must be licensed, certified, or registered to practice by the 
State in which they perform the functions, as applicable. All personnel 
who fall into this category must act exclusively within the scope of 
the State license, certification or registration. In proposed Sec.  
418.114(b), ``Personnel qualifications for physicians, speech-language 
pathologists, and home health aides,'' we proposed to include those 
personnel requirements that are included in the Act.
    When a State does not have a licensure, certification, or 
registration requirement, the hospice would apply the qualifications in 
proposed Sec.  418.114(c), ``Personnel qualifications when no State 
licensing laws or State certification or registration requirements 
exist.'' This category would consist of all personnel qualifications 
specified in existing Sec.  418.3, ``Definitions,'' including a 
requirement that a social worker have a baccalaureate degree from a 
school of social work accredited by the Council on Social Work 
Education (proposed Sec.  418.114(c)(7)).
    In Sec.  418.114(d), we proposed a new requirement that a hospice 
obtain a criminal background check for all hospice and contract 
employees before employment at the hospice. We believe that this is an 
important safety measure to protect both patients and the hospice. We 
did not propose any specific type, scope, or frequency requirements for 
completing the background check.
    Comment: A commenter noted that the proposed title of this CoP is 
``Personnel qualifications for licensed professionals,'' and that this 
title could be interpreted as to apply only to those individuals for 
whom licensure is available. As such, the commenter reasoned, the 
criminal background check requirement would not apply to unlicensed 
individuals.
    Response: Our intent, as stated in the proposed rule, is for all 
appropriate individuals to have background checks. We have removed the 
phrase ``for licensed professionals'' from the title of this CoP to 
avoid any confusion in this area.
    Comment: Several commenters supported the proposed requirement 
that, if a State offers licensure for any discipline, including social 
workers, the individuals practicing within that discipline must obtain 
State licensure. One commenter even suggested that social workers 
should be required to obtain the highest level of State licensure 
available to them. However, a few commenters disagreed, stating that 
social workers should not be required to obtain State licensure.
    Response: The existing hospice requirements at Sec.  418.72 require 
employees who provide services to be licensed, certified, or registered 
in accordance with applicable Federal and State laws. We believe that 
it is necessary to maintain this requirement in this final rule to 
ensure that the individuals furnishing services to hospice patients are 
legally authorized to furnish care in their respective disciplines. We 
believe that State licensure, certification and/or registration, where 
required by State law or regulation, help to ensure that individuals 
are qualified to furnish safe and effective care to patients and 
families. As professionals and equals among the IDG members, we believe 
that it is necessary to require social workers to meet the same 
licensure qualifications that all other hospice professionals are 
required to meet.
    Comment: The majority of commenters who submitted comments on our 
proposed personnel qualifications section made suggestions to revise 
the requirements for social workers. While some of these commenters 
agreed with our proposal to defer to State requirements for social 
workers, the majority of commenters believed that all hospice social 
workers should be required to meet the same basic qualifications. Of 
these commenters, many suggested that hospice social workers should be 
required to have a baccalaureate degree in social work from an 
accredited higher education institution. Other commenters suggested 
that a baccalaureate or higher degree in a field related to social 
work, such as psychology, would be an appropriate qualification for 
hospice social workers, while some commenters explicitly disagreed with 
this suggestion. Numerous other commenters suggested that hospice 
social workers should be required to have a Master of Social Work (MSW) 
degree from an accredited university. Of these commenters, several 
suggested that a waiver should be granted for hospices in rural areas 
to allow them to use the services of a social worker with a 
baccalaureate degree under the supervision of an MSW or a licensed 
mental health

[[Page 32160]]

professional with a graduate degree. Still other commenters suggested 
that, regardless of the degree that the social worker holds, he or she 
should be required to have one or two years of social work experience 
in a health care setting. Some commenters explicitly disagreed with 
this suggestion.
    Response: The large number of public comments submitted in 
reference to the personnel requirements for social workers, coupled 
with the divergent views expressed in the comments, leads us to believe 
that there is no standard or consensus in the hospice industry on this 
issue. Our goal is to balance the needs of patients and families at a 
very stressful time and the needs of hospices that may have difficulty 
employing personnel who meet appropriate personnel standards. We 
believe that all hospices should strive to employ the most qualified 
individuals possible to provide social work services to patients and 
families. In order to ensure that hospices employ a qualified 
individual as a social worker, we are requiring that a hospice social 
worker must at least meet one of the following options:
     Have a Master of Social Work (MSW) degree from a school of 
social work accredited by the Council on Social Work Education, and one 
year of experience in a health care setting;
     Have a baccalaureate degree in social work (BSW) from a 
school of social work accredited by the Council on Social Work 
Education, and one year of experience in a health care setting; or
     Have a baccalaureate degree in psychology, sociology, or 
other field related to social work, and at least one year of social 
work experience in a health care setting.
    If a hospice chooses to employ a social worker with a baccalaureate 
degree in social work, psychology, sociology, or other field related to 
social work, the services of that baccalaureate social worker must be 
provided under the supervision of a social worker with an MSW from a 
school of social work accredited by the Council on Social Work 
Education and one year of experience in a health care setting. We 
believe that requiring MSW supervision of BSW services will help ensure 
that patient and family needs are met in a complete and timely manner. 
The MSW supervisor role is that of an active advisor, consulting with 
the BSW on assessing the needs of patients and families, developing and 
updating the social work portion of the plan of care, and delivering 
care to patients and families. This supervision may occur in person, 
over the telephone, through electronic communication, or any 
combination thereof.
    Social workers with a baccalaureate degree from a school of social 
work accredited by the Council on Social Work Education and who are 
employed by the hospice before the effective date of this final rule 
are exempted from the MSW supervision requirement. Therefore, if a 
hospice currently employs a BSW, unsupervised by an MSW, it is not 
required to hire an MSW to supervise the BSW. If a hospice hires a new 
social worker with a baccalaureate degree and one year of experience in 
a health care setting, then the new baccalaureate social worker must be 
supervised by an MSW who has one year of experience in a health care 
setting.
    Comment: Many commenters suggested that the final rule should 
include personnel qualifications for chaplains. Commenters suggested 
that education (that is, a baccalaureate and graduate-level divinity or 
theological degree from a university accredited by the Council of 
Higher Education Accreditation and/or 4 units of clinical pastoral 
education), experience in the medical field, certification from a 
national organization, or any combination thereof would be appropriate 
to qualify a chaplain to care for hospice patients. Other commenters 
explicitly disagreed with this suggestion, stating that the final rule 
should not include personnel qualifications for chaplains or require 
them to be licensed or certified.
    Response: Hospices may choose to employ the individual(s) best 
suited to meet the needs of the hospice and its patients. If a hospice 
chooses to employ a chaplain, it may choose to use any criteria in 
selecting the appropriate candidate. We do not believe that it is 
appropriate to require hospices to use specific criteria to guide the 
selection of a spiritual counselor. Rather, the needs of the hospice's 
patient population should drive the selection of the appropriate 
person.
    Comment: A commenter suggested that, if physical therapist 
assistants furnish care to hospice patients, they should be required to 
be under the supervision of a physical therapist.
    Response: As a general statement, hospices are required to furnish 
physical therapy services in a manner consistent with accepted 
standards of practice. In addition, physical therapists and assistants 
are required to act only within the scope of their State license, 
certification, or registration. We believe that these requirements 
ensure that physical therapy services are provided in a safe and 
effective manner by and under the supervision of the appropriate 
personnel.
    In this final rule we are incorporating changes made by a separate 
final rule (72 FR 66222, 66406, November 27, 2007) to the personnel 
qualifications for physical therapists, physical therapist assistants, 
occupational therapists, occupational therapist assistants, and speech-
language pathologists. That final rule amended Sec.  418.92 of the 
existing hospice regulations to cross reference the revised personnel 
requirements contained in 42 CFR 484.4, thereby requiring physical 
therapists, physical therapist assistants, occupational therapists, 
occupational therapist assistants, and speech-language pathologists 
subject to the requirements of the hospice conditions of participation 
to meet the same personnel requirements as therapists subject to the 
requirements of the home health agency conditions of participation. In 
this final rule, we continue to require therapists who are subject to 
the requirements of the hospice conditions of participation to meet the 
same personnel requirements as therapists subject to the requirements 
of the home health agency conditions of participation, as was required 
by the November 27, 2007 final rule.
    We believe that these revised requirements, which went through the 
notice-and-comment rulemaking process separate from and more recently 
than the hospice conditions of participation continue to allow hospices 
the flexibility to employ or contract with individuals who are well 
qualified to provide therapy services to hospice patients. However, we 
are replacing the cross reference to the requirements of 42 CFR part 
484 with a duplicate of the requirements of Sec.  484.4. We believe 
that duplicating the relevant requirements of Sec.  484.4 in Sec.  
418.114(b)(4)-(8) will make it easier for hospices to know the 
personnel requirements that their therapists must meet in order to be 
considered qualified to provide services to hospice patients.
    Comment: A commenter suggested that we should incorporate the 
definition of the term ``licensed professionals'' from the home health 
regulations at 42 CFR part 484 in the personnel requirements for 
registered nurses at Sec.  418.114(c).
    Response: The home health regulations at 42 CFR part 484 do not 
define the term ``licensed professionals''; therefore we cannot 
incorporate this suggestion into the final rule.
    Comment: Some commenters suggested that we should add personnel 
qualifications for nurse practitioners.
    Response: Section 1861(aa)(5) of the Act describes a nurse 
practitioner for

[[Page 32161]]

purposes of Medicare as an individual ``who performs such services as 
such individual is legally authorized to perform (in the State in which 
the individual performs such services) in accordance with State law (or 
the State regulatory mechanism provided by State law), and who meets 
such training, education, and experience requirements (or any 
combination thereof) as the Secretary may prescribe in regulations.'' A 
Medicare-participating hospice that employs a nurse practitioner is 
expected to comply with these statutory requirements, and we believe 
that they are sufficient.
    Comment: Numerous commenters sought clarification about who was 
required to have a criminal background check. Some commenters suggested 
that volunteers should not be required to have a background check, 
while others suggested that only those individuals who provide direct 
patient care and/or who have access to patient financial information 
should be required to have background checks. Furthermore, some 
commenters suggested that only unlicensed hospice personnel should be 
required to have criminal background checks. Other commenters wanted to 
know if hospices would be required to obtain background checks on 
current employees, or only for employees hired after the effective date 
of this final rule. Still other commenters wanted to know if background 
checks were needed for individuals employed by a DME supplier or 
pharmacy that the hospice has a contract with. Some commenters 
suggested that, if background checks are required for contractors, the 
contracted entity would be the most appropriate entity to complete 
criminal background checks for its employees.
    Response: We believe that any individual who has direct patient 
contact or has access to a patient's records, clinical, financial or 
otherwise, should have a criminal background check because these 
individuals are in a position that enables them to violate patient 
rights to both safety and privacy. This includes all current paid 
hospice employees, volunteers, and contracted employees, as well as any 
new employees. If an office employee, such as a receptionist, does not 
have access to patient records, and does not make patient visits, then 
that employee is not required to have a criminal background check. If a 
volunteer is a homemaker, and thus has direct patient contact, he or 
she is required to have a background check. We understand that hospices 
would likely not actually conduct background checks on contracted 
employees. We have added a statement to Sec.  418.114(d)(1) that 
hospices must require, as part of their written agreement with a 
contractor, that the contractor provides the hospice a background check 
for each contracted employee who has direct hospice patient contact or 
access to hospice patient records. We believe that requiring all 
individuals who have direct patient contact or access to patient 
records to have background checks will help hospices assure that 
patient rights are protected at all times.
    Comment: Many commenters suggested that the requirements for 
criminal background checks (that is, scope, frequency, timing, etc.) 
should apply only in the absence of State requirements. Other 
commenters suggested that the timeframe for completing a criminal 
background check should be lengthened because it may take a few weeks 
to receive a background check from the State police and/or FBI. Still 
other commenters suggested that the scope of this requirement should be 
clarified.
    Response: We agree that if a State has particular laws or 
regulations requiring criminal background checks for hospice employees 
and contractors, then hospice compliance with such State requirements 
satisfies the intent of this requirement. If a State does not have any 
requirements, or does not have requirements for a specific discipline, 
then the requirements of this final rule must be met. In this final 
rule, we require hospices to obtain a criminal background check within 
three months of the date of employment for all states that the 
individual has lived or worked in for the past three years. We believe 
that it is essential to gather information on the individual's 
activities in several states to ensure that the criminal background 
check presents a complete and accurate picture of the individual's 
compliance with the law. In order to gather such information while 
allowing hospices to fill vacant positions in a timely fashion, we 
believe that it is necessary to alter the proposed timeframe from 
``before employment'' to ``within three months of the date of 
employment. * * *'' Therefore, if a State requires a registered nurse 
to have a State police background check completed within six months of 
employment, and the hospice complies with this State requirement when 
conducting background checks on its nurses, then the hospice is in 
compliance with this final rule even though the state standard is not 
as stringent. If that same State does not have requirements for 
background checks of physicians, then the hospice must obtain a 
criminal background check within three months of the date of employment 
for all states that the physician (paid, volunteer, or contracted) has 
lived or worked in for the past three years.
    Comment: A few commenters sought clarification on the relationship 
between the background check obtained by the hospice and the background 
check conducted by the State licensing body.
    Response: Many States require a criminal background check before a 
health care practitioner can obtain a State license, and some of these 
states require background checks to be updated when the license is 
renewed. However, not all states have a background check requirement in 
place for licensing. As described above, if a State has criminal 
background check requirements for a specific discipline, and the 
hospice complies with the State requirements for that discipline, then 
the hospice is in compliance with this Federal criminal background 
check requirement. This means an individual does not need a criminal 
background check if his or her license is current and State licensure 
requires a background check. If a State does not have such criminal 
background check requirements, then the hospice must comply with the 
Federal requirements described above.
    Comment: One commenter suggested that we should delay implementing 
the criminal background check requirement until completion of the 
background check demonstration project called for by the MMA.
    Response: While the results of the MMA background check 
demonstration project may provide further clarification on the 
particulars of implementing background check requirements in health 
care, we do not believe that it is appropriate to delay this important 
requirement. Hospices must make informed decisions regarding the staff 
(paid, volunteer, and contracted) that they use to care for patients. 
Without such vital information patients become vulnerable, and this can 
lead to negative patient outcomes.
    Comment: Some commenters noted that obtaining background checks 
will have a financial impact on hospices, while others noted that 
requiring volunteers to submit to background checks may decrease the 
number of willing volunteers.
    Response: We understand that obtaining background checks will have 
some degree of financial impact on hospices. We believe that this 
impact will be offset by a decreased level of hospice liability. 
Hospices will be able to exclude those individuals who may pose a 
threat to hospice patients, thereby decreasing the likelihood of

[[Page 32162]]

patient's rights violations and/or criminal and civil litigation.
    We also understand that some volunteers may perceive a criminal 
background check as an affront. However, we believe that explaining 
that background checks are a precaution that everyone must take, and 
that background checks are not meant to single anyone out, will ease 
volunteer concerns and not deter them from offering their time and 
services to hospices.
    Comment: A few commenters asked us to prescribe the exact offenses 
that would preclude a hospice from employing a certain individual. A 
commenter also asked us to include a waiver for individuals who have 
been reformed as well as protections for hospices to choose to 
terminate an individual's employment based on the results of the 
criminal background check.
    Response: We do not believe that it is appropriate to prescribe the 
circumstances under which an individual must be precluded from hospice 
employment on the basis of his or her criminal background check 
results. Hospices should consult applicable labor laws and regulations 
when developing their own policies and procedures for implementing the 
criminal background check requirement. In addition, hospices should 
inform current and prospective direct employees (including volunteers) 
and contracted employees about their criminal background check policy. 
We believe that a well-designed and openly implemented policy will help 
hospices choose the individuals best suited for hospice employment and 
service.
    Comment: A commenter suggested that the section for personnel 
requirements should be re-located to the beginning of the rule, rather 
than its proposed location at the end of the rule.
    Response: This rule is organized into two subparts, Subpart C--
Patient Care, and Subpart D--Organizational environment. Subpart C 
contains the conditions of participation related to providing direct 
patient care, while Subpart D contains the conditions of participation 
related to the administration of a hospice. Since the requirements for 
personnel qualifications relate more to the administration of a hospice 
than to the delivery of direct patient care, we believe that it is 
appropriate to keep the personnel qualifications section in its 
proposed location.

23. Condition of Participation: Compliance With Federal, State, and 
Local Laws and Regulations Related to the Health and Safety of Patients 
(Sec.  418.116)

    The provisions concerning licensure requirements for hospices are 
currently located at Sec.  418.72, ``Condition of participation: 
Licensure.'' We proposed to expand this condition by making a minor 
revision to the language at existing Sec.  418.72(a), requiring the 
hospice and its staff to operate and furnish services in compliance 
with all Federal, State, and local laws and regulations applicable to 
hospices related to the health and safety of patients.
    Under Sec.  418.116(b), ``Satellite locations,'' we proposed to 
continue to require that the hospice comply with the requirements of 
Sec.  420.206 regarding disclosure of ownership and control 
information. We also proposed that the hospice and any other satellite 
locations operated under the same provider number be licensed in 
accordance with applicable State licensure laws before the hospice 
could be reimbursed for Medicare services. This proposed provision 
would apply to the hospice as an entity, as well as to any personnel 
furnishing services to hospice patients. We proposed to recodify the 
current requirements at Sec.  418.92(b), regarding laboratory services, 
at Sec.  418.116(c).
    Comment: We received a minimal number of comments on the proposed 
rule concerning multiple location requirements in this section. The 
commenters requested that hospices be allowed to have multiple 
locations (previously known as satellite locations) and also asked 
about the procedures for the approval of such locations.
    Response: As previously noted in this preamble, we have deleted the 
term ``satellite'' and replaced it with ``multiple locations.'' 
Hospices are permitted to operate in multiple locations if they meet 
the requirements set forth in Sec.  418.3 and Sec.  418.100(f). The 
definition of ``multiple location'' as defined in Sec.  418.3 is ``a 
Medicare-approved location from which the hospice provides the same 
full range of hospice care and services that is required of the hospice 
issued the certification number. A multiple location must meet all of 
the conditions of participation applicable to hospices.'' The multiple 
location is part of the hospice and shares administration, supervision, 
and services with the hospice that was issued the certification number. 
In Sec.  418.100(f) we state that all multiple locations must be 
approved by Medicare before providing hospice care and services to 
Medicare patients. The hospice must continually monitor and manage all 
services provided at all of its locations to ensure that services are 
delivered in a safe and effective manner and to ensure that each 
patient and family receives the necessary care and services outlined in 
the plan of care. Procedures for requesting CMS approval of a multiple 
location will be set forth in the hospice interpretive guidelines, 
which will be made available after this final rule has been published. 
The interpretive guidelines will provide sub-regulatory instructions 
and parameters which will apply to multiple locations.

III. Provisions of the Final Regulations

    In this final rule we are adopting the provisions as set forth in 
the May 27, 2005 proposed rule with the following revisions. We have--

1. Definitions (Sec.  418.3)

     Deleted proposed revisions to the definition of the term 
``attending physician.''
     Amended the definition of ``bereavement counseling'' by 
adding the term ``before and''.
     Revised the definition of ``clinical note.''
     Added a definition of the term ``comprehensive 
assessment.''
     Added a definition of the term ``dietary counseling.''
     Deleted the definition of the term ``drug restraint.''
     Added a definition of the term ``initial assessment.''
     Amended the definition of ``licensed professional.''
     Amended the name and definition of ``satellite location,'' 
now referred to as ``multiple location.''
     Added a definition of the term ``physician.''
     Added a definition of the term ``physician designee.''
     Revised the definition of ``restraint,'' incorporating 
definitions of the terms ``restraint'', ``drug restraint'', and 
``physical restraint'' into a single definition.
     Revised the definition of ``seclusion.''
     Deleted the definitions of the terms ``physical 
restraint'' and ``progress note.''

2. Condition of Participation: Patient's Rights (Sec.  418.52)

     Renamed 418.52(a) ``Notice of rights and 
responsibilities.''
     Revised the phrasing of Sec.  418.52(a)(1).
     Redesignated and revised proposed Sec.  418.52(a)(3) to 
Sec.  418.106(e)(2)(i).
     Redesignated and revised proposed Sec.  418.52(a)(4) as 
Sec.  418.52(a)(3).

[[Page 32163]]

     Revised Sec.  418.52(b)(4) to clarify the hospice's 
responsibility for investigating and reporting violations of patient 
rights.
     Renamed and revised section 418.52(c) ``Rights of the 
patient'' to include several new patient rights.
     Deleted Sec.  418.52(d) ``Confidentiality of clinical 
records'' (now at 418.52(c)) and Sec.  418.52(e), ``Patient 
liability.''

3. Condition of Participation: Initial and Comprehensive Assessment of 
the Patient (Sec.  418.54)

    Revised the stem statement.
    Revised Sec.  418.54(a) to clarify the assessment timeframe.
    Revised Sec.  418.54(b) to clarify the role of the patient's 
attending physician, and expand the timeframe for completing the 
comprehensive assessment.
    Revised Sec.  418.54(c) to include new factors that must be 
considered during all comprehensive assessments. The new factors are 
functional status, imminence of death, and severity of symptoms.
    Renumbered Sec.  418.54(c)(3)(ii) as Sec.  418.54(c)(6), and 
revised the title of this section as ``Drug Profile.'' We also revised 
the factors that hospices must consider in the drug profile assessment.
    Revised the requirements for the ``bereavement assessment'' now at 
Sec.  418.54(c)(7) to require that a hospice incorporate information 
gathered from the initial assessment into the patient's plan of care 
and consider such information when developing the bereavement plan of 
care.
    Revised Sec.  418.54(d) to require an update of the comprehensive 
assessment at least every 15 days. We also deleted the requirement that 
the comprehensive assessment be updated at the time of each 
recertification.

4. Condition of Participation: Interdisciplinary Group, Care Planning, 
and Coordination of Services (Sec.  418.56)

    Revised the stem statement.
    Revised Sec.  418.56(a)(1) to maintain consistent terminology 
throughout the rule. In addition, we retained the existing hospice rule 
provision that requires the hospice to designate a registered nurse 
that is a member of the IDG to coordinate patient care, assessment, and 
care plan implementation.
    Revised the IDG requirements at Sec.  418.56(a)(1)(i) to require 
that the physician member of the IDG be an employee of or under 
contract with the hospice. We also revised Sec.  418.56 (a)(1)(iv), to 
retain the existing hospice requirement that the hospice IDG must 
include a pastoral or other counselor.
    Revised Sec.  418.56(a)(2) regarding the members of the IDG 
responsible for developing day-to-day hospice policies and procedures.
    Revised Sec.  418.56(b) to clarify that a patient's plan of care 
must be individualized to his or her needs and circumstances. 
Additionally, we revised this section to require a hospice to involve 
the patient and primary caregiver in developing the plan of care in 
accordance with the patient's needs. We also clarified which 
individuals must be educated and trained by the hospice in implementing 
the plan of care, as well as the extent of that education and training.
    Revised Sec.  418.56(c) to specify that the written plan of care 
must be individualized. We also added a provision that the plan of care 
must reflect patient and family goals.
    Revised Sec.  418.56(c)(1) to simplify the phrasing of the 
requirement.
    Removed the term ``targeted'' from Sec.  418.56(c)(3) to simplify 
its phrasing.
    Revised Sec.  418.56(c)(6) by changing ``family'' to 
``representative.''
    Revised Sec.  418.56(d). We removed specific mention of the role of 
the hospice medical director or physician designee in updating each 
patient's plan of care. We also revised the timeframes for updating the 
plan of care to at least every 15 days. Additionally, we added a 
requirement that the IDG must note the patient's progress toward 
specified goals when updating in the plan of care.
    Made several minor revisions to Sec.  418.56(e) that do not change 
the intent of the proposed and added a new requirement that hospice 
coordination and communication systems must ensure that information is 
shared with non-hospice health care providers furnishing services to 
patient.

5. Condition of Participation: Quality Assessment and Performance 
Improvement (Sec.  418.58)

    Removed the phrase ``focuses on the end-of-life support services 
provided'' from Sec.  418.58.
    Replaced the phrase ``end-of-life support services'' with ``hospice 
service'' in Sec.  418.58(a). In addition, we replaced the phrase ``for 
which there is evidence that improvement in those indicators will 
improve palliative outcomes'' with the phrase ``related to improved 
palliative outcomes.''
    Revised Sec.  418.58(b) to clarify our intent. In Sec.  
418.58(b)(2)(ii), we incorporated a requirement that quality indicator 
data must be used to identify priorities, as well as opportunities, for 
improvement. In Sec.  418.58(b)(3), we replaced the term ``specified'' 
with the term ``approved'' to clarify that the governing body is not 
necessarily the entity that establishes data collection specifications.
    Added a 240-day phase-in period to Sec.  418.58(d) to allow 
hospices more time to collect the initial program data.
    Revised Sec.  418.58(e) by adding a requirement that the governing 
body annually evaluates the hospice's QAPI program. We also added a 
requirement that the hospice governing body must identify at least one 
individual who is responsible for operating the QAPI program. Deleted 
proposed Sec.  418.58(e)(3) regarding expectations for patient safety.

6. Condition of Participation: Infection Control (Sec.  418.60)

    Expanded the scope of the hospice's infection control program to 
protect visitors as well as patients, families and hospice personnel.
    Replaced the term ``staff'' in proposed Sec.  418.60(c) with the 
terms ``employees'' and ``contracted providers.''

7. Condition of Participation: Licensed Professional Services (Sec.  
418.62)

    Revised Sec.  418.62(b) to clarify that licensed professionals 
providing care to hospice patients must actively participate in the 
coordination of all aspects of the patient's hospice care.

8. Condition of Participation: Core Services (Sec.  418.64)

    Revised Sec.  418.64 to permit hospices to utilize contracted 
staffing sources under extraordinary or other non-routine circumstances 
(for example, unanticipated periods of peak patient loads, short-term 
staffing shortages that interrupt patient care, and patient travel). 
Deleted the proposed requirement at Sec.  418.64(a) that hospice 
physicians be responsible for meeting a patient's general (that is, 
non-hospice) medical needs.
    Replaced the term ``nurse practitioner'' with ``registered nurse'' 
in Sec.  418.64(b)(2). We also deleted the proposed requirement at 
Sec.  418.64(b)(2) that the role and scope of nurse practitioner 
services be separately specified in the plan of care.
    Revised the requirements in Sec.  418.64(d) to clarify the role of 
counseling services, requiring that hospices make available counseling 
services, ``* * * to assist the patient and family in minimizing the 
stress and problems that arise from the terminal illness, related 
conditions, and the dying process.''
    Revised Sec.  418.64(d)(1)(i) to permit individuals with education 
(as well as experience) in grief/loss counseling to supervise a 
hospice's bereavement

[[Page 32164]]

program. Furthermore, we revised Sec.  418.64(d)(1)(ii) by removing the 
term ``other facility'' and removing the requirement that hospices must 
offer bereavement services to facility staff. We also revised Sec.  
418.64(d)(1)(iv) by changing ``provided'' to ``offered.''
    Revised Sec.  418.64(d)(2), renaming it ``Dietary counseling,'' to 
be more consistent with the terminology used throughout the rest of the 
rule.
    Revised section 418.64(d)(3)(iii) by removing the statement that 
hospices are not required to go to extraordinary lengths to facilitate 
clergy, pastoral, or other visits from this section. We added language 
that indicates that hospices must make all reasonable efforts to 
facilitate such visits.

9. Condition of Participation: Nursing Services--Waiver of Requirement 
That Substantially All Nursing Services Be Routinely Provided Directly 
by a Hospice (Sec.  418.66)

    Removed the requirement at proposed Sec.  418.66(d) that CMS may 
approve a maximum of two 1-year extensions for each initial waiver.

10. Condition of Participation: Waiver of Requirement--Physical 
Therapy, Occupational Therapy, Speech-Language Pathology, and Dietary 
Counseling (Sec.  418.74)

    Revised Sec.  418.74(d) by removing the requirement at 418.66(d) 
that CMS may approve a maximum of two 1-year extensions for each 
initial waiver.

11. Condition of Participation: Hospice Aide and Homemaker Services 
(Sec.  418.76)

    Revised Sec.  418.76 by changing its name from ``Home health aide 
and homemaker services'' to ``Hospice aide and homemaker services.''
    Revised Sec.  418.76(a)(ii) to clarify that the evaluation program 
used to measure aide competency must meet the specific requirements of 
Sec.  418.76(c) of this section. Clarified that the training or 
competency evaluation programs referred to in Sec.  418.76(a)(2) are 
those programs described in Sec.  418.76(a)(1).
    Added an option in Sec.  418.76(a)(1), that a hospice aide may be 
considered qualified if the aide has completed a training and 
competency evaluation program in accordance with the content and 
specifications of the nurse aide training program requirements for long 
term care facilities at 42 CFR part 483.
    Revised the language in Sec.  418.76(b)(1) to describe the training 
that hospice aides must complete. The revised requirement states that, 
``[h]ospice aide training must include classroom and supervised 
practical training.''
    Revised Sec.  418.76(c)(1) to clarify that a competency evaluation 
program is required to address the areas identified in Sec.  
418.76(b)(3) of this section, rather than the requirements of Sec.  
418.76(b)(1) through Sec.  418.76(b)(3). Revised the requirement in 
Sec.  418.76(c)(4) to specify that an aide is not considered to have 
successfully completed a competency evaluation if the aide has an 
``unsatisfactory'' rating in more than one required area.
    Deleted the proposed requirement in Sec.  418.76(d) that an 
organization excluded by Sec.  418.76(f) would be excluded from 
offering in-service training to hospice aides. This paragraph continues 
to exclude certain organizations from initially training hospice aides.
    Revised Sec.  418.76(e) to clarify that the requirements of this 
section apply to instructors providing both classroom and supervised 
practical training. We are no longer applying the requirements of this 
standard to those individuals performing competency evaluations or in-
service trainings. Third, we clarified the description of the training 
instructor by rearranging the language and clarifying that one year of 
the trainer's health care experience would be in the broad home care 
environment (that is, hospice or home health care), rather than in the 
more specific home health care environment.
    Revised Sec.  418.76(f) to state that any home health agency that, 
within the last two years, was out of compliance with the requirements 
of paragraphs Sec.  418.76(b) or Sec.  418.76(c) of this section was 
not eligible to train hospice aides, except with respect to in-service 
training.
    Deleted the proposed language in 418.76(g)(1) that an appropriate 
qualified therapist may make hospice aide assignments or supervise 
hospice aides. Also in section 418.76(g)(1), we added a new 
specification requiring the nurse who makes aide assignments for a 
specific aide and patient to be a member of that patient's hospice IDG.
    Revised Sec.  418.76(g)(2) to indicate that the hospice IDG as a 
whole may order aide services.
    Revised Sec.  418.76(h) by removing references to qualified 
therapists.
    Clarified the purpose of the every 14 day aide supervision visit in 
Sec.  418.76(h)(1)(i).
    Added a provision in Sec.  418.76(h)(1)(ii) stating that if during 
the supervision visit the nurse supervisor notes a potential area of 
concern regarding the way in which hospice aide services are being 
furnished, then the supervising registered nurse must make an on-site 
visit to the patient when the hospice aide is present, to observe and 
assess the aide while he or she is performing care.
    Added Sec.  418.76(h)(1)(iii) to clarify these problems identified 
during any hospice aide supervisory visits that cannot be resolved at 
that time by the supervising registered nurse, the hospice aide must 
complete a competency evaluation in accordance with Sec.  418.76(c). We 
also redesignated Sec.  418.76(h)(2) as Sec.  418.76(h)(3). We added a 
new section 418.76(h)(2) to require a hospice registered nurse to make 
an annual on-site visit to observe each hospice aide furnishing aide 
services to at least one patient. Hospices may determine the 
appropriate location to document this annual aide evaluation in 
accordance with their own policies and procedures.
    Deleted proposed 418.76(h)(3).
    Added a provision in Sec.  418.76(i)(2) that the individuals 
providing Medicaid personal care aide services may only be used by the 
hospice in implementing a patient's plan of care to the same extent 
that the hospice would routinely use a patient's family in implementing 
the plan of care.
    Added a provision in Sec.  418.76(i)(3) that a hospice must 
coordinate its hospice aide and homemaker services with the personal 
care aide services provided by Medicaid to ensure that patient needs 
are met.
    Reorganized Sec.  418.76(j) to clarify that homemakers must either 
meet the standards of Sec.  418.202(g) (in 42 CFR 418 Subpart F Covered 
Services) and complete hospice orientation, or meet the requirements 
for hospice aides at Sec.  418.76 as indicated in revised Sec.  
418.76(j)(2). There are no substantive changes to this paragraph.
    Revised the qualifications for the supervision of homemakers in 
Sec.  418.76(k) to require that such services be supervised by the same 
member of the IDG who coordinates the services.

12. Condition of Participation: Organization and Administration of 
Services (Sec.  418.100)

    Revised the requirements of Sec.  418.100(a) and Sec.  418.100 
(a)(1) to make clear that hospices must structure their operations to 
fully serve patients and families at the end of life.
    Clarified then relationship between a hospice's governing body and 
administrator in Sec.  418.100(b) by adding a provision that the 
administrator must be appointed by the governing body.
    Revised the requirement in Sec.  418.100(e) to state that hospices 
must maintain oversight responsibility for services furnished under 
contract.
    Revised the requirement in Sec.  418.100(e)(2) that contracted 
services

[[Page 32165]]

be provided by personnel having at least the same qualifications as 
hospice employees with a requirement that contracted services by 
provided by qualified personnel.
    Revised and reorganized Sec.  418.100(f) by replacing the term 
``satellite location'' with the term ``multiple location,'' and adding 
new requirements for Medicare approval.
    Revised Sec.  418.100(g) by adding (g)(1) and (2) to address the 
orientation of patient care employees in the hospice philosophy and the 
initial orientation of a hospice employee to his or her specific job 
duties. We also redesignated proposed paragraph (g) as (g)(3).

13. Condition of Participation: Medical Director (Sec.  418.102)

    Revised Sec.  418.102 by describing the employment relationship 
between the medical director and the hospice. We clarified that the 
medical director is either an employee of the hospice (paid or 
volunteer) or is an individual under contract with the hospice. We also 
revised the requirement to state that the hospice is responsible for 
designating the individual who fulfills the physician designee role in 
the medical director's absence.
    Inserted a new Sec.  418.102(a) to address contracting for medical 
director services, and redesignated the other paragraphs accordingly. 
The new paragraph specifies that hospices may choose to make 
arrangements for medical director services to be met through a contract 
with a self-employed doctor or through a contract with a professional 
entity or physicians group. Revised Sec.  418.102 (a)(2) specifies that 
if a hospice chooses to contract with a professional entity or 
physicians group for medical director services, the contract must 
identify a particular physician who will fulfill the hospice medical 
director's role and responsibilities.
    Redesignated Sec.  418.102(a) as Sec.  418.102(b) and revised it to 
delete the term ``criteria.''
    Deleted proposed Sec.  418.102(b)(2), which would have required the 
medical director to review the patient's and family's expectations and 
wishes for the continuation of hospice care at the time of each 
recertification.
    Redesignated and revised Sec.  418.102(c) as Sec.  418.102(d). The 
revision requires the hospice medical director to assume responsibility 
for the medical component of the hospice's patient care program. We 
deleted references to the joint responsibility of the IDG.

13. Condition of Participation: Clinical Records (Sec.  418.104)

    Revised Sec.  418.104(a) to clarify which documents must be 
included in the clinical record.
    Revised Sec.  418.104(a) to specify that all versions of the plan 
of care (initial and updated) must be in the clinical record. Likewise, 
we clarified that all assessments (initial, comprehensive, and updated 
comprehensive) must be included in the patient's clinical record. In 
addition, we removed the language that separate progress notes must be 
included in the clinical record because all notes, including notes that 
document a patient's progress, are included under the broad heading of 
``clinical notes.'' Furthermore, we removed the requirement that the 
clinical record must contain a patient's informed consent from this 
section. In its place, we require that the clinical record contain a 
copy of the notice of patient rights (in accordance with Sec.  
418.52(a)(3)), which requires a hospice to obtain the patient's or 
representative's signature confirming that he or she has received a 
copy of the notice of rights. Deleted the requirement in section Sec.  
418.104(b) that, ``[a]ll entries must be signed, and the hospice must 
be able to authenticate each handwritten and electronic signature of a 
primary author who has reviewed and approved the entry.'' We are 
requiring authentication and dating in accordance with hospice policy 
and accepted standards of practice.
    Revised Sec.  418.104(d) to specify the length of time that a 
hospice is required to retain a patient's clinical record after death 
or discharge from five years to six years in accordance with the HIPAA 
requirements.
    Revised Sec.  418.104(e) by replacing the term ``Medicare/Medicaid-
approved facility'' with ``Medicare/Medicaid-certified facility.''
    Revised Sec.  418.104(e)(1) and (2) by requiring only that the 
discharge summary be sent to the receiving facility/physician, and that 
the clinical record be made available only upon request.

