Friday,

May 27, 2005

Part II

Department of 

Health and Human 

Services

Centers for Medicare & Medicaid Services 

42 CFR Part 418

Medicare and Medicaid Programs: Hospice 

Conditions of Participation; Proposed 

Rule

30840 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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.

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 patientcentered, 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 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 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 § 418.112, and the changes 

to the nursing services standard at 

proposed § 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 

30842 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

quality of care it furnishes to its patients 

and their families. 

The last three requirements establish 

a cycle of individual care and hospicewide 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 selfassessment 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 

§ 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, outcomeoriented 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 § 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 § 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 § 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 § 418.3) 

Existing § 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 § 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 

§ 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, speechlanguage 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. 

30844 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 Medicareapproved 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 § 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 § 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 § 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 

§ 418.54 Through § 418.62) 

The patient care assessment, 

planning, and palliative care process 

represented by the next four CoPs 

(§ 418.54 through § 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 § 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 outcomeoriented 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. 

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

§ 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 § 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 § 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 § 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 § 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 § 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 processoriented 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 

30846 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

comprehensively assess hospice 

patients. However, we recognize that the 

proposed 4-day timeframe for 

completing the initial comprehensive 

assessment as proposed in § 418.54(b) 

and 14-day timeframe for updating the 

comprehensive assessment as proposed 

in § 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 § 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 selfdetermination, 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 

§ 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 § 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 § 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 § 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 § 418.56(b), 

Plan of care, is the same as the existing 

standard at § 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 

§ 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;

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

§ 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 dayto-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 § 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 § 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 preemptive 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, 

30848 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 § 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 

§ 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 

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

§ 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 § 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 § 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 § 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 § 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 § 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 § 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 

30850 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

training is one way to assure staff 

understanding. 

In § 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 § 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 

§ 418.62) 

Sections of current regulations at 

§ 418.82, Nursing services; § 418.84, 

Medical social services; and § 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 § 418.82, 

§ 418.84, and § 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, speechlanguage 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 § 418.64 and the non-core 

services condition at § 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 § 418.64)

The conditions of participation 

containing the current core services 

requirements are in § 418.80, Furnishing 

of core services; § 418.82, Nursing 

services; § 418.84, Medical social 

services; § 418.86, Physician services; 

and § 418.88, Counseling services. We 

are proposing to combine these into a 

single condition. We are also proposing 

to incorporate the requirement at 

existing § 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 nonroutine 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 shortterm 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 § 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 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 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 § 418.64(c), we are 

proposing to maintain the current 

medical social services requirement 

found at § 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 § 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 § 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 § 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 

§ 418.70) 

The current CoP governing the 

provision of other services is contained 

in § 418.90. The hospice must ensure 

that the services described in § 418.72 

through § 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 § 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 

§ 418.72) 

Currently, the CoP concerning 

physical therapy, occupational therapy, 

and speech language pathology is laid 

out at § 418.92. We are proposing to 

recodify this CoP at § 418.72 without 

changes. 

30852 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

Condition of Participation: Waiver of 

Requirement—Physical Therapy, 

Occupational Therapy, SpeechLanguage Pathology, and Dietary 

Counseling (Proposed § 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 § 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 § 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 § 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 § 418.94. We are proposing in 

§ 418.76 that a home health aide 

completes a State-established or other 

training program, and in § 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 § 484.36. 

For example, we would continue to 

permit a home health aide to meet the 

proposed § 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, 

§ 418.76(j), homemaker qualifications, 

has been adapted from the existing 

§ 418.94. The proposed standard 

clarifies that a qualified homemaker is 

a home health aide as described in 

§ 418.76 or an individual who has met 

the standards in § 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, § 418.76(h), Supervision of 

home health aides, would be revised 

from the current § 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. Onsite supervisory visits will still be 

required every 14 days as in the current 

rule at § 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, § 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 § 418.78) 

The current CoP for volunteers is 

located at § 418.70. We are proposing to 

recodify this CoP at § 418.78 with minor 

changes. We are removing the existing 

§ 418.70(f), regarding the availability of 

clergy, because the role of the pastoral, 

clergy, or other spiritual counselor is 

described in proposed § 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 § 418.100) 

[If you choose to comment on issues in 

this section, please include the caption 

‘‘ORGANIZATION AND 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 30853

ADMINISTRATION’’ at the beginning of 

your comments.] 

We are proposing to revise existing 

regulations at § 418.50, General 

provisions, § 418.52, Governing body, 

and § 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 wellmanaged 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, § 418.100), we have taken the 

current CoPs and proposed changing 

them to standards:

• Governing body and administrator 

(existing § 418.52). 

• Continuation of care (existing 

§ 418.60). 

