[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Proposed Rules]
[Pages 30840-30893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9935]



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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 418



Medicare and Medicaid Programs: Hospice Conditions of Participation; 
Proposed Rule

  Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed 
Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-3844-P]
RIN 0938-AH27


Medicare and Medicaid Programs: Hospice Conditions of 
Participation

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise the existing conditions of 
participation that hospices must meet to participate in the Medicare 
and Medicaid programs. The proposed requirements focus on the care 
delivered to patients and their families by hospices and the outcomes 
of that care. The proposed requirements continue to reflect an 
interdisciplinary view of patient care and allow hospices flexibility 
in meeting quality standards. These changes are an integral part of the 
Administration's efforts to achieve broad-based improvements in the 
quality of health care furnished through the Medicare and Medicaid 
programs.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on July 26, 2005.

ADDRESSES: In commenting, please refer to file code CMS-3844-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments to http://www.cms.hhs.gov/regulations/ecomments (attachments should be in 
Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft 
Word).
    2. By mail. You may mail written comments (one original and two 
copies) to the following address ONLY: Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Attention: CMS-3844-
P, P.O. Box 8010, Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by mailing your 
comments to the addresses provided at the end of the ``Collection of 
Information Requirements'' section in this document.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:
Mary Rossi-Coajou, (410) 786-6051.
Danielle Shearer, (410) 786-6617.
Steve Miller, (410) 786-6656.

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this rule to assist us in fully considering issues 
and developing policies. You can assist us by referencing the file code 
CMS-3844-P and the specific ``issue identifier'' that precedes the 
section on which you choose to comment.
    Inspection of Public Comments: Comments received timely will be 
available for public inspection as they are received, generally 
beginning approximately 3 weeks after publication of a document, at the 
headquarters of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of 
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view 
public comments, phone 1-800-743-3951.

I. Introduction

    As the single largest payer for health care services in the United 
States, the Federal Government assumes a critical responsibility for 
the delivery and quality of care furnished under its programs. 
Historically, we have adopted a quality assurance approach that has 
been directed toward identifying health care providers that furnish 
poor quality care or fail to meet minimum Federal standards. These 
problems would either be corrected or would lead to the exclusion of 
the provider from participation in the Medicare or Medicaid programs. 
However, we have found that this problem-focused approach has inherent 
limits. Ensuring quality through the enforcement of prescriptive health 
and safety standards, rather than improving the quality of care for all 
patients, has resulted in our expending much of our resources on 
dealing with marginal providers, rather than on stimulating broad-based 
improvements in quality of care.
    Eliciting quality health care for Federal beneficiaries from CMS-
certified providers and suppliers requires taking advantage of 
continuing advances in the health care delivery field. As a result, we 
are revising the Medicare hospice requirements, which are also used by 
Medicaid, to focus on a patient-centered, outcome-oriented process that 
promotes patient care foremost, rather than penalizing unproductive 
providers. We have developed a set of core requirements for hospice 
services that encompass the following: Patient rights, comprehensive 
assessment, and patient care planning and coordination by a hospice 
interdisciplinary group (IDG). Overarching these requirements is a 
quality assessment and performance improvement program that builds on 
the philosophy that a provider's own quality management system is key 
to improved patient care performance. The objective is to achieve a 
balanced regulatory approach by ensuring that a hospice furnishes 
health care that meets essential health and quality standards, while 
ensuring that it monitors and improves its own performance.
    To achieve this objective, we are working to revise not only the 
hospice requirements but the requirements for several other major 
health care provider types, such as hospitals, home health agencies, 
and end-stage renal disease facilities, through separate rules. All of 
the revised requirements are directed towards improving patient 
outcomes of care and satisfaction.

II. Background

A. The Medicare Hospice Benefit

    Hospice care is an approach to caring for the terminally ill 
individual that provides palliative care rather than traditional 
medical care and curative treatment. Palliative care is treatment for 
the relief of pain and other

[[Page 30841]]

uncomfortable symptoms through the appropriate coordination of all 
aspects of care needed to maximize personal comfort and relieve 
distress. Hospice care allows the patient to remain at home as long as 
possible by providing support to the patient and family, and keeping 
the patient as comfortable as possible while maintaining his or her 
dignity and quality of life. A hospice uses an interdisciplinary 
approach to deliver medical, social, physical, emotional, and spiritual 
services through the use of a broad spectrum of caregivers.
    Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 
(TEFRA), Public Law 97-248, added section 1861(dd) to the Social 
Security Act (the Act) to provide coverage for hospice care to 
terminally ill Medicare beneficiaries who elect to receive care from a 
Medicare-participating hospice.
    Under the authority of section 1861(dd) of the Act, the Secretary 
has established the Conditions of Participation (CoPs) that a hospice 
must meet to participate in Medicare and/or Medicaid, and these are 
currently set forth at 42 CFR part 418. The CoPs apply to a hospice as 
an entity as well as to the services furnished to each individual under 
hospice care. Under section 1861(dd) of the Act, the Secretary is 
responsible for ensuring that the CoPs, and their enforcement, are 
adequate to protect the health and safety of individuals under hospice 
care and to promote the effective and efficient use of Medicare funds. 
To implement this requirement, State survey agencies conduct surveys of 
hospices to assess their compliance with the CoPs.

B. Why Revise the Conditions of Participation?

    The hospice CoPs were originally promulgated on December 16, 1983 
(48 FR 56008) and were amended on December 11, 1990 (55 FR 50831) 
largely to implement provisions of section 6005(b) of the Omnibus 
Budget Reconciliation Act of 1989 (Pub. L. 101-239). However, many of 
the current CoPs have remained unchanged since their inception.
    We are proposing changes to the current CoPs based on four main 
considerations. First, we considered the suggestions that emerged from 
the Secretary's Advisory Committee on Regulatory Reform. In an effort 
to make regulations more predictable and responsive to relevant 
stakeholders, the Committee heard public testimony on a variety of 
hospice related topics and developed recommendations to address key 
issues that were highlighted. The two largest changes that resulted 
from the Committee's recommendations are the clarification of the 
relationship between nursing facilities and hospices at proposed Sec.  
418.112, and the changes to the nursing services standard at proposed 
Sec.  418.110(b).
    Our second consideration was the Balanced Budget Act of 1997 (Pub. 
L. 105-33) because it made changes to the hospice statute that need to 
be incorporated into the CoPs.
    Our third consideration was prompted by sections 408 and 946 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(Pub. L. 108-173). Section 408 amended the Social Security Act to 
permit a nurse practitioner to be deemed a patient's attending 
physician when the patient elects hospice care. Section 946 amended 
section 1861(dd), Hospice Care: Hospice Program, of the Act to permit a 
hospice to enter into an arrangement with another hospice to provide 
core hospice services, or to provide highly specialized services of a 
registered professional nurse, in certain circumstances.
    Finally, this revision is part of a larger effort to bring about 
improvements in the quality of care furnished to Medicare and Medicaid 
beneficiaries through an outcome-oriented approach to quality of care 
responsibilities. The existing hospice CoPs do not contain patient-
centered, outcome-oriented standards, nor do they provide for the 
operation of a quality assessment and performance improvement program.
    Historically, we have established requirements for participation in 
the Medicare program that address the structure and process of health 
care. These early requirements are the result of professional 
consensus. Enforcing structure and process requirements by identifying 
deficient providers has not been adequate to meet the growing 
challenges associated with the changing hospice care environment. For 
example, rather than focusing on the relationship between the needs of 
patients and the staff available in an inpatient facility, the current 
regulations require that a registered nurse be present on every shift. 
Hospices often contract with local nursing facilities to provide 
inpatient respite care, and these facilities are only required to have 
a registered nurse on duty for a single eight hour shift each day. A 
hospice would have to supplement the nursing facility's staff with its 
own, at a significant cost to the hospice, even if the needs and acuity 
of the patient do not require a registered nurse. A hospice that did 
not supplement the facility's staff could be cited for not meeting the 
requirements, even though the requirements had no relevance to the 
needs of the patient. Thus, revisions to the hospice CoPs are 
essential.

C. Transforming the Hospice Conditions of Participation

    Before developing these proposed CoPs for hospices, we received 
advice and suggestions from the hospice industry, professional 
associations, practitioner communities, consumer advocates, and State 
and other governmental agencies with an interest in, or responsibility 
for, hospice regulation and oversight. Based on these suggestions, we 
have developed the following principles:
     Focus on the continuous, integrated health care process 
that a patient/family experiences across all aspects of hospice care, 
and on activities that center around patient assessment, care planning, 
service delivery, and quality assessment and performance improvement.
     Use a patient-centered, interdisciplinary approach that 
recognizes the contributions of various skilled professionals and other 
support personnel and their interaction with each other to meet the 
patient's needs.
     Incorporate an outcome-oriented quality assessment and 
performance improvement program.
     Facilitate flexibility in how a hospice meets performance 
expectations.
     Require that patient rights are ensured.
     Use performance measurement systems to evaluate and 
improve care.
    Based on these principles, we are proposing to set forth four core 
conditions of participation: Patient Rights, Patient/Family Assessment, 
Interdisciplinary Care Planning and Coordination of Services, and 
Quality Assessment and Performance Improvement.
     The Patient Rights CoP emphasizes a hospice's 
responsibility to respect and promote the rights of each hospice 
patient.
     The comprehensive Patient/Family Assessment CoP reflects 
the critical nature of a comprehensive assessment in determining 
appropriate treatments and accomplishing desired health outcomes.
     The Care Planning and Coordination of Services CoP 
incorporates the interdisciplinary team approach to providing hospice 
care.
     The Quality Assessment and Performance Improvement CoP 
charges each hospice with the responsibility for carrying out a 
performance effort to effect continuing improvement in the

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quality of care it furnishes to its patients and their families.
    The last three requirements establish a cycle of individual care 
and hospice-wide performance improvement. First, the patient's needs 
are comprehensively assessed and outcome measure data are collected. 
Second, the interdisciplinary group, in consultation with the patient's 
attending physician, establishes a plan of care to address those needs. 
Third, the plan of care is implemented and the results of the care are 
evaluated through updates of the comprehensive assessment and plan of 
care. Fourth, the outcome measure data collected during the initial and 
updated comprehensive assessments are analyzed to identify practices 
that lead to positive outcomes as well as opportunities for 
improvement. Finally, the hospice uses the results of such analyses to 
implement performance improvement activities. These activities will 
influence the establishment of plans of care and their implementation, 
thus creating a continuous cycle of individual care and an ongoing 
effort to improve the hospice's performance related to identified 
outcomes of care for all patients.
    This cycle of care adapts to changing standards of practice while 
addressing issues that surveyors have identified. Below is a list of 
the most cited deficiencies found by surveyors (year ending September 
3, 2002):
    1. Plan of care was not complete.
    2. No written plan was established.
    3. Plan was not reviewed at specific intervals.
    4. Plan did not include an assessment of needs.
    5. Plan was not established before providing care.
    6. RN supervisory visits were not made for home health aide 
services.
    7. No plan of care was included for bereavement services.
    8. Hospice did not conduct a self-assessment of quality and care 
provided.
    9. Clinical record was not maintained for every patient.
    10. Interdisciplinary group did not review and update the plan of 
care for each patient.
    We note that 8 of the 10 top deficiencies are related to plan of 
care, assessment, and quality assurance. Based on industry comments and 
our own surveys, we believe that the current plan of care condition 
contained in Sec.  418.58 must be strengthened. We did this by creating 
a separate condition for the assessment of individual needs and for the 
time frames related to that assessment. We also revised the quality 
assurance requirement and strengthened the plan of care requirement.
    These requirements would focus provider and surveyor efforts on the 
actual care delivered to the patient, the performance of the hospice as 
an organization, and the impact of the medical, physical, social, 
emotional, and spiritual care delivered to the patient.
    We are proposing to retain some of the current process-oriented 
requirements when they are likely to produce desirable outcomes and/or 
prevent harmful outcomes. These proposed CoPs invest in hospices the 
responsibility for improving patient care performance, rather than 
relying on an externally based approach where prescriptive requirements 
are enforced through the punitive aspects of the survey process.
    This change signals an opportunity for CMS, hospices, and States to 
join in a partnership for improvement. When implemented, hospice 
programming will reflect a patient-centered, outcome-oriented approach 
that will likely alter the manner in which CMS and States manage the 
survey process. We believe that this approach will provide 
opportunities for improvement in patient care that have been lacking in 
the past. The addition of a strong quality assessment and performance 
improvement requirement will stimulate the hospice to continuously 
monitor its performance and find opportunities for improvement.

D. Development of Outcome-Based Performance Measures for Hospices

[If you choose to comment on issues in this section, please include the 
caption ``OUTCOME-BASED PERFORMANCE MEASURES'' at the beginning of your 
comments.]
    We are proposing to require that hospices implement an outcome-
based internal performance improvement program that can be used to 
measure individual patient outcomes. The information a hospice gleans 
from its own data analysis will serve as a baseline for hospice quality 
improvement. Measures quantify quality and are tools for the hospice to 
use in assessing and improving patient care, outcomes, and 
satisfaction. An outcome based performance program can help hospices 
improve the effectiveness and efficiency of their services, improve the 
outcomes of care they provide, and increase patient satisfaction with 
their services.
    Hospice outcome measures, data elements, tools, and instructions 
for using them have already been developed by the industry. A Task 
Force initiative was sponsored and convened by the National Hospice 
Work Group (NHWG) and the National Hospice and Palliative Care 
Organization (NHPCO) in 1999. We participated in the development of the 
measures and provided technical assistance for pilot testing of the 
measures. The Task Force was invited to present the results of the 
measurement development work and results of the pilot studies to us in 
November 2000.
    The work of the Task Force resulted in four measures for the 
outcome domains of self-determination, comfort, safety, and effective 
grieving. The hospice industry rapidly moved to include these four 
measures in the data set that they encourage member hospices to use and 
report. The data elements and instructions for using the measures are 
publicly available on the NHPCO Web site at http://www.nhpco.org.
    These outcome-based measures are part of a national reporting 
process created by the hospice industry. If a hospice chooses to 
participate in the NHCPO process, it submits its data to the NHPCO (or 
its contractor). Reports are then generated for a hospice to compare 
its performance with other hospices. The hospice may also choose to 
send additional information for the NHPCO reporting process in the 
areas of pertinent utilization data, appropriateness and effectiveness 
of services, and patient/family satisfaction. All hospices that 
participate in the NHPCO reporting process must comply with regulations 
mandated by the Health Insurance Portability and Accountability Act of 
1996 (Pub.L. 104-191, ``HIPAA''). Regulations implementing HIPAA were 
published on December 28, 2000 (65 FR 82462) and were amended on August 
14, 2002 (67 FR 53182).
    We are not proposing to require that hospices participate in the 
NHPCO process described above, but hospices may choose to use some of 
the measures the NHPCO is already using as part of its comprehensive 
assessment of the patient, and as part of the organization's quality 
assessment and performance improvement program. Hospices may also 
develop their own data elements and measurement processes. 
Participating in the NHPCO outcome measurement and reporting process 
would assist hospices in meeting the requirements of proposed Sec.  
418.54(e). At this time, we are neither proposing that hospices use any 
particular measures of outcomes, nor that they report data to us. 
However, we may consider doing so in the future.
    We invite comments from the public on this aspect of the proposed 
rule.

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III. Provisions of the Proposed Regulations

A. Overview

    Under our proposal, the hospice conditions of participation would 
continue to be set forth in regulations under 42 CFR part 418. However, 
since many of the existing requirements in part 418 would be revised, 
consolidated with other requirements, or eliminated, we are proposing 
changes to the existing organizational scheme. A significant change 
would be to group all CoPs directly related to patient care and place 
them together in a separate subpart. CoPs concerning hospice 
organization and administration would be contained in another subpart. 
We believe that this proposed organization better reflects a patient/
family-centered orientation and helps illustrate that patient 
assessment, care planning, and quality assessment and improvement 
efforts are central to the delivery of high quality care.

B. Subpart A, General Provisions

    The revised conditions would begin with existing Sec.  418.2 that 
specifies the statutory authority and scope of the part for the ensuing 
regulations. Section 418.1 would remain unchanged.
1. Scope of the Part (Proposed Sec.  418.2)
    Section 418.2 would be revised to reflect the reorganization of the 
part and to include an introductory statement describing the purpose of 
the part.
2. Definitions (Proposed Sec.  418.3)
    Existing Sec.  418.3 sets forth definitions for terms used in the 
hospice CoPs. This section is being revised in order to provide further 
clarification. We are proposing to move existing definitions of 
``physician'' and ``social worker'' to proposed Sec.  418.114, 
personnel requirements. We believe these definitions better fit in this 
new condition. We propose to include the following definitions:
     Attending physician (revised)
     Bereavement counseling (revised)
     Cap Period (same)
     Clinical note (new)
     Drug restraint (new)
     Employee (revised)
     Hospice (revised)
     Hospice care (new)
     Licensed professional (new)
     Palliative care (new)
     Physical restraint (new)
     Progress note (new)
     Representative (revised)
     Restraint (new)
     Satellite location (new)
     Seclusion (new)
     Terminally ill (revised)

    These definitions would be revised to read as follows:
    Attending physician means a--
    (a)(1) Doctor of medicine or osteopathy legally authorized to 
practice medicine and surgery by the State in which he or she performs 
that function or action; or (2) Nurse practitioner who meets the 
training, education and experience requirements as the Secretary may 
prescribe; and
    (b) Is identified by the individual, at the time he or she elects 
to receive hospice care, as having the most significant role in the 
determination and delivery of the individual's medical care.
    Here after, except as indicated, the term ``attending physician'' 
includes nurse practitioners.
    We modified this definition to address changes made to the Act by 
Congress in section 408 of the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003 (Pub. L. 108-173) (``MMA''). Nurse 
practitioners are often the primary medical health care professionals 
for some patients, particularly those residing in rural areas. For 
example, a nurse practitioner that works in conjunction with a doctor 
may be the health care professional a patient sees most often. The 
patient would develop a relationship with the nurse practitioner, and 
would like the nurse practitioner to continue to be involved in his or 
her care once he or she elects the hospice benefit. Under the current 
regulations, this is not allowed. Under the proposed regulations, we 
would permit a nurse practitioner to continue serving his or her 
patient as that patient's attending physician once that patient elects 
to receive hospice care. We believe that this would ensure the 
continuity of care and improve the quality of care because the health 
care professional most familiar with the patient, his or her 
conditions, and his or her personal situation would be involved in 
developing the plan of care and in making other important decisions.
    Within the provisions of section 408 of the MMA nurse practitioners 
are prohibited from certifying or recertifying a patient's terminal 
illness. CMS will publish additional information regarding section 408 
in a forthcoming Federal Register document.
    Bereavement counseling means emotional, psychosocial, and spiritual 
support and services provided after the death of the patient to assist 
with issues related to grief, loss, and adjusting.
    Cap period means the 12-month period ending October 31 used in the 
application of the cap on overall hospice reimbursement as specified in 
Sec.  418.309.
    Clinical note means a notation of a contact with the patient that 
is written and dated by any person providing services, and that 
describes signs and symptoms, treatments and medications administered, 
including the patient's reaction and/or response, and any changes in 
physical or emotional condition.
    Drug restraint means a medication used to control behavior or to 
restrict the patient's freedom of movement which is not a standard 
treatment for a patient's medical or psychiatric condition.
    Employee means a person who works for the hospice and for whom the 
hospice is required to issue a W-2 form on his or her behalf, or if the 
hospice is a subdivision of an agency or organization, an employee of 
the agency or organization who is appropriately trained and assigned to 
the hospice or is a volunteer under the jurisdiction of the hospice.
    Hospice means a public agency or private organization or 
subdivision of either of these that is primarily engaged in providing 
hospice care as defined in this section.
    Hospice care means a comprehensive set of services described in 
1861(dd)(1) of the Act, identified and coordinated by an 
interdisciplinary team to provide for the physical, psychosocial, 
spiritual, and emotional needs of a terminally ill patient and/or 
family members, as delineated in a specific patient plan of care.
    Licensed professional means a licensed person sanctioned by the 
State in which services are delivered, furnishing services such as 
skilled nursing care, physical therapy, speech-language pathology, 
occupational therapy, and medical social services.
    Palliative care means patient and family-centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care throughout the continuum of illness involves 
addressing physical, intellectual, emotional, social, and spiritual 
needs and to facilitate patient autonomy, access to information, and 
choice.
    Physical restraint means any manual method or physical or 
mechanical device, material, or equipment attached to the patient's 
body that he or she cannot easily remove that restricts freedom of 
movement or normal access to one's body.
    Progress note means a written notation, dated and signed by any 
person providing services, that summarizes facts about the care 
furnished and the patient's response during a given period of time.

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    Representative means an individual who has the authority under 
State law (whether by statute or pursuant to an appointment by the 
courts of the State) to authorize or terminate medical care or to elect 
or revoke the election of hospice care on behalf of a terminally ill 
patient who is mentally or physically incapacitated. This may include a 
legal guardian.
    Restraint means either a physical restraint or a drug used as a 
restraint.
    Satellite location means a Medicare-approved location from which 
the hospice provides hospice care and services within a portion of the 
total geographic area served by the hospice provider issued the 
provider agreement number. The satellite location is part of the 
hospice and shares administration, supervision, and services in a 
manner that renders it unnecessary for the satellite location to 
independently meet the conditions of participation as a hospice.
    We are proposing to add this definition to recognize long-standing 
Medicare survey and certification policies, which allow for the 
operation of multiple locations by a single hospice provider. We are 
proposing that a hospice satellite location be approved by CMS before 
it begins to furnish service to patients. In the past, some hospices 
were found to be furnishing services from locations that had not been 
shown to be in compliance with applicable regulations. We envision the 
approval process to be consistent with determining that patients 
receive safe services from the satellite location in question. As is 
done for other appropriate providers and suppliers, we are accepting 
comment on applying the Medicare Appeals Procedures that affect 
participation in the Medicare program (42 CFR 498.3). If a hospice, 
including any or all satellite locations, is accredited by an 
accrediting organization such as JCAHO or CHAP, the hospice and each 
satellite location must still receive Medicare approval.
    Seclusion means the confinement of a person in a room or an area 
where a person is isolated and physically prevented from leaving.
    Terminally ill means that a patient has a medical prognosis that 
his or her life expectancy is six months or less if the illness runs 
its normal course.

C. Subpart B, Eligibility, Election and Duration of Benefits

    Subpart B concerns eligibility, election, and duration of hospice 
benefits. We are not proposing changes to this subpart at this time.

D. Subpart C, Conditions of Participation--Patient Care

1. Patient's Rights, Condition of Participation (Proposed Sec.  418.52)
[If you choose to comment on issues in this section, please include the 
caption ``PATIENTS RIGHTS'' at the beginning of your comments.]
    This section would replace the current condition of participation, 
Informed consent, laid out at Sec.  418.62. This condition would set 
forth certain rights to which hospice patients would be entitled, and 
would require that hospices inform each patient of these rights and 
that hospice personnel ensure and support these rights. Among these 
rights would be the following, laid out at proposed Sec.  418.52: Being 
informed in advance regarding the care to be provided; having an 
opportunity to participate in care planning; voicing grievances; being 
assured of confidentiality of records; having personal property 
respected; being informed whether services are covered or not covered, 
and having information provided in writing. We are proposing to specify 
that the patient must also be informed about factors that affect 
palliation and comfort. We believe that these revisions would act as an 
additional safeguard of patient health and safety. Open communication 
between hospice staff and the patient, and patient access to palliative 
information is vital to enhancing the patient's participation in his or 
her coordinated care planning. All hospices must also comply with the 
Privacy Rule published in the Federal Register on December 28, 2000 (65 
FR 82461) as amended on August 14, 2002 (67 FR 53182) and contained in 
45 CFR parts 160 and 164.
    We are specifically soliciting public comment on this proposed 
condition of participation.
2. The Cycle of Care: Assessment, Planning, and Delivery (Proposed 
Sec.  418.54 Through Sec.  418.62)
    The patient care assessment, planning, and palliative care process 
represented by the next four CoPs (Sec.  418.54 through Sec.  418.62) 
can be seen as a cycle. Through the use of a comprehensive assessment, 
accurate and timely patient information is made available for use in 
the patient care process. The palliative care process consists of all 
hospice care and services furnished to the patient and family. The 
patient palliative care process results in an effect on the patient's 
condition, whether it is positive or negative. The assessment of the 
effectiveness of palliative care then results in subsequent care 
decisions, and the cycle begins anew. Through this cycle, accurate 
patient and family information obtained from each comprehensive 
assessment should yield effective and appropriate palliative care 
decisions, thus generating a positive effect on patient care and 
desired outcomes.
Condition of Participation: Comprehensive Assessment of the Patient 
(Proposed Sec.  418.54)
    The proposed comprehensive assessment requirement reflects our view 
that a patient-centered, interdisciplinary, and systematic patient 
assessment is essential to improving patient quality of care and 
patient outcomes.
    In hospice care, the comprehensive assessment of the patient 
contributes to quality of care improvements in closely linked stages. 
First, the information generated from an interdisciplinary 
comprehensive assessment is a vital tool for developing a hospice 
patient's plan of care that will guide decisions on how best to 
determine the individual care and support needs of the patient. Second, 
based on updates of the comprehensive assessment, a hospice is able to 
track the patient's progress towards achieving the desired care 
outcomes, and where this does not occur, make appropriate changes to 
the patient's plan of care. Finally, the hospice is able to evaluate 
the results of its care decisions, thus yielding information to help 
form the hospice's future care planning process. We believe this 
approach reflects contemporary standard practice for many hospices, and 
we are proposing to revise the CoPs to support this outcome-oriented 
approach.
    The centerpiece of this outcome-oriented approach is that each 
patient receives a patient-specific comprehensive assessment that 
identifies the patient's need for medical, nursing, psychosocial, 
emotional and spiritual care. The care needs identified in the 
assessment would include, but not be limited to, those necessary for 
palliation and management of the terminal illness and related medical 
conditions. The comprehensive assessment would be completed by the 
interdisciplinary group in consultation with the individual's attending 
physician to ensure that each member of the interdisciplinary group 
provided input within the scope of that individual's practice. We 
believe that the patient-specific comprehensive assessment requirement 
we are proposing is already recognized and practiced by the hospice 
industry in general.

[[Page 30845]]

    The existing CoPs contain few requirements that address the need 
for patient assessment; therefore, we are emphasizing the importance of 
the comprehensive assessment by establishing it as a separate CoP. In 
hospice surveys nationwide, we have identified a pattern of healthcare 
related deficiencies that indicate that the current assessment 
requirements are not sufficient. The fourth most frequently cited 
deficiency is that the plan of care did not include an assessment of 
the patient's needs. The frequency with which this area is cited 
indicates that there are a significant number of hospices that are not 
doing enough to properly assess their patients.
    The expanded assessment condition would guide these deficient 
hospices in thoroughly assessing their patients by identifying the 
general areas that should be included in each assessment and by 
identifying time frames for the completion of assessments. We believe 
that this proposed CoP would enable hospices to specifically identify 
patient care needs. Once a hospice has completed a timely and thorough 
assessment of the patient, it can develop an accurate plan of care that 
reflects the needs identified during the assessment. The accuracy and 
timeliness of the plan of care may lead to an improvement in the 
quality of the hospice experience for the patient and his or her 
family.
    In addition, we believe that the broad assessment outline we are 
proposing will encourage hospices to exercise flexibility in 
determining how best to achieve positive outcomes. We believe that this 
approach is consistent with currently accepted practices in hospices.
    In Sec.  418.54(a), Initial assessment, we are proposing that a 
registered nurse make the initial assessment visit to determine the 
patient's immediate care and support needs within 24 hours after the 
hospice receives a physician's admission order for care (unless another 
date is specified by the physician). We realize that some hospices meet 
with patients and their families, at their request, before the actual 
admission for care orders are received, and this regulation would not 
prevent this practice. However, meeting with a patient and his or her 
family before the patient's physician orders hospice care would not 
satisfy the initial assessment requirement.
    In Sec.  418.54(b), Time frame for completion of the comprehensive 
assessment, we are proposing that the hospice interdisciplinary group, 
in consultation with the hospice medical director or physician designee 
and/or the individual's attending physician, complete the comprehensive 
assessment in a timely manner consistent with the patient's immediate 
needs, but no later than 4 calendar days after the patient elects the 
hospice benefit. We believe that most hospices already complete the 
assessment within this time frame and, due to the decreased length of 
stay, as explained in the discussion of Sec.  418.54(d), Update of the 
comprehensive assessment, and the potential severity of the patient's 
condition, we believe it is essential to ensure that patients are 
assessed in a timely manner.
    Section Sec.  418.54(c), Content of the comprehensive assessment, 
would describe the requirements for the content of the comprehensive 
assessment that we believe are critical to quality hospice care. These 
content requirements are at the core of hospice care and are needed to 
evaluate the patient's need for physical, social, emotional, medical, 
and spiritual care.
    Under proposed Sec.  418.54(c)(3)(ii), Drug therapy, the patient's 
comprehensive assessment would have to` include a review of the 
patient's current medication. The review and accompanying documentation 
would include identification of the following items:
     Ineffective drug therapy;
     Unwanted side and toxic effects; and
     Drug interactions.
    This review must be repeated as necessary to ensure that the 
patient continues to receive drug therapy that is effective and 
appropriate for his or her needs. A review of a patient's drugs would 
be included in the initial assessment and in the development of the 
plan of care. This review could occur at any time, but specifically 
when a patient is prescribed or begins to take any new drug and/or when 
use of a drug is discontinued.
    In Sec.  418.54(d), Update of the comprehensive assessment, we are 
proposing that the comprehensive assessment be updated by the 
interdisciplinary group as frequently as the patient's condition 
requires, but no less frequently than every 14 days. We believe that 
these frequent reviews are necessary and predictive of quality outcomes 
for two reasons:
    (1) In the terminal stages of care, patient status needs, 
circumstances, and family expectations can change greatly, affecting 
the type and frequency of services that should be furnished. 
Reassessments assist the hospice in developing a more responsive care 
plan. The interdisciplinary group would use assessment information to 
guide necessary reviews and/or changes to the patient's plan of care.
    (2) We are proposing that a hospice medical director or physician 
designee be required to recertify a patient for hospice care at 
specific intervals as stated in Sec.  418.21. We believe 
recertification, which occurs at the end of the initial and subsequent 
90-day benefit periods (and at the end of the remaining benefit periods 
as described in Sec.  418.21), serves as a logical point for updating 
an assessment in addition to the minimum 14 days and when the patient's 
condition changes.
    We believe that to ensure quality and timely care for our hospice 
beneficiaries, timely completion of the initial assessment requirement 
and the comprehensive assessment update requirement is necessary. In 
2001 the average length of enrollment in hospice care was 51 days (2002 
Nov. Medicare National Summary for HHA, Hospice, SNF, and outpatient CY 
1999-2001, http://www.cms.hhs.gov/statistics/feeforservice/National 
Summary.pdf). According to research by the NHPCO, in 2000 the average 
length of enrollment in hospice care was 48 days (2000 NHPCO National 
Data Set Summary Report, 2001 Nov.). There has been some concern 
regarding short lengths of stay. Hospices have been admitting patients 
late in their terminal illness and those patients need extensive 
hospice services and resources initially, and right before death. In 
order to ensure that patients receive the necessary services and thus 
begin to benefit from hospice care at the earliest time possible, we 
believe that it is important that the comprehensive patient assessment 
be completed within the time frame that we have proposed. A delay in 
completing the initial comprehensive assessment and the updated 
assessments is ultimately not as beneficial to the patient and family 
as if the patient had entered hospice care and received timely 
assessments to determine the proper care to be provided.
    These requirements, though process-oriented in part, are predictive 
of good patient care and safety. Our rationale for requiring the 
completion of the initial comprehensive assessment is that a new 
patient being referred to a hospice for initiation of services is at a 
point of immediate need and often in crisis. Likewise, maintaining an 
ineffective plan of care could jeopardize patient health and safety. 
Regular assessment updates would minimize this possibility.
    We believe that the comprehensive assessment requirements pose 
little or no burden for hospices because it is a current standard of 
practice to

[[Page 30846]]

comprehensively assess hospice patients. However, we recognize that the 
proposed 4-day timeframe for completing the initial comprehensive 
assessment as proposed in Sec.  418.54(b) and 14-day timeframe for 
updating the comprehensive assessment as proposed in Sec.  418.54(d) 
may set higher performance expectations for some hospices then the 
self-imposed standards they currently utilize. We believe that if a 
hospice recognizes that it is not capable of furnishing services within 
these timeframes, new patients should not be accepted for care.
    We welcome public comments on the review of our proposed timeframes 
for the initial comprehensive assessment and updated comprehensive 
assessment. We believe the timeframes are reasonable and consistent 
with current hospice practice.

[If you choose to comment on issues in this section, please include the 
caption ``ASSESSMENT TIME FRAMES'' at the beginning of your comments.]
    Under the proposed Sec.  418.54(e), Patient outcome measures, we 
are proposing that a patient's comprehensive assessment include 
measurement and documentation of aspects of care that are essential 
outcomes of optimal hospice care. Documentation is carried out in the 
same way for all patients through what we refer to as data elements. 
The hospice may develop its own data elements or use existing, 
externally developed data elements. However, some of the data elements 
should be related to the domains of self-determination, comfort, 
safety, and effective grieving related to bereavement services. If a 
hospice chooses to collect information for the data elements developed 
by the NHPCO, it may also choose to submit this information to the 
NHCPO. However, submission must be in accordance with the HIPAA privacy 
rule (45 CFR Parts 160 and 164). The hospice may also choose to send 
additional information for the NHPCO reporting process in the areas of 
pertinent utilization data, appropriateness and effectiveness of 
services, and patient/family satisfaction.
    The data elements used by the hospice must be an integral part of 
both the initial comprehensive and updated assessments. The application 
of these data elements to the identified domains must be documented in 
a systematic and retrievable way for each patient, as the outcome 
measurements will be used in patient care planning and coordinating 
services. Measurements will also be used (in the aggregate) for the 
hospice quality assessment and performance improvement program.
    We want to emphasize that we are not proposing that hospices use 
any specific data elements to measure domain outcomes. We are simply 
proposing that hospices collect the data necessary to evaluate the 
quality of care they are providing and use this information in a 
systematic and retrievable way. Hospices may develop their own data 
elements related to the aspects of care related to hospice and 
palliation, such as self-determination, comfort, safety, and effective 
grieving, or may use the data elements related to the seven outcome 
measures in the NHPCO data set (http://www.nhpco.org).
    Currently, there is insufficient evidence for a valid and reliable 
common set of measures (that is, data elements) for use in hospice 
care. We are aware that the industry is studying this area. We also 
know that there are many measures that are currently used to help gauge 
the processes of care for hospice patients and to make adjustments to 
care on their basis. For example, there are multiple scales for use in 
pain management, anxiety, and depression, and there are several 
quality-of-life scales appearing in the relevant literature (http://www.nhpco.org and http://www.chcr.brown.edu/pcoc/toolkit.htm). Some 
measurable outcomes can be captured in single items while others 
require multiple items to capture the full range of measurement issues.
    We welcome comments on our ``outcome measures'' approach to this 
proposed regulation. We are particularly interested in comments as to 
whether this approach is necessary in assessment, care planning, 
service delivery, and most importantly, to the hospice's quality 
assessment and performance improvement program.