14. Condition of Participation: Drugs and Biologicals, Medical 
Supplies, and Durable Medical Equipment (Sec.  418.106)

    Revised this CoP by combining the requirements of proposed Sec.  
418.106 and proposed Sec.  418.110(m) and Sec.  418.110(n).
    Revised Sec.  418.106(a) to now require the hospice to ensure that 
the IDG confers with a qualified individual with education and training 
in drug management who is an employee of, or under contract with, the 
hospice to ensure that drugs and biologicals meet each patient's needs. 
This section also requires a hospice that provides inpatient care 
directly in its own facility to provide pharmacy services under the 
direction of a qualified licensed pharmacist who is an employee of, or 
under contract with, the hospice. Incorporated the proposed 
requirements of Sec.  418.110(n) in section 418.106(b). Drug orders 
must only be given by a physician or nurse practitioner. If a drug 
order is given verbally or electronically, it must be given to a 
licensed nurse, nurse practitioner, pharmacist, or physician, and must 
be recorded and signed immediately by the receiver. The prescribing 
individual must sign the order in accordance with State and Federal 
regulations.
    Inserted new section 418.106(c), ``Dispensing of drugs and 
biologicals,'' to incorporate elements of proposed Sec.  418.110(m) and 
(n). This new standard requires a hospice to have a written policy to 
promote dispensing accuracy, maintain current and accurate records of 
the receipt and disposition of all controlled drugs, and obtain drugs 
and biologicals from community or institutional pharmacists or its own 
stock. Some of these requirements (that is, policy for dispensing 
accuracy and controlled drug records) only apply to those hospices that 
choose to maintain their own drug and biological stocks.
    Revised Sec.  418.106(d) to combine proposed standards Sec.  
418.106(a)(2) and Sec.  418.110(n)(2). Revised Sec.  418.106(d) is 
divided into two elements, one for patients receiving care in their 
home and another for patients receiving care in a hospice inpatient 
facility. If a patient is receiving care in his or her home, the 
hospice IDG must determine the patient's and/or family's ability to 
safely administer drugs and biologicals in the home. If a patient is 
receiving care in an inpatient facility operated by the hospice, then 
drugs may only be administered to the patient by a designated list of 
individuals working in the inpatient facility.
    Revised Sec.  418.106(e) to combine and revise the requirements of 
Sec.  418.106(b) and Sec.  418.110(n)(3), Sec.  418.110(n)(4), and 
Sec.  418.110(n)(5). A hospice must ensure that all drugs and 
biologicals are labeled with appropriate use and cautionary 
instructions, as well as an expiration date, in accordance with 
accepted standards of practice. In addition, a hospice must have 
written policies and procedures for the management and disposal of 
controlled drugs in a patient's home, and must provide and discuss them 
with the patient and family at the time when controlled drugs are 
initially ordered. Furthermore,

[[Page 32166]]

a hospice that operates its own inpatient facility must dispose of 
controlled drugs in compliance with State and Federal requirements and 
its own policies and procedures. It must also store drugs and 
biologicals in a secure area. Certain controlled drugs must be stored 
in locked compartments within the secure area, and access to those 
locked compartments must be restricted to those individuals who are 
permitted to administer these drugs. Any discrepancies in the 
acquisition, storage, dispensing, administration, disposal, or return 
of controlled drugs in the hospice's inpatient facility must be 
investigated immediately, and reported, if necessary. An investigation 
report must be made available to State and/or federal officials, if 
required.
    Revised Sec.  418.106(f) to clarify the hospice's responsibility 
for durable medical equipment and medical supplies and the hospice's 
contractual relationship with a durable medical equipment supplier. 
Specifically, section 418.106(f)(1) and (2) have been revised to state 
that, regardless of whether the hospice provides durable medical 
equipment and medical supplies directly or under contract, the hospice 
must ensure the following: That manufacturer recommendations for 
routine and preventive maintenance are followed; that maintenance 
policies are developed when no manufacturer recommendations exist; that 
equipment is safe; that equipment works as intended; that patients, 
families, and other caregivers receive instruction in the safe use of 
equipment and supplies; and that patients, families, and other 
caregivers are able to demonstrate the safe and appropriate use of 
equipment and supplies.
    Added Sec.  418.106(f)(3) to state that, if a hospice chooses to 
contract with an entity for durable medical equipment, it may only 
contract with a durable medical equipment supplier that meets the 
Medicare Supplier Quality and Accreditation Standards at 42 CFR 424.57.

15. Condition of Participation: Short-Term Inpatient Care (Sec.  
418.108)

    Revised 418.108(b)(2) to require a facility providing only the 
respite level of care to meet the 24-hour nursing needs of all patients 
in accordance with each patient's plan of care. A facility providing 
only the respite level of care is not required to automatically have 
registered nurse present on all shifts to provide direct patient care.

16. Condition of Participation: Hospices That Provide Inpatient Care 
Directly (Sec.  418.110)

    Revised the opening paragraph of this CoP to clarify that the 
requirements of Sec.  418.110 apply only to those inpatient facilities 
operated by a hospice. Where a hospice has its ``own inpatient 
facility,'' either in a freestanding building or as a section located 
in the building of another provider type, the requirements of Sec.  
418.110 apply to the building or applicable portion thereof as if it 
were physically located with the hospice administrative offices, as 
well as to the hospice patients receiving care within that building.
    Added a requirement at Sec.  418.110(b)(2), originally at Sec.  
418.100(a) of the existing hospice regulations, that at least one 
registered nurse must provide direct patient care on each shift. 
However, unlike the current Sec.  418.100(a), this requirement only 
applies if the hospice inpatient facility is providing general 
inpatient care to one or more patients.
    Removed the proposed requirements Sec.  418.110(c)(1)(i) and (ii), 
that a hospice must report safety breaches and that hospices must 
prevent, report, and correct equipment failures.
    Deleted Sec.  418.110(d)(4) and Sec.  418.110(d)(5), the phase-in 
provisions requiring hospices to comply with certain emergency lighting 
and door latching requirements as of March 13, 2006.
    Redesignated proposed paragraph Sec.  418.110(d)(6) as paragraph 
Sec.  418.110(d)(4).
    Added an exception to Sec.  418.110(f)(1)(iv) with respect to the 
number of patients that may occupy a single room. Redesignated proposed 
Sec.  418.110(o) as Sec.  418.110(m), and revised it to correspond with 
the seclusion and restraint requirements for hospitals.
    Revised proposed Sec.  418.110(o)(6) as Sec.  418.110(n) to provide 
more detailed guidance regarding the role of staff training in safely 
and successfully implementing restraint or seclusion techniques. These 
changes conform to the requirements of the hospital conditions of 
participation.
    Redesignated proposed Sec.  418.110(o)(7) as Sec.  418.110(o) to 
provide more detailed requirements regarding death reporting 
requirements.

16. Condition of Participation: Hospices That Provide Hospice Care to 
Residents of a SNF/NF or ICF/MR (Sec.  418.112)

    Deleted the term ``other facilities'' throughout this section.
    Revised Sec.  418.112(b) to clarify a hospice's responsibility for 
care furnished to hospice patients who reside in a SNF/NF or ICF/MR. A 
hospice assumes all responsibility for the professional management of 
all hospice services furnished to residents, including hospice-related 
inpatient care. All services furnished by the hospice must be in 
accordance with the individualized plans of care.
    Deleted Sec.  418.112 (c) and (d), and redesignated the remaining 
sections accordingly.
    Redesignated Sec.  418.112(e) as Sec.  418.112(c), deleted some 
provisions, clarified other provisions, and incorporated new provisions 
regarding the written agreement between a hospice and a SNF/NF or ICF/
MR.
    Redesignated Sec.  418.112(f) as Sec.  418.112(d) and replaced some 
of the detailed plan of care requirements included in the proposed 
standard with a cross reference to the requirements of Sec.  418.56. We 
also clarified that the hospice must discuss changes in a patient's 
plan of care with the patient or the patient's representative, as well 
as with representatives of the SNF/NF or ICF/MR where the patient 
resides.
    Revised Sec.  418.112(g) (redesignated as Sec.  418.112(e)) to 
clarify the hospice's patient care coordination responsibility.
    Deleted proposed Sec.  418.112(h).
    Revised Sec.  418.112(i) and redesignated it as Sec.  418.112(f) to 
clarify that a hospice is not required to provide orientation training 
itself if another hospice has already done so.

17. Condition of Participation: Personnel Qualifications (Sec.  
418.114)

    Revised Sec.  418.114(a) by combining the requirements of proposed 
standards Sec.  418.114(a) and Sec.  418.116(a). The revised Sec.  
418.114 requires that all professionals who furnish hospice services be 
currently licensed, certified or registered to provide services in 
accordance with applicable Federal, State, and local laws. Furthermore, 
all professionals must act only within the scope of their license, 
certification, or registration.
    Revised Sec.  418.114(b) by replacing the proposed term ``home 
health aides'' with the final term ``hospice aides.'' We also added 
revised personnel requirements for social workers at Sec.  
418.114(b)(3).
    Revised personnel requirements for physical therapists, physical 
therapy assistants, occupational therapists, occupational therapy 
assistants, and speech-language pathologists to incorporate changes 
made to these sections in a separate final rule (72 FR 66222, November 
27, 2007) Revised Sec.  418.114(d) to provide more specificity

[[Page 32167]]

about the timing and scope of the criminal background check 
requirement.

18. Condition of Participation: Compliance With Federal, State, and 
Local Laws and Regulations Related to the Health and Safety or Patients 
(Sec.  418.116)

    Moved proposed Sec.  418.116(a) to a similar provision at final 
Sec.  418.114(a).
    Replaced the term ``satellite locations'' with the term ``multiple 
locations'' in final Sec.  418.116(a) (proposed Sec.  418.116(b)) to 
conform to other sections of the final rule.

IV. Crosswalk

Provisions Not Cited in the Crosswalk are Unchanged in the Final Rule

----------------------------------------------------------------------------------------------------------------
          Proposed citation               Proposed condition         Final citation          Final condition
----------------------------------------------------------------------------------------------------------------
418.3................................  Definitions............  Same...................  Definitions.
                                       New....................  418.3..................  Initial assessment,
                                                                                          Comprehensive
                                                                                          assessment, Physician
                                                                                          designee, and Dietary
                                                                                          counseling.
                                       Satellite location.....  Same...................  Multiple location, New
                                                                                          and amended language.
                                       Bereavement counseling,  Same...................  New and amended
                                        Clinical note,                                    language.
                                        Employee, Hospice
                                        care, Licensed
                                        professional,
                                        Restraint, Seclusion.
                                       Attending physician,     .......................  Deleted.
                                        Cap period, Drug
                                        restraint, Physical
                                        restraint, Progress
                                        note, Terminally ill.
418.52...............................  Patient Rights.........  Same...................  Patient Rights.
418.52(a)(1).........................  The hospice must         Same...................  New and amended
                                        provide the patient or                            language.
                                        representative with
                                        verbal and written
                                        notice of the
                                        patient's rights and
                                        responsibilities in a
                                        language and manner
                                        that the patient
                                        understands during the
                                        initial evaluation
                                        visit in advance of
                                        furnishing care.
418.52(a)(3).........................  The hospice must inform  418.106(e)(2)(i).......  Relocated and amended
                                        the patient and family                            language.
                                        of the hospice's drug
                                        policies and
                                        procedures, including
                                        the policies and
                                        procedures regarding
                                        the tracking and
                                        disposing of
                                        controlled substances.
418.52(a)(4).........................  The hospice must         418.52(a)(3)...........  New and amended
                                        maintain documentation                            language.
                                        showing that it has
                                        complied with the
                                        requirements of this
                                        section and that the
                                        patient or
                                        representative has
                                        demonstrated an
                                        understanding of these
                                        rights.
418.52(b)(4)(i)......................  The hospice must--       418.52(b)(4)(i) and      New and amended
                                        Ensure that all          418.52(b)(4)(iv).        language.
                                        alleged violations
                                        involving
                                        mistreatment, neglect,
                                        or verbal, mental,
                                        sexual, and physical
                                        abuse, including
                                        injuries of unknown
                                        source, and
                                        misappropriation of
                                        patient property are
                                        reported to State and
                                        local bodies having
                                        jurisdiction
                                        (including to the
                                        State survey and
                                        certification agency)
                                        within at least 5
                                        working days of the
                                        incident, and
                                        immediately to the
                                        hospice administrator.
                                        Investigations and/or
                                        documentation of all
                                        alleged violations
                                        must be conducted in
                                        accordance with
                                        established procedures.
418.52(b)(4)(ii).....................  Immediately investigate  Same...................  New and amended
                                        all alleged violations                            language.
                                        and immediately take
                                        action to prevent
                                        further potential
                                        abuse while the
                                        alleged violation is
                                        being verified.
418.52(4)(iv)........................  Investigate complaints   418.52(b)(4)(ii).......  Amended language.
                                        made by a patient or
                                        the patient's family
                                        or representative
                                        regarding treatment or
                                        care that is (or fails
                                        to be) furnished, lack
                                        of respect for the
                                        patient or the
                                        patient's property by
                                        anyone furnishing
                                        services on behalf of
                                        the hospice, and
                                        document both the
                                        existence of the
                                        complaint and the
                                        steps taken to resolve
                                        the complaint.
418.52(c)............................  Pain management and      418.52(c)(1)...........  New and amended
                                        symptom control.                                  language.
                                       New....................  418.52(c)(2)...........  New.
                                       New....................  418.52(c)(3)...........  New.
                                                                418.52(c)(4)...........  New.
                                                                418.52(c)(6)...........  New.
                                       New....................  418.52(c)(7)...........  New.
                                                                418.52(c)(8)...........  New.
418.52(d)............................  Confidentiality of       418.52(c)(5)...........  Same.
                                        clinical records.
418.52(e)............................  Patient liability......  Deleted................  Deleted.
418.54...............................  Initial and              Same...................  Same.
                                        Comprehensive
                                        Assessment of the
                                        Patient.
418.54(a)............................  Initial assessment: The  Same...................  New and amended
                                        hospice registered                                language.
                                        nurse must make an
                                        initial assessment
                                        visit within 24 hours
                                        after the hospice
                                        receives a physician's
                                        admission order for
                                        care (unless ordered
                                        otherwise by the
                                        physician), to
                                        determine the
                                        patient's immediate
                                        care and support needs.
418.54(b)............................  Timeframe for            Same...................  New and amended
                                        completion of the                                 language.
                                        comprehensive
                                        assessment: The
                                        hospice
                                        interdisciplinary
                                        group in consultation
                                        with the individual's
                                        attending physician,
                                        must complete the
                                        comprehensive
                                        assessment no later
                                        than 4 calendar days
                                        after the patient
                                        elects the hospice
                                        benefit.

[[Page 32168]]

 
418.54(c)............................  Content of the           Same...................  New and amended
                                        comprehensive                                     language.
                                        assessment: The
                                        comprehensive
                                        assessment must
                                        identify the physical,
                                        psychosocial,
                                        emotional, and
                                        spiritual needs
                                        related to the
                                        terminal illness that
                                        must be addressed in
                                        order to promote the
                                        hospice patient's well-
                                        being, comfort, and
                                        dignity throughout the
                                        dying process. The
                                        comprehensive
                                        assessment describes--
418.54(c)(1).........................  The nature and           Same...................  New and amended
                                        condition causing                                 language.
                                        admission (including
                                        the presence or lack
                                        of objective data and
                                        subjective
                                        complaints);
418.54(c)(3).........................  Factors that must be     Same...................  New and amended
                                        considered in                                     language.
                                        developing
                                        individualized care
                                        plan interventions,
                                        including--
418.54(c)(3)(i)......................  Bereavement. An initial  418.54(c)(7)...........  New and amended
                                        bereavement assessment                            language.
                                        of the needs of the
                                        patient's family and
                                        other individuals
                                        focusing on the
                                        social, spiritual, and
                                        cultural factors that
                                        may impact their
                                        ability to cope with
                                        the patient's death.
                                        Information gathered
                                        from the initial
                                        bereavement assessment
                                        must be incorporated
                                        into the bereavement
                                        plan of care.
418.(c)(3)(ii).......................  Drug therapy. A review   418.54(c)(6)...........  New and amended
                                        of the patient's                                  language.
                                        prescription and over-
                                        the-counter drug
                                        profile, including but
                                        not limited to
                                        identification of the
                                        following--
418.54(c)(3)(ii)(A)..................  Ineffective drug         418.54(c)(6)(i)........  New and amended
                                        therapy;.                                         language.
418.54(c)(3)(ii)(B)..................  Unwanted drug side and   418.54(c)(6)(ii).......  New and amended
                                        toxic effects; and                                language.
418.54(c)(3)(ii)(C)..................  Drug interactions......  418.54(c)(6)(iii)......  New and amended
                                                                                          language.
                                       New....................  418.54(c)(6)(iv).......  Duplicate therapy.
                                       New....................  418.54(c)(6)(v)........  Laboratory monitoring.
418.54(c)(4).........................  The need for referrals   418.54(c)(8)...........  Same.
                                        and further evaluation
                                        by appropriate health
                                        professionals.
418.54(d)............................  Update of the            Same...................  New and amended
                                        comprehensive                                     language.
                                        assessment.
418.54(d)(1).........................  As frequently as the     418.54(d)..............  Amended language.
                                        patient requires, but
                                        no less frequently
                                        than every 14 days;
                                        and
418.54(d)(2).........................  At the time of each      Deleted................  Deleted.
                                        recertification.
418.56...............................  Sec.   418.56 Condition  Same...................  Amended language.
                                        of participation:
                                        Interdisciplinary
                                        group care planning
                                        and coordination of
                                        services.
                                       The hospice must
                                        designate an
                                        interdisciplinary
                                        group or groups as
                                        specified in paragraph
                                        (a) of this section
                                        which, in consultation
                                        with the patient's
                                        attending physician,
                                        must prepare a written
                                        plan of care for each
                                        patient. The plan of
                                        care must specify the
                                        hospice care and
                                        services necessary to
                                        meet the patient and
                                        family-specific needs
                                        identified in the
                                        comprehensive
                                        assessment and as it
                                        relates to the
                                        terminal illness and
                                        related conditions.
418.56(a)(1).........................  Standard: Approach to    Same...................  New and amended
                                        service delivery. (1)                             language.
                                        The hospice must
                                        designate an
                                        interdisciplinary
                                        group or groups
                                        composed of
                                        individuals who work
                                        together to meet the
                                        physical, medical,
                                        social, emotional, and
                                        spiritual needs of the
                                        hospice patients and
                                        families facing
                                        terminal illness and
                                        bereavement.
                                        Interdisciplinary
                                        group members must
                                        provide the care and
                                        services offered by
                                        the hospice, and the
                                        group in its entirety
                                        must supervise the
                                        care and services. The
                                        hospice must designate
                                        a qualified health
                                        care professional that
                                        is a member of the
                                        interdisciplinary
                                        group to provide
                                        coordination of care
                                        and to ensure
                                        continuous assessment
                                        of each patient's and
                                        family's needs and
                                        implementation of the
                                        interdisciplinary plan
                                        of care. The
                                        interdisciplinary
                                        group must include,
                                        but is not limited to,
                                        individuals who are
                                        qualified and
                                        competent to practice
                                        in the following
                                        professional roles:
418.54(a)(1)(i)......................  A doctor of medicine or  Same...................  Amended language.
                                        osteopathy (who is not
                                        the patient's
                                        attending physician).
418.54(a)(1)(iv).....................  A pastoral, clergy, or   Same...................  Amended language.
                                        other spiritual
                                        counselor.
418.56(a)(2).........................  If the hospice has more  Same...................  Amended language.
                                        than one
                                        interdisciplinary
                                        group, it must
                                        designate in advance
                                        only one of those
                                        groups to establish
                                        policies governing the
                                        day-to-day provision
                                        of hospice care and
                                        services.
418.56(b)............................  Plan of care: All        Same...................  New and amended
                                        hospice care and                                  language.
                                        services furnished to
                                        patients and their
                                        families must follow a
                                        written plan of care
                                        established by the
                                        hospice
                                        interdisciplinary
                                        group in collaboration
                                        with the attending
                                        physician. The hospice
                                        must ensure that each
                                        patient and family and
                                        primary caregiver(s)
                                        receive education and
                                        training provided by
                                        the hospice as
                                        appropriate to the
                                        care and services
                                        identified in the plan
                                        of care.

[[Page 32169]]

 
418.56(c)............................  Content of the plan of   Same...................  New and amended
                                        care: The hospice must                            language.
                                        develop a written plan
                                        of care for each
                                        patient that reflects
                                        prescribed
                                        interventions based on
                                        the problems
                                        identified in the
                                        initial comprehensive
                                        and updated
                                        comprehensive
                                        assessments, and other
                                        assessments. The plan
                                        of care must include
                                        but not be limited to--
 
418.56(c)(1).........................  Interventions to         Same...................  Amended language.
                                        facilitate the
                                        management of pain and
                                        symptoms;
418.56(c)(3).........................  Measurable targeted      Same...................  Amended language,
                                        outcomes anticipated
                                        from implementing and
                                        coordinating the plan
                                        of care;
418.56(c)(6).........................  The interdisciplinary    Same...................  Amended language.
                                        group's documentation
                                        of patient and family
                                        understanding,
                                        involvement, and
                                        agreement with the
                                        plan of care, in
                                        accordance with the
                                        hospice's own
                                        policies, in the
                                        clinical record.
418.56(d)............................  Review of the plan: The  Same...................  Amended language.
                                        medical director or
                                        physician designee,
                                        and the hospice
                                        interdisciplinary team
                                        (in collaboration with
                                        the individual's
                                        attending physician to
                                        the extent possible)
                                        must review, revise
                                        and document the plan
                                        as necessary at
                                        intervals specified in
                                        the plan but no less
                                        than every 14 calendar
                                        days. A revised plan
                                        of care must include
                                        information from the
                                        patient's updated
                                        comprehensive
                                        assessment and the
                                        patient's progress
                                        toward outcomes
                                        specified in the plan
                                        of care.
418.56(e)............................  Coordination of          Same...................  New and amended
                                        services: The hospice                             language.
                                        must develop and
                                        maintain a system of
                                        communication and
                                        integration, in
                                        accordance with the
                                        hospice's own policies
                                        and procedures, to--
418.56(e)(1).........................  Ensure the               Same...................  Amended language.
                                        interdisciplinary
                                        group, through its
                                        designated
                                        professionals,
                                        maintains
                                        responsibility for
                                        directing,
                                        coordinating, and
                                        supervising the care
                                        and services provided;
418.56(e)(4).........................  Provide for and ensure   Same...................  Amended language.
                                        the ongoing sharing of
                                        information between
                                        all disciplines
                                        providing care and
                                        services in the home,
                                        in outpatient
                                        settings, and in
                                        inpatient settings,
                                        irrespective whether
                                        the care and services
                                        are provided directly
                                        or under arrangement.
                                       New....................  New 418.56(e)(5).......  New.
418.58...............................  Quality assessment and   Same...................  New and amended
                                        performance                                       language.
                                        improvement: The
                                        hospice must develop,
                                        implement, and
                                        maintain an effective,
                                        ongoing, hospice-wide
                                        data-driven quality
                                        assessment and
                                        performance
                                        improvement program.
                                        The hospice's
                                        governing body must
                                        ensure that the
                                        program: Reflects the
                                        complexity of its
                                        organization and
                                        services; involves all
                                        hospice services
                                        (including those
                                        services furnished
                                        under contract or
                                        arrangement); focuses
                                        on indicators related
                                        to improved palliative
                                        outcomes; focuses on
                                        the end-of-life
                                        support services
                                        provided; and takes
                                        actions to demonstrate
                                        improvement in hospice
                                        performance. The
                                        hospice must maintain
                                        documentary evidence
                                        of its quality
                                        assessment and
                                        performance
                                        improvement program
                                        and be able to
                                        demonstrate its
                                        operation to CMS.
418.58(a)(1).........................  Program scope: (1) The   Same...................  Amended language.
                                        program must at least
                                        be capable of showing
                                        measurable improvement
                                        in indicators for
                                        which there is
                                        evidence that
                                        improvement in those
                                        indicators will
                                        improve palliative
                                        outcomes and end-of-
                                        life support services.
418.58(b)(2)(ii).....................  Identify opportunities   Same...................  Amended language.
                                        for improvement.
418.58(b)(3).........................  The frequency and        Same...................  Amended language.
                                        detail of the data
                                        collection must be
                                        specified by the
                                        hospice's governing
                                        body.
418.58(d)(1)-(d)(2)..................  Performance improvement  Same...................  New and amended
                                        projects: (1) The                                 language.
                                        number and scope of
                                        distinct improvement
                                        projects conducted
                                        annually must reflect
                                        the scope, complexity,
                                        and past performance
                                        of the hospice's
                                        services and
                                        operations. (2) The
                                        hospice must document
                                        what quality
                                        improvement projects
                                        are being conducted,
                                        the reasons for
                                        conducting these
                                        projects, and the
                                        measurable progress
                                        achieved on these
                                        projects.
418.58(e)-(e)(1).....................  Executive                Same...................  Amended language.
                                        responsibilities: The
                                        hospice's governing
                                        body is responsible
                                        for ensuring the
                                        following: (1)That an
                                        ongoing program for
                                        quality improvement
                                        and patient safety is
                                        defined, implemented
                                        and maintained;

[[Page 32170]]

 
418.58(e)(2).........................  That the hospice-wide    Same...................  Amended language.
                                        quality assessment and
                                        performance
                                        improvement efforts
                                        address priorities for
                                        improved quality of
                                        care and patient
                                        safety, and that all
                                        improvement actions
                                        are evaluated for
                                        effectiveness; and
418.58(e)(3).........................  That clear expectations  Deleted................  Deleted.
                                        for patient safety are
                                        established.
                                       New....................  418.58(e)(3)...........  New.
418.60...............................  Infection Control: The   Same...................  Amended language.
                                        hospice must maintain
                                        and document an
                                        effective infection
                                        control program that
                                        protects patients,
                                        families and hospice
                                        personnel by
                                        preventing and
                                        controlling infections
                                        and communicable
                                        diseases.
418.60(b)(2)(ii).....................  A plan for the           Same...................  Amended language.
                                        appropriate actions
                                        that are expected to
                                        result in improvement
                                        and disease prevention.
418.62...............................  Licensed professional    Same...................  Same.
                                        services.
418.62(b)............................  Licensed professionals   Same...................  Amended language.
                                        must actively
                                        participate in the
                                        coordination of all
                                        aspects of the
                                        patient's care, in
                                        accordance with
                                        current professional
                                        standards and
                                        practice, including
                                        participating in
                                        ongoing
                                        interdisciplinary
                                        comprehensive
                                        assessments,
                                        developing and
                                        evaluating the plan of
                                        care, and contributing
                                        to patient and family
                                        counseling and
                                        education; and
418.64...............................  Core Services: A         Same...................  New and amended
                                        hospice must routinely                            language.
                                        provide substantially
                                        all core services
                                        directly by hospice
                                        employees. These
                                        services must be
                                        provided in a manner
                                        consistent with
                                        acceptable standards
                                        of practice. These
                                        services include
                                        nursing services,
                                        medical social
                                        services, and
                                        counseling. The
                                        hospice may contract
                                        for physician services
                                        as specified in Sec.
                                        418.64(a). A hospice
                                        may, under
                                        extraordinary or other
                                        non-routine
                                        circumstances, enter
                                        into a written
                                        arrangement with
                                        another Medicare
                                        certified hospice
                                        program for the
                                        provision of core
                                        services to supplement
                                        hospice employee/staff
                                        to meet the needs of
                                        patients.
                                       Circumstances under
                                        which a hospice may
                                        enter into a written
                                        arrangement for the
                                        provision of core
                                        services include:
                                        Unanticipated periods
                                        of high patient loads,
                                        staffing shortages due
                                        to illness or other
                                        short-term temporary
                                        situations that
                                        interrupt patient
                                        care; and temporary
                                        travel of a patient
                                        outside of the
                                        hospice's service area.
418.64(a)............................  Physician services: The  Same...................  Amended language.
                                        hospice medical
                                        director, physician
                                        employees, and
                                        contracted
                                        physician(s) of the
                                        hospice, in
                                        conjunction with the
                                        patient's attending
                                        physician, are
                                        responsible for the
                                        palliation and
                                        management of the
                                        terminal illness,
                                        conditions related to
                                        the terminal illness,
                                        and the general
                                        medical needs of the
                                        patient.
                                       (1) All physician
                                        employees and those
                                        under contract, must
                                        function under the
                                        supervision of the
                                        hospice medical
                                        director.
                                       (2) All physician
                                        employees and those
                                        under contract shall
                                        meet this requirement
                                        by either providing
                                        the services directly
                                        or through
                                        coordinating patient
                                        care with the
                                        attending physician.
                                       (3) If the attending
                                        physician is
                                        unavailable, the
                                        medical director,
                                        contracted physician,
                                        and/or hospice
                                        physician employee is
                                        responsible for
                                        meeting the medical
                                        needs of the patient.
418.64(b)............................  Nursing services: (1)    Same...................  Amended language.
                                        The hospice must
                                        provide nursing care
                                        and services by or
                                        under the supervision
                                        of a registered nurse.
                                        Nursing services must
                                        ensure that the
                                        nursing needs of the
                                        patient are met as
                                        identified in the
                                        patient's initial
                                        comprehensive
                                        assessment and updated
                                        assessments.
                                       (2) If State law
                                        permits nurse
                                        practitioners (NPs) to
                                        see, treat and write
                                        orders for patients,
                                        then NPs may provide
                                        services to
                                        beneficiaries
                                        receiving hospice
                                        care. The role and
                                        scope of the services
                                        provided by a NP that
                                        is not the
                                        individual's attending
                                        physician must be
                                        specified in the
                                        individual's plan of
                                        care.
                                       (3) Highly specialized
                                        nursing services that
                                        are provided so
                                        infrequently that the
                                        provision of such
                                        services by direct
                                        hospice employees
                                        would be impracticable
                                        and prohibitively
                                        expensive, may be
                                        provided under
                                        contract.

[[Page 32171]]

 
418.64(d)............................  Counseling services:     Same...................  New and amended
                                        Counseling services                               language.
                                        for adjustment to
                                        death and dying must
                                        be available to both
                                        the patient and the
                                        family. Counseling
                                        services must include
                                        but are not limited to
                                        the following:
418.64(d)(1)(i)......................  Bereavement counseling.  Same...................  Amended language.
                                        The hospice must: Have
                                        an organized program
                                        for the provision of
                                        bereavement services
                                        furnished under the
                                        supervision of a
                                        qualified professional
                                        with experience in
                                        grief/loss counseling.
418.64(d)(1)(ii).....................  Make bereavement         Same...................  Amended language.
                                        services available to
                                        the family and other
                                        individuals in the
                                        bereavement plan of
                                        care up to one year
                                        following the death of
                                        the patient.
                                        Bereavement counseling
                                        also extends to
                                        residents and
                                        employees of a SNF/NF,
                                        ICF/MR, or other
                                        facility when
                                        appropriate and
                                        identified in the
                                        bereavement plan of
                                        care.
418.64(d)(1)(iv).....................  Develop a bereavement    Same...................  Amended.
                                        plan of care that
                                        notes the kind of
                                        bereavement services
                                        to be provided and the
                                        frequency of service
                                        delivery. A special
                                        coverage provision for
                                        bereavement counseling
                                        is specified in Sec.
                                        418.204(c).
418.64(d)(2).........................  Nutritional counseling.  Same...................  Renamed: Dietary
                                        Nutritional                                       Counseling.
                                        counseling, when
                                        identified in the plan
                                        of care, must be
                                        performed by a
                                        qualified individual,
                                        which include
                                        dietitians as well as
                                        nurses and other
                                        individuals who are
                                        able to address and
                                        assure that the
                                        dietary needs of the
                                        patient are met.
418.64(d)(3)(i)-(iv).................  Spiritual counseling.    Same...................  Amended language.
                                        The hospice must:
                                       (i) Provide an
                                        assessment of the
                                        patient's and family's
                                        spiritual needs;
                                       (ii) Provide spiritual
                                        counseling to meet
                                        these needs in
                                        accordance with the
                                        patient's and family's
                                        acceptance of this
                                        service, and in a
                                        manner consistent with
                                        patient and family
                                        beliefs and desires;
                                       (iii) Facilitate visits
                                        by local clergy,
                                        pastoral counselors,
                                        or other individuals
                                        who can support the
                                        patient's spiritual
                                        needs to the best of
                                        its ability. The
                                        hospice is not
                                        required to go to
                                        extraordinary lengths
                                        to do so; and
                                          (iv) Advise the
                                           patient and family
                                           of this service.
418.66...............................  Nursing services--       Same...................  Same.
                                        Waiver of requirement
                                        that substantially all
                                        nursing services be
                                        routinely provided
                                        directly by a hospice.
418.66(a)............................  CMS may waive the        Same...................  Amended language.
                                        requirement in Sec.
                                        418.64(b) that a
                                        hospice provide
                                        nursing services
                                        directly, if the
                                        hospice is located in
                                        a nonurbanized area.
                                        The location of a
                                        hospice that operates
                                        in several areas is
                                        considered to be the
                                        location of its
                                        central office. The
                                        hospice must provide
                                        evidence to CMS that
                                        it has made a good
                                        faith effort to hire a
                                        sufficient number of
                                        nurses to provide
                                        services. CMS may
                                        waive the requirement
                                        that nursing services
                                        be furnished by
                                        employees based on the
                                        following criteria:
                                          (1) The location of
                                           the hospice's
                                           central office is
                                           in a nonurbanized
                                           area as determined
                                           by the Bureau of
                                           the Census.
                                       (2) There is evidence
                                        that a hospice was
                                        operational on or
                                        before January 1, 1983
                                        including--
                                       (i) Proof that the
                                        organization was
                                        established to provide
                                        hospice services on or
                                        before January 1,
                                        1983;
                                       (ii) Evidence that
                                        hospice-type services
                                        were furnished to
                                        patients on or before
                                        January 1, 1983; and
                                          (iii) Evidence that
                                           hospice care was a
                                           discrete activity
                                           rather than an
                                           aspect of another
                                           type of provider's
                                           patient care
                                           program on or
                                           before January 1,
                                           1983.
                                       (3) By virtue of the
                                        following evidence
                                        that a hospice made a
                                        good faith effort to
                                        hire nurses:
                                       (i) Copies of
                                        advertisements in
                                        local newspapers that
                                        demonstrate
                                        recruitment efforts;
                                       (ii) Job descriptions
                                        for nurse employees;
                                       (iii) Evidence that
                                        salary and benefits
                                        are competitive for
                                        the area; and

[[Page 32172]]

 
                                          (iv) Evidence of any
                                           other recruiting
                                           activities (for
                                           example, recruiting
                                           efforts at health
                                           fairs and contacts
                                           with nurses at
                                           other providers in
                                           the area).
418.66(d)............................  CMS may approve a        Same...................  Amended language.
                                        maximum of two 1-year
                                        extensions for each
                                        initial waiver. If a
                                        hospice wishes to
                                        receive a 1-year
                                        extension, it must
                                        submit a request to
                                        CMS before the
                                        expiration of the
                                        waiver period, and
                                        certify that the
                                        conditions under which
                                        it originally
                                        requested the initial
                                        waiver have not
                                        changed since the
                                        initial waiver was
                                        granted.
418.74...............................  Waiver of requirement--  Same...................  Same.
                                        Physical therapy,
                                        occupational therapy,
                                        speech-language
                                        pathology, and dietary
                                        counseling.
418.74(a)............................  A hospice located in a   Same...................  Amended language.
                                        non-urbanized area may
                                        submit a written
                                        request for a waiver
                                        of the requirement for
                                        providing physical
                                        therapy, occupational
                                        therapy, speech-
                                        language pathology,
                                        and dietary counseling
                                        services. The hospice
                                        may seek a waiver of
                                        the requirement that
                                        it make physical
                                        therapy, occupational
                                        therapy, speech-
                                        language pathology,
                                        and dietary counseling
                                        services (as needed)
                                        available on a 24-hour
                                        basis. The hospice may
                                        also seek a waiver of
                                        the requirement that
                                        it provide dietary
                                        counseling directly.
                                       The hospice must
                                        provide evidence that
                                        it has made a good
                                        faith effort to meet
                                        the requirements for
                                        these services before
                                        it seeks a waiver. CMS
                                        may approve a waiver
                                        application on the
                                        basis of the following
                                        criteria: (1) The
                                        hospice is located in
                                        a non-urbanized area
                                        as determined by the
                                        Bureau of the Census.
                                       (2) The hospice
                                        provides evidence that
                                        it had made a good
                                        faith effort to make
                                        available physical
                                        therapy, occupational
                                        therapy, speech-
                                        language pathology,
                                        and dietary counseling
                                        services on a 24-hour
                                        basis and/or to hire a
                                        dietary counselor to
                                        furnish services
                                        directly. This
                                        evidence must include--
 
                                       (i) Copies of
                                        advertisements in
                                        local newspapers that
                                        demonstrate
                                        recruitment efforts;
                                       (ii) Physical therapy,
                                        occupational therapy,
                                        speech-language
                                        pathology, and dietary
                                        counselor job
                                        descriptions;
                                       (iii) Evidence that
                                        salary and benefits
                                        are competitive for
                                        the area; and
                                          (iv) Evidence of any
                                           other recruiting
                                           activities (for
                                           example, recruiting
                                           efforts at health
                                           fairs and contact
                                           discussions with
                                           physical therapy,
                                           occupational
                                           therapy, speech-
                                           language pathology,
                                           and dietary
                                           counseling service
                                           providers in the
                                           area).
418.74(d)............................  CMS may approve a        Same...................  Amended language.
                                        maximum of two 1-year
                                        extensions for each
                                        initial waiver. If a
                                        hospice wishes to
                                        receive a 1 year
                                        extension, it must
                                        submit a request to
                                        CMS prior to the
                                        expiration of the
                                        waiver period and
                                        certify that
                                        conditions under which
                                        it originally
                                        requested the waiver
                                        have not changed since
                                        the initial waiver was
                                        granted.
418.76...............................  Home health aide and     Same...................  New and amended
                                        homemaker services:                               language.
                                        All home health aide
                                        services must be
                                        provided by
                                        individuals who meet
                                        the personnel
                                        requirements specified
                                        in paragraph (a) of
                                        this section.
                                        Homemaker services
                                        must be provided by
                                        individuals who meet
                                        the personnel
                                        requirements specified
                                        in paragraph (j) of
                                        this section.
418.76(a)(1).........................  Home health aide         Same...................  New and amended
                                        qualifications:.                                  language.
                                       (i) A training program
                                        and competency
                                        evaluation as
                                        specified in
                                        paragraphs (b) and (c)
                                        of this section
                                        respectively; or
                                       (ii) A competency        Same...................  New and amended
                                        evaluation program; or                            language.
                                          (iii) A State         418.76(a)(1)(iv).......  Same.
                                           licensure program
                                           that meets the
                                           requirements of
                                           paragraphs (b) and
                                           (c) of this section.
New..................................  New....................  418.76(a)(1)(iii)......  New.