• Professional management 

responsibility (existing § 418.56). 

• In-service training (existing 

§ 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 inservice 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, § 418.50(b)(3), Required 

services; § 418.52, Governing body; 

§ 418.82(c), Acceptable standards of 

practice; § 418.92(a), PT, OT and SLP; 

and § 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 § 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 § 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 

§ 418.82(c) into § 418.64, Core services 

and § 418.70, Furnishing of non-core 

services. 

In the proposed governing body and 

administrator standard at § 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 § 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 § 418.100(d), Continuation of care, 

the current standard is at § 418.60. We 

are proposing to recodify this section at 

§ 418.100(d) without change. 

In § 418.100(e), Professional 

management responsibility, we are 

proposing to revise some of the current 

requirements found at § 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 § 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 

30854 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 § 418.52 through 

§ 418.116.

Proposed § 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 § 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 § 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 § 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, § 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 § 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 § 418.21. 

Within § 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 § 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 § 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 § 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 § 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 § 418.22(c) and 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 30855

described in proposed § 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 § 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 

§ 418.74(b) as § 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 § 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 § 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 § 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 § 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 § 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 § 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 

§ 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 

§ 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 § 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 § 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 

30856 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 § 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 § 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 § 418.98(a), Shortterm inpatient care, as § 418.108(a), 

Inpatient care for symptom management 

and pain control. 

The references to the condition at 

§ 418.108(b), Inpatient care for respite 

purposes, would no longer focus on 

process as in the existing § 418.98. 

Rather, the updated standards reflect 

expected outcomes of care. 

We would eliminate the existing 

requirement found at § 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 § 418.108(c), 

Inpatient care provided under 

arrangement, we would incorporate 

many of the existing requirements in 

existing § 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 § 418.108(d), 

Inpatient care limitation, and 

§ 418.108(e), Exemption from limitation, 

we are proposing to re-codify the 

existing requirements at § 418.98(c) and 

(d), respectively, without changes. 

Condition of Participation: Hospices 

That Provide Inpatient Care Directly 

(Proposed § 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 § 418.110, we are 

proposing to revise the existing 

requirements, currently located at 

§ 418.100, as follows: 

Under § 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 

§ 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 § 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 § 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 § 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 § 418.110(c)(1)(iii) 

we have retained the existing 

requirement at § 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 § 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 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 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 § 418.110(d), Fire protection, we 

are proposing to recodify, without 

change, the existing provisions in 

§ 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 § 418.110(e), Patient areas, 

would be recodified from § 418.100(e) 

without change. 

Proposed § 418.110(f), Patient rooms, 

would be revised. We are proposing in 

§ 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 (§ 418.100(f), 

with only minor language changes that 

would not change the substantive 

requirements of the regulation.

Proposed § 418.110(g), Toilet/bathing 

facilities, is linked with patient rooms 

in the current requirement found at 

§ 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 § 418.100(g) bathroom facilities, 

except to recodify it at § 418.110(h) and 

rename it, Plumbing facilities. 

In § 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 § 418.100(h), Linen, 

as § 418.110(k) without substantive 

change. 

In proposed § 418.110(l), Meal service 

and menu planning, we are proposing to 

revise the existing § 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 § 418.110(m), Pharmaceutical 

services, we are proposing to re-codify 

the existing requirement found at 

§ 418.100(k) without substantive 

change. 

In § 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 § 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 

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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 § 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 § 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 § 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 § 418.20 to 

§ 418.30), as a patient who resides in his 

or her home in the community. 

At proposed § 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 § 418.100. This 

standard reinforces our belief that 

continuity of care is crucial for hospice 

care in any setting. 

In proposed § 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 § 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 § 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 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 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 § 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 § 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 § 418.112(h), 

Transfer, revocation, or discharge from 

hospice care, we would specify that the 

proposed requirement for discharge or 

revocation found at § 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 § 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 § 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 

§ 418.114. We discuss the personnel 

qualifications in detail below. 

(1) General qualifications (proposed 

§ 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 § 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 

§ 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 

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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 speechlanguage 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 § 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 § 418.114(c). This 

category would consist of all current 

personnel qualifications specified in 

proposed § 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 fulltime 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 § 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. 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 30861

Condition of Participation: Compliance 

With Federal State and Local Laws and 

Regulations Related to Health and 

Safety of Patients (Proposed § 418.116)

The provisions concerning licensure 

requirements for hospices are currently 

located at § 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 § 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 § 418.116(b), Multiple 

locations, we would continue to require 

that the hospice comply with the 

requirements of § 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 § 418.92(b), 

regarding laboratory services, at 

§ 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

Current conditions

(Part 418, subpart C, D, E) 

Citation

existing

section 

Proposed condition Citation 

Scope of Subpart

Definitions ................................................................................... 418.3 Definitions .................................... 418.3 

General provisions ..................................................................... 418.50 

(a) Compliance .................................................................... .................... Organization and Administration 

of Services.

