32088 Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 418 

[CMS–3844–F] 

RIN 0938–AH27 

Medicare and Medicaid Programs: 

Hospice Conditions of Participation 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

existing conditions of participation that 

hospices must meet to participate in the 

Medicare and Medicaid programs. The 

final conditions address the comments 

that we received on the proposed rule 

published on May 27, 2005. This final 

rule focuses on the care delivered to 

patients and their families by hospices 

and the outcome of that care. The final 

requirements continue to reflect the 

unique interdisciplinary view of patient 

care and allow hospices flexibility in 

meeting quality standards. These 

changes are an integral part of the 

Administration’s efforts to achieve 

broad based improvements in the 

quality of health care and our efforts to 

improve the quality of care furnished 

through the Medicare and Medicaid 

programs. 

EFFECTIVE DATE: These regulations are 

effective on December 2, 2008. 

The incorporation by reference of 

certain publications listed in the 

regulations is approved by the Director 

of the Federal Register as of December 

2, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Steve Miller, (410) 786–6656; Mary 

Rossi-Coajou, (410) 786–6051; Danielle 

Shearer, (410) 786–6617; or Jeannie 

Miller, (410) 786–3164. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Hospice care is an approach to caring 

for the terminally ill individual that 

provides palliative care rather than 

traditional medical care and curative 

treatment. Palliative care is an approach 

that improves the quality of life of 

patients and their families facing the 

problems associated with lifethreatening illness through the 

prevention and relief of suffering by 

means of early identification, 

assessment and treatment of pain and 

other issues. Hospice care allows the 

patient to remain at home as long as 

possible by providing support to the 

patient and family, and by keeping the 

patient as comfortable as possible while 

maintaining his or her dignity and 

quality of life. A hospice uses an 

interdisciplinary approach to deliver 

medical, social, physical, emotional, 

and spiritual services through the use of 

a broad spectrum of caregivers. 

Section 122 of the Tax Equity and 

Fiscal Responsibility Act of 1982 

(TEFRA), Public Law 97–248, added 

section 1861(dd) to the Social Security 

Act (the Act) to provide coverage for 

hospice care to terminally ill Medicare 

beneficiaries who elect to receive care 

from a Medicare-participating hospice. 

Under the authority of section 1861(dd) 

of the Act, the Secretary has established 

the Conditions of Participation (CoPs) 

that a hospice must meet to participate 

in Medicare and/or Medicaid, and these 

conditions are set forth at 42 CFR part 

418. The CoPs apply to a hospice as an 

entity as well as to the services 

furnished to each individual under 

hospice care. Under section 1861(dd) of 

the Act, the Secretary is responsible for 

ensuring that the CoPs, and their 

enforcement, are adequate to protect the 

health and safety of individuals under 

hospice care. To implement this 

requirement, State survey agencies 

conduct surveys of hospices to assess 

their compliance with the CoPs. 

The hospice CoPs were originally 

published on December 16, 1983 (48 FR 

56008) and were amended on December 

11, 1990 (55 FR 50831) largely to 

implement provisions of section 6005(b) 

of the Omnibus Budget Reconciliation 

Act of 1989 (Pub. L. 101–239). However, 

many of the current CoPs have remained 

unchanged since their inception. 

As the single largest payer for health 

care services in the United States, the 

Federal Government assumes a critical 

responsibility for the delivery and 

quality of care furnished under its 

programs. Historically, we have adopted 

a quality assurance approach that has 

been directed toward identifying health 

care providers that furnish poor quality 

care or fail to meet minimum Federal 

standards. These problems would either 

be corrected or would lead to the 

exclusion of the provider from 

participation in the Medicare or 

Medicaid programs. However, we have 

found that this problem-focused 

approach has inherent limits. Ensuring 

quality through the enforcement of 

prescriptive health and safety standards, 

rather than improving the quality of care 

for all patients, has resulted in our 

expending much of our resources on 

dealing with marginal providers, rather 

than on stimulating broad-based 

improvements in quality of care. 

In order to take advantage of 

continuing advances in the health care 

delivery field, incorporate changes 

made to the Act, and incorporate 

recommendations made by various 

government agencies we are revising the 

Medicare hospice CoPs, which are also 

used by Medicaid. The revised CoPs 

focus on a patient-centered, outcomeoriented, and transparent process that 

promotes quality patient care for every 

patient every time. 

We have developed a set of core 

requirements for hospice services that 

encompass the following: Patient rights, 

comprehensive assessment, patient care 

planning and coordination by a hospice 

interdisciplinary group (IDG). 

Overarching these requirements is a 

quality assessment and performance 

improvement program that builds on the 

philosophy that a provider’s own 

quality management system is key to 

improved patient care performance. The 

objective is to achieve a balanced 

regulatory approach by ensuring that a 

hospice furnishes health care that meets 

essential health and quality standards, 

while ensuring that it monitors and 

improves its own performance. 

We are revising the CoPs based on 

four main considerations. First, we 

considered the recommendations from 

the Secretary’s Advisory Committee on 

Regulatory Reform. In an effort to make 

regulations more predictable and 

responsive to relevant stakeholders, the 

Committee heard public testimony on a 

variety of hospice-related topics and 

developed recommendations to address 

key issues that were highlighted. The 

Committee recommended that we 

clarify the relationship between nursing 

facilities and hospices (found in our 

final rule at § 418.112); change the 

requirements for 24-hour nursing 

services for hospices providing respite 

care (§ 418.108 of the final rule); and 

clarify that all qualified individuals, 

including nurses, are permitted to 

furnish dietary counseling 

(§ 418.64(d)(2) of the final rule). 

Second, we considered the Balanced 

Budget Act of 1997 (Pub. L. 105–33) 

because it made changes to the hospice 

statute that must now be incorporated 

into the CoPs. Specifically, the Balanced 

Budget Act of 1997 (BBA) permitted 

hospices to provide physician services, 

including those of a medical director, 

under contract (§ 418.64 and § 418.102 

of the final rule). It also allowed 

hospices located in non-urbanized areas 

to receive a waiver of the requirement 

that physical therapy, occupational 

therapy, speech-language pathology, 

and dietary counseling be available on 

a 24-hour as needed basis (§ 418.74 of 

the final rule). Additionally, the 


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legislation allowed hospices located in 

non-urbanized areas to receive a waiver 

of the requirement that dietary therapy 

be provided by hospice employees 

(§ 418.74 of the final rule). 

Third, we considered section 946 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173). Section 

946 of the MMA amended section 

1861(dd) of the Act, to permit a hospice 

to enter into an arrangement with 

another hospice to provide core hospice 

services or to provide the highly 

specialized services of a registered 

professional nurse, in certain 

circumstances (§ 418.64 of the final 

rule). 

Finally, this revision is part of a larger 

effort to bring about improvements in 

the quality of care furnished to hospice 

patients and their families through an 

outcome-oriented approach to patient 

care. The revised CoPs focus on the core 

elements of hospice care that are 

necessary to achieve positive patient 

outcomes to meet the growing 

challenges associated with the changing 

hospice care environment such as 

increasingly diverse patient populations 

and care settings. 

Before developing the proposed CoPs 

for hospices, published in the Federal 

Register on May 27, 2005, we analyzed 

our hospice survey data, and received 

advice and suggestions from the hospice 

industry, professional associations, 

practitioner communities, consumer 

advocates, and State and other 

governmental agencies with an interest 

in, or responsibility for, hospice 

regulation and oversight. Based on the 

data and suggestions, we developed the 

following principles: 

• Focus on the continuous, integrated 

health care process that a patient/family 

experiences across all aspects of hospice 

care, and on activities that center 

around patient assessment, care 

planning, service delivery, and quality 

assessment and performance 

improvement; 

• Use a patient-centered, 

interdisciplinary approach that 

recognizes the contributions of various 

skilled professionals and other support 

personnel and their interaction with 

each other to meet the patient’s needs; 

• Incorporate an outcome-oriented 

quality assessment and performance 

improvement program; 

• Facilitate flexibility in how a 

hospice meets performance 

expectations; 

• Require that patient rights are 

ensured; and 

• Use performance measurement 

systems to evaluate and improve care. 

Based on these principles and the 

public comments that were submitted 

regarding the May 2005 proposed rule, 

we are setting forth this final rule. 

II. Provisions of the Proposed 

Regulations and the Analysis and 

Responses to Public Comments 

On May 27, 2005, we set forth 

proposed rules for hospices that choose 

to participate in Medicare and 

Medicaid. We proposed to revise all of 

the existing conditions of participation 

(CoPs), and to add several new CoPs to 

address aspects of hospice care that we 

believe need attention. This section will 

briefly describe the content of each CoP 

in the proposed rule. 

We proposed no changes to Subparts 

B (Eligibility, Election and Duration of 

Benefits), G (Payment for Hospice Care), 

or H (Coinsurance) of 42 CFR part 418. 

We received 205 timely items of 

correspondence that raised numerous 

issues. These comments, detailed below, 

came from accrediting bodies, consumer 

advocacy organizations, hospices, 

individuals, national health care 

provider organizations, State agencies, 

and State health care provider 

organizations. 

1. Scope of the Part (§ 418.2) 

We proposed to revise § 418.2 to 

reflect the reorganization of the part and 

to include an introductory statement 

describing the purpose of the part. We 

did not receive any comments on this 

section. Therefore, we are adopting the 

provisions as proposed. 

2. Definitions (§ 418.3) 

We proposed to remove, revise, and 

add numerous definitions to this section 

in order to clarify the meaning of the 

proposed rule. We proposed to move the 

definitions of ‘‘physician’’ and ‘‘social 

worker’’ from the definitions section to 

the personnel requirements section at 

§ 418.114 because the definitions set 

forth the standards that these 

individuals must meet in order to 

function in a hospice. In addition, as it 

is not a condition of participation, and 

is only used for hospice payment 

purposes, we proposed to maintain the 

existing definition of the term ‘‘cap 

period.’’

We proposed to revise the definitions 

of the terms ‘‘attending physician’’, 

‘‘bereavement counseling’’, ‘‘employee’’, 

‘‘hospice’’, ‘‘representative’’, and 

‘‘terminally ill’’. Finally, we proposed to 

add definitions for the following terms: 

‘‘clinical note’’, ‘‘drug restraint’’, 

‘‘hospice care’’, ‘‘licensed professional’’, 

‘‘palliative care’’, ‘‘physical restraint’’, 

‘‘progress note’’, ‘‘restraint’’, ‘‘satellite 

location’’, and ‘‘seclusion’’. 