[[Page 32173]]

 
418.76(a)............................  (2) A home health aide   Same...................  New and amended
                                        is not considered to                              language.
                                        have completed a
                                        training program, or a
                                        competency evaluation
                                        program if, since the
                                        individual's most
                                        recent completion of
                                        the program(s), there
                                        has been a continuous
                                        period of 24
                                        consecutive months
                                        during which none of
                                        the services furnished
                                        by the individual as
                                        described in Sec.
                                        409.40 of this chapter
                                        were for compensation.
                                        If there has been a 24
                                        month lapse in
                                        furnishing services,
                                        the individual must
                                        complete another
                                        training and/or
                                        competency evaluation
                                        program before
                                        providing services, as
                                        specified in paragraph
                                        (a)(1) of this section.
418.76(b)............................  Content and duration of  Same...................  Amended language.
                                        home health aide
                                        classroom and
                                        supervised practical
                                        training: (1) Home
                                        health aide training
                                        must include classroom
                                        and supervised
                                        practical classroom
                                        training in a
                                        practicum laboratory
                                        or other setting in
                                        which the trainee
                                        demonstrates knowledge
                                        while performing tasks
                                        on an individual under
                                        the direct supervision
                                        of a registered nurse
                                        or licensed practical
                                        nurse, who is under
                                        the supervision of a
                                        registered nurse.
                                        Classroom and
                                        supervised practical
                                        training combined must
                                        total at least 75
                                        hours.
                                       (2) A minimum of 16
                                        hours of classroom
                                        training must precede
                                        a minimum of 16 hours
                                        of supervised
                                        practical training as
                                        part of the 75 hours.
                                       (3) A home health aide
                                        training program must
                                        address each of the
                                        following subject
                                        areas:
                                       (4) The hospice must
                                        maintain documentation
                                        that demonstrates that
                                        the requirements of
                                        this standard are met.
418.76(c)............................  Competency evaluation:   Same...................  Amended language.
                                        An individual may
                                        furnish home health
                                        services on behalf of
                                        a hospice only after
                                        that individual has
                                        successfully completed
                                        a competency
                                        evaluation program as
                                        described in this
                                        section.
418.76(c)(1).........................  (1) The competency       Same...................  Amended language.
                                        evaluation must
                                        address each of the
                                        subjects listed in
                                        paragraphs (b)(1)
                                        through (b)(3) of this
                                        section. Subject areas
                                        specified under
                                        paragraphs (b)(3)(i),
                                        (b)(3)(iii),
                                        (b)(3)(ix), (b)(3)(x)
                                        and (b)(3)(xi) of this
                                        section must be
                                        evaluated by observing
                                        an aide's performance
                                        of the task with a
                                        patient. The remaining
                                        subject areas may be
                                        evaluated through
                                        written examination,
                                        oral examination, or
                                        after observation of a
                                        home health aide with
                                        a patient.
418.76(c)(2).........................  (2) A home health aide   Same...................  Amended language.
                                        competency evaluation
                                        program may be offered
                                        by any organization,
                                        except as specified in
                                        paragraph (f) of this
                                        section.
418.76(c)(4).........................  (4) A home health aide   Same...................  New and amended
                                        is not considered                                 language.
                                        competent in any task
                                        for which he or she is
                                        evaluated as
                                        unsatisfactory. An
                                        aide must not perform
                                        that task without
                                        direct supervision by
                                        a registered nurse
                                        until after he or she
                                        has received training
                                        in the task for which
                                        he or she was
                                        evaluated as
                                        ``unsatisfactory,''
                                        and successfully
                                        completes a subsequent
                                        evaluation.
418.76(d)............................  In-service training: A   Same...................  Amended language.
                                        home health aide must
                                        receive at least 12
                                        hours of in-service
                                        training during each
                                        12-month period. In-
                                        service training may
                                        occur while an aide is
                                        furnishing care to a
                                        patient.
                                       (1) In-service training
                                        may be offered by any
                                        organization except
                                        one that is excluded
                                        by paragraph (f) of
                                        this section, and must
                                        be supervised by a
                                        registered nurse.
                                       (2) The hospice must
                                        maintain documentation
                                        that demonstrates the
                                        requirements of this
                                        standard are met.
418.76(e)............................  Qualifications for       Same...................  Amended language.
                                        instructors conducting
                                        classroom supervised
                                        practical training,
                                        competency evaluations
                                        and in-service
                                        training:
                                       Classroom supervised
                                        practical training
                                        must be performed by
                                        or under the
                                        supervision of a
                                        registered nurse who
                                        possesses a minimum of
                                        two years nursing
                                        experience, at least
                                        one year of which must
                                        be in home health
                                        care. Other
                                        individuals may
                                        provide instruction
                                        under the general
                                        supervision of a
                                        registered nurse.

[[Page 32174]]

 
418.76(f)............................  Eligible training        Same...................  Amended language.
                                        organizations. A home
                                        health aide training
                                        program may be offered
                                        by any organization
                                        except by a home
                                        health agency that,
                                        within the previous 2
                                        years--
                                       (1) Was out of
                                        compliance with the
                                        requirements of
                                        paragraphs (b) or (c)
                                        of this section;
                                       (2) Permitted an
                                        individual that does
                                        not meet the
                                        definition of a
                                        ``qualified home
                                        health aide'' as
                                        specified in paragraph
                                        (a) of this section to
                                        furnish home health
                                        aide services (with
                                        the exception of
                                        licensed health
                                        professionals and
                                        volunteers);
                                       (3) Was subjected to an
                                        extended (or partial
                                        extended) survey as a
                                        result of having been
                                        found to have
                                        furnished substandard
                                        care (or for other
                                        reasons at the
                                        discretion of CMS or
                                        the State);
                                       (4) Was assessed a
                                        civil monetary penalty
                                        of $5,000 or more as
                                        an intermediate
                                        sanction;
                                       (5) Was found by CMS to
                                        have compliance
                                        deficiencies that
                                        endangered the health
                                        and safety of the home
                                        health agency's
                                        patients and had
                                        temporary management
                                        appointed to oversee
                                        the management of the
                                        home health agency;
                                       (6) Had all or part of
                                        its Medicare payments
                                        suspended; or
                                       (7) Was found by CMS or
                                        the State under any
                                        Federal or State law
                                        to have:
418.76(g)............................  Home health aide         Deleted................  Deleted stem.
                                        assignments and
                                        duties: A registered
                                        nurse or the
                                        appropriate qualified
                                        therapist that is a
                                        member of the
                                        interdisciplinary team
                                        makes home health aide
                                        assignments.
418.76(g)(1).........................  Home health aides are    Same...................  New and amended
                                        assigned to a specific                            language.
                                        patient by a
                                        registered nurse or
                                        the appropriate
                                        qualified therapist.
                                        Written patient care
                                        instructions for a
                                        home health aide must
                                        be prepared by a
                                        registered nurse or
                                        other appropriate
                                        skilled professional
                                        (i.e., a physical
                                        therapist, speech-
                                        language pathologist,
                                        or occupational
                                        therapist) who is
                                        responsible for the
                                        supervision of a home
                                        health aide as
                                        specified under
                                        paragraph (h) of this
                                        section.
418.76(g)(2).........................  A home health aide       Same...................  Amended language.
                                        provides services that
                                        are:
                                       (i) Ordered by the
                                        physician or nurse
                                        practitioner;
                                       (ii) Included in the
                                        plan of care;
                                       (iii) Permitted to be
                                        performed under State
                                        law by such home
                                        health aide; and
                                          (iv) Consistent with
                                           the home health
                                           aide training.
418.76(g)(3).........................  The duties of a home     Same...................  Amended language.
                                        health aide include:
                                       (i) The provision of
                                        hands on personal
                                        care;
                                       (ii) The performance of
                                        simple procedures as
                                        an extension of
                                        therapy or nursing
                                        services;
                                       (iii) Assistance in
                                        ambulation or
                                        exercises; and
                                          (iv) Assistance in
                                           administering
                                           medications that
                                           are ordinarily self
                                           administered.
418.76(g)(4).........................  Home health aides must   Same...................  Amended language.
                                        report changes in the
                                        patient's medical,
                                        nursing,
                                        rehabilitative, and
                                        social needs to a
                                        registered nurse or
                                        other appropriate
                                        licensed professional,
                                        as the changes relate
                                        to the plan of care
                                        and quality assessment
                                        and improvement
                                        activities. Home
                                        health aides must also
                                        complete appropriate
                                        records in compliance
                                        with the hospice's
                                        policies and
                                        procedures.
418.76(h)............................  Supervision of home      418.76(h)(1) and (h)(2)  New and amended
                                        health aides: (l) A                               language.
                                        registered nurse or
                                        qualified therapist
                                        must make an onsite
                                        visit to the patient's
                                        home no less
                                        frequently than every
                                        14 days to assess the
                                        home health aide's
                                        services. The home
                                        health aide does not
                                        have to be present
                                        during this visit. A
                                        registered nurse or
                                        qualified therapist
                                        must make an onsite
                                        visit to the location
                                        where the patient is
                                        receiving care in
                                        order to observe and
                                        assess each aide while
                                        he or she is
                                        performing care no
                                        less frequently than
                                        every 28 days.
418.76(h)(2).........................  The supervising nurse    418.76(h)(3)...........  Amended language.
                                        or therapist must
                                        assess an aide's
                                        ability to demonstrate
                                        initial and continued
                                        satisfactory
                                        performance in meeting
                                        outcome criteria that
                                        include, but is not
                                        limited to--
                                       (i) Following the
                                        patient's plan of care
                                        for completion of
                                        tasks assigned to the
                                        home health aide by
                                        the registered nurse
                                        or qualified
                                        therapist;

[[Page 32175]]

 
                                       (ii) Creating
                                        successful
                                        interpersonal
                                        relationships with the
                                        patient and family;
                                       (iii) Demonstrating
                                        competency with
                                        assigned tasks;
                                       (iv) Complying with
                                        infection control
                                        policies and
                                        procedures; and
                                       (v) Reporting changes
                                        in the patient's
                                        condition.
418.76(h)(3).........................  If the hospice chooses   Deleted................  Deleted.
                                        to provide home health
                                        aide services under
                                        contract with another
                                        organization, the
                                        hospice's
                                        responsibilities
                                        include, but are not
                                        limited to--
                                       (i) Ensuring the
                                        overall quality of
                                        care provided by an
                                        aide;
                                       (ii) Supervising an
                                        aide's services as
                                        described in
                                        paragraphs (h)(l) and
                                        (h)(2) of this
                                        section; and
                                       (iii) Ensuring that
                                        home health aides who
                                        provide services under
                                        arrangement have met
                                        the training and/or
                                        competency evaluation
                                        requirements of this
                                        condition.
                                       New....................  418.76(h)(3)...........  New language.
418.76(i)............................  Individuals furnishing   418.76(i) and (i)(1)...  Amended language.
                                        Medicaid personal care
                                        aide-only services
                                        under a Medicaid
                                        personal care benefit.
                                        An individual may
                                        furnish personal care
                                        services, as defined
                                        in Sec.   440.167 of
                                        the Code of Federal
                                        Regulations, on behalf
                                        of a hospice or home
                                        health agency. Before
                                        the individual may
                                        furnish personal care
                                        services, the
                                        individual must be
                                        found competent by the
                                        State to furnish those
                                        services. The
                                        individual only needs
                                        to demonstrate
                                        competency in the
                                        services the
                                        individual is required
                                        to furnish.
                                                                418.76(i)(2)...........  New language.
                                                                418.76(i)(3)...........  New language.
418.76(j)............................  Homemaker                Same...................  New and amended
                                        qualifications. A                                 language.
                                        qualified homemaker is
                                        a home health aide as
                                        described in Sec.
                                        418.76 or an
                                        individual who meets
                                        the standards in Sec.
                                         418.202(g) and has
                                        successfully completed
                                        hospice orientation
                                        addressing the needs
                                        and concerns of
                                        patients and families
                                        coping with a terminal
                                        illness.
418.76(k)............................  Homemaker supervision    Same...................  New and amended
                                        and duties.                                       language.
                                       (1) Homemaker services
                                        must be coordinated by
                                        a member of the
                                        interdisciplinary
                                        group.
                                       (2) Instructions for
                                        homemaker duties must
                                        be prepared by a
                                        member of the
                                        interdisciplinary
                                        group.
                                       (3) Homemakers must
                                        report all concerns
                                        about the patient or
                                        family to the member
                                        of the
                                        interdisciplinary
                                        group who is
                                        coordinating homemaker
                                        services.
----------------------------------------------------------------------------------------------------------------
                        Subpart D Conditions of Participation: Organizational Environment
----------------------------------------------------------------------------------------------------------------
418.100..............................  Organization and         Same...................  New and amended
                                        administration of                                 language.
                                        services. The hospice
                                        must organize, manage,
                                        and administer its
                                        resources to provide
                                        the hospice care and
                                        services to patients,
                                        caregivers and
                                        families necessary for
                                        the palliation and
                                        management of terminal
                                        illness.
418.100(a)...........................  Serving the hospice      Same...................  New and amended
                                        patient and family.                               language.
                                        The hospice must
                                        ensure--(1) That each
                                        patient receives and
                                        experiences hospice
                                        care that optimizes
                                        comfort and dignity;
                                        and (2) That each
                                        patient experience
                                        hospice care that is
                                        consistent with
                                        patient and family
                                        needs and desires.
418.100(c)...........................  Services: (1) A hospice  Same...................  Amended language.
                                        must be primarily
                                        engaged in providing
                                        the following care and
                                        services and must do
                                        so in a manner that is
                                        consistent within
                                        accepted standards of
                                        practice:
                                          (i) Nursing services
                                          (ii) Medical social
                                           services.
                                          (iii) Physician
                                           services.
                                          (iv) Counseling
                                           services, including
                                           spiritual
                                           counseling, dietary
                                           counseling, and
                                           bereavement
                                           counseling.
                                          (v) Home health
                                           aide, volunteer,
                                           and homemaker
                                           services.
                                          (vi) Physical
                                           therapy,
                                           occupational
                                           therapy and speech-
                                           language pathology
                                           therapy services.
                                          (vii) Short-term
                                           inpatient care.
                                          (viii) Medical
                                           supplies (including
                                           drugs and
                                           biologicals) and
                                           medical appliances.

[[Page 32176]]

 
                                       (2) Nursing services,
                                        physician services,
                                        and drugs and
                                        biologicals (as
                                        specified in Sec.
                                        418.106) must be made
                                        routinely available on
                                        a 24-hour basis 7 days
                                        a week. Other covered
                                        services must be
                                        available on a 24-hour
                                        basis when reasonable
                                        and necessary to meet
                                        the needs of the
                                        patient and family.
418.100(e)...........................  Professional management  Same...................  Amended language.
                                        responsibility. A
                                        hospice that has a
                                        written agreement with
                                        another agency,
                                        individual, or
                                        organization to
                                        furnish any services
                                        under arrangement,
                                        must retain
                                        administrative and
                                        financial management,
                                        and supervision of
                                        staff and services for
                                        all arranged services,
                                        to ensure the
                                        provision of quality
                                        care. Arranged
                                        services must be
                                        supported by written
                                        agreements that
                                        require that all
                                        services be--
                                       (1) Authorized by the
                                        hospice;
                                       (2) Furnished in a safe
                                        and effective manner
                                        by personnel having at
                                        least the same
                                        qualifications as
                                        hospice employees; and
                                          (3) Delivered in
                                           accordance with the
                                           patient's plan of
                                           care.
418.100(f)...........................  Hospice satellite        Same...................  Renamed. Amended
                                        locations: (1) All                                language.
                                        hospice satellite
                                        locations must be
                                        approved by CMS before
                                        providing hospice care
                                        and services to
                                        Medicare patients. The
                                        determination that a
                                        satellite location
                                        does or does not meet
                                        the definition of a
                                        satellite location, as
                                        set forth in this
                                        part, is an initial
                                        determination, as set
                                        forth in Sec.   498.3.
                                       (2) The hospice must
                                        continually monitor
                                        and manage all
                                        services provided at
                                        all of its locations
                                        to ensure that
                                        services are delivered
                                        in a safe and
                                        effective manner and
                                        to ensure that each
                                        patient and family
                                        receives the necessary
                                        care and services
                                        outlined in the plan
                                        of care.
418.100(g)...........................  In-service training: A   Same...................  Renamed. New and
                                        hospice must assess                               amended language.
                                        the skills and
                                        competence of all
                                        individuals furnishing
                                        care, including
                                        volunteers furnishing
                                        services, and, as
                                        necessary, provide in-
                                        service training and
                                        education programs
                                        where required. The
                                        hospice must have
                                        written policies and
                                        procedures describing
                                        its method(s) of
                                        assessment of
                                        competency and
                                        maintain a written
                                        description of the in-
                                        service training
                                        provided during the
                                        previous 12 months.
418.102..............................  Medical director. The    Same...................  Amended language.
                                        hospice must designate
                                        a physician to serve
                                        as medical director.
                                        The medical director
                                        must be a doctor of
                                        medicine or osteopathy
                                        who is either employed
                                        by, or under contract
                                        with, the hospice.
                                        When the medical
                                        director is not
                                        available, a physician
                                        designated by the
                                        medical director
                                        assumes the same
                                        responsibilities and
                                        obligations as the
                                        medical director. The
                                        medical director and
                                        physician designee
                                        coordinate with other
                                        physicians and health
                                        care professionals to
                                        ensure that each
                                        patient experiences
                                        medical care that
                                        reflects hospice
                                        policy.
418.102(a)...........................  Initial certification    418.102(b).............  Amended language.
                                        of terminal illness.
                                        The medical director
                                        or physician designee
                                        reviews the clinical
                                        information for each
                                        hospice patient and
                                        provides written
                                        certification that it
                                        is anticipated that
                                        the patient's life
                                        expectancy is 6 months
                                        or less if the illness
                                        runs its normal
                                        course. The physician
                                        must consider the
                                        following criteria
                                        when making this
                                        determination:
                                          (1) The primary
                                           terminal condition.
                                          (2) Related
                                           diagnosis(es), if
                                           any.
                                          (3) Current
                                           subjective and
                                           objective medical
                                           findings.
                                          (4) Current
                                           medication and
                                           treatment orders.
                                          (5) Information
                                           about the medical
                                           management of any
                                           of the patient's
                                           conditions
                                           unrelated to the
                                           terminal illness.
New..................................                           418.102(a).............  New.
418.102(b)...........................  Recertification of the   418.102(c).............  Amended language.
                                        terminal illness.
                                        Before the
                                        recertification period
                                        for each patient, as
                                        described in Sec.
                                        418.21(a), the medical
                                        director or physician
                                        designee must review:
                                       (1) The patient's
                                        clinical information;
                                        and
                                          (2) The patient's     Deleted................  Deleted.
                                           and family's
                                           expectations and
                                           wishes for the
                                           continuation of
                                           hospice care.

[[Page 32177]]

 
418.102(c)...........................  Coordination of medical  Deleted................  Deleted.
                                        care. The medical
                                        director or physician
                                        designee, and the
                                        other members of the
                                        interdisciplinary
                                        group are jointly
                                        responsible for the
                                        coordination of the
                                        patient's medical care
                                        in its entirety. The
                                        medical director or
                                        physician designee is
                                        also responsible for
                                        directing the
                                        hospice's quality
                                        assessment and
                                        performance
                                        improvement program.
New..................................  New....................  418.102(d).............  New.
418.104(a)...........................  Clinical records.        Same...................  New and amended
                                        Content. Each                                     language.
                                        patient's record must
                                        include the following:
                                          (1) The plan of
                                           care, initial
                                           assessment,
                                           comprehensive
                                           assessment, and
                                           updated
                                           comprehensive
                                           assessments,
                                           clinical notes, and
                                           progress notes.
                                          (2) Informed
                                           consent,
                                           authorization, and
                                           election forms.
                                          (3) Responses to
                                           medications,
                                           symptom management,
                                           treatments, and
                                           services.
                                          (4) Outcome measure
                                           data elements, as
                                           described in Sec.
                                           418.54(e) of this
                                           subpart.
                                          (5) Physician
                                           certification and
                                           recertification of
                                           terminal illness as
                                           required in Sec.
                                           418.22 and
                                           described in Sec.
                                           418.102(a) and Sec.
                                             418.102(b)
                                           respectively.
                                          (6) Any advance
                                           directives as
                                           described in Sec.
                                           418.52(a)(3).
418.104(b)...........................  Authentication. All      Same...................  New and amended
                                        entries must be                                   language.
                                        legible, clear,
                                        complete, and
                                        appropriately
                                        authenticated and
                                        dated. All entries
                                        must be signed, and
                                        the hospice must be
                                        able to authenticate
                                        each handwritten and
                                        electronic signature
                                        of a primary author
                                        who has reviewed and
                                        approved the entry.
418.104(d)...........................  Retention of records:    Same...................  Amended language.
                                        Patient clinical
                                        records must be
                                        retained for 5 years
                                        after the death or
                                        discharge of the
                                        patient, unless State
                                        law stipulates a
                                        longer period of time.
                                        If the hospice
                                        discontinues
                                        operation, hospice
                                        policies must provide
                                        for retention and
                                        storage of clinical
                                        records. The hospice
                                        must inform its State
                                        agency and its CMS
                                        Regional office where
                                        such clinical records
                                        will be stored and how
                                        they may be accessed.
418.104(e)...........................  Discharge or transfer    Same...................  New and amended
                                        of care: (1) If the                               language.
                                        care of a patient is
                                        transferred to another
                                        Medicare/Medicaid
                                        approved facility, the
                                        hospice must forward a
                                        copy of the patient's
                                        clinical record and
                                        the hospice discharge
                                        summary to that
                                        facility.
                                       (2) If a patient
                                        revokes the election
                                        of hospice care, or is
                                        discharged from
                                        hospice because
                                        eligibility criteria
                                        are no longer met, the
                                        hospice must provide a
                                        copy of the clinical
                                        record and the hospice
                                        discharge summary of
                                        this section to the
                                        patient's attending
                                        physician.
                                       (3) The hospice
                                        discharge summary must
                                        include--
                                       (i) A summary of the
                                        patient's stay
                                        including treatments,
                                        symptoms and pain
                                        management;
                                       (ii) The patient's
                                        current plan of care;
                                       (iii) The patient's
                                        latest physician
                                        orders; and
                                          (iv) Any other
                                           documentation that
                                           will assist in post-
                                           discharge
                                           continuity of care.
418.106(a)...........................  Drugs and biologicals,   418.106(d).............  Partially deleted and
                                        medical supplies, and                             moved to stem.
                                        durable medical
                                        equipment.
                                        Administration of
                                        Drugs and biologicals:
                                        (1) All drugs and
                                        biologicals must be
                                        administered in
                                        accordance with
                                        accepted hospice and
                                        palliative care
                                        standards of practice
                                        and according to the
                                        patient's plan of care.
418.106(a)...........................  (2) The                  418.106(d)(1)..........  Renamed. New and
                                        interdisciplinary                                 amended language.
                                        group, as part of the
                                        review of the plan of
                                        care, must determine
                                        the ability of the
                                        patient and/or family
                                        to safely self-
                                        administer drugs and
                                        biologicals.
New..................................  New....................  418.106(a).............  Renamed. New and
                                                                                          amended language.
418.106(b)...........................  Controlled drugs: The    418.106(e).............  Renamed. New and
                                        hospice must have a                               amended language.
                                        written policy for
                                        tracking, collecting,
                                        and disposing of
                                        controlled drugs
                                        maintained in the
                                        patient's home. During
                                        the initial hospice
                                        assessment, the use
                                        and disposal of
                                        controlled substances
                                        must be discussed with
                                        the patient and family
                                        to ensure the patient
                                        and family are
                                        educated regarding the
                                        uses and potential
                                        dangers of controlled
                                        substances. The
                                        hospice nurse must
                                        document that the
                                        policy was discussed
                                        with the patient and
                                        family.

[[Page 32178]]

 
418.110(n)(1)........................  New....................  418.106(b).............  Renamed. New and
                                                                                          amended language.
418.106(c)...........................  Use and maintenance of   418.106(f).............  New and amended
                                        equipment and                                     language.
                                        supplies. (1) The
                                        hospice must follow
                                        manufacturer
                                        recommendations for
                                        performing routine and
                                        preventive maintenance
                                        on durable medical
                                        equipment. The
                                        equipment must be safe
                                        and work as intended
                                        for use in the
                                        patient's environment.
                                        Where there is no
                                        manufacturer
                                        recommendation for a
                                        piece of equipment,
                                        the hospice must
                                        develop in writing its
                                        own repair and routine
                                        maintenance policy.
                                        The hospice may use
                                        persons under contract
                                        to ensure the
                                        maintenance and repair
                                        of durable medical
                                        equipment.
                                       (2) The hospice must
                                        ensure that the
                                        patient, where
                                        appropriate, as well
                                        as the family and/or
                                        other caregiver(s),
                                        receive instruction in
                                        the safe use of
                                        durable medical
                                        equipment and
                                        supplies. The patient,
                                        family, and/or
                                        caregiver must be able
                                        to demonstrate the
                                        appropriate use of
                                        durable medical
                                        equipment to the
                                        satisfaction of the
                                        hospice staff.
418.110(m)...........................  .......................  418.106(c).............  Renamed. New and
                                                                                          amended language.
418.110(n)(2)........................  .......................  418.106(d)(2)..........  Renamed. New and
                                                                                          amended language.
418.106(b) and 418.110(n)(3)-(5).....  .......................  418.106(e).............  Renamed. New and
                                                                                          amended language.
New..................................  New....................  418.106(f)(3)..........  Amended language.
418.108(a)...........................  Inpatient care for       Same...................  Amended language.
                                        symptom management and
                                        pain control.
                                        Inpatient care for
                                        pain control and
                                        symptom management
                                        must be provided in
                                        one of the following:
                                        (1) A Medicare-
                                        approved hospice that
                                        meets the conditions
                                        of participation for
                                        providing inpatient
                                        care directly as
                                        specified in Sec.
                                        418.110. (2) A
                                        Medicare-participating
                                        hospital or a skilled
                                        nursing facility that
                                        also meets the
                                        standards specified in
                                        Sec.   418.110(b) and
                                        (f) regarding 24-hour
                                        nursing services and
                                        patient areas.
418.108(b)...........................  Inpatient care for       Same...................  New and amended
                                        respite purposes:                                 language.
                                        Inpatient care for
                                        respite purposes must
                                        be provided by one of
                                        the following:
                                          (1) A provider
                                           specified in
                                           paragraph (a) of
                                           this section.
                                          (2) A Medicare/
                                           Medicaid approved
                                           nursing facility
                                           that also meets the
                                           standards specified
                                           in Sec.   418.110
                                           (b) and (f).
418.108(c)...........................  Inpatient care provided  Same...................  Amended language.
                                        under arrangements. If
                                        the hospice has an
                                        arrangement with a
                                        facility to provide
                                        for short-term
                                        inpatient care, the
                                        arrangement is
                                        described in a legally
                                        binding written
                                        agreement that at a
                                        minimum specifies--
                                       (1) That the hospice
                                        supplies the inpatient
                                        provider a copy of the
                                        patient's plan of care
                                        and specifies the
                                        inpatient services to
                                        be furnished;
                                       (2) That the inpatient
                                        provider has
                                        established patient
                                        care policies
                                        consistent with those
                                        of the hospice and
                                        agrees to abide by the
                                        palliative care
                                        protocols and plan of
                                        care established by
                                        the hospice for its
                                        patients;
                                       (3) That the hospice
                                        patient's inpatient
                                        clinical record
                                        includes a record of
                                        all inpatient services
                                        furnished, events
                                        regarding care that
                                        occurred at the
                                        facility, and that a
                                        copy of the inpatient
                                        clinical record and
                                        discharge summary is
                                        available to the
                                        hospice at the time of
                                        discharge;
                                       (4) That the inpatient
                                        facility has
                                        identified a
                                        individual within the
                                        facility who is
                                        responsible for the
                                        implementation of the
                                        provisions of the
                                        agreement;
                                       (5) That the hospice
                                        retains responsibility
                                        for arranging the
                                        training of personnel
                                        who will be providing
                                        the patient's care in
                                        the inpatient facility
                                        and that a description
                                        of the training and
                                        the names of those
                                        giving the training is
                                        documented; and
                                       (6) That a way to
                                        verify that
                                        requirements in
                                        paragraphs (c)(1)
                                        through (c)(5) of this
                                        section have been met
                                        is established.
418.110..............................  Hospices that provide
                                        inpatient care
                                        directly.
418.110..............................  A hospice that provides  Same...................  New language.
                                        inpatient care
                                        directly must
                                        demonstrate compliance
                                        with all of the
                                        following standards:

[[Page 32179]]

 
418.110(b)...........................  Twenty-four hour         Same...................  New language.
                                        nursing services: The
                                        hospice facility must
                                        provide 24-hour
                                        nursing services that
                                        meet the nursing needs
                                        of all patients and
                                        are furnished in
                                        accordance with each
                                        patient's plan of
                                        care. Each patient
                                        must receive all
                                        nursing services as
                                        prescribed and must be
                                        kept comfortable,
                                        clean, well-groomed,
                                        and protected from
                                        accident, injury, and
                                        infection.
418.110(c)...........................  Physical environment.    Same...................  Amended language.
                                        The hospice must
                                        maintain a safe
                                        physical environment
                                        free of hazards for
                                        patients, staff, and
                                        visitors.
                                       (1) Safety management.
                                        (i) The hospice must
                                        address real or
                                        potential threats to
                                        the health and safety
                                        of the patients,
                                        others, and property.
                                        The hospice must
                                        report a breach of
                                        safety to appropriate
                                        State and local bodies
                                        having regulatory
                                        jurisdiction and
                                        correct it promptly.
                                          (ii) The hospice
                                           must take steps to
                                           prevent equipment
                                           failure and when a
                                           failure occurs,
                                           report it to the
                                           appropriate State
                                           and local bodies
                                           having regulatory
                                           jurisdiction and
                                           correct it promptly.
                                          (iii) The hospice
                                           must have a written
                                           disaster
                                           preparedness plan
                                           in effect for
                                           managing the
                                           consequences of
                                           power failures,
                                           natural disasters,
                                           and other
                                           emergencies that
                                           would affect the
                                           hospice's ability
                                           to provide care.
                                           The plan must be
                                           periodically
                                           reviewed and
                                           rehearsed with
                                           staff (including
                                           non-employee staff)
                                           with special
                                           emphasis placed on
                                           carrying out the
                                           procedures
                                           necessary to
                                           protect patients
                                           and others.
418.110(c)...........................  (2) Physical plant and   Same...................  Amended language.
                                        equipment. The hospice
                                        must develop
                                        procedures for
                                        managing the control,
                                        reliability, and
                                        quality of--
                                       (i) The routine storage
                                        and prompt disposal of
                                        trash and medical
                                        waste;
                                       (ii) Light,
                                        temperature, and
                                        ventilation/air
                                        exchanges throughout
                                        the hospice;
418.110(d)...........................  Fire protection........  Same...................  Amended language.
418.110(f)...........................  Patient rooms: (1) The   Same...................  New and amended
                                        hospice must ensure                               language.
                                        that patient rooms are
                                        designed and equipped
                                        for nursing care, as
                                        well as the dignity,
                                        comfort, and privacy
                                        of patients.
                                       (2) The hospice must
                                        accommodate a patient
                                        and family request for
                                        a single room whenever
                                        possible.
                                       (3) Each patient's room
                                        must--
                                       (i) Be at or above
                                        grade level;
                                       (ii) Contain a suitable
                                        bed and other
                                        appropriate furniture
                                        for each patient;
                                       (iii) Have closet space
                                        that provides security
                                        and privacy for
                                        clothing and personal
                                        belongings;
                                       (iv) Accommodate no
                                        more than two
                                        patients;
                                       (v) Provide at least 80
                                        square feet for each
                                        residing patient in a
                                        double room and at
                                        least 100 square feet
                                        for each patient
                                        residing in a single
                                        room; and
                                          (vi) Be equipped
                                           with an easily-
                                           activated,
                                           functioning device
                                           accessible to the
                                           patient, that is
                                           used for calling
                                           for assistance.
418.110(f)(4)........................  For an existing          Same...................  New and amended
                                        building, CMS may                                 language.
                                        waive the space and
                                        occupancy requirements
                                        of paragraphs
                                        (f)(2)(iv) and
                                        (f)(2)(v) of this
                                        section for a period
                                        of time if it
                                        determines that--(i)
                                        Imposition of the
                                        requirements would
                                        result in unreasonable
                                        hardship on the
                                        hospice if strictly
                                        enforced; or
                                        jeopardize its ability
                                        to continue to
                                        participate in the
                                        Medicare program; and
418.110(m)...........................  Pharmaceutical           418.106(a).............  New and amended
                                        services: Under the                               language.
                                        direction of a
                                        qualified pharmacist,
                                        the hospice must
                                        provide pharmaceutical
                                        services such as drugs
                                        and biologicals and
                                        have a written process
                                        in place that ensures
                                        dispensing accuracy.
418.110(m)...........................  The hospice will         418.54(a)(6)...........  New and amended
                                        evaluate a patient's                              language.
                                        response to the
                                        medication therapy,
                                        identify adverse drug
                                        reactions, and take
                                        appropriate corrective
                                        action.
418.110(m)...........................  Drugs and biologicals    418.106(c).............  New and amended
                                        must be obtained from                             language.
                                        community or
                                        institutional
                                        pharmacists or stocked
                                        by the hospice.

[[Page 32180]]

 
418.110(m)...........................  The hospice must         418.106 Stem...........  New and amended
                                        furnish the drugs and                             language.
                                        biologicals for each
                                        patient, as specified
                                        in each patient's plan
                                        care.
418.110(m)...........................  The use of drugs and     418.100(c) and 418.116.  New and amended
                                        biologicals must be                               language.
                                        provided in accordance
                                        with accepted
                                        professional
                                        principles and
                                        appropriate Federal,
                                        State, and local laws.
418.110(n)...........................  Pharmacist: A licensed   418.106(a).............  New and amended
                                        pharmacist must                                   language.
                                        provide consultation
                                        on all aspects of the
                                        provision of
                                        pharmaceutical care in
                                        the facility,
                                        including ordering,
                                        storage,
                                        administration,
                                        disposal, and record
                                        keeping of drugs and
                                        biologicals.
418.110(n)(1)........................  Orders for medications.  418.106(b).............  New and amended
                                                                                          language.
                                       (i) A physician as
                                        defined by section
                                        1861(r)(1) of the Act,
                                        or a nurse
                                        practitioner in
                                        accordance with the
                                        plan of care and State
                                        law, must order all
                                        medications for the
                                        patient.
                                       (ii) If the medication
                                        order is verbal or
                                        given by or through
                                        electronic
                                        transmission--
                                       (A) The physician must
                                        give it only to a
                                        licensed nurse, nurse
                                        practitioner (where
                                        appropriate),
                                        pharmacist, or another
                                        physician; and
                                       (B) The individual
                                        receiving the order
                                        must record and sign
                                        it immediately and
                                        have the prescribing
                                        physician sign it in
                                        accordance with State
                                        and Federal
                                        regulations.
418.110(n)(2)........................  Administration of        418.106(d)(2)..........  New and amended
                                        medications.                                      language.
                                        Medications must be
                                        administered by only
                                        the following
                                        individuals:
                                          (i) A licensed
                                           nurse, physician,
                                           or other health
                                           care professional
                                           in accordance with
                                           their scope of
                                           practice.
                                          (ii) An employee who
                                           has completed a
                                           State-approved
                                           training program in
                                           medication
                                           administration.
                                          (iii) The patient,
                                           upon approval by
                                           the attending
                                           physician.
418.110(n)(3)........................  Labeling of drugs and    418.106(e)(1)..........  New and amended
                                        biologicals. Drugs and                            language.
                                        biologicals must be
                                        labeled in accordance
                                        with currently
                                        accepted professional
                                        practice and must
                                        include appropriate
                                        accessory and
                                        cautionary
                                        instructions, as well
                                        as an expiration date
                                        (if applicable).
418.110(n)(4)........................  Drug management          418.106(e)(3)..........  New and amended
                                        procedures. (i) All                               language.
                                        drugs and biologicals
                                        must be stored in
                                        secure areas. All
                                        drugs listed in
                                        Schedules II, III, IV,
                                        and V of the
                                        Comprehensive Drug
                                        Abuse Prevention and
                                        Control Act of 1976
                                        must be stored in
                                        locked compartments
                                        within such secure
                                        storage areas. Only
                                        personnel authorized
                                        to administer
                                        controlled medications
                                        may have access to the
                                        locked compartments.
                                       (ii) The hospice must
                                        keep current and
                                        accurate records of
                                        the receipt and
                                        disposition of all
                                        controlled drugs.
                                       (iii) Any discrepancies
                                        in the acquisition,
                                        storage, use,
                                        disposal, or return of
                                        controlled drugs must
                                        be investigated
                                        immediately by the
                                        pharmacist and hospice
                                        administrator and
                                        where required
                                        reported to the
                                        appropriate State
                                        agency. A written
                                        account of the
                                        investigation must be
                                        made available to
                                        State and Federal
                                        officials.
418.110(n)(5)........................  Drug disposal.           418.106(e)(2)(ii)......  New and amended
                                        Controlled drugs no                               language.
                                        longer needed by a
                                        patient must be
                                        disposed of in
                                        compliance with the
                                        hospice policy and in
                                        accordance with State
                                        and Federal
                                        requirements.
418.110(o)(1)........................  Seclusion and            418.110(m).............  Same.
                                        restraint: (1) The
                                        patient has the right
                                        to be free from
                                        seclusion and
                                        restraint, of any
                                        form, imposed as a
                                        means of coercion,
                                        discipline,
                                        convenience, or
                                        retaliation by staff.
418.110(o)(1)........................  The term restraint
                                        includes either a
                                        physical restraint or
                                        a drug that is being
                                        used as a restraint. A
                                        physical restraint is
                                        any manual method or
                                        physical or mechanical
                                        device, material or
                                        equipment attached or
                                        adjacent to the
                                        patient's body that he
                                        or she cannot easily
                                        remove, that restricts
                                        free movement of,
                                        normal function of, or
                                        normal access to one's
                                        body.

[[Page 32181]]

 
                                       A drug used as a         418.3..................  Same.
                                        restraint is a
                                        medication used to
                                        control behavior or to
                                        restrict the patient's
                                        freedom of movement
                                        and is not a standard
                                        treatment for a
                                        patient's medical or
                                        psychiatric condition.
                                        Seclusion is the
                                        confinement of a
                                        person alone in a room
                                        or an area where a
                                        person is physically
                                        prevented from leaving.
418.110(o)(2)........................  Seclusion and restraint  418.110(m) and           Same.
                                        can only be used in      418.110(m)(1).
                                        emergency situations
                                        if needed to ensure
                                        the patient's or
                                        others' physical
                                        safety, and only if
                                        less restrictive
                                        interventions have
                                        been tried, determined
                                        and documented to be
                                        ineffective.
418.110(o)(3)(i).....................  The use of restraint     418.110(m)(2)..........  New and amended
                                        and seclusion must be--                           language.
 