[If you choose to comment on issues in this section, please include the 
caption ``OUTCOME MEASURES'' at the beginning of your comments.]
Condition of Participation: Interdisciplinary Group Care Planning and 
Coordination of Services (Proposed Sec.  418.56)
[If you choose to comment on issues in this section, please include the 
caption ``PLAN OF CARE'' or ``COORDINATION OF SERVICES'' where 
appropriate, at the beginning of your comments.]
    The existing condition of participation concerning the plan of care 
is set forth at Sec.  418.58. We are proposing to revise the contents 
of this section and place them in a new condition, ``Interdisciplinary 
group care planning and coordination of services'' (proposed Sec.  
418.56). The proposed condition would contain five standards that 
reflect the interdisciplinary approach to hospice care delivery.
    As proposed, each patient and family would have a written plan of 
care developed by the hospice interdisciplinary group in consultation 
with the patient's attending physician that specifies the hospice care 
and services necessary to meet the patient/family-specific needs 
identified in the comprehensive and updated assessments. All hospice 
services furnished to patients and their families must follow this 
written plan of care.
    Under proposed Sec.  418.56(a), Approach to service delivery, we 
are proposing that the hospice designate an interdisciplinary group or 
groups composed of individuals who work together to meet the physical, 
medical, social, emotional, and spiritual needs of the hospice patients 
and families facing terminal illness and bereavement. We believe that 
the role of the interdisciplinary group is paramount in directing and 
monitoring the patient care and is one of the factors that makes the 
hospice benefit unique. The hospice would designate a qualified health 
care professional who is a member of the interdisciplinary group to 
provide program coordination, ensure the continuous assessment of each 
patient's and family's needs, and ensure the implementation and 
revision of the plan of care.
    The proposed standard at Sec.  418.56(b), Plan of care, is the same 
as the existing standard at Sec.  418.58(a), with one addition. We are 
including a reference to the patient's family when establishing the 
plan of care. We would require that all hospice services furnished to 
patients and their families follow a written plan of care established 
by the hospice interdisciplinary group in collaboration with the 
attending physician. Family plays an important role in the care of a 
hospice patient, and this change reflects that role.
    Under the proposed standard at Sec.  418.56(c), Content of the plan 
of care, we would require that each patient's plan of care reflect 
interventions for problems identified in the comprehensive and updated 
assessments. This requirement ensures that care and services are 
appropriate to the level of each patient's and family's specific needs. 
The plan of care must include the following:
     Interventions to facilitate the management of pain and 
symptoms;
     A detailed statement of the scope and frequency of 
services required to meet the patient's and family's specific needs;

[[Page 30847]]

     Measurable outcomes anticipated from implementing and 
coordinating the plan of care;
     Drugs and treatment necessary to meet the needs of the 
patient;
     Medical supplies and appliances required to meet the needs 
of the patient; and
     The interdisciplinary group's documentation in the 
clinical record indicating the patient's and family's understanding, 
involvement, and agreement with the plan.
    As we noted in the description of the previous standard, we are 
proposing to add a requirement that the plan address the patient's and 
family's expectations, understanding, agreement, and ability to 
participate in the care as the patient and family desire. Since family 
members need to understand the importance of their role in care of the 
hospice patient, their input and agreement regarding care is essential 
in developing a productive relationship with the hospice. We would 
expect a hospice to document the patient's and family's understanding 
of and agreement to the plan of care in accordance with its own 
policies. This could include an attestation signed by the patient and 
family, a note in the clinical record, and/or another form of 
documentation decided upon by the hospice governing body.
    Proposed standard Sec.  418.56(d), Review of the plan of care, 
would require that a revised plan of care include current information 
from the patient's updated comprehensive assessment and information 
concerning the patient's progress toward achieving outcomes specified 
in the plan of care. The plan of care must be reviewed at intervals 
specified in the plan but no less frequently than every 14 calendar 
days. We believe that it is essential to include the requirement that 
actual care provided also be changed as needed, thus establishing the 
essential linkage between assessment information, evaluation of 
treatment results, and plan of care modification.
    We also propose to require that the hospice take steps to involve 
the patient's attending physician in the review of the patient's plan 
of care. The attending physician often has had a lengthy relationship 
with the patient; and his or her input into the review of the plan of 
care can be invaluable. We do not have the authority in the Conditions 
of Participation governing hospices to require that an attending 
physician, an individual who is not an employee of the hospice and thus 
not governed by these hospice regulations, participate in this process. 
However, we can and are proposing that the hospice collaborate with the 
patient's attending physician to the extent possible when reviewing the 
plan of care. We believe that requiring hospices to involve interested 
attending physicians will benefit patients by helping to ensure that 
the care described in the plan of care reflects the needs and desires 
of patients and their families.
    We are proposing to add a new standard, Coordination of services, 
at Sec.  418.56(e). This standard would require that the hospice 
maintain a system of communication and integration to enable the 
interdisciplinary group to ensure the overall provision of care and the 
efficient implementation of the day-to-day policies. These new 
standards would also make it easier for the hospice to ensure that the 
care and services are provided in accordance with the plan of care, and 
that all care and services provided are based on the comprehensive and 
updated assessments of the patient's and family's needs. An effective 
communication system would also enable the hospice to ensure ongoing 
liaison of all disciplines providing care and services in the home, 
outpatient, and inpatient settings, notwithstanding the manner in which 
the care and services are furnished.
    We believe that this standard is appropriate for two reasons. 
First, a hospice patient typically encounters many services delivered 
at different times by a variety of individuals with different skills. 
An efficient method of communication and integration of observations 
among members of the interdisciplinary group and others providing care 
is essential to meet and respond to the patient's and family's needs in 
a timely manner. Second, effective communication and coordination of 
services will assist a hospice in avoiding a duplication of effort or a 
furnishing of conflicting services.
    We recognize the value of an interdisciplinary approach to the 
delivery of hospice services. This approach to care reflects actual 
industry practice, and as a result, we believe the proposed requirement 
is in step with the hospice industry.
    We are specifically soliciting public comment on the proposed 
requirements for the content of the plan of care, the time frames for 
review of the plan of care, and the new coordination of services 
standard.
Condition of Participation: Quality Assessment and Performance 
Improvement (Proposed Sec.  418.58)
[If you choose to comments on issues in this section, please include 
the caption ``QAPI'' at the beginning of your comments.]
    The existing Sec.  418.66, Condition of participation--Quality 
assurance, relies on a problem-oriented approach to identify and 
resolve patient care issues. Failure to meet the quality assurance 
condition is consistently one of the top 10 deficiencies cited by 
surveyors nationwide. According to the hospice industry associations, 
hospices are no longer using the quality assurance model. During the 
last decade the health care industry, including the hospice industry, 
has moved beyond the problem-oriented, after-the-fact corrective 
approach of quality assurance to an approach that focuses on a pre-
emptive plan that continuously addresses quality assessment and 
performance improvement (QAPI). Hospice industry associations have 
indicated that their upgraded QAPI systems are incompatible with the 
existing quality assurance condition. Therefore, the providers who have 
moved beyond quality assurance in order to make meaningful and 
sustained quality improvements in their own programs are actually in 
violation of the outdated quality assurance condition.
    On the other end of the spectrum are providers who are truly 
deficient because they do not have any quality program. These providers 
would find more guidance in the proposed regulation. In the following 
section of this preamble we will discuss two publicly available 
resources for data measures, an integral part of the proposed QAPI 
requirement. In the proposed regulation we have outlined when those 
should be collected and what role they play in the proposed QAPI 
condition. In addition, we have described the scope of the proposed 
QAPI program requirement, the guidelines for identifying performance 
improvement activities, and the individuals responsible for ensuring 
that a hospice has a QAPI program. The proposed regulations provide 
hospices that are unsure of what is expected of them with the 
guidelines to begin tailoring a QAPI program that meets their needs and 
circumstances.
    Therefore, we believe that this proposed condition will reduce the 
number of deficient providers by recognizing those who are practicing 
QAPI and guiding reluctant providers to meet current standards of 
practice. The proposed QAPI requirement would raise the performance 
expectations for hospices seeking entrance into the Medicare program, 
as well the expectations of those currently participating in Medicare. 
We are proposing that each hospice develop,

[[Page 30848]]

implement, and maintain an effective, continuous quality assessment and 
performance improvement program that stimulates the hospice to 
constantly monitor and improve its own performance, and to be 
responsive to the needs, desires, and satisfaction levels of the 
patients and families it serves.
    The desired overall outcome of this proposed CoP is that the 
hospice will drive its own quality improvement activities and improve 
its provision of services. With an effective quality assessment and 
performance improvement program in place and operating properly, the 
hospice can better identify and reinforce the activities it is doing 
well, identify its activities that are leading to poor patient 
outcomes, and take actions to improve performance.
    This proposed condition requires the hospice to develop, implement, 
and maintain an effective data driven quality assessment and 
performance improvement program (QAPI). The program establishes a 
planned approach to quality improvement and takes into account the 
complexity of the hospice's organization and services, including those 
provided directly or under arrangement. The hospice must take whatever 
actions are necessary to implement improvements in its performance as 
identified by its quality assessment and performance improvement 
program. The hospice is also responsible for ensuring that the 
professional services it offers are carried out within current clinical 
practice guidelines as well as professional practice standards 
applicable to hospice care.
    In the first proposed standard under this condition at Sec.  
418.58(a), Standard: Program scope, we are proposing that the hospice's 
quality assessment and performance improvement program must include, 
but not be limited to, an ongoing program that is able to show 
measurable improvement in indicators that are linked to improving 
palliative outcomes and end-of-life support services. We expect that a 
hospice will use standards of care and the findings made available in 
current literature to select indicators to monitor its program. The 
hospice must measure, analyze, and track these quality indicators, 
including areas such as adverse patient events and other aspects of 
performance that assess processes of care, hospice services, and 
operations. Adverse patient events, as used in the field, are 
occurrences that are harmful or contrary to the targeted patient 
outcomes.
    The second proposed standard under Sec.  418.58(b) Program data, 
would require the hospice program to incorporate quality indicator 
data, including patient care data and other relevant data, into its 
QAPI program. This would include data that are received from or 
submitted to hospice professional organizations. A fundamental barrier 
in identifying quality care at the end of life is the lack of 
measurement tools. Measurement tools can identify opportunities for 
improving medical care and examining the impact of interventions.
    CMS does not currently require the submission of data from hospices 
to calculate quality measures but is interested in the development of a 
set of measures. Hospice measures were submitted and discussed as part 
of the recent National Quality Forum process identifying home health 
measures but were withdrawn and added to the more focused end of life 
discussions. CMS would be interested in comments regarding clinical 
measures, patient experience of care measures, and systems measures 
(use of information technology, staffing, follow up mechanisms) 
specific to hospice care. These comments should include existing 
measures in use, measures to be developed, data collection methods and 
issues, and how measures are currently being used. We are especially 
interested in the feasibility, usability, if the measures presented are 
proprietary or publicly available, and burden of collecting and 
reporting the measures.
    An example of available measurement tools would be the hospice 
outcome measures, data elements, tools, and instructions developed by a 
hospice industry task force in which the CMS participated as a 
stakeholder. A Task Force initiative was sponsored and convened by the 
National Hospice Work Group (NHWG) and the National Hospice and 
Palliative Care Organization (NHPCO) in 1999. We participated in 
developing the measures and provided technical assistance for pilot 
testing the measures. In addition to the work that has already been 
done in this area, we are committed to working with all relevant 
interest groups and associations as they develop and provide hospices 
with model quality assessment and performance improvement programs and 
other services.
    The work of the Task Force resulted in measures addressing the 
outcome domains of self-determined life closure, comfortable dying, 
safe dying, and effective grieving. The hospice industry moved to 
include these measures in the data set that they encourage member 
hospices to use and report. The data elements, tools, and instructions 
for using the measures are publicly available on the NHPCO website 
http://www.nhpco.org.
    If a hospice chooses to participate in this voluntary process as 
described in the NHPCO web site, it would collect the specified data 
elements, analyze the data to assess its performance, and implement 
performance improvement projects to address weaknesses while 
reinforcing strengths. A hospice may also choose to submit its data to 
the NHPCO or its contractor. The national reporting process includes 
pertinent utilization data, appropriateness and effectiveness of 
services, and patient and family satisfaction. Reports are then 
generated by the NHPCO for hospices to compare their performance with 
other hospices.
    All hospices that choose to utilize the NHPCO reporting process 
will need to follow the HIPAA Privacy Rule. We believe that 
participating in the NHPCO reporting process in order to improve the 
quality of care delivered to patients would probably be deemed to be 
part of the hospice's health care operations under the HIPAA Privacy 
Rule. The NHPCO would be doing work on behalf of the hospice. 
Therefore, it appears that the hospice and the NHPCO would be required 
to have a business associate agreement, ensuring that the NHPCO would 
protect the health information submitted by the hospice. Sample 
business associate language is available at http://www.hhs.gov/ocr/hipaa/contractprov.html. Hospices should confer with their legal 
counsel to ensure that their disclosures are in compliance with the 
Department's rules. Once the business associate agreement was in place 
and the hospice began to submit its data, it would not need individual 
authorization to disclose protected health information to the NHPCO. In 
addition, the hospice would not need to account for the disclosures to 
the NHPCO.
    We are not proposing to require that hospices use any particular 
process or outcome measures. However, a hospice that uses the available 
quality measures may be able to expect an enhanced degree of insight 
into the quality of its services and patient satisfaction than if it 
began the outcome-measure development process anew. In addition to the 
NHPCO measures, there are many other resources available. One of these 
resources, for example, is the ``TIME: Toolkit of Instruments to 
Measure End of life care,'' developed by Brown University. It can be 
found at http://www.chcr.brown.edu/pcoc/toolkit.htm. This Toolkit takes 
steps toward crossing the measurement barrier by creating patient-
focused, family-centered survey instruments that address the needs and

[[Page 30849]]

concerns of patients and their families, as defined by them.
    The hospice could also develop its own data elements and 
measurement process as part of its quality assessment and performance 
improvement program. A hospice is free to develop a program that meets 
its needs. We recognize the diversity of provider needs and concerns 
with respect to QAPI programs. As such, a provider's QAPI program will 
not be judged against a specific model.
    Under the proposed standard, Program data, found at Sec.  
418.58(b), the hospice is expected to monitor the effectiveness of 
services and be able to target areas for improvement. The main goal of 
the quality assessment and performance improvement standard is to 
identify and correct ineffective and/or unsafe care. We expect hospices 
to assess their patient load and identify circumstances that could lead 
to significant patient care issues and concentrate quality assessment 
and performance improvement energies in these areas. For example, 
patients with minimal support care, those experiencing frequent 
exacerbations of symptoms, and those whose diagnosis and care may be 
unique to the hospice, may be the subject of more intense quality 
assessment and performance improvement activity. We expect a hospice to 
be able to demonstrate consistent performance progress in successful 
quality assessment and performance improvement interventions.
    The third standard under the quality assessment and performance 
improvement program at proposed Sec.  418.58(c), Program activities, 
states that the hospice must set priorities for its performance 
improvement activities that: focus on high risk, high volume and 
problem-prone areas; consider the prevalence and severity of identified 
problems; and give priority to improvement activities that affect 
palliative, patient safety, and quality of care outcomes. We expect 
that a hospice would take immediate action to correct any identified 
problems that directly or potentially threatened the care and safety of 
patients. Prioritizing areas of improvement is essential for the 
hospice to gain a strategic view of its operating environment and to 
ensure the consistent quality of care provided over time.
    In Sec.  418.58(c) we are also proposing to require the hospice to 
track adverse patient events, analyze their causes, and implement 
preventive actions that include feedback and learning throughout the 
hospice. The hospice's quality assessment and performance improvement 
program is expected to view staff as full partners in quality 
improvement. Because staff members are in a unique position to provide 
the hospice with structured feedback on its performance and suggestions 
on how performance can be improved, we expect the hospice to 
demonstrate how staff contribute to its quality improvement program.
    We are proposing at Sec.  418.58(d), Performance improvement 
projects, to require that the number and scope of improvement projects 
conducted annually must reflect the scope, complexity, and past 
performance of the hospice's services and operations. The hospice must 
document what improvement projects are being conducted, the reasons for 
conducting them, and the measurable progress achieved on these 
projects. We believe that giving hospices the flexibility to review 
their own organization and quality performance and improvement program 
may improve the effectiveness and efficiency of their services, improve 
the outcomes of care they provide, and potentially improve beneficiary 
satisfaction with their services.
    We are proposing at Sec.  418.58(e), Executive responsibilities, to 
require the hospice's governing body to be responsible and accountable 
for ensuring that the ongoing quality improvement program is defined, 
implemented, and maintained. The governing body must ensure that the 
program addresses priorities for improved quality of care and patient 
safety. The governing body must also specify the frequency and detail 
of the data collection and ensure that all quality improvement actions 
are evaluated for effectiveness. The governing body's most important 
role is to ensure that staff are furnishing and patients are receiving 
the most appropriate level of care. Therefore, it is incumbent on the 
governing body to lend its full support to agency quality improvement 
and performance improvement efforts.
    We are specifically soliciting public comments on this proposed 
condition of participation.
Condition of Participation: Infection Control (Proposed Sec.  418.60)
[If you choose to comments on issues in this section, please include 
the caption ``INFECTION CONTROL'' at the beginning of your comments.]
    There is no current requirement for infection control other than 
the requirement at Sec.  418.100(a) that ``* * * each patient is to be 
kept comfortable, clean, well groomed, and protected from accident, 
injury, and infection.'' We are now proposing a new CoP due to the 
seriousness and hazards of infectious and communicable diseases. There 
is a substantial amount of research from government agencies and 
private organizations regarding the effect of infections and 
communicable diseases in the inpatient environment. This research 
documents their widespread prevalence. While there is less research 
that examines infections and communicable diseases in the home, the 
effect of both on the health and safety of patients and the cost of 
patient care cannot be dismissed. In response, the health care industry 
has developed guidelines and recommendations for managing preventative 
programs. For example, the Association for Professionals in Infection 
Control and Epidemiology, Inc. have published ``Requirements for 
infrastructure and essential activities of infection control and 
epidemiology in out-of-hospital settings: A Consensus Panel report'' 
(http://www.apic.org/pdf/cpinfra2.pdf). The Joint Commission on 
Accreditation of Healthcare Organizations (JCAHO) responded to the 
issue by designing new infection control standards for, among others, 
home care providers. These standards will become effective in 2005. Due 
to the negative effects on patient health and safety that are posed by 
infections and communicable diseases, and due to the significant amount 
of public, industry, and government attention that this issue has 
generated, we believe that hospices need to address infection control 
in a more complete manner.
    In this proposed CoP, we are requiring hospices to take specific 
actions to address the prevention and control of infections and 
disease, and to educate patients, staff, and caregivers on their 
hazards, prevention, and control. It is essential that agencies 
consider the devastating effects of rampant communicable disease as 
they carry out their quality assessment and performance improvement 
programs. As a result, we expect the hospice to maintain an effective 
and up-to-date infection control program that may be part of its 
overall quality assessment and performance improvement program.
    We recognize that a hospice cannot be directly responsible for the 
maintenance of an infection-free environment in an individual's home or 
inpatient setting. We are proposing in Sec.  418.60(a), Prevention, 
that hospices follow accepted infection control standards of practice 
and ensure that all staff that provide hospice services know and use 
these current best prevention practices to curb the spread of 
infection. Periodic

[[Page 30850]]

training is one way to assure staff understanding.
    In Sec.  418.60(b),Control, we are proposing that the hospice 
engage in an ongoing system-wide program that focuses on the 
surveillance, identification, prevention, control, and investigation of 
infections and communicable disease. We expect the hospice to use best 
control practices in this endeavor. We are also expecting that each 
hospice educate its staff, as well as patients, families, and other 
caregivers in the ``current best practices'' for controlling the spread 
of infections within the home during the course of the family/care 
givers' interactions. Where infection and/or communicable disease is 
identified, we expect that this information is made part of the 
hospice's quality assessment and performance improvement program.
    In Sec.  418.60(c), Education, we are proposing a standard allowing 
the hospice flexibility in meeting its infection control, prevention 
and education objectives. For example, the amount of training in 
infection control necessary for the hospice's personnel would depend on 
the patient mix and experience of the staff. While we would expect that 
established best practices be adhered to, we are not proposing any 
specific approaches to meeting this requirement. However, all staff and 
family will be educated on the use of standard precautions for the 
safety of the patient, family and caregivers. We will expect to see 
clear evidence that the hospice aggressively seeks to minimize the 
spread of disease and infection through the use of effective techniques 
by its staff and through its efforts to help families and care givers 
understand what can and should be done to minimize infection.
    We are specifically soliciting public comments on this proposed 
condition of participation.
Condition of Participation: Licensed Professional Services (Proposed 
Sec.  418.62)
    Sections of current regulations at Sec.  418.82, Nursing services; 
Sec.  418.84, Medical social services; and Sec.  418.92, Physical 
therapy, occupational therapy and speech-language pathology, identify 
detailed tasks that must be performed by agency staff.
    We are proposing to delete Sec.  418.82, Sec.  418.84, and Sec.  
418.92, and replace them with a more simplified condition, licensed 
professional services. Instead of identifying detailed tasks, we are 
broadly describing the expected contributions of the licensed 
professionals who are furnishing hospice services.
    We are proposing that licensed professionals who provide services 
to hospice patients either directly or under arrangement must 
participate in coordinating all aspects of care, including updating the 
interdisciplinary comprehensive assessments, developing and evaluating 
plans of care, participating in patient and family counseling, 
participating in the quality assessment and performance improvement 
plan, and participating in in-service training. The expected outcome is 
the coordinated, comprehensive, interdisciplinary delivery of 
appropriate and effective licensed professional services delivered and 
supervised by health care professionals who practice under State 
licensure requirements and the hospice's policies and procedures. 
Licensed professional services, for purposes of this section, include 
skilled nursing care, physical therapy, speech-language pathology, 
occupational therapy, and medical social services. The services of 
these licensed professionals are described in more detail under the 
core services condition proposed at Sec.  418.64 and the non-core 
services condition at Sec.  418.70.
    Medicare makes a distinction between providing services directly, 
as opposed to providing services under arrangement. The most common way 
services are provided directly is through the use of employees. The 
common law definition of ``employee'' fundamentally relates to whether 
a person is under control by the entity or individual providing the 
services. The ``physician referral provisions'' at section 1877(h)(2) 
of the Act references the Internal Revenue Service (IRS) ``employee'' 
definition. Section 1877(h)(2) provides that an individual is 
considered to be ``employed by'' or an ``employee'' of an entity if the 
individual would be considered to be an employee of the entity under 
the usual common law rules applicable in determining the employer-
employee relationship (as applied for purposes of section 3121(d)(2) of 
the Internal Revenue Code of 1986).
Condition of Participation: Core Services (Proposed Sec.  418.64)
    The conditions of participation containing the current core 
services requirements are in Sec.  418.80, Furnishing of core services; 
Sec.  418.82, Nursing services; Sec.  418.84, Medical social services; 
Sec.  418.86, Physician services; and Sec.  418.88, Counseling 
services. We are proposing to combine these into a single condition. We 
are also proposing to incorporate the requirement at existing Sec.  
418.50(b)(3) that core services be provided in a manner consistent with 
accepted standards of practice.
    This section has been revised to reflect changes to the Act made by 
section 946 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (``MMA''). In accordance with that provision, 
we are proposing to allow a hospice (the primary hospice) to enter into 
arrangements with another Medicare certified hospice to obtain core 
hospice services. This could be done under extraordinary or other non-
routine circumstances. Pursuant to Section 1861(dd)(5)(D) of the Act, 
as added by section 946(a) of the MMA, those circumstances are: 
Unanticipated periods of high patient loads; staffing shortages due to 
illness or other short-term temporary situations that interrupt patient 
care such as natural disasters; and temporary travel of a patient 
outside the hospice's service area. We believe that the new MMA 
provision authorizes us to propose that hospices may not routinely 
contract for a specific level of care (e.g., continuous care) or for 
specific hours of care (e.g., evenings and week-ends), as these are 
regularly occurring situations that hospices are able to plan staffing 
for.
    We propose to require that contractual arrangements under the 
provision be set forth in a legally binding written agreement between 
the hospices. The written agreement would ensure that contracted staff 
meet all hospice personnel qualifications and receive necessary 
training. The primary hospice would be responsible for enforcing the 
contractual provisions. This would ensure that the primary hospice 
maintains professional management responsibility for the service(s) 
being provided and the individual(s) providing such service(s), as 
described in sections 418.62, Skilled professional services and 
418.100, Organization and administration of services. These sections 
require contracted services to be provided according to professional 
standards and practices. Finally, contracted individuals would be 
required to actively participate in the coordination of care, including 
patient assessment and care planning, and in the primary hospice's in-
service training and quality assessment and performance improvement 
programs.
    The physician services requirement would be changed to allow the 
use of contracted physicians, including the medical director (see 
proposed 418.102).
    In proposed Sec.  418.64(b), Nursing services, we would add 
specific language to address the role of nurse practitioners in 
providing hospice care. The services provided by nurse practitioners 
continue to be guided by

[[Page 30851]]

Medicare statutory requirements. Within these statutory requirements, 
we propose to allow nurse practitioners to perform many other hospice 
functions that are in the scope of their practice and license, as well 
as within the laws of the State in which they practice.
    In this standard we have also proposed to allow hospices to provide 
certain types of nursing services under a legally binding written 
contract. This change also results from section 946 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, which 
added new 1861(dd)(5)(E) to the Act. These nursing services must be 
highly specialized and provided non routinely and so infrequently that 
their provision by hospice employees would be impracticable and 
prohibitively expensive. We recognize that it may be cost-prohibitive 
for a hospice to employ a nurse that possesses very highly specialized 
skills when he or she may only care for a few patients a year. By 
allowing hospices to contract with specialized nursing providers or 
others to provide these highly specialized nursing services to the few 
patients who require them, hospices will be able to better implement an 
efficient staffing plan and ensure proficiency in the skilled service 
being provided. Highly specialized services, as described, would not 
include continuous care because, while time intensive, such care does 
not require highly specialized nursing skills.
    As with all other contracting arrangements, the hospice would be 
required to maintain professional management responsibility for the 
service(s) being provided under arrangement as well as the 
individual(s) providing them. The responsibilities of both the primary 
hospice and the ``lending'' nursing provider would need to be outlined 
in the written agreement, and there would have to be a mechanism in 
place to ensure that the terms of the agreement were met. To that end, 
the contracted individual(s) would have to provide care in accordance 
with professional standards of practice; actively participate in the 
coordination of care, including the comprehensive patient assessment 
and the formulation of the plan of care; and actively participate in 
the hospice's inservice training and quality assessment and performance 
improvement programs.
    In proposed Sec.  418.64(c), we are proposing to maintain the 
current medical social services requirement found at Sec.  418.84. This 
standard would continue to require that medical social services be 
provided by a qualified social worker under the direction of a 
physician. This standard would also require that medical social 
services, when accepted by a patient and family, be based on an 
assessment of that patient's psychosocial needs.
    In proposed Sec.  418.64(d), we address the counseling services 
that would be available to hospice patients. Those services would be 
bereavement, nutritional, and spiritual counseling. In the bereavement 
counseling section, we propose that a hospice would be required to have 
an organized program of bereavement services furnished under the 
supervision of a qualified professional with experience in grief/loss 
counseling. These services would be required to be made available to 
individuals identified in the bereavement plan of care up to one year 
following the death of the patient and would reflect the needs of those 
individuals. When appropriate, residents and staff of a SNF/NF, ICF/MR, 
or other facility would be offered bereavement services.
    In the nutritional counseling section, we propose to alter the 
standard to allow qualified individuals such as dietitians and nurses 
to furnish this service, provided that it is within their scope of 
practice and expertise according to State law. We believe that allowing 
other qualified individuals to participate in nutritional counseling 
will give hospices greater flexibility and will help ensure that all 
hospice patients have access to this service when needed. This proposal 
for increased flexibility is a result of recommendations made by the 
Secretary's Advisory Committee on Regulatory Reform.
    In the spiritual counseling section we propose that a hospice would 
be required to assess the patient's and family's spiritual needs and 
provide spiritual counseling to meet those needs in accordance with the 
patient's and family's beliefs and desires. If a patient and family do 
not desire spiritual counseling, then they would not have to be 
provided this service. If a patient and family do desire spiritual 
counseling, then a hospice would be expected to facilitate visits by 
local clergy, pastoral counselors, or others to the best of its 
ability. We have examined the relevant jurisprudence regarding the 
provision of spiritual counseling by Medicare certified hospices (Kong 
v. Scully et al. 341 F.3d 1132 (9th Cir. 2003) reh. den. as amended, 
357 F.3d 895 (9th Cir. 2004). We do not see any impediment to requiring 
hospices to offer spiritual services if a patient and family so desire.
Condition of Participation: Nursing Services Waiver of Requirement That 
Substantially All Nursing Services Be Routinely Provided Directly by a 
Hospice (Proposed Sec.  418.66)
[If you choose to comment on issues in this section, please include the 
caption ``STATUTORY NURSING WAIVER'' at the beginning of your 
comments.]
    The requirements for obtaining a nursing services waiver as 
provided by section 1861(dd)(5) of the Act is currently set forth in 
Sec.  418.83, and remains virtually unchanged in this proposal. This 
condition provides hospices the opportunity to obtain a waiver from the 
requirement that substantially all nursing services be routinely 
provided directly by the hospice. The Act specifies that to obtain a 
waiver a hospice must be located in an area that is not an urbanized 
area, must have been in operation on or before January 1, 1983, and 
must demonstrate a good faith effort to hire a sufficient number of 
nurse employees. Section 1861(dd)(5)(B) of the Act specifies that if a 
waiver is requested by an organization that meets the statutory 
requirements, and if it is submitted in the form and contains the 
information required by the Secretary, the waiver will be deemed 
granted unless the request is denied in 60 days after the request is 
received by the Secretary.
    This waiver, set in statute, may be obsolete. We do not know how 
many hospices meet the criteria for the waiver, nor do we know if any 
hospices actually use the waiver. We request comments on the use of 
this waiver.
Condition of Participation: Furnishing of Non-Core Services (Proposed 
Sec.  418.70)
    The current CoP governing the provision of other services is 
contained in Sec.  418.90. The hospice must ensure that the services 
described in Sec.  418.72 through Sec.  418.78 are provided directly by 
employees of the hospice or by others under an arrangement with the 
hospice. This is discussed further in proposed Sec.  418.100. As with 
core services, non-core services should be provided in a manner 
consistent with current standards of practice.
Condition of Participation: Physical Therapy, Occupational Therapy, and 
Speech-Language Pathology (Proposed Sec.  418.72)
    Currently, the CoP concerning physical therapy, occupational 
therapy, and speech language pathology is laid out at Sec.  418.92. We 
are proposing to recodify this CoP at Sec.  418.72 without changes.

[[Page 30852]]

Condition of Participation: Waiver of Requirement--Physical Therapy, 
Occupational Therapy, Speech-Language Pathology, and Dietary Counseling 
(Proposed Sec.  418.74)
    We are proposing a new CoP that provides for a waiver of the 
requirement that physical therapy (PT), occupational therapy (OT), 
speech-language pathology (SLP) and dietary counseling services be 
provided as needed on a 24-hour basis. In addition, the waiver allows 
the hospice to provide the above services directly or under 
arrangements made by the hospice, as specified in current Sec.  418.56.
    We may approve a hospice's request for a waiver of the requirement 
that it furnish PT, OT, SLP and/or dietary counseling services if it is 
located in a nonurbanized area and can demonstrate that it has been 
unable, despite diligent efforts, to recruit appropriate personnel. 
Hospices will be required to submit evidence of their efforts to hire. 
We will apply similar requirements as are used for the nursing services 
waiver requests found in proposed Sec.  418.66. As in the case for a 
waiver of nursing services, eligibility for a waiver is based on the 
primary location of a hospice. For a hospice that operates in several 
areas, its primary location is considered to be the location of its 
central office. The hospice must provide evidence that it made a good 
faith effort to hire a sufficient number of PTs, SLPs, OTs, and dietary 
counselors to provide services directly through hospice employees or 
under arrangement.
Condition of Participation: Home Health Aide and Homemaker Services 
(Proposed Sec.  418.76)
    Section 1861(dd)(1)(D) of the Act requires Medicare covered home 
health aide services to be furnished by an individual who has 
successfully completed training or a competency evaluation program that 
meets the requirements established by the Secretary. This section also 
provides for coverage of ``homemaker'' services.
    Currently, the condition of participation concerning home health 
aide and homemaker services is set forth at Sec.  418.94. We are 
proposing in Sec.  418.76 that a home health aide completes a State-
established or other training program, and in Sec.  418.76(b) we 
outline requirements that this training must meet. Except for minor 
reorganization, these training requirements are consistent with 
existing home health aide requirements in Sec.  484.36.
    For example, we would continue to permit a home health aide to meet 
the proposed Sec.  418.76(a), Home health aide qualifications, 
requirement in one of three ways: by completing a training and 
competency evaluation program that meets the proposed training 
requirements, by completing a competency evaluation program, or by 
completing a State licensure program that meets the proposed training 
requirements. We propose to include three separate ways to meet the 
proposed requirement because we understand that home health aides come 
to hospices with various levels of experience and qualifications. We 
would expect that, if a State licenses home health aides, then an aide 
would meet those licensure requirements and would, in fact, be licensed 
by that State. If a State does not have licensure requirements, then we 
would expect that a home health aide who had not previously 
participated in a training program that meets the proposed requirements 
would be trained in a program that meets the proposed requirements. In 
addition, we would expect that, following such training, that aide 
would be evaluated in a systematic way to assess his or her skills and 
competencies before performing patient care. If, however, a home health 
aide has already completed a training program that meets the proposed 
requirements while employed at another provider, then we would only 
expect the aide to complete a competency evaluation program at his or 
her new employer. We believe that this would make it easier for aides 
to change employers and faster for hospices to get qualified new 
employees out in the field. One of the skills a home health aide would 
be required to master is the ability to observe, report, and document 
patient status and the care or service furnished. We believe that clear 
and effective communication between the many providers of hospice care 
is an important part of ensuring high quality patient care. We believe 
that a home health aide should be able to both verbally report and 
document in writing what he or she observes and does at a patient's 
home.
    Three standards have been particularly adapted for the hospice 
conditions of participation. First, Sec.  418.76(j), homemaker 
qualifications, has been adapted from the existing Sec.  418.94. The 
proposed standard clarifies that a qualified homemaker is a home health 
aide as described in Sec.  418.76 or an individual who has met the 
standards in Sec.  418.202(g) and has successfully completed hospice 
orientation addressing the needs and concerns of patients and families 
coping with a terminal illness. Homemaker services may include 
assistance in maintenance of a safe and healthy environment to enable 
the patient to benefit from care that is furnished.
    Second, Sec.  418.76(h), Supervision of home health aides, would be 
revised from the current Sec.  484.36(d) to require that a registered 
nurse or appropriate qualified therapist conduct an on-site supervisory 
visit every 28 days while the home health aide is providing care. 
Thorough supervision of home health aides is crucial to ensuring that 
the patient's and family's needs are being met, and conducting 
supervisory visits when the aide is present and performing his or her 
duties is the only way to provide such thorough supervision. On-site 
supervisory visits will still be required every 14 days as in the 
current rule at Sec.  484.36(d)(2), but the aide would not be required 
to be present for these visits. This supervision schedule would allow 
hospices to maintain control over the quality and continuity of care 
being provided, and would help ensure that all patients receiving home 
health aide services are having their needs met by such services.
    Finally, Sec.  418.76(k) would require a member of the 
interdisciplinary group to coordinate homemaker services, and supply 
instructions for the homemaker on duties to be performed. The homemaker 
would be required to report all concerns about the patient or family to 
the member of the IDG who was coordinating the homemaker services. We 
have proposed these changes to ensure proper training and supervision, 
and to protect the quality of the homemaker services provided.
Condition of Participation: Volunteers (Proposed Sec.  418.78)
    The current CoP for volunteers is located at Sec.  418.70. We are 
proposing to recodify this CoP at Sec.  418.78 with minor changes. We 
are removing the existing Sec.  418.70(f), regarding the availability 
of clergy, because the role of the pastoral, clergy, or other spiritual 
counselor is described in proposed Sec.  418.56(a)(1)(iv), 
Interdisciplinary group, care planning and coordination of services. 
This change does not preclude the hospice from continuing to use or 
starting to use clergy as volunteers.