418.100(c)(2) 

(b) Required services .......................................................... .................... Organization and Administration 

of Services.

418.100(c)(2) 

(c)(1) 24 hour nursing, physician services, and drugs and 

biologics.

.................... Organization and Administration 

of Services.

418.100(c)(1) 

(2) Other 24 hour services. 

(3) Utilize accepted standards of practice ................................. .................... Core Services and Furnishing of 

Non-core Services.

418.64 and 418.72 

(d) Disclosure of information ............................................... .................... Deleted.

Medical director: The medical director is: A hospice employee, a 

doctor of medicine or osteopathy, responsible for the medical 

component of the hospice’s patient care program.

418.54 Medical Director .......................... 418.102 

Professional management ................................................................. 418.56 

(a) Continuity of care ................................................................. .................... Deleted. 

(b) Written agreement: 

(1) Identification of services to be provided ....................... .................... Interdisciplinary Group Care 

Planning and Coordination of 

services.

418.56(c) 

(2) Express authorization of the hospice required for all 

services.

.................... Organization and Administration 

of Services.

418.100(e)(1) 

(3) Coordination, supervision, and evaluation of contracted services..................... Organization and Administration 

of Services.

418.100(e) 

(4) Roles of hospice and contractor in admission, assessment, and interdisciplinary group..................... Deleted 

(5) Documentation of services furnished by contractor ...... .................... Organization and administration 

of services.

418.100(e) 

(6) Personnel qualifications ................................................ .................... Organization and administration

of services.

418.100(e)(2) 

(c) Professional management .................................................... .................... Organization and administration 

of services.

418.100(e) 

(d) Financial responsibility. 

(e) Inpatient care: 

(1) Copy of the patient plan of care specifying the services to be provided is given to inpatient provider..................... Short term inpatient care ............ 418.108(c)(1) 

(2) Inpatient provider abides by hospice patient care protocols and maintains compatible policies..................... Short term inpatient care ............ 418.108(c)(2) 

(3) Medical record provided to hospice upon request. 

Must include all inpatient services and events and a 

copy of the discharge summary.

.................... Short term inpatient care ............ 418.108(c)(3) 

(4) Responsibility for implementing agreement provisions .................... Short term inpatient care ............ 418.108(c)(4) 

30862 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

DERIVATION TABLE—Continued

Current conditions

(Part 418, subpart C, D, E) 

Citation

existing

section 

Proposed condition Citation 

(5) Hospice responsible for training all care providers ....... .................... Short term inpatient care ............ 418.108(c)(5) 

NEW Comprehensive Assessment of 

the Patient Initial assessment.

418.54 

.................... (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 and maintained for 

each individual admitted to a hospice program and the care provided to an individual must be in accordance with the plan.

.................... Interdisciplinary Group Care 

Planning and Coordination of 

Services.

418.56 

(a) Plan established by attending physician, medical director 

or physician designee and interdisciplinary group prior to 

providing care.

.................... Interdisciplinary Group Care 

planning and Coordination of 

Service.

418.56(b) 

(b) Plan reviewed, updated, and documented at specified intervals by attending physician, medical director or physician 

designee and the interdisciplinary group.

.................... Interdisciplinary Group Care 

Planning and Coordination of 

Services.

418.56(d) 

(c) Plan includes assessment of needs and identification of 

services. It state in the scope and frequency of services 

needed.

.................... Interdisciplinary Group Care 

Planning and Coordination of 

Services.

418.56(c) 

Continuation of care: No discontinuation or diminishment of care 

due to the Medicare beneficiary’s inability to pay for that care.

418.60 Organization and Administration 

of Services.

418.100(d) 

Informed Consent: The Informed consent 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.

418.62 Patient Rights .............................. 418.52(a) 

Inservice training: A hospice must provide an ongoing program for 

the training of its employees.

418.64 Organization and Administration 

of services.

418.100(g) 

Quality assurance: A hospice must conduct an ongoing, comprehensive, intetrated, self-assessment of the quality and appropriateness of all care provided. The findings are used to correct 

problems and revise hospice policies. Those responsible for the 

quality assurance program must.

418.66 Quality Assessment and performance Improvement.418.60 

(a) Implement and report on activities and mechanisms for 

monitoring the quality of patient care.

.................... Quality Assessment and performance Improvement.418.60(d) 

(b) Identify and resolve problems .............................................. .................... Deleted. 

(c) Make suggesitons for improving patient care ...................... .................... Quality Assessment performance 

Improvement.