We proposed to add nurse 

practitioners to the definition of 

‘‘attending physician’’ because section 

408 of the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) changed the statutory 

definition of ‘‘attending physician’’ to 

include nurse practitioners with respect 

to some (but not all) aspects of hospice 

services. 

The terms ‘‘drug restraint’’, ‘‘physical 

restraint’’, and ‘‘seclusion’’ were 

presented for the first time in the 

proposed rule. Seclusion and restraint 

requirements were proposed because 

anecdotal evidence suggested that there 

are occasions when hospice inpatient 

facilities must use seclusion and/or 

restraints for patient and/or staff safety. 

Moreover, Section 591 of the Public 

Health Service (PHS) Act, as added by 

the Children’s Health Act (Pub. L. 106–

310), prohibits the use of restraint and 

seclusion, except under specific 

circumstances, in any health care 

facility, that receives support in any 

form from any program supported in 

whole or in part with funds 

appropriated to any Federal department 

or agency. 

We proposed to define the term 

‘‘satellite location’’ to codify longstanding Medicare survey and 

certification policies that permit 

hospices to operate multiple locations 

under a single provider number. 

Multiple locations were not an issue 

when the hospice CoPs were originally 

implemented, and, as such, were not 

addressed. We believed that the 

proposed definition would help 

hospices determine when they do or do 

not need to obtain Medicare approval 

for a new location and what criteria 

would be used by Medicare in 

approving or denying a multiple 

location application. 

Comment: Many commenters 

requested that changes be made to the 

proposed definition of ‘‘attending 

physician.’’ Some of these commenters 

requested that, in addition to ‘‘nurse 

practitioner,’’ we also add ‘‘advanced 

practice nurse,’’ ‘‘clinical nurse 

specialist,’’ and ‘‘physician’s assistant’’

to the definition of ‘‘attending 

physician’’ in order to broaden the 

category of individuals who could 

receive payment in that capacity. A 

single commenter suggested that we 

defer to the States to determine training, 

education and experience requirements 

for nurse practitioners. Another 

commenter suggested that the definition 

of ‘‘attending physician’’ should be 

divided into two definitions, one for 

physicians and one for nurse 

practitioners. Still another commenter 

requested that we delete the 


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requirement that an attending physician 

must be legally authorized to practice 

surgery by the State in which he or she 

performs that function because surgery 

is not a specialty necessary to be 

considered qualified as an attending 

physician. Several other commenters 

requested that we specify in the 

definition of ‘‘attending physician’’ that 

a patient’s attending physician may be 

a hospice employee. Another 

commenter suggested that we add a 

statement that a nurse practitioner may 

cover for an attending physician in the 

attending physician’s absence. 

Response: Section 408(a) of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (Pub. L. 108–173) (MMA) amended 

the term ‘‘attending physician’’ at 

section 1861(dd)(3)(B) of the Act 

specifically for hospices to allow nurse 

practitioners to function as a patient’s 

attending physician if the patient 

identifies the nurse practitioner as such. 

Following publication of the proposed 

rule, CMS published two final rules (70 

FR 45144 and 72 FR 50214) on other 

matters that, among other things, 

modified the definition of the term 

‘‘attending physician’’ to incorporate 

changes made by the MMA. We are 

deferring to these final rules. 

Furthermore, Section 1861(r)(1) of the 

Act specifically defines a physician as 

‘‘a doctor of medicine or osteopathy 

legally authorized to practice medicine 

and surgery by the State in which he 

performs such function or action.’’ We 

believe that this statutory definition is 

appropriate for hospice providers, as 

well as for the many other health care 

providers for which it is used. We do 

not have the authority to delete the term 

‘‘and surgery’’ from this definition. 

We do not believe that it is necessary 

to state in the definition that an 

attending physician may be an 

employee of the hospice. The decision 

as to who is or is not the attending 

physician belongs to the patient 

regardless of that individual’s 

employment relationship (or lack 

thereof) with the hospice. We do not 

prohibit attending physicians from 

being hospice employees as long as it is 

the patient’s choice to decide whether 

or not to have an attending physician 

and who that attending physician will 

be during the patient’s hospice care. In 

addition to consulting with the hospice 

interdisciplinary group (IDG) regarding 

the patient’s hospice care, the attending 

physician retains responsibility for 

meeting the patient’s needs that are not 

related to the terminal illness and that 

terminal illness’s related conditions. 

The attending physician is typically 

someone with whom the patient had a 

relationship before electing to receive 

hospice care. The role of the attending 

physician is to provide a long term 

perspective on the patient and family 

that takes into account their medical 

and personal history. The attending 

physician is not typically an individual 

provided by the hospice to fill this role 

because a patient does not have an 

attending physician, although we 

recognize that this does occur at times. 

We also do not believe that it is 

necessary to state that a nurse 

practitioner may act on behalf of the 

attending physician in the attending 

physician’s absence. If the attending 

physician is unable to fulfill his or her 

duties, then the hospice physicians are 

responsible for fulfilling the attending 

physician’s duties in his or her absence 

in accordance with § 418.64(a)(3) of the 

final rule. Therefore, there is no need for 

the attending physician to designate 

another individual to cover his or her 

hospice patients. The role and function 

of the nurse practitioner is also 

addressed in CMS hospice payment 

policies (see, for example, 42 CFR 

418.304(e)). 

Comment: A commenter requested 

that we revise the definition of 

‘‘bereavement counseling’’ to reflect the 

fact that bereavement counseling begins 

before the patient dies. The commenter 

noted that the proposed rule even 

required the initial step of bereavement 

counseling to begin before the patient’s 

death by requiring that the initial 

bereavement assessment be completed 

at the time of the comprehensive 

assessment. Another commenter 

questioned the qualifications of persons 

providing bereavement counseling and 

indicated that we should consider 

adding language to address this question 

within the definition of ‘‘bereavement 

counseling.’’ Another commenter 

requested that we specify, in the 

definition of bereavement counseling, 

that the counseling only applies to the 

patient’s immediate family members as 

set out in the Act. 

Response: We agree that effective 

bereavement counseling must begin 

before the patient’s death and that the 

proposed rule and this final rule reflect 

this practice by requiring a bereavement 

assessment early in the patient’s hospice 

stay. To clarify our intent, at section 

§ 418.3 of this final rule, we are revising 

the definition of ‘‘bereavement 

counseling’’ to specify that it occurs 

both before and after the patient’s death. 

With respect to counseling immediate 

family members, current practice in 

many hospices is expanding this 

activity. Many hospice programs have 

extensive bereavement programs that 

extend beyond immediate family 

members to embrace other caregivers, 

friends, and the larger community. As 

the commenter pointed out, the statute 

at section 1861(dd)(2)(A)(i) of the Act 

mandates bereavement counseling for 

the immediate family of the terminally 

ill individuals, but does not explicitly 

limit counseling to only such family 

members. We believe that limiting 

counseling to immediate family 

members would disregard the work that 

many hospices do for other persons 

whose relationship with the patient is 

important. To restrict bereavement 

counseling to a select few would 

discourage hospices from providing this 

service, thus harming the bereaved and 

the larger community. Therefore, we did 

not insert language limiting the 

definition of ‘‘bereavement counseling’’

to immediate family members. 

Bereavement counseling is part of the 

hospice’s bundled daily payment rate. 

In order to facilitate bereavement 

counseling services beginning at an 

early time and being furnished to 

whomever the hospice assesses as 

needing services, we believe that it is 

necessary to allow hospices flexibility 

in deciding who is qualified to provide 

bereavement services in accordance 

with their own policies, current 

standards of practice, and other 

applicable Federal, State, and local laws 

and regulations. In the proposed and 

final rule at § 418.64(d), we require that 

counseling services, including 

bereavement counseling, are provided 

by or under the supervision of a 

qualified individual with experience in 

grief or loss counseling. Some hospices 

may use a social worker while other 

hospices may choose to use chaplains or 

volunteers to provide this service. This 

flexibility allows hospices to meet the 

needs of their patients and families in 

a manner that works best for their needs 

and resources. Therefore, we are not 

prescribing who may or may not furnish 

bereavement counseling services. 

Thus, the revised definition for 

‘‘bereavement counseling’’ is as follows: 

‘‘Bereavement counseling means 

emotional, psychosocial, and spiritual 

support and services provided before 

and after the death of the patient to 

assist with issues related to grief, loss, 

and adjustment.’’

Comment: Numerous commenters 

indicated that the proposed definitions 

for the terms ‘‘clinical note’’ and 

‘‘progress note’’ were either unnecessary 

or redundant. The commenters 

suggested that these definitions either 

be deleted or further clarified to 

distinguish their purpose. In addition, 

many commenters suggested that the 

terms ‘‘psychosocial’’ and ‘‘spiritual 

note’’ be added to the definition of 


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‘‘clinical note’’ to reflect the fact that 

individuals who furnish psychosocial 

and spiritual care such as social 

workers, counselors and chaplains also 

write notations in the patient’s clinical 

record. 

Response: Notations in a patient’s 

clinical record by individuals furnishing 

services on behalf of a hospice are 

standard practice. They are a primary 

and crucial means of communication 

between various care providers who are 

in the patient’s home at different times 

while furnishing different services. 

Therefore, we believe that it is 

important to acknowledge their use in 

the hospice environment by requiring 

their presence in the patient’s clinical 

record. At the same time, we agree that 

having two separate definitions for 

notations is not necessary and may even 

be confusing. Therefore, at § 418.3, we 

are using a single definition, ‘‘clinical 

note,’’ that addresses notations 

regarding both the patient and the 

family. We also added the terms 

‘‘psychosocial’’ and ‘‘spiritual’’ to the 

definition to reflect the need for this 

important information in the patient’s 

clinical record. The condensed and 

revised definition is as follows: 

‘‘Clinical note means a notation of a 

contact with the patient and/or the 

family that is written and dated by any 

person providing services and that 

describes signs and symptoms, 

treatments and medications 

administered, including the patient’s 

reaction and/or response, and any 

changes in physical, emotional, 

psychosocial or spiritual condition 

during a given period of time.’’

We would like to point out that the 

term ‘‘clinical note’’ does not limit the 

notations only to those individuals who 

are clinicians. Clinical notes may be 

written by any individual furnishing 

care and services to a patient, including 

volunteers, homemakers, vendors, etc. 

Indeed, we would expect that clinical 

notes from all individuals would be 

included in the clinical record because 

the goal of the clinical note is to include 

as much information as possible to 

ensure that all hospice care providers 

have complete and correct information 

to use in making care decisions and 

furnishing care. 