Subpart D, Conditions of Participation, Organizational Environment

Condition of Participation: Organization and Administration of Services 
(Proposed Sec.  418.100)
[If you choose to comment on issues in this section, please include the 
caption ``ORGANIZATION AND

[[Page 30853]]

ADMINISTRATION'' at the beginning of your comments.]
    We are proposing to revise existing regulations at Sec.  418.50, 
General provisions, Sec.  418.52, Governing body, and Sec.  418.56, 
Professional management, by creating a new condition. This new 
condition would simplify the structure of these current requirements 
and clarify new performance expectations for the governing body. We 
believe the structure of the current requirements does not establish 
clear performance expectations for the operation of all services. The 
overall goal of the revised requirement would be to ensure a management 
structure that is organized and accountable. We believe that a well-
managed hospice will be more likely to allocate resources so that 
patients maintain their highest functional capacity.
    In the proposed organization and administration of services 
condition (that is, Sec.  418.100), we have taken the current CoPs and 
proposed changing them to standards:
     Governing body and administrator (existing Sec.  418.52).
     Continuation of care (existing Sec.  418.60).
     Professional management responsibility (existing Sec.  
418.56).
     In-service training (existing Sec.  418.64).
    We would also include a standard clearly listing the services that 
the statute requires hospices to furnish. We are also proposing to add 
a new standard for in-service training that would require a hospice to 
provide in-service training to all individuals, including volunteers, 
to address identified skill and competency gaps. The hospice would be 
required to have written policies and procedures describing its methods 
for assessing skills and competency. It would also be required to 
maintain a written description of in-service trainings offered during 
the previous 12 months.
    Currently, Sec.  418.50(b)(3), Required services; Sec.  418.52, 
Governing body; Sec.  418.82(c), Acceptable standards of practice; 
Sec.  418.92(a), PT, OT and SLP; and Sec.  418.96(a), Administration of 
drugs and biologics, all exist as separate standards. To emphasize the 
importance of continuity of care and the focus on quality, regardless 
of the site of service, we are proposing to move these existing 
provisions and incorporate their performance expectation into the 
quality assessment and performance improvement program that is proposed 
at Sec.  418.58.
    We have long used the term ``in accordance with accepted standards 
of practice,'' in various provider and supplier requirements, (such as 
in the existing Sec.  418.82(c)) to set a performance expectation and 
to be able to employ regulatory authority to shed light on 
inappropriate and/or dangerous practices. We are proposing to retain 
this authority and move the existing Sec.  418.82(c) into Sec.  418.64, 
Core services and Sec.  418.70, Furnishing of non-core services.
    In the proposed governing body and administrator standard at Sec.  
418.100(b) we emphasize the responsibility of the hospice governing 
body (or designated persons so functioning) for the management and 
provision of all hospice services including fiscal operations, quality 
assessment, performance improvement, and the appointment of the 
administrator. The actual approach to the administration of the hospice 
is left to the discretion of the governing body, thereby affording the 
hospice management flexibility. The proposed governing body standard 
reflects our goal of promoting the effective management and 
administration of the hospice as an organizational entity without 
dictating prescriptive requirements for how a hospice must meet that 
goal.
    Section 418.100(c), Services, includes nursing, medical social 
services, physician services, counseling services, home health aide and 
homemaker services, therapy services, short-term inpatient care and 
medical supplies. The nursing services, physician services, and drugs/
biologicals as specified in Sec.  418.100(c)(2) must be routinely 
available on a 24-hour basis. All other covered services must be 
available on a 24-hour basis when reasonable and necessary to meet the 
needs of the patient and family.
    In Sec.  418.100(d), Continuation of care, the current standard is 
at Sec.  418.60. We are proposing to recodify this section at Sec.  
418.100(d) without change.
    In Sec.  418.100(e), Professional management responsibility, we are 
proposing to revise some of the current requirements found at Sec.  
418.56(b) and (c). This standard would require written agreements for 
services furnished under arrangement, and would require that the 
hospice retain professional management and supervisory and financial 
responsibility for all services that are provided to the patient and 
family. The hospice would be required to ensure that all services 
provided are authorized by the hospice, are furnished in a safe and 
effective manner by qualified personnel, and that items and/or services 
specified in the plan of care are provided.
    In Sec.  418.100(f)(1), we are proposing a new standard to address 
the issue of multiple service locations. Our goal is to establish clear 
requirements in order to ensure patient comfort, patient safety, and 
the provision of a consistent level of care throughout the hospice 
organization. This provision is intended to codify long-standing 
Medicare survey and certification policy, which allows for the 
operation of multiple locations by a single hospice provider with a 
single Medicare agreement.
    We are adding the definition of a hospice satellite location. The 
way in which hospices are organized has changed since the original 
regulations were promulgated. Today, unlike small community based 
hospices that were operating when the Medicare hospice benefit first 
began, it is common to find large hospice organizations serving a 
patient population widely dispersed throughout a sizeable geographic 
area. Some existing hospices operate from multiple locations. We 
believe it is appropriate to develop a basis in regulation to better 
clarify this organizational structure and we have been asked by 
hospices to more fully consider the nature of the relationship between 
a hospice and a satellite location.
    We expect that any hospice that requests to establish a satellite 
location will be able to demonstrate how it is able to manage and 
monitor all of the services provided in its entire service area, 
including services from a satellite location. Patients who receive care 
and services from a hospice satellite location must receive the full 
range of services that are documented in the plan of care. We will 
consider the following factors in our review of a hospice's request to 
establish a satellite location:
     The hospice's ability to supervise the satellite location 
to ensure the timely provision of quality care for patients and 
families receiving care.
     The hospice's past compliance history.
     Relevant State issues and recommendations including a 
reciprocal agreement between the States to assure that at least one of 
the State agencies assumes responsibility for any necessary surveys of 
the satellite location in situations in which a hospice provides 
services in satellite locations across state lines.
     The hospice's assurance that each patient receives care 
from an assigned interdisciplinary group that works effectively 
together to identify and meet the physical, social, emotional, and 
spiritual needs of the hospice patients and families receiving care.
    Before operating a satellite location, a hospice must enroll with 
the fiscal intermediary and notify the State agency

[[Page 30854]]

and CMS of all currently approved satellite locations at the time it 
requests approval for any additional satellite locations. If a hospice 
provides care and services to Medicare beneficiaries at an unapproved 
or disapproved satellite location, such services may be determined to 
be non-covered. At the time of any satellite location closure the 
hospice is expected to notify the fiscal intermediary, State agency and 
CMS.
    Hospice satellite locations are also subject to survey by the State 
survey agency or CMS regional office. Deficiencies that are identified 
at any satellite location will apply to the entire hospice issued the 
provider agreement number. Satellite locations must comply with the 
hospice conditions of participation at Sec.  418.52 through Sec.  
418.116.
    Proposed Sec.  418.100(g), Inservice training, applies to 
volunteers and employees, including those employed under arrangement or 
contract. We are expecting a hospice to take steps to develop 
appropriate inservice programs or to arrange to acquire training from 
others.
    We are not dictating a specific inservice training program, but 
rather we expect each hospice to determine the scope of its own 
program, including the manner in which it chooses to assess competence 
levels, determine training content, and determine the duration and 
frequency of training.
    We are specifically soliciting public comment on this proposed 
condition of participation.
Condition of Participation: Medical Director (Proposed Sec.  418.102)
[If you choose to comment on issues in this section, please include the 
caption ``MEDICAL DIRECTOR'' at the beginning of your comments.]
    We would revise the existing medical director CoP at Sec.  418.54 
by incorporating current requirements and expanding it to illustrate 
the importance of having a medical director or physician designee 
coordinate the activities of physicians and other health care 
professionals to ensure that care is appropriate and reflects the 
hospice philosophy. To maintain patient care and coordination of 
services, the medical director or physician designee appointed by the 
medical director, must either be a hospice employee or under contract 
with the hospice. A contractual arrangement with another agency or 
organization is not permitted.
    Section 418.102(a), Initial certification of terminal illness, 
would incorporate the provisions of current Sec.  418.22, and require 
that the medical director or physician designee review the patient's 
clinical information and provide written certification that the 
individual has a medical prognosis that his/her life expectancy is 6 
months or less if the illness runs its normal course. The certification 
would have to be based on the medical director's or physician 
designee's clinical judgment regarding the normal course of the 
individual's illness.
    In the second standard, Sec.  418.102(b), Recertification of the 
terminal illness, we would require that the medical director or 
physician designee review the clinical information and the patient and 
family's expectations and wishes for hospice care on an ongoing basis 
and before each updated assessment. Assessments would be required to be 
updated at least every 14 calendar days according to Sec.  418.54(d). 
In addition, this standard would also require that the assessment be 
updated at the time of each recertification. The timeframes for 
recertification are described in Sec.  418.21.
    Within Sec.  418.102(c), Coordination of medical care, we are 
proposing that the medical director or physician designee and the 
hospice interdisciplinary group maintain responsibility for 
coordinating a patient's medical care in all settings, even when 
multiple physicians are participating in the care. This level of 
coordination ensures that the patient receives continuous medical care 
and services that are consistent with the hospice philosophy.
    We are also proposing to require that the medical director or 
physician designee be responsible for the hospice's quality assessment 
and performance improvement program. This program and implementation of 
its findings are critical to ensuring that patients receive effective 
and meaningful care.
    We are specifically soliciting public comment on this proposed 
condition.
Condition of Participation: Clinical Records (Proposed Sec.  418.104)
[If you choose to comment on issues in this section, please include the 
caption ``CLINICAL RECORDS'' at the beginning of your comments.]
    The proposed condition of participation, Clinical records, would 
incorporate several of the existing requirements in Sec.  418.74 of the 
current regulation, Central clinical records. We are proposing to add a 
new requirement that the clinical record contain accurate clinical 
information that is available to the physician and hospice staff.
    The proposed condition continues to require that all clinical 
records contain past and current findings and that they are maintained 
for each patient who is admitted by the hospice.
    We are also providing an opportunity for the hospice to choose to 
maintain clinical records electronically if it desires and recognize 
that some hospices are beginning to maintain electronic records. The 
use of electronic health records (EHRs) has the potential to improve 
patient care and improve efficiency. We anticipate that the use of 
electronic health records will become widespread, and will be required 
in future hospice conditions of participation.
    We also recognize that there may be significant barriers for 
hospices that are interested in maintaining electronic health records 
(EHRs) for their patients. We are interested in learning how the final 
hospice CoPs and/or other future regulations can reduce or eliminate 
those barriers.
    We are interested in public comments on the following areas:
    1. What are the components of an electronic health record (EHR)? 
What are the advantages and disadvantages of using an EHR in a hospice 
setting?
    2. Should an EHR include a personal health record which is 
accessible to the patient? What are the positive and negative 
consequences (e.g. caregivers less likely to record certain procedures 
or observations) of personal health records?
    3. What are the barriers (e.g. technical, clinical) to implementing 
an EHR system in a hospice?
    It is obvious that there are many different issues regarding the 
institutionalization of EHRs. We are aware that some hospices have 
already chosen to pursue this option to one degree or another. We are 
interested in knowing what their experience has been thus far. How have 
electronic health records impacted the way they allocate and deliver 
patient care, and how has this, in turn, impacted patient outcomes?
    At Sec.  418.104(a), Content, we would retain the requirement that 
the record include all assessments (including the initial assessment 
and all updated assessments), plan of care, consent and election forms, 
and clinical and progress notes. We are proposing the following 
requirements for the content of the clinical record--
     Advance directive information as described in proposed 
Sec.  418.52(a)(3);
     Informed consent, authorization and election forms;
     Responses to medications, symptom management, treatments 
and services;
     Patient process and outcome measures as they relate to the 
plan of care; and
     Physician certification of terminal illness as required in 
Sec.  418.22(c) and

[[Page 30855]]

described in proposed Sec.  418.102(a) and (b).
    We recognize that there has been some confusion between the meaning 
of clinical note and progress note. To eliminate this confusion, we 
have defined ``clinical note'' and ``progress note'' in the definitions 
section. The key differences between clinical and progress notes are 
that:
    1. Clinical notes summarize an actual patient encounter (as this 
term is used in the field) while progress notes do not necessarily have 
to; and
    2. Clinical notes comprehensively describe the care provided during 
that encounter while progress notes briefly summarize care furnished 
(which could cover a span of time) and the patient's response. We 
believe that these definitions, adopted from the current conditions of 
participation for home health agencies (42 CFR part 484) will provide 
needed clarity and will ensure that the records contain information 
necessary to provide high quality patient care.
    We are proposing to add a new standard at Sec.  418.104(b), 
Authentication, that requires authentication of clinical records. All 
entries must be legible, clear, complete, and appropriately 
authenticated and dated. Authentication would include verification of 
handwritten and/or electronic signatures by signature logs or a 
computer secure entry of a unique identifier for a primary author who 
has reviewed and approved the entry. This new standard addresses 
technological changes in information management such as the 
computerization of records as well as electronic signatures. A similar 
requirement is in the conditions of participation for hospitals.
    We are proposing to re-codify the existing requirement found in 
Sec.  418.74(b) as Sec.  418.104(c), Protection of information. This 
re-codified provision would require that all patient information, 
including the clinical record and its contents, be safeguarded against 
loss or unauthorized use. The text would also be revised to reflect 
that all hospices must also comply with the Privacy Rule published in 
the Federal Register on December 28, 2000 (65 FR 82461) as amended on 
August 14, 2002 (67 FR 53182) and contained in 45 CFR parts 160 and 
164.
    Under Sec.  418.104(d), Retention of records, we propose to ensure 
protection of the patients information by adding a new requirement that 
patient records be retained for 5 years after the death or discharge of 
the patient, unless State law stipulates a longer period of time. If 
the hospice discontinues operation, hospice policies would be required 
to provide for the retention and storage of clinical records. The 
hospice would be required to notify the State agency and its CMS 
regional office where the clinical records would be stored.
    Under proposed Sec.  418.104(e)(1), Discharge or transfer of care, 
we have proposed a new requirement that Medicare/ Medicaid-approved 
hospice facilities forward a copy of the patient's clinical record and 
hospice discharge summary to the facility to which the patient is being 
transferred. This would help to ensure that the information flow 
between the hospice and the transfer facility is smooth, so that the 
level of care will continue without being compromised.
    Under Sec.  418.104(e)(2), we would add a new requirement that the 
hospice provide a copy of the patient's clinical record and hospice 
discharge summary to the attending physician if the patient revoked the 
election of hospice care or was discharged from hospice because 
eligibility criteria were no longer met. This requirement was added to 
ensure that the patient's attending physician would be aware of the 
most current clinical information.
    The hospice discharge summary requirement proposed at Sec.  
418.104(e)(3) would be a new requirement and would detail what would be 
required to be contained in the discharge summary. The purpose of the 
discharge summary is to provide important clinical information to those 
medical and other health professionals who will be assuming the care of 
the patient upon discharge from the hospice. At a minimum, the 
discharge summary would contain information that accurately describes 
the patient's stay, current plan of care, recent treatment, symptom, 
and pain management information, most recent physician orders, and any 
other documentation that would assist in post-discharge continuity of 
care.
    Under Sec.  418.104(f), Retrieval of clinical records, we would 
require that clinical records, whether in hard copy or electronic form, 
be made readily available to, and retrievable by, an appropriate 
authority.
    We are specifically soliciting public comment on this proposed 
condition of participation.
Condition of Participation: Drugs, Controlled Drugs, Biologicals, 
Medical Supplies, and Durable Medical Equipment (Proposed Sec.  
418.106)
[If you choose to comment on issues in this section, please include the 
caption ``DRUGS, SUPPLIES, and DME'' at the beginning of your 
comments.]
    This condition of participation revises the current requirement, 
found at Sec.  418.96, and would clarify that durable medical 
equipment, supplies, appliances, and drugs and biologicals related to 
the palliation and management of the terminal illness and related 
conditions, as identified in the plan of care, must be provided by the 
hospice while the patient is under hospice care.
    In addition, restrictions regarding the use of controlled 
substances in the patient's home would be conveyed more clearly. We 
believe that the hospice, as well as the patient and family, need to 
share in the responsibility and accountability for maintaining 
controlled substances in the home. Primary responsibility rests with 
the hospice, and the hospice must assume responsibility to educate the 
family about the proper use and disposal of drugs and biologicals and 
the consequences of misuse.
    Section 418.106(a)(1), Administration of drugs and biologicals, 
would require that all drugs and biologicals be administered in 
accordance with accepted hospice and palliative care standards of 
practice and according to the patient's plan of care. In Sec.  
418.106(a)(2) we are proposing to add a new requirement that the 
interdisciplinary group be responsible for periodically reviewing the 
plan of care to determine whether the patient and/or family continues 
to have the ability to safely administer drugs and biologicals.
    Under proposed Sec.  418.106(b), Controlled drugs in the patient's 
home, the hospice would ensure the safe delivery and accountability of 
controlled drugs in the patient's home. The hospice would have to have 
a policy for the tracking, collecting, and disposing of controlled 
drugs maintained in the patient's home. During the initial assessment, 
the hospice policy regarding the use and disposal of controlled drugs 
would be required to be discussed with the patient and family, and the 
hospice nurse would be required to document that the policy had been 
discussed with the patient and family. Because controlled drugs can 
pose significant danger to patients if improperly ingested or abused, 
educating patients and families may prevent unwanted complications.
    In Sec.  418.106(c), Use and maintenance of equipment and supplies, 
a hospice would be responsible for overseeing the use of durable 
medical equipment and supplies in the patient's home. Through the 
Medicare survey process and beneficiary complaints, we have found

[[Page 30856]]

that equipment that is not properly maintained does not perform 
properly and may harm the patient. Under this proposal, the hospice 
would be responsible for making certain that equipment being furnished 
under the plan of care is operating safely. The hospice may carry out 
this responsibility through a contractual arrangement with others, but 
would continue to maintain primary responsibility.
    Stressing the importance of providing families with information and 
levels of comfort relative to the care being furnished to family 
members, we are proposing a new medical equipment and supplies 
requirement. The hospice would be required to take action to ensure 
that the family received instruction in the safe use of equipment and 
supplies. In order for the family to participate in providing quality 
care to the patient, the family members would need to understand how 
and when to use equipment and supplies.
    We are specifically soliciting public comment on this proposed 
condition of participation.
Condition of Participation: Short-Term Inpatient Care (Proposed Sec.  
418.108)
[If you choose to comment on issues in this section, please include the 
caption ``SHORT TERM INPATIENT CARE'' at the beginning of your 
comments.]
    Under proposed Sec.  418.108, we would retain the requirement that 
hospices make inpatient care available for pain control, symptom 
management, and respite purposes, and that care be provided either in 
the hospice or in a participating Medicare or Medicaid facility.
    We would recodify the current requirement found at Sec.  418.98(a), 
Short-term inpatient care, as Sec.  418.108(a), Inpatient care for 
symptom management and pain control.
    The references to the condition at Sec.  418.108(b), Inpatient care 
for respite purposes, would no longer focus on process as in the 
existing Sec.  418.98. Rather, the updated standards reflect expected 
outcomes of care.
    We would eliminate the existing requirement found at Sec.  
418.100(a)(2), requiring a registered nurse to provide direct patient 
care on each shift. We believe that the patient's plan of care and the 
patient's condition should determine the amount and skill level of 
nursing care required, as well as the skill level and State licensing 
requirements of the staff to provide requisite care. If the patient 
does not need care by a registered nurse, imposing a requirement on a 
hospice that mandates a registered nurse to be in attendance on a 
particular shift to serve the patient will have no effect on the 
patient's care.
    Under proposed Sec.  418.108(c), Inpatient care provided under 
arrangement, we would incorporate many of the existing requirements in 
existing Sec.  418.56(e). In particular, we would require that a 
hospice train the personnel who would be providing patient care in an 
inpatient facility. The hospice model of patient care is very different 
from the curative model of patient care that medical personnel are 
trained in. Therefore, in order to ensure that patients in inpatient 
facilities continue to receive care that is consistent with the hospice 
philosophy (i.e., proactive pain management, interdisciplinary care), 
it is important that inpatient facility personnel be trained to 
understand the hospice philosophy and model of care.
    Under proposed Sec.  418.108(d), Inpatient care limitation, and 
Sec.  418.108(e), Exemption from limitation, we are proposing to re-
codify the existing requirements at Sec.  418.98(c) and (d), 
respectively, without changes.
Condition of Participation: Hospices That Provide Inpatient Care 
Directly (Proposed Sec.  418.110)
[If you choose to comment on issues in this section, please include the 
caption ``INPATIENT CARE'' at the beginning of your comments.]
    Under proposed Sec.  418.110, we are proposing to revise the 
existing requirements, currently located at Sec.  418.100, as follows:
    Under Sec.  418.110(a), Staffing, we would include the expectation 
that staffing for all services provided by the hospice reflect the 
volume of patients, patient acuity, and the level of intensity of the 
services as reflected in the plan of care to ensure that expected 
outcomes of care are achieved and negative outcomes are avoided. We 
also would eliminate our requirement that a registered nurse provide 
direct patient care each shift when the condition of the patient does 
not require the care of a registered nurse on each shift. This change 
would reduce the staffing burden for hospices and is a result of 
recommendations made by the Secretary's Advisory Committee on 
Regulatory Reform.We are proposing to remove the requirement in the 
existing Sec.  418.100(a)(2) that each shift include a registered nurse 
that provides direct patient care for those patients who are receiving 
short-term inpatient care for symptom management. We are proposing in 
Sec.  418.110(b), 24-hour nursing services, that the hospice facility 
provide 24-hour nursing services that meet the nursing needs of all 
patients and are furnished in accordance with each patient's plan of 
care, as well as the skill level of the staff that provides care, in 
accordance with State licensing requirements. We would require that 
each patient be kept comfortable, clean, well-groomed and protected 
from accident, injury, and infection.
    When assessing a facility's compliance with this proposed 
regulation, we would expect to see that the staffing level met the 
needs of the patients. For example, if a patient experiences unexpected 
break-through pain and needs additional pain management, we would 
expect that a staff member with the appropriate skills be available to 
care for that patient. If a staff member with the appropriate skills, 
and knowledge is not available to care for that patient and assure that 
his or her pain is effectively managed, then the hospice would be 
considered to be out of compliance with this proposed regulation.
    In Sec.  418.110(c), Physical environment, we are proposing that 
the hospice maintain a safe physical environment that is free of 
hazards for patients, staff, and visitors. In Sec.  418.110(c)(1), 
Safety management, in paragraphs (c)(1)(i) and (c)(1)(ii), we are 
proposing that the hospice prevent situations that pose a threat to the 
health and safety of the patients, others, or property whenever 
possible. The hospice would be required to promptly report and 
investigate all incidents that involve injury to patients, staff or 
visitors, or that involve damage to property. The hospice would be 
required to report such incidents to the appropriate State and local 
bodies having regulatory jurisdiction. The hospice would also be 
required to take action to correct the problems promptly. The hospice 
would be required to take steps to prevent equipment failures and 
correct and report any equipment failures promptly. In Sec.  
418.110(c)(1)(iii) we have retained the existing requirement at Sec.  
418.100(b) that the hospice periodically rehearse with staff a disaster 
preparedness plan for managing the consequences of natural disasters 
and other emergencies that affect the hospice's ability to provide 
care. We believe that special emphasis should be placed on carrying out 
the procedures necessary to protect the patients and others.
    In Sec.  418.110(c)(2), Physical plant and equipment, paragraphs 
(c)(2)(i) through (c)(2)(iv), we are proposing that there be procedures 
for the management of light, temperature, and ventilation controls 
throughout the hospice (including air exchange) for patient care. The 
hospice

[[Page 30857]]

would be required to make battery lamps and flashlights available in 
all areas not served by an emergency electrical supply source. The 
hospice would be required to make available an emergency gas and water 
supply. All equipment would be required to be properly maintained.
    In Sec.  418.110(d), Fire protection, we are proposing to recodify, 
without change, the existing provisions in Sec.  418.100(d). These 
provisions were amended on January 10, 2003 (68 FR 1374) to adopt the 
year 2000 version of the Life Safety Code. They were also amended on 
August 11, 2004 to clarify the effective date of the roller latch 
prohibition (69 FR 49266). In addition, they were amended on March 25, 
2005 (70 FR 15229) to address the use and placement of alcohol-based 
hand rubs.
    Proposed Sec.  418.110(e), Patient areas, would be recodified from 
Sec.  418.100(e) without change.
    Proposed Sec.  418.110(f), Patient rooms, would be revised. We are 
proposing in Sec.  418.110(f)(3)(iv) that each room accommodate no more 
than two patients. We are proposing the two patients per room 
requirement in recognition of the fact that hospice patients in the 
inpatient setting are critically ill and may be actively dying. These 
patients and their families need the additional privacy that a two 
patient room affords them in order to help preserve the patient's 
comfort and dignity during the dying process. We believe this is the 
standard accommodation in most facilities.
    Due to the potentially high cost of retrofitting older buildings, 
the proposed rule would allow existing hospice facilities with more 
than two patients in each room to receive a waiver of this requirement. 
This waiver would be based on whether or not the hospice was already 
providing direct inpatient care when this regulation would become 
effective. That is, if a hospice is providing direct inpatient care in 
a building on the day before the effective date of a final rule, and 
they had more than two patients in each room, then the hospice would 
qualify for a waiver of the proposed requirement. If a hospice chose to 
begin operating its own inpatient unit after the effective date of a 
final rule, then it would not qualify for the proposed waiver, and 
would thus be required to have no more than two patients per room.
    The remaining paragraphs in this standard would be virtually the 
same as in the current requirement (Sec.  418.100(f), with only minor 
language changes that would not change the substantive requirements of 
the regulation.
    Proposed Sec.  418.110(g), Toilet/bathing facilities, is linked 
with patient rooms in the current requirement found at Sec.  
418.100(f). We are proposing to revise this requirement as a stand-
alone standard. As such, it would highlight our concern for the 
adequacy of toilet and bathing facilities, and would provide more 
flexibility for State agency surveyors in evaluating the 
appropriateness of these facilities. We believe it is important for the 
privacy and comfort of the patient and family to have toilet and 
bathing facilities in each patient room, or conveniently located near 
the patient's room.
    We are proposing no changes to existing Sec.  418.100(g) bathroom 
facilities, except to recodify it at Sec.  418.110(h) and rename it, 
Plumbing facilities.
    In Sec.  418.110(i), Infection control, we are proposing to revise 
infection control standards to conform to those required of other 
provider types, such as home health agencies and hospitals. We would 
require a hospice to establish an infection control program that 
protects patients, families, and staff against communicable diseases 
and would prevent and control the spread of infections. The infection 
control program would be required to follow national infection control 
standards and be part of the hospice's overall quality assurance and 
performance improvement and education program. We also propose to 
retain the requirement that hospices provide a sanitary environment by 
following accepted standards of practice.
    We are not proposing any specific approaches to meeting the 
infection control requirement, but we would expect to see clear 
evidence that the hospice aggressively sought to minimize the spread of 
infection through the use of infection control techniques, such as 
standard precautions by its staff, and through the efforts made by the 
hospice to help families and caregivers minimize the spread of 
infection.
    We are proposing to re-codify the current requirement Sec.  
418.100(h), Linen, as Sec.  418.110(k) without substantive change.
    In proposed Sec.  418.110(l), Meal service and menu planning, we 
are proposing to revise the existing Sec.  418.100(j). We would make 
this standard less restrictive, and would emphasize the need for a 
hospice to focus more on outcomes rather than process. Specifically, we 
believe that a hospice should focus on meeting the patient's 
nutritional and plan of care needs. We would eliminate several 
structural requirements, such as serving at least three meals at 
regular times, with no more than 14 hours between substantial evening 
and breakfast meals, and having a staff member trained in food 
management or nutrition.
    In Sec.  418.110(m), Pharmaceutical services, we are proposing to 
re-codify the existing requirement found at Sec.  418.100(k) without 
substantive change.
    In Sec.  418.110(n), Pharmacist, we would assign this requirement a 
higher level of importance by making it a standard. However, we would 
retain the essential elements of the current requirement.