418.60(c)(3) 

Interdisciplinary group: The hospice must designate an interdisciplinary group(s) composed of individuals who provide or supervise care and services offered by the hospice.418.68 IDG Group Care Planning and 

Coordination of Services.

418.56(a) 

(a) The interdisciplinary group(s) must include certain specialists..................... IDG Care Planning and Coordination of Services 418.56(a) 

(b) The interdisciplinary group is responsible for—

(1) Participation in the establishment of the plan of care .. .................... IDG Care Planning and Coordination of Services.418.56(b) 

(2) Provision of supervision of hospice care and services .................... IDG Care Planning and Coordination of Services.418.56(a)(1)(3) 

(3) Periodic review and updating of the plan of care for 

each individual receiving hospice care; and.

.................... IDG Care Planning and Coordination of Services.418.56(d) 

(4) Establishment of policies governing the day-to-day 

provision of hospice care and services.

.................... IDG Care Planning and Coordination of Services.418.56(a)(2) 

Only one interdisciplinary group chosen in advance may execute the functions described in the paragraph (b)(4) of this 

section.

.................... Deleted.

(d) Designating a registered nurse to coordinate the implementation of the plan of care for each patient..................... IDG Care Planning and Coordination of Services.418.56(a)(1) 

Volunteers: The hospice in accordance with the numerical standards, specified in paragraph (e) of this section, uses volunteers, 

in defined roles, under the supervision of a designated hospice 

employee.

418.70 Volunteers ................................... 418.78

(a) The hospice must provide appropriate orientation and 

training.

.................... Volunteers ................................... 418.78(a) 

(b) Volunteers must be used in direct patient care or administrative roles..................... Volunteers ................................... 418.78(b) 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 30863

DERIVATION TABLE—Continued

Current conditions

(Part 418, subpart C, D, E) 

Citation

existing

section 

Proposed condition Citation 

(c) The hospice must document active and ongoing efforts to 

recruit and retain volunteers.

.................... Volunteers ................................... 418.78(c) 

(d) The hospice must document the cost savings achieved 

through volunteer use. Documentation must include—

.................... Volunteers ................................... 418.78(d) 

(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 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.

.................... Volunteers ................................... 418.78(e) 

(f) Reasonable efforts made to arrange for visits of members 

of religious organizations to patients who request such visits 

and must advise patients of this opportunity.

.................... Deleted. 

Licensure: The hospice and all its employees must be licensed in 

accordance with applicable Federal, State, and local laws and 

regulations.

418.72 Compliance with Federal, State & 

local laws & regulations related 

to health & safety of patients.

418.116 

(a) The hospice must be licensed if State or local law provides 

for licensure.

.................... Personnel Qualifications for 

Skilled Professionals; and 

Compliance with Federal, State 

& local laws & regulations related to health & safety of patients.

418.114 and 

418.116(a) 

(b) Employees who provide services must be licensed, certified or registered in accordance with applicable Federal or 

State laws.

Central Clinical Records: Establishment 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.

418.74 Clinical Records .......................... 418.104 

(a) Clinical record is comprehensive. Entries are made and 

signed for all services provided whether furnished directly or 

under arrangements made by the hospice. Each individual’s 

record contains—.

.................... Clinical Records .......................... 418.104(a) 

(1) Initial and subsequent assessments ............................. .................... Clinical Records .......................... 418.104(a)(1) 

(2) Plan of care ................................................................... .................... Clinical Records .......................... 418.104(a)(1) 

(3) Identification data .......................................................... .................... Deleted. 

(4) Consent and authorization and election forms ............. .................... Clinical Records .......................... 418.104(a)(2) 

(5) Pertinent medical history ............................................... .................... Deleted. 

(6) Complete documentation of all services and events .... .................... Clinical Records .......................... 418.104(a)(1) 

(b) Protection of information. The hospice must safeguard the 

clinical record against loss, destruction, and unauthorized 

use.

.................... Clinical Records .......................... 418.104(c) 

Subpart D—Condition of Participation: Core Services: 

Furnishing of Core Services: Hospice 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.

418.80 Core services .............................. 418.64 

Nursing services: Nursing care and services provided by or under 

the supervision of a registered nurse.

418.82 Core services .............................. 418.64(b) 

(a) The nursing needs of the patients must be met .................. .................... Core services .............................. 418.64(b) 

(b) Patient care responsibility of nursing personnel must be 

specified.

.................... Deleted. 

(c) Services are provided in accordance with recognized 

standards of practice.

.................... Core services .............................. 418.66 

Waiver of all requirements that substantially all nursing services be 

routinely services be routinely provided directly by a hospice.