Comment: Many commenters were 

confused by the terms ‘‘initial 

assessment’’ and ‘‘comprehensive 

assessment’’ as they are used in 

§ 418.54, ‘‘Initial and Comprehensive 

assessment of the patient.’’ The 

commenters requested definitions for 

these terms in order to help clarify the 

difference between the two assessment 

requirements to ensure that the proper 

information was being gathered within 

the stated timeframes. 

Response: We agree that adding 

definitions of these two terms will help 

ensure that patients are being assessed 

in a timely fashion. We are clarifying 

that the initial assessment is to 

determine the patient’s immediate care 

needs. Hospices must complete this 

abbreviated assessment in 48 hours. The 

comprehensive assessment must assess 

in-depth all of the patient’s areas of 

need and will ensure that hospices are 

fully aware of the patient’s current 

status. Hospices will be able to use these 

assessments to establish an 

individualized hospice plan of care that 

meets the patient’s needs. We did not, 

as some commenters suggested, specify 

which disciplines must complete the 

comprehensive assessment. Hospices 

provide many different services and not 

every patient will require an assessment 

by a provider of each of those services. 

If, upon completion of the initial 

assessment, it is determined that a 

patient may benefit from physical 

therapy services, then we would expect 

a physical therapist to complete a 

physical therapy assessment as part of 

the comprehensive assessment. 

However, if there is no indication that 

the therapy services may benefit the 

patient, then a therapy assessment by a 

therapist would be unnecessary. The 

new definitions for ‘‘initial assessment’’

and ‘‘comprehensive assessment’’ are 

added at § 418.3 as follows: 

‘‘Initial assessment means an 

evaluation of the patient’s physical, 

psychosocial and emotional status 

related to the terminal illness and 

related conditions to determine the 

patient’s immediate care and support 

needs.’’

‘‘Comprehensive assessment means a 

thorough evaluation of the patient’s 

physical, psychosocial, emotional and 

spiritual status related to the terminal 

illness and related conditions. This 

includes a thorough evaluation of the 

caregiver’s and family’s willingness and 

capability to care for the patient.’’

Comment: A number of commenters 

asked us to define the terms ‘‘dietary 

counseling’’ and/or ‘‘dietitian’’ to help 

clarify what type of counseling hospices 

are required to provide to their patients, 

and who may furnish this service. A few 

commenters further suggested that we 

should differentiate between dietary 

counseling furnished by a dietitian and 

dietary counseling furnished by a 

qualified individual such as a nurse or 

nutritionist. 

Response: Section 1861(dd)(1)(H) of 

the Social Security Act (the Act) 

requires hospice facilities to provide 

‘‘counseling (including dietary 

counseling) with respect to care of the 

terminally ill individual and adjustment 

to his death.’’ However, the term 

‘‘dietary counseling’’ has never been 

defined for hospices, and there is a great 

deal of confusion in the hospice 

industry regarding exactly what 

constitutes ‘‘dietary counseling.’’

Therefore, we agree that a definition of 

‘‘dietary counseling’’ is necessary. The 

definition at § 418.3 reads as follows: 

‘‘Dietary counseling means education 

and interventions provided to the 

patient and family regarding appropriate 

nutritional intake as the patient’s 

condition progresses. Dietary counseling 

is provided by qualified individuals, 

which may include a registered nurse, 

dietitian or nutritionist, when identified 

in the patient’s plan of care.’’

We do not agree that we should 

prescribe what type of counseling must 

be provided by a dietitian. We would 

expect that, based on an assessment of 

the patient’s dietary needs, a hospice 

would furnish dietary counseling 

services through an individual whose 

skills best meet the patient’s identified 

needs. We believe that the needs of the 

individual patient, rather than preset 

rules, should be the determining factor 

relative to services and staff. We do not 

believe it is appropriate to define the 

term ‘‘dietitian’’ or establish personnel 

requirements for dietitians because we 

believe that hospices should have the 

flexibility to employ an individual that 

would meet the needs of their patients 

in accordance with all other applicable 

Federal, State, and local laws and 

regulations. 

Comment: A few commenters 

submitted suggestions for the proposed 

definition of the term ‘‘employee.’’ A 

single commenter asked that we replace 

the definition of the term ‘‘employee’’

with a definition of the term ‘‘staff.’’

Another commenter suggested that, 

through the definition of the term, 

hospice employees should be required 

to be appropriately trained in death and 

dying. 

Response: The term ‘‘employee’’ is 

singular and is used throughout the 

regulation to refer to the direct 

relationship between the hospice and 

the individual in terms of furnishing 

services (that is, a direct employee), 

supervision, and lines of authority and 

responsibility. The term ‘‘staff,’’ on the 

other hand, is plural and may include 

individuals who are contracted through 

an outside entity, supervised by that 

outside entity, and primarily 

responsible to that outside entity. 

‘‘Staff,’’ as a broader term, is not an 

appropriate substitution for the term 

‘‘employee’’ in these definitions. 


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Additionally, it is not appropriate to 

require in the definition of the term 

‘‘employee’’ that an employee must be 

trained in issues related to death and 

dying. We agree that thorough training 

in issues related to death and dying is 

necessary for all individuals furnishing 

patient care services, including 

clinicians and patient care volunteers. 

In final § 418.100(g)(1) we now require 

hospices to educate all hospice 

employees who have patient contact in 

the hospice philosophy. Education in 

the hospice philosophy would, we 

believe, encompass issues related to 

death and dying, as the commenter 

suggested. It is not necessary for office 

employees with no patient contact to be 

trained in issues relating to death and 

dying. To require the training for all 

employees, regardless of their role 

within the hospice organization, would 

unnecessarily burden hospices and 

divert resources from more critical 

patient care activities. Therefore, we are 

not requiring all hospice employees to 

receive such training. 

Comment: A commenter suggested 

that, in the definition of ‘‘hospice care,’’

we should specify that hospice care may 

be provided in the home, the 

community, or a facility. 

Response: Hospice care is currently 

being furnished in a variety of settings, 

and we do not believe that it is 

necessary or appropriate to specify in 

this rule where hospice care may be 

provided. To do so may unintentionally 

preclude hospices from providing 

services in settings that are appropriate 

but that are outside of an established 

definition. 

Comment: Numerous commenters 

requested changes to the definition of 

‘‘licensed professional.’’ Many of those 

commenters suggested that dietary 

therapy should be added to the list of 

examples of services that should be 

furnished by a licensed professional. 

Another commenter suggested deleting 

the list of examples because the 

examples may inadvertently limit the 

types of services that should be 

provided by licensed professionals. Yet 

another commenter suggested that 

medical social services should be 

deleted from the list of examples 

because not all States license social 

workers. Therefore, in those States 

where no State licensure for social 

workers exists, medical social services, 

CMS presumes, that the commenter is 

advocating that such services be 

furnished by a professional without a 

license. 

Response: We agree that the proposed 

definition needs to be clarified. While 

the commenters are correct in 

suggesting that dietary therapy should 

be provided by a licensed professional, 

whether a nurse, dietitian or 

nutritionist, we agree with the 

commenter who suggested that the mere 

presence of the list of services is 

limiting. Therefore, while we agree that 

dietary therapy should be provided by 

a licensed professional, we are not 

adding dietary therapy to the list of 

examples. Rather, at § 418.3, we are 

deleting the entire list of examples 

because they are unnecessary and may 

be confusing. Deleting the list of 

examples also addresses the 

commenter’s concern regarding the 

licensure status of social workers. We 

recognize that some States may not 

license social workers or other health 

care disciplines, and we do not intend 

to imply that States must provide 

licensure for all health care disciplines 

furnishing hospice services. Rather, our 

intent, as proposed at § 418.116(a) and 

finalized at § 418.114(a) is that if a State 

licenses a particular health care 

discipline, then any individual working 

within that discipline in the hospice 

environment must obtain and maintain 

that State license. If no State license 

exists for a particular discipline, and if 

that individual meets all other 

personnel and training requirements as 

required by this rule and any other 

applicable Federal, State, or local laws, 

regulations, policies, and requirements, 

then it is acceptable for that individual 

to furnish services to hospice patients 

absent a State license. 

Comment: Numerous commenters 

requested clarification on the definition 

of the term ‘‘satellite location.’’

Specifically, hospices requested that the 

definition include: Concrete criteria that 

hospices must meet in order to be 

considered satellite locations, 

information about the approval and 

survey process, and information about 

the type of services furnished by 

satellite locations. 

Response: The term ‘‘satellite 

location’’ is now referred to as ‘‘multiple 

locations,’’ and § 418.3 has been 

modified to reflect this change. We 

believe that this new terminology more 

accurately describes those entities that 

furnish a full array of services from two 

or more locations. We have also 

clarified our intent by stating that 

multiple locations are those locations 

‘‘from which the hospice provides the 

same full range of hospice care and 

services that is required of the hospice 

issued the certification number.’’ We 

note that the term ‘‘certification 

number’’ is now used in place of the 

term ‘‘provider number.’’ This change 

reflects a change in the terminology 

used by CMS to describe the number 

issued to a hospice to identify it in 

certain Medicare systems. 

We believe that clarifying that a 

multiple location provides the same full 

array of services as the hospice location 

originally issued the certification 

number will alleviate commenter 

concerns that convenience sites where 

staff stop in to complete paperwork or 

check messages, or warehouse sites 

where equipment is stored would need 

to be approved by Medicare as multiple 

locations. We note that although we do 

not require hospices to obtain approval 

for warehouse and other single function 

sites, States may still require hospices to 

receive approval from State or local 

authorities. The requirement that 

multiple locations must share 

administration, supervision, and 

services with the hospice that was 

issued the certification number is 

relocated from the definition of the term 

at § 418.3 to the paragraph addressing 

multiple locations at § 418.100(f)(1)(ii). 

We continue to believe that it is the 

level of control and supervision 

exercised by the hospice that was issued 

the certification number over the 

multiple location, rather than mileage 

limitations or staffing levels, which 

determines whether or not a site is a 

multiple location of an existing hospice 

or a completely separate hospice. 

We do not believe that it is 

appropriate to add specific criteria or 

procedures for the approval of multiple 

locations in the regulatory definition 

because this level of specificity may 

reduce our ability to adapt to rapid 

changes in the hospice industry related 

to the use of multiple locations. Rather, 

we will continue to address specific 

criteria and procedures for multiple 

locations in sub-regulatory guidance 

such as the State Operations Manual. 