                                       (i) Selected only when
                                        less restrictive
                                        measures have been
                                        found ineffective to
                                        protect the patient or
                                        others from harm;
418.110(o)(3)(ii)....................  Carried out in           418.110(m)(4) and        New and amended
                                        accordance with the      418.110(m)(7).           language.
                                        order of a physician.
                                        The following will be
                                        superseded by more
                                        restrictive State
                                        laws:
418.110(o)(3)(ii)(A).................  Orders for seclusion or  418.110(m)(5)..........  Amended language.
                                        restraints must never
                                        be written as a
                                        standing order or an
                                        as needed basis (that
                                        is, PRN).
418.110(o)(3)(ii)(B).................  The hospice medical      418.110(m)(6)..........  Amended language.
                                        director or physician
                                        designee must be
                                        consulted as soon as
                                        possible if restraint
                                        or seclusion is not
                                        ordered by the hospice
                                        medical director or
                                        physician designee.
418.110(o)(3)(ii)(C).................  A hospice medical        418.110(m)(11) and       New and amended
                                        director or physician    418.110(m)(12).          language.
                                        designee must see the
                                        patient and evaluate
                                        the need for restraint
                                        or seclusion within 1
                                        hour after initiation
                                        of this intervention.
418.110(o)(3)(ii)(D).................  Each order for a         418.110(m)(7)..........  New and amended
                                        physical restraint or                             language.
                                        seclusion must be in
                                        writing and limited to
                                        4 hours for adults; 2
                                        hours for children and
                                        adolescents ages 9
                                        through 17; or 1 hour
                                        for patients under the
                                        age of 9. The original
                                        order may only be
                                        renewed in accordance
                                        with these limits for
                                        up to a total of 24
                                        hours. After the
                                        original order
                                        expires, a physician
                                        must reassess the
                                        patient's need before
                                        issuing another
                                        seclusion and
                                        restraint order.
418.110(o)(3)(iii)...................  In accordance with the   418.110(m)(3)(i).......  Amended language.
                                        interdisciplinary
                                        group and a written
                                        modification to the
                                        patient's plan of
                                        care;
418.110(o)(3)(iv)....................  Implemented in the       418.110(m)(2)..........  Amended language.
                                        least restrictive
                                        manner possible not to
                                        interfere with the
                                        palliative care being
                                        provided;
418.110(o)(3)(v).....................  In accordance with       418.110(m)(3)(ii)......  Amended language.
                                        safe, appropriate
                                        restraining techniques.
418.110(o)(3)(vi)....................  Ended at the earliest    418.110(m)(8)..........  Amended language.
                                        possible time; and
418.110(o)(3)(vii)...................  Supported by medical     418.110(m)(15).........  New and amended
                                        necessity and the                                 language.
                                        patient's response or
                                        outcome, and
                                        documented in the
                                        patient's clinical
                                        record.
418.110(o)(4)........................  A restraint and          418.110(m)(14).........  Amended language.
                                        seclusion may not be
                                        used simultaneously
                                        unless the patient is--
 
                                       (i) Continually
                                        monitored face to face
                                        by an assigned staff
                                        member; or
                                          (ii) Continually
                                           monitored by staff
                                           using video and
                                           audio equipment.
                                           Staff must be in
                                           immediate response
                                           proximity to the
                                           patient.
418.110(o)(5)........................  The condition of the     418.110(m)(9)..........  New and amended
                                        patient who is in a                               language.
                                        restraint or in
                                        seclusion must
                                        continually be
                                        assessed, monitored,
                                        and reevaluated by an
                                        assigned staff member.
418.110(o)(6)........................  All staff who have       418.110(n).............  New and amended
                                        direct patient contact                            language.
                                        must have ongoing
                                        education and training
                                        in the proper and safe
                                        use of seclusion and
                                        restraint application
                                        and techniques and
                                        alternative methods
                                        for handling behavior,
                                        symptoms, and
                                        situations that
                                        traditionally have
                                        been treated through
                                        the use of restraints
                                        or seclusion.
418.110(o)(7)........................  The hospice must report  418.110(o).............  New and amended
                                        to the CMS regional                               language.
                                        office any death that
                                        occurs while the
                                        patient is restrained
                                        or in seclusion,
                                        within 24 hours after
                                        a patient has been
                                        removed from restraint
                                        or seclusion.
418.112..............................  Hospices that provide    Same...................  New and amended
                                        hospice care to                                   language.
                                        residents of a SNF/NF,
                                        ICF/MR, or other
                                        facilities. In
                                        addition to meeting
                                        the conditions of
                                        participation at Sec.
                                         418.10 through Sec.
                                        418.116, a hospice
                                        that provides hospice
                                        care to residents of a
                                        SNF/NF, ICF/MR, or
                                        other residential
                                        facility must abide by
                                        the following
                                        additional standards.

[[Page 32182]]

 
418.112(a)...........................  Resident eligibility     Same...................  New and amended
                                        election, and duration                            language.
                                        of benefits. Medicare
                                        patients receiving
                                        hospice services and
                                        residing in a SNF, NF,
                                        or other facility must
                                        meet the Medicare
                                        hospice eligibility
                                        criteria as identified
                                        in Sec.   418.20
                                        through Sec.   418.30.
418.112(b)...........................  Professional             Same...................  New and amended
                                        management: The                                   language.
                                        hospice must assume
                                        full responsibility
                                        for professional
                                        management of the
                                        resident's hospice
                                        care, in accordance
                                        with the hospice
                                        conditions of
                                        participation and make
                                        any arrangements
                                        necessary for
                                        inpatient care in a
                                        participating Medicare/
                                        Medicaid facility
                                        according to Sec.
                                        418.100.
418.112(c)...........................  Core services: A         418.64.................  New and amended
                                        hospice must routinely                            language.
                                        provide all core
                                        services. These
                                        services include
                                        nursing services,
                                        medical social
                                        services, and
                                        counseling services.
                                       The hospice may
                                        contract for physician
                                        services as stated in
                                        Sec.   418.64(a). A
                                        hospice may use
                                        contracted staff
                                        provided by another
                                        Medicare certified
                                        hospice to furnish
                                        core services, if
                                        necessary, to
                                        supplement hospice
                                        employees in order to
                                        meet the needs of
                                        patients under
                                        extraordinary or other
                                        non-routine
                                        circumstances, as
                                        described in Sec.
                                        418.64.
418.112(d)...........................  Medical director: The    418.112(e).............  New and amended
                                        medical director and                              language.
                                        physician designee of
                                        the hospice must
                                        provide overall
                                        coordination of the
                                        medical care of the
                                        hospice resident that
                                        resides in an SNF, NF,
                                        or other facility. The
                                        medical director and
                                        physician designee
                                        must communicate with
                                        the medical director
                                        of the SNF/NF, the
                                        patient's attending
                                        physician, and other
                                        physicians
                                        participating in the
                                        provision of care for
                                        the terminal and
                                        related conditions to
                                        ensure quality care
                                        for the patient and
                                        family.
418.112(e)...........................  Written agreement: The   418.112(c).............  New and amended
                                        hospice and the                                   language.
                                        facility must have a
                                        written agreement that
                                        specifies the
                                        provision of hospice
                                        services in the
                                        facility. The
                                        agreement must be
                                        signed by authorized
                                        representatives of the
                                        hospice and the
                                        facility before the
                                        provision of hospice
                                        services.
418.112(e)(1) and (e)(2).............  The written agreement    Deleted................  Deleted.
                                        must include at least
                                        the following:
                                          (1) The written
                                           consent of the
                                           patient or the
                                           patient's
                                           representative that
                                           hospice services
                                           are desired.
                                          (2) The services
                                           that the hospice
                                           will furnish and
                                           that the facility
                                           will furnish.
418.112(e)(3)........................  The manner in which the  418.112(c)(1)..........  Amended language.
                                        facility and the
                                        hospice are to
                                        communicate with each
                                        other to ensure that
                                        the needs of the
                                        patient are addressed
                                        and met 24 hours a day.
418.112(e)(4)(i) and (ii)............  A provision that the     418.112(c)(2),           Amended language.
                                        facility immediately     418.112(c)(2)(i) and
                                        notifies the hospice     418.112(c)(2)(ii).
                                        if--
                                       (i) A significant
                                        change in the
                                        patient's physical,
                                        mental, social, or
                                        emotional status
                                        occurs;
                                       (ii) Clinical
                                        complications appear
                                        that suggest a need to
                                        alter the plan of
                                        care;
418.112(e)(4)(iii)...................  A life threatening       Deleted................  Deleted.
                                        condition appears;
418.112(e)(4)(iv)....................  A need to transfer the   418.112(c)(2)(iii).....  Amended language.
                                        patient from the
                                        facility and the
                                        hospice makes
                                        arrangements for, and
                                        remains responsible
                                        for, any necessary
                                        continuous care or
                                        inpatient care
                                        necessary related to
                                        the terminal illness;
                                        or
418.112(e)(4)(v).....................  The patient dies.......  418.112(c)(2)(iv)......  Amended language.
418.112(e)(5)........................  A provision stating      418.112(c)(3)..........  Amended language.
                                        that the hospice
                                        assumes responsibility
                                        for determining the
                                        appropriate course of
                                        care, including the
                                        determination to
                                        change the level of
                                        services provided.
418.112(e)(6)........................  An agreement that it is  418.112(c)(4)..........  New and amended
                                        the facility's primary                            language.
                                        responsibility to
                                        furnish room and board.
New..................................  New....................  418.112(c)(5)..........  New.

[[Page 32183]]

 
418.112(e)(7)........................  A delineation of the     418.112(c)(6)..........  New and amended
                                        hospice's                                         language.
                                        responsibilities,
                                        which include, but are
                                        not limited to,
                                        providing medical
                                        direction and
                                        management of the
                                        patient, nursing,
                                        counseling (including
                                        spiritual and dietary
                                        counseling), social
                                        work, bereavement
                                        counseling for
                                        immediate family
                                        members, provision of
                                        medical supplies and
                                        durable medical
                                        equipment, and drugs
                                        necessary for the
                                        palliation of pain and
                                        symptoms associated
                                        with the terminal
                                        illness, as well as
                                        all other hospice
                                        services that are
                                        necessary for the care
                                        of the resident's
                                        terminal illness.
418.112(e)(8)........................  A provision that the     418.112(c)(7)..........  Amended language.
                                        hospice may use the
                                        facility's nursing
                                        personnel where
                                        permitted by law and
                                        as specified by the
                                        facility to assist in
                                        the administration of
                                        prescribed therapies
                                        included in the plan
                                        of care only to the
                                        extent that the
                                        hospice would
                                        routinely utilize the
                                        services of a hospice
                                        resident's family in
                                        implementing the plan
                                        of care.
New..................................  New....................  418.112(c)(8)..........  New.
New..................................  New....................  418.112(c)(9)..........  New.
418.112(f)...........................  Hospice plan of care: A  418.112(d).............  New and amended
                                        written plan of care                              language.
                                        must be established
                                        and maintained for
                                        each facility patient
                                        and must be developed
                                        by and coordinated
                                        with the hospice
                                        interdisciplinary
                                        group in consultation
                                        with facility
                                        representatives and in
                                        collaboration with the
                                        attending physician.
                                        All care provided must
                                        be in accordance with
                                        this plan.
418.112(f)...........................  The plan must reflect    418.56(b) and (c)......  New and amended
                                        the hospice's policies                            language.
                                        and procedures in all
                                        aspects and be based
                                        on an assessment of
                                        the patient's needs
                                        and unique living
                                        situation in the
                                        facility. It must
                                        include the patient's
                                        current medical,
                                        physical, social,
                                        emotional, and
                                        spiritual needs.
                                        Directives for
                                        management of pain and
                                        other symptoms must be
                                        addressed and updated
                                        as necessary to
                                        reflect the patient's
                                        status.
418.112(f)(1)........................  The plan of care must    418.112(d)(1)..........  Amended language.
                                        identify the care and
                                        services that are
                                        needed and
                                        specifically identify
                                        which provider is
                                        responsible for
                                        performing the
                                        respective functions
                                        that have been agreed
                                        upon and included in
                                        the plan of care.
418.112(f)(2)........................  The plan of care         418.112(d)(2)..........  Amended language.
                                        reflects the
                                        participation of the
                                        hospice, the facility,
                                        and the patient and
                                        family to the extent
                                        possible.
418.112(f)(3)........................  In conjunction with      418.56(d)..............  New and amended
                                        representatives of the                            language.
                                        facility, the plan of
                                        care must be reviewed
                                        at intervals specified
                                        in the plan but no
                                        less often than every
                                        14 calendar days.
418.112(f)(4)........................  Any changes in the plan  418.112(d)(3)..........  Amended language.
                                        of care must be
                                        discussed among all
                                        caregivers and must be
                                        approved by the
                                        hospice before
                                        implementation.
418.112(g)...........................  Coordination of          418.112(e)(1)..........  New and amended
                                        services: The hospice                             language.
                                        must designate a
                                        member of its
                                        interdisciplinary
                                        group to coordinate
                                        the implementation of
                                        the plan of care with
                                        the representatives of
                                        the facility. The
                                        hospice must provide
                                        the facility with the
                                        following information:
                                       (1) Plan of care.......
418.112(g)(2)-(g)(6).................  (2) Patient or           418.112(e)(3)..........  New and amended
                                        patient's                                         language.
                                        representative hospice
                                        consent form and
                                        advance directives.
                                       (3) Names and contact
                                        information for
                                        hospice personnel
                                        involved in hospice
                                        care of the patient.
                                       (4) Instructions on how
                                        to access the
                                        hospice's 24-hour on-
                                        call system.
                                       (5) Medication
                                        information specific
                                        to the patient.
                                       (6) Physician orders...
418.112(h)...........................  Transfer, revocation,    Deleted................  Deleted.
                                        or discharge from
                                        hospice care:
                                        Requirements for
                                        discharge or
                                        revocation from
                                        hospice care, Sec.
                                        418.104(e), apply.
                                        Discharge from or
                                        revocation of hospice
                                        care does not directly
                                        impact the eligibility
                                        to continue to reside
                                        in an SNF, NF, ICF/MR,
                                        or other facility.
418.112(i)...........................  Orientation and          418.112(f).............  Amended language.
                                        training: Hospice
                                        staff must orient
                                        facility staff
                                        furnishing care to
                                        hospice patients in
                                        the hospice
                                        philosophy, including
                                        hospice policies and
                                        procedures regarding
                                        methods of comfort,
                                        pain control, symptom
                                        management, as well as
                                        principles about death
                                        and dying, individual
                                        responses to death,
                                        patient rights,
                                        appropriate forms, and
                                        record keeping
                                        requirements.
418.114..............................  Personnel                Same...................  Renamed.
                                        qualifications for
                                        licensed professionals.

[[Page 32184]]

 
418.114(a)...........................  General qualification    Same...................  New and amended
                                        requirements. Except                              language.
                                        as specified in
                                        paragraph (c) of this
                                        section, all
                                        professionals who
                                        furnish services
                                        directly, under an
                                        individual contract,
                                        or under arrangements
                                        with a hospice, must
                                        be legally authorized
                                        (licensed, certified
                                        or registered) to
                                        practice by the State
                                        in which he or she
                                        performs such
                                        functions or actions,
                                        and must act only
                                        within the scope of
                                        his or her State
                                        license, or State
                                        certification, or
                                        registration. All
                                        personnel
                                        qualifications must be
                                        kept current at all
                                        times.
418.114(b)...........................  Personnel                Same...................  Renamed. New and
                                        qualifications for                                amended language.
                                        physicians, speech-
                                        language pathologists,
                                        and home health aides:
                                        The following
                                        qualifications must be
                                        met:
418.114(b)(1)........................  Physicians.............  Same and 418.3.........  New and amended
                                                                                          language.
418.114(b)(2)........................  Speech language          418.114(b)(4)..........  New and amended
                                        pathologists.                                     language.
418.114(b)(3)........................  Home health aides......  418.114(b)(2)..........  Renamed. New and
                                                                                          amended language.
418.114(c)...........................  Personnel                Same...................  New and amended
                                        qualifications when no                            language.
                                        State licensing,
                                        certification, or
                                        registration
                                        requirements exist. If
                                        no State licensing
                                        laws, certification or
                                        registration
                                        requirements exist for
                                        the profession, the
                                        following requirements
                                        must be met:
418.114(c)(1)........................  Occupational therapist.  418.114(b)(5)..........  New and amended
                                                                                          language.
418.114(c)(2)........................  Occupational therapy     418.114(b)(6)..........  New and amended
                                        assistant.                                        language.
418.114(c)(3)........................  Physical therapist.....  418.114(b)(7)..........  New and amended
                                                                                          language.
418.114(c)(4)........................  Physical therapist       418.114(b)(8)..........  New and amended
                                        assistant.                                        language.
418.114(c)(5)........................  Registered nurse. A      418.114(c)(1)..........  New and amended
                                        graduate of a school                              language.
                                        of professional
                                        nursing.
418.114(c)(6)........................  Licensed practical       418.114(c)(2)..........  New and amended
                                        nurse. A person who                               language.
                                        has completed a
                                        practical nursing
                                        program.
418.114(c)(7)........................  Social worker..........  418.114(b)(3)..........  New and amended
                                                                                          language.
418.114(d)...........................  Criminal background      Same...................  New and amended
                                        checks: The hospice                               language.
                                        must obtain a criminal
                                        background check on
                                        each hospice employee
                                        and contracted
                                        employee before
                                        employment at the
                                        hospice.
418.116(a)...........................  Standard: Licensure of   418.114(a).............  Relocated and amended.
                                        staff. Any persons who
                                        provide hospice
                                        services must be
                                        licensed, certified,
                                        or registered in
                                        accordance with
                                        applicable Federal,
                                        State and local laws.
418.116(b)...........................  Standard: Multiple       418.116(a).............  Amended language.
                                        locations. Every
                                        hospice must comply
                                        with the requirements
                                        of Sec.   420.206 of
                                        this chapter regarding
                                        disclosure of
                                        ownership and control
                                        information. All
                                        hospice satellite
                                        locations must be
                                        approved by CMS and
                                        licensed in accordance
                                        with State licensure
                                        laws, if applicable,
                                        before providing
                                        Medicare reimbursed
                                        services.
----------------------------------------------------------------------------------------------------------------

V. Collection of Information

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
    The need for the information collection and its usefulness in 
carrying out the proper functions of our agency.
    The accuracy of our estimate of the information collection burden.
    The quality, utility, and clarity of the information to be 
collected.
    Recommendations to minimize the information collection burden on 
the affected public, including automated collection techniques.
    Therefore, we are soliciting public comment on each of these issues 
for the following sections of this document that contain information 
collection requirements.

Condition of Participation: Patient's Rights (Sec.  418.52)

    Section 418.52(a)(1) states that a hospice must provide the patient 
or representative with verbal and written notice of the patient's right 
and responsibilities. The notification must be presented in a manner 
and language consistent with the patient's ability to comprehend the 
information. Section 418.52(a)(2) requires a hospice to inform and 
distribute written information on its policies concerning advance 
directives. The information must include a description of applicable 
State laws. Section 418.52(a)(3) states that a hospice must obtain the 
patient's or representative's signature confirming that he or she has 
received a copy of the notice of rights.
    The burden associated with the notification requirements contained 
in Sec.  418.52(a) is the time and effort necessary for a hospice to: 
develop the notification form; provide, both verbally and in writing, 
the patient or the patient's representative with a notice of patient's 
rights; inform and distribute information pertaining to its policies on 
advance directives and applicable State laws; obtain signatures from 
either the patient or representative confirming receipt of a copy of 
the notice of rights. There are 2,872 hospices that must comply with 
the aforementioned requirements. We estimate that it will take each 
hospice 8 hours to develop the form and 5 minutes to meet the 
requirements in Sec.  418.52(a)(1-3). We estimate that each hospice 
will on average provide 303 notifications per year for a total one time 
burden of 22,976 hours and annual burden of 72,518 hours.
    Section 418.52(b) sets out the right of the patients to exercise 
these patient rights and requires hospices to show respect for property 
and person. Specifically, Sec.  418.52(b)(4)(i) states that a hospice 
is accountable for ensuring

[[Page 32185]]

that 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 furnishing 
services on behalf of the hospice are reported immediately to the 
hospice administrator. Section 418.52(b)(4)(ii) requires a hospice to 
immediately investigate all alleged violations involving anyone 
furnishing services on behalf of the hospice and immediately take 
preventative action to avoid additional violations. As part of the 
investigation, the hospice must document and maintain all records 
associated with the alleged violations in accordance with established 
procedures. Section 418.52(b)(4)(iv) further requires that a hospice 
report all confirmed violations to the State and local bodies having 
jurisdiction within 5 working days of becoming aware of the violation.
    The burden associated with the recordkeeping and reporting 
requirements described in Sec.  418.52(b) is the time and effort 
necessary to report all alleged violations to the hospice 
administrator, to conduct and document an investigation and to maintain 
record of the documented investigation. There is also burden associated 
with reporting all verified allegations to the State and local bodies 
that have jurisdiction. We anticipate that each of the 2,872 hospices 
will investigate, document, and report 15 violations per year. We 
estimate that it will take each hospice 60 minutes per event to satisfy 
the requirements contained in Sec.  418.52(b). The estimated annual 
burden associated with the requirements contained in Sec.  418.52(b) is 
43,080 hours.

Condition of Participation: Initial and Comprehensive Assessment of the 
Patient (Sec.  418.54)

    Section 418.54 contains the information collection requirements 
associated with the initial and comprehensive assessment of the 
patient. Section 418.54(a) requires a hospice to conduct the initial 
patient assessment within 48 hours after the patient or representative 
elects the hospice benefit. Section 418.54(b) states that the hospice 
IDG must complete the patient's comprehensive assessment no later than 
5 calendar days after the patient or representative elects the hospice 
benefit. Section 418.54(c) sets out the content of the assessment. 
Section 418.54(d) requires that the comprehensive patient assessment be 
updated as needed based on the patient's condition, but no less 
frequently than every 15 days.
    The burden associated with the requirements in Sec.  418.54 is the 
time and effort necessary to document and maintain the patient 
assessment. While these requirements are subject to the PRA, the 
associated burden is exempt as stated in 5 CFR 1320.3(b)(2); conducting 
patient assessments is a usual and customary business practice. The 
time, effort, and financial resources necessary to comply with a 
collection of information that would be incurred by a person in the 
normal course of their activities are considered to be usual and 
customary and is exempt from the PRA.

Condition of Participation: Interdisciplinary Group Care Planning and 
Coordination of Services (Sec.  418.56)

    Section 418.56(a) requires a hospice that has more than one IDG to 
designate a group to establish policies governing the day-to-day 
provision of hospice care and services. The burden associated with this 
requirement is the time and effort necessary to draft, implement, and 
maintain the policies governing the day-to-day provision of hospice 
care services. While this requirement is subject to the PRA, the burden 
is considered to be usual and customary and is exempt as stated under 5 
CFR 1320.3(b)(2).
    Section 418.56(b) requires all hospice care and services furnished 
to patients and their families to follow an established plan of care 
established by the hospice IDG and the patient's caregivers. In 
addition, a hospice must ensure that each patient and the primary 
caregiver(s) receive education and training provided by the hospice. 
The education and training must be specific to the individual's 
responsibilities with respect to the care and services outlined in the 
plan of care. The burden associated with this requirement is the time 
and effort associated with educating and training the patient and 
patient caregiver(s). This requirement is currently approved under OMB 
control number 0938-0302. The expiration date for the approval is 
August 31, 2009.
    Section 418.56(c) requires hospices to develop an individualized 
written plan of care for each patient. The plan of care must contain 
the information described in Sec.  418.56(c)(1)-(6). Section 418.56(d) 
states that the hospice interdisciplinary team must review, revise, and 
document the individualized plan of care as frequently as the patient's 
condition warrants, but no less frequently than every 15 days. The 
burden associated with these requirements is the time and effort 
associated with drafting, reviewing, revising, and maintaining the plan 
of care. This requirement is currently approved under OMB control 
number 0938-0302, with an expiration date of August 31, 2009.
    Section 418.56(e) describes the standard for the coordination of 
hospice services. Specifically, it states that a hospice must develop 
and maintain a system of communication and integration to ensure the 
information contained in Sec.  418.56(e)(1)-(5). The burden associated 
with this requirement is the time and effort required to develop and 
maintain the system of communication in accordance with the hospice's 
policies and procedures. While this requirement is subject to the PRA, 
the associated burden is considered to be usual and customary as stated 
in 5 CFR 1320.3(b)(2).

Condition of Participation: Quality Assessment and Performance 
Improvement (Sec.  418.58)

    Section 418.58 states that a hospice must develop, implement, and 
maintain an effective, ongoing, hospice-wide data-driven quality 
assessment and performance improvement (QAPI) program. In addition, the 
hospice must maintain documentary evidence of its quality assessment 
and performance improvement program and be able to demonstrate its 
operation to CMS. Section 418.58(a) describes the required scope of the 
QAPI program. Specifically, Sec.  418.58(a)(1) discusses the 
documentation requirements. The QAPI program must be able to 
demonstrate measurable improvement in indicators related to improved 
palliative outcomes and hospice services. Section 418.58(a)(2) states 
that the hospice must measure, analyze, and track quality indicators.
    Section 418.58(b)(2) states that a hospice must use the data to 
monitor the effectiveness and safety of services and quality of care. 
As part of the monitoring process, the data must be used to identify 
improvement opportunities. The data must also be used to assist in the 
prioritization of the aforementioned opportunities for improvement.
    Section 418.58(c)(2) states that as part of performance improvement 
activities, a hospice must track adverse patient events, analyze their 
causes, and implement preventative actions and mechanisms that include 
feedback and learning throughout the hospice. Section 418.58(c)(3) 
requires a hospice to measure its success and track performance in its 
performance improvement initiatives to ensure that the improvements are 
continuous.
    Section 418.58(d) discusses that standard for performance 
improvement projects. Hospices are responsible for developing, 
implementing, and evaluating performance improvement projects. Section 
418.58(d)(2) requires

[[Page 32186]]

hospices to document their performance improvement projects, the reason 
for conducting each project, and the measurable progress achieved as a 
result of the projects.
    The burden associated with the requirements contained in Sec.  
418.58 is the time and effort necessary to develop, draft, and 
implement a QAPI program. As part of the QAPI program, there is also 
burden associated with recording quality data for performance 
improvement initiatives. We estimate that for all 2,872 hospices, 1 
hour per hospice will be required to comply with the documentation of 
the domains and measures, 91 hours per hospice for data entry and 48 
hours to aggregate the data. This is an annual burden of 140 hours per 
hospice to meet the requirement of this section. The estimated annual 
burden associated with the requirements in Sec.  418.58 is 402,080 
hours annually.

Condition of Participation: Infection Control (Sec.  418.60)

    Section 418.60(a) requires hospices to maintain and document an 
effective infection control program. The goal of the program is to 
protect patients, families, visitors, and hospice staff by preventing 
and controlling infectious and communicable diseases. Section 418.60(b) 
provides the standard for effective hospice infection control programs. 
Section 418.60(c) describes the standard for education with respect to 
infection control. Hospices must provide infection control education to 
employees, contracted providers, patients, and family members and other 
care givers.
    The burden associated with the requirements in Sec.  418.60(a)-(c) 
is the time and effort associated with developing, implementing, 
documenting, and maintaining an effective infection control program. 
There is also burden associated with providing infection control 
education. While these requirements are subject to the PRA, the burden 
is exempt as stated in 5 CFR 1320.3(b)(2). The existence of an 
effective infection control program is a usual and customary business 
practice in the hospice care industry.

Condition of Participation: Core Services (Sec.  418.64)

    Section 418.64 states that hospices may contract for the physician 
services contained in Sec.  418.64(a). A hospice may also enter into a 
written agreement with another Medicare-certified hospice program for 
the provision of the core services. The burden associated with these 
requirements is the time and effort necessary to develop, draft, sign, 
and maintain contracts and written agreements. The burden associated 
with these requirements is exempt from the PRA as stated in 5 CFR 
1320.3(b)(2); the use of contracted physicians and the use of written 
agreements between two Medicare certified hospice programs for the 
provision of core services constitutes a usual and customary business 
practice.
    Section 418.64(d) describes the standard for counseling services. 
Hospices are required to make counseling services available to patients 
and families to provide comfort and assistance with coping and stress 
management associated with the dying process. Specifically, section 
Sec.  418.64(d)(1)(iv) states that as part of bereavement counseling, a 
hospice must develop a bereavement plan of care that notes the kind of 
bereavement services to be offered and the frequency of service 
delivery. Section 418.64(d)(3) states that a hospice must provide an 
assessment of the patient's and family's spiritual needs, provide 
spiritual counseling to meet those needs in a manner that is accepted 
by the patient and family and is consistent with their respective 
beliefs, facilitate visits by individuals that can meet the patient's 
spiritual needs, and advise the patient and family of the availability 
of the aforementioned bereavement counseling services. We believe the 
requirements in Sec.  418.64(d) are usual and customary business 
practices; and therefore, the burden is not subject to the PRA as 
stipulated in 5 CFR 1320.3(b)(2).

Condition of Participation: Nursing Services--Waiver of Requirement 
That Substantially All Nursing Services Be Routinely Provided Directly 
by a Hospice (Sec.  418.66)

    Section 418.66(a) allows CMS to waive the requirement in Sec.  
418.64(b) that a hospice provide nursing services directly, if the 
hospice is located in a nonurbanized area. To obtain a waiver, the 
hospice must provide evidence to CMS that it made good faith efforts to 
hire a sufficient number of nurses to provide services. As part of CMS' 
review process, the hospice must meet the criteria outlined in Sec.  
418.66(a)(1)-(3). To obtain an extension for a currently approved 
waiver, a hospice must submit its request to CMS prior to the 
expiration of the waiver period and certify that the conditions under 
which the hospice originally requested the waiver have not changed. The 
burden associated with this requirement is the time and effort 
associated with a hospice demonstrating good faith efforts for its 
staffing process and submitting a certified extension request to CMS 
stating that the circumstances that caused the original waiver request 
have not changed. We believe this requirement and the associated burden 
is exempt from the PRA under 5 CFR 1320.3(c)(4). We believe the 
requirement will affect less than 10 entities on an annual basis.

Waiver of Requirement--Physical Therapy, Occupational Therapy, Speech-
Language Pathology, and Dietary Counseling (Sec.  418.74)

    Section 418.74(a) allows CMS to waive the requirement for providing 
physical therapy, occupational therapy, speech-language pathology, and 
dietary counseling services (as needed) on a 24-hour basis for hospices 
located in non-urbanized areas. In addition, CMS can waive the 
requirement that a hospice provide dietary counseling directly. To 
obtain a waiver, a hospice must provide evidence to CMS that it made 
good faith efforts to meet the requirements for the aforementioned 
services prior to submitting a waiver request. As part of CMS' review 
process, a hospice's waiver request must meet the criteria outlined in 
Sec.  418.74(a)(1)-(2). To obtain an extension for a currently approved 
waiver as stated in Sec.  418.74(d), a hospice must submit its request 
to CMS prior to the expiration of the waiver period and certify that 
the conditions under which the hospice originally requested the waiver 
have not changed. The burden associated with this requirement is the 
time and effort associated with a hospice demonstrating good faith 
efforts for its staffing process and submitting a certified extension 
request to CMS stating that the circumstances that caused the original 
waiver request have not changed. We believe this requirement and the 
associated burden is exempt from the PRA under 5 CFR 1320.3(c)(4). We 
believe the requirement will affect less than 10 entities on an annual 
basis.

Condition of Participation: Hospice Aide and Homemaker Services (Sec.  
418.76)

    Section 418.76(b) outlines the standard for the content and 
duration of hospice aide classroom and supervised practical training. A 
hospice aide training program must meet the criteria in Sec.  
418.76(b)(1)-(3). Section 418.76(b)(4) requires that a hospice maintain 
documentation demonstrating that its training program meets the 
requirement of the standard contained in Sec.  418.76(b). We estimate 
that it will take each hospice 5 minutes to document and maintain 
records that its hospice aide training program met all of the 
requirements contained in this

[[Page 32187]]

section, for a total annual burden of 239 hours.
    Section 418.76(c) describes the standard for competency 
evaluations. In particular, Sec.  418.76(c)(5) states that a hospice 
must maintain documentation that all individuals furnishing hospice 
aide services on behalf of a hospice successfully completed a 
competency evaluation program. The competency evaluation program must 
meet the requirements specified under Sec.  418.76(b)(3). The burden 
associated with this requirement is the time and effort necessary to 
maintain documentation that demonstrates all individuals furnishing 
hospice aide services on behalf of a hospice successfully completed a 
competency evaluation program. We estimate it will take each hospice 5 
minutes to meet this requirement, for a total annual burden of 239 
hours.
    Section 418.76(d) discusses the standard for in-service training. 
Hospices are required to maintain documentation that all hospice aides 
have received at least 12 hours of in-service training during each 12-
month period. The burden associated with this requirement is the time 
and effort necessary to document and maintain record of the required 
in-service training. We estimate it will take each hospice 2 hours 
annually to meet this requirement. The estimate total annual burden for 
this requirement is 5,744 hours.
    Section 418.76(g) describes the standard for hospice aide 
assignments and duties. Specifically, Sec.  418.76(g)(1) states that 
written patient care instructions for a hospice aide must be drafted by 
a registered nurse responsible for the supervision of a hospice aide. 
The burden associated with this requirement is the time and effort 
necessary for a registered nurse responsible for supervising a hospice 
aide to draft written patient care instructions for the hospice aide. 
We believe this is a usual and customary business practice and is 
thereby exempt from the PRA under 5 CFR 1320.3(b)(2).
    Section 418.76(h) explains the standard for the supervision of 
hospice aides. In particular, Sec.  418.76(h)(1)(i) stated that a 
registered nurse must make an onsite visit to a patient's home no less 
frequently than every 14 days to assess and document the quality of 
care and services provided by the hospice care aide and to ensure that 
the services ordered by the hospice's IDG meet the patient's needs. The 
burden associated with this requirement is the time and effort 
necessary for a nurse to conduct an onsite evaluation of a hospice care 
aide in the patient's home, to document the quality of care provided by 
the hospice care aide, and to evaluate the services ordered by the IDG 
to ensure that they are consistent with the patient's needs. We believe 
this is a usual and customary business practice and is thereby exempt 
from the PRA under 5 CFR 1320.3(b)(2).
    Section 418.76(h)(2) states that a registered nurse must also make 
an annual onsite visit to the location to the location where a patient 
is receiving care to observe and evaluate each aide while he or she is 
performing care. Section 418.76(h)(3) details the contents of the 
registered nurse's assessment required in 418.76(h)(3). The burden 
associated with this requirement is the time and effort necessary for a 
registered nurse to make an annual on site visit to observe and 
evaluate each hospice aide while they perform care. In addition, they 
must document the evaluation. We estimate to meet this requirement that 
5 supervisory visits will be conducted on an annual basis per hospice 
with a total of 14,360 visits annually. We believe it will take each 
nurse 5 minutes to document the onsite visit. The estimated total 
annual burden associated with this requirement is 1,197 hours.
    Section 418.76(i)(1) contains the standard for individuals 
furnishing Medicaid personal care aide-only services under a Medicaid 
personal care benefit. Prior to furnishing personal care services, an 
individual must demonstrate competency in the services they are 
required to furnish. The burden associated with this requirement is the 
time and effort necessary to demonstrate competency. While this 
requirement is subject to the PRA, we believe the associated burden is 
exempt stated in 5 CFR 1320.3(b)(2). We believe this is a usual and 
customary business practice.
    Section 418.76(k)(2) requires the instructions for homemaker duties 
to be prepared by a member of the hospice IDG. The burden associated 
with this requirement is the time and effort necessary for a member of 
the IDG to develop and draft instructions for homemaker duties. We 
believe this is a usual and customary business practice and is thereby 
exempt from the PRA under 5 CFR 1320.3(b)(2).
    Section 418.76(k)(3) states that homemakers must report all 
concerns about the patient or family to the member of the IDG who is 
coordinating the homemaker's services. The burden associated with this 
requirement is the time and effort needed for the homemaker to report 
all concerns. We believe the burden is exempt as stated in 5 CFR 
1320.3(b)(2); this is a usual and customary business practice.

Conditions of Participation--Volunteers (Sec.  418.78)

    Section 418.78(a) states that a hospice must document, maintain, 
and provide volunteer orientation and training that is consistent with 
hospice industry standards. We estimate on average that a hospice would 
provide orientation and training six times per year; we estimate that 
it will take no longer than five minutes to document each orientation 
section for a total of 30 minutes per year per hospice. The total 
annual burden associated with this requirement is 1,436 hours.
    Section 418.78(c) requires hospices to document and demonstrate 
viable and ongoing efforts to recruit and retain volunteers. The burden 
associated with this requirement is the time and effort necessary to 
document and demonstrate the recruitment and retention efforts. We 
estimate that it will take each hospice 3 hours to document and 
demonstrate its recruitment and retention efforts, for a total annual 
burden of 8,616 hours.
    The cost-saving standard in Sec.  418.78(d) requires hospices to 
document the cost savings achieved through the use of volunteers. We 
estimate that complying with this requirement will take 3 hours per 
hospice per year, or 8,616 annual hours.
    Section 418.78(e) requires hospices to document and maintain 
records on the use of volunteers for patient care and administrative 
services, including the type of services and time worked. The burden 
associated with this requirement is the time and effort necessary to 
document and maintain the volunteer records. We estimate that recording 
these examples would take approximately 600 hours per hospice for a 
total annual burden of 1,723,200 hours.

Condition of Participation: Organization and Administration of Services 
(Sec.  418.100)

    Section 418.100(e) describes the standard for professional 
management responsibilities. A hospice that has a written agreement 
with another agency, individual, or organization to furnish any 
services under arrangement, must retain administrative and financial 
management, and oversight of staff and services for all arranged 
services, to ensure the provision of quality care. The burden 
associated with this requirement is the time and effort necessary to 
develop, draft, execute and maintain the written agreements. We believe 
these written agreements are part of the usual and customary business 
practices of

[[Page 32188]]

hospices and are thereby exempt from the PRA under 5 CFR 1320.3(b)(2).
    Section 418.100(f)(2) states that a hospice must continually 
monitor and manage all services provided at all of its locations. The 
burden associated with this requirement is the time and effort 
necessary to monitor and manage all of the services provided at all of 
its locations. The burdens associated with this requirement is 
considered to be usual and customary as stated in 5 CFR 1320.3(b)(2) 
and is thereby exempt from the PRA.
    Section 418.100(g) describes the standard for training. In 
particular, Sec.  418.100(g)(2) requires a hospice to provide an 
initial orientation for each employee that addresses the employee's 
specific job duties. Section 418.100(g)(3) requires a hospice to have 
written policies and procedures describing its method(s) of assessment 
of competency. In addition, the hospice must maintain a written 
description of the in-service training provided during the previous 12 
months. The burden associated with the requirements of this section is 
considered to be usual and customary under 5 CFR 1320.3(b)(2); usual 
and customary burdens are exempt from the PRA.