[If you choose to comment on the issues contained in paragraph (o) of 
this section, please include the caption ``SECLUSION AND RESTRAINT'' at 
the beginning of your comments.]
    Section 418.110(o), Seclusion and restraint, would be a new 
standard. A number of accidental injuries and deaths across inpatient 
providers due to the use of seclusion and restraints have been 
documented. Therefore, we discourage the use of seclusion and 
restraints, but are aware that their application may be warranted for 
brief periods or in rare instances. In response to the accidental 
deaths and injuries, we published (in 1999) a new condition in the 
hospital CoPs that included a new standard at Sec.  482.13(f), 
Standard: Seclusion and restraint for behavior management.
    The hospital seclusion and restraint CoP was the basis for the 
proposed hospice seclusion and restraint CoP. We also considered the 
seclusion and restraint language in section 3207 of the Children's 
Health Act (CHA), Public Law 106-310, codified at section 591 of the 
Public Health Service Act (42 U.S.C. 290ii). The CHA provision requires 
that any health care facility that receives Federal funds, including 
Medicare approved hospices, protect and promote every patient's right 
to be free from ``any restraints or involuntary seclusions imposed for 
purposes of discipline or convenience.'' The CHA clearly described the 
circumstances in which restraints or seclusion may be appropriate. The 
proposed seclusion and restraint requirement for hospices would codify 
the changes made to the Act by the CHA. We believe that adding this new 
requirement to the hospice CoPs may promote safe use of seclusion and 
restraints and may prevent accidental injury or death while a patient 
is receiving care as an inpatient in a hospice.
    We have focused this standard on the proper use of seclusion and 
restraints, the need for hospice personnel to receive training and 
education in the proper use of seclusion and restraint application and 
techniques, and the

[[Page 30858]]

need for hospice personnel to receive training and education in 
alternative methods for handling situations that arise. We emphasize 
that seclusion and restraint may only be used if needed to improve the 
resident's well-being or protect him or her or others from harm, and 
only when less restrictive interventions have been determined 
ineffective. We encourage the public to comment on this standard, 
especially with respect to instances where seclusion and restraint are 
appropriate and inappropriate.
Condition of Participation: Hospices That Provide Hospice Care to 
Residents of a SNF/NF, ICF/MR, or Other Facilities (Proposed Sec.  
418.112)
[If you choose to comment on issues in this section, please include the 
caption ``RESIDENTS RESIDING IN A FACILITY'' at the beginning of your 
comments.]
    Hospice care is an approach to treatment that recognizes that the 
impending death of an individual warrants a change in the focus from 
curative care to palliative care (relief of pain and other 
uncomfortable symptoms). The goal of hospice care is to help terminally 
ill individuals to continue life with minimal disruption to normal 
activities while remaining primarily in the home environment.
    A participating hospice may provide care to an eligible patient in 
an environment that the patient chooses to be his or her home. This 
includes hospice care provided to residents who choose to live in 
skilled nursing facilities, nursing facilities, intermediate care 
facilities, mental retardation facilities, and other facilities.
    The provision of hospice care to residents of those facilities has 
come under scrutiny as a result of Operation Restore Trust (ORT) 
activities and Inspector General (OIG) reports from 1996, 1997, and 
1998. An OIG report released in 1997 found that ``contractual 
arrangements between hospices and nursing homes present vulnerabilities 
for inappropriate use of excessive Medicare and Medicaid payments being 
made to hospices or to nursing homes'' (U.S. D.H.H.S. OIG, Hospice and 
Nursing Home Contractual Relationships, Nov. 1997, OEI-05-95-00251. See 
also, OIG Special Fraud Alert, Fraud and Abuse, Nursing Home 
Arrangements with Hospices, Mar. 1998). In addition, in 2000 the 
Assistant Secretary for Planning and Evaluation (ASPE) Office of 
Disability, Aging and Long-Term Care Policy and the Urban Institute 
published a report entitled ``Synthesis and Analysis of Medicare 
Hospice Benefit Executive Summary and Recommendations'' (Harvell, 
Jennie; Jackson, Beth; Gage, Barbara; Miller, Susan; and Mor, Vincent, 
2000 March). This report made several recommendations, some of which 
related to training and hospice care outcome measurement.
    The relationship between hospices and nursing facilities was also 
addressed by the Secretary's Advisory Committee on Regulatory Reform. 
The committee focused on clarifying the responsibilities of each 
provider and on the patients accessing the hospice benefit while they 
are facility residents. Based on the recommendations of the committee, 
as well as the reports from Operation Restore Trust, the Office of 
Inspector General, and the Assistant Secretary for Planning and 
Evaluation, we would add this new condition of participation. We are 
preparing a separate regulatory document to address long-term care 
facility obligations regarding residents receiving hospice services.
    To ensure that quality hospice care is provided to eligible 
patients, we are proposing a new condition at Sec.  418.112, Hospices 
that provide care to residents of a SNF/NF, ICF/MR or other facility. 
Regardless of where the hospice patient resides, the responsibility for 
developing and implementing an appropriate plan of care rests with the 
hospice.
    Under proposed Sec.  418.112(a), Resident eligibility, election and 
duration of benefits, we would specify that it is incumbent upon the 
hospice to ensure that the resident meets all the same Medicare 
eligibility requirements for hospice care (found at Sec.  418.20 to 
Sec.  418.30), as a patient who resides in his or her home in the 
community.
    At proposed Sec.  418.112(b), Professional management, the hospice 
would be expected to assume full responsibility for all of the hospice 
care provided to the resident. This would include making arrangements 
for any inpatient care that the patient would require in accordance 
with Sec.  418.100. This standard reinforces our belief that continuity 
of care is crucial for hospice care in any setting.
    In proposed Sec.  418.112(c), Core services, (and in accordance 
with sections 1861(dd)(1) and (2)(A) of the Act), the hospice would be 
required to provide all necessary core services to its patients in the 
same manner that it would provide core services to a patient residing 
in a home in the community. The plan of care would have to identify the 
care and services that were needed and specify which provider would be 
responsible for providing that care. It is not reasonable to expect the 
hospice to delegate any of its standard hospice core services to the 
nursing or residential facility staff.
    In proposed Sec.  418.112(d), Medical director, a hospice medical 
director would be expected to play an integral role in providing 
medical supervision to the hospice interdisciplinary group and in 
providing overall coordination of the patient's plan of care. The 
medical director's expertise in managing pain and symptoms associated 
with the patient's terminal disease is necessary, regardless of the 
setting in which the patient is receiving hospice services to ensure 
that the hospice patient has access to quality hospice care. Therefore, 
the medical director must communicate with all facility physicians and 
the attending physician and other professionals involved in developing 
and/or implementing the patient's plan of care.
    Under proposed Sec.  418.112(e), Written agreement, we are 
proposing that a comprehensive and legally binding written agreement be 
developed between the hospice and facility and that it be in effect 
before any hospice care is provided to a facility resident. The purpose 
of the written agreement would be to ensure that the duties and 
responsibilities of the hospice and facility are clearly articulated 
and executed in a manner that ensures that the resident will receive 
quality hospice care. The written agreement would be required to 
include the following:
    (1) Written consent and documentation of the patient or the 
patient's representative that hospice services were desired;
    (2) Identification of the services that the hospice and the 
facility would provide;
    (3) The manner in which the facility and the hospice would 
communicate to ensure that the needs of the patient were addressed and 
met 24 hours a day; and
    (4) A requirement that the facility immediately notify the hospice 
when--
    (i) A significant change in the patient's physical, mental, social 
or emotional status occurred;
    (ii) Clinical complications appeared that suggested a need to alter 
the plan of care;
    (iii) A life threatening condition(s) appeared;
    (iv) A need to transfer the patient from the facility arose; and
    (v) The patient died.
    As the primary entity responsible for the patient's care, the 
hospice should assume responsibility for determining the appropriate 
course of care and the decision to change the level of services 
provided. The hospice would make arrangements for, and remain

[[Page 30859]]

responsible for, any necessary continuous care or necessary inpatient 
care related to the terminal illness.
    We would require that the agreement delineate the facility's 
responsibilities, including room and board and other services and 
treatment, support or otherwise. We would also require a delineation of 
the hospice's responsibilities including medical direction and 
management of the patient, as well as nursing, counseling (including 
spiritual and dietary counseling), social work, bereavement counseling 
for family members, the provision of medical supplies and durable 
medical equipment, and the provision of drugs necessary for the 
palliation of pain and symptoms associated with the terminal illness. 
The hospice would be required to provide directly substantially all of 
the services necessary for the care of the patient's terminal illness.
    The hospice would be able to utilize the facility's nursing 
personnel (where permitted by the facility and by law), for the 
administration of prescribed therapies included in the plan of care, 
but only to the extent that the hospice would routinely use the 
services of a hospice patient's family in implementing the plan of 
care.
    These would be mandatory agreement provisions, but would not limit 
the scope of the relationship between the hospice and the facility. 
Additional provisions could be added subject to mutual agreement.
    Under proposed Sec.  418.112(f), Hospice plan of care, just as 
required for hospice services furnished to patients not residing in an 
inpatient facility, we are proposing that a written plan of care would 
be required to be established and maintained for each facility patient. 
The plan of care would be required to be coordinated with and developed 
by the hospice interdisciplinary group and SNF/NF, ICF/MR, or other 
facility in collaboration with the attending physician. The care 
provided would have to be in accordance with the plan. The plan would 
have to reflect the hospice philosophy in all aspects and be based on 
an assessment of the patient's needs and unique living situation in the 
facility. The plan would have to address the patient's current medical, 
physical, social, emotional, and spiritual needs based on the problems 
identified in the initial comprehensive and updated comprehensive 
assessments, and other assessments. Directives for the management of 
pain would have to be addressed and updated as necessary to reflect the 
patient's status.
    We are proposing that the plan of care identify the care and 
services that would be needed and specifically identify which provider 
would be responsible for performing the respective functions that were 
agreed upon and included in the plan of care. The performance of the 
functions should reflect the participation of the hospice, SNF/NF, ICF/
MR, or other facility, and the patient and family to the extent 
possible. The plan of care would need to be reviewed at least every 14 
days and as needed to reflect changes in the patient's condition. In 
conjunction with members of the facility's team, the hospice and the 
attending physician would have to discuss any changes in the plan of 
care, and these changes would have to be approved by the hospice before 
implementation.
    At proposed Sec.  418.112(g), Coordination of services, we are 
proposing that the hospice designate a member of the interdisciplinary 
group to coordinate the implementation of the plan. The hospice would 
provide the facility with the plan of care, hospice consent form, 
contact information for hospice personnel involved in the care of the 
resident, instructions on accessing the hospice 24-hour on-call system, 
medication information specific to the patient, physician orders, and 
any advance directives. We believe that these requirements would ensure 
effective communication between the hospice and the facility.
    Under proposed Sec.  418.112(h), Transfer, revocation, or discharge 
from hospice care, we would specify that the proposed requirement for 
discharge or revocation found at Sec.  418.104(e) applies. In addition, 
we would specify that discharge or revocation of the hospice care would 
not impact the eligibility to continue to reside in a SNF/NF, ICF/MR, 
or other facility.
    At proposed Sec.  418.112(i), Orientation and training of staff, we 
would specify that the hospice staff would be required to train 
facility staff who provide care to hospice patients on aspects of the 
hospice philosophy and unique program features, including policies and 
procedures, methods of comfort, pain control and symptom management, 
general principles about death and dying and individual responses, 
patient rights, appropriate forms, and record keeping requirements.
    We are specifically soliciting public comment on this proposed 
condition of participation.
Condition of Participation: Personnel Qualifications for Licensed 
Professionals (Proposed Sec.  418.114)

[If you choose to comment on issues in this section, please include the 
caption ``PERSONNEL QUALIFICATIONS'' at the beginning of your 
comments.]

    We are proposing significant revisions to the personnel 
qualifications for hospice employees. Specifically, we would provide 
that in cases where personnel requirements are not statutory, or do not 
relate to a specific payment provision, we would require personnel to 
meet State certification or licensure requirements. Under our proposal, 
the personnel qualifications would fall into three basic categories 
that include: (1) General qualifications, (2) personnel qualifications 
for physicians, speech-language pathologists, and home health aides, 
and (3) personnel qualifications when no State licensing laws or State 
certification or registration requirements exist. Under our proposed 
reorganization of part 418, the personnel qualifications would be 
located at Sec.  418.114. We discuss the personnel qualifications in 
detail below.
    (1) General qualifications (proposed Sec.  418.114(a)).
    This category would encompass licensed professionals who provide 
hospice services directly, either as employees or under individual 
contract, or under arrangement with a hospice. These professionals must 
be licensed, or certified or registered to practice by the State in 
which they perform the functions, as applicable. All personnel who fall 
into this category must act exclusively within the scope of the State 
license, certification or registration. Examples of personnel who fall 
into this category are registered nurses, licensed practical nurses, 
physical therapists, and physical therapist assistants; all States 
currently have licensing or certification requirements for these 
caregivers.
    (2) Personnel qualifications for physicians, speech-language 
pathologists, and home health aides (proposed Sec.  418.114(b)).
    Section 1861(r) of the Act defines a physician as a doctor of 
medicine, osteopathy, or podiatry legally authorized to practice 
medicine and/or surgery by the State in which that function or action 
is performed. We would refer to this definition at Sec.  418.114(b)(1). 
Sections 1861(ll)(1) and (3)(A) of the Act define a qualified speech-
language pathologist as an individual with a master's or doctoral 
degree in speech-language pathology who is licensed as a speech-
language pathologist by the State in which the individual furnishes 
those services. In the case of an individual who furnishes services in 
a State that does not license speech-language pathologists, the

[[Page 30860]]

individual must have successfully completed 350 clock hours of 
supervised clinical practicum (or is in the process of accumulating the 
supervised clinical experience), performed not less than 9 months of 
supervised full-time speech-language pathology services after obtaining 
a master's or doctoral degree in speech-language pathology or a related 
field, and successfully completed a national examination in speech-
language pathology approved by the Secretary.
    Section 1891(a) of the Act also defines the qualifications for home 
health aides. However, we believe that the description of 
qualifications for home health aides would be more appropriately 
located under the home health aide services CoP. Thus, the requirement 
would be cross-referenced at proposed Sec.  418.76(a).
    (3) Personnel qualifications when no State licensing laws or State 
certification or registration requirements exist.
    When a State does not have a licensure, certification, or 
registration requirement, the hospice would apply the qualifications in 
Sec.  418.114(c). This category would consist of all current personnel 
qualifications specified in proposed Sec.  418.3, Definitions. We 
understand that portion of these qualifications may seem outdated. 
However, we believe that there may still be individuals who met the 
requirements of the 1960s and 1970s and who are still practicing in 
their chosen field today. Therefore, we propose to include these 
personnel qualifications. We welcome comments on these revisions.

[If you choose to comment on issues related to the qualification 
standards for social workers, please include the caption ``SOCIAL 
WORK'' at the beginning of your comments.]
    We are specifically requesting comment on the qualifications for a 
social worker. Hospice care marks the passage from life to death. The 
services furnished by a hospice takes on a higher level of importance 
that greatly affects a patient's physical and emotional comfort, and 
which will be remembered by family members forever. The social worker 
plays an important role in providing these services to patients and 
their families. Patients often enter hospice care in a time of crisis 
and they along with their families sometimes require intense 
interventions that are handled by a social worker. Patients and their 
families rely on social workers for emotional support and guidance 
during the patient's care.
    Later, the social worker's goal is to help family members during 
the bereavement process through in-depth counseling. Bereavement 
counseling can take many forms, depending on the individuals who will 
be receiving it. For example, one patient's family may require intimate 
counseling sessions for the patient's children while a large group 
session may be more appropriate for nursing facility staff and 
residents. Determining the exact needs of these individuals and meeting 
those needs through counseling sessions and other support mechanisms 
requires the expertise of a qualified social worker.
    At present, a social worker is required to possess a bachelor's 
degree in social work from an accredited school. There is no consensus 
regarding the optimum qualifications that a social worker must possess 
when furnishing services to a hospice patient. However, there is strong 
anecdotal evidence that a social worker who possess a Master's of 
Social Work (MSW) degree from an accredited institution and who has at 
least one year of health care experience would provide a higher level 
patient care. Anecdotal evidence also exists that suggests that 
patients and families that receive services from a Master's of social 
work are more satisfied with the care they receive.
    In addition to the patient care advantages that MSWs offer, a 
hospice may anticipate a reduction in overall and per patient costs 
when utilizing MSWs who have at least one year of experience. A study 
conducted by the National Hospice and Palliative Care Organization 
(NHPCO) found that an increase in social work experience after academic 
training resulted in decreased overall care costs, including nights of 
continuous care. The study concludes that, ``[h]ospice programs will 
benefit by hiring the best qualified and most experienced social 
workers available.'' (Reese, Dana J.; Raymer, Mary; and Richardson, 
Joan, National Hospice Social Work Survey, 2000 March).
    Two issues may contribute to limiting any change in the social work 
qualification requirement-- the availability of personnel to work full 
time, and the availability of personnel to serve rural areas. Some 
hospices may not be able to employ an MSW on a full-time basis. Even if 
CMS were to increase the education requirement to an MSW level, 
hospices would still be allowed to employ individuals with a bachelor's 
degree in some circumstances. These individuals would be able to work 
under the supervision of an MSW and would be identified as social work 
assistants. A social work assistant would be defined as an individual 
who has a bachelor's degree from a school accredited by the Council on 
Social Work Education, or a bachelor's degree in psychology, sociology 
or another field related to social work.
    In 2001, 4,087 MSWs were employed by the nation's 2,316 hospices 
(National Association for Homecare, 2002 Hospice Industry Report, 
http://www.nahc.org/Consumer/hpcstats.html). We recognize that MSWs may 
not be available in all areas. If a hospice chooses to also utilize the 
services of a social work assistant, then the MSW would only have to be 
employed part-time to supervise the services. According to the NHPCO 
study, ``[a]ppropriate clinical supervision is essential for social 
workers. Like any other profession, social workers require supervision 
by seasoned social work practitioners to continue to grow into high 
quality skilled professionals.''
    We are specifically soliciting comments about whether the care 
furnished by an MSW should be considered the standard of care for 
hospice patients. Would an MSW provide a higher level of care than a 
social worker with a bachelor's degree? Should CMS require that any 
social worker, regardless of the degree, have at least one year of 
experience in a health care setting? Should CMS allow social work 
assistants with bachelor's degrees to function under the supervision of 
an MSW? Would increasing the qualifications for social workers to an 
MSW while retaining social work assistants with bachelor's degrees 
impact patient access to social work services? Would employing both 
social workers and social work assistants ensure that hospices have the 
flexibility to meet the needs of patients and their families?
    Please note that the policy regarding credentialing would not apply 
under Medicare Part B, when a specific level or education or training 
is specified as a precondition for reimbursement. For example, Part B 
payment may be made for the services of clinical social workers, and 
the law specifically defines a clinical social worker in section 
1861(hh) of the Act. Thus, the definitions contained in this section 
generally would apply for hospice certification purposes only in States 
where there were no State licensure requirements.
    In Sec.  418.114(d), we are proposing a new requirement that a 
hospice be required to obtain a criminal background check for all 
hospice and contract employees before employment at the hospice. We 
believe that this is an important safety measure to protect both 
patients and the hospice. We are soliciting public comment on this 
proposed standard.

[[Page 30861]]

Condition of Participation: Compliance With Federal State and Local 
Laws and Regulations Related to Health and Safety of Patients (Proposed 
Sec.  418.116)
    The provisions concerning licensure requirements for hospices are 
currently located at Sec.  418.72, Condition of participation: 
Licensure. We are proposing to expand this condition in the following 
manner:
    We would make a minor revision to the language at existing Sec.  
418.72(a), which would require the hospice and its staff to operate and 
furnish services in compliance with all Federal, State, and local laws 
and regulations applicable to hospices related to health and safety of 
patients. The State agency and CMS would exercise discretion in 
determining whether a violation of an applicable Federal, State, or 
local law or regulation related to health and safety would be cited as 
a violation under the Medicare CoPs. We would not cite a hospice whose 
problem was remedied. We will cite hospices when violations of Federal, 
State, and local laws and regulations affect the health and safety of 
patients; the ability of hospices to deliver quality services; the 
rights and well-being of patients; and/or the management of the hospice 
and its ability to recruit qualified staff.
    Under Sec.  418.116(b), Multiple locations, we would continue to 
require that the hospice comply with the requirements of Sec.  420.206 
regarding disclosure of ownership and control information. We would 
also provide that the hospice and any other satellite locations 
operated under the same provider number be licensed in accordance with 
applicable State licensure laws before the hospice could be reimbursed 
for Medicare services. This provision seeks to ensure that hospice 
patients receive the same level of quality care from the appropriate 
personnel at all sites of service. The requirement that hospices comply 
with State licensure laws before providing services to Medicare 
beneficiaries would apply to the hospice as an entity as well as to any 
personnel furnishing services to hospice patients.
    We are proposing to recodify the current requirements at Sec.  
418.92(b), regarding laboratory services, at Sec.  418.116(c).

IV. Hospice Crosswalk (Cross Refers Existing Requirements to Proposed 
Requirements)

    The following table shows the relationship of the former sections 
to the current ones.

                                                Derivation Table
----------------------------------------------------------------------------------------------------------------
                                              Citation
 Current conditions  (Part 418, subpart C,    existing     Proposed condition                Citation
                   D, E)                      section
----------------------------------------------------------------------------------------------------------------
Scope of Subpart
    Definitions...........................        418.3  Definitions...........  418.3
    General provisions....................       418.50
        (a) Compliance....................  ...........  Organization and        418.100(c)(2)
                                                          Administration of
                                                          Services.
        (b) Required services.............  ...........  Organization and        418.100(c)(2)
                                                          Administration of
                                                          Services.
        (c)(1) 24 hour nursing, physician   ...........  Organization and        418.100(c)(1)
         services, and drugs and biologics.               Administration of
                                                          Services.
    (2) Other 24 hour services.
    (3) Utilize accepted standards of       ...........  Core Services and       418.64 and 418.72
     practice.                                            Furnishing of Non-
                                                          core Services.
        (d) Disclosure of information.....  ...........  Deleted...............
Medical director: The medical director is:       418.54  Medical Director......  418.102
 A hospice employee, a doctor of medicine
 or osteopathy, responsible for the
 medical component of the hospice's
 patient care program.
Professional management...................       418.56
    (a) Continuity of care................  ...........  Deleted.
    (b) Written agreement:
        (1) Identification of services to   ...........  Interdisciplinary       418.56(c)
         be provided.                                     Group Care Planning
                                                          and Coordination of
                                                          services.
        (2) Express authorization of the    ...........  Organization and        418.100(e)(1)
         hospice required for all services.               Administration of
                                                          Services.
        (3) Coordination, supervision, and  ...........  Organization and        418.100(e)
         evaluation of contracted services.               Administration of
                                                          Services.
        (4) Roles of hospice and            ...........  Deleted
         contractor in admission,
         assessment, and interdisciplinary
         group.
        (5) Documentation of services       ...........  Organization and        418.100(e)
         furnished by contractor.                         administration of
                                                          services.
        (6) Personnel qualifications......  ...........  Organization and        418.100(e)(2)
                                                          administration of
                                                          services.
    (c) Professional management...........  ...........  Organization and        418.100(e)
                                                          administration of
                                                          services.
    (d) Financial responsibility.
    (e) Inpatient care:
        (1) Copy of the patient plan of     ...........  Short term inpatient    418.108(c)(1)
         care specifying the services to                  care.
         be provided is given to inpatient
         provider.
        (2) Inpatient provider abides by    ...........  Short term inpatient    418.108(c)(2)
         hospice patient care protocols                   care.
         and maintains compatible policies.
        (3) Medical record provided to      ...........  Short term inpatient    418.108(c)(3)
         hospice upon request. Must                       care.
         include all inpatient services
         and events and a copy of the
         discharge summary.
        (4) Responsibility for              ...........  Short term inpatient    418.108(c)(4)
         implementing agreement provisions.               care.

[[Page 30862]]

 
        (5) Hospice responsible for         ...........  Short term inpatient    418.108(c)(5)
         training all care providers.                     care.
                                                    NEW  Comprehensive           418.54
                                                          Assessment of the
                                                          Patient Initial
                                                          assessment.
                                            ...........  (a) Time frame for the
                                                          completion of the
                                                          comprehensive
                                                          assessment
                                            ...........  (b) Content of the
                                                          comprehensive
                                                          assessment
                                            ...........  (c) Update of the
                                                          comprehensive
                                                          assessment
                                            ...........  (d) Outcome measures
                                                          on the patient
Plan of Care..............................       418.58
A written plan of care must be established  ...........  Interdisciplinary       418.56
 and maintained for each individual                       Group Care Planning
 admitted to a hospice program and the                    and Coordination of
 care provided to an individual must be in                Services.
 accordance with the plan.
    (a) Plan established by attending       ...........  Interdisciplinary       418.56(b)
     physician, medical director or                       Group Care planning
     physician designee and                               and Coordination of
     interdisciplinary group prior to                     Service.
     providing care.
    (b) Plan reviewed, updated, and         ...........  Interdisciplinary       418.56(d)
     documented at specified intervals by                 Group Care Planning
     attending physician, medical director                and Coordination of
     or physician designee and the                        Services.
     interdisciplinary group.
    (c) Plan includes assessment of needs   ...........  Interdisciplinary       418.56(c)
     and identification of services. It                   Group Care Planning
     state in the scope and frequency of                  and Coordination of
     services needed.                                     Services.
Continuation of care: No discontinuation         418.60  Organization and        418.100(d)
 or diminishment of care due to the                       Administration of
 Medicare beneficiary's inability to pay                  Services.
 for that care.
Informed Consent: The Informed consent           418.62  Patient Rights........  418.52(a)
 form specifies the type of care and
 services that may be provided during the
 course of the illness, and it must be
 completed for every individual, either
 from the individual or representative as
 defined in 418.3.
Inservice training: A hospice must provide       418.64  Organization and        418.100(g)
 an ongoing program for the training of                   Administration of
 its employees.                                           services.
Quality assurance: A hospice must conduct        418.66  Quality Assessment and  418.60
 an ongoing, comprehensive, intetrated,                   performance
 self-assessment of the quality and                       Improvement.
 appropriateness of all care provided. The
 findings are used to correct problems and
 revise hospice policies. Those
 responsible for the quality assurance
 program must.
    (a) Implement and report on activities  ...........  Quality Assessment and  418.60(d)
     and mechanisms for monitoring the                    performance
     quality of patient care.                             Improvement.
    (b) Identify and resolve problems.....  ...........  Deleted.
    (c) Make suggesitons for improving      ...........  Quality Assessment      418.60(c)(3)
     patient care.                                        performance
                                                          Improvement.
Interdisciplinary group: The hospice must        418.68  IDG Group Care          418.56(a)
 designate an interdisciplinary group(s)                  Planning and
 composed of individuals who provide or                   Coordination of
 supervise care and services offered by                   Services.
 the hospice.
    (a) The interdisciplinary group(s)      ...........  IDG Care Planning and   418.56(a)
     must include certain specialists.                    Coordination of
                                                          Services
    (b) The interdisciplinary group is
     responsible for--
        (1) Participation in the            ...........  IDG Care Planning and   418.56(b)
         establishment of the plan of care.               Coordination of
                                                          Services.
        (2) Provision of supervision of     ...........  IDG Care Planning and   418.56(a)(1)(3)
         hospice care and services.                       Coordination of
                                                          Services.
        (3) Periodic review and updating    ...........  IDG Care Planning and   418.56(d)
         of the plan of care for each                     Coordination of
         individual receiving hospice                     Services.
         care; and.
        (4) Establishment of policies       ...........  IDG Care Planning and   418.56(a)(2)
         governing the day-to-day                         Coordination of
         provision of hospice care and                    Services.
         services.
    Only one interdisciplinary group        ...........  Deleted...............
     chosen in advance may execute the
     functions described in the paragraph
     (b)(4) of this section.
    (d) Designating a registered nurse to   ...........  IDG Care Planning and   418.56(a)(1)
     coordinate the implementation of the                 Coordination of
     plan of care for each patient.                       Services.
Volunteers: The hospice in accordance with       418.70  Volunteers............  418.78
 the numerical standards, specified in
 paragraph (e) of this section, uses
 volunteers, in defined roles, under the
 supervision of a designated hospice
 employee.
    (a) The hospice must provide            ...........  Volunteers............  418.78(a)
     appropriate orientation and training.
    (b) Volunteers must be used in direct   ...........  Volunteers............  418.78(b)
     patient care or administrative roles.

[[Page 30863]]

 
    (c) The hospice must document active    ...........  Volunteers............  418.78(c)
     and ongoing efforts to recruit and
     retain volunteers.
    (d) The hospice must document the cost  ...........  Volunteers............  418.78(d)
     savings achieved through volunteer
     use. Documentation must include--
        (1) Necessary positions which are
         occupied by volunteers.
        (2) The work time spent by
         volunteers occupying those
         positions; and
        (3) Estimates of the dollar costs
         of paying employees to occupy the
         positions identified in (d)(1)
         for the time specified in (d)(2).
    (e) Volunteer staff providing direct    ...........  Volunteers............  418.78(e)
     patient care and administrative
     support must equal at least 5 percent
     of the total patient care hours of
     all paid hospice employees and
     contract staff. Any expansion of care
     and services achieved by using
     volunteers, including the type of
     services and time worked, must be
     recorded.
    (f) Reasonable efforts made to arrange  ...........  Deleted.
     for visits of members of religious
     organizations to patients who request
     such visits and must advise patients
     of this opportunity.
Licensure: The hospice and all its               418.72  Compliance with         418.116
 employees must be licensed in accordance                 Federal, State &
 with applicable Federal, State, and local                local laws &
 laws and regulations.                                    regulations related
                                                          to health & safety of
                                                          patients.
    (a) The hospice must be licensed if     ...........  Personnel               418.114 and
     State or local law provides for                      Qualifications for     418.116(a)
     licensure.                                           Skilled
                                                          Professionals; and
                                                          Compliance with
                                                          Federal, State &
                                                          local laws &
                                                          regulations related
                                                          to health & safety of
                                                          patients.
    (b) Employees who provide services                                           ...............................
     must be licensed, certified or
     registered in accordance with
     applicable Federal or State laws.
Central Clinical Records: Establishment          418.74  Clinical Records......  418.104
 and maintenance of a clinical record for
 every patient. The record must be
 complete, promptly and accurately
 documented, readily accessible and
 systematically organized to facilitate
 retrieval.
    (a) Clinical record is comprehensive.   ...........  Clinical Records......  418.104(a)
     Entries are made and signed for all
     services provided whether furnished
     directly or under arrangements made
     by the hospice. Each individual's
     record contains--.
        (1) Initial and subsequent          ...........  Clinical Records......  418.104(a)(1)
         assessments.
        (2) Plan of care..................  ...........  Clinical Records......  418.104(a)(1)
        (3) Identification data...........  ...........  Deleted.                ...............................
        (4) Consent and authorization and   ...........  Clinical Records......  418.104(a)(2)
         election forms.
        (5) Pertinent medical history.....  ...........  Deleted.                ...............................
        (6) Complete documentation of all   ...........  Clinical Records......  418.104(a)(1)
         services and events.
    (b) Protection of information. The      ...........  Clinical Records......  418.104(c)
     hospice must safeguard the clinical
     record against loss, destruction, and
     unauthorized use.
Subpart D--Condition of Participation:
 Core Services:
Furnishing of Core Services: Hospice             418.80  Core services.........  418.64
 employees must routinely provide all core
 services. Contracted staff may supplement
 hospice employees to meet patient needs
 during peak periods or under
 extraordinary circumstances. The hospice
 must maintain professional, financial,
 and administrative responsibility for
 contracted services and must assure that
 the qualifications of staff and services
 provided meet specified requirements. See
 exception in 418.83.
Nursing services: Nursing care and               418.82  Core services.........  418.64(b)
 services provided by or under the
 supervision of a registered nurse.
    (a) The nursing needs of the patients   ...........  Core services.........  418.64(b)
     must be met.
    (b) Patient care responsibility of      ...........  Deleted.                ...............................
     nursing personnel must be specified.
    (c) Services are provided in            ...........  Core services.........  418.66
     accordance with recognized standards
     of practice.
Waiver of all requirements that                  418.83  Nursing service waver   418.66
 substantially all nursing services be                    (re-codified).
 routinely services be routinely provided
 directly by a hospice.
    (a) Waiver if located in non-urbanized                                       ...............................
     area, operational on or before
     January 1, 1983, and good faith
     effort made to fulfill staffing
     needs.

[[Page 30864]]

 
    (b) Any waiver request is deemed to be                                       ...............................
     granted unless it is denied within 60
     days after it is received.
    (c) Waivers will remain effective for                                        ...............................
     one year at a time.
    (d) HCFAa may approve a maximum of two                                       ...............................
     one-year extensions for each initial
     waiver.
Medical social services: Medical social          418.84  Core services.........  418.64(c)
 services must be provided by a qualified
 social worker, under the direction of a
 physician.
Physician services: In addition to               418.86  Core services.........  418.64(a)
 palliation and management of terminal
 illness and related conditions, physician
 employees of the hospice must also meet
 the general medical needs of the patient.
Counseling services: Counseling services,        418.88  Core services.........  418.64(d)
 including bereavement, dietary, and
 spiritual counseling, must be available
 to both the individual and the family.
    (a) Organized program for the           ...........  Core services.........  418.64(d)(1)
     provision of bereavement services
     under the supervision of a qualified
     professional. A special coverage is
     specified in 418.204(c).
    (b) Provision of dietary counseling     ...........  Core services.........  418.64(d)(2)
    (c) Spiritual counseling must include   ...........  Core services.........  418.64(d)(3)
     notice to patients as to the
     availability of the clergy as
     provided in 418.70(f).
    (d) Counseling may be provided by       ...........  Deleted.
     others.
Subpart E--Condition of Participation:
 Other services:
Furnishing other services: The services          418.90  Furnishing of non core  418.70
 described in this subpart must be                        services.
 provided directly by hospice employees or
 under arrangements made by the hospice as
 specified in 418.56.
Physical therapy, occupational therapy and    418.92(a)                          418.70, 418.72
 speech language pathology.
    (a) Physical therapy, occupational      ...........  Physical therapy,       418.70, 418.72
     therapy, and speech-language                         occupational therapy
     pathology services must be available                 and speech language
     and provided under acceptable                        pathology and dietary
     standards of practice.                               counseling, Non-core
                                                          services.
    (b)(1) Laboratory testing services      ...........  Compliance with         418.116(c)(1)
     must be in compliance with all                       Federal, State &
     applicable requirements of part 493                  local laws &
     of this chapter.                                     regulations related
                                                          to the health &
                                                          safety of patients.
    (2) All referral laboratories must be   ...........  Compliance with         418.116(c)(2)
     certified in the appropriate                         Federal, State &
     specialties and subspecialties of                    local laws &
     services. See part 493 of this                       regulations & related
     chapter.                                             to the health &
                                                          safety of patients.
Home health aide and homemaker service:          418.94  Home Health Aide and    418.76
 Home health aide and homemaker must be                   homemaker services.
 services available and adequate in
 frequency to meet the needs of the
 patients. A home health aide is a person
 who meets the training, attitude and
 skill requirements specified in 484.36 of
 this chapter.
    (a) Standard: A registered nurse        ...........  Home health aide and    418.76(h)(1)
     visits the home site at least every                  homemaker services
     two weeks when aide services arebeing                (revised).
     provided, and conducts an assessment
     of the aide services.
    (b) Standard: A registered nurse        ...........  Home health aide and    418.76(g)(1)
     prepares written instructions for                    homemaker services.
     patient care. Duties include, but may
     not be limited to, the duties
     specified in 484.36(c) of this
     chapter.
Medical supplies: Medical supplies,              418.96  Drugs, controlled       418.106
 appliances, drugs and biologicals must be                drugs, and
 provided for the palliation and                          biologicals, medical
 management of the terminal illness and                   supplies and durable
 related conditions.                                      medical equipment.
    (a) All drugs and biologicals must be   ...........  Drugs, controlled       418.106(a)
     administered in accordance with                      drugs, and
     accepted standards of practice.                      biologicals, medical
                                                          supplies and durable
                                                          medical equipment.
    (b) The hospice must have a policy for  ...........  Drugs, controlled       418.106(b)
     the disposal of extraneous controlled                drugs, and
     drugs maintained in the patient's                    biologicals, medical
     home.                                                supplies and durable
                                                          medical equipment.
    (c) Only certain individuals may        ...........  Deleted.
     administer drugs and biologicals.
Short term inpatient care: Inpatient care   ...........  Short term inpatient    418.108
 must be available for pain control,                      care.
 symptom management and respite purposes,
 and must be provided in a participating
 Medicare or Medicaid facility.
    (a) Inpatient care for pain control     ...........  Short term inpatient    418.108(a)
     and symptom management must be                       care.
     provided in one of the following:

[[Page 30865]]

 
        (1) A hospice that meets the        ...........  Short term inpatient    418.108(a)(1)
         standards for providing inpatient                care.
         care directly specified in
         418.100.
        (2) A hospice or skilled nursing    ...........  Short term inpatient    418.108(a)(2)
         facility that also meets the                     care.
         standards of 418.100(a) and (e).
    (b) Inpatient care for respite          ...........  Short term inpatient    418.108(b)
     purposes must be provided by:.                       care.
        (1) A provider specified in         ...........  Short term inpatient    418.108(b)(1)
         paragraph (a) of this section.                   care.
        (2) An intermediate care facility   ...........  Short term inpatient    418.108(b)(2)
         (ICF) meeting the standards in                   care (delete ICF and
         418.100 (a) and (e).                             replace with nursing
                                                          facility (NF)).
    (c) Inpatient care for Medicare         ...........  Short term inpatient    418.108(d)
     beneficiaries may not exceed 20                      care.
     percent of the total number of days
     for this beneficiary group.
    (d) Exemption from limitation in        ...........  Short term inpatient    418.108(e)
     paragraph (c).                                       care.
Hospices that provide inpatient care            418.100  Hospices that provide   418.110
 directly: A hospice that provides                        inpatient care
 inpatient care directly must comply with                 directly.
 all of the following standards.
    (a) Twenty-four hour nursing services:
        (1) The facility provides 24-hour   ...........  Hospices that provide   418.110(b)
         nursing services in accordance                   inpatient care
         with patient plan of care                        directly.
         sufficient to meet total nursing
         needs.
        (2) Each shift includes a direct    ...........  Deleted...............
         care registered nurse.
    (b) The hospice has an acceptable       ...........  Hospices that provide   418.110(c)(1)(iii)
     written plan, periodically rehearsed                 inpatient care
     with staff, with internal and                        directly.
     external disaster procedures.
    (c) The hospice must meet all Federal,  ...........  Compliance with         418.116
     State and local laws, regulations,                   Federal, State &
     and codes pertaining to health and                   local laws and
     safety.                                              regulations related
                                                          to health and safety
                                                          of patients.
    (d) Fire protection...................  ...........  Hospices that provide   418.110(d)(1)
                                                          inpatient care
                                                          directly.
        (1) Hospices must comply with the
         1985 edition of the Life Safety
         Code of the NFPA. See exceptions
         in (d)(2) and (3).
        (2) Waiver for specific provisions
         of Life Safety Code.
        (3) 1981 edition compliance by May
         9, 1988 will be considered as
         meeting this standard.
        (4) Restrictions on facilities of
         two or more stories not of fire
         resistive construction.
    (e) Patient areas.....................  ...........  Hospices that provide   418.110(e)
                                                          inpatient care
                                                          directly.
        (1) Design and equipment of
         patient/family areas.
        (2) Specifications for patient/
         family accommodations
        (3) Visitor specifications.
    (f) Patient rooms and toilet            ...........  Hospices that provide   418.110(f)
     facilities..                                         inpatient care
                                                          directly.
        (1) Specifications for equipment,
         size, and location of patient
         rooms and toilet.
        (2) Waiver of space and occupancy
         requirements for unreasonable
         hardships.
    (g) Requirements for bathroom           ...........  Hospices that provide   418.110(g),
     facilities.                                          inpatient care         418.110(h)
                                                          directly.
    (h) Requirements for linens...........  ...........  Hospices that provide   418.110(k)
                                                          inpatient care
                                                          directly.
    (i) Isolating areas for patients with   ...........  Hospices that provide   418.110(j),
     infectious diseases.                                 inpatient care         418.110(i)
                                                          directly.
    (j) Meal service and menu planning....  ...........  Hospices that provide   418.110(l)
                                                          inpatient care
                                                          directly.
        (1) Three meals a day served at         418.100  Deleted.                ...............................
         regular times; no more than 14
         hours between substantial evening
         meal and breakfast.
        (2) Procure, store, prepare,        ...........  Deleted.                ...............................
         distribute, and serve all food
         under sanitary conditions.
        (3) Have a staff member trained or
         experienced in food management or
         nutrition.
        (4) A professionally qualified
         dietitian must plan and supervise
         a menu for patients requiring
         special diets.
    (k) Pharmaceutical services. The        ...........  Hospices that provide   418.110(m)
     hospice provides appropriate methods                 inpatient care
     and procedures for the dispensing and                directly.
     administering of drugs and
     biologicals.