418.83 Nursing service waver (re-codified).418.66 

(a) Waiver if located in non-urbanized area, operational on or 

before January 1, 1983, and good faith effort made to fulfill 

staffing needs. 

30864 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

DERIVATION TABLE—Continued

Current conditions

(Part 418, subpart C, D, E) 

Citation

existing

section 

Proposed condition Citation 

(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 services must be provided 

by a qualified social worker, under the direction of a physician.

418.84 Core services .............................. 418.64(c) 

Physician services: In addition to palliation and management of 

terminal illness and related conditions, physician employees of 

the hospice must also meet the general medical needs of the 

patient.

418.86 Core services .............................. 418.64(a) 

Counseling services: Counseling services, including bereavement, 

dietary, and spiritual counseling, must be available to both the 

individual and the family.

418.88 Core services .............................. 418.64(d) 

(a) Organized program for the provision of bereavement services under the supervision of a qualified professional. A 

special coverage is specified in 418.204(c).

.................... Core services .............................. 418.64(d)(1) 

(b) Provision of dietary counseling .................... Core services .............................. 418.64(d)(2) 

(c) Spiritual counseling must include notice to patients as to 

the availability of the clergy as provided in 418.70(f).

.................... Core services .............................. 418.64(d)(3) 

(d) Counseling may be provided by others ............................... .................... Deleted. 

Subpart E—Condition of Participation: Other services: 

Furnishing other services: The services described in this subpart 

must be provided directly by hospice employees or under arrangements made by the hospice as specified in 418.56.

418.90 Furnishing of non core services .. 418.70 

Physical therapy, occupational therapy and speech language pathology.418.92(a) 418.70, 418.72 

(a) Physical therapy, occupational therapy, and speech-language pathology services must be available and provided 

under acceptable standards of practice.

.................... Physical therapy, occupational 

therapy and speech language 

pathology and dietary counseling, Non-core services.

418.70, 418.72 

(b)(1) Laboratory testing services must be in compliance with 

all applicable requirements of part 493 of this chapter.

.................... Compliance with Federal, State & 

local laws & regulations related 

to the health & safety of patients.

418.116(c)(1) 

(2) All referral laboratories must be certified in the appropriate 

specialties and subspecialties of services. See part 493 of 

this chapter.

.................... Compliance with Federal, State & 

local laws & regulations & related to the health & safety of 

patients.

418.116(c)(2) 

Home health aide and homemaker service: Home health aide and 

homemaker must be 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.

418.94 Home Health Aide and homemaker services.418.76 

(a) Standard: A registered nurse visits the home site at least 

every two weeks when aide services arebeing provided, 

and conducts an assessment of the aide services.

.................... Home health aide and homemaker services (revised).418.76(h)(1) 

(b) Standard: A registered nurse prepares written instructions 

for patient care. Duties include, but may not be limited to, 

the duties specified in 484.36(c) of this chapter.

.................... Home health aide and homemaker services.418.76(g)(1) 

Medical supplies: Medical supplies, appliances, drugs and 

biologicals must be provided for the palliation and management 

of the terminal illness and related conditions.

418.96 Drugs, controlled drugs, and 

biologicals, medical supplies 

and durable medical equipment.

418.106 

(a) All drugs and biologicals must be administered in accordance with accepted standards of practice..................... Drugs, controlled drugs, and 

biologicals, medical supplies 

and durable medical equipment.

418.106(a) 

(b) The hospice must have a policy for the disposal of extraneous controlled drugs maintained in the patient’s home..................... Drugs, controlled drugs, and 

biologicals, medical supplies 

and durable medical equipment.

418.106(b) 

(c) Only certain individuals may administer drugs and 

biologicals.

.................... Deleted. 

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.

.................... Short term inpatient care ............ 418.108 

(a) Inpatient care for pain control and symptom management 

must be provided in one of the following: 

.................... Short term inpatient care ............ 418.108(a) 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 30865

DERIVATION TABLE—Continued

Current conditions

(Part 418, subpart C, D, E) 

Citation

existing

section 

Proposed condition Citation 

(1) A hospice that meets the standards for providing inpatient care directly specified in 418.100..................... Short term inpatient care ............ 418.108(a)(1) 

(2) A hospice or skilled nursing facility that also meets the 

standards of 418.100(a) and (e).

.................... Short term inpatient care ............ 418.108(a)(2) 

(b) Inpatient care for respite purposes must be provided by: ... .................... Short term inpatient care ............ 418.108(b) 

(1) A provider specified in paragraph (a) of this section .... .................... Short term inpatient care ............ 418.108(b)(1) 

(2) An intermediate care facility (ICF) meeting the standards in 418.100 (a) and (e)..................... Short term inpatient care (delete 

ICF and replace with nursing 

facility (NF)).