Condition of Participation: Medical Director (Sec.  418.102)

    Section 418.102(b) requires hospice medical directors or physician 
designees to review the clinical information for each hospice patient 
and provide written certification that it is anticipated that the 
patient's life expectancy is 6 months or less if the illness runs its 
normal course. Prior to making a certification statement, the medical 
director or physician designee must consider the issues discussed in 
Sec.  418.102(b)(1)-(5). Section 418.102(c) states that before the 
recertification period for each patient, as described in Sec.  
418.21(a), the medical director or physician designee must review the 
patient's clinical information.
    The burden associated with the requirements contained in Sec.  
418.102(b)-(c) is the time and effort necessary to review the written 
certification. We estimate this process requires 10 minutes per 
patient. We estimate the burden for each hospice to be 50 hours 
annually. The total annual burden associated with the requirements of 
this section is 143,600 hours.

Condition of Participation: Clinical Records (Sec.  418.104)

    Section 418.104 requires a hospice to maintain a clinical record 
for each patient. The required contents of the record are listed in 
Sec.  418.104(a). The burden associated with the requirement is the 
time and effort necessary to document and maintain the information 
listed in Sec.  418.104(a). The maintenance of clinical records is a 
usual and customary business practice; the burden associated with 
maintaining a clinical record is exempt form the PRA under 5 CFR 
1320.3(b)(2).
    Section 418.104(b) requires that all of the entries in a clinical 
record be authenticated. The entries must be legible, clear, complete, 
and consistent with hospice policy. The burden associated with this 
requirement is considered to be usual and customary under 5 CFR 
1320.3(b)(2). This usual and customary burden is therefore exempt from 
the PRA.
    Section 418.104(d) describes the standard for the retention of 
records. 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. If the hospice discontinues operation, hospice policies 
must provide for retention and storage of clinical records. The burden 
associated with these requirements is the time and effort necessary to 
maintain records for 6 years after the death or discharge of the 
patient, and to draft, implement, and maintain the record retention 
policy in the event that the HHA discontinues operation. While this 
requirement is subject to the PRA, we believe the associated burden is 
exempt as stated in 5 CFR 1320.3(b)(2). The development and maintenance 
of a record retention policy is a usual and customary business 
practice.
    Section 418.104(f) describes the standard for the retrieval of 
clinical records. Clinical records, whether in hard copy or electronic 
form, must be made readily available on request by an appropriate 
authority. The burden associated with this requirement is the time and 
effort required to disclose a clinical record to an appropriate 
authority. While this requirement is subject to the PRA, we believe the 
associated burden is exempt as stated in 5 CFR 1320.3(b)(2). Making 
clinical records available to the appropriate authority is part of the 
survey and certification process and imposes no additional burden as a 
usual and customary business practice.

Condition of Participation: Drugs, Controlled Drugs and Biologicals, 
Medical Supplies, and Durable Medical Equipment (Sec.  418.106)

    Section 418.106(b) describes the standard for the ordering of 
drugs. In particular, Sec.  418.106(b)(2)(ii) states that the 
individual receiving a drug order must record and sign it immediately 
and have the prescribing person sign it in accordance with State and 
Federal regulations. The burden associated with this requirement is the 
time and effort necessary for the recipient of the order record and 
sign the order and to have the prescribing person sign the 
prescription. The burden associated with this requirement is exempt 
under both 5 CFR 1320.3(b)(2) and 5 CFR 1320.3(b)(3). As defined in 5 
CFR 1320.3(b)(2), this process is a usual and customary business 
practice. As defined in 5 CFR 1320.3(b)(3), a State requirement would 
exist even in the absence of the Federal requirement. The associated 
burden is thereby exempt from the PRA.
    Section 418.106(c)(2) states that a hospice that provides inpatient 
care directly in its own facility must have a written policy in place 
that promotes dispensing accuracy. Additionally, this section requires 
that a hospice that provides inpatient care directly must maintain 
current and accurate records of the receipt and disposition of all 
controlled drugs. The burden associated with this requirement is the 
time and effort necessary to develop, draft, implement, and maintain a 
written policy that promotes dispensing accuracy and to maintain 
controlled drug records. The existence of this type of policy and these 
records are usual and customary business practices. The burden 
associated with this section is exempt from the PRA under 5 CFR 
1320.3(b)(2).
    Section 418.106(e) discusses the standard for labeling, disposing 
and storing of drugs and biologicals. Specifically, Sec.  
418.106(e)(2)(i) states that a hospice must have a written policy for 
the management and disposal of controlled drugs in the patient's home. 
As required by Sec.  418.106(e)(2)(i)(A), a hospice must provide a copy 
of the written policy required in Sec.  418.106(e)(2)(i) to the 
patient, and his/her representative and family. Additionally, the 
hospice must discuss the hospice policy for managing the safe use and 
disposal of controlled drugs with the patient or representative and the 
family in a language and manner they can understand to ensure that 
these parties are educated regarding the safe use and disposal of 
controlled drugs, as required by Sec.  418.106(e)(2)(i)(B). Section 
418.106(e)(2)(i)(C) requires a hospice to document in a patient's 
clinical record that the written policy for managing controlled drugs 
was provided and discussed. Section 418.106(e)(2)(ii) states that a 
hospice maintain current and accurate records of the receipt and 
disposition of all controlled drugs.

[[Page 32189]]

    The burden associated with the requirements contained in Sec.  
418.106(e)(2) is the time and effort necessary to provide a written 
copy of the policy on the management and disposal of controlled drugs 
in the patient's home to the patient representative and family. There 
is also some burden associated with the hospice explaining the policy 
to the patient or representative and the family. In addition, there is 
a burden associated with documenting in the patient's clinical record 
that the written policy for managing and controlled drugs was provided 
and discussed. We believe the burden associated with the aforementioned 
requirements is exempt from the PRA under 5 CFR 1320.3(b)(2), as they 
are part of the usual and customary business practice for hospices.
    Section 418.106(e)(3)(ii) states that the hospice pharmacist and 
the hospice administrator are required to immediately investigate any 
discrepancies in the acquisition, storage, dispensing, administration, 
disposal, or return of controlled drugs. The event must be reported to 
the appropriate State authority. A written account of the investigation 
must be made available to State and Federal officials if required by 
law or regulation. The burden associated with this requirement is 
exempt under both 5 CFR 1320.3(b)(2) and 5 CFR 1320.3(h)(6). As defined 
in 5 CFR 1320.3(b)(2), documenting an investigation and reporting the 
investigation to the appropriate State authority is a usual and 
customary business practice. Additionally, the burden associated with 
making a written account of the investigation available to State and 
Federal officials upon request is exempt from the PRA under 5 CFR 
1320.3(h)(6); the information will be collected from individual 
hospices on a case by case basis. As stated under in 5 CFR 
1320.3(h)(6), information collection requests addressed to a single 
``person'' as defined in 5 CFR 1320.3(b)(4), are exempt from the PRA.
    Section 418.106(f)(1) states that a hospice must ensure that repair 
and routine maintenance policies are developed in situations when a 
manufacturer's recommendation for a piece of equipment is nonexistent. 
Section 418.106(f)(2) requires a hospice to ensure that the patient, 
family, and other caregivers receive instruction in the safe use of 
durable medical equipment and supplies. After providing instruction, 
the patient, family, and/or caregiver must be able to demonstrate the 
appropriate use of durable medical equipment. The burden associated 
with the requirements in Sec.  418.106(f)(1)-(2) is the time and effort 
necessary to develop, draft, implement, and maintain repair and routine 
maintenance policies. There is also burden associated with providing 
proper instruction on the use of durable medical equipment to patient, 
family members, and caregivers. As defined in 5 CFR 1320.3(b)(2), 
providing proper instruction on the use of durable medical equipment to 
patient, family members, and caregivers is a usual and customary 
business practice.

Condition Of Participation--Short-Term Inpatient Care (Sec.  418.108)

    Section 418.108(c) requires the use of a written agreement if a 
hospice has an arrangement with a facility to provide short-term 
inpatient care. At a minimum, the agreement must address the issues 
outlined in Sec.  418.108(c)(1)-(6). The burden associated with this 
requirement is the time and effort necessary to develop, draft, 
execute, and maintain the written agreement. While this requirement is 
subject to the PRA, the burden is exempt under 5 CFR 1320.2(b)(2). The 
use of the written agreements between facilities is a usual and 
customary business practice.

Condition Of Participation: Hospices That Provide Inpatient Care 
Directly (Sec.  418.110)

    Section 418.110(c)(1)(ii) states that a hospice must have a written 
disaster preparedness plan in effect to manage emergencies that might 
compromise the hospice's ability to provide care. Additionally, the 
plan must be periodically reviewed. The burden associated with this 
requirement is the time and effort necessary to develop, draft, 
implement, maintain, and periodically review the disaster preparedness 
plan. Section 418.110(c)(2) requires hospices to develop procedures for 
managing physical plant issues.
    The burden associated with the requirements in Sec.  418.108(c) is 
the time and effort necessary to draft, implement, maintain, and review 
the facility's disaster preparedness plans and procedures to address 
physical plant issues. While these requirements are subject to the PRA, 
we believe the associated burden is exempt as stated in 5 CFR 
1320.3(b)(2).
    Section 418.110(m)(3)(i) specifies that the use of restraint and 
seclusion must be used in accordance with a written modification to the 
plan of care. The use of restraint and seclusion must be implemented in 
accordance with safe and appropriate restraint and seclusion techniques 
as determined by hospice policy in accordance with State law. The 
burden associated with this requirement is the time and effort 
necessary to modify the plan of care in writing to include the 
physician order for restraint and seclusion.
    Section 418.110(m)(4) states that the use or restraint or seclusion 
must be done in accordance with a physician's orders. There is a burden 
associated with creating a physician's order. However, we believe the 
burden associated with the aforementioned requirements is exempt from 
the PRA under 5 CFR 1320.3(b)(2), as they are part of the usual and 
customary business practice for hospices.
    Section 418.110(m)(7)(ii) states that prior to writing a new order 
for the use of restraint or seclusion, a physician must see and assess 
the patient. The burden associated with this requirement is the time 
and effort necessary for the ordering physician to see and assess the 
patient.
    Section 418.110(m)(15) states that when restraint or seclusion is 
used, a patient's clinical record must contain the documentation 
outlined in Sec.  418.110(m)(15)(i)-(v). The burden associated with 
this requirement is the time and effort necessary to compile the 
documentation specified in Sec.  418.110(m)(15)(i)-(v) in the patient's 
clinical record. We estimate the collective burden associated with the 
requirements contained in 418.110(m)(3)(i), 418.110(m)(7)(ii), and 
418.110(m)(15) to be 45 minutes per event per hospice for a total of 
8,702 events annually. The annual burden associated with the 
aforementioned information collection requirements is 6,527 hours.
    Section 418.110(n) discusses the standard for restraint or 
seclusion staff training requirements. Specifically, Sec.  
418.110(n)(1) states that all patient care staff working in the hospice 
inpatient facility must be trained and able to demonstrate competency 
in the application of restraints, implementation of seclusion, 
monitoring, assessment and providing care for a patient in restraint or 
seclusion. Section 418.110(n)(4) states that a hospice must document in 
the personnel records that each employee successfully completed the 
restraint and seclusion training and demonstrated competency. We 
estimate that it will take 96 hours to comply with these requirements. 
The estimated total annual burden associated with these requirements is 
275,512 hours.
    Section 418.110(o) states that hospices must report deaths 
associated with the use of restraint or seclusion. The hospice staff 
must document in the

[[Page 32190]]

decedents clinical record the date and time the death was reported to 
CMS. We cannot accurately estimate the number of deaths that would 
occur annually as a result of restraint or seclusion. However, we 
believe the number is less than 10 per year. While this requirement is 
subject to the PRA, we believe the burden is exempt under 5 CFR 
1320.3(c)(4), as it would affect less than 10 entities.

Condition of Participation: Hospices That Provide Hospice Care To 
Residents of a SNF/NF or ICF/MR (Sec.  418.112)

    Section 418.112(c) discusses the requirement that a hospice and 
SNF/NF or ICF/MR must have a written agreement that specifies the 
provision of hospice services in the facility. The agreement must be 
signed by authorized representatives of the hospices and the SNF/NF or 
ICF/MR prior to the provision of hospice care services. At a minimum, 
the written agreements must address the issues listed in Sec.  
418.112(c)(1)-(8). The burden associated with this requirement is the 
time and effort necessary to develop, draft, sign, and maintain the 
written agreement. However, the use of this type of written agreement 
is a usual and customary business practice; the associated burden is 
exempt from the PRA under 5 CFR 1320.3(b)(2).
    Section 418.112(d) discusses the standard for the hospice plan of 
care. A written plan of care must be established and maintained in 
consultation with SNF/NF or ICF/MR representatives. The burden 
associated with this requirement is discussed in detail under our 
discussion of Sec.  418.56(c).

Condition of Participation: Personnel Qualifications (Sec.  418.114)

    Section 418.114(d)(1) requires hospices to obtain criminal 
background checks on all hospice employees who have direct patient 
contact or access to patient records. Additionally, all hospice 
contracts must require that all contracted entities obtain criminal 
background checks on contracted employees who have direct patient 
contact or access to patient records. The burden associated with this 
requirement is the time and effort necessary to conduct background 
checks and the time and effort necessary to develop, draft, and 
maintain contracts that require all contracted staff to obtain 
background checks. While this requirement is subject to the PRA, we 
believe the associated burden is exempt as stated in 5 CFR 
1320.3(b)(2). While fulfilling these requirements, a hospice will not 
incur any burden above and beyond its usual and customary business 
practice.

                         Table XX.--Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                                   Total annual
         Regulation section(s)               OMB control No.        Respondents      Responses    burden (hours)
----------------------------------------------------------------------------------------------------------------
Sec.   418.52(a)......................  0938-New................           2,872         870,216          72,518
Sec.   418.52(b)......................  0938-New................           2,872          43,080          43,080
Sec.   418.56(b-c)....................  0938-0302...............           2,874           2,874       9,930,912
Sec.   418.58.........................  0938-New................           2,872           2,872         402,080
Sec.   418.76(b)(4)...................  0938-New................           2,872           2,872             239
Sec.   418.76(c)......................  0938-New................           2,872           2,872             239
Sec.   418.76(d)......................  0938-New................           2,872           2,872           5,744
Sec.   418.76(h)(2)...................  0938-New................           2,872          14,360           1,197
Sec.   418.78(a)......................  0938-New................           2,872           2,872           1,436
Sec.   418.78(c)......................  0938-New................           2,872           2,872           8,616
Sec.   418.78(d)......................  0938-New................           2,872           2,872           8,616
Sec.   418.78(e)......................  0938-New................           2,872           2,872       1,723,200
Sec.   418.102(b-c)...................  0938-New................           2,872           2,872         143,600
Sec.   418.110(m)(15).................  0938-New................           2,872           8,702           6,527
Sec.   418.110(n)(1-4)................  0938-New................           2,872           2,872         275,512
���������������������������������������
    Total.............................  ........................           2,874         967,952      12,623,516
----------------------------------------------------------------------------------------------------------------

    We have submitted a copy of this final rule to OMB for its review 
of the information collection requirements contained within this 
document. These requirements are not effective until they are approved 
by OMB.

VI. Regulatory Impact Analysis

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 (as amended by Executive Order 13258, which 
merely reassigns responsibility of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($110 million or more in any 1 year). 
This is not a major rule, since the overall economic impact for all 
proposed new Conditions of Participation is estimated to be $40.7 
million in the first year.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small government 
jurisdictions. Individuals and States are not included in the 
definition of a small entity. For purposes of the RFA, most hospices 
(approximately 82% of Medicare certified facilities) are considered to 
be small entities, either by virtue of their nonprofit or government 
status or by having revenues of less than $12.5 million in any one year 
(for details, see the Small Business Administration's regulation that 
sets forth size standards for health care industries at 65 FR 69432). 
We estimate there are approximately 2,872 hospices with average 
admissions of approximately 303 patients per hospice (based on the 
number of patients in 2005 divided by the number of hospices in 2005). 
The National Hospice and Palliative Care

[[Page 32191]]

Organization (Facts and Figures--2005 Findings) estimates that 82.4 
percent of hospice patients are Medicare beneficiaries; thus we have 
not considered other sources of revenue in this analysis.
    We certify that this rule would not have a significant impact on a 
substantial number of small entities because the cost of this rule is 
less than 1 percent of total hospice Medicare revenue. According to the 
CMS 2005 national expenditure data, Medicare paid $8.2 billion to 
providers for hospice care in FY 2005. We estimate this rule will cost 
hospices approximately $40.7 million or approximately $32,223 per 
average hospice (operating its own inpatient unit and requiring the 
supervisory services of an MSW) in the first year. An average hospice 
that does not operate its own inpatient unit and does not need to hire 
an MSW, accounting for the vast majority of hospices, will expend 
$11,151 to comply with this final rule in the first year. While we 
understand that a few very small hospices (described below) may expend 
a larger percentage of their revenue to comply with this rule, we 
believe that this group of hospices is quite small.
    We understand that there are different sizes of hospices and that 
the burden for hospices of different sizes will vary. Therefore, we 
have assessed the burden for hospices that are smaller than the 
statistically average hospice used for calculations in part B of this 
section, Anticipated Effects on Hospices. The smaller hospices have 
been broken up into two categories based on the number of routine home 
care days, the most common level of hospice care provided. The 
categories are group 1 hospices providing 0 to 1,754 routine home care 
days, and group 2 hospices providing 1,755 to 4,373 routine home care 
days. Group 1 hospices, averaging 67 patients per year, would spend 
approximately $18,980 or $5,980, depending on the need to hire and MSW 
supervisor, to comply with these regulations. The average hospice in 
this group received $229,406 from Medicare for routine home care days 
under the 2005 hospice payment rates. Group 2 hospices, averaging 167 
patients per year, would spend approximately $21,191 or $8,191, also 
depending on the need to hire an MSW supervisor, to comply with these 
regulations. The average hospice in this group received $571,945 from 
Medicare for routine home care days under the 2005 rates.
    The time and cost burden for these providers is less than that of 
the average hospice used in part B of this section because a portion of 
the burden associated with these regulations is directly related to 
patient care and the staff necessary to provide care. Therefore, a 
consistently smaller patient census leads to reduced burden because the 
smaller hospices have less staff, complete less data collection and 
less patient rights orientation etc. These estimates of the annual 
burden for smaller hospices make only minor adjustments to the 
estimated quality assessment and performance improvement burden 
described in part B of this section in the area of patient level data 
collection. Additionally, these figures do not include the time and 
cost burden estimates associated with a hospice inpatient facility 
because it is very uncommon for a hospice with a small annual patient 
census to operate its own inpatient facility. We estimate that the 
financial burden for group 1 hospices would be approximately 8.25 or 
2.5 percent of the payment received for routine home care days, 
depending on whether or not the hospice needs to hire an MSW 
supervisor. For group 2 hospices, the financial burden would be 3.75 or 
1.5 percent of the payment received for routine home care days, also 
depending on whether or not the hospice needs to hire an MSW 
supervisor. Since employing an MSW is considered the standard within 
the hospice industry, we believe that very few group 1 and 2 hospices 
will incur the additional expense of hiring an MSW above their present 
level of staffing (see B., Anticipated Effects on Hospices, Personnel 
qualifications for a more detailed discussion). These percentages do 
not include amounts paid by Medicare for continuous home care days, 
respite care days, and regular inpatient care days. The percentages 
also do not include amounts paid by Medicaid, private insurers, and 
individual patients, which account for approximately 18 percent of 
hospice revenue. Additionally, these percentages do not include 
additional income from fundraising, donations, foundations, etc. that 
hospices routinely use to finance operations and programs. Therefore, 
we believe that the actual cost incurred by a group 1 or a group 2 
hospice accounts for a significantly smaller portion of hospice's 
overall revenue, and does not have a significant impact on a 
substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a metropolitan 
statistical area and has fewer than 100 beds. We believe that this rule 
would not have a significant impact on the operations of a substantial 
number of small rural hospitals, since there are few hospice programs 
in those facilities. Section 202 of the Unfunded Mandates Reform Act of 
1995 also requires that agencies assess anticipated costs and benefits 
before issuing any rule whose mandates require spending in any one year 
of $100 million in 1995 dollars, updated annually for inflation. That 
threshold level is currently approximately $127 million. This final 
rule does not contain mandates that will impose spending costs on 
State, local, or tribal governments in the aggregate, or by the private 
sector of $127 million.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct compliance costs on State or local governments, 
preempts State law, or otherwise has Federalism implications. This rule 
has no Federalism implications.

B. Anticipated Effects on Hospices

    As described in the preamble, this final rule contains both new 
provisions and provisions that are carried over from the existing 
hospice regulations. For purposes of this section, we have assessed the 
impact of all provisions that may present a burden to a hospice.
    Within this section, we have made several assumptions and estimates 
in order to assess the time that it would take for a hospice to comply 
with the provisions and the associated costs of compliance. We have 
detailed these assumptions and estimates in the table below. We have 
also detailed many, but not all, of the standards within each CoP, and 
have noted whether or not there is an impact for each. However, the 
requirements contained in many provisions are already standard medical 
or business practices. These requirements would, therefore, not provide 
additional burden to hospice providers.
    Our assumptions are based on the idea of an average hospice, culled 
from national averages. While we understand that there is no average 
hospice, the idea of an average hospice allows us to quantify the 
impact of this final rule on a hospice's resources. For purposes of 
this section only, we describe an average hospice as one that is:

Freestanding;
Not-for-profit;

[[Page 32192]]

26 day median length of stay (NHPCO Facts & Figures 2005);
303 annual admissions;
40 employees and volunteers;
27% of patients residing in a SNF/NF, ICF/MR or assisted living 
facility; and

 Table 1.--Assumptions and Estimates Used Throughout the Impact Analysis
                                 Section
------------------------------------------------------------------------
 
------------------------------------------------------------------------
 of Medicare hospices nationwide.....................     2,872
 of hospice patients nationwide......................   869,201
 of patients per average hospice.....................       303
Hourly rate of registered nurse...............................       $35
Hourly rate of office employee................................       $14
Hourly rate of administrator..................................       $49
Hourly rate of home health aide...............................       $19
Hourly rate of MSW............................................       $25
Hourly rate of pharmacist.....................................       $56
Hourly rate of clinical manager...............................       $36
Hourly rate of QAPI coordinator...............................       $35
Hourly rate of medical director...............................     $114
------------------------------------------------------------------------
Note: All salary estimates include benefits package worth 30% of the
  fringe base salary.

Patient Rights (Sec.  418.52)

    The final rule expands on the informed consent section (Sec.  
418.62) of the current rule, recognizing that hospice patients are 
entitled to certain rights that must be protected and preserved, and 
that all patients must be able to freely exercise those rights.
    (a) Standard: Notice of Rights. A hospice is required to provide 
patients or their representatives with written and verbal notice of the 
patient's rights and responsibilities during the initial assessment 
visit. A hospice is also required to document that the notice of rights 
was provided by obtaining the patient's or representative's signature. 
A hospice must also inform and distribute written information to the 
patient regarding its policies on advance directives. We estimate that 
it will take eight hours on a one-time basis for a hospice to develop a 
patient rights form, at a cost of $392, based on the assumption that an 
administrator will develop the form. We estimate that it will take 
approximately five minutes per patient to incorporate this information 
into the existing informed consent process. At the average hourly rate 
for a registered nurse, it will cost $2.92 per patient to fulfill the 
requirement.

8 hours x $49 an hour = $392
$35 hour/60 minutes = $0.58 minute x 5 minutes = $3

    (b) Standard: Exercise of rights and respect for property and 
person. A hospice is required to investigate and document all 
allegations of abuse, unexplained injuries, and misappropriations of 
patient property involving hospice employees and contractors. Hospice 
employees and contractors must report alleged patient rights violations 
to the hospice administrator, and must report verified violations to 
appropriate State and local bodies having jurisdiction. A hospice must 
also take action to correct problems once they are identified.
    We expect that a hospice administrator will investigate alleged 
patient rights violations. We estimate that as many as 5% (15) of an 
average hospice's patients would require a one-hour-long 
investigational session, for a total of 15 hours per hospice. The cost 
for the entire hospice industry would be $2,110,920 a year, while the 
cost for an average hospice would be $735 a year.

15 investigations per hospice x 1 hour per investigation = 15 hours 
per hospice
$49 hour x 15 hours per hospice = $735 per average hospice
15 hours per hospice x 2872 hospices = 43,080 hours nationwide
$735 per average hospice x 2872 hospices = $2,110,920

    (c) Standard: Rights of the patient. There is no burden associated 
with this standard.

                                                       Table 2.--Patient Rights Burden Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Time per        Time per                                        Cost per
                        Standard                              patient         hospice       Total time       Cost per         average       Total cost
                                                             (minutes)        (hours)         (hours)         patient         hospice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop form (1st year).................................             N/A               8          22,976             N/A            $392      $1,125,824
Notice of rights (annual)...............................               5           25.25          72,433              $3             885       2,538,130
Exercise of rights (annual).............................             N/A              15          43,080             N/A             735       2,110,920
                                                         -----------------------------------------------------------------------------------------------
    Totals..............................................               5           48.25         138,489               3           2,012       4,649,379
--------------------------------------------------------------------------------------------------------------------------------------------------------

Comprehensive Patient Assessment (Sec.  418.54)

    (a) Standard: Initial assessment and (b) Standard: Timeframe for 
completion of the comprehensive assessment. The existing rule (Sec.  
418.58(c)) requires the hospice to assess the patient's needs and to 
state in detail the scope and frequency of services needed. The final 
rule goes beyond this by specifying the time for completing the 
assessment, the factors to be included in the assessment, and the time 
for updating the assessment. However, we do not believe this will add 
any additional burden, since this section of the proposed rule reflects 
the contemporary standard practice of hospice programs.
    (c) Standard: Content of the comprehensive assessment. The 
assessment must identify the physical, psychosocial, emotional, and 
spiritual needs related to the terminal illness and related conditions 
that must be addressed in order to promote a hospice patient's well-
being, comfort and dignity throughout the dying process. The assessment 
will include factors such as the patient's physical and nutritional 
needs, pain status, and psychological state. The assessment will also 
address complications and risk factors, functional status, imminence of 
death, severity of symptoms, drug profile and bereavement. This differs 
from the current rule in that it describes what must be included in the 
assessment. The factors of the comprehensive assessment were identified 
by the hospice industry and reflect standard industry practice.
    (d) Standard: Update of the comprehensive assessment. Updates of 
the patient's comprehensive assessment must be conducted at least every 
15 days or as frequently as the condition of the patient requires. The 
current regulation allows the plan of care to determine the frequency 
of updates. However, due to the rapidly changing status of hospice 
patients, it is standard practice for a hospice to update a patient 
assessment at least every 15 days, and often more frequently. This 15-
day requirement is also in line with the recertification periods, at 
which time a hospice must review the patient's clinical information to 
determine whether a patient continues to be terminally ill with a 
prognosis of 6 months or less if the illness runs its usual course. 
This new standard simply codifies current industry practice and does 
not present a burden.
    (e) Standard: Patient outcome measures. The comprehensive

[[Page 32193]]

assessment must include consistent, pre-determined data elements that 
allow for the measurement of patient care outcomes. (Note: There is no 
data reporting element.) We believe this standard will pose a burden on 
the hospice provider. However, the burden of collecting information 
related to these outcome measures is calculated as part of a hospice's 
quality assessment and performance improvement program.

Interdisciplinary Group, Care Planning and Coordination of Services 
(Sec.  418.56)

    The final rule makes several changes to the existing rule to 
improve patient care and lessen burden.
    (a) Standard: Approach to service and delivery. This standard 
describes the members of the IDG and its role in patient care planning 
and delivery. There is no burden associated with this standard.
    (b) Standard: Plan of care and (c) Standard: Content of the plan of 
care. This section describes the general content areas of each 
patient's plan of care. The items that are required under the final 
rule are already included in the standard industry patient plan of 
care.
    (d) Standard: Review of the plan of care. The existing rule states 
that a patient's plan of care must be reviewed at intervals specified 
in the initial plan of care. The final rule requires that the plan of 
care be reviewed at least every 15 days. Several commenters noted that 
documenting an update to a patient's plan of care takes 1-2 hours of a 
nurse's time per update. We agree that updating a patient's plan of 
care requires a fair amount of nursing time. However, we do not believe 
that requiring a hospice to update a patient's plan of care on a 
regularly scheduled and as needed basis will present a burden because 
these are already standard practices within the hospice industry.

Quality Assessment and Performance Improvement (Sec.  418.58)

    The quality assessment and performance improvement (QAPI) 
requirement builds off of the existing quality assurance requirement. 
Indeed, quality assurance is already part of standard hospice practice. 
This rule requires a data-driven approach to assessing and improving 
quality in all aspects of hospice care, from clinical services to 
staffing to contracts, that enables hospices to develop a clear 
understanding of their strengths and weaknesses in a wide variety of 
areas. However, at this time we do not prescribe the precise areas that 
each hospice must examine, nor do we prescribe the precise mechanisms 
for these examinations. Rather, we provide a basic outline of what QAPI 
is and how we expect it to function in the hospice environment. Each 
hospice is free to decide how to implement the QAPI requirement in a 
manner that reflects its own unique needs and goals.
    In response to public comments stating that we underestimated the 
impact of the QAPI CoP on the average hospice, we have significantly 
revised our impact assessment methodology. Rather than describing the 
impact in proportion to the impact that this same CoP had on hospitals, 
we have described the impact in three general phases that we believe an 
average hospice will go through. These phases are based off of our 
experience in implementing the QAPI requirements of the proposed rule 
in the Rural Hospice Demonstration project required by section 409 of 
the MMA, and from discussions with hospice industry representatives who 
are active in implementing QAPI programs nationwide. The description of 
these phases, and the hour and dollar estimates that accompany them 
were not available at the time that the proposed hospice rule was 
published. We believe that this new information more accurately 
reflects the hospice environment.
    While we have outlined these phases below, we stress that a hospice 
is not required to approach QAPI in this manner. We are not requiring a 
hospice to collect data for a specific domain; use specific quality 
measures, policies and procedures, or forms; submit data to an outside 
body; or conduct a specified number of performance improvement 
projects. A hospice may choose to implement a data-driven, 
comprehensive QAPI program that meets the requirements of this rule in 
any way that meets its individual needs. These phases described below 
simply provide a framework for assessing the potential impact of the 
QAPI requirement upon an average hospice.
    In phase one, we believe that a hospice will:
    Identify quality domains and measurements that reflect its 
organizational complexity; involve all hospice services; affect 
palliative outcomes, patient safety, and quality of care; focus on high 
risk, high volume, or problem-prone areas; and track adverse patient 
events;
    Develop policies and procedures to ensure that data is consistently 
collected, documented, retrieved, and analyzed in an accurate manner; 
and
    Educate hospice employees and contractors about the QAPI 
requirement, philosophy, policies, and procedures.
    In phase two, we believe that a hospice will:
    Enter data into patient clinical records during patient assessments 
and IDG meetings;
    Aggregate data by collecting the same pieces of data from patient 
clinical records and other sources (for example, human resource 
records, pharmacy records, etc.);
    Analyze the data that is aggregated through charts, graphs, and 
various other methods to identify patterns, anomalies, areas of 
concern, etc. that may be useful in targeting areas for improvement; 
and
    Develop, implement, and evaluate major and minor performance 
improvement projects based on a thorough analysis of the data 
collected.
    In phase three, we believe that a hospice will:
    Identify new domains and measures that may replace or be in 
addition to the domains and measures already being monitored by the 
hospice;
    Develop and/or revise policies and procedures to accommodate the 
new domains and measures; and
    Educate hospice employees and contractors on the new domains and 
measures, as well as the policies and procedures for them.
    In addition to these three phases, a hospice will likely allocate 
resources to an individual responsible for the general overall 
coordination of its QAPI program. For simplicity, we refer to this 
individual as the QAPI coordinator; however, a hospice is not required 
to use this title.
    Based on these three phases, we have anticipated the impact of the 
QAPI requirement on a hospice's resources. In phase one, we anticipate 
that a hospice will use 12 hours to identify quality domains and 
measures. These hours will be distributed among the three members of 
the hospice's QAPI committee. While we do not require a hospice to have 
a QAPI committee, we believe that most hospices will choose to do so. 
The hospice model is based on the idea of an interdisciplinary group of 
people working together, and we believe that hospices will choose to 
use this group decision-making model in the QAPI process as well. We 
believe that the QAPI committee will include the QAPI coordinator, the 
hospice administrator, and a clinical manager. We estimate that the 
QAPI committee will meet four times quarterly for 1 hour each meeting 
to identify appropriate quality domains and measures. The total cost 
for an average hospice to identify the domains and measures, then, is 
$480.


[[Page 32194]]


4 meetings x 1 hour per meeting x $35/hour for QAPI coordinator = 
$140
4 meetings x 1 hour per meeting x $49/hour for administrator = $196
4 meetings x 1 hour per meeting x $36/hour for clinical manager = 
$144

    While we anticipate that a hospice will use resources to develop 
policies and procedures and educate staff, we believe that these 
activities are part of standard business practice and do not pose an 
additional burden to a hospice. For example, a hospice already conducts 
a regular in-service training program for its employees in accordance 
with the in-service training requirement at existing Sec.  418.64. A 
hospice can incorporate QAPI training into this existing in-service 
training program with no associated increase in burden.
    In phase two, we anticipate that a hospice will use 91 hours to 
enter data (at the time of each assessment, 40.4 hours + at the time of 
each IDG meeting, 50.5 hours), 48 hours to aggregate data, and 12 hours 
to analyze data. Although thoroughly assessing a patient is already 
standard practice, we believe that collecting quality measure data 
during the patient assessment will be a new practice for many hospices. 
We estimate that a hospice will spend 40.4 hours a year to collect 
patient-level quality data during patient assessments, and that a 
registered nurse is the most likely person to perform this data 
collection.

4 minutes per patient assessment to collect quality data x 2 
assessments per patient x 303 patients = 40.4 hours x $35/hr for a 
registered nurse = $1,414

    The QAPI CoP requires a hospice to use the quality data collected 
during the patient assessment during the IDG meeting to monitor the 
effectiveness of interventions in helping the patient and family 
achieve desired outcomes. While a hospice IDG already makes decisions 
based on the information contained in the patient's clinical record, 
they may not be systematically documenting this analysis and its 
results. We believe that documenting the results of the data analysis 
(for example, any changes to the plan of care based on the specific 
quality measure data) during the IDG meeting will require additional 
time for each patient. We estimate that this activity will require 50.5 
hours for an average hospice, based on an assumed five minutes per 
patient to document quality measure analysis. We believe that the 
registered nurse assigned to coordinate the patient's plan of care is 
the individual most likely to document this information.

5 minutes per patient to document during IDG meeting x 2 IDG 
meetings per patient x 303 patients = 50.5 hours x $35/hour for a 
registered nurse = $1,768

    In addition to using quality measure data on a patient level, a 
hospice must gather the patient-level data and other data. Once 
gathered, a hospice must organize the data in a meaningful way. We 
estimate that, in order to ensure that the volume of gathered data is 
manageable, a hospice will gather its data once a month. A hospice may 
choose to gather data on a more or less frequent basis to suit its 
needs and circumstances. Some hospices may choose to gather all 
patient-level data, while others may choose to gather data from a 
sample of all patient-level data. Likewise, some hospices may choose to 
gather data from a wide variety of administrative files, while others 
may choose to select only a few administrative data sources. There are 
many combinations that a hospice may choose to use when it comes to 
gathering data, and no single approach is considered preferable to 
another. Given this variability, it is difficult to estimate how long 
an average hospice may spend gathering and organizing data. For 
purposes of this analysis only, we assume that an average hospice will 
use four hours per month to gather data, for a total of 48 hours a 
year. We believe that an office employee will perform the data 
aggregation and organization.

4 hours a month to gather and organize data x 12 months = 48 hours x 
$14/hr for an office employee = $672

    Following data gathering and organization, a hospice must analyze 
the data to identify trends, patterns, anomalies, areas of strength and 
concern, etc. We believe that this data analysis will be done by the 
QAPI committee described previously. In order to identify trends and 
patterns, the committee would need to examine several months of data at 
the same time. Therefore, we assume that the committee will meet once 
every quarter to examine the data and make decisions based off of it. 
We assume that these meetings will be one hour each, for a total cost 
of $480.

4 meetings x 1 hour per meeting x $35/hour for QAPI coordinator = 
$140
4 meetings x 1 hour per meeting x $49/hour for administrator = $196
4 meetings x 1 hour per meeting x $36/hour for clinical manager = 
$144

    Performance improvement projects follow all of the data entry, 
gathering, organization, and analysis. A hospice must conduct projects 
to improve its performance in areas where a weakness is identified. 
Performance improvement projects must reflect the hospice's scope, 
complexity, and past performance. They must also be data-driven, and 
affect palliative outcomes, patient safety, and quality of care. 
Although this final rule more clearly describes a performance 
improvement project, its basis, and its purpose, are fundamentally the 
same as the current requirement at Sec.  418.66, ``Quality assurance.'' 
That requirement states that, ``A hospice must * * * correct identified 
problems and * * * revise hospice policies if necessary * * * [and] 
[m]ake suggestions for improving patient care.'' Since a hospice 
already makes an organized effort to improve patient care in all of its 
facets, and since providing safe and effective care at all times for 
all patients is the essential charge of all health care providers, 
including hospices, we believe that conducting both major and minor 
performance improvement projects is already a standard of practice 
within the hospice industry. Therefore there is no additional burden 
associated with this provision.
    Phase three of the QAPI process builds upon the QAPI program that a 
hospice already has in place. We estimate that a hospice will use three 
hours a year to identify new domains and quality measures, and we 
believe that the QAPI committee will perform this task. Just as in 
phase one, we believe that the tasks of developing and/or updating the 
hospice's policies and procedures and educating the hospice's staff and 
contractors are standard practice within the hospice industry.

1 meeting x 1 hour per meeting x $35/hour for QAPI coordinator = $35
1 meeting x 1 hour per meeting x $49/hour for administrator = $49
1 meeting x 1 hour per meeting x $36/hour for clinical manager = $36

    In order to ensure the adequate functioning of a hospice's QAPI 
program, a hospice must designate an individual to be responsible for 
its QAPI program. We estimate that a QAPI coordinator will spend 1.5 
hours per week overseeing the QAPI program, performing various 
functions as needed, for a total of 78 hours per year.