[[Page 30866]]

 
        (1) Licensed pharmacist The         ...........  Hospices that provide   418.110(n)
         hospice must--.                                  inpatient care.
            (i) employ a licensed
             pharmacist; or
            (ii) have a formal agreement
             with a licensed pharmacist to
             advise the hospice on
             ordering, storage,
             administration, disposal and
             record keeping of drugs and
             biologicals.
        (2) Orders for medications........  ...........  Hospices that provide   418.110(n)
                                                          inpatient care
                                                          directly.
            (i) Physician orders all
             patient medications.
            (ii) Verbal medication order:
                (A) Only given to a
                 registered nurse,
                 pharmacist, or physician.
                (B) the individual
                 receiving the order must
                 record and sign it
                 immediately and have the
                 prescribing physician
                 sign it in a manner
                 consistent with good
                 medical practice.
        (3) Medications are administered
         only by one of the individuals
         specified.
        (4) The pharmaceutical service has
         procedures for control and
         accountability of all drugs and
         biological throughout the
         facility, including record
         keeping and reconciliation
         procedures.
        (5) The labeling of drugs and
         biologicals is based on currently
         accepted professional principles,
         and includes the appropriate
         accessory and cautionary
         instructions, as well as the
         expiration date when applicable.
        (6) All drugs and biologicals are
         stored and locked in compartments
         under proper temperature controls
         and only authorized personnel
         have access to the keys.
         Separately locked compartments
         are provided for schedule II and
         other drugs subject to abuse,
         except under single unit package
         drug distribution systems. An
         emergency medication kit is kept
         readily available.
        (7) Extraneous controlled drugs
         are disposed of in compliance
         with State requirements. When
         none apply, the pharmacist and a
         registered nurse must dispose of
         the drugs and prepare a record of
         the disposal.
                                                    NEW  Hospices that provide   418.110(o)
                                                          inpatient care
                                                          directly: Seclusion
                                                          and Restraint.
                                                    NEW  Waiver of Physical      418.74
                                                          therapy, occupational
                                                          therapy and speech
                                                          language pathology
                                                          and dietary
                                                          counseling.
                                                    NEW  Hospices that provide   418.112
                                                          hospices care to
                                                          residents of a SNF/
                                                          NF, ICF/MR or other
                                                          facility In addition
                                                          to meeting the
                                                          conditions of
                                                          participation at
                                                          418.10 through
                                                          418.116, a hospice
                                                          that provides hospice
                                                          care to residents of
                                                          a SNF/NF, ICF/MR, or
                                                          other residential
                                                          facility abide by the
                                                          following additional
                                                          standards.
                                            ...........  (a) Standard: Resident  418.112(a)
                                                          eligibility,
                                                          election, and
                                                          duration of benefits.
                                            ...........  (b) Standard:           418.112(b)
                                                          Professional
                                                          management.
                                            ...........  (c) Standard: Core      418.112(c)
                                                          services.
                                            ...........  (d) Standard: Medical   418.112(d)
                                                          director.
                                            ...........  (e) Standard: Written   418.112(e)
                                                          agreement.
                                            ...........  (f) Standard: Hospice   418.112(f)
                                                          plan of care.
                                            ...........  (g) Standard:           418.112(g)
                                                          Coordination of
                                                          services.
                                            ...........  (h) Standard:           418.112(h)
                                                          Transfer, revocation,
                                                          or discharge from
                                                          hospice.

[[Page 30867]]

 
                                            ...........  (i) Standard:           418.112(i)
                                                          Orientation and
                                                          training of staff.
                                                    NEW  Personnel               418.114
                                                          qualifications.
                                            ...........  (a) General             418.114(a)
                                                          qualification
                                                          requirements.
                                            ...........  (b) Federally defined   418.114(b)
                                                          qualifications.
                                            ...........  (c) Personnel           418.114(c)
                                                          qualifications when
                                                          no States licensing
                                                          laws, certification
                                                          or registration
                                                          requirements exist.
                                            ...........  Criminal background     418.114(d)
                                                          checks.
                                                    NEW  Compliance with         418.116
                                                          Federal, State, &
                                                          local laws and
                                                          regulations related
                                                          to health and safety
                                                          of patients The
                                                          hospice and its staff
                                                          must operate and
                                                          furnish services in
                                                          compliance with all
                                                          applicable Federal,
                                                          State, & local laws &
                                                          regulations related
                                                          to the health &
                                                          safety of patients.
                                                          If State and local
                                                          law provides for
                                                          licensing of
                                                          hospices, the hospice
                                                          must be licensed.
                                            ...........  (a) Standard:           418.116(a)
                                                          Licensure of staff.
                                            ...........  (b) Standard: Multiple  418.116(b)
                                                          locations.
                                            ...........  (c) Standard:           418.116(c)
                                                          Laboratory services.
----------------------------------------------------------------------------------------------------------------

V. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information is submitted to the Office 
of Management and Budget (OMB) for review and approval. In order to 
fairly evaluate whether an information collection should be approved by 
OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment 
on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
information collection requirements discussed below. The following 
information collection requirements in this proposed rule and the 
associated burdens are subject to PRA.

Section 418.52 Condition of Participation: Patient's Rights

    Paragraph (a) of this section would require that the hospice 
provide each patient with: a verbal and written notice of the patient's 
rights and responsibilities during the initial evaluation visit, in 
advance of furnishing care; written information concerning its policies 
on advance directives, including a description of applicable State law; 
and written or verbal information regarding the hospice's drug policies 
and procedures, including the tracking and disposing of controlled 
substances. The hospice would also be required to maintain 
documentation showing that it complied with the requirements of this 
section and that the patient or representative demonstrated an 
understanding of these rights.
    The burden associated with these requirements would be the time 
associated with disclosing the information and documenting that the 
hospice did disclose the information. We estimate that this would take 
approximately 5 minutes per patient or 24.58 hours per hospice, for an 
annual total of 59,417 hours.
    Paragraph (b) of this section would require a hospice to document a 
patient/representative complaint, and the steps taken by the hospice to 
resolve it.
    The burden associated with this requirement would be the time it 
took to document the necessary aspects of the issues. We anticipate 15 
complaints per year per hospice and 15 minutes to document the 
complaint and resolution activities, for a total of 9,045 hours 
annually.
    Paragraph (e) of this section would require the patient to be 
informed of the extent to which payment may be expected from the 
patient, Medicare or Medicaid, third-party payers, or other resources 
of funding known to the hospice, verbally and in writing, and in a 
language that he or she can understand, before care is initiated. The 
burden associated with this requirement would be the time it would take 
to notify patients. We estimate that it would take no more than 5 
minutes per patient, for a total of 24.58 hours per hospice and 59,417 
hours nationally.

Section 418.54 Condition of Participation: Comprehensive Assessment of 
the Patient

    This section would require each hospice to conduct and document in 
writing a comprehensive patient-specific assessment, and maintain 
documentation of the assessment and any updates.
    The burden associated with this requirement would be the time it 
would

[[Page 30868]]

take to record the assessment and any changes/updates to it. We believe 
that documenting a patient assessment is a usual and customary business 
practice and as such the burden is not subject to the PRA.

Section 418.56 Condition of Participation: Interdisciplinary Group Care 
Planning and Coordination of Services

    This section would require all hospice care and services furnished 
to patients and their families to follow a written plan of care 
established by the hospice interdisciplinary group in collaboration 
with the attending physician. The hospice would be required to ensure 
that each patient/family and primary caregiver(s) receive education and 
training provided by the hospice as appropriate to the care and 
services identified in the plan of care. The section would specify the 
minimum elements the plan of care must include.
    In addition, the medical director or physician designee and the 
hospice interdisciplinary team, in collaboration with the individual's 
attending physician, would be required to review, revise and document 
the plan as necessary at intervals specified in the plan, but no less 
than every 14 calendar days. A revised plan of care would have to 
include information from the patient's updated comprehensive 
assessment, and would have to document the patient's progress toward 
the outcomes specified in the plan of care.
    These requirements are subject to the PRA; however, they are 
currently approved under OMB control number 0938-0302 with a current 
expiration date of September 30, 2006.
    The burden associated with these requirements would be the time it 
would take to document the plan of care (10 minutes) and any revisions 
to it (15 minutes) in the clinical record. We estimate that it would 
take 25 minutes to comply with these requirements per patient, for a 
total of 123 hours on average per hospice, and 297,083 hours 
nationally.

Section 418.58 Condition of Participation: Quality Assessment and 
Performance Improvement

    This section would require a hospice to develop, implement, and 
maintain an effective ongoing hospice-wide data-driven quality 
assessment and performance improvement (QAPI) program. The hospice's 
governing body would have to ensure that the program reflected the 
complexity of its organization and services; involved all hospice 
services, including those services furnished under contract or 
arrangement; focused on indicators related to improved palliative 
outcomes and end-of-life support services provided; and took actions to 
demonstrate improvement in hospice performance. The hospice would be 
required to maintain and demonstrate evidence of its quality assessment 
and performance improvement program and be able to demonstrate its 
operation to the CMS.
    The hospice would be required to take actions aimed at performance 
improvement and, after implementing those actions, the hospice must 
measure its success and track its performance to ensure that 
improvements were sustained.
    The hospice would be required to document what quality improvement 
projects were being conducted, the reasons for conducting these 
projects, and the measurable progress achieved on these projects.
    The burden associated with this requirement would be the time it 
would take to document the development of the quality assessment and 
performance improvement and associated activities. We estimate that it 
would take each hospice an average of 24 hours per year to comply with 
these requirements for a total of 57,888 hours annually.

Section 418.60 Condition of Participation: Infection Control

    The hospice would be required to maintain and document a 
coordinated infection control program that protected patients, families 
and hospice personnel by preventing and controlling infections and 
communicable diseases.
    The burden associated with this requirement would be the time it 
would take to document the program. We believe that this proposed 
requirement reflects usual and customary medical and business practice; 
thus the burden is not subject to the PRA.

Section 418.64 Condition of Participation: Core Services

    We are proposing that a hospice could choose to enter into an 
arrangement with another hospice to obtain personnel to furnish core 
hospice services under certain circumstances. Such an arrangement would 
have to be supported by a legally binding written agreement. The burden 
associated with this requirement would be the time required to 
negotiate, draft and sign an agreement. We believe that this 
requirement is a customary and usual business practice. Thus, the 
burden would not be subject to the PRA.
    Under the nursing services standard for this condition, the hospice 
could enter into a written agreement for the provision of certain 
nursing services by an outside body. The burden associated with this 
requirement would be the time required to negotiate, draft and sign an 
agreement. We believe that this requirement is a customary and usual 
business practice. Thus, the burden would not be subject to the PRA.
    Under the counseling standard for this condition, the hospice would 
be required to advise the patient/family that the hospice would 
facilitate visits by local clergy, pastoral counselor, or other 
individuals who could support the patient's spiritual needs. We believe 
that this requirement is a customary and usual hospice practice, and is 
therefore not subject to the PRA.

Section 418.66 Condition of Participation: Nursing Services Waiver of 
Requirement That Substantially all Nursing Services Be Routinely 
Provided Directly by a Hospice

    Under this section, if a hospice wanted a waiver from the 
requirement that substantially all nursing services be routinely 
provided by the hospice, it would be required to provide evidence that 
it made a good faith effort to hire a sufficient number of nurses to 
provide services. To extend the waiver, the hospice would be required 
to submit a request to CMS attesting that the conditions under which it 
originally requested the initial waiver had not changed since the 
initial waiver was granted.
    The burden associated with this requirement would be the time it 
would take to provide the necessary documentation, and the time it 
would take to request an extension. We estimate that there will be no 
more than 5 hospices providing the information and requesting 
extensions. Under section 1320.3, this requirement would not be subject 
to the PRA as it would affect fewer than 10 entities.

Section 418.74 Condition of Participation: Waiver of Requirement-
Physical Therapy, Occupational Therapy, Speech-Language Pathology, and 
Dietary Counseling

    A hospice located in a non-urbanized area would be able to submit a 
written request for a waiver of the requirement that the hospice 
directly provide physical therapy, occupational therapy, speech-
language pathology, and dietary counseling services. The hospice would 
be able to seek a waiver of the requirement that it make physical 
therapy, occupational therapy, speech-language pathology, and dietary 
counseling services (as needed) available on a 24-hour basis. The

[[Page 30869]]

hospice would also be able to seek a waiver of the requirement that it 
provide dietary counseling directly. The hospice would have to provide 
evidence that it had made a good faith effort to meet the requirements 
for these services before it sought such a waiver. To extend the 
waiver, the hospice would be required to submit a request to CMS 
recertifying that the conditions under which it originally requested 
the initial waiver had not changed since the initial waiver was 
granted.
    The burden associated with this requirement would be the time it 
would take to provide the necessary documentation and the time it would 
take to request an extension. We estimate that there would be no more 
than 5 hospices providing the information and requesting extensions. 
Under section 1320.3, this requirement would not be subject to the PRA, 
since it would affect fewer than 10 entities.

Section 418.76 Condition of Participation: Home Health Aide and 
Homemaker Services

    Under this section, the hospice would be required to maintain 
documentation that it met the requirements of the standard concerning 
the content and duration of home health aide classroom and supervised 
practical training, competency evaluation, and in-service training.
    We estimate that it would take approximately 5 minutes per home 
health aide to document meeting this standard and that 2,412 home 
health aides would be trained each year nationally, for a total of 201 
hours annually.
    Under this section, written patient care instructions would have to 
be prepared by a registered nurse or other licensed professional.
    We believe that this requirement reflects a usual and customary 
business practice and the burden would not be subject to the PRA.
    Home health aides would be required to report changes in the 
patient's medical, nursing, rehabilitative, and social needs to a 
registered nurse or other appropriate licensed professional, and 
complete appropriate records in compliance with the hospice's policies 
and procedures. In addition, as members of the interdisciplinary team, 
home health aides would be required to report any change in a patient's 
condition as the change related to the plan of care and quality 
assessment and performance improvement activities.
    Under this section as well, homemakers would be required to report 
all concerns about the patient or family to the member of the 
interdisciplinary group who was coordinating homemaker services.
    We believe that reporting and documenting this is a usual and 
customary business practice and, as such, the burden would not be 
subject to the PRA.

Section 418.78 Conditions of Participation--Volunteers

    Under this section, the hospice would be required to maintain, 
document and provide volunteer orientation and training that was 
consistent with hospice industry standards.
    We estimate that on average a hospice would provide orientation and 
training 6 times per year and that it would take no more than five 
minutes to document each orientation session, for a total of 30 minutes 
per year, and a national total of 1,206 hours.
    Under this section, the hospice would be required to document 
savings achieved through the use of volunteers.
    We estimate that this activity would take approximately 3 hours per 
hospice per year, or 7,236 hours nationally.
    The hospice would also be required to record examples of patient 
care tasks and administrative services performed by volunteers, 
including the type of services and time worked.
    We estimate that recording these examples would take approximately 
600 hours per year per hospice, or 1,447,200 hours nationally.

Section 418.100 Condition of Participation: Organization and 
Administration of Services

    Under paragraph (e) of this section, arranged services would be 
required to be supported by written agreements that would have to 
require specified activities.
    Written agreements are a necessary part of usual and customary 
business practice; thus, the burden would be exempt from the PRA under 
section 1320.3(b)(2).
    Under paragraph (g), the hospice would be required to have written 
policies and procedures describing its method(s) of assessing 
competency and would be required to maintain a written description of 
the in-service training provided during the previous 12 months.
    Written policies and procedures are a necessary part of usual and 
customary business practice; thus, we believe that the burden would be 
exempt from the PRA under section 1320.3(b)(2).

Section 418.102 Condition of Participation: Medical Director

    This section would require the medical director or physician 
designee to review the clinical information for each hospice patient 
and provide written certification that it was anticipated that the 
patient's life expectancy was 6 months or less if the illness were to 
run its normal course.
    The burden associated with this would be the review time and the 
written certification. We estimate that it would take approximately 10 
minutes per patient, for a total of 49 hours per hospice annually and 
118,833 nationally.

Section 418.104 Condition of Participation: Clinical Records

    Under this section the hospice would be required to maintain on 
each patient a clinical record that contained accurate clinical 
information and was available to the patient's attending physician and 
hospice staff.
    The burden associated with this requirement would be the time it 
would take to maintain a record on each patient. We believe that the 
requirement reflects usual and customary medical practices and, as 
such, the burden would not be subject to the PRA.
    Paragraph (e) of this section would require that, if the care of a 
patient were transferred to another Medicare/Medicaid-approved 
facility, the hospice would be required to forward a copy of the 
patient's clinical record and the hospice discharge summary to that 
facility. If a patient revoked the election of hospice care, or was 
discharged from hospice because eligibility criteria were no longer 
met, the hospice would have to provide a copy of the clinical record 
and the hospice discharge summary of this section to the patient's 
attending physician.
    The burden associated with this requirement would be the time it 
took to forward the clinical record and discharge summary. This is a 
usual and customary business practice, and as such the burden would not 
be subject to the PRA.

Section 418.106 Condition of Participation: Drugs, Controlled Drugs and 
Biologicals, Medical Supplies, and Durable Medical Equipment

    Under paragraph (b), the hospice would be required to have a 
written policy for tracking, collecting, and disposing of controlled 
drugs maintained in the patient's home.
    The burden associated with this requirement would be the time it 
would require to put the policy in writing. Written policies are a 
necessary part of usual and customary business practice; thus, we 
believe that the burden would be exempt from the PRA under section 
1320.3(b)(2).

[[Page 30870]]

    Under paragraph (b) of this section, during the initial hospice 
assessment, the use and disposal of controlled substances would be 
required to be discussed with the patient and family to ensure the 
patient and family were educated regarding the use and potential danger 
of controlled substances. The hospice nurse would be required to 
document that the policy was discussed with the patient and family.
    We anticipate that the discussion and documentation of the 
discussion would take approximately 5 minutes per patient, and 24.58 
hours per hospice, for a total of 59,417 hours annually for all 
patients.
    Under paragraph (c) of this section, if, for a piece of equipment, 
there were no manufacturer recommendations for repair and routine 
maintenance, the hospice would be required to develop in writing its 
own repair and routine maintenance policy.
    The burden associated with this requirement would be the time 
required to put the policy in writing. Written policies are a necessary 
part of usual and customary business practice; thus, we believe that 
the burden would be exempt from the PRA under section 1320.3(b)(2).

Section 418.108 Condition of Participation--Short-Term Inpatient Care

    If the hospice had an arrangement with a facility to provide for 
short-term inpatient care, the arrangement would have to be described 
in a legally binding written agreement that at a minimum contained 
specified elements.
    The burden associated with this requirement would be the time it 
took to negotiate, draft, and sign the agreement. Having written 
agreements is a usual and customary business practice and, as such, we 
believe that the burden would not be subject to the PRA.

Section 418.110 Condition of Participation: Hospices That Provide 
Inpatient Care Directly

    Under paragraph (c)(1)(i) of this section, we would require a 
hospice to report breaches of safety and equipment failures to the 
appropriate State and local bodies having regulatory jurisdiction.
    The reporting burden associated with this requirement would be the 
time required to report such safety and equipment breaches. We estimate 
that there would be approximately 110 safety and equipment breaches 
annually nationwide. Filing a report regarding these events would take 
approximately 30 minutes per event for a total of 55 hours annually 
nationwide.
    Under paragraph (c)(1)(iii) of this section, the hospice would be 
required to have a written disaster preparedness plan in effect for 
managing the consequences of power failures, natural disasters, and 
other emergencies that might affect the hospice's ability to provide 
care.
    The burden associated with this requirement would be the time it 
took to write the disaster preparedness plan. We believe that hospices 
will each spend 1 hour developing a disaster plan for a total of 2,412 
hours on a one time basis.
    Under paragraph (m) of this section, under the direction of a 
qualified pharmacist, the hospice would be required to provide 
pharmaceutical services such as drugs and biologicals and have a 
written protocol in place that would ensure dispensing accuracy.
    The burden associated with this requirement would be the time it 
took to devise and write down the protocol. We believe that having such 
a protocol in writing is a usual and customary business practice, and, 
as such, we believe that the burden would be exempt from the PRA.
    Paragraph (n) of this section would require a physician to order 
all medications for a patient; all drugs and biologicals to be labeled 
in accordance with accepted professional practice, containing specified 
information; and would require the hospice to keep current and accurate 
records of the receipt and disposition of all controlled drugs. Any 
discrepancies in the acquisition, storage, use, disposal, or return of 
controlled drugs would have to be investigated immediately by the 
pharmacist and hospice administrator and, where required, reported to 
the appropriate State agency; a written account of the investigation 
would be required to be made available to State and Federal officials.
    The burden associated with these requirements would be the time 
required to (1) document orders, label drugs, and maintain current and 
accurate records of the receipt and disposition of all controlled 
drugs; and (2) document, investigate, and report drug discrepancies. We 
believe that the first requirement, concerning ongoing documentation, 
reflects customary and usual medical and business practices and the 
burden would therefore be exempt under the PRA. For the documentation, 
investigation and reporting of drug discrepancies, we estimate that 
there are 55 events annually that would require such documentation, and 
that each event would require one hour of labor to meet the proposed 
requirements for a total of 55 hours nationally annually.
    Paragraph (o) of this section would require orders for a physical 
restraint or seclusion to be written, and that physical restraint or 
seclusion be supported by a documented order and the patient's response 
or outcome and documented in the patient's clinical record. In 
addition, the hospice must report any death that occurs while the 
patient is restrained or in seclusion.
    We estimate that there would be approximately 7,130 incidents of 
physical restraint or seclusion and that it would take approximately 4 
minutes to write the orders and to document the incident, for an annual 
national total of 475 hours. Additionally, it would take six hours for 
a hospice to develop a customized pre-printed seclusion and restraint 
order, totaling 14,472 hours nationwide on a one-time basis.
    We have no concrete estimate of the number of deaths that would 
occur per year that occurred while the patient was restrained or 
secluded. We believe that the number of deaths is less than 10 per 
year, and we would expect that number to decrease as hospices implement 
the proposed new seclusion and restraint requirements. Therefore, under 
section 1320.3, this requirement is not subject to the PRA, as it would 
affect fewer than 10 entities.

Section 418.112 Condition of Participation: Hospices That Provide 
Hospice Care to Residents of a SNF/NF, ICF/MR, or Other Facility

    Paragraph (e) of this section would require the hospice and the 
other facility to have a written agreement that would specify the terms 
under which the hospice would provide hospice services in the facility, 
and would require the agreement to be signed by authorized 
representatives of the hospice and the facility, before the hospice 
could provide such hospice services. The written agreement would have 
to include specified information and documents.
    The burden associated with this requirement would be the time 
required to draft and sign an agreement and to gather the information 
to be sent on each patient. Both of these requirements can be 
considered customary and usual medical and business practices. Thus, 
the burden would not be subject to the PRA.
    Paragraph (f) of this section would require a written plan of care 
to be established and maintained for each facility patient, developed 
by and coordinated with the hospice interdisciplinary group in 
consultation

[[Page 30871]]

with facility representatives, and in collaboration with the 
individual's attending physician. The plan of care would be required to 
include specified information.
    This proposed burden is included with the burden discussed under 
section 418.56.
    Under paragraph (g) of this section we would require a hospice to 
provide the facility with the following information specified in this 
paragraph.
    The burden associated with this requirement would be the time 
required by staff to compile the information. However, we believe that 
such information compilation is a usual and customary medical and 
business practice. Thus, the burden would not be subject to the PRA.

Section 418.114 Condition of Participation: Personnel Qualifications 
for Skilled Professionals

    Paragraph (d) of this section would require each hospice to obtain 
a criminal background check on each employee, including but not limited 
to those employees who have hands-on patient contact, those who are 
employed in an administrative or maintenance capacity, those who are 
volunteers, and those who provide services under contract. The 
background check would be required to be obtained before the hospice 
would employ that person.
    In 2002, 39 states required criminal background checks for hospice 
employees. In these states approximately 70,395 hospice employees have 
already received a criminal background check, thus greatly reducing the 
overall burden. We estimate that hospices that have not previously 
performed background checks, accounting for 19,876 hospice employees, 
would each obtain 39 criminal background checks initially. Each 
background check request form would take 6 minutes to prepare and send, 
for a total of 4 hours per hospice the first year. For each year 
thereafter all hospices would complete background checks on 
approximately 8 new employees per year for a total of 48 minutes per 
hospice per year and 1,852 hours nationally per year.
    The total burden of these requirements would be 2,117,529 hours 
annually and 16,888 hours on a one-time basis.
    To comment on these information collection and record keeping 
requirements, please mail copies directly to the following:

Centers for Medicare & Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Regulations Development and 
Issuances Group, Attn: William Parham, Room C5-14-03, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Christopher Martin, CMS Desk Officer, (CMS-3844-P), 
[email protected]. Fax: (202) 395-6974.

VI. Impact Analysis

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 (as amended by Executive Order 13258, which 
merely reassigns responsibility of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($110 million or more in any 1 year). 
This is not a major rule, since the overall economic impact for all 
proposed new Conditions of Participation is estimated to be $13.7 
million annually.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and government agencies. 
Individuals and States are not included in the definition of a small 
entity. For purposes of the RFA, most hospices (approximately 73% of 
Medicare certified facilities) are considered to be small entities, 
either by virtue of their nonprofit or government status or by having 
revenues of $6 million to $29 million in any one year (for details, see 
the Small Business Administration's regulation that sets forth size 
standards for health care industries at 65 FR 69432). We estimate there 
are approximately 2,412 hospices with average admissions of 
approximately 295 patients per hospice (based on the number of patients 
in 2003 divided by the number of hospices in 2003). The National 
Hospice and Palliative Care Organization estimates that 79 percent of 
hospice patients are Medicare beneficiaries, thus we have not 
considered other sources of revenue in this analysis.
    We certify that this rule would not have a significant impact on a 
substantial number of small entities because the cost of this rule is 
less than 1 percent of total hospice Medicare revenue. According to the 
CMS 2003 national expenditure data, Medicare paid $5.7 billion to 
providers for hospice care in 2003. We estimate this rule will cost 
hospices approximately $16.9 million or approximately $7,389 per 
statistically average hospice annually.
    We understand that there are different sizes of hospices and that 
the burden for hospices of different sizes will vary. Therefore, we 
have assessed the burden for hospices that are smaller than the 
statistically average hospice used for calculations in part B of this 
section, Anticipated effects on hospices. The smaller hospices have 
been broken up into three categories based on the number of routine 
home care days, the most common level of hospice care provided. The 
categories are: group 1 hospices providing 0 to 1,754 routine home care 
days; group 2 hospices providing 1,755 to 4,373 routine home care days; 
and group 3 hospices providing 4,374 to 9,681 routine home care days. 
Group 1 hospices, averaging 23 patients per year, would spend 
approximately $1,845 to comply with the proposed regulations. The 
average hospice in this group received $101,181 from Medicare for 
routine home care days under the 2002 hospice payment rates. Group 2 
hospices, averaging 77 patients per year would spend approximately 
$2,936 to comply with the proposed regulations. The average hospice in 
this group received $325,533 from Medicare for routine home care days 
under the 2002 rates. Group 3 hospices, averaging 173 patients per 
year, will spend approximately $4,889 to comply with the proposed 
regulations. The average hospice in this group received $767,550 from 
Medicare for routine home care days under the 2002 rates.
    The time and cost burden for these providers is significantly less 
than that of the statistically average hospice used in part B of this 
section because the majority of the burden imposed by the proposed 
regulations is directly tied to patient care and the staff necessary to 
provide care. Therefore, a reduced patient census leads to reduced 
burden. These figures do not, however, adjust the estimated quality 
assessment and performance improvement burden

[[Page 30872]]

described in part B of this section. We estimate that t he financial 
burden for group 1 hospices would be 1.75 percent of the payment 
received for routine home care days. For group 2 hospices the financial 
burden would be less than 1 percent, and for group 3 hospices the 
financial burden would be less than 0.75 percent of Medicare payments 
for routine home care days. These percentages do not include amounts 
paid by Medicare for continuous home care days, respite care days, and 
regular inpatient care days. The percentages also do not include 
amounts paid by Medicaid, private insurers, and individual patients, 
which account for approximately 21 percent of hospice revenue.
    In addition, section 1102 (b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. We 
believe that this rule would not have a significant impact on the 
operations of a substantial number of small rural hospitals, since 
there are few hospice programs in those facilities.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any proposed rule that may result in an expenditure of $110 
million or more in any one year by a State, local, or tribal 
government, in the aggregate, or by the private sector. This rule has 
no impact on the expenditures of State, local, or tribal governments, 
and the impact on the private sector is estimated to be far less than 
$110 million.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct compliance costs on State 
or local governments, preempts State law, or otherwise has Federalism 
implications. This rule has no Federalism implications.

B. Anticipated Effects on Hospices

    As described in the preamble, this proposed regulation contains 
both new provisions and provisions that are carried over from the 
existing hospice regulations. For purposes of this section, we have 
assessed the impact of the new provisions. The provisions contained in 
the existing regulations are simply being re-codified and therefore do 
not present a new burden to hospices.
    Within this section, we have made several assumptions and estimates 
in order to assess the time that it would take for a hospice to comply 
with the provisions and the associated costs of compliance. We have 
detailed these assumptions and estimates in the table below. We have 
also detailed many, but not all, of the standards within each CoP, and 
have noted whether or not there is an impact for each. However, the 
requirements contained in many provisions are already standard medical 
or business practices. These requirements would, therefore, not provide 
additional burden to hospice providers.