Comment: A commenter requested 

clarification about the definition of 

‘‘palliative care’’ and its relationship to 

the requirement that, in order for a 

Medicare beneficiary to qualify for the 

Medicare hospice benefit, the 

beneficiary must be certified as being 

terminally ill. Specifically, the 

commenter asked if palliative care could 

be provided by a hospice to individuals 

who are not terminally ill or who have 

not elected the Medicare hospice 

benefit. 

Response: Hospice care is a very 

specific type of care provided within a 

defined timeframe at the end of life. 

Palliative care, on the other hand, can 

be provided at any time of life when 

there is a need to anticipate, prevent 

and treat suffering to optimize a 

patient’s quality of life. Hospices have a 

long history of providing palliative care 

and are often in a position to provide 


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the care either on a direct or contract 

basis to patients who either do not 

qualify for the Medicare hospice benefit 

(or another health care insurer’s hospice 

benefit) or who do not choose to forgo 

curative treatment in order to elect the 

Medicare hospice benefit. We do not 

prohibit hospices from providing these 

palliative care services to patients that 

do not elect or qualify for hospice care, 

as long as the hospices are primarily 

engaged in furnishing hospice care as 

required by section 1861(dd) of the Act. 

Comment: A few commenters 

requested that we define the term 

‘‘physician designee’’ as it was proposed 

in § 418.102, ‘‘Medical director.’’ The 

commenters believed that a definition 

would help to clarify this individual’s 

role. 

Response: We agree that defining this 

term will help clarify what 

responsibilities this individual has as 

well as when those responsibilities are 

assumed. The purpose of the physician 

designee role is to ensure that, if the 

medical director is unavailable, there is 

a predetermined, qualified individual 

who can assume all of the medical 

director’s responsibilities. Having a 

predetermined individual who is ready 

and able to assume the medical director 

responsibilities will help to ensure that 

patients receive high quality hospice 

care even when the usual medical 

director is not available to perform his 

or her duties. With this in mind, we are 

adding a definition for ‘‘physician 

designee’’ at § 418.3 to read as follows: 

‘‘Physician designee means a doctor of 

medicine or osteopathy designated by 

the hospice who assumes the same 

responsibilities and obligations as the 

medical director when the medical 

director is not available.’’

Comment: Several commenters asked 

us to clarify the definition of the term 

‘‘representative’’ by recognizing case 

law, common law, and health care 

powers of attorney in determining 

whether or not an individual is a 

patient’s representative. 

Response: The proposed definition of 

‘‘representative’’ states that a 

representative is an individual who has 

the authority under State law to 

authorize or terminate care on the 

patient’s behalf. In the context of this 

definition, we are deferring to State law 

in its entirety, including statutes, agency 

regulations, and binding court rulings. 

Since designations of health care 

powers of attorney are deemed to 

appoint legal representatives by most, if 

not all states, our proposed definition 

would include individuals granted 

health care powers of attorney. Thus, 

case law, common law, and health care 

powers of attorney are subsumed within 

the definition of the term 

‘‘representative’’, and there is no need to 

amend it. 

Comment: A majority of commenters 

requested that we revise the proposed 

definition of ‘‘drug restraint’’ to remove 

the stigma associated with the term 

‘‘drug.’’ A minority of commenters 

requested that we delete the definition 

of ‘‘drug restraint’’ completely, and 

suggested that the hospice industry at 

large or hospices individually should be 

allowed to determine a definition. 

Response: Drugs have long played a 

prevalent role in hospice care. They are 

used to relieve pain, calm anxiety, 

improve breathing and support the 

patient. However, the idea of drugs used 

as restraints is relatively new in hospice 

care and has provoked much anxiety in 

the hospice industry. We understand 

that hospices are concerned about an 

overly restrictive definition of the term 

‘‘drug restraint.’’ We also understand 

that hospices are concerned about State 

surveyors applying the drug restraint 

regulations applicable to other health 

care providers to hospices. We believe 

that these regulations clearly apply only 

to hospice inpatient facilities (hospice 

programs do not have outpatient 

facilities). Deleting the definition of 

‘‘drug restraint’’ will not resolve 

providers’ uncertainty, and will only 

leave hospices and patients in the 

untenable position of not knowing what 

is and is not a drug restraint; and simply 

renaming the definition as ‘‘chemical 

restraint’’ will not resolve the ambiguity 

either. While we acknowledge that the 

term ‘‘drug’’ may have a negative 

connotation among patients, we are not 

requiring hospices to use this term 

when discussing medications or 

chemicals with patients. Hospices are 

free to refer to drugs used for any 

purpose within the hospice in a manner 

that suits their patients and their 

representatives, families, other 

caregivers, and the hospice. Moreover, 

section 591(d)(1)(B) of the PHS Act 

prohibits the use of drugs ‘‘used as a 

restraint to control behavior or restrict 

the resident’s freedom of movement that 

is not a standard treatment for the 

resident’s medical or psychiatric 

condition.’’ This provision of the Act 

applies to any health care facility that 

receives any financial support from any 

program receiving Federal dollars. 

Comment: Many commenters 

suggested that we narrow the definition 

of ‘‘drug restraint’’ to tailor it to the 

hospice environment. Specifically, 

commenters requested that we indicate, 

in the definition, that a drug is only 

considered a restraint if it is not an 

accepted treatment within a hospice 

program. The commenters expressed 

concern that drugs that may be 

considered restraints in other health 

care settings (for example, long term 

care facilities) are not restraints in 

hospice care because those drugs are 

used to treat distressing symptoms (for 

example, terminal restlessness). A single 

commenter requested that we not 

consider a drug to be a restraint if that 

drug is requested by the patient or the 

patient’s representative while another 

commenter suggested that drugs should 

only be considered restraints if they are 

used inappropriately. 

Response: Narrowing the definition of 

‘‘drug restraint’’ by specifying that a 

drug is not a restraint if it is a ‘‘standard 

treatment within a hospice program’’

may hinder hospices from adopting new 

symptom management drugs in the 

future because they may have not yet 

met the ‘‘standard treatment within a 

hospice program’’ criteria. Our final 

language states that drugs used as a 

restraint are drugs that are not standard 

treatment or dosage for the patient’s 

condition, and we believe that this will 

afford adequate protection to the 

hospice patient population. Therefore, 

we are not adding this additional 

limitation to the definition. 

Similarly, narrowing the definition by 

adding a provision that a drug is not a 

restraint if it is requested is not 

appropriate. Requesting a drug does not 

alter its status as a restraint. In fact, 

there are times when a patient, 

representative or family member may 

request that a drug be administered to 

protect a patient from his or her own 

behavior. The requestor would, in 

essence, be asking for a restraint. Once 

the drug is administered, the patient 

would require the increased level of 

supervision required by this rule in 

order to ensure the patient’s safety and 

well being at all times. Therefore, we are 

not adding a provision to exclude drugs 

from the definition of ‘‘drug restraint’’ if 

those drugs are requested by the patient 

or family. 

Furthermore, narrowing the definition 

of ‘‘drug restraint’’ to those drugs that 

are used inappropriately is not suitable. 

There are drugs commonly used in the 

hospice environment for symptom 

management that can also be used 

appropriately as drug restraints under 

limited circumstances when warranted 

by the patient’s condition and needs as 

documented in the patient’s clinical 

record. 

Comment: A few commenters 

suggested that we should use the same 

definition of ‘‘chemical restraint’’ for 

hospices as we do for other provider 

types. 

Response: We agree that using the 

same definition will help to ensure that 


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hospice patients receive the same level 

of care and protection regardless of 

where they receive health care services. 

In addition, we agree that using the 

same definition will help to ensure that 

employees moving from another 

provider type to the hospice setting will 

more likely be familiar with the 

regulatory requirements. Therefore, at 

§ 418.3, we are adopting the same 

definition and definitional format for 

drug restraints as is used in the Hospital 

Conditions of Participation. We are 

deleting the definitions of ‘‘drug 

restraint’’ and ‘‘physical restraint’’ in 

favor of a more expansive definition of 

‘‘restraint’’ that encompasses both drug 

and physical restraints. We believe that 

having a single definition, rather than 

three separate definitions, will simplify 

the regulation and increase the public’s 

understanding of the requirements. The 

specific section of the new ‘‘restraint’’

definition that applies to drug restraints 

is as follows: 

‘‘A drug or medication when it is used 

as a restraint to manage the patient’s 

behavior or restrict the patient’s 

freedom of movement and is not a 

standard treatment or dosage for the 

patient’s condition.’’

Comment: Many commenters 

suggested changes for the definition of 

‘‘physical restraint’’ ranging from a 

suggestion to delete the definition to a 

suggestion that devices adjacent to the 

patient’s body also be considered 

physical restraints. 

Response: As with ‘‘drug restraints,’’

we understand that there is a great deal 

of apprehension and uncertainty 

regarding physical restraints. In the 

preamble to the proposed rule we asked 

for public comments regarding instances 

when physical restraints may or may 

not be appropriate and necessary. We 

heard from a few commenters that 

bedrails and positional devices are used 

for patient safety, and for assisting 

patients in functioning independently. 

No commenters described a single 

instance where physical restraints have 

been, or to their knowledge, are now 

used, whether appropriately or 

inappropriately, for patient safety, 

behavior management or any other 

purpose. The lack of specific comments 

leads us to conclude that this is an issue 

that most hospices choose not to 

discuss. Without this input, we are 

unable to gauge the level of physical 

restraint utilization in the hospice 

industry or the purposes of that 

utilization. 

The Children’s Health Act (CHA) 

requires us to promulgate regulations 

concerning the use of restraints in 

hospices. Deleting the definition of 

‘‘physical restraint’’ would be in conflict 

with the requirements of the CHA and 

will not alleviate the concern about the 

safe and proper use of physical 

restraints. Indeed, deleting the 

definition will only leave hospices 

wondering whether their practices 

constitute physical restraint and what 

precautions should be taken to ensure 

patient safety and well being. We do not 

believe that this is in the best interest of 

patients or hospices; therefore we are 

including a definition to address 

physical restraints. Moreover, section 

591 of the PHS Act sets forth a statutory 

definition, which is the basis for 

enforcing regulations on the use of 

restraints. 