1.5 hours/week x 52 weeks = 78 hours x $35/hour = $2,730

[[Page 32195]]



                   Table 3.--Quality Assessment and Performance Improvement Burden Assessment
----------------------------------------------------------------------------------------------------------------
                                                     Time per
                    Standard                          hospice       Total time       Cost per       Total cost
                                                      (hours)         (hours)         hospice
----------------------------------------------------------------------------------------------------------------
Identify domains and measures (1st year)........              12          34,464            $480      $1,378,560
Enter data \1\ (1st year and annual)............              91         261,352           3,182       9,138,704
Aggregate data \1\ (1st year and annual)........              48         137,856             672       1,929,984
Data analysis (1st year and annual).............              12          34,464             480       1,378,560
QAPI coordinator (1st year and annual)..........              78         224,016           2,730       7,840,560
Update domains and measures (annual)............               3           8,616             120         344,640
                                                 ---------------------------------------------------------------
    Total 1st year..............................             241       * 692,152           7,544    * 21,666,368
    Total annually..............................             232       * 666,304           7,184    * 20,632,448
----------------------------------------------------------------------------------------------------------------
* Note: The overall national estimates are based on the assumption that every hospice will begin to develop and
  implement a QAPI program upon the effective date of this final rule. Anecdotal evidence suggests that many
  hospices began developing and implementing QAPI programs upon publication of the proposed hospice rule, and
  therefore will not be impacted to the same extent as we have estimated above. Thus, we expect that the actual
  impact of this final requirement will be less than estimated in this section.

Infection Control (Sec.  418.60)

    There is no specific existing requirement for infection control 
other than what is briefly mentioned in the existing Sec.  418.100(i), 
``Standard: Isolation areas.'' However, we believe that hospice 
clinicians such as nurses, physicians, and therapists are already using 
infection control practice as part of the current requirement that 
hospice clinicians provide services to patients in accordance with 
accepted standards of practice. It is an accepted standard of practice 
to use infection control methods when caring for patients. This final 
regulation reinforces those positive infection control practices and 
addresses the serious nature of infectious and communicable diseases. 
Infection control and standard precautions are long-standing clinical 
practices that are standard throughout the medical industry.
    This final CoP requires a hospice to continue to take specific and 
appropriate actions to address the prevention and control of 
infections, including patient, staff, and caregiver education. We 
acknowledge that this is a new focus; however, we do not believe this 
will add any regulatory burden, since this section of the final rule 
reflects contemporary standard practice in hospice programs.

Core Services (Sec.  418.64)

    The final rule allows core services to be provided under contract 
in certain extraordinary or other non-routine circumstances as 
described, allowing hospices more flexibility. One specific provision 
allows a hospice to contract for highly specialized nursing services, 
providing even more staffing flexibility. The option to contract out 
for highly specialized nursing services allows a hospice to provide 
such highly specialized services at a lower cost than if it directly 
employed an individual(s) to perform such services. A hospice that 
chooses to contract for core services or highly specialized nursing 
services must have a contract with the entity providing the contracted 
services. Negotiating, documenting and signing a business contract is 
standard business practice and does not impose a burden.
    (d) Standard: Counseling services. The final rule also requires a 
hospice to offer bereavement services to appropriate residents of a 
SNF/NF or ICF/MR. Residents of a facility often act as a patient's 
family, providing care, support, and companionship throughout the 
terminal illness. In such cases, we believe that it is appropriate for 
a hospice to offer bereavement services to the affected residents in 
the same manner that bereavement services are offered to a patient's 
family. Since offering and subsequently providing bereavement services 
to a patient's family is standard practice, we do not believe that 
extending such services to those who act as a patient's family in a 
SNF/NF or ICF/MR imposes an additional burden upon a hospice relative 
to the burden of providing bereavement services to a patient's family.

Waiver of Requirement--Physical Therapy, Occupational Therapy, Speech-
Language Pathology, and Dietary Counseling (Sec.  418.74)

    This waiver, currently implemented through a memorandum from CMS's 
Center for Medicaid and State Operations, will reduce the compliance 
burden on hospices located in non-urbanized areas. If the hospice 
program demonstrates that recruitment efforts were unsuccessful, it may 
request certain waivers with respect to PT, OT, speech-language 
pathology, and dietary counseling. There have been no applications for 
this waiver in the past 5 years; therefore we believe that the burden 
is negligible.

Hospice Aide and Homemaker Services (Sec.  418.76)

    Hospice aide and homemaker services are an integral part of hospice 
care, yet they receive little attention in the current regulation. 
These services are briefly addressed in Sec.  418.94 with a standard 
regarding the supervision of home health aide services and a standard 
regarding written patient care instructions. These two standards appear 
in the final regulation, with some minor alterations. The final 
regulation also adds several new requirements.
    (b) Standard: Content and duration of hospice aide classroom and 
supervised practical training; (c) Standard: Competency evaluation; (d) 
Standard: In-service training.
    These three standards describe the ways in which a hospice aide can 
meet the qualification requirements. All of these standards require the 
hospice to maintain documentation that each hospice aide meets these 
qualifications. The burden associated with these standards is the time 
to complete the required documentation. We estimate that it will take 
five minutes to document the information and that an office employee 
will complete this task. In addition, we have calculated the burden 
based on an employee turnover rate of 30% (2002 NHPCO National Data Set 
Summary Report), meaning that we expect that the average hospice would 
replace 30% of its hospice aides in a given year, or roughly one 
hospice aide a year based on the employment of 5 hospice aides. Based 
on the above-mentioned estimates and assumptions, we estimate that will 
cost an average hospice $1.17 to document that its hospice aides meet 
the qualification

[[Page 32196]]

requirements, for a total cost of $3,360 nationwide.

$14 an hour for an office employee to document compliance/60 minutes 
= $0.23 minute x 5 minutes per aide to document compliance = $1.17 x 
1 document per year = $1.17 per hospice
$1.17 per hospice x 2,872 hospices = $3,360
5 min to document x 2872 hospices = 14,360/60min = 239 hours

    (g) Standard: Hospice aide assignments and duties. The hospice aide 
is required to report changes in the patient's needs to a registered 
nurse, and complete appropriate records in compliance with the 
hospice's policies and procedures. This new requirement reflects the 
standard industry practice of maintaining communication between all 
healthcare providers and maintaining a complete patient record.
    (h) Standard: Supervision of hospice aides. This standard retains 
the current rule's requirement that a registered nurse visit the 
patient's home to assess hospice aide services every 14 days. This 
standard also requires that a registered nurse visit the patient's home 
annually or more frequently when there are care/performance issues, 
when the aide is providing services in the home. We believe that 
thoroughly supervising employees is standard practice and does not 
increase burden.
    (j) Standard: Homemaker qualifications. The final regulation 
requires homemakers to complete a hospice orientation program 
addressing the needs and concerns of patients and families coping with 
a terminal illness. We believe that this standard does not impose any 
additional regulatory burden because hospices train all of their 
employees, including homemakers, to deal with the realities of hospice 
care.
    (k) Standard: Homemaker supervision and duties. A member of the IDG 
is required to develop written instructions for the homemaker. We have 
also added a requirement that a member of the IDG must coordinate and 
supervise the homemaker services. We believe that providing patient 
care instructions, coordinating care, and supervising homemakers are 
usual and customary practice; therefore, this requirement would not 
impose any additional regulatory burden.

                                             Table 4.--Hospice Aide and Homemaker Services Burden Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Time per                                        Cost per
                        Standard                           Time per aide      hospice       Total time     Cost per aide      average       Total cost
                                                             (minutes)       (minutes)        (hours)                         hospice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation (based on 1 new hospice aide per year)....               5               5             239           $1.17           $1.17          $3,360
                                                         -----------------------------------------------------------------------------------------------
    Totals..............................................               5               5             239            1.17            1.17           3,360
--------------------------------------------------------------------------------------------------------------------------------------------------------

Organization and Administration of Services (Sec.  418.100)

    The revised requirements for the organization and administration of 
services are essentially the same as those in the previous conditions 
of participation. We added a requirement to clarify the relationship 
between the hospice governing body and the hospice administrator. This 
clarification presents no burden for a hospice.
    (f) Standard: Hospice multiple locations. We also added a 
requirement that a hospice must apply to CMS to receive authorization 
for the opening of a multiple location. This practice is currently 
mandated through a June 1997 memorandum from CMS' Center for Medicaid 
and State Operations. Requesting approval from CMS to provide services 
to Medicare and Medicaid patients from a particular location is 
standard practice in the industry and does not present a burden for a 
hospice.
    (g) Standard: Training. Finally, we added two employee training 
requirements. First, we added a requirement that a hospice must provide 
an initial orientation for each employee that addresses the employee's 
specific job duties. Second, we added a specification for the 
maintenance of in-service training records to help a hospice document 
its compliance with the provision of in-service training requirement. 
These additions reflect standard practice in the industry and present 
no additional burden.

Medical Director (Sec.  418.102)

    This rule includes a new requirement that a hospice must designate 
a physician to assume the role and responsibilities of the medical 
director when the medical director is not available. All hospices 
routinely meet the medical needs of their patients 24 hours a day, 
including the need for physician services. As such, they must already 
have a physician available at all times. A single physician cannot 
fulfill this 24-hour a day hospice physician role; therefore hospices 
already have more than one physician available. We believe that 
identifying the alternative physician as the physician designee, ready 
and able to fulfill the medical director role in the medical director's 
absence, does not pose a burden to a hospice.
    (a) Standard: Medical director contract. We added a provision 
permitting the medical director to work under a contractual 
arrangement, reducing the program and hiring burden on the hospice. If 
a hospice chooses to secure medical director services through a 
contract, this rule requires the contract to specify the physician who 
will serve as the medical director. Identifying a single individual to 
serve as the hospice medical director is standard practice in the 
hospice industry and does not present a burden.
    (b) Standard: Initial certification of terminal illness and (c) 
Standard: Recertification of the terminal illness. This rule codifies 
the current standards of practice to which medical directors adhere for 
certifying and recertifying a patient's terminally ill status.
    (d) Standard: Medical director responsibility. This rule re-
codifies the requirement that the medical director or designee has 
responsibility for the medical component of the hospice's patient care 
program. It is standard practice for the hospice medical director to 
lead, and thus bear responsibility for, the medical component of the 
hospice's patient care services. Therefore, this re-codified provision 
does not impose a burden upon a hospice.

Clinical Records (Sec.  418.104)

    This rule adds specificity in regard to content, authentication, 
retrievability, retention, and transfer of records. It requires a 
hospice to include all relevant patient care information in each 
patient's clinical record in order to facilitate communication and 
coordination among all disciplines involved in a patient's care. It 
also requires a hospice to ensure that clinical record entries are 
legible, clear, complete, and authenticated in

[[Page 32197]]

accordance with its own policies. Furthermore, this rule requires a 
hospice to protect and retain the information contained in the clinical 
record in accordance with the Department's rules regarding personal 
health information at 45 CFR parts 160 and 164. All of these 
requirements reflect standard hospice practices and do not pose a 
burden.
    (e) Standard: Discharge or transfer of care. This rule requires a 
hospice to prepare and send a comprehensive discharge summary for all 
patients that are discharged alive. The discharge summary must include 
a summary of the patient's stay, the patient's current plan of care, 
the most recent physician orders, and any other documentation to aid in 
post-discharge care of the patient. These are standard elements for 
discharge summaries in the health care industry, including the hospice 
industry. This rule also requires a hospice to send a copy of the 
patient's clinical record to the provider assuming care of the patient, 
if the provider assuming care requests a copy of the clinical record. A 
comprehensive discharge summary should remove any reason for the 
provider assuming care to request a copy of the patient's clinical 
record. Therefore, we do not believe that this requirement will pose a 
burden to a hospice. We believe that these discharge requirements 
reflect standard industry practice and add no burden.

Drugs, Medical Supplies and Durable Medical Equipment (Sec.  418.106)

    (a) Standard: Managing drugs and biologicals. We added a 
requirement that a hospice must ensure that its IDG(s) confers with an 
individual with education and training in drug management to ensure 
that drugs and biologicals meet each patient's needs. A hospice may 
meet this requirement in a variety of ways that is, by hiring or 
contracting with a pharmacist(s), by contracting with a pharmacy 
benefit management company, by hiring or contracting with a physician 
or other clinician with the necessary education and training in drug 
management (for example, a physician who is board certified in 
palliative care once board certification is available in October 2008), 
or by ensuring the appropriate education and training of one or more 
existing hospice employees.
    For purposes of our analysis only, we are estimating the impact of 
this provision based on the assumption that an average hospice will 
choose to use a pharmacist to meet this requirement. We have made this 
assumption based on two factors. First, pharmacists are relatively 
easier to access in most parts of the country as compared to clinicians 
who have specialized drug management education and training. Second, 
pharmacist services can be easily accessed by phone and electronic 
communications through a local pharmacy or a pharmacy benefit 
management company. Hospices are in no way required to use a pharmacist 
to fulfill this role. We estimate that an average hospice already 
spends $123,842 annually to provide drugs and biologicals for its 
patients ($15.72 per patient day (dollar figure is not adjusted for 
inflation) for drugs and biologicals based on 2001 Millman USA report 
titled ``The Costs of Hospice Care: An Actuarial Evaluation of the 
Medicare Hospice Benefit'' and consistent with the 2002 NHPCO National 
Data Set). Based on discussions with the leading hospice pharmacy 
benefit management company, for approximately this same price ($12-18 
per patient day), a hospice may contract with a pharmacy benefit 
management company to provide all drugs and biologicals for its 
patients. In addition, the pharmacy benefit management company allows a 
hospice IDG to speak with a pharmacist on a 24-hour basis to gather 
information, input, and advice from the pharmacist regarding an 
individual patient's drug and biological profile. Contracting with a 
pharmacy benefit management company and utilizing its pharmacists 
satisfies the new requirement without increasing a hospice's 
expenditures beyond what it is currently spending to provide drugs and 
biologicals alone. Since hospices currently have the option of 
contracting with a pharmacy benefit management company to comply with 
this requirement without increasing overall pharmacy costs, we do not 
believe that this new requirement poses a burden to a hospice. As of 
January 2008 approximately 1,600 hospices currently use the services of 
pharmacy benefit management companies.
    If a hospice decides not to use a pharmacy benefit management 
company, it may also choose to employ or contract with a pharmacist(s) 
for pharmacist advisement services. A hospice that chooses to use the 
services of a pharmacist (or other individual with specialized 
education and training in drug management) in lieu of a pharmacy 
benefit management company retains the responsibility and flexibility 
of managing the purchase of drugs and biologicals. We estimate that it 
requires 30 minutes for an individual such as a pharmacist to initially 
review a patient's drug and biologicals profile and advise the IDG 
during the time of the patient's comprehensive assessment and 
development of the plan of care. Additionally, we estimate that it 
requires 15 minutes of a individual's time to review updates to the 
patient's drug profile and advise the IDG about updates to the 
patient's plan of care. Based on a 26 day median length of stay, 
patients would likely receive two updates to their plans of care. Using 
these estimates, a hospice would expend $56 per patient to secure 
pharmacist advisement services. An average hospice would expend $16,968 
annually to secure pharmacist advisement services for all of its 
patients. We have not estimated the cost associated with a hospice 
using an individual from another clinical discipline who has 
specialized education and training in drug management because we are 
unsure of what disciplines would be used in this role, depending upon 
the needs of each hospice.

30 minute initial advisement per patient at $28 + 15 minute update 
advisement per patient at $14 + 15 minute update advisement per 
patient at $14 = $56 per patient for all pharmacists advisement 
services
$56 per patient x 303 patients = $16,968

    (b) Standard: Ordering of drugs, (c) Standard: Dispensing of drugs 
and biologicals and (d) Standard: Administration of drugs and 
biologicals. We added requirements governing the ordering, dispensing, 
and administration of drugs and biologicals. Having written policies 
and procedures in place to manage drugs and biologicals, and educating 
patients and families about these policies and procedures is standard 
practice in the hospice industry. Therefore, these requirements pose no 
burden to a hospice.
    (e) Standard: Labeling, disposing and storing of drugs and 
biologicals. This standard requires a hospice to ensure safe labeling 
of all drugs and biologicals in accordance with current standards of 
practice. This standard also requires a hospice-operated inpatient 
facility to investigate discrepancies involving controlled drugs and to 
document an account of the investigation. Of the 2,533 deficiencies 
issued by State surveyors in 1,161 surveys in 2006, two were 
potentially related to controlled drug discrepancies. The 1,161 surveys 
in 2006 represent approximately 30 percent of all hospices. Therefore, 
we can expect that if all hospices were surveyed, six deficiencies 
would be issued that are potentially related controlled drug 
discrepancies. We do not expect a significant increase in

[[Page 32198]]

discrepancies, and estimate that six investigations would be conducted 
and documented throughout the hospice industry.
    The rule requires the hospice's pharmacist and administrator to 
conduct controlled drug investigations. We estimate that a thorough 
investigation, including an examination of the records of incoming and 
outgoing drugs and biologicals, and report would require one hour per 
incident. The entire industry would thus spend six hours annually at a 
cost of $624 to fulfill this requirement. Maintaining inventory records 
incoming and outgoing drugs and biologicals is a usual and customary 
business practice and is not a burden.

$55 hour + $49 hour = $104 hour x 1 hour investigation = $104 per 
investigation
$104 per investigation x 6 investigations = $624 industry wide

    In addition, we added a requirement regarding documentation of 
patient and family drug education. A hospice must document in the 
patient's clinical record that it provided a copy of its controlled 
drug policy to the patient and family at the time when a controlled 
drug is first ordered. A hospice must also document that it discussed 
the controlled drug policy with the patient and family. Documenting the 
provision of the material and the education session requires 
approximately five minutes, and will likely be completed by a 
registered nurse. Fulfilling the requirement would cost $2.25 per 
patient based upon the average hourly rate for a registered nurse.

$27 hour/60 minutes = $0.45 minute x 5 minutes = $2.25
$2.25 per patient x 303 patients = $682
$2.25 per patient x 303 patients x 2872 hospices = $1,957,986

    (f) Standard: Use and maintenance of equipment and supplies. We 
added a requirement that a hospice must ensure that manufacturer 
recommendations for routine and preventive maintenance of equipment are 
followed. If manufacturer recommendations do not exist, a hospice must 
ensure that maintenance policies are developed. A hospice must also 
ensure that the patient and family receive instruction regarding the 
use of equipment and supplies, and that the patient and family can 
safely demonstrate the use of the equipment and supplies. Hospices 
already require their equipment and supply vendors to properly maintain 
the equipment supplied to hospice patients. Therefore, we believe that 
this maintenance requirement does not impose a burden. Additionally, 
hospices already assure that patients and families can operate the 
supplied equipment. When a patient and family safely and effectively 
use equipment, the hospice does not need to continually send its staff 
to the patient's home for equipment problems. Since this routine 
education already occurs, benefiting both the patient and the hospice, 
this requirement does not impose a burden.
    The vast majority of hospices provide durable medical equipment and 
supplies under contract with one or more vendors. For this reason, we 
added a requirement that a hospice may only contract with a durable 
medical equipment supplier that meets the Medicare DMEPOS Supplier 
Standards at 42 CFR 424.57. We do not believe that this requirement 
will compromise a hospice's ability to secure a contract or 
significantly increase the cost of that contract because most vendors 
choose to meet the Medicare Supplier Standards in order to furnish 
equipment and supplies to Medicare beneficiaries. Therefore, there is 
sufficient competition among vendors to provide high quality services 
at a reasonable cost to hospices seeking contracts.

                                    Table 5.--Drugs, Medical Supplies and Durable Medical Equipment Burden Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Time per
                                                             Time per         average     Total industry     Cost per        Cost per     Total industry
                        Standard                              patient        hospiace      time (hours)       patient         average          cost
                                                             (minutes)        (hours)                                         hospice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Policy Education...................................               5           25.25          72,518           $2.25         $681.75      $1,957,986
Drug Discrepancy Investigation..........................             N/A             N/A               6             N/A             N/A             624
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................               5           25.25          72,524            2.25          681.75       1,958,610
--------------------------------------------------------------------------------------------------------------------------------------------------------

Short Term Inpatient Care (Sec.  418.108)

    (b) Standard: Inpatient care for respite purposes. This rule allows 
a hospice to contract for respite care with a facility that does not 
have a registered nurse on-duty providing direct patient care 24-hours 
a day. This provision will make it easier for hospices to contract with 
long term care facilities.
    (c) Standard: Inpatient care provided under arrangements. This rule 
provides additional guidance with respect to the substance of the 
written agreement between a hospice and an inpatient facility, which we 
believe is a usual and customary business practice. Therefore, this 
provision therefore does not increase regulatory burden.
    (d) Standard: Inpatient care limitation and (e) Standard: Exemption 
from limitation. This rule also maintains the 20 percent limitation on 
inpatient days and the exemption to this limitation. These requirements 
are statutory and have been in place since the inception of the 
Medicare hospice benefit. They reflect the goal of the hospice movement 
and benefit to keep patients in their home, where most patients prefer 
to stay. Therefore, they are standard practice.

Hospices That Provide Inpatient Care Directly (Sec.  418.110)

    (b) Standard: Twenty-four hour nursing services. This rule includes 
the 24-hour nursing requirement from the existing rule. In short, a 
hospice that provides general inpatient care directly must have a 
registered nurse who provides direct patient care on each shift. This 
requirement has been in place since the inception of the Medicare 
hospice Conditions of Participation. As such, it is standard practice 
and does not pose a burden.
    (c) Standard: Physical environment through (l) Standard: Meal 
service and menu planning. This rule requires a hospice to maintain a 
safe physical environment in its inpatient facility. A hospice must:
    Have and rehearse a disaster preparedness plan;
    Manage all aspects of the building (that is, waste, water supply, 
and ventilation);
    Comply with applicable fire safety requirements;
    Have a home-like atmosphere with sufficient space and amenities;
    Have an adequate infection control program;
    Have clean linens and properly handle soiled ones; and
    Serve meals to meet patient needs.
    These requirements are standard practice in hospice-operated 
inpatient facilities and pose no additional burden.
    (m) Standard: Restraint or seclusion, (n) Standard: Restraint or 
seclusion staff training requirements and (o) Standard:

[[Page 32199]]

Death reporting requirements. This rule adds considerable detail in 
regard to seclusion and restraint. This section is adapted from the 
language of the Patient's Rights Condition of Participation for 
hospitals published as a Final Rule in the Federal Register in December 
2006, and codified at 42 CFR 482.13. While we anticipate that hospices 
with their own inpatient facilities will be impacted by this rule, we 
do not have the benefit of several key pieces of information. For 
example, we do not have reliable data on the prevalence of restraint 
and seclusion use, data on the volume of staff in inpatient hospices, 
or data on the varying levels and qualifications of hospice staff who 
may be involved in restraint and seclusion use. Factors such as size, 
services rendered, staffing, and patient populations vary as well. We 
are hesitant to make impact estimates in this final rule that may not 
account for these and other unforeseen variations. Thus, we reserve the 
right to provide estimates when feasible. Below we discuss the 
anticipated effects on providers of the standards related to restraints 
and seclusion.
    (m) Standard: Restraint or seclusion. Standard 418.110(m) sets out 
the patient's rights in the event he or she is restrained or secluded, 
and limits when and by whom restraint or seclusion can be implemented. 
We recognize that there will be some impact associated with performing 
patient assessment and monitoring to ensure that seclusion and 
restraint are only used when necessary and are implemented in a safe 
and effective manner. However, patient assessment and monitoring are 
standard components of patient care, and this requirement does not pose 
a burden to a hospice.
    Section 418.110(m)(6) requires that the medical director or 
physician designee must be consulted as soon as possible if the 
attending physician did not order the restraint or seclusion. Although 
this may minimally increase burden to hospices, we believe it is a best 
practice for patient safety.
    We have added elements at Sec.  418.110(m)(14) that monitoring must 
occur face-to-face by trained staff or by using both video and audio 
equipment, when there is simultaneous use of restraint and seclusion. 
We have added elements at Sec.  418.110(m)(15) regarding the 
documentation that must be included in the patient's medical record 
when the patient is restrained or secluded, including the 1-hour face-
to-face medical and behavioral evaluation if restraint or seclusion is 
used to manage violent or self-destructive behavior, the patient's 
behavior and intervention used, alternatives or other less restrictive 
interventions attempted (as applicable), the patient's condition or 
symptom(s) that warranted restraint or seclusion use, and the patient's 
response to the use of the restraint or seclusion intervention, 
including the need for continued use of restraint or seclusion. We do 
not believe additional burdens are imposed by this requirement since it 
is a routine and customary practice to document the circumstances 
surrounding such an event for comprehensiveness of patient care.
    In response to the December 19, 1997 proposed rule that we 
published concerning the use of seclusion and restraint in hospitals, 
the National Association of Psychiatric Health Systems (NAPHS) supplied 
data from fifty members for the time and cost of complying with the CMS 
requirements that a physician evaluate a patient face-to-face within 1 
hour of the initiation of restraint or seclusion. The NAPHS stated 
their respondents reported it took an estimated 30 minutes to 1 hour to 
document all the specific elements required by CMS after a restraint or 
seclusion episode. This included several elements unique to the rule 
such as physician notification if the restraint was ordered by someone 
other than the patient's attending physician.
    We believe that the time associated with documenting seclusion or 
restraint episode in a hospice is similar to that in a hospital. Thus, 
our burden estimate is based on a median timeframe (that is, 45 
minutes) that we believe it takes to complete the required 
documentation in the patient's clinical record. However, since we are 
unable to estimate the prevalence of restraint and seclusion, we can 
not apply this estimate to assess the associated burden across 
hospices.
    (n) Standard: Restraint or seclusion staff training requirements. 
Standard 418.110(n) identifies the training requirements for all staff 
involved in the use of seclusion and restraint in the hospice inpatient 
facility. While we have tried to minimize the burden which will be 
placed on hospices in order to meet this requirement, we believe it is 
important for the provision of safe and effective restraint or 
seclusion use. We require that before staff apply restraints, implement 
seclusion, perform associated monitoring and assessment of the 
restrained or secluded patient, or provide care for a restrained or 
secluded patient, the staff must be trained and able to demonstrate 
competency in the performance of these actions. The staff training 
requirements address the following broad areas: Training intervals, 
training contents, trainer requirements, and trainer documentation.
    To reduce burden and create a reasonable requirement while assuring 
patient safety, we have mandated that only those staff who are involved 
in the application of restraint or seclusion or performing associated 
monitoring and assessment of, or providing care for restrained or 
secluded patients have this training. While we expect physicians to be 
trained in the proper use of restraint or seclusion, we do not expect 
that they will be trained with the other hospice staff. Thus, we have 
not included physicians in the burden associated with these 
requirements. Instead, we require the remaining hospice staff who have 
direct contact with patients must be trained in restraint or seclusion 
use.
    In this final rule, we have specified broad topics to be covered in 
training, and have not required that staff be trained by an outside 
organization. We believe that in-house training may be more economical 
than sending staff off-site for instruction. However, hospices have the 
option of sending either selected or all staff to outside training if 
they believe that this is warranted.
    Thus, we have based our burden estimate on having the actual number 
of trainers attend the training from an outside organization one time. 
We believe that most hospices would, in turn, have these trained 
individuals function as program developers and trainers of the 
appropriate hospice staff. We believe in most instances this 
professional will be a registered nurse.
    Train-the-trainer programs are the way many hospices provide staff 
instruction. The four day instructor certification program given by the 
Crisis Prevention Institute (CPI, INC.) costs $1,200 dollars in tuition 
plus travel, lodging, and participant salary (HYPERLINK ``http://www.crisisprevention.com'' www.crisisprevention.com).
    We estimate, on average, that roundtrip travel for each nurse will 
cost approximately $400 to cover the need for either local or distant 
travel, lodging for each nurse will costs approximately $120 per night 
x 3 nights, and the meals and incidental expenses (M&IE) will be 
approximately $50 per day depending upon the location within the 
designated state. Thus, we anticipate the cost to train one nurse would 
be $3,280. If all 906 hospices (estimate based on March 2006 Hospice 
Facts & Statistics report from the Hospice Association of America that 
31.54 percent of hospices have their own inpatient facilities) with 
inpatient facilities were to send one

[[Page 32200]]

nurse to such training, the total cost for the 906 hospices would be 
$2,971,680.

$1,200 for instructor certification program + $400 airfare + $360 
for 3 days lodging + $200 for 4 days M&IE + $1120 for nurse salary 
at $35 per hour x 8 hours per day x 4 days = $3,280 per nurse per 
hospice inpatient facility.
$3,280 per nurse per hospice x 906 hospices = $2,971,680

    We believe that hospices will add seclusion and restraint training 
onto their existing in-service training programs. The train-the-trainer 
program described above will provide hospices with the necessary 
personnel and materials to implement a staff-wide seclusion and 
restraint training program. We estimate that developing this staff-wide 
training program will require 40 hours of the trainer's time on a one-
time basis for all affected hospices, at a cost of $1,400 per hospice 
inpatient facility.
    We require that each individual who will potentially be involved in 
restraint and seclusion of a patient have training in the proper 
techniques. According to the NAPHS, initial training in de-escalation 
techniques, restraint and seclusion policies and procedures, and 
restraint and seclusion techniques range from 7 to 16 hours of staff 
and instructor time.
    Using data from a March 2006 Hospice Association of America report, 
there were 116,148 total hospice employees and volunteers in 2005. Of 
these employees and volunteers, 32,412 employees and volunteers were 
nurses and physicians. Thus the average hospice operating its own 
inpatient facility has 11 nurse and physician employees and volunteers. 
We realize that some hospices will have more or less employees and 
volunteers to train. Based on one nurse trainer conducting an 8 hour 
training course for 11 hospice inpatient employees and volunteers, we 
estimate that this requirement will cost $3,360.

8 trainer hours at $35/hr = $280
88 trainee hours at $35/hr = $3080
$280 trainer cost + $3080 trainee costs = $3,360

    We require that each individual will receive annual updates to the 
training and that the annual training will also be documented. Again, 
according to NAPHS, annual updates are about 4 hours of staff and 
instructor time per each employee who has direct patient contact. 
Again, an average size hospice has 11 employees who have direct patient 
contact that must to be trained in de-escalation techniques. Therefore, 
we estimate that it will cost $1,680 annually to update each person's 
training.

4 trainer hours at $35/hr = $140
44 trainee hours at $35/hr = $1540
$140 trainer costs + $1540 trainee costs = $1,680

    Additionally, we required recordkeeping for documenting in each 
trained individual's personnel record that he or she has successfully 
completed training. We estimate that it will take the trainer 5 minutes 
per trainee to document each participant's completion of the training. 
As described above, we estimate that 11 hospice employees and 
volunteers will be trained.

5 minutes per trainee x 11 trainees = 55 minutes annually
55 minutes x $35/hr = $32 annually
55 minutes per hospice x 906 hospices = 830.5 hours industry wide
830.5 hours industry wide x $35/hr = $29,067.5 industry wide

    Finally, we require that each hospice revise its training program 
annually as needed. We estimate this task, completed by the trainer, to 
take approximately 4 hours annually per hospice.

4 hours x $35/hr = $140 per hospice
$140 per hospice x 906 hospices = $126,840 industry wide

    (o) Standard: Death reporting requirements. This requirement 
applies to all deaths associated with the use of restraint or seclusion 
throughout the hospice inpatient facility. A hospice must report to CMS 
each death that occurs while a patient is in restraint or seclusion at 
the hospice inpatient facility, each death that occurs within 24 hours 
after the patient has been removed from restraint or seclusion, and the 
hospice must report each death known to the hospice that occurs within 
1 week after restraint or seclusion where it is reasonable to assume 
that the use of restraint seclusion contributed directly or indirectly 
to a patient's death.
    Each death referenced in this section must be reported to CMS by 
telephone no later than the close of business the next business day 
following knowledge of the patient's death. We have no data from which 
to base an estimate on the number of deaths in hospice that may be 
related to the use of seclusion and restraint. However, based on a lack 
of family complaints to State agencies or CMS we believe such deaths to 
be a rare occurrence. Although our goal is to ensure the safe and 
appropriate use of seclusion and restraint and reduce associated 
deaths, we are aware that the actual number of reported deaths from 
seclusion and restraint may increase due to these reporting 
requirements.
    Thus, we anticipate there will be burden associated with this 
requirement due to the increased number of deaths that will be reported 
by the hospice industry. Given the lack of historical data, we assume 
the number of reports certainly should average less than one per 
hospice inpatient facility per year. Thus, we believe the impact 
associated with this provision (that is, making a telephone call and 
filling in a written report) to be negligible.

              Table 6.--Hospices That Provide Inpatient Care Directly Burden Assessment (One Time)
----------------------------------------------------------------------------------------------------------------
                                                                                           Total
                                                                             Cost per    
              Standard                   Time per  average     Total time    average     of hospice   Total cost
                                              hospice           (hours)      hospice     inpatient
                                                                                         facilities
----------------------------------------------------------------------------------------------------------------
 4 day trainer training.............   32 hours.............       16,896       $3,280          906   $2,971,680
 Staff training program development.   40 hours.............       21,120        1,400          906    1,268,400
Staff training......................   96 hours.............       50,688        3,360          906    3,044.160
 Staff training records.............   55 minutes...........        830.5           32          906       29,068
                                     =========================
    Totals 1st year.................   169 hours............       89,535       $8,072          906   $7,313,308
----------------------------------------------------------------------------------------------------------------


[[Page 32201]]


               Table 7.--Hospices That Provide Inpatient Care Directly Burden Assessment (Annual)
----------------------------------------------------------------------------------------------------------------
                                                                              Total
                                                                                 Cost per
              Standard                   Time per average      Total time   of hospice    average     Total cost
                                              hospice           (hours)     inpatient     hospice
                                                                            facilities
----------------------------------------------------------------------------------------------------------------
Staff training update...............   48 hours.............       43,488          906       $1,680   $1,522,080
Staff training records..............   55 minutes...........        830.5          906           32       29,068
                                     =========================
Staff training program update.......   4 hours..............        3,624          906          140      126,840
 
    Totals annually.................   53 hours.............       47,943          906        1,852    1,677,988
----------------------------------------------------------------------------------------------------------------

Hospices That Provide Hospice Care to Residents of a SNF/NF or ICF/MR 
(Sec.  418.112)

    (c) Standard: Written agreement. This rule establishes the minimum 
content of the written agreement that a hospice provider must have with 
a SNF/NF or ICF/MR if the hospice is caring for a resident of the 
facility. Establishing a contract with another provider to coordinate 
patient care is standard practice and does not pose a burden to a 
hospice that chooses to care for patients in these settings.
    (d) Standard: Hospice plan of care. This rule also includes several 
requirements for a patient's plan of care that are in addition to the 
plan of care requirements in Sec.  418.56(b), (c), and (d). If a 
hospice patient is a resident of a SNF/NF or ICF/MR, the hospice plan 
of care for the patient must reflect the participation of the hospice, 
the facility, the patient, and the family to the extent possible. In 
addition, the hospice plan of care must identify which provider (the 
hospice or the facility) is responsible for each activity identified in 
the plan of care. Any changes in the hospice plan of care must be 
discussed by the hospice with the patient or representative, and 
facility representatives. The hospice must approve all changes to the 
hospice plan of care before the changes are implemented.
    (e) Standard: Coordination of services. In addition to the plan of 
care requirements, we added a coordination of services standard. This 
new standard requires a hospice to designate an IDG member to 
coordinate a patient's care with facility representatives, and 
communicate with facility representatives and other health care 
providers. The standard also requires the hospice IDG to communicate 
with all physicians involved in the care of a particular patient. These 
communication and coordination requirements are essential to providing 
safe, quality patient care.
    Any additional effort by hospice personnel to meet these 
requirements will, we believe, be offset by the reduced costs 
associated with the provision of more effective and efficient patient 
care. For example, by communicating and coordinating with a facility, a 
hospice can avoid situations where duplicative or contradictory orders 
are issued by the hospice physician and the facility physician. If 
duplicative orders are avoided, the hospice may be able to eliminate 
the duplicative service, thereby decreasing hospice expenditures while 
maintaining quality patient care. If contradictory orders are avoided, 
a hospice can avoid furnishing care that is rendered ineffective by the 
opposing care furnished by the facility. This, too, would decrease 
hospice expenditures, while at the same time improving the patient's 
well being.
    Furthermore, the standard requires a hospice to provide a facility 
with specified information about the patient's care. With the exception 
of the election and advanced directives forms, certification forms, and 
physician orders, all of the specified information is routinely 
provided to a patient's caregiver(s). Since the facility is the 
caregiver, providing this information presents no burden to a hospice. 
We estimate that providing the facility with the election and advanced 
directives forms, certification forms, and physician orders for each 
patient would cost $2.33 per patient, based on 10 minutes of an office 
employee's time to fax the required documents to the facility. 
According to a March 2006 report from the Hospice Association of 
America (``Hospice Facts & Statistics''), 27.19 percent of hospice 
patients nationwide resided in a SNF or other long term care facility. 
Therefore, we estimate that hospices will provide forms to SNFs/NFs and 
ICFs/MR for 236,336 hospice patients residing in those facilities. We 
also estimate that the average hospice will provide care to 82 patients 
residing in a SNF/NF or ICF/MR (236,336 patients nationwide / 2,872 
hospices).

82 patients in a facility x 10 minutes per patient to provide forms 
/ 60 minutes = 13.7 hours per hospice
13.7 hours x office employee at $14/hr = $192
10 minutes per patient x 236,336 patients nationwide / 60 minutes = 
39,389 hours industry wide
39,389 hours x $14/hr = $551,446
$551,446/236,336 patients = $2.33 per patient

    (f) Standard: Orientation and training of staff. Finally, this rule 
requires a hospice to assure the orientation of SNF/NF and ICF/MR staff 
caring for hospice patients. Staff orientation must address the 
following topics: hospice philosophy; hospice policies regarding 
patient comfort methods, pain control, and symptom management; 
principles about death and dying; individual responses to death; 
patient rights; appropriate forms; and record keeping requirements. As 
many commenters noted, not every hospice will conduct the orientation 
itself because several hospices may serve residents of a single 
facility. Rather, many hospices will rely on the orientation already 
provided by another hospice. We do not know exactly how many hospices 
serve patients residing in a SNF/NF or ICF/MR, or how many of those 
facilities are served by multiple hospices. Therefore, we cannot 
estimate the number of hospices that will conduct orientation sessions 
for SNF/NF and ICF/MR staff. We believe that any burden associated with 
orienting SNF/NF and ICF/MR will be minimal because hospices already 
orient patients and families/caregivers about many of the topics 
covered in this standard (that is, hospice philosophy and principles 
about death and dying). Since the SNF/NF or ICF/MR staff act as the 
patient's care giver, orienting them would be very similar to orienting 
the patient's family/caregiver.