 Table 1.--Assumptions and Estimates Used Throughout the Impact Analysis
                                 Section
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Number of Medicare hospices nationwide.......................      2,412
Number of hospice patients nationwide........................    713,000
Number of patients per average hospice.......................        295
Hourly rate of registered nurse..............................        $27
Hourly rate of office employee...............................        $19
Hourly rate of administrator.................................        $42
Hourly rate of home health aide..............................        $14
Hourly rate of pharmacist....................................        $45
Hourly rate of medical director..............................        $84
------------------------------------------------------------------------

Patient Rights (Sec.  418.52)
    The proposed rule would expand on the informed consent section 
(Sec.  418.62) of the current rule, recognizing that hospice patients 
are entitled to certain rights that must be protected and preserved, 
and that all patients must be able to freely exercise those rights.
    (a) Standard: Notice of Rights. A hospice would be required to 
provide patients or their representatives with written and verbal 
notice of the patient's rights and responsibilities during the initial 
evaluation and would have to document this notification as well as 
document that the patient/representative understands their rights.
    A hospice would also be required to inform and distribute written 
information regarding its policies on advance directives, and it would 
have to inform the patient, representative, and family of its drug 
policies and procedures. We estimate that it would take eight hours on 
a one-time basis for a hospice to develop a patient rights form, at a 
cost of $336, based on the assumption that an administrator will 
develop the form. We estimate that it would take approximately five 
minutes per patient to incorporate this information into the existing 
informed consent process. At the average hourly rate for a registered 
nurse, it would cost $2.25 per patient to fulfill the requirement.
     8 hours x $42 an hour = $336
     $27 hour/60 minutes = $0.45 minute x 5 minutes = $2.25
    (b) Standard: Exercise of rights and respect for property and 
person. A hospice would be required to investigate and document all 
allegations, unexplained injuries, and misappropriations. It would be 
required to report such incidents to the hospice administrator and 
appropriate State and local bodies having jurisdiction, and take action 
to correct problems once they were identified.
    We expect that a hospice administrator would handle the 
investigations. We estimate that as many as 5% (15) of an average 
hospice's patients would require a one hour-long investigational 
session, for a total of 15 hours per hospice. We estimate that hospices 
will spend, on average, three minutes per patient, at a cost of $2.10 
per patient per year to comply with this provision. The cost for the 
entire hospice industry would be $1,497,300 a year, while the cost for 
an average hospice would be $619.50 a year.
     15 hours x 60 minutes = 900 minutes, 900 minutes/295 
patients = 3 minutes per patient
     $42 hour/60 minutes = $0.70 per minute x 3 minutes per 
patient = $2.10 per patient
     $2.10 per patient x 713,000 patients = 1,497,300,
     $2.10 per patient x 295 patients = $619.50
    (c) Standard: Pain management and symptom control. There is no 
burden associated with this standard.
    (d) Standard: Confidentiality of clinical records. There is no 
burden associated with this standard.
    (e) Standard: Patient liability. A hospice would be required to 
inform a patient verbally and in writing about his or her payment 
liability. Developing a form to notify patients is not a burden because 
CMS has already developed this form, CMS-R131, Advanced Beneficiary 
Notice (ABN). Informing the patient verbally and in writing would take 
five minutes per patient to fulfill, or 24.58 hours per average hospice 
and 59,417 hours nationwide. The estimated cost would be $2.25 per 
patient, $663.75 per hospice, and $1,604,250 nationwide.
     5 minutes per patient x 295 patients = 24.58 hours
     5 minutes per patient x 713,000 patients = 59,417 hours
     $27 hour/60 minutes = $0.45 minute x 5 minutes = $2.25
     $2.25 per patient x 295 patients = $663.75
     $2.25 per patient x 713,000 patients = $1,604,250

[[Page 30873]]



                                   Table 2.--Patient Rights Burden Assessment
----------------------------------------------------------------------------------------------------------------
                                    Time per     Time per                                Cost per
            Standard                patient       hospice     Total time    Cost per      average     Total cost
                                   (minutes)      (hours)      (hours)      patient       hospice
----------------------------------------------------------------------------------------------------------------
Notice of rights................            5         24.58       59,417        $2.25       $663.75   $1,604,250
Exercise of rights..............            3         15          34,740         2.10        630       1,408,325
Notice of liability.............            5         24.58       59,417         2.25        663.75    1,604,250
                                 --------------
    Totals......................           13         64.16      153,574         6.60      1,947       4,705,800
----------------------------------------------------------------------------------------------------------------

Comprehensive Patient Assessment (Sec.  418.54)
    The existing rule (Sec.  418.58(c)) requires the hospice to assess 
the patient's needs and to state in detail the scope and frequency of 
services needed. The proposed rule would go beyond this by specifying 
the time for completing the assessment, the factors to be included in 
the assessment, and the time for updating the assessment. However, we 
do not believe this will add any additional burden, since this section 
of the proposed rule reflects the contemporary standard practice of 
hospice programs.
    Standard: Content of the comprehensive assessment. The assessment 
would be required to identify the physical, psychosocial, emotional, 
and spiritual needs related to the terminal illness. Every assessment 
would likely include factors such as the patient's physical and 
nutritional needs, pain status, and psychological state. This differs 
from the current rule in that it describes what would be included in 
the plan of care. The factors that are described were identified by the 
industry and reflect standard industry practice.
    Standard: Update of the comprehensive assessment. Updates of the 
patient's comprehensive assessment would have to be conducted at least 
every 14 days and at the time of each recertification. The current 
regulation allows the plan of care to determine the frequency of 
updates. However, due to the rapidly changing status of hospice 
patients it is standard practice for hospices to update patient 
assessments at least every 14 days, and often more frequently; 
therefore, this proposed new standard is simply codifying current 
industry practice and should not present a burden.
    Standard: Patient outcome measures. The comprehensive assessment 
would have to include consistent pre-determined data elements that 
allowed for the measurement of outcomes. (Note: There is no data 
reporting element.)
    We believe this standard would pose a burden on the hospice 
provider. However, the burden of collecting information related to 
these outcome measures is calculated as part of a hospice's quality 
assessment and performance improvement program. If a hospice currently 
collects data and calculates values for measures that are reported to 
the NHPCO, it will meet the requirement in the proposed rule.
Interdisciplinary Group, Care Planning and Coordination of Services 
(Sec.  418.56)
    The proposed rule makes several changes to the existing rule to 
improve patient care and lessen burden.
    (a) Standard: Approach to service and delivery. Unlike the existing 
requirement that a registered nurse must implement a patient's plan of 
care, this new rule would allow any qualified member of the 
interdisciplinary group to implement a patient's plan of care, 
lessening the burden on hospices and the demand on registered nurses.
    (c) Standard: Content of the plan of care. This section goes into 
further detail about the content of each patient's plan of care than 
the existing regulation does. The burden of including these items is 
accounted for in the development of the plan of care, as described in 
part 2 of this section. The items that would be required under the 
proposed rule are already included in the standard industry patient 
plan of care.
    (d) Standard: Review of the plan of care. The existing rule states 
that a patient's plan of care should be reviewed at intervals specified 
in the initial plan of care. The proposed rule would require that it be 
reviewed at least every two weeks. We estimate that documenting the 
update of a patient's plan of care would take five minutes per patient 
and that each patient's plan of care would be updated 3 times, based on 
a an average 51 day length of stay (2002 nov., Medicare National 
Summary for HHA, Hospice, SNF, and outpatient CY 1999-2001). This 
amounts to 15 minutes per patient, or 73.75 hours per hospice, at a 
cost of $6.75 per patient for a registered nurse to complete the 
updates.
     $27 hour/60 minutes = $0.45 minute x 15 minutes = $6.75
     $6.75 per patient x 295 patients = $1,991.25
     $6.75 per patient x 713,000 patients = $4,812,750

        Table 3.--Interdisciplinary Group, Care, Planning, and Coordination of Services Burden Assessment
----------------------------------------------------------------------------------------------------------------
                                      Time per     Time per                               Cost per
             Standard                 patient      hospice     Total time    Cost per     average     Total cost
                                     (minutes)     (hours)      (hours)      patient      hospice
----------------------------------------------------------------------------------------------------------------
Update plan of care...............           15        73.75      178,250        $6.75    $1,991.25   $4,812,750
                                   --------------
    Totals........................           15        73.75      178,250         6.75     1,991.25    4,812,750
----------------------------------------------------------------------------------------------------------------

Quality Assessment and Performance Improvement (Sec.  418.58)
    The current rule requires a hospice to maintain a quality assurance 
program that involves an ongoing, comprehensive, integrated self-
assessment by the hospice of the quality and appropriateness of care 
(Sec.  418.66). The proposed rule would provide more guidance to 
providers and would require approximately 24 hours a year to implement. 
Many providers are already using comprehensive quality assessment and 
performance improvement programs for accreditation or

[[Page 30874]]

independent improvement purposes, including one designed by the NHPCO. 
For those providers who choose to develop their own quality assessment 
and performance improvement program, we estimate that it would take 12 
hours to create a program. We also estimate that hospices would spend 4 
hours a year collecting and analyzing data. In addition, we estimate 
that hospices would spend 3 hours a year training their staff and 5 
hours a year implementing performance improvement activities. Both the 
program development and implementation would most likely be managed by 
that hospice's administration. Based on an administrator's hourly rate, 
the total cost of the quality assessment and performance improvement 
condition of participation would be $1,008 per hospice.
     $42 per hour x 24 hours = $1,008
    Our hourly burden estimates are based on the proportion of patients 
to hours that is found in the CMS final rule, Hospital Conditions of 
Participation: Quality Assessment and Performance Improvement at 68 FR 
3435 (January 24, 2003). CMS estimated that a hospital would spend 80 
hours collecting and analyzing data on 12 identified measures. 
According to 2002 CMS statistics, in 2000, 5,985 hospitals discharged 
11.8 million patients. This means that the statistically average 
hospital discharged approximately 2,000 patients that year. Therefore, 
collecting and analyzing data for 2,000 patients would take 80 hours, 
for a ratio of 80 hours/2,000 patients (or 4 hours/100 patients). Based 
on this estimate, for the average 295 patient hospice, we believe that 
this ratio would be 12 hours/295 patients. However, we do not expect 
hospices to collect information on 12 measures, as hospitals are 
required to do. Hospices that collect information in the four suggested 
areas (self-determination, comfort, safety, and effective grieving) 
would have one third the burden required to collect the 12 hospital 
measures, or 4 hours. This ratio methodology is also used to assess the 
burden in all other quality assessment and performance improvement 
areas.
    (a) Standard: Program scope. Under the existing regulation, 
hospices must assess the quality and appropriateness of the care they 
provide. This new standard would expand on the rule by requiring that 
the existing assessment become a formal quality assessment and 
performance improvement program that is capable of showing measurable 
improvement through the use of quality indicator data.
    (b) Standard: Program data. The proposed rule would require the use 
of quality indicator data in a quality assessment and performance 
improvement program, but would not require any specific data collection 
or utilization, nor would it require hospices to report the collected 
data. This would give hospices flexibility and minimize burden.
    (c) Standard: Program activities. This new standard would identify 
certain areas that would be required to be covered in a hospice's 
customized quality assessment and performance improvement program. The 
categories would be sufficiently broad to allow for a vast range of 
acceptable compliance methods. This would minimize burden.

                   Table 4.--Quality Assessment and Performance Improvement Burden Assessment
----------------------------------------------------------------------------------------------------------------
                                                                Time per
                          Standard                              hospice     Total time    Cost per    Total cost
                                                                (hours)      (hours)      hospice
----------------------------------------------------------------------------------------------------------------
QAPI development............................................           12       28,944         $504   $1,215,648
QAPI implementation.........................................           12       28,944          504    1,215,648
                                                             --------------
    Total annually..........................................           24       57,888        1,008    2,431,296
----------------------------------------------------------------------------------------------------------------

Infection Control (Sec.  418.60)
    There is no specific existing requirement for infection control 
other than what is briefly mentioned in the existing Sec.  418.100(i), 
Standard: Isolation areas. However, we believe that hospice clinicians 
such as nurses, physicians, and therapists are already using infection 
control practice as part of the current requirement that hospice 
clinicians provide services to patients in accordance with accepted 
standards of practice. It is an accepted standard of practice to use 
infection control methods when caring for patients. This proposed 
regulation would reinforce those positive infection control practices 
and would address the serious nature and potential hazards of 
infectious and communicable diseases. Infection control and standard 
precautions are long-standing clinical practices that are standard 
throughout the medical industry. This proposed CoP would require 
hospices to continue to take specific and appropriate actions to 
address the prevention and control of infections, and to educate the 
patients, staff and caregivers on the hazards, prevention and control 
of infections. We acknowledge that this is a new focus; however, we do 
not believe this would add any regulatory burden, since this section of 
the proposed rule reflects contemporary standard practice in hospice 
programs.
Core Services (Sec.  418.64)
    The proposed rule would allow core services to be provided under 
contract with another Medicare certified hospice in certain 
extraordinary or other non-routine circumstances as described, allowing 
hospices more flexibility. In addition, it would allow hospices to 
contract for highly specialized nursing services, allowing for even 
more flexibility. The option to contract out for highly specialized 
nursing services would allow hospices to provide such highly 
specialized services at a lower cost than if the hospice directly 
employed individuals to perform such services. We are proposing that 
hospices that choose to contract for core services or highly 
specialized nursing services must have a contract with the entity 
providing the contracted services. Negotiating, documenting and signing 
a business contract is a standard business practice and does not impose 
a burden.
    The proposed rule also would require that a psychosocial assessment 
of the patient be undertaken by the social worker providing medical 
social services. There is no substantive change to this regulatory 
burden.
Waiver of Requirement--Physical Therapy, Occupational Therapy, Speech-
Language Pathology, and Dietary Counseling (Sec.  418.74)
    This proposed waiver, currently implemented through a memorandum 
from CMS's Center for Medicaid and State Operations, would reduce the 
compliance burden on hospices located in non-urbanized areas. If the 
hospice program could demonstrate that recruitment efforts were 
unsuccessful, it

[[Page 30875]]

could request certain waivers with respect to PT, OT, speech-language 
pathology, and dietary counseling. Thus far there have been less than 
five applications for this waiver in the last four years; therefore we 
believe that the burden is negligible.
Home Health Aide and Homemaker Services (Sec.  418.76)
    Home health aide and homemaker services are an integral part of 
hospice care, yet they receive little attention in the current 
regulation. These services are briefly addressed in Sec.  418.94 with a 
standard regarding the supervision of home health aide services and a 
standard regarding written patient care instructions. These two 
standards appear in the proposed regulation, with some minor 
alterations. The proposed regulation also would add several new 
requirements.
    (b) Standard: Content and duration of home health aide classroom 
and supervised practical training; (c) Standard: Competency evaluation; 
(d) Standard: In-service training. These three standards would describe 
the ways in which a home health aide could meet the proposed 
qualification requirements. All of these standards would require the 
hospice to maintain documentation that each home health aide met these 
qualifications. The burden associated with these standards is the time 
it would take to complete the required documentation. We estimate that 
it would take five minutes to document the information and that an 
office employee would complete this task. In addition, we have 
calculated the burden based on an assumed employee turnover rate of 
20%, meaning that we expect that the average hospice would replace 20% 
of its home health aides in a given year, or roughly one home health 
aide a year based on the employment of 5 home health aides. We believe 
that this is a reasonable assumption. Based on the above-mentioned 
estimates and assumptions, we estimate that will cost an average 
hospice $1.60 to document that its home health aides meet the proposed 
qualification requirements, for a total cost of $3,859.20 nationwide.
     19 an hour/60 minutes = $0.32 minute x 5 minutes to 
document that requirements are met per home health aide = $1.60 x 1 
document per year = $1.60 per hospice
     $1.60 per hospice x 2,412 hospices = $3,859.20
    (g) Standard: Home health aide assignments and duties. The home 
health aide would be required to report changes in the patient's needs 
to a registered nurse, and complete appropriate records in compliance 
with the hospice's policies and procedures. This new requirement 
reflects the standard industry practice of maintaining communication 
between all healthcare providers and maintaining a complete patient 
record.
    (h) Standard: Supervision of home health aides. This standard would 
retain the current rule's requirement that a registered nurse or 
qualified therapist visit the patient's home to assess home health aide 
services every 14 days. It also would add a requirement that a 
registered nurse or qualified therapist visit the patient's home every 
28 days when the aide is providing services in the home. We believe 
that thoroughly supervising employees is standard practice and does not 
increase burden.
    (j) Standard: Homemaker qualifications. The proposed regulation 
would require homemakers to complete a hospice orientation program 
addressing the needs and concerns of patients and families coping with 
a terminal illness. We believe that this standard would not impose any 
additional regulatory burden because hospices train all their 
employees, including homemakers, to deal with the realities of hospice 
care; this is already accepted standard practice in the industry.
    (k) Standard: Homemaker supervision and duties. The 
interdisciplinary group would be required to develop written 
instructions for the homemaker. We believe that providing patient care 
instructions is a usual and customary medical practice; therefore, this 
requirement would not impose any additional regulatory burden.

                       Table 5.--Home Health Aide and Homemaker Services Burden Assessment
----------------------------------------------------------------------------------------------------------------
                                      Time per     Time per                               Cost per
             Standard                   aid        hospice     Total time    Cost per     average     Total cost
                                     (minutes)    (minutes)     (hours)        aid        hospice
----------------------------------------------------------------------------------------------------------------
Documentation (based on 1 new HHA             5            5          201        $1.60        $1.60    $3,859.20
 per year) *......................
                                   --------------
    Totals........................            5            5          201         1.60         1.60     3,859.20
----------------------------------------------------------------------------------------------------------------

Organization and Administration of Services (Sec.  418.100)
    The proposed requirement is essentially the same as the current 
regarding the organization and administration of services. However, the 
proposed rule would add a specification that a hospice's satellite 
locations be approved by CMS, a practice that is currently mandated 
through a June 1997 memorandum from CMS' Center for Medicaid and State 
Operations. A specification for the maintenance of in-service training 
records and a requirement that education/training be given to the 
patient, family and primary caregiver would also be new regulations. 
However, we believe all of these additions reflect standard practice in 
the industry and present no additional burden.
Medical Director (Sec.  418.102)
    The existing rule requires that the medical director be an employee 
of the hospice. The proposed rule would permit the medical director to 
work under a contractual arrangement; this would reduce the program and 
hiring burden on the hospice, particularly if the hospice is in a rural 
area.
    We believe that the proposed rule would merely codify the current 
standards of practice to which medical directors adhere. For example, 
coordinating with other physicians and health care professionals, 
considering broad criteria when making the determination that hospice 
care is appropriate, and reviewing relevant information prior to the 
date that re-certification is necessary are all standard procedures.
Clinical Records (Sec.  418.104)
    The proposed rule would permit hospices to maintain records 
electronically. This would provide flexibility and reduce burden. While 
the proposed rule also would add specificity in regard to content, 
authentication, retrievability, retention, and transfer of records, we 
believe that these additions reflect standard industry practice and 
would therefore add no burden.

[[Page 30876]]

Drugs, Medical Supplies and Durable Medical Equipment (Sec.  418.106)
    (a) Standard: Administration of drugs and biologicals. The proposed 
rule would require the interdisciplinary group to periodically review 
the plan of care to determine whether the patient and/or family 
continued to have the ability to safely administer drugs and 
biologicals. This review, however, would not burden hospices because it 
would be part of the standard 14 day review of the patient's plan of 
care that already would be performed by the interdisciplinary group. 
The current rule details persons permitted to administer drugs. The 
proposed rule would eliminate this level of specificity, thus giving 
the hospice greater flexibility. The proposed rule would require only 
that drugs be administered in accordance with standards of practice and 
the patient's plan of care.
    (b) Standard: Controlled drugs in the patient's home. The current 
rule requires that the hospice have a policy for the disposal of 
controlled drugs maintained in the patient's home. The proposed rule 
would add to the existing rule a requirement that the hospice have a 
policy for tracking and collecting these drugs. The proposed rule would 
require the use and disposal of controlled substances to be discussed 
with the family, and would require the hospice nurse to document this 
discussion. Developing written policies is part of usual and customary 
medical and business practices. Thus, this standard would create no 
additional burden.
    The second requirement, a documented education session regarding 
hospice drug policies would require approximately five minutes during 
the initial evaluation conducted by a registered nurse. Fulfilling the 
requirement would cost $2.25 per patient based upon the average hourly 
rate for a registered nurse.
     $27 hour/60 minutes = $0.45 minute x 5 minutes = $2.25
     $2.25 per patient x 295 patients = $663.75
     $2.25 per patient x 713,000 patients = $1,604,250
    (c) Standard: Use and maintenance of equipment and supplies. The 
existing rule does not address the use of durable medical equipment, 
but the proposed regulation would do so. The proposed rule would add a 
requirement that the hospice ensure that there is a process for routine 
and preventive maintenance of equipment, that the family receives 
instruction in regard to the use of equipment and supplies, and that 
the safe use of equipment and supplies be demonstrated and monitored. 
This requirement would be fulfilled by the individual most frequently 
at the home, usually a home health aide. Performing these duties would 
take approximately 15 minutes per patient.
     $14 hour/60 minutes = $0.23 minute x 15 minutes per 
patient= $3.45 per patient
     $3.45 per patient x 295 patients = $1,017.75
     $3.45 per patient x 713,000 patients = $2,459,850

                Table 6.--Drugs, Medical Supplies and Durable Medical Equipment Burden Assessment
----------------------------------------------------------------------------------------------------------------
                                                   Time per      Total
                                      Time per     average      industry     Cost per     Cost per      Total
             Standard                 patient      hospice        time       patient      average      industry
                                     (minutes)    (minutes)     (hours)                   hospice        cost
----------------------------------------------------------------------------------------------------------------
Drug Education....................            5        24.58       59,417        $2.25      $663.75   $1,604,250
Equipment.........................           15        73.75      178,250         3.45     1,017.75    2,459,850
                                   --------------
    Totals........................           20        98.33      237,667         5.70     1,681.50   4,064,100>
----------------------------------------------------------------------------------------------------------------

Short Term Inpatient Care (Sec.  418.108)
    The proposed rule would be more specific than the current rule with 
respect to the substance of the written agreement, which we believe is 
a usual and customary business practice. This provision therefore would 
not increase regulatory burden.
Hospices That Provide Inpatient Care Directly (Sec.  418.110)
    (a) Standard: Staffing. The existing rule is highly prescriptive in 
requiring a registered nurse to provide direct patient care on each 
shift. We would eliminate this requirement, to reflect the proposed 
regulation's focus on expected outcomes of care. We believe that the 
patient plan of care drives the amount and skill level of the nursing 
care that would be required and therefore would help the hospice 
determine staffing levels that would reflect the volume of patients, 
patient acuity, and the level of intensity of the nursing care 
required. This approach would give the hospice greater flexibility in 
staffing and therefore reduce the hospice's regulatory burden.
    (c) Standard: Physical Environment. In addition to the existing 
requirement of having and practicing a disaster plan, under the 
proposed regulations a hospice would be required to report safety 
breaches and equipment failures to the appropriate State and local 
bodies having jurisdiction. The entities to which a hospice would 
report a breach or failure would depend on the nature of the breach or 
failure. Additional guidance on this standard would be included in 
another CMS document, such as the State Operations Manual.
    Complying with this standard would require additional staff time. 
In 2001, 1,375 deficiencies were issued by State surveyors for 
violations of the Medicare hospice Conditions of Participation. At 
least some of these deficiencies were related to the physical 
environment of inpatient hospices. We estimate that 110 of those 
deficiencies were related to the safety of the physical environment and 
equipment. Therefore, we believe that approximately 110 safety breaches 
and equipment failures would need to be reported annually by the 
hospice industry.
    We estimate that reporting safety breaches and equipment failures 
would take 30 minutes per episode to complete. This task would be 
completed by a hospice administrator. Each report, therefore, would 
cost $21, for an industry total of $2,310 annually.
     110 reports x 30 minutes per report = 55 hours nationwide
     $42 hour/60 minutes = $0.70 minute x 30 minutes = $21 per 
report
     $21 per report x 110 reports = $2,310
    (i) Standard: Infection Control, contains a cross-reference to 
standards contained in Sec.  418.60. A discussion of the burden of 
those requirements is discussed in that section.
    (l) Standard: Meal service and menu planning. The existing rule is 
highly prescriptive in terms of specifying the number of meals, meal 
spacing, meal planning, and menu planning. The proposed rule would give 
these hospices far greater flexibility by requiring only that the food 
be sanitary,

[[Page 30877]]

nutritious (including therapeutic diets that are in the plan of care), 
fulfilling, palatable and attractive. We believe that this would reduce 
the hospice's burden.
    (n) Standard: Pharmacist. The proposed rule would provide greater 
flexibility in regard to administering medication by permitting any 
health care professional to carry out this function, if it were in 
accordance with his/her scope of practice. We believe that this would 
reduce the hospice's regulatory burden.
    The proposed rule also would require hospices to investigate 
discrepancies involving controlled drugs and to document an account of 
the investigation. Of the 1,375 deficiencies issued by State surveyors 
in 2001, we estimate that 55 were related to controlled drug 
violations. We do not expect a significant increase in violations, and 
estimate that 55 investigations would be conducted and documented 
throughout the hospice industry.
    The proposed rule would require the hospice's pharmacist and 
administrator to conduct controlled drug investigations. We estimate 
that a thorough investigation, including an examination of the records 
of incoming and outgoing drugs and biologicals, and report would 
require one additional hour per incident. The entire industry would 
thus spend 55 hours annually at a cost of $4,785 to fulfill this 
requirement. Maintaining inventory records incoming and outgoing drugs 
and biologicals is a usual and customary business practice and is not a 
burden.
     $42 hour + $45 hour = $87 hour x 1 hour investigation = 
$87 per investigation
     $87 per investigation x 55 investigations = $4,785
    (o) Standard: Seclusion and restraint. The proposed rule would add 
considerable detail in regard to seclusion and restraint. This section 
would be adapted from the language of the Patient's Rights Condition of 
Participation for hospitals published as an Interim Final Rule in the 
Federal Register in July 1999, currently codified at 42 CFR 482.13. The 
burden associated with this standard would be the time it would take to 
document the need for seclusion and/or restraint, and the time to write 
the order. We estimate that a hospice would spend 6 hours to develop 
this form, for a nationwide total of 14,472 hours. After this one-time 
expenditure, it would take four minutes per patient to meet this 
documentation requirement for a total of 475 hours nationwide, based on 
an estimate of the use of seclusion and/or restraint on 1% of the 
entire patient population. The annual cost of this standard would 
therefore be $39,928 nationwide.
     6 hours per hospice x 2,412 hospices = 14,472 hours to 
develop form
     6 hours per hospice x $42 hour = $252 to develop form
     $252 to develop form x 2,412 hospices = $607,824
     713,000 patients x 0.01 percent = 7,130 patients 
nationwide requiring seclusion or restraint x 4 minutes per patient to 
complete form = 475 hours nationwide to complete form
     7,130 patients nationwide requiring seclusion or 
restraint/2,412 hospices = 3 patients per hospice requiring seclusion 
or restraint
     $84 hour/60 minutes = $1.40 minute x 4 minutes per patient 
to complete form = $5.60 per patient to complete form
     $5.60 per patient x 3 patients per hospice requiring 
seclusion or restraint = $16.80 per hospice
     $5.60 per patient x 7,130 patients = $39,928
    There would also be costs associated with developing training 
programs for staff regarding restraint and seclusion use and 
alternative interventions; however, we are not dictating how a hospice 
meets this requirement. Therefore, hospices would have the flexibility 
to decide how to meet this requirement. We believe that the benefits 
associated with training staff would far outweigh the costs involved, 
since proper training would protect the hospice from situations of 
inappropriate restraint and seclusion use and situations that could 
lead to patient injuries and/or deaths.
    Finally, hospices would have to report to CMS, through the 
appropriate CMS regional office, all deaths that occur while a patient 
is restrained or in seclusion. We have no concrete estimate of the 
number of deaths that occur per year. There could be a nominal cost 
involved in making a telephone call to the appropriate CMS regional 
office; however, because we expect that this regulation would reduce 
the number of deaths from restraint and seclusion use, we estimate that 
the number of reports would average less than one call per hospice per 
year. Therefore, we think the cost will be negligible.

                                        Table 7.--Hospices That Provide Inpatient Care Directly Burden Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                             Cost per
              Standard                    Time per  patient         Time per hospice        Total time       Cost per         average       Total cost
                                                                                              (hours)         patient         hospice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical environment................  1 second................  5 minutes...............              55           $0.01           $1.00          $2,310
Pharmacist..........................  1 second................  5 minutes...............              55            0.01            2.06           4,785
Seclusion form development..........  1 minute................  6 hours.................          14,472            0.84          252            607,824
Seclusion form completion...........  4 minutes...............  12 minutes..............             475            5.60           16.80          39,928
                                     ---------------------------
    Totals..........................  5 minutes...............  6.25 hours..............          15,057            6.46          271.86        $654,847
--------------------------------------------------------------------------------------------------------------------------------------------------------

Hospices That Provide Hospice Care to Residents of a SNF/NF, ICF/MR or 
Other Facility (Sec.  418.112)
    The proposed rule would specify the minimum content of the written 
agreement hospice providers and facilities would be required to have 
and would recodify existing regulations concerning information sharing 
practices. These requirements reflect usual and customary business 
practices and would not increase a hospice's regulatory burden.
Personnel Qualifications (Sec.  418.114)
    The proposed rule's personnel qualification section would specify 
that the current qualifications would apply only where there were no 
State licensing laws, or State certification or registration 
requirements for the profession. Additionally, the proposed rule would 
require a background check for each employee involved in direct patient 
care. In 2002, 39 states required criminal background checks for 
hospice employees. In these states, approximately 70,411 hospice 
employees already received a criminal background check, thus greatly 
reducing the overall potential burden. We estimate that hospices that 
have not previously performed background checks, accounting for 
approximately 19,876 hospice employees, would each

[[Page 30878]]

obtain 39 criminal background checks initially. Each background check 
request form would take 6 minutes to prepare and send, for a total of 4 
hours per hospice the first year. For each year thereafter, we estimate 
that all hospices would complete background checks on approximately 8 
new employees per year for a total of 48 minutes per hospice per year 
and 408 hours nationally per year.
     90,271 employees in 2001 according to National Association 
for Home Care 2002 Hospice Industry Report/50 states = 1,805 average 
number of employees per state x 39 states already requiring background 
checks = 70,395 already required to have background checks
     90,271 total employees x 70,395 already required to have 
background checks = 19,876 employees not already required to have 
background checks
     90,271 employees/2,316 hospices in 2001 = 39 employees per 
average hospice
     39 employees x 6 minutes per check = 4 hours per hospice
     19,876 employees x 6 minutes per check = 1,988 hours 
nationwide
    We estimate that the average cost for an individual background 
check is $12.50. We understand that some states may charge more or less 
that this fee to conduct a background check. In addition, some hospices 
may choose to conduct more extensive background checks that may cost 
more. We are not proposing to require that hospices conduct a specific 
type of background check or obtain such a check from a specific source. 
The flexibility of the proposed requirement would allow hospices to 
identify the most cost efficient method of meeting the requirement.
     $12.50 per check x 39 employees requiring checks = $487.50
     $12.50 per check x 19,876 employees requiring checks = 
$248,250

                              Table 8.--Personnel Qualifications Burden Assessment
----------------------------------------------------------------------------------------------------------------
  Time per check     Time per average   Total industry time   Cost per     Total cost per
    (minutes)       hospice  (minutes)         (hours)         check      average hospice    Total industry cost
----------------------------------------------------------------------------------------------------------------
6................  1st year--4 hours    1st year--1,988         $12.50  1st year--$487.50    1st year--$248,250
                    annually--48.        hours annually--                annually--$100.      annually--51,000.
                                         408.
----------------------------------------------------------------------------------------------------------------


                             Table 9.--Total Burden Assessment Proposed Requirements
                               [Total time and cost for all altered or new CoPs:]
----------------------------------------------------------------------------------------------------------------
   Total time per patient     Total time per   Total industry   Total cost per   Total cost per   Total industry
         (minutes)           hospice (hours)   time  (hours)       patient          hospice            cost
----------------------------------------------------------------------------------------------------------------
53.........................             275          644,625           $25.51           $7,389      $16,920,902
----------------------------------------------------------------------------------------------------------------

    2. Effects on other providers:
    Effects on other providers: We do not expect this regulation to 
affect any other provider.
    3. Effects on the Medicare and Medicaid programs:
    The costs to the Medicare and Medicaid programs resulting from this 
rule will be negligible.

C. Alternatives Considered

    One alternative was to keep the existing CoPs. We concluded this 
was not a reasonable option because our existing CoPs are problem-
focused. As discussed in the preamble, the problem-focused approach has 
inherent limits. Trying to ensure quality through the enforcement of 
prescriptive health and safety standards, rather than trying to improve 
quality of care for all patients, would not contribute to hospice 
improvement or stimulate broad-based quality of care initiatives.
    Revising the existing CoPs would take advantage of continuing 
advances in the health care delivery field. We believe it is necessary 
to keep pace with growing demands for services.
    In addition, listed below are other alternatives.
Patient's Rights (Sec.  418.52)
    We considered including more prescriptive rights regarding privacy 
of a hospice patient's medical information. However, the privacy rule 
published in the Federal Register on December 28, 2000 (65 FR 82461) as 
amended on August 14, 2002 (67 FR 53182) and contained in 45 CFR parts 
160 and 164, protects patient privacy adequately.
Comprehensive Assessment of the Patient (Sec.  418.54)
    We considered not proposing the Comprehensive Assessment CoP. 
However, because the third most cited deficiency noted during hospice 
surveys is the absence of the assessment of needs, we believe it is 
essential to address this area. We also heard from hospice industry 
representatives, who recommended that we include a provision dealing 
with comprehensive assessment. Our decision to propose a general 
assessment requirement is based on the knowledge that individual 
hospices understand patient assessments and why an assessment is 
important to overall quality of care.
Interdisciplinary Group Care Planning and Coordination of Services 
(Sec.  418.56)
    We considered leaving the current CoPs as written. However, it was 
logical to have the coordination of services, the interdisciplinary 
group requirements, and the care planning requirements in one CoP. 
Since the interdisciplinary approach to the delivery of hospice 
services reflects actual practice for hospices, we believe that this 
new proposed regulation would support current industry practice.
Quality Assessment and Performance Improvement Sec.  418.58
    We discussed eliminating any reference to the use of quality 
indicator data, including patient care data, for regulatory purposes. 
But, in light of the existing hospital and home health quality 
assessment and performance improvement activities requirements, we 
believe hospices must begin to build a foundation where quality 
indicators can be used to gather patient-related information. The use 
of quality indicator data would help in creating an effective quality 
assessment and performance improvement program. As a result, the 
hospices would be able to

[[Page 30879]]

better identify activities that lead to poor patient outcomes, and 
would be able to take corrective action to improve performance.
Infection Control (Sec.  418.60)
    We considered leaving the existing CoP, which has very little 
reference to infection control. We also considered making infection 
control a standard under proposed Sec.  418.58, Quality assessment and 
performance improvement. However, we believe that the serious nature 
and potential hazards of infectious and communicable diseases warrants 
a separate and identifiable CoP. This new condition would work in 
concert with the hospice's responsibility to carry out a quality 
assessment and performance improvement program that is geared to 
patient health and safety.
Licensed Professionals (Sec.  418.62)
    We considered rewriting each existing CoP instead of combining all 
of them into the proposed CoP, Sec.  418.62. However, we decided that 
the current CoPs were outdated and too prescriptive, and that a new 
condition would offer hospices more flexibility.
Medical Director (Sec.  418.102)
    We changed part of this CoP because section 4445 of the Balanced 
Budget Act of 1997 mandated that CMS give hospices the option to 
utilize contractual relationships between hospices and physicians. 
Previously, physicians could only furnish services as direct hospice 
employees.
Clinical Records (Sec.  418.104)
    We considered keeping the current CoP as written, but opted to 
clarify some of its standards to reflect current hospice practice. For 
example, we included the provision that hospices may use electronic 
records.
Drugs, Controlled Drugs, Biologicals, Medical Supplies, and Durable 
Medical Equipment (Sec.  418.106)
    We considered a wide range of changes for this CoP. We enhanced the 
requirement for controlled substances in the home. We considered 
requiring the hospice, patient, and family to account for the 
controlled substance including disposal of the substance. We also 
considered requiring a pharmacist to conduct drug reviews on each 
patient record. However, we decided to discard these suggestions 
because they could place too much burden on hospices. We believe that 
the current CoPs needed to be strengthened and therefore, we opted to 
require the hospice, patient, and family to share in the accountability 
of controlled substances in the home.
Inpatient Care (Short-Term, Long-Term, and ICFs/MR) (Sec.  418.108, 
Sec.  418.112)
    Consideration was given to maintaining this CoP and revising the 
Long Term Care CoPs. However, we decided against relying on a future 
change in the Long Term Care CoPs and revised the hospice CoPs to the 
extent possible, to clarify the roles of SNF/NFs and hospices.
    We also decided to separate out hospice care provided to hospice 
patients in SNF/NF, ICF/MR and other facilities. Thus, instead of a 
single CoP that addresses hospice care provided in all inpatient 
facilities, we created a CoP entitled Short Term Inpatient Care and 
then a second CoP entitled Hospices that Provide Care to Residents in a 
SNF/NF, ICF/MR or Non certified facility. We chose this alternative 
because the concerns were related to coordination of care issues 
expressed by hospice and inpatient facility providers.
Personnel Qualifications (Sec.  418.114)
    More prescriptive requirements addressing personnel qualifications 
were considered. As an example, we considered utilizing only Federal 
definitions for personnel qualifications instead of deferring to State 
law.
    However, we decided to defer to State law for two reasons. First, 
we wanted to be consistent with other health care providers, and 
second, we believe a State can best determine what qualifications are 
needed to fit its population's needs. Each hospice has the option to 
require more stringent qualifications of its practitioners.