At the same time, however, we are 

sensitive to commenters’ concerns that 

the definition of ‘‘physical restraint,’’ as 

was proposed, could include bedrails 

and positional devices. Bedrails and 

positional devices may have the effect of 

restraining one patient but not another, 

depending on the individual patient’s 

condition and circumstances. For 

example, a partial bedrail may assist one 

patient to enter and exit the bed 

independently while acting as a 

restraint for another patient. Patients 

who attempt to exit a bed through, 

between, over, or around bedrails are at 

risk of injury or death. The potential for 

serious injury is more likely from a fall 

from a bed with raised bedrails than 

from a fall from a bed where bedrails are 

not used. Bedrails also potentially 

increase the likelihood that the patient 

will spend more time in bed and fall 

when attempting to transfer from the 

bed. To address these potential hazards, 

many long term care facilities have 

replaced the use of bedrails with lower 

beds, perimeter mattresses, alarms, and 

sitters for restless individuals. We 

encourage hospices to have a dialogue 

with their long term care facility 

colleagues about the safe and 

appropriate use of bedrails for hospice 

patients, as we believe that both parties 

can learn from their successes. To 

reflect the fact that it is the function and 

effect of a device, rather than a device 

itself, that determines whether or not 

the device is a physical restraint, we 

have revised the definition at § 418.3 as 

follows: 

‘‘Restraint means: (a) Any manual 

method, physical or mechanical device, 

material, or equipment that immobilizes 

or reduces the ability of a patient to 

move his or her arms, legs, body, or 

head freely, not including devices, such 

as orthopedically prescribed devices, 

surgical dressings or bandages, 

protective helmets, or other methods 

that involve the physical holding of a 

patient for the purpose of conducting 

routine physical examinations or tests, 

or to protect the patient from falling out 

of bed, or to permit the patient to 

participate in activities without the risk 

of physical harm (this does not include 

a physical escort).’’

This language almost precisely tracks 

591(d)(1)(A) of the PHS Act, and 

matches the definition in the Hospital 

Conditions of Participation. As a 

commenter suggested, physical restraint 

applies to any device that has a 

restrictive effect, regardless of whether 

the device is attached to or adjacent to 

a patient’s body. It is the effect of the 

device, rather than its location, that 

makes it a restraint. Using the same 

definition for hospices as is used for 

other provider types will help ensure 

that patients are consistently provided 

the same quality of care and supervision 

when restraints are used, regardless of 

whether those patients are in a hospital 

or a hospice inpatient facility. At the 

same time, using the same definition 

will make staff transitions between 

different provider types easier because 

the same set of restraint rules will apply 

to some other provider types. This may 

be particularly helpful to hospices that 

have occasion to furnish services under 

contract where a nurse or other 

practitioner may be more familiar with 

the rules governing restraints in 

hospitals. Having the same definition 

will help to ensure that there is no 

conflict between the practitioner’s 

previous background and training and 

the applicable hospice rules. 

Comment: Several commenters noted 

that the proposed definition of the term 

‘‘seclusion’’ implies that any placement 

of patients in private rooms would 

constitute seclusion. One commenter 

suggested that the term should be 

completely removed. 

Response: While it was not our intent, 

we agree that the proposed definition of 

‘‘seclusion’’ could embrace private 

rooms. Therefore, at § 418.3, we have 

revised the definition of ‘‘seclusion’’ by 

adding the term ‘‘involuntary.’’ Patients 

who request private rooms do so 

voluntarily, and therefore would not be 

in seclusion. However, if a patient is 

placed alone in a private room against 

his or her will and is not permitted 

visitors or egress from that room, then 

the patient would be considered to be in 

seclusion. We also believe that it is 

essential for the term ‘‘seclusion’’ to 

remain in this rule. Seclusion, as 

defined in section 591(d)(2) of the PHS 

Act, may only be used under 

circumstances described at 591(b). 

Deleting the term ‘‘seclusion’’ will not 

assist hospices in complying with the 

statutory requirement, and will only 

leave hospice facilities and patients in 

the untenable position of not knowing 


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what situations do and do not qualify as 

‘‘seclusion’’ and whether they may be in 

violation of the Children’s Health Act. 

We do not believe that this is in the best 

interest of hospices or their patients. 

Comment: A few commenters 

requested that we delete the definition 

of the term ‘‘terminally ill’’ because it is 

a term that may discourage patients 

from accepting hospice care. 

Response: Section 1861(dd) of the Act 

establishes the Medicare hospice benefit 

for beneficiaries who are terminally ill 

with a prognosis of 6 months or less if 

the illness runs its normal course. The 

definition that we proposed is the same 

definition that is used in the Act. We 

believe that this is necessary to maintain 

the definition in this rule because this 

term is used in the hospice payment 

rules. 

Comment: A number of commenters 

requested that we define the term 

‘‘family’’ using a very broad, patientdirected approach that allows the 

patient to identify those who are 

considered to be his or her ‘‘family.’’

Response: We do not believe that a 

single definition of the term ‘‘family’’

would benefit beneficiaries or hospices. 

The meaning of ‘‘family’’ can change 

depending on circumstances and 

availability of persons close to the 

patient. While allowing the patient to 

identify his or her ‘‘family’’ would be 

ideal, this may not be possible for 

patients who cannot communicate and 

who do not have written information 

available for the hospice. We have 

decided that it would be most 

appropriate to allow each hospice to 

establish its own policy on what 

‘‘family’’ means in its community and 

with its own patients. 

Comment: A single commenter 

requested that we add a definition for 

the term ‘‘unnecessary drugs’’ to include 

drugs used in excessive dosages, for 

excessive durations, without adequate 

monitoring, without adequate 

indications for use, or in the presence of 

adverse events. 

Response: The term ‘‘unnecessary 

drugs’’ did not appear within the 

proposed rule. The concept is very 

interesting and may be useful to 

hospices when assessing a patient’s 

drug therapy regimen as required by 

§ 418.54(c), Content of the 

comprehensive assessment. We have 

incorporated some of the commenter’s 

concerns in our final rule at section 

418.54(c)(6). This section requires 

hospices to review a patient’s 

prescription and over-the-counter drugs 

in use at the time of the assessment, 

including, but not limited to, an 

identification of the effectiveness of the 

drug therapy regimen, any potential or 

existing drug side effects, any potential 

or existing drug interactions, any 

duplicate drug therapies, and any drug 

therapy requiring laboratory monitoring. 

Excessive dosages or durations, or 

inadequate monitoring would likely 

lead to effectiveness and side effect 

issues that will be assessed during the 

comprehensive assessment and 

subsequent updates. The IDG, in 

conference with an individual who has 

specialized education and training in 

drug management, such as a pharmacist, 

will be required to address these issues 

in the patient’s individualized hospice 

plan of care. 

Comment: A commenter suggested 

that we should define the term ‘‘adverse 

event’’ using the Joint Commission 

patient safety event taxonomy. Another 

commenter suggested that we should 

define the term as an, ‘‘unanticipated, 

non-therapeutic response or injury’’. 

Response: While we agree that using 

the Joint Commission patient safety 

taxonomy or suggested definition may 

be helpful for some hospices, we do not 

believe that a single definition of 

‘‘adverse event’’ would meet the needs 

of all hospices at this time. In general, 

an adverse event would be any action or 

inaction by a hospice that causes harm 

to a hospice patient. We believe that 

hospices are capable of determining 

what is or is not an adverse event based 

on the characteristics and needs of their 

patient populations and staff. We 

recognize that hospices are seeking 

further guidance on this issue, and we 

plan to provide such guidance in future 

sub-regulatory guidance, such as the 

State Operations Manual and 

Interpretive Guidelines. 

Comment: A few commenters 

requested that we define the term 

‘‘homemaker services’’ with specific 

references to the Medicaid personal care 

benefit that many states offer to 

Medicaid beneficiaries. Commenters 

asked for clarification about the role of 

homemakers in hospice care, their 

relationship to Medicaid personal care 

aides, and the qualifications for 

individuals who furnish homemaker 

services. 

Response: Section 418.202(g) in 

subpart F of the current hospice 

regulations states, ‘‘[h]omemaker 

services may include assistance in 

maintenance of a safe and healthy 

environment and services to enable the 

individual to carry out the treatment 

plan.’’ We believe that this language 

adequately describes the role that 

homemakers play in hospice care, and 

we are making no changes to it in this 

final rule. 

Each State establishes its own 

Medicaid personal care aide benefit, 

pursuant to our regulations at 42 CFR 

440.167, including its own eligibility 

criteria, scope of services to be 

provided, and personnel qualifications. 

Medicaid regulations impose only 

minimal restrictions on the state’s 

discretion regarding these services. 

Hospice care is meant to supplement the 

care provided by the patient’s caregiver. 

If the individual(s) furnishing Medicaid 

personal care services is functioning as 

the patient’s caregiver, then the hospice 

would not be expected to replace the 

Medicaid personal care providers with 

its own homemaker services on a roundthe-clock basis. The Medicare hospice 

benefit is not meant to be a caregiver 

benefit and should not be expected to 

function as such. Hospices should work 

with their respective State Medicaid 

agencies if they have questions about 

who pays for services provided to 

patients eligible for both Medicare and 

Medicaid. 

With regard to who is qualified to 

furnish homemaker services on behalf of 

a hospice, we proposed in § 418.76(j) 

that a homemaker must have either 

completed home health aide training 

requirements or must have successfully 

completed a hospice’s orientation 

addressing the needs and concerns of 

patients and families coping with a 

terminal illness. We continue to believe 

that either home health aide (now 

referred to as a hospice aide) training or 

hospice orientation provides sufficient 

knowledge for an individual to function 

as a homemaker under the supervision 

of the IDG, and our final requirements 

at § 418.76(j) and § 418.76(k) reflect this. 

Comment: Several commenters 

requested that we define the term 

‘‘nursing services.’’ Most of these 

commenters defined the term to include 

those services furnished by a registered 

nurse, licensed practical nurse (LPN), 

licensed vocational nurse (LVN), nurse 

practitioner or other advanced practice 

nurse. However, the commenters were 

divided on whether or not services 

should be allowed to be delegated by a 

nurse to a hospice aide and whether 

these delegated services should be 

considered nursing services. 

Response: The intent of section 

1861(dd) of the Act has always been to 

require hospices to furnish nursing 

services to their patients as part of the 

Medicare hospice benefit. Hospices 

have complied with this requirement for 

the past two decades using the services 

of a variety of different categories of 

nurses ranging from nurse practitioners 

to licensed vocational nurses to 

registered nurses. Hospices have not, to 

our knowledge, had any difficulty in 

determining what constitutes nursing 

services and we see no reason to 


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establish a definition for the term at this 

time. 

It is important to point out that if we 

had included delegated services in the 

definition of the term ‘‘nursing 

services,’’ then the inclusion would 

effectively prohibit hospices from 

contracting for hospice aide services. 