[[Page 32202]]



        Table 8.--Hospices That Provide Hospice Care to Residents of a SNF/NF or ICF/MR Burden Assessment
----------------------------------------------------------------------------------------------------------------
                                                   Time per
                                      Time per     average     Total time    Cost per     Cost per
             Standard                 patient      hospice      (hours)      patient      average     Total cost
                                     (minutes)     (hours)                                hospice
----------------------------------------------------------------------------------------------------------------
Providing forms to facility.......           10         13.7       39,389        $2.33         $192     $551,446
                                   -----------------------------------------------------------------------------
    Totals........................           10         13.7       39,389         2.33          192      551,446
----------------------------------------------------------------------------------------------------------------

Personnel Qualifications (Sec.  418.114)

    (b) Standard: Personnel qualifications for certain disciplines and 
(c) Standard: Personnel qualifications when no State licensing, 
certification or registration requirements exist. The final rule 
establishes personnel qualifications for a variety of positions within 
a hospice. In particular, this rule establishes the personnel 
qualifications for hospice social workers. A social worker in a hospice 
must meet one of the following qualifications:
     Have a Master of Social Work (MSW) degree from a school of 
social work accredited by the Council on Social Work Education and one 
year of experience in a health care setting;
     Have a baccalaureate degree in social work (BSW) from a 
school of social work accredited by the Council on Social Work 
Education and one year of experience in a health care setting; or
     Have a baccalaureate degree in psychology, sociology, or 
other field related to social work and at least one year of social work 
experience in a health care setting.
    If a hospice chooses to employ a social worker with a baccalaureate 
degree in social work, psychology, sociology, or other field related to 
social work, the services of the baccalaureate social worker (BSW) must 
be provided under the supervision of a social worker with an MSW from a 
school of social work accredited by the Council on Social Work 
Education and one year of experience in a health care setting. The MSW 
supervisor role is that of an active advisor, consulting with the BSW 
on assessing the needs of patients and families, developing and 
updating the social work portion of the plan of care, and delivering 
care to patients and families. This supervision may occur in person, 
over the telephone, through electronic communication, or any 
combination thereof.
    Social workers with a baccalaureate degree from a school of social 
work accredited by the Council on Social Work Education and who are 
employed by the hospice before the effective date of this final rule 
are exempted from the MSW supervision requirement. Therefore, if a 
hospice currently employs a BSW, it is not required to hire an MSW to 
supervise the BSW. If a hospice hires a new social worker with a 
baccalaureate degree and one year of experience in a health care 
setting, then the new baccalaureate social worker must be supervised by 
an MSW who has one year of experience in a health care setting.
    The impact associated with this social work qualification 
requirement is the expense of employing an MSW to supervise a BSW. By 
virtue of the personnel qualifications for social workers in hospice 
that have been in effect since 1983, all hospices are already required 
to have, at minimum, a social worker with a baccalaureate degree in 
social work from a school of social work accredited by the Council on 
Social Work Education. Therefore, all hospices should qualify for the 
exemption for MSW supervision described above.
    We are aware that many hospices already employ at least one MSW to 
provide direct patient care. In fact, when tracking the number of 
social workers serving hospice patients, the Hospice Association of 
America only reports the number of MSWs (6,177 in 2005) working in the 
hospice industry, rather than the number of BSWs, precisely because an 
MSW is the standard level of care within hospice. Thus, we believe that 
the number of hospices currently solely relying on BSWs is relatively 
low. We do not know the precise number of hospices without an MSW. For 
purposes of this estimate only, we assume that 33 percent of hospices 
(944) rely solely on BSWs to provide social work services to patients. 
Of the 944 hospices without an MSW, we estimate that 25 percent will 
hire a social worker after the effective date of this rule (based on a 
25% social worker turnover rate described in the ``Hospice Salary & 
Benefits Report 2006-2007'' issued by the Hospital & Healthcare 
Compensation Service and the ``2002 NHPCO National Data Set Summary 
Report''). Therefore, an estimated 236 hospices a year would be 
required to employ an MSW on a part-time basis to supervise the 
services of a BSW.
    Based on information from the ``Hospice Facts & Statistics 2006'' 
report, the ``Assuring the Sufficiency of Frontline Workforce: A 
National Study of Licensed Social Workers'' report, and the ``Licensed 
Social Workers in the United States, 2004'' report, we estimate that 
the annual compensation for a full-time, supervisory, MSW working in 
the hospice industry is $52,811 ($25/hr). Furthermore, we estimate that 
a hospice would employ an MSW for 10 hours a week to supervise the care 
and services provided by a BSW. As such, we estimate that an affected 
hospice would spend $13,000 annually to employ a part-time supervisory 
MSW to meet the requirements of this rule.

10 hours per week for MSW at $25/hour x 52 weeks = $13,000
$13,000 x 236 hospices = $3,068,000
10 hours per week x 52 weeks = 520 hours annually
520 hours x 236 hospices = 122,720 hours industry wide

    (d) Standard: Criminal background checks. Additionally, this final 
rule requires a background check for each employee providing direct 
patient contact or accessing patient records. In 2006, 40 states 
required criminal background checks for hospice employees. In these 
states, approximately 92,920 hospice employees already received a 
criminal background check, thus greatly reducing the overall potential 
burden. We estimate that hospices that have not previously performed 
background checks, accounting for approximately 23,228 hospice 
employees, will each obtain 40 criminal background checks initially. 
Each background check request form will take 6 minutes to prepare and 
send, for a total of 4 hours per hospice the first year. For each year 
thereafter, we estimate that hospices in states that do not require 
background checks will complete background checks on approximately 10 
new employees per year, for a total of 1 hour per affected hospice per 
year, and 582 hours nationally per year.

116,148 employees in 2005 according to National Association for Home 
Care 2005 Hospice Facts and Statistics/50 states = 2,323 average 
number of employees per

[[Page 32203]]

state x 40 states already requiring background checks = 92,920 
already required to have background checks
116,148 total employees - 92,920 already required to have background 
checks = 23,228 employees not already required to have background 
checks
116,148 employees/2,872 hospices in 2005 = 40 employees per average 
hospice
40 employees x 6 minutes per check = 4 hours per hospice
23,228 employees x 6 minutes per check = 2,323 hours nationwide
2,872 hospices nationwide/50 states = 57.4 average number of 
hospices per state x 10 states not currently requiring background 
checks = 574 affected hospices.
574 affected hospice x 10 new employees requiring background checks 
per year x 6 minutes per check/60 minutes = 96 hours

    We researched a wide variety of agencies that perform criminal 
background checks and determined that the average cost for an 
individual background check is $17.00 plus $1 for 6 minutes of clerical 
time per background check to process the paper work. We understand that 
some agencies or states may charge more or less than this fee to 
conduct a background check. In addition, some hospices may choose to 
conduct more extensive background checks that may cost more.
    We are not requiring that hospices conduct a specific type of 
background check (that is, State or Federal) or obtain such a check 
from a specific source (that is, State police or FBI). The flexibility 
of the requirement will allow hospices to identify the most cost 
efficient method of meeting the requirement.

$18 per check x 40 employees requiring checks = $720
$18 per check x 23,228 employees not already requiring checks = 
$418,104
$18 per check x 10 new employees requiring checks = $180.00 per 
hospice
$180 per hospice x 574 affected hospices = $103,320


                                                   Table 9.--Personnel Qualifications Burden Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Time per average                               Total  of       Total cost per
              Standard                       hospice           Total industry time     affected hospices       average hospice      Total industry cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
MSW supervisor.....................   520 hours............   122,720 hours........   236.................   $13,000.............   $3,068,000
Criminal background check..........   1st year--4 hours--     1st year--2,323         574.................   1st year--$720--       1st year--$418,104--
                                      annually 1 hour.        hours--annually 96                             annually $180.         annually $103,320
                                                              hours.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................   1st year--524 hours--  1st year--125,043        N/A.................   1st year--$13,720--    1st Year--
                                      Annually 521 hours.     hours--Annually                                Annually $13,180.      $3,486,104--Annually
                                                              122,816 hours.                                                        $3,171,320
--------------------------------------------------------------------------------------------------------------------------------------------------------

Compliance with Federal, State, and Local Laws and Regulations Related 
to the Health and Ssafety of Patients (Sec.  418.116)

    This final condition of participation requires that the hospice 
operate and furnish services in compliance with applicable Federal, 
State, and local laws and regulations related to the health and safety 
of patients. We do not believe this will add any regulatory burden, 
since this section of the final rule reflects current requirements and 
contemporary standard practice in hospice.

                                      Table 10.--Total Burden Assessment for All Requirements in the First Year CoP
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Total time per       Total time per      Total industry      Total cost per      Total cost per     Total industry
                                        patient          average hospice           time               patient        average hospice          cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient rights..................   5 minutes.........   48.25 hours.......   138,489 hours....  $3................              2,012          4,649,379
QAPI............................   N/A...............   241 hours.........   692,152 hours....   N/A..............              7,544         21,666,368
Hospice aide....................   N/A...............   5 minutes.........   239 hours........   N/A..............               1.17              3,360
Drugs and DME...................   5 minutes.........   25.25 hours.......   72,524 hours.....   2.25.............             681.75          1,958,610
Inpatient care directly.........   N/A...............   169 hours.........   89,535 hours.....   N/A..............              8,072          7,313,308
SNF/NF or ICF/MR................   10 minutes........   13.7 hours........   39,389 hours.....   2.33.............                192            551,446
Personnel qualifications........   N/A...............  524 hours..........   125,043 hours....   N/A..............             13,720          3,486,104
                                 -----------------------------------------------------------------------------------------------------------------------
    Total.......................   20 minutes........   1,021.3 hours.....   1,157,371 hours..   7.58.............         *32,222.92         40,754,007
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Includes cost of operating an inpatient facility and hiring a MSW supervisor. Most hospices will not incur these expenses. Therefore, this rule will
  cost most hospices $11,151 in the first year.

    We believe that the burden associated with this rule is reasonable 
and necessary to ensure the health and safety of all hospice patients. 
In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and budget.
2. Effects on other providers:
    Effects on other providers: We do not expect this regulation to 
affect any other provider.

List of Subjects in 42 CFR Part 418

    Health Facilities, Hospice Care, Medicare, Incorporation by 
reference, Reporting and record keeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR Chapter IV as set forth below:

[[Page 32204]]

PART 418--HOSPICE CARE

0
1. The authority citation for part 418 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

Subpart A--General Provision and Definitions


0
2. Section 418.2 is revised to read as follows:


Sec.  418.2  Scope of the part.

    This part establishes requirements and the conditions of 
participation that hospices must meet, and be in compliance with, in 
order to participate in the Medicare program. Subpart A of this part 
sets forth the statutory basis and scope and defines terms used in this 
part. Subpart B of this part specifies the eligibility requirements and 
the benefit periods. Subpart C of this part specifies the conditions of 
participation that hospice providers must meet regarding patient and 
family care. Subpart D of this part specifies the organizational 
environment that hospice providers must meet as conditions of 
participation. Subpart E is reserved for future use. Subpart F 
specifies coinsurance amounts applicable to hospice care.


0
3. Section 418.3 is amended by:
0
a. Revising the definitions of ``Bereavement counseling,'' 
``Employee,'' ``Hospice,'' ``Physician,'' ``Representative,'' and 
``Terminally ill''; and
0
b. Adding the definitions of ``Clinical note,'' ``Comprehensive 
assessment,'' ``Dietary counseling,'' ``Hospice care,'' ``Initial 
assessment,'' ``Licensed professional'' ``Multiple location,'' 
``Palliative care,'' ``Physician designee,'' ``Restraint,'' and 
``Seclusion.''
    The revisions and additions read as follows:


Sec.  418.3  Definitions.

    For the purposes of this part--
* * * * *
    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.
* * * * *
    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.
    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.
    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.
    Employee means a person who: (1) Works for the hospice and for whom 
the hospice is required to issue a W-2 form on his or her behalf; (2) 
if the hospice is a subdivision of an agency or organization, an 
employee of the agency or organization who is assigned to the hospice; 
or (3) is a volunteer under the jurisdiction of the hospice.
    Hospice means a public agency or private organization or 
subdivision of either of these that is primarily engaged in providing 
hospice care as defined in this section.
    Hospice care means a comprehensive set of services described in 
1861(dd)(1) of the Act, identified and coordinated by an 
interdisciplinary group to provide for the physical, psychosocial, 
spiritual, and emotional needs of a terminally ill patient and/or 
family members, as delineated in a specific patient plan of care.
    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.
    Licensed professional means a person licensed to provide patient 
care services by the State in which services are delivered.
    Multiple location means a Medicare-approved location from which the 
hospice provides the same full range of hospice care and services that 
is required of the hospice issued the certification number. A multiple 
location must meet all of the conditions of participation applicable to 
hospices.
    Palliative care means patient and family-centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care throughout the continuum of illness involves 
addressing physical, intellectual, emotional, social, and spiritual 
needs and to facilitate patient autonomy, access to information, and 
choice.
    Physician means an individual who meets the qualifications and 
conditions as defined in section 1861(r) of the Act and implemented at 
Sec.  410.20 of this chapter.
    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.
    Representative means an individual who has the authority under 
State law (whether by statute or pursuant to an appointment by the 
courts of the State) to authorize or terminate medical care or to elect 
or revoke the election of hospice care on behalf of a terminally ill 
patient who is mentally or physically incapacitated. This may include a 
legal guardian.
    Restraint means--(1) 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); or
    (2) A drug or medication when it is used as a restriction 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.
    Seclusion means the involuntary confinement of a patient alone in a 
room or an area from which the patient is physically prevented from 
leaving.
    Terminally ill means that the individual has a medical prognosis 
that his or her life expectancy is 6 months or less if the illness runs 
its normal course.


0
4. Subparts C and D are revised and Subpart E is removed and reserved 
to read as follows:

Subpart C--Conditions of Participation: Patient Care
Sec.
418.52 Condition of participation: Patient's rights.
418.54 Condition of participation: Initial and comprehensive 
assessment of the patient.

[[Page 32205]]

418.56 Condition of participation: Interdisciplinary group, care 
planning, and coordination of services.
418.58 Condition of participation: Quality assessment and 
performance improvement.
418.60 Condition of participation: Infection control.
418.62 Condition of participation: Licensed professional services.

CORE SERVICES

418.64 Condition of participation: Core services.
418.66 Condition of participation: Nursing services waiver of 
requirement that substantially all nursing services be routinely 
provided directly by a hospice.

NON-CORE SERVICES

418.70 Condition of participation: Furnishing of non-core services.
418.72 Condition of participation: Physical therapy, occupational 
therapy, and speech-language pathology.
418.74 Waiver of requirement--Physical therapy, occupational 
therapy, speech-language pathology and dietary counseling.
418.76 Condition of participation: Hospice aide and homemaker 
services.
418.78 Condition of participation: Volunteers.
Subpart D--Conditions of Participation: Organizational Environment
418.100 Condition of participation: Organization and administration 
of services.
418.102 Condition of participation: Medical director.
418.104 Condition of participation: Clinical records.
418.106 Condition of participation: Drugs and biologicals, medical 
supplies, and durable medical equipment.
418.108 Condition of participation: Short-term inpatient care.
418.110 Condition of participation: Hospices that provide inpatient 
care directly.
418.112 Condition of participation: Hospices that provide hospice 
care to residents of a SNF/NF or ICF/MR.
418.114 Condition of participation: Personnel qualifications.
418.116 Condition of participation: Compliance with Federal, State, 
and local laws and regulations related to the health and safety of 
patients.
Subpart E--[Removed and Reserved]

Subpart C--Conditions of Participation: Patient Care


Sec.  418.52  Condition of participation: Patient's rights.

    The patient has the right to be informed of his or her rights, and 
the hospice must protect and promote the exercise of these rights.
    (a) Standard: Notice of rights and responsibilities.
    (1) During the initial assessment visit in advance of furnishing 
care the hospice must provide the patient or representative with verbal 
(meaning spoken) and written notice of the patient's rights and 
responsibilities in a language and manner that the patient understands.
    (2) The hospice must comply with the requirements of subpart I of 
part 489 of this chapter regarding advance directives. The hospice must 
inform and distribute written information to the patient concerning its 
policies on advance directives, including a description of applicable 
State law.
    (3) The hospice must obtain the patient's or representative's 
signature confirming that he or she has received a copy of the notice 
of rights and responsibilities.
    (b) Standard: Exercise of rights and respect for property and 
person. (1) The patient has the right:
    (i) To exercise his or her rights as a patient of the hospice;
    (ii) To have his or her property and person treated with respect;
    (iii) To voice grievances regarding treatment or care that is (or 
fails to be) furnished and the lack of respect for property by anyone 
who is furnishing services on behalf of the hospice; and
    (iv) To not be subjected to discrimination or reprisal for 
exercising his or her rights.
    (2) If a patient has been adjudged incompetent under state law by a 
court of proper jurisdiction, the rights of the patient are exercised 
by the person appointed pursuant to state law to act on the patient's 
behalf.
    (3) If a state court has not adjudged a patient incompetent, any 
legal representative designated by the patient in accordance with state 
law may exercise the patient's rights to the extent allowed by state 
law.
    (4) The hospice must:
    (i) Ensure that all alleged violations involving mistreatment, 
neglect, or verbal, mental, sexual, and physical abuse, including 
injuries of unknown source, and misappropriation of patient property by 
anyone furnishing services on behalf of the hospice, are reported 
immediately by hospice employees and contracted staff to the hospice 
administrator;
    (ii) Immediately investigate all alleged violations involving 
anyone furnishing services on behalf of the hospice and immediately 
take action to prevent further potential violations while the alleged 
violation is being verified. Investigations and/or documentation of all 
alleged violations must be conducted in accordance with established 
procedures;
    (iii) Take appropriate corrective action in accordance with state 
law if the alleged violation is verified by the hospice administration 
or an outside body having jurisdiction, such as the State survey agency 
or local law enforcement agency; and
    (iv) Ensure that verified violations are reported to State and 
local bodies having jurisdiction (including to the State survey and 
certification agency) within 5 working days of becoming aware of the 
violation.
    (c) Standard: Rights of the patient. The patient has a right to the 
following:
    (1) Receive effective pain management and symptom control from the 
hospice for conditions related to the terminal illness;
    (2) Be involved in developing his or her hospice plan of care;
    (3) Refuse care or treatment;
    (4) Choose his or her attending physician;
    (5) Have a confidential clinical record. Access to or release of 
patient information and clinical records is permitted in accordance 
with 45 CFR parts 160 and 164.
    (6) Be free from mistreatment, neglect, or verbal, mental, sexual, 
and physical abuse, including injuries of unknown source, and 
misappropriation of patient property;
    (7) Receive information about the services covered under the 
hospice benefit;
    (8) Receive information about the scope of services that the 
hospice will provide and specific limitations on those services.


Sec.  418.54  Condition of participation: Initial and comprehensive 
assessment of the patient.

    The hospice must conduct and document in writing a patient-specific 
comprehensive assessment that identifies the patient's need for hospice 
care and services, and the patient's need for physical, psychosocial, 
emotional, and spiritual care. This assessment includes all areas of 
hospice care related to the palliation and management of the terminal 
illness and related conditions.
    (a) Standard: Initial assessment. 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.)
    (b) Standard: Timeframe for completion of the comprehensive 
assessment. The hospice interdisciplinary group, in consultation with 
the individual's attending physician (if any), must complete the 
comprehensive assessment no later than

[[Page 32206]]

5 calendar days after the election of hospice care in accordance with 
Sec.  418.24.
    (c) Standard: Content of the comprehensive assessment.
    The comprehensive assessment must identify the physical, 
psychosocial, emotional, and spiritual needs related to the terminal 
illness that must be addressed in order to promote the hospice 
patient's well-being, comfort, and dignity throughout the dying 
process. The comprehensive assessment must take into consideration the 
following factors:
    (1) The nature and condition causing admission (including the 
presence or lack of objective data and subjective complaints).
    (2) Complications and risk factors that affect care planning.
    (3) Functional status, including the patient's ability to 
understand and participate in his or her own care.
    (4) Imminence of death.
    (5) Severity of symptoms.
    (6) Drug profile. A review of all of the patient's prescription and 
over-the-counter drugs, herbal remedies and other alternative 
treatments that could affect drug therapy. This includes, but is not 
limited to, identification of the following:
    (i) Effectiveness of drug therapy.
    (ii) Drug side effects.
    (iii) Actual or potential drug interactions.
    (iv) Duplicate drug therapy.
    (v) Drug therapy currently associated with laboratory monitoring.
    (7) Bereavement. An initial bereavement assessment of the needs of 
the patient's family and other individuals focusing on the social, 
spiritual, and cultural factors that may impact their ability to cope 
with the patient's death. Information gathered from the initial 
bereavement assessment must be incorporated into the plan of care and 
considered in the bereavement plan of care.
    (8) The need for referrals and further evaluation by appropriate 
health professionals.
    (d) Standard: Update of the comprehensive assessment.
    The update of the comprehensive assessment must be accomplished by 
the hospice interdisciplinary group (in collaboration with the 
individual's attending physician, if any) and must consider changes 
that have taken place since the initial assessment. It must include 
information on the patient's progress toward desired outcomes, as well 
as a reassessment of the patient's response to care. The assessment 
update must be accomplished as frequently as the condition of the 
patient requires, but no less frequently than every 15 days.
    (e) Standard: Patient outcome measures. (1) The comprehensive 
assessment must include data elements that allow for measurement of 
outcomes. The hospice must measure and document data in the same way 
for all patients. The data elements must take into consideration 
aspects of care related to hospice and palliation.
    (2) The data elements must be an integral part of the comprehensive 
assessment and must be documented in a systematic and retrievable way 
for each patient. The data elements for each patient must be used in 
individual patient care planning and in the coordination of services, 
and must be used in the aggregate for the hospice's quality assessment 
and performance improvement program.


Sec.  418.56  Condition of participation: Interdisciplinary group, care 
planning, and coordination of services.

    The hospice must designate an interdisciplinary group or groups as 
specified in paragraph (a) of this section which, in consultation with 
the patient's attending physician, must prepare a written plan of care 
for each patient. The plan of care must specify the hospice care and 
services necessary to meet the patient and family-specific needs 
identified in the comprehensive assessment as such needs relate to the 
terminal illness and related conditions.
    (a) Standard: Approach to service delivery. (1) The hospice must 
designate an interdisciplinary group or groups composed of individuals 
who work together to meet the physical, medical, psychosocial, 
emotional, and spiritual needs of the hospice patients and families 
facing terminal illness and bereavement. Interdisciplinary group 
members must provide the care and services offered by the hospice, and 
the group, in its entirety, must supervise the care and services. The 
hospice must designate a registered nurse that is a member of the 
interdisciplinary group to provide coordination of care and to ensure 
continuous assessment of each patient's and family's needs and 
implementation of the interdisciplinary plan of care. The 
interdisciplinary group must include, but is not limited to, 
individuals who are qualified and competent to practice in the 
following professional roles:
    (i) A doctor of medicine or osteopathy (who is an employee or under 
contract with the hospice).
    (ii) A registered nurse.
    (iii) A social worker.
    (iv) A pastoral or other counselor.
    (2) If 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.
    (b) Standard: Plan of care. All hospice care and services furnished 
to patients and their families must follow an individualized written 
plan of care established by the hospice interdisciplinary group in 
collaboration with the attending physician (if any), the patient or 
representative, and the primary caregiver in accordance with the 
patient's needs if any of them so desire. The hospice must ensure that 
each patient and the primary care giver(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.
    (c) Standard: Content of the plan of care. The hospice must develop 
an individualized written plan of care for each patient. The plan of 
care must reflect patient and family goals and interventions based on 
the problems identified in the initial, comprehensive, and updated 
comprehensive assessments. The plan of care must include all services 
necessary for the palliation and management of the terminal illness and 
related conditions, including the following:
    (1) Interventions to manage pain and symptoms.
    (2) A detailed statement of the scope and frequency of services 
necessary to meet the specific patient and family needs.
    (3) Measurable outcomes anticipated from implementing and 
coordinating the plan of care.
    (4) Drugs and treatment necessary to meet the needs of the patient.
    (5) Medical supplies and appliances necessary to meet the needs of 
the patient.
    (6) The interdisciplinary group's documentation of the patient's or 
representative's level of understanding, involvement, and agreement 
with the plan of care, in accordance with the hospice's own policies, 
in the clinical record.
    (d) Standard: Review of the plan of care. The hospice 
interdisciplinary group (in collaboration with the individual's 
attending physician, if any) must review, revise and document the 
individualized plan as frequently as the patient's condition requires, 
but no less frequently than every 15 calendar days. A revised plan of 
care must include information from the patient's updated comprehensive 
assessment and must note the patient's progress toward outcomes and 
goals specified in the plan of care.
    (e) Standard: Coordination of services. The hospice must develop 
and maintain

[[Page 32207]]

a system of communication and integration, in accordance with the 
hospice's own policies and procedures, to--
    (1) Ensure that the interdisciplinary group maintains 
responsibility for directing, coordinating, and supervising the care 
and services provided.
    (2) Ensure that the care and services are provided in accordance 
with the plan of care.
    (3) Ensure that the care and services provided are based on all 
assessments of the patient and family needs.
    (4) Provide for and ensure the ongoing sharing of information 
between all disciplines providing care and services in all settings, 
whether the care and services are provided directly or under 
arrangement.
    (5) Provide for an ongoing sharing of information with other non-
hospice healthcare providers furnishing services unrelated to the 
terminal illness and related conditions.


Sec.  418.58  Condition of participation: Quality assessment and 
performance improvement.

    The hospice must develop, implement, and maintain an effective, 
ongoing, hospice-wide data-driven quality assessment and performance 
improvement program. The hospice's governing body must ensure that the 
program: Reflects the complexity of its organization and services; 
involves all hospice services (including those services furnished under 
contract or arrangement); focuses on indicators related to improved 
palliative outcomes; and takes actions to demonstrate improvement in 
hospice performance. The hospice must maintain documentary evidence of 
its quality assessment and performance improvement program and be able 
to demonstrate its operation to CMS.
    (a) Standard: Program scope. (1) The program must at least be 
capable of showing measurable improvement in indicators related to 
improved palliative outcomes and hospice services.
    (2) The hospice must measure, analyze, and track quality 
indicators, including adverse patient events, and other aspects of 
performance that enable the hospice to assess processes of care, 
hospice services, and operations.
    (b) Standard: Program data. (1) The program must use quality 
indicator data, including patient care, and other relevant data, in the 
design of its program.
    (2) The hospice must use the data collected to do the following:
    (i) Monitor the effectiveness and safety of services and quality of 
care.
    (ii) Identify opportunities and priorities for improvement.
    (3) The frequency and detail of the data collection must be 
approved by the hospice's governing body.
    (c) Standard: Program activities. (1) The hospice's performance 
improvement activities must:
    (i) Focus on high risk, high volume, or problem-prone areas.
    (ii) Consider incidence, prevalence, and severity of problems in 
those areas.
    (iii) Affect palliative outcomes, patient safety, and quality of 
care.
    (2) Performance improvement activities must track adverse patient 
events, analyze their causes, and implement preventive actions and 
mechanisms that include feedback and learning throughout the hospice.
    (3) The hospice must take actions aimed at performance improvement 
and, after implementing those actions, the hospice must measure its 
success and track performance to ensure that improvements are 
sustained.
    (d) Standard: Performance improvement projects. Beginning February 
2, 2009 hospices must develop, implement, and evaluate performance 
improvement projects.
    (1) 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.
    (2) The hospice must document what performance improvement projects 
are being conducted, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.
    (e) Standard: Executive responsibilities. The hospice's governing 
body is responsible for ensuring the following:
    (1) That an ongoing program for quality improvement and patient 
safety is defined, implemented, and maintained, and is evaluated 
annually.
    (2) That the hospice-wide quality assessment and performance 
improvement efforts address priorities for improved quality of care and 
patient safety, and that all improvement actions are evaluated for 
effectiveness.
    (3) That one or more individual(s) who are responsible for 
operating the quality assessment and performance improvement program 
are designated.


Sec.  418.60  Condition of participation: Infection control.

    The 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.
    (a) Standard: Prevention. The hospice must follow accepted 
standards of practice to prevent the transmission of infections and 
communicable diseases, including the use of standard precautions.
    (b) Standard: Control. The hospice must maintain a coordinated 
agency-wide program for the surveillance, identification, prevention, 
control, and investigation of infectious and communicable diseases 
that--
    (1) Is an integral part of the hospice's quality assessment and 
performance improvement program; and
    (2) Includes the following:
    (i) A method of identifying infectious and communicable disease 
problems; and
    (ii) A plan for implementing the appropriate actions that are 
expected to result in improvement and disease prevention.
    (c) Standard: Education. The hospice must provide infection control 
education to employees, contracted providers, patients, and family 
members and other caregivers.


Sec.  418.62  Condition of participation: Licensed professional 
services.

    (a) Licensed professional services provided directly or under 
arrangement must be authorized, delivered, and supervised only by 
health care professionals who meet the appropriate qualifications 
specified under Sec.  418.114 and who practice under the hospice's 
policies and procedures.
    (b) Licensed professionals must actively participate in the 
coordination of all aspects of the patient's hospice care, in 
accordance with current professional standards and practice, including 
participating in ongoing interdisciplinary comprehensive assessments, 
developing and evaluating the plan of care, and contributing to patient 
and family counseling and education; and
    (c) Licensed professionals must participate in the hospice's 
quality assessment and performance improvement program and hospice 
sponsored in-service training.

Core Services


Sec.  418.64  Condition of participation: Core services.

    A hospice must routinely provide substantially all core services 
directly by hospice employees. These services must be provided in a 
manner consistent with acceptable standards of practice. These services 
include nursing services, medical social services, and counseling. The 
hospice may contract for physician services as specified in paragraph 
(a) of this section. A hospice

[[Page 32208]]

may use contracted staff, if necessary, to supplement hospice employees 
in order to meet the needs of patients under extraordinary or other 
non-routine circumstances. A hospice may also enter into a written 
arrangement with another Medicare certified hospice program for the 
provision of core services to supplement hospice employee/staff to meet 
the needs of patients. Circumstances under which a hospice may enter 
into a written arrangement for the provision of core services include: 
Unanticipated periods of high patient loads, staffing shortages due to 
illness or other short-term temporary situations that interrupt patient 
care; and temporary travel of a patient outside of the hospice's 
service area.
    (a) Standard: Physician services. The hospice medical director, 
physician employees, and contracted physician(s) of the hospice, in 
conjunction with the patient's attending physician, are responsible for 
the palliation and management of the terminal illness and conditions 
related to the terminal illness.
    (1) All physician employees and those under contract, must function 
under the supervision of the hospice medical director.
    (2) All physician employees and those under contract shall meet 
this requirement by either providing the services directly or through 
coordinating patient care with the attending physician.
    (3) If the attending physician is unavailable, the medical 
director, contracted physician, and/or hospice physician employee is 
responsible for meeting the medical needs of the patient.
    (b) Standard: Nursing services. (1) The hospice must provide 
nursing care and services by or under the supervision of a registered 
nurse. Nursing services must ensure that the nursing needs of the 
patient are met as identified in the patient's initial assessment, 
comprehensive assessment, and updated assessments.
    (2) If State law permits registered nurses to see, treat, and write 
orders for patients, then registered nurses may provide services to 
beneficiaries receiving hospice care.
    (3) Highly specialized nursing services that are provided so 
infrequently that the provision of such services by direct hospice 
employees would be impracticable and prohibitively expensive, may be 
provided under contract.
    (c) Standard: Medical social services. Medical social services must 
be provided by a qualified social worker, under the direction of a 
physician. Social work services must be based on the patient's 
psychosocial assessment and the patient's and family's needs and 
acceptance of these services.
    (d) Standard: Counseling services. Counseling services 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. Counseling services 
must include, but are not limited to, the following:
    (1) Bereavement counseling. The hospice must:
    (i) Have an organized program for the provision of bereavement 
services furnished under the supervision of a qualified professional 
with experience or education in grief or loss counseling.
    (ii) Make bereavement services available to the family and other 
individuals in the bereavement plan of care up to 1 year following the 
death of the patient. Bereavement counseling also extends to residents 
of a SNF/NF or ICF/MR when appropriate and identified in the 
bereavement plan of care.
    (iii) Ensure that bereavement services reflect the needs of the 
bereaved.
    (iv) Develop a bereavement plan of care that notes the kind of 
bereavement services to be offered and the frequency of service 
delivery. A special coverage provision for bereavement counseling is 
specified in Sec.  418.204(c).
    (2) Dietary counseling. Dietary counseling, when identified in the 
plan of care, must be performed by a qualified individual, which 
include dietitians as well as nurses and other individuals who are able 
to address and assure that the dietary needs of the patient are met.
    (3) Spiritual counseling. The hospice must:
    (i) Provide an assessment of the patient's and family's spiritual 
needs.
    (ii) Provide spiritual counseling to meet these needs in accordance 
with the patient's and family's acceptance of this service, and in a 
manner consistent with patient and family beliefs and desires.
    (iii) Make all reasonable efforts to facilitate visits by local 
clergy, pastoral counselors, or other individuals who can support the 
patient's spiritual needs to the best of its ability.
    (iv) Advise the patient and family of this service.


Sec.  418.66  Condition of participation: Nursing services--Waiver of 
requirement that substantially all nursing services be routinely 
provided directly by a hospice.

    (a) CMS may waive the requirement in Sec.  418.64(b) that a hospice 
provide nursing services directly, if the hospice is located in a non-
urbanized area. The location of a hospice that operates in several 
areas is considered to be the location of its central office. The 
hospice must provide evidence to CMS that it has made a good faith 
effort to hire a sufficient number of nurses to provide services. CMS 
may waive the requirement that nursing services be furnished by 
employees based on the following criteria:
    (1) The location of the hospice's central office is in a non-
urbanized area as determined by the Bureau of the Census.
    (2) There is evidence that a hospice was operational on or before 
January 1, 1983 including the following:
    (i) Proof that the organization was established to provide hospice 
services on or before January 1, 1983.
    (ii) Evidence that hospice-type services were furnished to patients 
on or before January 1, 1983.
    (iii) Evidence that hospice care was a discrete activity rather 
than an aspect of another type of provider's patient care program on or 
before January 1, 1983.
    (3) By virtue of the following evidence that a hospice made a good 
faith effort to hire nurses:
    (i) Copies of advertisements in local newspapers that demonstrate 
recruitment efforts.
    (ii) Job descriptions for nurse employees.
    (iii) Evidence that salary and benefits are competitive for the 
area.
    (iv) Evidence of any other recruiting activities (for example, 
recruiting efforts at health fairs and contacts with nurses at other 
providers in the area).
    (b) Any waiver request is deemed to be granted unless it is denied 
within 60 days after it is received.
    (c) Waivers will remain effective for 1 year at a time from the 
date of the request.
    (d) If a hospice wishes to receive a 1-year extension, it must 
submit a request to CMS before the expiration of the waiver period, and 
certify that the conditions under which it originally requested the 
initial waiver have not changed since the initial waiver was granted.

Non-Core Services


Sec.  418.70  Condition of participation: Furnishing of non-core 
services.

    A hospice must ensure that the services described in Sec.  418.72 
through Sec.  418.78 are provided directly by the hospice or under 
arrangements made by the hospice as specified in Sec.  418.100. These 
services must be provided in a manner consistent with current standards 
of practice.

[[Page 32209]]

Sec.  418.72  Condition of participation: Physical therapy, 
occupational therapy, and speech-language pathology.

    Physical therapy services, occupational therapy services, and 
speech-language pathology services must be available, and when 
provided, offered in a manner consistent with accepted standards of 
practice.


Sec.  418.74  Waiver of requirement--Physical therapy, occupational 
therapy, speech-language pathology, and dietary counseling.

    (a) A hospice located in a non-urbanized area may submit a written 
request for a waiver of the requirement for providing physical therapy, 
occupational therapy, speech-language pathology, and dietary counseling 
services. The hospice may seek a waiver of the requirement that it make 
physical therapy, occupational therapy, speech-language pathology, and 
dietary counseling services (as needed) available on a 24-hour basis. 
The hospice may also seek a waiver of the requirement that it provide 
dietary counseling directly. The hospice must provide evidence that it 
has made a good faith effort to meet the requirements for these 
services before it seeks a waiver. CMS may approve a waiver application 
on the basis of the following criteria:
    (1) The hospice is located in a non-urbanized area as determined by 
the Bureau of the Census.
    (2) The hospice provides evidence that it had made a good faith 
effort to make available physical therapy, occupational therapy, 
speech-language pathology, and dietary counseling services on a 24-hour 
basis and/or to hire a dietary counselor to furnish services directly. 
This evidence must include the following:
    (i) Copies of advertisements in local newspapers that demonstrate 
recruitment efforts.
    (ii) Physical therapy, occupational therapy, speech-language 
pathology, and dietary counselor job descriptions.
    (iii) Evidence that salary and benefits are competitive for the 
area.
    (iv) Evidence of any other recruiting activities (for example, 
recruiting efforts at health fairs and contact discussions with 
physical therapy, occupational therapy, speech-language pathology, and 
dietary counseling service providers in the area).
    (b) Any waiver request is deemed to be granted unless it is denied 
within 60 days after it is received.
    (c) An initial waiver will remain effective for 1 year at a time 
from the date of the request.
    (d) If a hospice wishes to receive a 1-year extension, it must 
submit a request to CMS before the expiration of the waiver period and 
certify that conditions under which it originally requested the waiver 
have not changed since the initial waiver was granted.


Sec.  418.76  Condition of participation: Hospice aide and homemaker 
services.