D. Conclusion

    We are not preparing analyses for either the RFA or section 1102(b) 
of the Act because we have determined, and we certify, that this 
proposed rule would not have a significant economic impact on a 
substantial number of small entities or a significant impact on the 
operations of a substantial number of small rural hospitals.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

VII. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and time specified in the DATES 
section of this preamble, and, if we proceed with a subsequent 
document, we will respond to the comments in the preamble to that 
document.

List of Subjects in 42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR part 418 as follows:

PART 418--HOSPICE CARE

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

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

    2. Section 418.2 is revised to read as follows:


Sec.  418.2  Scope of the part.

    This part establishes requirements and the conditions of 
participation that hospices must meet, and be in compliance with, in 
order to participate in the Medicare program. Subpart A of this part 
sets forth the statutory basis and scope and defines terms used in this 
part. Subpart B of this part specifies the eligibility requirements and 
the benefit periods. Subpart C of this part specifies the conditions of 
participation that hospice providers must meet regarding patient and 
family care. Subpart D of this part specifies the organizational 
environment that hospice providers must meet as conditions of 
participation. Subpart E is reserved for future use. Subpart F 
specifies coinsurance amounts applicable to hospice care.
    3. Section 418.3 is revised to read as follows:


Sec.  418.3  Definitions

    For the purposes of this part--
    Attending physician means a--
    (1)(i) Doctor of medicine or osteopathy legally authorized to 
practice medicine and surgery by the State in which he or she performs 
that function or action; or
    (ii) Nurse practitioner who meets the training, education and 
experience requirements as the Secretary may prescribe; and
    (2) Is identified by the individual, at the time he or she elects 
to receive hospice care, as having the most significant role in the 
determination and delivery of the individual's medical care.
    Bereavement counseling means emotional, psychosocial, and spiritual 
support and services provided after the

[[Page 30880]]

death of the patient to assist with issues related to grief, loss, and 
adjusting.
    Cap period means the 12-month period ending October 31 used in the 
application of the cap on overall hospice reimbursement specified in 
Sec.  418.309.
    Clinical note means a notation of a contact with the patient that 
is written and dated by any person providing services and that 
describes signs and symptoms, treatments and medications administered, 
including the patient's reaction and/or response, and any changes in 
physical or emotional condition.
    Drug restraint means a medication used to control behavior or to 
restrict the patient's freedom of movement which is not a standard 
treatment for a patient's medical or psychiatric condition.
    Employee means a person who works for the hospice and for whom the 
hospice is required to issue a W-2 form on his or her behalf, or if the 
hospice is a subdivision of an agency or organization, an employee of 
the agency or organization who is appropriately trained and assigned to 
the hospice or is a volunteer under the jurisdiction of the hospice.
    Hospice means a public agency or private organization or 
subdivision of either of these that is primarily engaged in providing 
hospice care as defined in this section.
    Hospice care means a comprehensive set of services described in 
1861(dd)(1) of the Act, identified and coordinated by an 
interdisciplinary team to provide for the physical, psychosocial, 
spiritual, and emotional needs of a terminally ill patient and/or 
family members, as delineated in a specific patient plan of care.
    Licensed professional means a licensed person sanctioned by the 
State in which services are delivered, furnishing services such as 
skilled nursing care, physical therapy, speech-language pathology, 
occupational therapy, and medical social services.
    Palliative care means patient and family-centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care throughout the continuum of illness involves 
addressing physical, intellectual, emotional, social, and spiritual 
needs and to facilitate patient autonomy, access to information, and 
choice.
    Physical restraint means any manual method or physical or 
mechanical device, material, or equipment attached to the patient's 
body that he or she cannot easily remove that restricts freedom of 
movement or normal access to one's body.
    Progress note means a written notation, dated and signed by any 
person providing services, that summarizes facts about the care 
furnished and the patient's response during a given period of time.
    Representative means an individual who has the authority under 
State law (whether by statute or pursuant to an appointment by the 
courts of the State) to authorize or terminate medical care or to elect 
or revoke the election of hospice care on behalf of a terminally ill 
patient who is mentally or physically incapacitated. This may include a 
legal guardian.
    Restraint means either a physical restraint or a drug used as a 
restraint.
    Satellite location means a Medicare-approved location from which 
the hospice provides hospice care and services within a portion of the 
total geographic area served by the hospice location issued the 
provider agreement number. The satellite location is part of the 
hospice and shares administration, supervision, and services in a 
manner that renders it unnecessary for the satellite location to 
independently meet the conditions of participation as a hospice.
    Seclusion means the confinement of a person in a room or an area 
where a person is isolated and physically prevented from leaving.
    Terminally ill means that the patient has a medical prognosis that 
his or her life expectancy is 6 months or less if the illness runs its 
normal course.

Subpart E--[Removed and Reserved]

    4. Subpart E is removed and reserved.
    5. Subparts C and D are revised to read as follows:
Subpart C--Conditions of Participation: Patient Care
Sec.
418.52 Condition of participation: Patient's rights.
418.54 Condition of participation: Comprehensive assessment of the 
patient.
418.56 Condition of participation: Interdisciplinary group care 
planning and coordination of services.
418.58 Condition of participation: Quality assessment and 
performance improvement.
418.60 Condition of participation: Infection control.
418.62 Condition of participation: Licensed professional services.

Core Services

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

Noncore Services

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

Subpart C--Conditions of Participation: Patient Care


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

    The patient has the right to be informed of his or her rights, and 
the hospice must protect and promote the exercise of these rights.
    (a) Standard: Notice of rights. (1) The hospice must provide the 
patient or representative with verbal and written notice of the 
patient's rights and responsibilities in a language and manner that the 
patient understands during the initial evaluation visit in advance of 
furnishing care.
    (2) The hospice must comply with the requirements of subpart I of 
part 489 of this chapter regarding advance directives. The hospice must 
inform and distribute written information to the patient concerning its 
policies on advance directives, including a description of applicable 
State law.
    (3) The hospice must inform the patient and family of the hospice's 
drug

[[Page 30881]]

policies and procedures, including the policies and procedures 
regarding the tracking and disposing of controlled substances.
    (4) The hospice must maintain documentation showing that it has 
complied with the requirements of this section and that the patient or 
representative has demonstrated an understanding of these rights.
    (b) Standard: Exercise of rights and respect for property and 
person. (1) The patient has the right--
    (i) To exercise his or her rights as a patient of the hospice;
    (ii) To have his or her property and person treated with respect; 
and
    (iii) To voice grievances regarding treatment or care that is (or 
fails to be) furnished and the lack of respect for property by anyone 
who is furnishing services on behalf of the hospice; and
    (iv) To not be subjected to discrimination or reprisal for 
exercising his or her rights.
    (2) If a patient has been adjudged incompetent under State law by a 
court of proper jurisdiction, the rights of the patient are exercised 
by the person appointed pursuant to State law to act on the patient's 
behalf.
    (3) If a State court has not adjudged a patient incompetent, any 
legal representative designated by the patient in accordance with State 
law may exercise the patient's rights to the extent allowed by State 
law.
    (4) The hospice must--
    (i) Ensure that all alleged violations involving mistreatment, 
neglect, or verbal, mental, sexual, and physical abuse, including 
injuries of unknown source, and misappropriation of patient property 
are reported to State and local bodies having jurisdiction (including 
to the State survey and certification agency) within at least 5 working 
days of the incident, and immediately to the hospice administrator. 
Investigations and/or documentation of all alleged violations must be 
conducted in accordance with established procedures.;
    (ii) Immediately investigate all alleged violations and immediately 
take action to prevent further potential abuse while the alleged 
violation is being verified;
    (iii) Take appropriate corrective action in accordance with State 
law if the alleged violation is verified by the hospice administration 
or an outside body having jurisdiction, such as the State survey agency 
or local law enforcement agency; and
    (iv) Investigate complaints made by a patient or the patient's 
family or representative regarding treatment or care that is (or fails 
to be) furnished, lack of respect for the patient or the patient's 
property by anyone furnishing services on behalf of the hospice, and 
document both the existence of the complaint and the steps taken to 
resolve the complaint.
    (c) Standard: Pain management and symptom control. The patient has 
a right to receive effective pain management and symptom control from 
the hospice.
    (d) Standard: Confidentiality of clinical records. The hospice must 
maintain the confidentiality of clinical records. Access to or release 
of patient information and clinical records is permitted in accordance 
with 45 CFR parts 160 and 164.
    (e) Standard: Patient liability. Before care is initiated, the 
patient must be informed, verbally and in writing, and in a language 
that he or she can understand, of the extent to which payment may be 
expected from the patient, Medicare or Medicaid, third-party payers, or 
other resources of funding known to the hospice.


Sec.  418.54  Condition of participation: Comprehensive assessment of 
the patient.

    The hospice must conduct and document in writing a patient-specific 
comprehensive assessment that identifies the patient's need for hospice 
care and services, and the patient's need for medical, nursing, 
psychosocial, emotional, and spiritual care. This care includes, but is 
not limited to, the palliation and management of the terminal illness 
and related medical conditions.
    (a) Standard: Initial assessment. The hospice registered nurse must 
make an initial assessment visit within 24 hours after the hospice 
receives a physician's admission order for care (unless ordered 
otherwise by the physician), to determine the patient's immediate care 
and support needs.
    (b) Standard: Time frame for completion of the comprehensive 
assessment. The hospice interdisciplinary group in consultation with 
the individual's attending physician, must complete the comprehensive 
assessment no later than 4 calendar days after the patient elects the 
hospice benefit.
    (c) Standard: Content of the comprehensive assessment. The 
comprehensive assessment must identify the physical, psychosocial, 
emotional, and spiritual needs related to the terminal illness that 
must be addressed in order to promote the hospice patient's well-being, 
comfort, and dignity throughout the dying process. The comprehensive 
assessment describes--
    (1) The nature and condition causing admission (including the 
presence or lack of objective data and subjective complaints);
    (2) Complications and risk factors that affect care planning;
    (3) Factors that must be considered in developing individualized 
care plan interventions, including--
    (i) Bereavement. An initial bereavement assessment of the needs of 
the patient's family and other individuals focusing on the social, 
spiritual, and cultural factors that may impact their ability to cope 
with the patient's death. Information gathered from the initial 
bereavement assessment must be incorporated into the bereavement plan 
of care.
    (ii) Drug therapy. A review of the patient's prescription and over-
the-counter drug profile, including but not limited to identification 
of the following--
    (A) Ineffective drug therapy;
    (B) Unwanted drug side and toxic effects; and
    (C) Drug interactions.
    (4) The need for referrals and further evaluation by appropriate 
health professionals.
    (d) Standard: Update of the comprehensive assessment. The update of 
the comprehensive assessment must be accomplished by the hospice 
interdisciplinary group and must consider changes that have taken place 
since the initial assessment. It must include information on the 
patient's progress toward desired outcomes, as well as a reassessment 
of the patient's response to care. The assessment update must be 
accomplished--
    (1) As frequently as the condition of the patient requires, but no 
less frequently than every 14 days; and
    (2) At the time of each recertification.
    (e) Standard: Patient outcome measures. (1) The comprehensive 
assessment must include data elements that allow for measurement of 
outcomes. The hospice must measure and document data in the same way 
for all patients. The data elements must take into consideration 
aspects of care related to hospice and palliation.
    (2) The data elements must be an integral part of the comprehensive 
assessment and must be documented in a systematic and retrievable way 
for each patient. The data elements for each patient must be used in 
individual patient care planning and in the coordination of services, 
and must be used in the aggregate for the hospice's quality assessment 
and performance improvement program.

[[Page 30882]]

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

    The hospice must designate an interdisciplinary group or groups as 
specified in paragraph (a) of this section which, in consultation with 
the patient's attending physician, must prepare a written plan of care 
for each patient. The plan of care must specify the hospice care and 
services necessary to meet the patient and family-specific needs 
identified in the comprehensive assessment and as it relates to the 
terminal illness and related conditions.
    (a) Standard: Approach to service delivery. (1) The hospice must 
designate an interdisciplinary group or groups composed of individuals 
who work together to meet the physical, medical, social, emotional, and 
spiritual needs of the hospice patients and families facing terminal 
illness and bereavement. Interdisciplinary group members must provide 
the care and services offered by the hospice, and the group in its 
entirety must supervise the care and services. The hospice must 
designate a qualified health care professional that is a member of the 
interdisciplinary group to provide coordination of care and to ensure 
continuous assessment of each patient's and family's needs and 
implementation of the interdisciplinary plan of care. The 
interdisciplinary group must include, but is not limited to, 
individuals who are qualified and competent to practice in the 
following professional roles:
    (i) A doctor of medicine or osteopathy (who is not the patient's 
attending physician).
    (ii) A registered nurse.
    (iii) A social worker.
    (iv) A pastoral, clergy, or other spiritual counselor.
    (2) If the hospice has more than one interdisciplinary group, it 
must designate in advance only one of those groups to establish 
policies governing the day-to-day provision of hospice care and 
services.
    (b) Standard: Plan of care. All hospice care and services furnished 
to patients and their families must follow a written plan of care 
established by the hospice interdisciplinary group in collaboration 
with the attending physician. The hospice must ensure that each patient 
and family and primary caregiver(s) receive education and training 
provided by the hospice as appropriate to the care and services 
identified in the plan of care.
    (c) Standard: Content of the plan of care. The hospice must develop 
a written plan of care for each patient that reflects prescribed 
interventions based on the problems identified in the initial 
comprehensive and updated comprehensive assessments, and other 
assessments. The plan of care must include but not be limited to--
    (1) Interventions to facilitate the management of pain and 
symptoms;
    (2) A detailed statement of the scope and frequency of services 
necessary to meet the specific patient and family needs;
    (3) Measurable targeted outcomes anticipated from implementing and 
coordinating the plan of care;
    (4) Drugs and treatment necessary to meet the needs of the patient;
    (5) Medical supplies and appliances necessary to meet the needs of 
the patient; and
    (6) The interdisciplinary group's documentation of patient and 
family understanding, involvement, and agreement with the plan of care, 
in accordance with the hospice's own policies, in the clinical record.
    (d) Standard: Review of the plan of care. The medical director or 
physician designee, and the hospice interdisciplinary team (in 
collaboration with the individual's attending physician to the extent 
possible) must review, revise and document the plan as necessary at 
intervals specified in the plan but no less than every 14 calendar 
days. A revised plan of care must include information from the 
patient's updated comprehensive assessment and the patient's progress 
toward outcomes specified in the plan of care.
    (e) Standard: Coordination of services. The hospice must develop 
and maintain a system of communication and integration, in accordance 
with the hospice's own policies and procedures, to--
    (1) Ensure the interdisciplinary group, through its designated 
professionals, maintains responsibility for directing, coordinating, 
and supervising the care and services provided;
    (2) Ensure that care and services are provided in accordance with 
the plan of care;
    (3) Ensure that the care and services provided are based on all 
assessments of the patient and family needs; and
    (4) Provide for and ensure the ongoing sharing of information 
between all disciplines providing care and services in the home, in 
outpatient settings, and in inpatient settings, irrespective whether 
the care and services are provided directly or under arrangement.


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

    The hospice must develop, implement, and maintain an effective, 
ongoing, hospice-wide data-driven quality assessment and performance 
improvement program. The hospice's governing body must ensure that the 
program: Reflects the complexity of its organization and services; 
involves all hospice services (including those services furnished under 
contract or arrangement); focuses on indicators related to improved 
palliative outcomes; focuses on the end-of-life support services 
provided; and takes actions to demonstrate improvement in hospice 
performance. The hospice must maintain documentary evidence of its 
quality assessment and performance improvement program and be able to 
demonstrate its operation to CMS.
    (a) Standard: Program scope. (1) The program must at least be 
capable of showing measurable improvement in indicators for which there 
is evidence that improvement in those indicators will improve 
palliative outcomes and end-of-life support services.
    (2) The hospice must measure, analyze, and track quality 
indicators, including adverse patient events, and other aspects of 
performance that enable the hospice to assess processes of care, 
hospice services, and operations.
    (b) Standard: Program data. (1) The program must utilize quality 
indicator data, including patient care, and other relevant data, in the 
design of its program.
    (2) The hospice must use the data collected to--
    (i) Monitor the effectiveness and safety of services and quality of 
care; and
    (ii) Identify opportunities for improvement.
    (3) The frequency and detail of the data collection must be 
specified by the hospice's governing body.
    (c) Standard: Program activities. (1) The hospice's performance 
improvement activities must--
    (i) Focus on high risk, high volume, or problem-prone areas;
    (ii) Consider incidence, prevalence, and severity of problems in 
those areas; and
    (iii) Affect palliative outcomes, patient safety, and quality of 
care.
    (2) Performance improvement activities must track adverse patient 
events, analyze their causes, and implement preventive actions and 
mechanisms that include feedback and learning throughout the hospice.
    (3) The hospice must take actions aimed at performance improvement 
and, after implementing those actions, the hospice must measure its 
success and track performance to ensure that improvements are 
sustained.
    (d) Standard: Performance improvement projects. (1) The number and 
scope of distinct improvement

[[Page 30883]]

projects conducted annually must reflect the scope, complexity, and 
past performance of the hospice's services and operations.
    (2) The hospice must document what quality improvement projects are 
being conducted, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.
    (e) Standard: Executive responsibilities. The hospice's governing 
body is responsible for ensuring the following:
    (1) That an ongoing program for quality improvement and patient 
safety is defined, implemented and maintained;
    (2) That the hospice-wide quality assessment and performance 
improvement efforts address priorities for improved quality of care and 
patient safety, and that all improvement actions are evaluated for 
effectiveness; and
    (3) That clear expectations for patient safety are established.


Sec.  418.60  Condition of participation: Infection control.

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


Sec.  418.62  Condition of participation: Licensed professional 
services.

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

Core Services


Sec.  418.64  Condition of participation: Core services.

    A hospice must routinely provide substantially all core services 
directly by hospice employees. These services must be provided in a 
manner consistent with acceptable standards of practice. These services 
include nursing services, medical social services, and counseling. The 
hospice may contract for physician services as specified in Sec.  
418.64(a). A hospice may, under extraordinary or other non-routine 
circumstances, enter into a written arrangement with another Medicare 
certified hospice program for the provision of core services to 
supplement hospice employee/staff to meet the needs of patients. 
Circumstances under which a hospice may enter into a written 
arrangement for the provision of core services include: Unanticipated 
periods of high patient loads, staffing shortages due to illness or 
other short-term temporary situations that interrupt patient care; and 
temporary travel of a patient outside of the hospice's service area.
    (a) Standard: Physician services. The hospice medical director, 
physician employees, and contracted physician(s) of the hospice, in 
conjunction with the patient's attending physician, are responsible for 
the palliation and management of the terminal illness, conditions 
related to the terminal illness, and the general medical needs of the 
patient.
    (1) All physician employees and those under contract, must function 
under the supervision of the hospice medical director.
    (2) All physician employees and those under contract shall meet 
this requirement by either providing the services directly or through 
coordinating patient care with the attending physician.
    (3) If the attending physician is unavailable, the medical 
director, contracted physician, and/or hospice physician employee is 
responsible for meeting the medical needs of the patient.
    (b) Standard: Nursing services. (1) The hospice must provide 
nursing care and services by or under the supervision of a registered 
nurse. Nursing services must ensure that the nursing needs of the 
patient are met as identified in the patient's initial comprehensive 
assessment and updated assessments.
    (2) If State law permits nurse practitioners (NPs) to see, treat 
and write orders for patients, then NPs may provide services to 
beneficiaries receiving hospice care. The role and scope of the 
services provided by a NP that is not the individual's attending 
physician must be specified in the individual's plan of care.
    (3) Highly specialized nursing services that are provided so 
infrequently that the provision of such services by direct hospice 
employees would be impracticable and prohibitively expensive, may be 
provided under contract.
    (c) Standard: Medical social services. Medical social services must 
be provided by a qualified social worker, under the direction of a 
physician. Social work services must be based on the patient's 
psychosocial assessment and the patient's and family's needs and 
acceptance of these services.
    (d) Standard: Counseling services. Counseling services for 
adjustment to death and dying must be available to both the patient and 
the family. Counseling services must include but are not limited to the 
following:
    (1) Bereavement counseling. The hospice must:
    (i) Have an organized program for the provision of bereavement 
services furnished under the supervision of a qualified professional 
with experience in grief/loss counseling.
    (ii) Make bereavement services available to the family and other 
individuals in the bereavement plan of care up to one year following 
the death of the patient. Bereavement counseling also extends to 
residents and employees of a SNF/NF, ICF/MR, or other facility when 
appropriate and identified in the bereavement plan of care.
    (iii) Ensure that bereavement services reflect the needs of the 
bereaved.
    (iv) Develop a bereavement plan of care that notes the kind of 
bereavement services to be provided and the frequency of service 
delivery. A special coverage provision for bereavement counseling is 
specified in Sec.  418.204(c).

[[Page 30884]]

    (2) Nutritional counseling. Nutritional counseling, when identified 
in the plan of care, must be performed by a qualified individual, which 
include dietitians as well as nurses and other individuals who are able 
to address and assure that the dietary needs of the patient are met.
    (3) Spiritual counseling. The hospice must:
    (i) Provide an assessment of the patient's and family's spiritual 
needs;
    (ii) Provide spiritual counseling to meet these needs in accordance 
with the patient's and family's acceptance of this service, and in a 
manner consistent with patient and family beliefs and desires;
    (iii) Facilitate visits by local clergy, pastoral counselors, or 
other individuals who can support the patient's spiritual needs to the 
best of its ability. The hospice is not required to go to extraordinary 
lengths to do so; and
    (iv) Advise the patient and family of this service.


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

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

Non-Core Services


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

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


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

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


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

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


Sec.  418.76  Condition of participation: Home health aide and 
homemaker services.

    All home health aide services must be provided by individuals who 
meet the personnel requirements specified in paragraph (a) of this 
section. Homemaker services must be provided by individuals who meet 
the personnel requirements specified in paragraph (j) of this section.
    (a) Standard: Home health aide qualifications. (1) A qualified home 
health aide is a person who has successfully completed--
    (i) A training program and competency evaluation as specified in 
paragraphs (b) and (c) of this section respectively; or
    (ii) A competency evaluation program; or
    (iii) A State licensure program that meets the requirements of 
paragraphs (b) and (c) of this section.
    (2) A home health aide is not considered to have completed a 
training program, or a competency evaluation

[[Page 30885]]

program if, since the individual's most recent completion of the 
program(s), there has been a continuous period of 24 consecutive months 
during which none of the services furnished by the individual as 
described in Sec.  409.40 of this chapter were for compensation. If 
there has been a 24-month lapse in furnishing services, the individual 
must complete another training and/or competency evaluation program 
before providing services, as specified in paragraph (a)(1) of this 
section.
    (b) Standard: Content and duration of home health aide classroom 
and supervised practical training. (1) Home health aide training must 
include classroom and supervised practical classroom training in a 
practicum laboratory or other setting in which the trainee demonstrates 
knowledge while performing tasks on an individual under the direct 
supervision of a registered nurse or licensed practical nurse, who is 
under the supervision of a registered nurse. Classroom and supervised 
practical training combined must total at least 75 hours.
    (2) A minimum of 16 hours of classroom training must precede a 
minimum of 16 hours of supervised practical training as part of the 75 
hours.
    (3) A home health aide training program must address each of the 
following subject areas:
    (i) Communication skills, including the ability to read, write, and 
verbally report clinical information to patients, care givers, and 
other hospice staff;
    (ii) Observation, reporting, and documentation of patient status 
and the care or service furnished;
    (iii) Reading and recording temperature, pulse, and respiration;
    (iv) Basic infection control procedures;
    (v) Basic elements of body functioning and changes in body function 
that must be reported to an aide's supervisor;
    (vi) Maintenance of a clean, safe, and healthy environment;
    (vii) Recognizing emergencies and the knowledge of emergency 
procedures and their application;
    (viii) The physical, emotional, and developmental needs of and ways 
to work with the populations served by the hospice, including the need 
for respect for the patient, his or her privacy, and his or her 
property;
    (ix) Appropriate and safe techniques in performing personal hygiene 
and grooming tasks, including items on the following basic checklist--
    (A) Bed bath;
    (B) Sponge, tub, and shower bath;
    (C) Hair shampoo (sink, tub, and bed);
    (D) Nail and skin care;
    (E) Oral hygiene; and
    (F) Toileting and elimination;
    (x) Safe transfer techniques and ambulation.
    (xi) Normal range of motion and positioning.
    (xii) Adequate nutrition and fluid intake.
    (xiii) Any other task that the hospice may choose to have an aide 
perform. The hospice is responsible for training home health aides, as 
needed, for skills not covered in the basic checklist, as described in 
paragraph (b)(3)(ix) of this section.
    (4) The hospice must maintain documentation that demonstrates that 
the requirements of this standard are met.
    (c) Standard: Competency evaluation. An individual may furnish home 
health services on behalf of a hospice only after that individual has 
successfully completed a competency evaluation program as described in 
this section.
    (1) The competency evaluation must address each of the subjects 
listed in paragraphs (b)(1) through (b)(3) of this section. Subject 
areas specified under paragraphs (b)(3)(i), (b)(3)(iii), (b)(3)(ix), 
(b)(3)(x) and (b)(3)(xi) of this section must be evaluated by observing 
an aide's performance of the task with a patient. The remaining subject 
areas may be evaluated through written examination, oral examination, 
or after observation of a home health aide with a patient.
    (2) A home health aide competency evaluation program may be offered 
by any organization, except as specified in paragraph (f) of this 
section.
    (3) The competency evaluation must be performed by a registered 
nurse in consultation with other skilled professionals, as appropriate.
    (4) A home health aide is not considered competent in any task for 
which he or she is evaluated as unsatisfactory. An aide must not 
perform that task without direct supervision by a registered nurse 
until after he or she has received training in the task for which he or 
she was evaluated as ``unsatisfactory,'' and successfully completes a 
subsequent evaluation.
    (5) The hospice must maintain documentation that demonstrates the 
requirements of this standard are being met.
    (d) Standard: In-service training. A home health aide must receive 
at least l2 hours of in-service training during each 12-month period. 
In-service training may occur while an aide is furnishing care to a 
patient.
    (1) In-service training may be offered by any organization except 
one that is excluded by paragraph (f) of this section, and must be 
supervised by a registered nurse.
    (2) The hospice must maintain documentation that demonstrates the 
requirements of this standard are met.
    (e) Standard: Qualifications for instructors conducting classroom 
supervised practical training, competency evaluations and in-service 
training. Classroom supervised practical training must be performed by 
or under the supervision of a registered nurse who possesses a minimum 
of two years nursing experience, at least one year of which must be in 
home health care. Other individuals may provide instruction under the 
general supervision of a registered nurse.
    (f) Standard: Eligible training organizations. A home health aide 
training program may be offered by any organization except by a home 
health agency that, within the previous 2 years--
    (1) Was out of compliance with the requirements of paragraphs (b) 
or (c) of this section;
    (2) Permitted an individual that does not meet the definition of a 
``qualified home health aide'' as specified in paragraph (a) of this 
section to furnish home health aide services (with the exception of 
licensed health professionals and volunteers);
    (3) Was subjected to an extended (or partial extended) survey as a 
result of having been found to have furnished substandard care (or for 
other reasons at the discretion of CMS or the State);
    (4) Was assessed a civil monetary penalty of $5,000 or more as an 
intermediate sanction;
    (5) Was found by CMS to have compliance deficiencies that 
endangered the health and safety of the home health agency's patients 
and had temporary management appointed to oversee the management of the 
home health agency;
    (6) Had all or part of its Medicare payments suspended; or
    (7) Was found by CMS or the State under any Federal or State law to 
have:
    (i) Had its participation in the Medicare program terminated;
    (ii) Been assessed a penalty of $5,000 or more for deficiencies in 
Federal or State standards for home health agencies;
    (iii) Been subjected to a suspension of Medicare payments to which 
it otherwise would have been entitled;
    (iv) Operated under temporary management that was appointed by a 
governmental authority to oversee the operation of the home health 
agency and to ensure the health and safety of the home health agency's 
patients; or

[[Page 30886]]

    (v) Been closed by CMS or the State, or had its patients 
transferred by the State.
    (g) Standard: Home health aide assignments and duties. A registered 
nurse or the appropriate qualified therapist that is a member of the 
interdisciplinary team makes home health aide assignments.
    (l) Home health aides are assigned to a specific patient by a 
registered nurse or the appropriate qualified therapist. Written 
patient care instructions for a home health aide must be prepared by a 
registered nurse or other appropriate skilled professional (i.e., a 
physical therapist, speech-language pathologist, or occupational 
therapist) who is responsible for the supervision of a home health aide 
as specified under paragraph (h) of this section.
    (2) A home health aide provides services that are:
    (i) Ordered by the physician or nurse practitioner;
    (ii) Included in the plan of care;
    (iii) Permitted to be performed under State law by such home health 
aide; and
    (iv) Consistent with the home health aide training.
    (3) The duties of a home health aide include:
    (i) The provision of hands-on personal care;
    (ii) The performance of simple procedures as an extension of 
therapy or nursing services;
    (iii) Assistance in ambulation or exercises; and
    (iv) Assistance in administering medications that are ordinarily 
self-administered.
    (4) Home health aides must report changes in the patient's medical, 
nursing, rehabilitative, and social needs to a registered nurse or 
other appropriate licensed professional, as the changes relate to the 
plan of care and quality assessment and improvement activities. Home 
health aides must also complete appropriate records in compliance with 
the hospice's policies and procedures.
    (h) Standard: Supervision of home health aides. (1) A registered 
nurse or qualified therapist must make an onsite visit to the patient's 
home no less frequently than every 14 days to assess the home health 
aide's services. The home health aide does not have to be present 
during this visit. A registered nurse or qualified therapist must make 
an onsite visit to the location where the patient is receiving care in 
order to observe and assess each aide while he or she is performing 
care no less frequently than every 28 days.
    (2) The supervising nurse or therapist must assess an aide's 
ability to demonstrate initial and continued satisfactory performance 
in meeting outcome criteria that include, but is not limited to--
    (i) Following the patient's plan of care for completion of tasks 
assigned to the home health aide by the registered nurse or qualified 
therapist;
    (ii) Creating successful interpersonal relationships with the 
patient and family;
    (iii) Demonstrating competency with assigned tasks;
    (iv) Complying with infection control policies and procedures; and
    (v) Reporting changes in the patient's condition.
    (3) If the hospice chooses to provide home health aide services 
under contract with another organization, the hospice's 
responsibilities include, but are not limited to--
    (i) Ensuring the overall quality of care provided by an aide;
    (ii) Supervising an aide's services as described in paragraphs 
(h)(1) and (h)(2) of this section; and
    (iii) Ensuring that home health aides who provide services under 
arrangement have met the training and/or competency evaluation 
requirements of this condition.
    (i) Standard: Individuals furnishing Medicaid personal care aide-
only services under a Medicaid personal care benefit. An individual may 
furnish personal care services, as defined in Sec.  440.167 of the Code 
of Federal Regulations, on behalf of a hospice or home health agency. 
Before the individual may furnish personal care services, the 
individual must be found competent by the State to furnish those 
services. The individual only needs to demonstrate competency in the 
services the individual is required to furnish.
    (j) Standard: Homemaker qualifications. A qualified homemaker is a 
home health aide as described in Sec.  418.76 or an individual who 
meets the standards in Sec.  418.202(g) and has successfully completed 
hospice orientation addressing the needs and concerns of patients and 
families coping with a terminal illness.
    (k) Standard: Homemaker supervision and duties. (1) Homemaker 
services must be coordinated by a member of the interdisciplinary 
group.
    (2) Instructions for homemaker duties must be prepared by a member 
of the interdisciplinary group.
    (3) Homemakers must report all concerns about the patient or family 
to the member of the interdisciplinary group who is coordinating 
homemaker services.


Sec.  418.78  Conditions of participation: Volunteers.

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

Subpart D--Conditions of Participation: Organizational Environment


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

    The hospice must organize, manage, and administer its resources to 
provide the hospice care and services to patients, caregivers and 
families necessary for the palliation and management of terminal 
illness.
    (a) Standard: Serving the hospice patient and family. The hospice 
must ensure--
    (1) That each patient receives and experiences hospice care that 
optimizes comfort and dignity; and
    (2) That each patient experience hospice care that is consistent 
with patient and family needs and desires.
    (b) Standard: Governing body and administrator. A governing body 
(or

[[Page 30887]]

designated persons so functioning) assumes full legal authority and 
responsibility for the management of the hospice, the provision of all 
hospice services, its fiscal operations, and continuous quality 
assessment and performance improvement. A qualified administrator 
reports to the governing body and is responsible for the day-to-day 
operation of the hospice. The administrator must be a hospice employee 
and possess education and experience required by the hospice's 
governing body.
    (c) Standard: Services. (1) A hospice must be primarily engaged in 
providing the following care and services and must do so in a manner 
that is consistent within accepted standards of practice:
    (i) Nursing services.
    (ii) Medical social services.
    (iii) Physician services.
    (iv) Counseling services, including spiritual counseling, dietary 
counseling, and bereavement counseling.
    (v) Home health aide, volunteer, and homemaker services.
    (vi) Physical therapy, occupational therapy and speech-language 
pathology therapy services.
    (vii) Short-term inpatient care.
    (viii) Medical supplies (including drugs and biologicals) and 
medical appliances.
    (2) Nursing services, physician services, and drugs and biologicals 
(as specified in Sec.  418.106) must be made routinely available on a 
24-hour basis 7 days a week. Other covered services must be available 
on a 24-hour basis when reasonable and necessary to meet the needs of 
the patient and family.
    (d) Standard: Continuation of care. A hospice may not discontinue 
or reduce care provided to a Medicare or Medicaid beneficiary because 
of the beneficiary's inability to pay for that care.
    (e) Standard: Professional management responsibility. A hospice 
that has a written agreement with another agency, individual, or 
organization to furnish any services under arrangement, must retain 
administrative and financial management, and supervision of staff and 
services for all arranged services, to ensure the provision of quality 
care. Arranged services must be supported by written agreements that 
require that all services be--
    (1) Authorized by the hospice;
    (2) Furnished in a safe and effective manner by personnel having at 
least the same qualifications as hospice employees; and
    (3) Delivered in accordance with the patient's plan of care.
    (f) Standard: Hospice satellite locations. (1) All hospice 
satellite locations must be approved by CMS before providing hospice 
care and services to Medicare patients. The determination that a 
satellite location does or does not meet the definition of a satellite 
location, as set forth in this part, is an initial determination, as 
set forth in Sec.  498.3.
    (2) The hospice must continually monitor and manage all services 
provided at all of its locations to ensure that services are delivered 
in a safe and effective manner and to ensure that each patient and 
family receives the necessary care and services outlined in the plan of 
care.
    (g) Standard: In-service training. A hospice must assess the skills 
and competence of all individuals furnishing care, including volunteers 
furnishing services, and, as necessary, provide in-service training and 
education programs where required. The hospice must have written 
policies and procedures describing its method(s) of assessment of 
competency and maintain a written description of the in-service 
training provided during the previous 12 months.