We believe that this de facto prohibition 

would occur because those contracted 

hospice aides would routinely be 

furnishing delegated nursing services, 

and section 1861(dd) of the Act requires 

that substantially all nursing services 

should be furnished by direct hospice 

employees. We do not think that the 

commenters intended to establish this 

de facto prohibition on contracting for 

hospice aide services. 

Comment: A commenter asked us to 

define the term ‘‘covering physician’’ as 

a physician acting on behalf of the 

attending physician. 

Response: The term ‘‘covering 

physician’’ did not appear in the 

proposed rule. If the patient’s attending 

physician is not available to care for his 

or her patients, then a hospice physician 

would assume care responsibilities. In 

accordance with the proposed and final 

rule at § 418.64(a)(3), a hospice is 

responsible for providing an alternate 

physician to meet the medical needs of 

the patient in the attending physician’s 

absence. 

Comment: A few commenters asked 

us to add a definition for the term 

‘‘social worker.’’ Some commenters 

proposed maintaining the current 

definition as an individual with a 

Bachelors degree in Social Work from 

an accredited university. Others 

suggested raising the requirement to a 

Masters degree in Social Work from an 

accredited university. 

Response: We believe that the 

commenters raise important issues, 

which are discussed in a subsequent 

portion of the preamble. We are 

relocating the credential requirements 

for social workers from the definitions 

section to the new personnel 

requirements section (§ 418.114). We 

believe that this new, central location 

for all credentialing requirements is the 

appropriate location for the social work 

credentialing requirements as well. 

Therefore, we are addressing these 

suggestions in the personnel 

qualifications section of this rule. 

Comment: Several commenters asked 

us to add definitions for the four levels 

of care provided in hospice (routine 

home care, continuous home care, 

respite care, and general inpatient care). 

A few commenters even provided their 

own definitions for these levels of care. 

Response: These ‘‘levels of care’’ are 

payment rather than health and safety 

issues, and therefore we are not 

addressing them in this rule. These 

terms are used specifically in reference 

to our hospice payment rules found at 

42 CFR 418 Subpart F ‘‘Covered 

Services’’ and Subpart G ‘‘Payment for 

Hospice Care.’’ In these two subparts, 

specific criteria for these payment levels 

are detailed, and these criteria 

constitute the definitions for these 

payment terms. 

Comment: Some commenters asked us 

to define the term ‘‘plan of care,’’ and 

suggested the plan of care should be 

defined as a written document that 

addresses the patient and family needs 

identified in the comprehensive 

assessment and is updated as needed. 

Response: We agree with the 

commenters that the plan of care must 

be a written document and that it must 

address the status of the patient and 

family as identified in the 

comprehensive and updated 

assessments. We also agree that the plan 

of care should be updated as frequently 

as necessary based on changing status 

and needs. We do not believe that it is 

necessary to define ‘‘plan of care’’

because pertinent issues are being 

specified in this final rule at § 418.56, 

‘‘Interdisciplinary group, care planning, 

and coordination of services.’’ Section 

418.56 requires that a hospice IDG 

‘‘prepare a written plan of care for each 

patient. The plan of care must specify 

the hospice care and services necessary 

to meet the patient and family-specific 

needs identified in the comprehensive 

assessment as such needs relate to the 

terminal illness and related conditions.’’

In addition, § 418.56(d) will require that 

the plan of care be updated by the IDG 

‘‘as frequently as the patient’s condition 

requires, but no less frequently than 

every 15 calendar days.’’ We believe 

that these requirements adequately 

address the commenters’ concerns. 

Comment: A commenter requested 

that we define the term ‘‘spiritual 

assessment’’ to ensure that these 

assessments address more than a 

person’s religious affiliation. 

Response: Our inclusion of ‘‘spiritual 

assessments’’ in hospices should not be 

solely related to religious affiliation (or 

lack thereof). These assessments might 

focus on a patient’s sense of peace, 

purpose, beliefs, etc., but may not be 

warranted for all patients, particularly if 

they already have an available spiritual/ 

emotional support system. Therefore, 

we do not believe that it is in the best 

interest of hospice patients and hospice 

providers to prescribe exactly what 

constitutes a spiritual assessment. A 

definition may unintentionally interfere 

with the individualized, patientcentered hospice care that we require 

hospices to furnish. We do not intend 

for this regulation to suggest that any 

spiritual counseling or services be 

provided to a hospice patient or family 

against their wishes. 

Comment: Many commenters asked 

us to define the phrase ‘‘patient’s home’’

or ‘‘patient’s residence’’ as a house, 

apartment, SNF/NF, ICF/MR, assisted 

living facility, adult home, shelter, 

foster home or any other place where a 

patient lives. 

Response: We are unable to develop a 

single definition of the terms ‘‘home’’ or 

‘‘residence’’ at this time. We will 

consider these suggestions for future 

rulemaking. 

Comment: Many commenters 

requested a definition of the term 

‘‘facility’’ as it is used in proposed and 

final § 418.112. 

Response: The general term ‘‘facility’’

has been removed from this condition of 

participation (CoP) in favor of a more 

specific list of the facility types to 

which § 418.112 applies. As the general 

term no longer appears in the rule in the 

context of § 418.112, it is no longer 

necessary to define it. 

Comment: A commenter suggested 

that we define the term ‘‘hospice 

patient’’ as a patient who has been 

certified as being terminally ill and who 

has accepted the care of a hospice 

agency. 

Response: There is no single 

definition of ‘‘hospice patient’’ that can 

encompass all types of patients treated 

by a hospice and all eligibility criteria 

for all payment sources. Certifying a 

patient’s terminally ill status is a 

Medicare and Medicaid payment 

requirement that does not necessarily 

apply to other health insurance or 

private pay patients. To say that uncertified patients are not ‘‘hospice 

patients’’ by excluding them from the 

definition would be inappropriate. 

However, ‘‘hospice patients’’ for 

Medicare payment purposes are those 

Medicare beneficiaries certified under 

§ 418.22 and electing hospice services 

under § 418.24. Furthermore, we note 

that the term ‘‘hospice patient’’ does not 

appear in statute or regulation, and, as 

such, we do not believe that it requires 

a definition in this rule. 

3. Condition of Participation: Patient’s 

Rights (Proposed § 418.52) 

We proposed to replace the existing 

CoP, Informed consent, at § 418.62, with 

a new patient rights CoP. The proposed 

patient rights CoP was divided into five 

standards. The first standard, ‘‘(a) 

Notice of rights,’’ would have required 

hospices to develop a notice of rights, 

including information about advance 

directives and the hospice’s controlled 


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drug policies. Under the proposed 

requirement, hospices would have been 

required to present the notice of rights 

verbally (meaning spoken) and in 

writing to patients and families in a 

language and manner that they are able 

to understand. This would have 

occurred before the hospice furnished 

care to a patient and family. Hospices 

would also have been required to 

document the patient’s or 

representative’s understanding of the 

notice of rights. 

In standard (b), ‘‘Exercise of rights 

and respect for property and person,’’

we proposed that the patient would be 

able to exercise his or her rights, be 

respected, voice grievances, and not be 

subjected to discrimination or reprisal. 

We also proposed that hospices would 

investigate and report all alleged 

violations of patient rights, and take 

appropriate corrective action where 

necessary. 

The third standard, ‘‘(c) Pain 

management and symptom control,’’

proposed that patients would have the 

right to receive effective pain 

management and symptom control from 

the hospice. 

Standard (d), ‘‘Confidentiality of 

clinical records,’’ proposed that 

hospices would be required to maintain 

the confidentiality of clinical records in 

accordance with the Privacy Rule 

published in the Federal Register on 

December 28, 2000 (65 FR 82461) as 

amended on August 14, 2002 (67 FR 

53182) and set out at 45 CFR parts 160 

and 164. 

Finally, the fifth standard, ‘‘(e) Patient 

liability,’’ proposed that patients would 

be informed about the extent to which 

payment may be expected from the 

patient, Medicare or Medicaid, thirdparty payers, or other sources, verbally 

and in writing in a language that the 

patient was able to understand. This 

standard proposed that this information 

would be provided to patients before 

care was furnished. The intent of this 

standard was to ensure that patients 

were aware of their potential out-ofpocket costs for hospice care, such as 

co-payments, so that they would not be 

surprised by financial concerns at this 

stressful time. 

Comment: A majority of commenters 

on this issue expressed concern about 

the proposed requirement that hospices 

provide a notice of the patient’s rights 

and responsibilities verbally, as well as 

in writing, in a language and manner 

that the patient would understand. 

Many of these commenters requested 

that hospices not be required to furnish 

written notices in obscure or otherwise 

uncommon languages. Other 

commenters requested that the choice of 

language(s) used to communicate be left 

to the discretion of each hospice or that 

the communication be done in 

accordance with guidance issued by the 

Department of Health and Human 

Services (HHS) related to Title VI of the 

Civil Rights Act of 1964, Prohibition 

Against National Origin Discrimination 

Affecting Limited English Proficient 

Persons. Still other commenters 

requested that we specifically recognize 

in the regulation that interpreters, 

family or otherwise, be permitted to 

facilitate communication of the notice of 

rights to patients and families. 

Response: We recognize that this is an 

area of concern for hospices, as it may 

be challenging for hospices to 

communicate with patients who speak 

languages other than English. However, 

ensuring that patients are aware of their 

rights and how to exercise them are vital 

components of improving overall 

hospice quality and patient satisfaction. 

If patients are unaware of their rights or 

the methods and protections available 

for exercising those rights, then 

hospices cannot expect to receive valid 

feedback from patients on ways to 

improve their services. Without the 

valid feedback, true quality 

measurement and improvement cannot 

exist. Therefore, we believe it is in the 

interest of patients and hospices to 

ensure that all patients, regardless of 

their communication needs, are 

informed of their patient rights. 

Even so, we are sensitive to the 

concerns of hospice providers. The HHS 

guidance on Title VI (August 8, 2003, 68 

FR 47311) applies to those entities that 

receive federal financial assistance from 

HHS, including hospices. This guidance 

presents four areas for hospices to 

consider when developing and 

implementing strategies to meet the 

needs of limited English proficient 

persons. The guidance recognizes the 

role of professional translation services, 

as well as family and friends of the 

patient, in communicating important 

information to patients, including the 

notice of rights. Hospices are already 

expected to comply with the HHS 

guidance, and doing so will enable them 

to comply with the requirements of the 

proposed rule. 

Using family and friends as 

translators should not be the 

communication plan of choice for the 

hospice for its patients who do not 

speak English, unless the patient 

specifically requests this approach. 