418.108(b)(2) 

(c) Inpatient care for Medicare beneficiaries may not exceed 

20 percent of the total number of days for this beneficiary 

group.

.................... Short term inpatient care ............ 418.108(d) 

(d) Exemption from limitation in paragraph (c) .......................... .................... Short term inpatient care ............ 418.108(e) 

Hospices that provide inpatient care directly: A hospice that provides inpatient care directly must comply with all of the following 

standards.

418.100 Hospices that provide inpatient 

care directly.

418.110 

(a) Twenty-four hour nursing services: 

(1) The facility provides 24-hour nursing services in accordance with patient plan of care sufficient to meet 

total nursing needs.

.................... Hospices that provide inpatient 

care directly.

418.110(b) 

(2) Each shift includes a direct care registered nurse ....... .................... Deleted.

(b) The hospice has an acceptable written plan, periodically 

rehearsed with staff, with internal and external disaster procedures.

.................... Hospices that provide inpatient 

care directly.

418.110(c)(1)(iii) 

(c) The hospice must meet all Federal, State and local laws, 

regulations, and codes pertaining to health and safety.

.................... Compliance with Federal, State & 

local laws and regulations related to health and safety of 

patients.

418.116 

(d) Fire protection ....................................................................... .................... Hospices that provide inpatient 

care directly.

418.110(d)(1) 

(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 inpatient 

care directly.

418.110(e) 

(1) Design and equipment of patient/family areas. 

(2) Specifications for patient/family accommodations 

(3) Visitor specifications. 

(f) Patient rooms and toilet facilities. ......................................... .................... Hospices that provide inpatient 

care directly.

418.110(f) 

(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 facilities .................................... .................... Hospices that provide inpatient

care directly.

418.110(g), 

418.110(h) 

(h) Requirements for linens ....................................................... .................... Hospices that provide inpatient 

care directly.

418.110(k) 

(i) Isolating areas for patients with infectious diseases ............. .................... Hospices that provide inpatient 

care directly.

418.110(j), 

418.110(i) 

(j) Meal service and menu planning .......................................... .................... Hospices that provide inpatient

care directly.

418.110(l) 

(1) Three meals a day served at regular times; no more 

than 14 hours between substantial evening meal and 

breakfast.

418.100 Deleted. 

(2) Procure, store, prepare, distribute, and serve all food 

under sanitary conditions.

.................... Deleted. 

(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 hospice provides appropriate 

methods and procedures for the dispensing and administering of drugs and biologicals.

.................... Hospices that provide inpatient 

care directly.

418.110(m) 

30866 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

DERIVATION TABLE—Continued

Current conditions

(Part 418, subpart C, D, E) 

Citation

existing

section 

Proposed condition Citation 

(1) Licensed pharmacist The hospice must— .................... .................... Hospices that provide inpatient 

care.

418.110(n) 

(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 inpatient

care directly.

418.110(n) 

(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 inpatient 

care directly: Seclusion and 

Restraint.

418.110(o) 

NEW Waiver of Physical therapy, occupational therapy and speech 

language pathology and dietary counseling.

418.74 

NEW Hospices that provide 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.

418.112 

(a) Standard: Resident eligibility, 

election, and duration of benefits.

418.112(a) 

(b) Standard: Professional management.418.112(b) 

(c) Standard: Core services ........ 418.112(c) 

(d) Standard: Medical director ..... 418.112(d) 

(e) Standard: Written agreement 418.112(e) 

(f) Standard: Hospice plan of 

care.

418.112(f) 

(g) Standard: Coordination of 

services.

418.112(g) 

(h) Standard: Transfer, revocation, or discharge from hospice.418.112(h) 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 30867

DERIVATION TABLE—Continued

Current conditions

(Part 418, subpart C, D, E) 

Citation

existing

section 

Proposed condition Citation 

(i) Standard: Orientation and 

training of staff.

418.112(i) 

NEW Personnel qualifications .............. 418.114 

(a) General qualification requirements.418.114(a) 

(b) Federally defined qualifications.418.114(b) 

(c) Personnel qualifications when 

no States licensing laws, certification or registration requirements exist.

418.114(c) 

Criminal background checks ....... 418.114(d) 

NEW Compliance with 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.

418.116 

(a) Standard: Licensure of staff .. 418.116(a) 

(b) Standard: Multiple locations .. 418.116(b) 

(c) Standard: Laboratory services 418.116(c) 

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 patientspecific assessment, and maintain 

documentation of the assessment and 

any updates. 

The burden associated with this 

requirement would be the time it would 

30868 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 datadriven 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 RequirementPhysical 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, speechlanguage pathology, and dietary 

counseling services (as needed) 

available on a 24-hour basis. The 

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

30870 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 

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

Christopher_Martin@omb.eop.gov.