    All hospice aide services must be provided by individuals who meet 
the personnel requirements specified in paragraph (a) of this section. 
Homemaker services must be provided by individuals who meet the 
personnel requirements specified in paragraph (j) of this section.
    (a) Standard: Hospice aide qualifications. (1) A qualified hospice 
aide is a person who has successfully completed one of the following:
    (i) A training program and competency evaluation as specified in 
paragraphs (b) and (c) of this section respectively.
    (ii) A competency evaluation program that meets the requirements of 
paragraph (c) of this section.
    (iii) A nurse aide training and competency evaluation program 
approved by the State as meeting the requirements of Sec.  483.151 
through Sec.  483.154 of this chapter, and is currently listed in good 
standing on the State nurse aide registry.
    (iv) A State licensure program that meets the requirements of 
paragraphs (b) and (c) of this section.
    (2) A hospice aide is not considered to have completed a program, 
as specified in paragraph (a)(1) of this section, if, since the 
individual's most recent completion of the program(s), there has been a 
continuous period of 24 consecutive months during which none of the 
services furnished by the individual as described in Sec.  409.40 of 
this chapter were for compensation. If there has been a 24-month lapse 
in furnishing services, the individual must complete another program, 
as specified in paragraph (a)(1) of this section, before providing 
services.
    (b) Standard: Content and duration of hospice aide classroom and 
supervised practical training. (1) Hospice aide training must include 
classroom and supervised practical training in a practicum laboratory 
or other setting in which the trainee demonstrates knowledge while 
performing tasks on an individual under the direct supervision of a 
registered nurse, or a licensed practical nurse, who is under the 
supervision of a registered nurse. Classroom and supervised practical 
training combined must total at least 75 hours.
    (2) A minimum of 16 hours of classroom training must precede a 
minimum of l6 hours of supervised practical training as part of the 75 
hours.
    (3) A hospice aide training program must address each of the 
following subject areas:
    (i) Communication skills, including the ability to read, write, and 
verbally report clinical information to patients, care givers, and 
other hospice staff.
    (ii) Observation, reporting, and documentation of patient status 
and the care or service furnished.
    (iii) Reading and recording temperature, pulse, and respiration.
    (iv) Basic infection control procedures.
    (v) Basic elements of body functioning and changes in body function 
that must be reported to an aide's supervisor.
    (vi) Maintenance of a clean, safe, and healthy environment.
    (vii) Recognizing emergencies and the knowledge of emergency 
procedures and their application.
    (viii) The physical, emotional, and developmental needs of and ways 
to work with the populations served by the hospice, including the need 
for respect for the patient, his or her privacy, and his or her 
property.
    (ix) Appropriate and safe techniques in performing personal hygiene 
and grooming tasks, including items on the following basic checklist:
    (A) Bed bath.
    (B) Sponge, tub, and shower bath.
    (C) Hair shampoo (sink, tub, and bed).
    (D) Nail and skin care.
    (E) Oral hygiene.
    (F) Toileting and elimination.
    (x) Safe transfer techniques and ambulation.
    (xi) Normal range of motion and positioning.
    (xii) Adequate nutrition and fluid intake.
    (xiii) Any other task that the hospice may choose to have an aide 
perform. The hospice is responsible for training hospice aides, as 
needed, for skills not covered in the basic checklist, as described in 
paragraph (b)(3)(ix) of this section.
    (4) The hospice must maintain documentation that demonstrates that 
the requirements of this standard are met.
    (c) Standard: Competency evaluation. An individual may furnish 
hospice aide services on behalf of a hospice only after that individual 
has successfully completed a competency evaluation program as described 
in this section.
    (1) The competency evaluation must address each of the subjects 
listed in paragraph (b)(3) of this section. Subject areas specified 
under paragraphs (b)(3)(i), (b)(3)(iii), (b)(3)(ix), (b)(3)(x) and 
(b)(3)(xi) of this section must be

[[Page 32210]]

evaluated by observing an aide's performance of the task with a 
patient. The remaining subject areas may be evaluated through written 
examination, oral examination, or after observation of a hospice aide 
with a patient.
    (2) A hospice aide competency evaluation program may be offered by 
any organization, except as described in paragraph (f) of this section.
    (3) The competency evaluation must be performed by a registered 
nurse in consultation with other skilled professionals, as appropriate.
    (4) A hospice aide is not considered competent in any task for 
which he or she is evaluated as unsatisfactory. An aide must not 
perform that task without direct supervision by a registered nurse 
until after he or she has received training in the task for which he or 
she was evaluated as ``unsatisfactory,'' and successfully completes a 
subsequent evaluation. A hospice aide is not considered to have 
successfully completed a competency evaluation if the aide has an 
``unsatisfactory'' rating in more than one of the required areas.
    (5) The hospice must maintain documentation that demonstrates the 
requirements of this standard are being met.
    (d) Standard: In-service training. A hospice aide must receive at 
least 12 hours of in-service training during each 12-month period. In-
service training may occur while an aide is furnishing care to a 
patient.
    (1) In-service training may be offered by any organization, and 
must be supervised by a registered nurse.
    (2) The hospice must maintain documentation that demonstrates the 
requirements of this standard are met.
    (e) Standard: Qualifications for instructors conducting classroom 
and supervised practical training. Classroom and supervised practical 
training must be performed by a registered nurse who possesses a 
minimum of 2 years nursing experience, at least 1 year of which must be 
in home care, or by other individuals under the general supervision of 
a registered nurse.
    (f) Standard: Eligible competency evaluation organizations. A 
hospice aide competency evaluation program as specified in paragraph 
(c) of this section may be offered by any organization except by a home 
health agency that, within the previous 2 years:
    (1) Had been of compliance with the requirements of Sec.  484.36(a) 
and (b) of this chapter.
    (2) Permitted an individual that does not meet the definition of a 
``qualified home health aide'' as specified in Sec.  484.36(a) of this 
chapter to furnish home health aide services (with the exception of 
licensed health professionals and volunteers).
    (3) Had been subjected to an extended (or partial extended) survey 
as a result of having been found to have furnished substandard care (or 
for other reasons at the discretion of CMS or the State).
    (4) Had been assessed a civil monetary penalty of $5,000 or more as 
an intermediate sanction.
    (5) Had been found by CMS to have compliance deficiencies that 
endangered the health and safety of the home health agency's patients 
and had temporary management appointed to oversee the management of the 
home health agency.
    (6) Had all or part of its Medicare payments suspended.
    (7) Had been found by CMS or the State under any Federal or State 
law to have:
    (i) Had its participation in the Medicare program terminated.
    (ii) Been assessed a penalty of $5,000 or more for deficiencies in 
Federal or State standards for home health agencies.
    (iii) Been subjected to a suspension of Medicare payments to which 
it otherwise would have been entitled.
    (iv) Operated under temporary management that was appointed by a 
governmental authority to oversee the operation of the home health 
agency and to ensure the health and safety of the home health agency's 
patients.
    (v) Been closed by CMS or the State, or had its patients 
transferred by the State.
    (g) Standard: Hospice aide assignments and duties.
    (1) Hospice aides are assigned to a specific patient by a 
registered nurse that is a member of the interdisciplinary group. 
Written patient care instructions for a hospice aide must be prepared 
by a registered nurse who is responsible for the supervision of a 
hospice aide as specified under paragraph (h) of this section.
    (2) A hospice aide provides services that are:
    (i) Ordered by the interdisciplinary group.
    (ii) Included in the plan of care.
    (iii) Permitted to be performed under State law by such hospice 
aide.
    (iv) Consistent with the hospice aide training.
    (3) The duties of a hospice aide include the following:
    (i) The provision of hands-on personal care.
    (ii) The performance of simple procedures as an extension of 
therapy or nursing services.
    (iii) Assistance in ambulation or exercises.
    (iv) Assistance in administering medications that are ordinarily 
self-administered.
    (4) Hospice aides must report changes in the patient's medical, 
nursing, rehabilitative, and social needs to a registered nurse, as the 
changes relate to the plan of care and quality assessment and 
improvement activities. Hospice aides must also complete appropriate 
records in compliance with the hospice's policies and procedures.
    (h) Standard: Supervision of hospice aides. (1) A registered nurse 
must make an on-site visit to the patient's home:
    (i) No less frequently than every 14 days to assess the quality of 
care and services provided by the hospice aide and to ensure that 
services ordered by the hospice interdisciplinary group meet the 
patient's needs. The hospice aide does not have to be present during 
this visit.
    (ii) If an area of concern is noted by the supervising nurse, then 
the hospice must make an on-site visit to the location where the 
patient is receiving care in order to observe and assess the aide while 
he or she is performing care.
    (iii) If an area of concern is verified by the hospice during the 
on-site visit, then the hospice must conduct, and the hospice aide must 
complete a competency evaluation in accordance with Sec.  418.76(c).
    (2) 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.
    (3) The supervising nurse must assess an aide's ability to 
demonstrate initial and continued satisfactory performance in meeting 
outcome criteria that include, but is not limited to--
    (i) Following the patient's plan of care for completion of tasks 
assigned to the hospice aide by the registered nurse.
    (ii) Creating successful interpersonal relationships with the 
patient and family.
    (iii) Demonstrating competency with assigned tasks.
    (iv) Complying with infection control policies and procedures.
    (v) Reporting changes in the patient's condition.
    (i) Standard: Individuals furnishing Medicaid personal care aide-
only services under a Medicaid personal care benefit. An individual may 
furnish personal care services, as defined in Sec.  440.167 of this 
chapter, on behalf of a hospice agency.
    (1) Before the individual may furnish personal care services, the 
individual must be found competent by the State (if regulated by the 
State) to furnish those services. The individual only

[[Page 32211]]

needs to demonstrate competency in the services the individual is 
required to furnish.
    (2) Services under 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.
    (3) The hospice must coordinate its hospice aide and homemaker 
services with the Medicaid personal care benefit to ensure the patient 
receives the hospice aide and homemaker services he or she needs.
    (j) Standard: Homemaker qualifications. A qualified homemaker is--
    (1) An individual who meets the standards in Sec.  418.202(g) and 
has successfully completed hospice orientation addressing the needs and 
concerns of patients and families coping with a terminal illness; or
    (2) A hospice aide as described in Sec.  418.76.
    (k) Standard: Homemaker supervision and duties.
    (1) Homemaker services must be coordinated and supervised by a 
member of the interdisciplinary group.
    (2) Instructions for homemaker duties must be prepared by a member 
of the interdisciplinary group.
    (3) Homemakers must report all concerns about the patient or family 
to the member of the interdisciplinary group who is coordinating 
homemaker services.


Sec.  418.78  Conditions of participation--Volunteers.

    The hospice must use volunteers to the extent specified in 
paragraph (e) of this section. These volunteers must be used in defined 
roles and under the supervision of a designated hospice employee.
    (a) Standard: Training. The hospice must maintain, document, and 
provide volunteer orientation and training that is consistent with 
hospice industry standards.
    (b) Standard: Role. Volunteers must be used in day-to-day 
administrative and/or direct patient care roles.
    (c) Standard: Recruiting and retaining. The hospice must document 
and demonstrate viable and ongoing efforts to recruit and retain 
volunteers.
    (d) Standard: Cost saving. The hospice must document the cost 
savings achieved through the use of volunteers. Documentation must 
include the following:
    (1) The identification of each position that is occupied by a 
volunteer.
    (2) The work time spent by volunteers occupying those positions.
    (3) Estimates of the dollar costs that the hospice would have 
incurred if paid employees occupied the positions identified in 
paragraph (d)(1) of this section for the amount of time specified in 
paragraph (d)(2) of this section.
    (e) Standard: Level of activity. Volunteers must provide day-to-day 
administrative and/or direct patient care services in an amount that, 
at a minimum, equals 5 percent of the total patient care hours of all 
paid hospice employees and contract staff. The hospice must maintain 
records on the use of volunteers for patient care and administrative 
services, including the type of services and time worked.

Subpart D--Conditions of participation: Organizational Environment


Sec.  418.100  Condition of Participation: Organization and 
administration of services.

    The hospice must organize, manage, and administer its resources to 
provide the hospice care and services to patients, caregivers and 
families necessary for the palliation and management of the terminal 
illness and related conditions.
    (a) Standard: Serving the hospice patient and family.
    The hospice must provide hospice care that--
    (1) Optimizes comfort and dignity; and
    (2) Is consistent with patient and family needs and goals, with 
patient needs and goals as priority.
    (b) Standard: Governing body and administrator. A governing body 
(or designated persons so functioning) assumes full legal authority and 
responsibility for the management of the hospice, the provision of all 
hospice services, its fiscal operations, and continuous quality 
assessment and performance improvement. A qualified administrator 
appointed by and reporting to the governing body is responsible for the 
day-to-day operation of the hospice. The administrator must be a 
hospice employee and possess education and experience required by the 
hospice's governing body.
    (c) Standard: Services. (1) A hospice must be primarily engaged in 
providing the following care and services and must do so in a manner 
that is consistent with accepted standards of practice:
    (i) Nursing services.
    (ii) Medical social services.
    (iii) Physician services.
    (iv) Counseling services, including spiritual counseling, dietary 
counseling, and bereavement counseling.
    (v) Hospice aide, volunteer, and homemaker services.
    (vi) Physical therapy, occupational therapy, and speech-language 
pathology services.
    (vii) Short-term inpatient care.
    (viii) Medical supplies (including drugs and biologicals) and 
medical appliances.
    (2) Nursing services, physician services, and drugs and biologicals 
(as specified in Sec.  418.106) must be made routinely available on a 
24-hour basis 7 days a week. Other covered services must be available 
on a 24-hour basis when reasonable and necessary to meet the needs of 
the patient and family.
    (d) Standard: Continuation of care. A hospice may not discontinue 
or reduce care provided to a Medicare or Medicaid beneficiary because 
of the beneficiary's inability to pay for that care.
    (e) Standard: Professional management responsibility. A hospice 
that has a written agreement with another agency, individual, or 
organization to furnish any services under arrangement must retain 
administrative and financial management, and oversight of staff and 
services for all arranged services, to ensure the provision of quality 
care. Arranged services must be supported by written agreements that 
require that all services be--
    (1) Authorized by the hospice;
    (2) Furnished in a safe and effective manner by qualified 
personnel; and
    (3) Delivered in accordance with the patient's plan of care.
    (f) Standard: Hospice multiple locations.
    If a hospice operates multiple locations, it must meet the 
following requirements:
    (1) Medicare approval.
    (i) All hospice multiple locations must be approved by Medicare 
before providing hospice care and services to Medicare patients.
    (ii) The multiple location must be part of the hospice and must 
share administration, supervision, and services with the hospice issued 
the certification number.
    (iii) The lines of authority and professional and administrative 
control must be clearly delineated in the hospice's organizational 
structure and in practice, and must be traced to the location that 
issued the certification number.
    (iv) The determination that a multiple location does or does not 
meet the definition of a multiple location, as set forth in this part, 
is an initial determination, as set forth in Sec.  498.3.
    (2) The hospice must continually monitor and manage all services

[[Page 32212]]

provided at all of its locations to ensure that services are delivered 
in a safe and effective manner and to ensure that each patient and 
family receives the necessary care and services outlined in the plan of 
care, in accordance with the requirements of this subpart and subparts 
A and C of this section.
    (g) Standard: Training.
    (1) A hospice must provide orientation about the hospice philosophy 
to all employees and contracted staff who have patient and family 
contact.
    (2) A hospice must provide an initial orientation for each employee 
that addresses the employee's specific job duties.
    (3) A hospice must assess the skills and competence of all 
individuals furnishing care, including volunteers furnishing services, 
and, as necessary, provide in-service training and education programs 
where required. The hospice must have written policies and procedures 
describing its method(s) of assessment of competency and maintain a 
written description of the in-service training provided during the 
previous 12 months.


Sec.  418.102  Condition of participation: Medical director.

    The hospice must designate a physician to serve as medical 
director. The medical director must be a doctor of medicine or 
osteopathy who is an employee, or is under contract with the hospice. 
When the medical director is not available, a physician designated by 
the hospice assumes the same responsibilities and obligations as the 
medical director.
    (a) Standard: Medical director contract. (1) A hospice may contract 
with either of the following--
    (i) A self-employed physician; or
    (ii) A physician employed by a professional entity or physicians 
group. When contracting for medical director services, the contract 
must specify the physician who assumes the medical director 
responsibilities and obligations.
    (b) Standard: Initial certification of terminal illness. The 
medical director or physician designee reviews the clinical information 
for each hospice patient and provides written certification that it is 
anticipated that the patient's life expectancy is 6 months or less if 
the illness runs its normal course. The physician must consider the 
following when making this determination:
    (1) The primary terminal condition;
    (2) Related diagnosis(es), if any;
    (3) Current subjective and objective medical findings;
    (4) Current medication and treatment orders; and
    (5) Information about the medical management of any of the 
patient's conditions unrelated to the terminal illness.
    (c) Standard: Recertification of the terminal illness. Before the 
recertification period for each patient, as described in Sec.  
418.21(a), the medical director or physician designee must review the 
patient's clinical information.
    (d) Standard: Medical director responsibility. The medical director 
or physician designee has responsibility for the medical component of 
the hospice's patient care program.


Sec.  418.104  Condition of participation: Clinical records.

    A clinical record containing past and current findings is 
maintained for each hospice patient. The clinical record must contain 
correct clinical information that is available to the patient's 
attending physician and hospice staff. The clinical record may be 
maintained electronically.
    (a) Standard: Content. Each patient's record must include the 
following:
    (1) The initial plan of care, updated plans of care, initial 
assessment, comprehensive assessment, updated comprehensive 
assessments, and clinical notes.
    (2) Signed copies of the notice of patient rights in accordance 
with Sec.  418.52 and election statement in accordance with Sec.  
418.24.
    (3) Responses to medications, symptom management, treatments, and 
services.
    (4) Outcome measure data elements, as described in Sec.  418.54(e) 
of this subpart.
    (5) Physician certification and recertification of terminal illness 
as required in Sec.  418.22 and Sec.  418.25 and described in Sec.  
418.102(b) and Sec.  418.102(c) respectively, if appropriate.
    (6) Any advance directives as described in Sec.  418.52(a)(2).
    (7) Physician orders.
    (b) Standard: Authentication. All entries must be legible, clear, 
complete, and appropriately authenticated and dated in accordance with 
hospice policy and currently accepted standards of practice.
    (c) Standard: Protection of information. The clinical record, its 
contents and the information contained therein must be safeguarded 
against loss or unauthorized use. The hospice must be in compliance 
with the Department's rules regarding personal health information as 
set out at 45 CFR parts 160 and 164.
    (d) Standard: Retention of records. 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. If the hospice 
discontinues operation, hospice policies must provide for retention and 
storage of clinical records. The hospice must inform its State agency 
and its CMS Regional office where such clinical records will be stored 
and how they may be accessed.
    (e) Standard: Discharge or transfer of care. (1) If the care of a 
patient is transferred to another Medicare/Medicaid-certified facility, 
the hospice must forward to the receiving facility, a copy of--
    (i) The hospice discharge summary; and
    (ii) The patient's clinical record, if requested.
    (2) If a patient revokes the election of hospice care, or is 
discharged from hospice in accordance with Sec.  418.26, the hospice 
must forward to the patient's attending physician, a copy of--
    (i) The hospice discharge summary; and
    (ii) The patient's clinical record, if requested.
    (3) The hospice discharge summary as required in paragraph (e)(1) 
and (e)(2) of this section must include--
    (i) A summary of the patient's stay including treatments, symptoms 
and pain management.
    (ii) The patient's current plan of care.
    (iii) The patient's latest physician orders. and
    (iv) Any other documentation that will assist in post-discharge 
continuity of care or that is requested by the attending physician or 
receiving facility.
    (f) Standard: Retrieval of clinical records. The clinical record, 
whether hard copy or in electronic form, must be made readily available 
on request by an appropriate authority.


Sec.  418.106  Condition of participation: Drugs and biologicals, 
medical supplies, and durable medical equipment.

    Medical supplies and appliances, as described in Sec.  410.36 of 
this chapter; durable medical equipment, as described in Sec.  410.38 
of this chapter; and drugs and biologicals related to the palliation 
and management of the terminal illness and related conditions, as 
identified in the hospice plan of care, must be provided by the hospice 
while the patient is under hospice care.
    (a) Standard: Managing drugs and biologicals.
    (1) The hospice must 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

[[Page 32213]]

under contract with the hospice to ensure that drugs and biologicals 
meet each patient's needs.
    (2) A hospice that provides inpatient care directly in its own 
facility must provide pharmacy services under the direction of a 
qualified licensed pharmacist who is an employee of or under contract 
with the hospice. 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.
    (b) Standard: Ordering of drugs.
    (1) Only a physician as defined by section 1861(r)(1) of the Act, 
or a nurse practitioner in accordance with the plan of care and State 
law, may order drugs for the patient.
    (2) If the drug order is verbal or given by or through electronic 
transmission--
    (i) It must be given only to a licensed nurse, nurse practitioner 
(where appropriate), pharmacist, or physician; and
    (ii) The individual receiving the order must record and sign it 
immediately and have the prescribing person sign it in accordance with 
State and Federal regulations.
    (c) Standard: Dispensing of drugs and biologicals.
    The hospice must--
    (1) Obtain drugs and biologicals from community or institutional 
pharmacists or stock drugs and biologicals itself.
    (2) The hospice that provides inpatient care directly in its own 
facility must:
    (i) Have a written policy in place that promotes dispensing 
accuracy; and
    (ii) Maintain current and accurate records of the receipt and 
disposition of all controlled drugs.
    (d) Standard: Administration of drugs and biologicals.
    (1) The interdisciplinary group, as part of the review of the plan 
of care, must determine the ability of the patient and/or family to 
safely self-administer drugs and biologicals to the patient in his or 
her home.
    (2) Patients receiving care in a hospice that provides inpatient 
care directly in its own facility may only be administered medications 
by the following individuals:
    (i) A licensed nurse, physician, or other health care professional 
in accordance with their scope of practice and State law;
    (ii) An employee who has completed a State-approved training 
program in medication administration; and
    (iii) The patient, upon approval by the interdisciplinary group.
    (e) Standard: Labeling, disposing, and storing of drugs and 
biologicals.
    (1) Labeling. Drugs and biologicals must be labeled in accordance 
with currently accepted professional practice and must include 
appropriate usage and cautionary instructions, as well as an expiration 
date (if applicable).
    (2) Disposing. (i) Safe use and disposal of controlled drugs in the 
patient's home. The hospice must have written policies and procedures 
for the management and disposal of controlled drugs in the patient's 
home. At the time when controlled drugs are first ordered the hospice 
must:
    (A) Provide a copy of the hospice written policies and procedures 
on the management and disposal of controlled drugs to the patient or 
patient representative and family;
    (B) Discuss 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; and
    (C) Document in the patient's clinical record that the written 
policies and procedures for managing controlled drugs was provided and 
discussed.
    (ii) Disposal of controlled drugs in hospices that provide 
inpatient care directly. The hospice that provides inpatient care 
directly in its own facility must dispose of controlled drugs in 
compliance with the hospice policy and in accordance with State and 
Federal requirements. The hospice must maintain current and accurate 
records of the receipt and disposition of all controlled drugs.
    (3) Storing. The hospice that provides inpatient care directly in 
its own facility must comply with the following additional 
requirements--
    (i) All drugs and biologicals must be stored in secure areas. All 
controlled drugs listed in Schedules II, III, IV, and V of the 
Comprehensive Drug Abuse Prevention and Control Act of 1976 must be 
stored in locked compartments within such secure storage areas. Only 
personnel authorized to administer controlled drugs as noted in 
paragraph (d)(2) of this section may have access to the locked 
compartments; and
    (ii) Discrepancies in the acquisition, storage, dispensing, 
administration, disposal, or return of controlled drugs must be 
investigated immediately by the pharmacist and hospice administrator 
and where required reported to the appropriate State authority. A 
written account of the investigation must be made available to State 
and Federal officials if required by law or regulation.
    (f) Standard: Use and maintenance of equipment and supplies.
    (1) The hospice must ensure that manufacturer recommendations for 
performing routine and preventive maintenance on durable medical 
equipment are followed. The equipment must be safe and work as intended 
for use in the patient's environment. Where a manufacturer 
recommendation for a piece of equipment does not exist, the hospice 
must ensure that repair and routine maintenance policies are developed. 
The hospice may use persons under contract to ensure the maintenance 
and repair of durable medical equipment.
    (2) The hospice must ensure that the patient, where appropriate, as 
well as the family and/or other caregiver(s), receive instruction in 
the safe use of durable medical equipment and supplies. The hospice may 
use persons under contract to ensure patient and family instruction. 
The patient, family, and/or caregiver must be able to demonstrate the 
appropriate use of durable medical equipment to the satisfaction of the 
hospice staff.
    (3) Hospices may only contract for durable medical equipment 
services with a durable medical equipment supplier that meets the 
Medicare DMEPOS Supplier Quality and Accreditation Standards at 42 CFR 
Sec.  424.57.


Sec.  418.108  Condition of participation: Short-term inpatient care.

    Inpatient care must be available for pain control, symptom 
management, and respite purposes, and must be provided in a 
participating Medicare or Medicaid facility.
    (a) Standard: Inpatient care for symptom management and pain 
control. Inpatient care for pain control and symptom management must be 
provided in one of the following:
    (1) A Medicare-certified hospice that meets the conditions of 
participation for providing inpatient care directly as specified in 
Sec.  418.110.
    (2) A Medicare-certified hospital or a skilled nursing facility 
that also meets the standards specified in Sec.  418.110(b) and (e) 
regarding 24-hour nursing services and patient areas.
    (b) Standard: Inpatient care for respite purposes.
    (1) Inpatient care for respite purposes must be provided by one of 
the following:
    (i) A provider specified in paragraph (a) of this section.
    (ii) A Medicare or Medicaid-certified nursing facility that also 
meets the standards specified in Sec.  418.110(f).
    (2) The facility providing respite care must provide 24-hour 
nursing services

[[Page 32214]]

that meet the nursing needs of all patients and are furnished in 
accordance with each patient's plan of care. Each patient must receive 
all nursing services as prescribed and must be kept comfortable, clean, 
well-groomed, and protected from accident, injury, and infection.
    (c) Standard: Inpatient care provided under arrangements. If the 
hospice has an arrangement with a facility to provide for short-term 
inpatient care, the arrangement is described in a written agreement, 
coordinated by the hospice, and at a minimum specifies--
    (1) That the hospice supplies the inpatient provider a copy of the 
patient's plan of care and specifies the inpatient services to be 
furnished;
    (2) That the inpatient provider has established patient care 
policies consistent with those of the hospice and agrees to abide by 
the palliative care protocols and plan of care established by the 
hospice for its patients;
    (3) That the hospice patient's inpatient clinical record includes a 
record of all inpatient services furnished 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;
    (4) That the inpatient facility has identified an individual within 
the facility who is responsible for the implementation of the 
provisions of the agreement;
    (5) 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 are documented; and
    (6) A method for verifying that the requirements in paragraphs 
(c)(1) through (c)(5) of this section are met.
    (d) Standard: Inpatient care limitation. The total number of 
inpatient days used by Medicare beneficiaries who elected hospice 
coverage in a 12-month period in a particular hospice may not exceed 20 
percent of the total number of hospice days consumed in total by this 
group of beneficiaries.
    (e) Standard: Exemption from limitation. Before October 1, 1986, 
any hospice that began operation before January 1, 1975, is not subject 
to the limitation specified in paragraph (d) of this section.


Sec.  418.110  Condition of participation: Hospices that provide 
inpatient care directly.

    A hospice that provides inpatient care directly in its own facility 
must demonstrate compliance with all of the following standards:
    (a) Standard: Staffing. The hospice is responsible for ensuring 
that staffing for all services reflects its volume of patients, their 
acuity, and the level of intensity of services needed to ensure that 
plan of care outcomes are achieved and negative outcomes are avoided.
    (b) Standard: Twenty-four hour nursing services. (1) The hospice 
facility must provide 24-hour nursing services that meet the nursing 
needs of all patients and are furnished in accordance with each 
patient's plan of care. Each patient must receive all nursing services 
as prescribed and must be kept comfortable, clean, well-groomed, and 
protected from accident, injury, and infection.
    (2) If at least one patient in the hospice facility is receiving 
general inpatient care, then each shift must include a registered nurse 
who provides direct patient care.
    (c) Standard: Physical environment. The hospice must maintain a 
safe physical environment free of hazards for patients, staff, and 
visitors.
    (1) Safety management.
    (i) The hospice must address real or potential threats to the 
health and safety of the patients, others, and property.
    (ii) The hospice must have a written disaster preparedness plan in 
effect for managing the consequences of power failures, natural 
disasters, and other emergencies that would affect the hospice's 
ability to provide care. The plan must be periodically reviewed and 
rehearsed with staff (including non-employee staff) with special 
emphasis placed on carrying out the procedures necessary to protect 
patients and others.
    (2) Physical plant and equipment. The hospice must develop 
procedures for controlling the reliability and quality of--
    (i) The routine storage and prompt disposal of trash and medical 
waste;
    (ii) Light, temperature, and ventilation/air exchanges throughout 
the hospice;
    (iii) Emergency gas and water supply; and
    (iv) The scheduled and emergency maintenance and repair of all 
equipment.
    (d) Standard: Fire protection. (1) Except as otherwise provided in 
this section--
    (i) The hospice must meet the provisions applicable to nursing 
homes of the 2000 edition of the Life Safety Code (LSC) of the National 
Fire Protection Association (NFPA). The Director of the Office of the 
Federal Register has approved the NFPA 101[supreg] 2000 edition of the 
Life Safety Code, issued January 14, 2000, for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the code is available for inspection at the CMS Information Resource 
Center, 7500 Security Boulevard, Baltimore, MD or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html. Copies may be obtained from the National Fire 
Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any 
changes in the edition of the Code are incorporated by reference, CMS 
will publish a notice in the Federal Register to announce the changes.
    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition 
of the LSC does not apply to hospices.
    (2) In consideration of a recommendation by the State survey 
agency, CMS may waive, for periods deemed appropriate, specific 
provisions of the Life Safety Code which, if rigidly applied would 
result in unreasonable hardship for the hospice, but only if the waiver 
would not adversely affect the health and safety of patients.
    (3) The provisions of the adopted edition of the Life Safety Code 
do not apply in a State if CMS finds that a fire and safety code 
imposed by State law adequately protects patients in hospices.
    (4) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a hospice may place alcohol-based hand rub 
dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal

[[Page 32215]]

Register has approved NFPA Temporary Interim Amendment 00-1(101) for 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. A copy of the code is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/codeoffederal_regulations/ibr_locations.html. Copies may be obtained 
from the National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02269. If any changes in the edition of the Code are 
incorporated by reference, CMS will publish a notice in the Federal 
Register to announce the changes.
    (e) Standard: Patient areas. The hospice must provide a home-like 
atmosphere and ensure that patient areas are designed to preserve the 
dignity, comfort, and privacy of patients.
    (1) The hospice must provide--
    (i) Physical space for private patient and family visiting;
    (ii) Accommodations for family members to remain with the patient 
throughout the night; and
    (iii) Physical space for family privacy after a patient's death.
    (2) The hospice must provide the opportunity for patients to 
receive visitors at any hour, including infants and small children.
    (f) Standard: Patient rooms. (1) The hospice must ensure that 
patient rooms are designed and equipped for nursing care, as well as 
the dignity, comfort, and privacy of patients.
    (2) The hospice must accommodate a patient and family request for a 
single room whenever possible.
    (3) Each patient's room must--
    (i) Be at or above grade level;
    (ii) Contain a suitable bed and other appropriate furniture for 
each patient;
    (iii) Have closet space that provides security and privacy for 
clothing and personal belongings;
    (iv) Accommodate no more than two patients and their family 
members;
    (v) Provide at least 80 square feet for each residing patient in a 
double room and at least 100 square feet for each patient residing in a 
single room; and
    (vi) Be equipped with an easily-activated, functioning device 
accessible to the patient, that is used for calling for assistance.
    (4) For a facility occupied by a Medicare-participating hospice on 
December 2, 2008, CMS may waive the space and occupancy requirements of 
paragraphs (f)(2)(iv) and (f)(2)(v) of this section if it determines 
that--
    (i) Imposition of the requirements would result in unreasonable 
hardship on the hospice if strictly enforced; or jeopardize its ability 
to continue to participate in the Medicare program; and
    (ii) The waiver serves the needs of the patient and does not 
adversely affect their health and safety.
    (g) Standard: Toilet and bathing facilities. Each patient room must 
be equipped with, or conveniently located near, toilet and bathing 
facilities.
    (h) Standard: Plumbing facilities. The hospice must--
    (1) Have an adequate supply of hot water at all times; and
    (2) Have plumbing fixtures with control valves that automatically 
regulate the temperature of the hot water used by patients.
    (i) Standard: Infection control. The hospice must maintain an 
infection control program that protects patients, staff and others by 
preventing and controlling infections and communicable disease as 
stipulated in Sec.  418.60.
    (j) Standard: Sanitary environment. The hospice must provide a 
sanitary environment by following current standards of practice, 
including nationally recognized infection control precautions, and 
avoid sources and transmission of infections and communicable diseases.
    (k) Standard: Linen. The hospice must have available at all times a 
quantity of clean linen in sufficient amounts for all patient uses. 
Linens must be handled, stored, processed, and transported in such a 
manner as to prevent the spread of contaminants.
    (l) Standard: Meal service and menu planning. The hospice must 
furnish meals to each patient that are--
    (1) Consistent with the patient's plan of care, nutritional needs, 
and therapeutic diet;
    (2) Palatable, attractive, and served at the proper temperature; 
and
    (3) Obtained, stored, prepared, distributed, and served under 
sanitary conditions.
    (m) Standard: Restraint or seclusion. All patients have the right 
to be free from physical or mental abuse, and corporal punishment. All 
patients have the right to be free from restraint or seclusion, of any 
form, imposed as a means of coercion, discipline, convenience, or 
retaliation by staff. Restraint or seclusion may only be imposed to 
ensure the immediate physical safety of the patient, a staff member, or 
others and must be discontinued at the earliest possible time.
    (1) Restraint or seclusion may only be used when less restrictive 
interventions have been determined to be ineffective to protect the 
patient, a staff member, or others from harm.
    (2) The type or technique of restraint or seclusion used must be 
the least restrictive intervention that will be effective to protect 
the patient, a staff member, or others from harm.
    (3) The use of restraint or seclusion must be--
    (i) In accordance with a written modification to the patient's plan 
of care; and
    (ii) Implemented in accordance with safe and appropriate restraint 
and seclusion techniques as determined by hospice policy in accordance 
with State law.
    (4) The use of restraint or seclusion must be in accordance with 
the order of a physician authorized to order restraint or seclusion by 
hospice policy in accordance with State law.
    (5) Orders for the use of restraint or seclusion must never be 
written as a standing order or on an as needed basis (PRN).
    (6) The medical director or physician designee must be consulted as 
soon as possible if the attending physician did not order the restraint 
or seclusion.
    (7) Unless superseded by State law that is more restrictive--
    (i) Each order for restraint or seclusion used for the management 
of violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others may only be 
renewed in accordance with the following limits for up to a total of 24 
hours:
    (A) 4 hours for adults 18 years of age or older;
    (B) 2 hours for children and adolescents 9 to 17 years of age; or
    (C) 1 hour for children under 9 years of age; and
    After 24 hours, before writing a new order for the use of restraint 
or seclusion for the management of violent or self-destructive 
behavior, a physician authorized to order restraint or seclusion by 
hospice policy in accordance with State law must see and assess the 
patient.
    (ii) Each order for restraint used to ensure the physical safety of 
the non-violent or non-self-destructive patient may be renewed as 
authorized by hospice policy.
    (8) Restraint or seclusion must be discontinued at the earliest 
possible time, regardless of the length of time identified in the 
order.
    (9) The condition of the patient who is restrained or secluded must 
be

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monitored by a physician or trained staff that have completed the 
training criteria specified in paragraph (n) of this section at an 
interval determined by hospice policy.
    (10) Physician, including attending physician, training 
requirements must be specified in hospice policy. At a minimum, 
physicians and attending physicians authorized to order restraint or 
seclusion by hospice policy in accordance with State law must have a 
working knowledge of hospice policy regarding the use of restraint or 
seclusion.
    (11) When restraint or seclusion is used for the management of 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others, the patient 
must be seen face-to-face within 1 hour after the initiation of the 
intervention--
    (i) By a--
    (A) Physician; or
    (B) Registered nurse who has been trained in accordance with the 
requirements specified in paragraph (n) of this section.
    (ii) To evaluate--
    (A) The patient's immediate situation;
    (B) The patient's reaction to the intervention;
    (C) The patient's medical and behavioral condition; and
    (D) The need to continue or terminate the restraint or seclusion.
    (12) States are free to have requirements by statute or regulation 
that are more restrictive than those contained in paragraph (m)(11)(i) 
of this section.
    (13) If the face-to-face evaluation specified in Sec.  
418.110(m)(11) is conducted by a trained registered nurse, the trained 
registered nurse must consult the medical director or physician 
designee as soon as possible after the completion of the 1-hour face-
to-face evaluation.
    (14) All requirements specified under this paragraph are applicable 
to the simultaneous use of restraint and seclusion. Simultaneous 
restraint and seclusion use is only permitted if the patient is 
continually monitored--
    (i) Face-to-face by an assigned, trained staff member; or
    (ii) By trained staff using both video and audio equipment. This 
monitoring must be in close proximity to the patient.
    (15) When restraint or seclusion is used, there must be 
documentation in the patient's clinical record of the following:
    (i) The 1-hour face-to-face medical and behavioral evaluation if 
restraint or seclusion is used to manage violent or self-destructive 
behavior;
    (ii) A description of the patient's behavior and the intervention 
used;
    (iii) Alternatives or other less restrictive interventions 
attempted (as applicable);
    (iv) The patient's condition or symptom(s) that warranted the use 
of the restraint or seclusion; and the patient's response to the 
intervention(s) used, including the rationale for continued use of the 
intervention.
    (n) Standard: Restraint or seclusion staff training requirements. 
The patient has the right to safe implementation of restraint or 
seclusion by trained staff.
    (1) Training intervals. All patient care staff working in the 
hospice inpatient facility must be trained and able to demonstrate 
competency in the application of restraints, implementation of 
seclusion, monitoring, assessment, and providing care for a patient in 
restraint or seclusion--
    (i) Before performing any of the actions specified in this 
paragraph;
    (ii) As part of orientation; and
    (iii) Subsequently on a periodic basis consistent with hospice 
policy.
    (2) Training content. The hospice must require appropriate staff to 
have education, training, and demonstrated knowledge based on the 
specific needs of the patient population in at least the following:
    (i) Techniques to identify staff and patient behaviors, events, and 
environmental factors that may trigger circumstances that require the 
use of a restraint or seclusion.
    (ii) The use of nonphysical intervention skills.
    (iii) Choosing the least restrictive intervention based on an 
individualized assessment of the patient's medical, or behavioral 
status or condition.
    (iv) The safe application and use of all types of restraint or 
seclusion used in the hospice, including training in how to recognize 
and respond to signs of physical and psychological distress (for 
example, positional asphyxia).
    (v) Clinical identification of