Hospices should make all reasonable 

efforts to secure a professional, objective 

translator for hospice-patient 

communications, including those 

involving the notice of patient rights. 

Furthermore, hospices should make all 

reasonable efforts to have written copies 

of the notice of rights available in the 

language(s) that are commonly spoken 

in the hospice’s service area. For those 

patients who speak uncommon 

languages in areas where professional 

translators for those languages are not 

readily available, using family and 

friends of the patient is an acceptable 

option. 

Comment: A commenter asked that 

we explicitly specify in § 418.52(a)(2) 

that patients have the right to refuse to 

formulate advance directives. 

Response: Under this final rule, 

hospices are required to comply with 42 

CFR part 489 Subpart I, ‘‘Advance 

directives.’’ Patients may choose to 

develop advance directives in 

accordance with applicable State 

requirements. Likewise, they may 

choose to not formulate advance 

directives. We believe that 42 CFR part 

489 adequately addresses all aspects of 

advance directives, including patient 

choice. Therefore, we are not adding the 

commenter’s suggestion. 

Comment: Some commenters asked 

that we clarify what type of 

documentation would be necessary to 

demonstrate that the hospice provided 

patients with a notice of rights and that 

the patient or representative 

demonstrated an understanding of the 

rights. A majority of commenters noted 

that language in the proposed rule, 

‘‘demonstrated an understanding of,’’

was imprecise and difficult to measure. 

Additional commenters suggested that 

language from the home health agency 

CoPs at 42 CFR 484.10 should be used 

in the hospice CoPs. Section 484.10 

states that ‘‘the HHA must maintain 

documentation that it has complied 

with the requirements of this section.’’

This language, commenters noted, 

would allow hospices to determine in 

their own policies how the 

documentation would be handled. 

Several other commenters suggested 

that hospices be required to obtain the 

patient’s or family’s signature, 

confirming that they received the notice 

of rights. 

Response: We agree that a more 

precise requirement will help hospices 

ensure that patients and families are 

fully informed about the notice of rights. 

Furthermore, we agree that more precise 

language will help hospices ensure that 

they are in compliance with our 

documentation requirements. Therefore, 

this final rule at § 418.52(a)(3) states, 

‘‘The hospice must obtain the patient’s 

or representative’s signature confirming 

that he or she has received a copy of the 

notice of rights and responsibilities.’’

Comment: Some commenters noted 

that State practices and laws may 


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govern a legal representative’s exercise 

of a patient’s rights as described in 

§ 418.52(b)(3). The commenters 

requested that we add the phrase ‘‘and 

practice’’ at the end of this requirement 

so it would read: ‘‘If a State court has 

not adjudged a patient incompetent, any 

legal representative designated by the 

patient in accordance with State law 

may exercise the patient’s rights to the 

extent allowed by State law and 

practice.’’

Response: Without more specific 

information from the commenters 

regarding what practices states may 

unofficially have in place, we do not 

believe that it is appropriate for us to 

add the phrase ‘‘and practice’’ to the 

requirement at this time. If more 

specific information is made available at 

a future time, we will reconsider this 

suggestion. 

Comment: Many commenters had 

concerns about the scope of the 

responsibilities of hospices when 

investigating and reporting violations of 

patient rights by hospice staff. In 

addition, the commenters had concerns 

about the proposed timeframes for 

investigating and reporting alleged 

violations to local authorities and State 

survey agencies. Specifically, the 

commenters noted that it would not be 

necessary to notify State and local 

bodies having jurisdiction about 

unverified violations. The commenters 

also noted that alleged violations may 

occur several days before the hospice 

becomes aware of them, and indicated 

that the reporting timeframe should not 

begin before a hospice even becomes 

aware of the alleged violation. 

Numerous commenters suggested that 

the patient rights requirement in the 

home health agency regulations at 

§ 484.10 might be more appropriate, 

while others suggested that the 

investigation and reporting 

requirements be deleted in their 

entirety. 

Response: Requiring hospices to 

investigate potential violations of 

patient rights by hospice staff (including 

contracted or arranged services) will 

protect patients and their families. 

Reporting violations (when verified in 

accordance with hospice policies and 

procedures and any applicable State and 

local laws and regulation) is an integral 

part of improving the quality of hospice 

care provided to Medicare beneficiaries. 

At the same time, adopting regulations 

more in line with those currently in the 

home health agency rules would not, we 

believe, be appropriate for the hospice 

industry because hospices typically care 

for more fragile patients and families in 

a wider variety of patient care settings, 

such as private homes, long term care 

facilities, and hospice inpatient units. 

The home health agency requirements 

are narrower than what we are 

requiring. We believe that a broader 

framework in these hospice regulations, 

coupled with a hospice’s own policies 

and procedures, will allow hospices to 

adapt the requirements to the particular 

needs and concerns of their patient 

populations now and in the future. 

However, we agree that further 

clarifications are warranted to ensure 

that a hospice assumes full 

responsibility for its staff, while not 

overwhelming the hospice with 

responsibilities beyond its control. To 

that end, we are requiring hospice staff 

that discover alleged violations to 

immediately report such allegations 

involving anyone furnishing services on 

behalf of the hospice, including 

contracted and arranged services, to the 

hospice’s administrator. The hospice 

administrator must investigate 

violations involving anyone furnishing 

services on behalf of the hospice and, if 

verified, the hospice must report the 

violation to State and local bodies 

having jurisdiction within 5 working 

days of any member of the hospice staff 

(including those furnishing contracted 

or arranged services) becoming aware of 

the violation in accordance with the 

hospice’s own policies and procedures. 

We would expect that significant 

violations, such as illegal actions by 

hospice staff, would be reported to State 

and local bodies. We believe that these 

modifications will ensure that violations 

are fully addressed while not 

overburdening hospices. 

Comment: A single commenter 

requested that we defer to State 

requirements for violation reporting. 

Response: If State requirements for 

reporting violations are stricter than our 

Federal requirements, then those stricter 

State requirements would take 

precedence. Stricter State requirements 

may be those that require violations to 

be reported regardless of whether they 

are verified or not, or requirements that 

verified violations be reported in less 

than 5 days. However, if State 

requirements are less stringent than 

Federal requirements, then the Federal 

requirements will take precedence. We 

believe that the scope and timeframes 

contained in this final rule are the 

minimum health and safety 

requirements with which facilities 

could reasonably be expected to 

comply. 

Comment: Several commenters 

specifically focused their concerns on 

the implementation of proposed 

§ 418.52(b)(4) in the context of the dual 

and possibly overlapping 

responsibilities of hospices that provide 

services to residents of long term care 

facilities. In particular, commenters 

suggested that hospices should only be 

held responsible for those individuals 

functioning on behalf of the hospice and 

that concerns pertaining to individuals 

functioning on behalf of the long term 

care facility should be the responsibility 

of that facility. 

Response: We agree that hospices 

should only be held responsible for 

investigating and reporting violations 

pertaining to their own employees and 

contractors. To address this comment, at 

§ 418.112(c)(8), we are setting forth a 

requirement that the written agreement 

between the hospice and the SNF/NF or 

ICF/MR must contain a provision 

whereby the hospice must report all 

alleged violations involving 

mistreatment, neglect, or verbal, mental, 

sexual, and physical abuse, including 

injuries of unknown source, and 

misappropriation of patient property by 

anyone unrelated to the hospice to the 

facility administrator within 24 hours of 

the hospice becoming aware of the 

alleged violation. 

This requirement will assure that the 

SNF/NF or ICF/MR is made aware of the 

alleged violation in a timely manner so 

that it can begin its own investigation 

and implement its own intervention(s). 

A hospice may also want to consider 

incorporating a provision in the contract 

to require a SNF/NF or ICF/MR to notify 

the hospice if any of its staff become 

aware of a potential patient rights 

violation involving hospice staff. Such a 

provision may enhance hospice-facility 

communication and cooperation. In 

addition, we will consider this issue 

when developing complementary 

regulations for long term care facilities. 

Comment: A few commenters asked 

that we define the term ‘‘immediately’’

as it applies to the timeframe for 

reporting alleged violations to the 

hospice’s administrator. The commenter 

recommended that the timeframe for 

reporting alleged violations be based on 

an assessment of the patient’s needs. 

Response: It is in the patient’s best 

interest to involve the hospice 

administrator at the time that the 

potential violation is noted to assure 

that the situation is adequately and 

expeditiously dealt with. Once notified, 

it is up to the hospice’s policies and 

procedures and the hospice 

administrator’s judgment, in accordance 

with this rule, to handle the allegation. 

The hospice administrator is the 

designated leader of the hospice and 

assumes responsibility for the care and 

services furnished by the hospice, 

whether directly or under contract. This 

is a 24-hour a day responsibility, and it 


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applies to incidences of alleged 

violations. 

Comment: Some of commenters 

expressed concern regarding the manner 

in which the terms ‘‘mistreatment’’ and 

‘‘injury’’ are used in the proposed 

patient’s rights CoP. They believe the 

terms to be vague and too difficult to 

judge objectively. 

Response: The terms ‘‘mistreatment’’

and ‘‘injury’’ encompass two important 

areas that affect patient safety and 

satisfaction. While other terms such as 

‘‘abuse’’ and ‘‘neglect’’ imply actual 

harm to a patient, ‘‘mistreatment’’ is a 

broader term that encompasses quality 

of life issues that are crucial as patients 

and families cope with death and dying. 

We understand that the broad nature of 

the term makes it difficult to judge. This 

judgment difficulty is exactly why we 

are requiring hospices to conduct their 

own internal investigation into the 

potential patient rights violation. We are 

leaving these terms mostly undefined so 

that hospices may determine whether 

‘‘mistreatment’’ or ‘‘injury’’ have 

occurred on a case-by-case basis. State 

tort liability laws may serve as a guide 

for hospices in determining whether 

‘‘mistreatment’’ or ‘‘injury’’ have 

occurred. Through a thorough 

investigation, hospices can determine, 

in accordance with their own policies 

and procedures, whether mistreatment 

occurred and what steps need to be 

taken to resolve the mistreatment and 

prevent future occurrences. 