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 

30872 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

described in part B of this section. We 

estimate that the 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 (§ 418.52) 

The proposed rule would expand on 

the informed consent section (§ 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 × $42 an hour = $336

• $27 hour/60 minutes = $0.45 

minute × 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 × 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 × 713,000 patients 

= 1,497,300, 

• $2.10 per patient × 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 × 295 patients 

= 24.58 hours 

• 5 minutes per patient × 713,000 

patients = 59,417 hours 

• $27 hour/60 minutes = $0.45 

minute × 5 minutes = $2.25

• $2.25 per patient × 295 patients = 

$663.75

• $2.25 per patient × 713,000 patients 

= $1,604,250

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 30873

TABLE 2.—PATIENT RIGHTS BURDEN ASSESSMENT

Standard 

Time per 

patient

(minutes) 

Time per 

hospice

(hours) 

Total time

(hours) 

Cost per

patient 

Cost per

average

hospice 

Total cost 

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 

(§ 418.54) 

The existing rule (§ 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 predetermined 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 (§ 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 × 15 minutes = $6.75 

• $6.75 per patient × 295 patients = 

$1,991.25 

• $6.75 per patient × 713,000 patients 

= $4,812,750

TABLE 3.—INTERDISCIPLINARY GROUP, CARE, PLANNING, AND COORDINATION OF SERVICES BURDEN ASSESSMENT

Standard 

Time per 

patient

(minutes) 

Time per 

hospice

(hours) 

Total time

(hours) 

Cost per

patient 

Cost per

average

hospice 

Total cost 

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 (§ 418.58) 

The current rule requires a hospice to 

maintain a quality assurance program 

that involves an ongoing, 

comprehensive, integrated selfassessment by the hospice of the quality 

and appropriateness of care (§ 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 

30874 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 × 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

Standard 

Time per 

hospice

(hours) 

Total time

(hours) 

Cost per 

hospice Total cost 

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 (§ 418.60) 

There is no specific existing 

requirement for infection control other 

than what is briefly mentioned in the 

existing § 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 (§ 418.64) 

The proposed rule would allow core 

services to be provided under contract 

with another Medicare certified hospice 

in certain extraordinary or other nonroutine 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 (§ 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 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 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 (§ 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 § 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 abovementioned 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 × 5 minutes to document that 

requirements are met per home health 

aide = $1.60 × 1 document per year = 

$1.60 per hospice 

• $1.60 per hospice × 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

Standard 

Time per 

aid

(minutes) 

Time per 

hospice

(minutes) 

Total time

(hours) Cost per aid 

Cost per

average

hospice 

Total cost 

Documentation (based on 1 new HHA per year) * .......... 5 5 201 $1.60 $1.60 $3,859.20 

Totals ........................................................................ 5 5 201 1.60 1.60 3,859.20 

Organization and Administration of 

Services (§ 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 inservice 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 (§ 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 recertification is necessary are all 

standard procedures. 

Clinical Records (§ 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. 

30876 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

Drugs, Medical Supplies and Durable 

Medical Equipment (§ 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 × 5 minutes = $2.25 

• $2.25 per patient × 295 patients = 

$663.75 

• $2.25 per patient × 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 × 15 minutes per patient= $3.45 

per patient 

• $3.45 per patient × 295 patients = 

$1,017.75 

• $3.45 per patient × 713,000 patients 

= $2,459,850

TABLE 6.—DRUGS, MEDICAL SUPPLIES AND DURABLE MEDICAL EQUIPMENT BURDEN ASSESSMENT

Standard 

Time per 

patient

(minutes) 

Time per 

average 

hospice

(minutes) 

Total industry time

(hours) 

Cost per

patient 

Cost per

average

hospice 

Total industry 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 (§ 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 (§ 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 × 30 minutes per report 

= 55 hours nationwide 

• $42 hour/60 minutes = $0.70 

minute × 30 minutes = $21 per report 

• $21 per report × 110 reports = 

$2,310 

(i) Standard: Infection Control, 

contains a cross-reference to standards 

contained in § 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, 

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

1 hour investigation = $87 per 

investigation 

• $87 per investigation × 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 × 2,412 

hospices = 14,472 hours to develop form 

• 6 hours per hospice × $42 hour = 

$252 to develop form 

• $252 to develop form × 2,412 

hospices = $607,824 

• 713,000 patients × 0.01 percent = 

7,130 patients nationwide requiring 

seclusion or restraint × 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 × 4 minutes per patient to 

complete form = $5.60 per patient to 

complete form 

• $5.60 per patient × 3 patients per 

hospice requiring seclusion or restraint 

= $16.80 per hospice 

• $5.60 per patient × 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

Standard Time per

patient 

Time per 

hospice 

Total time

(hours) 