Sec.  418.102  Condition of participation: Medical director.

    The hospice must designate a physician to serve as medical 
director. The medical director must be a doctor of medicine or 
osteopathy who is either employed by, or under contract with, the 
hospice. When the medical director is not available, a physician 
designated by the medical director assumes the same responsibilities 
and obligations as the medical director. The medical director and 
physician designee coordinate with other physicians and health care 
professionals to ensure that each patient experiences medical care that 
reflects hospice policy.
    (a) Standard: Initial certification of terminal illness. The 
medical director or physician designee reviews the clinical information 
for each hospice patient and provides written certification that it is 
anticipated that the patient's life expectancy is 6 months or less if 
the illness runs its normal course. The physician must consider the 
following criteria when making this determination:
    (1) The primary terminal condition.
    (2) Related diagnosis(es), if any.
    (3) Current subjective and objective medical findings.
    (4) Current medication and treatment orders.
    (5) Information about the medical management of any of the 
patient's conditions unrelated to the terminal illness.
    (b) Standard: Recertification of the terminal illness. Before the 
recertification period for each patient, as described in Sec.  
418.21(a), the medical director or physician designee must review:
    (1) The patient's clinical information; and
    (2) The patient's and family's expectations and wishes for the 
continuation of hospice care.
    (c) Standard: Coordination of medical care. The medical director or 
physician designee, and the other members of the interdisciplinary 
group are jointly responsible for the coordination of the patient's 
medical care in its entirety. The medical director or physician 
designee is also responsible for directing the hospice's quality 
assessment and performance improvement program.


Sec.  418.104  Condition of participation: Clinical records.

    A clinical record containing past and current findings is 
maintained for each hospice patient. The clinical record must contain 
accurate clinical information that is available to the patient's 
attending physician and hospice staff. The clinical record may be 
maintained electronically.
    (a) Standard: Content. Each patient's record must include the 
following:
    (1) The plan of care, initial assessment, comprehensive assessment, 
and updated comprehensive assessments, clinical notes, and progress 
notes.
    (2) Informed consent, authorization, and election forms.
    (3) Responses to medications, symptom management, treatments, and 
services.
    (4) Outcome measure data elements, as described in Sec.  418.54(e) 
of this subpart.
    (5) Physician certification and recertification of terminal illness 
as required in Sec.  418.22 and described in Sec.  418.102(a) and Sec.  
418.102(b) respectively.
    (6) Any advance directives as described in Sec.  418.52(a)(3).
    (b) Standard: Authentication. All entries must be legible, clear, 
complete, and appropriately authenticated and dated. All entries must 
be signed, and the hospice must be able to authenticate each 
handwritten and electronic signature of a primary author who has 
reviewed and approved the entry.
    (c) Standard: Protection of information. The clinical record, its 
contents and the information contained therein must be safeguarded 
against loss or unauthorized use. The hospice must be in compliance 
with the Department's rules regarding personal health

[[Page 30888]]

information set out at 45 CFR parts 160 and 164.
    (d) Standard: Retention of records. Patient clinical records must 
be retained for 5 years after the death or discharge of the patient, 
unless State law stipulates a longer period of time. If the hospice 
discontinues operation, hospice policies must provide for retention and 
storage of clinical records. The hospice must inform its State agency 
and its CMS Regional office where such clinical records will be stored 
and how they may be accessed.
    (e) Standard: Discharge or transfer of care. (1) If the care of a 
patient is transferred to another Medicare/Medicaid-approved facility, 
the hospice must forward a copy of the patient's clinical record and 
the hospice discharge summary to that facility.
    (2) If a patient revokes the election of hospice care, or is 
discharged from hospice because eligibility criteria are no longer met, 
the hospice must provide a copy of the clinical record and the hospice 
discharge summary of this section to the patient's attending physician.
    (3) The hospice discharge summary must include--
    (i) A summary of the patient's stay including treatments, symptoms 
and pain management;
    (ii) The patient's current plan of care;
    (iii) The patient's latest physician orders; and
    (iv) Any other documentation that will assist in post-discharge 
continuity of care.
    (f) Standard: Retrieval of clinical records. The clinical record, 
whether hard copy or in electronic form, must be made readily available 
on request by an appropriate authority.


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

    Medical supplies and appliances, as described in Sec.  410.36 of 
this chapter; durable medical equipment, as described in Sec.  410.38 
of this chapter; and drugs and biologicals related to the palliation 
and management of the terminal illness and related conditions, as 
identified in the hospice plan of care, must be provided by the hospice 
while the patient is under hospice care.
    (a) Standard: Administration of drugs and biologicals. (1) All 
drugs and biologicals must be administered in accordance with accepted 
hospice and palliative care standards of practice and according to the 
patient's plan of care.
    (2) The interdisciplinary group, as part of the review of the plan 
of care, must determine the ability of the patient and/or family to 
safely self-administer drugs and biologicals.
    (b) Standard: Controlled drugs in the patient's home. The hospice 
must have a written policy for tracking, collecting, and disposing of 
controlled drugs maintained in the patient's home. During the initial 
hospice assessment, the use and disposal of controlled substances must 
be discussed with the patient and family to ensure the patient and 
family are educated regarding the uses and potential dangers of 
controlled substances. The hospice nurse must document that the policy 
was discussed with the patient and family.
    (c) Standard: Use and maintenance of equipment and supplies. (1) 
The hospice must follow manufacturer recommendations for performing 
routine and preventive maintenance on durable medical equipment. The 
equipment must be safe and work as intended for use in the patient's 
environment. Where there is no manufacturer recommendation for a piece 
of equipment, the hospice must develop in writing its own repair and 
routine maintenance policy. The hospice may use persons under contract 
to ensure the maintenance and repair of durable medical equipment.
    (2) The hospice must ensure that the patient, where appropriate, as 
well as the family and/or other caregiver(s), receive instruction in 
the safe use of durable medical equipment and supplies. The patient, 
family, and/or caregiver must be able to demonstrate the appropriate 
use of durable medical equipment to the satisfaction of the hospice 
staff.


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

    Inpatient care must be available for pain control, symptom 
management, and respite purposes, and must be provided in a 
participating Medicare or Medicaid facility.
    (a) Standard: Inpatient care for symptom management and pain 
control. Inpatient care for pain control and symptom management must be 
provided in one of the following:
    (1) A Medicare-approved hospice that meets the conditions of 
participation for providing inpatient care directly as specified in 
Sec.  418.110.
    (2) A Medicare-participating hospital or a skilled nursing facility 
that also meets the standards specified in Sec.  418.110(b) and (f) 
regarding 24-hour nursing services and patient areas.
    (b) Standard: Inpatient care for respite purposes. Inpatient care 
for respite purposes must be provided by one of the following:
    (1) A provider specified in paragraph (a) of this section.
    (2) A Medicare/Medicaid approved nursing facility that also meets 
the standards specified in Sec.  418.110(b) and (f).
    (c) Standard: Inpatient care provided under arrangements. If the 
hospice has an arrangement with a facility to provide for short-term 
inpatient care, the arrangement is described in a legally binding 
written agreement that at a minimum specifies--
    (1) That the hospice supplies the inpatient provider a copy of the 
patient's plan of care and specifies the inpatient services to be 
furnished;
    (2) That the inpatient provider has established patient care 
policies consistent with those of the hospice and agrees to abide by 
the palliative care protocols and plan of care established by the 
hospice for its patients;
    (3) That the hospice patient's inpatient clinical record includes a 
record of all inpatient services furnished, events regarding care that 
occurred at the facility, and that a copy of the inpatient clinical 
record and discharge summary is available to the hospice at the time of 
discharge;
    (4) That the inpatient facility has identified a individual within 
the facility who is responsible for the implementation of the 
provisions of the agreement;
    (5) That the hospice retains responsibility for arranging the 
training of personnel who will be providing the patient's care in the 
inpatient facility and that a description of the training and the names 
of those giving the training is documented; and
    (6) That a way to verify that requirements in paragraphs (c)(1) 
through (c)(5) of this section have been met is established.
    (d) Standard: Inpatient care limitation. The total number of 
inpatient days used by Medicare beneficiaries who elected hospice 
coverage in a 12-month period in a particular hospice may not exceed 20 
percent of the total number of hospice days consumed in total by this 
group of beneficiaries.
    (e) Standard: Exemption from limitation. Before October 1, 1986, 
any hospice that began operation before January 1, 1975, is not subject 
to the limitation specified in paragraph (d) of this section.


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

    A hospice that provides inpatient care directly must demonstrate 
compliance with all of the following standards:
    (a) Standard: Staffing. The hospice is responsible for ensuring 
that staffing for

[[Page 30889]]

all services reflects its volume of patients, their acuity, and the 
level of intensity of services needed to ensure that plan of care 
outcomes are achieved and negative outcomes are avoided.
    (b) Standard: Twenty-four hour nursing services. The hospice 
facility must provide 24-hour nursing services that meet the nursing 
needs of all patients and are furnished in accordance with each 
patient's plan of care. Each patient must receive all nursing services 
as prescribed and must be kept comfortable, clean, well-groomed, and 
protected from accident, injury, and infection.
    (c) Standard: Physical environment. The hospice must maintain a 
safe physical environment free of hazards for patients, staff, and 
visitors.
    (1) Safety management. (i) The hospice must address real or 
potential threats to the health and safety of the patients, others, and 
property. The hospice must report a breach of safety to appropriate 
State and local bodies having regulatory jurisdiction and correct it 
promptly.
    (ii) The hospice must take steps to prevent equipment failure and 
when a failure occurs, report it appropriate State and local bodies 
having regulatory jurisdiction and correct it promptly.
    (iii) The hospice must have a written disaster preparedness plan in 
effect for managing the consequences of power failures, natural 
disasters, and other emergencies that would affect the hospice's 
ability to provide care. The plan must be periodically reviewed and 
rehearsed with staff (including non-employee staff) with special 
emphasis placed on carrying out the procedures necessary to protect 
patients and others.
    (2) Physical plant and equipment. The hospice must develop 
procedures for managing the control, reliability, and quality of--
    (i) The routine storage and prompt disposal of trash and medical 
waste;
    (ii) Light, temperature, and ventilation/air exchanges throughout 
the hospice;
    (iii) Emergency gas and water supply; and
    (iv) The scheduled and emergency maintenance and repair of all 
equipment.
    (d) Standard: Fire protection. (1) Except as otherwise provided in 
this section--
    (i) The hospice must meet the provisions applicable to nursing 
homes of the 2000 edition of the Life Safety Code (LSC) of the National 
Fire Protection Association The Director of the Office of the Federal 
Register has approved the NFPA 101 2000 edition of the Life Safety 
Code, issued January 14, 2000, for incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the code 
is available for inspection at the CMS Information Resource Center, 
7500 Security Boulevard, Baltimore, MD or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal register/code of federal regulations/ibr 
locations.html. Copies may be obtained from the National Fire 
Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any 
changes in the edition of the Code are incorporated by reference, CMS 
will publish a notice in the Federal Register to announce the changes.
    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition 
of the LSC does not apply to hospice.
    (2) In consideration of a recommendation by the State survey 
agency, CMS may waive, for periods deemed appropriate, specific 
provisions of the Life Safety Code which, if rigidly applied would 
result in unreasonable hardship for the hospice, but only if the waiver 
would not adversely affect the health and safety of patients.
    (3) The provisions of the adopted edition of the Life Safety Code 
do not apply in a State if CMS finds that a fire and safety code 
imposed by State law adequately protects patients in hospices.
    (4) Beginning March 13, 2006, a hospice must be in compliance with 
Chapter 9.2.9, Emergency lighting.
    (5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 
2 does not apply to hospices.
    (6) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a hospice may place alcohol-based hand rub 
dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this amendment, CMS will publish 
notice in the Federal Register to announce the changes.
    (e) Standard: Patient areas. The hospice must provide a home-like 
atmosphere and ensure that patient areas are designed to preserve the 
dignity, comfort, and privacy of patients.
    (1) The hospice must provide--
    (i) Physical space for private patient and family visiting;
    (ii) Accommodations for family members to remain with the patient 
throughout the night; and
    (iii) Physical space for family privacy after a patient's death.
    (2) The hospice must provide the opportunity for patients to 
receive visitors at any hour, including infants and small children.
    (f) Standard: Patient rooms. (1) The hospice must ensure that 
patient rooms are designed and equipped for nursing care, as well as 
the dignity, comfort, and privacy of patients.
    (2) The hospice must accommodate a patient and family request for a 
single room whenever possible.
    (3) Each patient's room must--
    (i) Be at or above grade level;
    (ii) Contain a suitable bed and other appropriate furniture for 
each patient;
    (iii) Have closet space that provides security and privacy for 
clothing and personal belongings;
    (iv) Accommodate no more than two patients;
    (v) Provide at least 80 square feet for each residing patient in a 
double room and at least 100 square feet for each patient residing in a 
single room; and
    (vi) Be equipped with an easily-activated, functioning device 
accessible to the patient, that is used for calling for assistance.
    (4) For an existing building, CMS may waive the space and occupancy 
requirements of paragraphs (f)(2)(iv) and (f)(2)(v) of this section for 
a period of time if it determines that--
    (i) Imposition of the requirements would result in unreasonable 
hardship on the hospice if strictly enforced; or

[[Page 30890]]

jeopardize its ability to continue to participate in the Medicare 
program; and
    (ii) The waiver serves the needs of the patient and does not 
adversely affect their health and safety.
    (g) Standard: Toilet/bathing facilities. Each patient room must be 
equipped with, or conveniently located near, toilet and bathing 
facilities.
    (h) Standard: Plumbing facilities. The hospice must--
    (1) Have an adequate supply of hot water at all times; and
    (2) Have plumbing fixtures with control valves that automatically 
regulate the temperature of the hot water used by patients.
    (i) Standard: Infection control. The hospice must maintain an 
infection control program that protects patients, staff and others by 
preventing and controlling infections and communicable disease as 
stipulated in Sec.  418.60.
    (j) Standard: Sanitary environment. The hospice must provide a 
sanitary environment by following current standards of practice, 
including nationally recognized infection control precautions, and 
avoid sources and transmission of infections and communicable diseases.
    (k) Standard: Linen. The hospice must have available at all times a 
quantity of clean linen in sufficient amounts for all patient uses. 
Linens must be handled, stored, processed, and transported in such a 
manner as to prevent the spread of contaminants.
    (l) Standard: Meal service and menu planning. The hospice must 
furnish meals to each patient that are--
    (1) Consistent with the patient's plan of care, nutritional needs, 
and therapeutic diet;
    (2) Palatable, attractive, and served at the proper temperature; 
and
    (3) Obtained, stored, prepared, distributed, and served under 
sanitary conditions.
    (m) Standard: Pharmaceutical services. Under the direction of a 
qualified pharmacist, the hospice must provide pharmaceutical services 
such as drugs and biologicals and have a written process in place that 
ensures dispensing accuracy. The hospice will evaluate a patient's 
response to the medication therapy, identify adverse drug reactions, 
and take appropriate corrective action. Drugs and biologicals must be 
obtained from community or institutional pharmacists or stocked by the 
hospice. The hospice must furnish the drugs and biologicals for each 
patient, as specified in each patient's plan care. The use of drugs and 
biologicals must be provided in accordance with accepted professional 
principles and appropriate Federal, State, and local laws.
    (n) Pharmacist. A licensed pharmacist must provide consultation on 
all aspects of the provision of pharmaceutical care in the facility, 
including ordering, storage, administration, disposal, and record 
keeping of drugs and biologicals.
    (1) Orders for medications. (i) A physician as defined by section 
1861(r)(1) of the Act, or a nurse practitioner in accordance with the 
plan of care and State law, must order all medications for the patient.
    (ii) If the medication order is verbal or given by or through 
electronic transmission--
    (A) The physician must give it only to a licensed nurse, nurse 
practitioner (where appropriate), pharmacist, or another physician; and
    (B) The individual receiving the order must record and sign it 
immediately and have the prescribing physician sign it in accordance 
with State and Federal regulations.
    (2) Administration of medications. Medications must be administered 
by only the following individuals:
    (i) A licensed nurse, physician, or other health care professional 
in accordance with their scope of practice.
    (ii) An employee who has completed a State-approved training 
program in medication administration.
    (iii) The patient, upon approval by the attending physician.
    (3) Labeling of drugs and biologicals. Drugs and biologicals must 
be labeled in accordance with currently accepted professional practice 
and must include appropriate accessory and cautionary instructions, as 
well as an expiration date (if applicable).
    (4) Drug management procedures. (i) All drugs and biologicals must 
be stored in secure areas. All drugs listed in Schedules II, III, IV, 
and V of the Comprehensive Drug Abuse Prevention and Control Act of 
1976 must be stored in locked compartments within such secure storage 
areas. Only personnel authorized to administer controlled medications 
may have access to the locked compartments.
    (ii) The hospice must keep current and accurate records of the 
receipt and disposition of all controlled drugs.
    (iii) Any discrepancies in the acquisition, storage, use, disposal, 
or return of controlled drugs must be investigated immediately by the 
pharmacist and hospice administrator and where required reported to the 
appropriate State agency. A written account of the investigation must 
be made available to State and Federal officials.
    (5) Drug disposal. Controlled drugs no longer needed by a patient 
must be disposed of in compliance with the hospice policy and in 
accordance with State and Federal requirements.
    (o) Standard: Seclusion and restraint. (1) The patient has the 
right to be free from seclusion and restraint, of any form, imposed as 
a means of coercion, discipline, convenience, or retaliation by staff. 
The term restraint includes either a physical restraint or a drug that 
is being used as a restraint. A physical restraint is any manual method 
or physical or mechanical device, material or equipment attached or 
adjacent to the patient's body that he or she cannot easily remove, 
that restricts free movement of, normal function of, or normal access 
to one's body. A drug used as a restraint is a medication used to 
control behavior or to restrict the patient's freedom of movement and 
is not a standard treatment for a patient's medical or psychiatric 
condition. Seclusion is the confinement of a person alone in a room or 
an area where a person is physically prevented from leaving.
    (2) Seclusion and restraint can only be used in emergency 
situations if needed to ensure the patient's or others' physical 
safety, and only if less restrictive interventions have been tried, 
determined and documented to be ineffective.
    (3) The use of restraint and seclusion must be--
    (i) Selected only when less restrictive measures have been found 
ineffective to protect the patient or others from harm;
    (ii) Carried out in accordance with the order of a physician. The 
following will be superseded by more restrictive State laws:
    (A) Orders for seclusion or restraints must never be written as a 
standing order or an as needed basis (that is, PRN).
    (B) The hospice medical director or physician designee must be 
consulted as soon as possible if restraint or seclusion is not ordered 
by the hospice medical director or physician designee.
    (C) A hospice medical director or physician designee must see the 
patient and evaluate the need for restraint or seclusion within 1 hour 
after initiation of this intervention.
    (D) Each order for a physical restraint or seclusion must be in 
writing and limited to 4 hours for adults; 2 hours for children and 
adolescents ages 9 through 17; or 1 hour for patients under the age of 
9. The original order may only be renewed in accordance with these 
limits for up to a total of 24 hours. After the original order expires, 
a physician must reassess the patient's need before

[[Page 30891]]

issuing another seclusion and restraint order.
    (iii) In accordance with the interdisciplinary group and a written 
modification to the patient's plan of care;
    (iv) Implemented in the least restrictive manner possible not to 
interfere with the palliative care being provided;
    (v) In accordance with safe, appropriate restraining techniques;
    (vi) Ended at the earliest possible time; and
    (vii) Supported by medical necessity and the patient's response or 
outcome, and documented in the patient's clinical record.
    (4) A restraint and seclusion may not be used simultaneously unless 
the patient is--
    (i) Continually monitored face to face by an assigned staff member; 
or
    (ii) Continually monitored by staff using video and audio 
equipment. Staff must be in immediate response proximity to the 
patient.
    (5) The condition of the patient who is in a restraint or in 
seclusion must continually be assessed, monitored, and reevaluated by 
an assigned staff member.
    (6) All staff who have direct patient contact must have ongoing 
education and training in the proper and safe use of seclusion and 
restraint application and techniques and alternative methods for 
handling behavior, symptoms, and situations that traditionally have 
been treated through the use of restraints or seclusion.
    (7) The hospice must report to the CMS regional office any death 
that occurs while the patient is restrained or in seclusion, within 24 
hours after a patient has been removed from restraint or seclusion.


Sec.  418.112  Condition of participation: Hospices that provide 
hospice care to residents of a SNF/NF, ICF/MR, or other facilities.

    In addition to meeting the conditions of participation at Sec.  
418.10 through Sec.  418.116, a hospice that provides hospice care to 
residents of a SNF/NF, ICF/MR, or other residential facility must abide 
by the following additional standards.
    (a) Standard: Resident eligibility, election, and duration of 
benefits. Medicare patients receiving hospice services and residing in 
a SNF, NF, or other facility must meet the Medicare hospice eligibility 
criteria as identified in Sec.  418.20 through Sec.  418.30.
    (b) Standard: Professional management. The hospice must assume full 
responsibility for professional management of the resident's hospice 
care, in accordance with the hospice conditions of participation and 
make any arrangements necessary for inpatient care in a participating 
Medicare/Medicaid facility according to Sec.  418.100.
    (c) Standard: Core services. A hospice must routinely provide all 
core services. These services include nursing services, medical social 
services, and counseling services. The hospice may contract for 
physician services as stated in Sec.  418.64(a). A hospice may use 
contracted staff provided by another Medicare certified hospice to 
furnish core services, if necessary, to supplement hospice employees in 
order to meet the needs of patients under extraordinary or other non-
routine circumstances, as described in Sec.  418.64.
    (d) Standard: Medical director. The medical director and physician 
designee of the hospice must provide overall coordination of the 
medical care of the hospice resident that resides in an SNF, NF, or 
other facility. The medical director and physician designee must 
communicate with the medical director of the SNF/NF, the patient's 
attending physician, and other physicians participating in the 
provision of care for the terminal and related conditions to ensure 
quality care for the patient and family.
    (e) Standard: Written agreement. The hospice and the facility must 
have a written agreement that specifies the provision of hospice 
services in the facility. The agreement must be signed by authorized 
representatives of the hospice and the facility before the provision of 
hospice services. The written agreement must include at least the 
following:
    (1) The written consent of the patient or the patient's 
representative that hospice services are desired.
    (2) The services that the hospice will furnish and that the 
facility will furnish.
    (3) The manner in which the facility and the hospice are to 
communicate with each other to ensure that the needs of the patient are 
addressed and met 24 hours a day.
    (4) A provision that the facility immediately notifies the hospice 
if--
    (i) A significant change in the patient's physical, mental, social, 
or emotional status occurs;
    (ii) Clinical complications appear that suggest a need to alter the 
plan of care;
    (iii) A life threatening condition appears;
    (iv) A need to transfer the patient from the facility and the 
hospice makes arrangements for, and remains responsible for, any 
necessary continuous care or inpatient care necessary related to the 
terminal illness; or
    (v) The patient dies.
    (5) A provision stating that the hospice assumes responsibility for 
determining the appropriate course of care, including the determination 
to change the level of services provided.
    (6) An agreement that it is the facility's primary responsibility 
to furnish room and board.
    (7) A delineation of the hospice's responsibilities, which include, 
but are not limited to, providing medical direction and management of 
the patient, nursing, counseling (including spiritual and dietary 
counseling), social work, bereavement counseling for immediate family 
members, provision of medical supplies and durable medical equipment, 
and drugs necessary for the palliation of pain and symptoms associated 
with the terminal illness, as well as all other hospice services that 
are necessary for the care of the resident's terminal illness.
    (8) A provision that the hospice may use the facility's nursing 
personnel where permitted by law and as specified by the facility to 
assist in the administration of prescribed therapies included in the 
plan of care only to the extent that the hospice would routinely 
utilize the services of a hospice resident's family in implementing the 
plan of care.
    (f) Standard: Hospice plan of care. A written plan of care must be 
established and maintained for each facility patient and must be 
developed by and coordinated with the hospice interdisciplinary group 
in consultation with facility representatives and in collaboration with 
the attending physician. All care provided must be in accordance with 
this plan. The plan must reflect the hospice's policies and procedures 
in all aspects and be based on an assessment of the patient's needs and 
unique living situation in the facility. It must include the patient's 
current medical, physical, social, emotional, and spiritual needs. 
Directives for management of pain and other symptoms must be addressed 
and updated as necessary to reflect the patient's status.
    (1) The plan of care must identify the care and services that are 
needed and specifically identify which provider is responsible for 
performing the respective functions that have been agreed upon and 
included in the plan of care.
    (2) The plan of care reflects the participation of the hospice, the 
facility, and the patient and family to the extent possible.

[[Page 30892]]

    (3) In conjunction with representatives of the facility, the plan 
of care must be reviewed at intervals specified in the plan but no less 
often than every 14 calendar days.
    (4) Any changes in the plan of care must be discussed among all 
caregivers and must be approved by the hospice before implementation.
    (g) Standard: Coordination of services. The hospice must designate 
a member of its interdisciplinary group to coordinate the 
implementation of the plan of care with the representatives of the 
facility. The hospice must provide the facility with the following 
information:
    (1) Plan of care.
    (2) Patient or patient's representative hospice consent form and 
advance directives.
    (3) Names and contact information for hospice personnel involved in 
hospice care of the patient.
    (4) Instructions on how to access the hospice's 24-hour on-call 
system.
    (5) Medication information specific to the patient
    (6) Physician orders.
    (h) Standard: Transfer, revocation, or discharge from hospice care. 
Requirements for discharge or revocation from hospice care, Sec.  
418.104(e), apply. Discharge from or revocation of hospice care does 
not directly impact the eligibility to continue to reside in an SNF, 
NF, ICF/MR, or other facility.
    (i) Standard: Orientation and training of staff. Hospice staff must 
orient facility staff furnishing care to hospice patients in the 
hospice philosophy, including hospice policies and procedures regarding 
methods of comfort, pain control, symptom management, as well as 
principles about death and dying, individual responses to death, 
patient rights, appropriate forms, and record keeping requirements.


Sec.  418.114  Condition of participation: Personnel qualifications for 
licensed professionals.

    (a) General qualification requirements. Except as specified in 
paragraph (c) of this section, all professionals who furnish services 
directly, under an individual contract, or under arrangements with a 
hospice, must be legally authorized (licensed, certified or registered) 
to practice by the State in which he or she performs such functions or 
actions, and must act only within the scope of his or her State 
license, or State certification, or registration. All personnel 
qualifications must be kept current at all times.
    (b) Personnel qualifications for physicians, speech-language 
pathologists, and home health aides. The following qualifications must 
be met:
    (1) Physicians. Physicians must meet the qualifications and 
conditions as defined in section 1861(r) of the Act and implemented at 
Sec.  410.20 of this chapter.
    (2) Speech language pathologists. Speech language pathologists must 
meet the qualifications specified in section 1861(ll)(1) of the Act. 
The individual must have a master's or doctoral degree in speech-
language pathology and must--
    (i) Be licensed as a speech-language pathologist by the State in 
which the individual furnishes such services, or,
    (ii) In the case of an individual who furnishes services in a State 
which does not license speech-language pathologists, must:
    (A) Have successfully completed 350 clock hours of supervised 
clinical practicum (or is in the process of accumulating such 
supervised clinical experience),
    (B) Have performed not less than 9 months of supervised full-time 
speech language pathology services after obtaining a master's or 
doctoral degree in speech-language pathology or a related field, and 
successfully completed the Praxis National Examination in Speech-
Language Pathology.
    (3) Home health aides. Home health aides must meet the 
qualifications required by section 1891(a)(3) of the Act and 
implemented at Sec.  484.75.
    (c) Personnel qualifications when no State licensing, certification 
or registration requirements exist. If no State licensing laws, 
certification or registration requirements exist for the profession, 
the following requirements must be met:
    (1) Occupational therapist. An occupational therapist must--
    (i) Be a graduate of an occupational therapy curriculum accredited 
by the American Occupational Therapy Association, and be eligible for 
the National Registration Examination of the American Occupational 
Therapy Association; or
    (ii) Have 2 years of appropriate experience as an occupational 
therapist, and have achieved a satisfactory grade on a proficiency 
examination conducted, approved, or sponsored by the U.S. Public Health 
Service, except that such determinations of proficiency do not apply 
with respect to persons initially licensed by a State or seeking 
initial qualification as an occupational therapist after December 31, 
1977.
    (2) Occupational therapy assistant. An occupational therapy 
assistant must--
    (i) Meet the requirements for certification as an occupational 
therapy assistant established by the American Occupational Therapy 
Association; or
    (ii) Have 2 years of appropriate experience as an occupational 
therapy assistant, and have achieved a satisfactory grade on a 
proficiency examination conducted, approved, or sponsored by the U.S. 
Public Health Service, except that such determinations of proficiency 
do not apply with respect to persons initially licensed by a State or 
seeking initial qualification as an occupational therapy assistant 
after December 31, 1977.
    (3) Physical therapist. A person who--
    (i) Has graduated from a physical therapy curriculum approved by--
    (A) The American Physical Therapy Association;
    (B) The Council on Medical Education of the American Medical 
Association and the American Physical Therapy Association; or
    (ii) Prior to January 1, 1966--
    (A) Was admitted to membership by the American Physical Therapy 
Association;
    (B) Was admitted to registration by the American Registry of 
Physical Therapists; or
    (C) Has graduated from a physical therapy curriculum in a 4-year 
college or university approved by a State department of education; or
    (iii) Has 2 years of appropriate experience as a physical 
therapist, and has achieved a satisfactory grade on a proficiency 
examination conducted, approved, or sponsored by the U.S. Public Health 
Service except that such determinations of proficiency do not apply 
with respect to persons initially licensed by a State or seeking 
qualification as a physical therapist after December 31, 1977; or
    (iv) Was licensed or registered prior to January 1, 1966, and prior 
to January 1, 1970, had 15 years of full-time experience in the 
treatment of illness or injury through the practice of physical therapy 
in which services were rendered under the order and direction of 
attending and referring doctors of medicine or osteopathy; or
    (v) If trained outside the United States--
    (A) Has graduated, since 1928, from a physical therapy curriculum 
approved in the country in which the curriculum was located and in 
which there is a member organization of the World Confederation for 
Physical Therapy;
    (B) Meets the requirements for membership in a member organization 
of the World Confederation for Physical Therapy.

[[Page 30893]]

    (4) Physical therapist assistant. A person who--
    (i) Has graduated from a 2-year college-level program approved by 
the American Physical Therapy Association; or
    (ii) Has 2 years of appropriate experience as a physical therapy 
assistant, and has achieved a satisfactory grade on a proficiency 
examination conducted, approved, or sponsored by the U.S. Public Health 
Service, except that these determinations of proficiency do not apply 
with respect to persons initially licensed by a State or seeking 
initial qualification as a physical therapy assistant after December 
31, 1977.
    (5) Registered nurse. A graduate of a school of professional 
nursing.
    (6) Licensed practical nurse. A person who has completed a 
practical nursing program.
    (7) Social worker. A person who has a baccalaureate degree from a 
school of social work accredited by the Council on Social Work 
Education.
    (d) Standard: Criminal background checks. The hospice must obtain a 
criminal background check on each hospice employee and contracted 
employee before employment at the hospice.


Sec.  418.116  Condition of participation: Compliance with Federal, 
State, and local laws and regulations related to health and safety of 
patients.

    The hospice and its staff must operate and furnish services in 
compliance with all applicable Federal, State, and local laws and 
regulations related to the health and safety of patients. If State or 
local law provides for licensing of hospices, the hospice must be 
licensed.
    (a) Standard: Licensure of staff. Any persons who provide hospice 
services must be licensed, certified, or registered in accordance with 
applicable Federal, State and local laws.
    (b) Standard: Multiple locations. Every hospice must comply with 
the requirements of Sec.  420.206 of this chapter regarding disclosure 
of ownership and control information. All hospice satellite locations 
must be approved by CMS and licensed in accordance with State licensure 
laws, if applicable, before providing Medicare reimbursed services.
    (c) Standard: Laboratory services. (1) If the hospice engages in 
laboratory testing other than assisting a patient in self-administering 
a test with an appliance that has been approved for that purpose by the 
FDA, the hospice must be in compliance with all applicable requirements 
of part 493 of this chapter.
    (2) If the hospice chooses to refer specimens for laboratory 
testing to a reference laboratory, the reference laboratory must be 
certified in the appropriate specialties and subspecialties of services 
in accordance with the applicable requirements of part 493 of this 
chapter.


Sec.  418.200  [Amended]

    6. Section 418.200 is amended by revising the reference ``Sec.  
418.58'' to read ``Sec.  418.56''.


Sec.  418.202  [Amended]

    7. In Sec.  418.202, paragraph (e) is amended by revising the 
reference ``Sec.  418.98(b)'' to read ``Sec.  418.108(b)'' and 
paragraph (g) is amended by revising the reference ``Sec.  418.94'' to 
read ``Sec.  418.76''.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: February 7, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: February 7, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-9935 Filed 5-26-05; 8:45 am]
BILLING CODE 4120-01-P