Cost per

patient 

Cost per average hospice Total cost 

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 (§ 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 (§ 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 

30878 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 × 39 states 

already requiring background checks = 

70,395 already required to have 

background checks 

• 90,271 total employees × 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 × 6 minutes per check 

= 4 hours per hospice 

• 19,876 employees × 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 × 39 employees 

requiring checks = $487.50 

• $12.50 per check × 19,876 

employees requiring checks = $248,250

TABLE 8.—PERSONNEL QUALIFICATIONS BURDEN ASSESSMENT

Time per 

check

(minutes) 

Time per average hospice

(minutes) 

Total industry time

(hours) 

Cost per 

check 

Total cost per average hospice Total industry cost 

6 ............. 1st year—4 hours annually—48.1st year—1,988 hours annually—408.$12.50 1st year—$487.50 annually—$100.1st year—$248,250 annually—51,000. 

TABLE 9.—TOTAL BURDEN ASSESSMENT PROPOSED REQUIREMENTS

[Total time and cost for all altered or new CoPs:] 

Total time 

per patient (minutes) Total time per hospice 

(hours) 

Total industry time

(hours) Total cost per patient Total cost per hospice Total industry 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 problemfocused 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 (§ 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 (§ 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 (§ 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 § 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 

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better identify activities that lead to 

poor patient outcomes, and would be 

able to take corrective action to improve 

performance. 

Infection Control (§ 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 § 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 (§ 418.62) 

We considered rewriting each existing 

CoP instead of combining all of them 

into the proposed CoP, § 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 (§ 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 (§ 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 (§ 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) (§ 418.108, § 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 (§ 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:

§ 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:

§ 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 

30880 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 

§ 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, speechlanguage 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 Medicareapproved 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, speechlanguage 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: Shortterm 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

§ 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 

Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 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, thirdparty payers, or other resources of 

funding known to the hospice.

§ 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-thecounter 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.

30882 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

§ 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.

§ 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 

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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.

§ 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 agencywide 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.

§ 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

§ 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 

§ 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 shortterm 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 § 418.204(c). 

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(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.

§ 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 § 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

§ 418.70 Condition of participation: 

Furnishing of non-core services. 

A hospice must ensure that the 

services described in § 418.72 through 

§ 418.78 are provided directly by the 

hospice or under arrangements made by 

the hospice as specified in § 418.100. 

These services must be provided in a 

manner consistent with current 

standards of practice.

§ 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.

§ 418.74 Waiver of requirement—Physical 

therapy, occupational therapy, speechlanguage pathology, and dietary 

counseling. 

(a) A hospice located in a nonurbanized 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, speechlanguage 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 nonurbanized 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.

§ 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 

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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 § 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 

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(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 selfadministered. 

(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 

§ 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 

§ 418.76 or an individual who meets the 

standards in § 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.

§ 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

§ 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 

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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-today 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 § 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 § 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 inservice training provided during the 

previous 12 months.

§ 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 § 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.

§ 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 § 418.54(e) of this 

subpart. 

(5) Physician certification and 

recertification of terminal illness as 

required in § 418.22 and described in 

§ 418.102(a) and § 418.102(b) 

respectively. 

(6) Any advance directives as 

described in § 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 

30888 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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.

§ 418.106 Condition of participation: 

Drugs, controlled drugs and biologicals, 

medical supplies, and durable medical 

equipment.

Medical supplies and appliances, as 

described in § 410.36 of this chapter; 

durable medical equipment, as 

described in § 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.

§ 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 § 418.110. 

(2) A Medicare-participating hospital 

or a skilled nursing facility that also 

meets the standards specified in 

§ 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 § 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.

§ 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 

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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, wellgroomed, 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 nonemployee 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 easilyactivated, 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 

30890 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

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 

§ 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 

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

§ 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 § 418.10 through 

§ 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 § 418.20 through § 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 

§ 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 

§ 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 § 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. 

30892 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Proposed Rules 

(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, 

§ 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.

§ 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 § 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 § 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. 

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

§ 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 § 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.

§ 418.200 [Amended] 

6. Section 418.200 is amended by 

revising the reference ‘‘§ 418.58’’ to read 

‘‘§ 418.56’’.

§ 418.202 [Amended] 

7. In § 418.202, paragraph (e) is 

amended by revising the reference 

‘‘§ 418.98(b)’’ to read ‘‘§ 418.108(b)’’ and 

paragraph (g) is amended by revising the 

reference ‘‘§ 418.94’’ to read ‘‘§ 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