The presence of the term ‘‘injury’’ is 

also important in this standard because 

it addresses other issues that may not 

constitute ‘‘abuse’’ or ‘‘neglect’’ but that 

nonetheless impact a patient’s wellbeing. We understand that some 

relatively minor injuries such as skin 

tears may be perceived as injuries. By 

maintaining the term ‘‘injury’’ in this 

standard, hospices are required to fully 

investigate incidents of minor injuries 

(like skin tears) to determine if they 

constitute a violation of a patient’s 

rights. If the internal investigation 

reveals that all appropriate steps were 

taken to prevent the minor injury, then 

the hospice may determine that the 

injury is not a violation of a patient’s 

rights. However, if the investigation 

reveals that reasonable precautions were 

not taken, then the hospice may 

determine that the injury is a violation 

of patient rights. In setting forth a 

standard in the final rule that requires 

hospices to report patient injuries to the 

hospice administrator, hospices have 

the opportunity to conduct a self 

assessment to determine if care 

processes need to be changed to 

improve the consistent delivery of 

quality care. 

Comment: Some commenters asked 

for clarification regarding proposed 

§ 418.52(c), which reads, ‘‘The patient 

has a right to receive effective pain 

management and symptom control from 

the hospice.’’ While the commenters 

supported the intent of this standard, 

they questioned its scope. One 

commenter wanted to know whether 

this standard would require hospices to 

furnish continuous home care, while 

another questioned if hospices were 

supposed to be responsible for pain and 

symptom management unrelated to the 

terminal and related conditions. Still 

another commenter suggested that 

hospices should be allowed to refer 

patients to other providers for pain and 

symptom management. 

Response: Effective pain and 

symptom management have long been 

the hallmark of hospice care, and we 

appreciate that the commenters 

recognized the importance of this 

patient right. We agree that hospices are 

required to furnish pain and symptom 

management for the terminal illness for 

which the patient is receiving hospice 

care and conditions related to the 

terminal illness. We have revised this 

standard and clarified this point at 

§ 418.52(c)(1). The continuous home 

care level of care described in the 

payment and coverage sections at 42 

CFR 418.204 and 418.302 may or may 

not be the most effective way to provide 

effective pain management and 

symptom control while maintaining a 

patient at home. 

It is acceptable for hospices to refer 

pain and symptom control issues 

unrelated to the terminal illness and 

related conditions to other providers. If 

a hospice were to make a referral, we 

would expect the hospice to coordinate 

its efforts with the other provider to 

avoid duplicative or contradictory 

therapies in accordance with final 

§ 418.56(e)(5). The goal of this 

coordination is to ensure that the 

patient’s hospice plan of care is 

implemented, and that the hospice care 

is furnished in concert with other care 

sources to ensure that all patient needs 

are met. In accordance with § 418.100(c) 

hospices are responsible for pain and 

symptom management related to the 

terminal illness and related conditions 

and should not refer patients to other 

providers for these issues. If a hospice 

does not have the expertise to handle 

pain and symptom management issues 

related to the terminal and related 

conditions, it is responsible for 

procuring the expertise for the patient as 

part of its regular hospice services. 

Comment: Many commenters 

suggested that we should add provisions 

stating that patients have the right to 

refuse treatment and the right to be 

involved in developing their plans of 

care. 

Response: We agree that these are 

important patient rights that should be 

included in this final rule. We believe 

that including these rights, at new 

§ 418.52(c)(2) and § 418.52(c)(3) 

respectively, will help to ensure that the 

patient’s goals and needs are 

consistently reflected in the hospice’s 

plan of care and actions. 

Comment: A few commenters 

requested that we add a provision 

requiring hospices to provide patients 

with a written statement of the scope of 

care and services that will and will not 

be provided. One commenter requested 

that we add a provision stating that 

patients have the right to receive 

information about the services covered 

under the hospice benefit. 

Response: We agree that providing a 

patient with general information about 

his or her hospice benefit is an 

important step in ensuring that hospice 

patients are educated about their rights. 

Therefore, we are establishing section 

418.52(c)(7), which requires hospices to 

provide this general benefit information. 

We also agree that providing a patient 

with general information about the 

scope of services that the hospice 

provides, as well as any limitations on 

those services, will further empower 

hospice patients and their caregivers to 

take an active role in hospice care 

planning. Providing the patient and 

family a list of services that the hospice 

may provide gives the patient and 

family an opportunity to request 

specific services that the IDG had not 

considered. Simply knowing that help is 

available may lead patients and families 

to reach out for it. For this reason, we 

are establishing section § 418.52(c)(8), 

which requires hospices to provide 

information about the scope of services 

that the hospice will provide to its 

patients, and specific limitations on 

those services. 

Comment: A single commenter 

requested that we add a specific 

provision stating that patients have the 

right to continue to maintain a 

relationship with their attending 

physician once they elect the hospice 

benefit. 

Response: It is understood and widely 

accepted throughout the health care 

community, including in the hospice 

industry, that patients should be 

allowed, even encouraged, to continue 

to work with their attending physicians 

as they transition from one health care 

provider or setting to another. The goal 

of this practice is to enhance continuity 

and quality of care by actively including 

the attending physician, who knows 


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that patient’s medical and family 

history, in planning and delivering the 

patient’s hospice care. We believe that 

this is in the best interest of patients and 

providers. Explicitly identifying a 

patient’s right to choose his or her 

attending physician without undue 

influence from a hospice will help 

ensure that hospices and patients 

continue to benefit from the knowledge 

of attending physicians. Therefore, we 

have added this patient right at 

§ 418.52(c)(4). 

Comment: A commenter requested 

that we add a provision stating that 

patients have the right to access, request 

amendments to, and receive an 

accounting of disclosures regarding 

their health information. 

Response: Patient rights regarding 

their health information are explicitly 

addressed in the HIPAA regulations at 

45 CFR 164.502(a)(2)(i) and 164.524. 

Hospices are already required to comply 

with these extensive regulations, and we 

see no need to duplicate the HIPAA 

patient rights requirements in this rule. 

Therefore, we are not adding this 

suggested provision. 

Comment: Many commenters 

expressed confusion and concern about 

our proposed requirement that hospices 

notify patients of the extent to which 

payment may be expected from the 

patient before care is initiated. 

Commenters sought clarification on how 

this requirement would dovetail with 

the Advanced Beneficiary Notice (ABN), 

long term care facility payments, and 

private health insurance payment rules. 

In addition, commenters wanted to 

know if, before care is initiated, 

hospices would be required to advise 

patients of those services that would not 

be covered by the hospice because those 

items would not be in the plan of care, 

even though the plan of care had not yet 

been formulated. Some commenters 

suggested that, rather than providing 

exact dollar amounts for patient 

liability, we should require a more 

general description about co-pays, 

Medicaid spend down requirements, 

etc. Other commenters requested that 

this notice not be in writing or that it 

be provided at the time of the initial 

assessment rather than before any care 

is provided. A single commenter 

requested that the requirement be 

phased in over a period of time. 

Response: The original intent of this 

proposed standard was to educate 

patients and families about their 

potential liability in consideration of all 

available payment sources. Patients and 

families often come to hospice after long 

illnesses with pressing financial 

concerns. In requiring hospices to 

provide information when services are 

first provided (particularly on 

Medicare’s comprehensive benefit with 

minimal co-pays) we sought to alleviate 

some of those financial worries. 

However, as many commenters noted, 

hospices regularly provide this payment 

overview as part of their patient intake 

process when patients are choosing 

whether or not to elect the hospice 

benefit. We encourage hospices to 

continue this practice. Furthermore, 

commenters noted that financial 

liability for long term care facility 

residents becomes very complicated and 

uncertain because of the patient’s 

residential status. Information provided 

before the start of care is likely to be 

inaccurate because hospices do not 

control the resident’s long term care 

facility liability. The proposed timing of 

the notification and its allencompassing nature make it 

impractical for hospices to implement 

and would likely not increase the 

benefit of hospice services to patients 

and families. Therefore, we are deleting 

this requirement. We believe that the 

existing ABN requirements at 42 CFR 

411.404, which require hospices to 

notify patients should a particular 

service or item potentially not be 

covered by Medicare, provide the most 

timely and accurate information to 

patients and families. The ABN should 

be delivered far enough in advance that 

the patient or representative has time to 

consider the options and make an 

informed choice. The ABN should be 

verbally reviewed with the patient or 

representative and any questions raised 

during that review should be answered 

before it is signed. 

Comment: A commenter requested 

that we add a provision to the patient’s 

rights CoP stating that patients have the 

right to refuse to participate in 

experimental research. 

Response: Ethical research practices 

dictate that patients must choose to 

participate in experimental research and 

that their participation or lack thereof 

may not negatively impact their wellbeing. In addition, although we 

acknowledge that it may occur at times, 

experimental research in palliative care 

is not, to our knowledge, a common 

occurrence. We believe that the existing 

patient opt-in research standard, 

combined with the rarity of the 

situation, does not warrant us issuing a 

new standard within this CoP. 

Comment: A few commenters 

suggested that we should add a 

provision, either in the ‘‘Patient’s 

rights’’ requirement or other 

requirements, that ensures that long 

term care facility residents are provided 

a choice of which hospice furnishes 

their care. 

Response: We are aware of concern 

within the hospice industry about long 

term care facilities that choose to not 

contract with hospice providers, or to 

only contract with a single hospice 

provider to furnish hospice services to 

residents. However, authority to govern 

long term care facilities’ actions is not 

contained in the hospice regulations 

found in 42 CFR part 418. Therefore, we 

are not adding the suggested 

requirement. We will however, take 

these comments into consideration as 

we review the long term care CoPs for 

possible future revisions that would 

address this aspect of long term care 

facility responsibility relative to the care 

of residents. 

Comment: Some commenters 

requested that we require hospices to 

recognize board-certified chaplains as 

advocates for patient rights in hospices. 

Response: We expect that all hospice 

employees and contractors should be 

patient rights advocates with the best 

interest of the patients in mind at all 

times. We are not requiring that 

hospices use patient advocates. 

However, if hospices choose to 

designate specific patient rights 

advocates, they are free to do so, and are 

free to select those individuals who are 

best suited for the task. Board-certified 

chaplains may serve well in the patient 

rights advocate capacity, and hospices 

are free to explore this option. 

Comment: Another commenter 

requested that we add a provision 

stating that patients should not be 

denied hospice care based on the cost of 

their reasonable and necessary palliative 

care. 

Response: Decisions about admission 

to hospice fall outside of the purview of 

this rule, which focuses on ensuring the 

safe and effective provision of quality 

care to patients and their families once 

the patient is admitted to a hospice. 

Although we take this issue very 

seriously, we are not incorporating the 

suggested provision in this rule. We 

note that providers, in general, cannot 

be required to provide services to 

Medicare patients (see Section 1802(a) 

of the Social Security Act). 

Comment: A single commenter 

suggested that patients should be 

required to demonstrate their 

willingness to comply with the plan of 

care. 

Response: We understand that patient 

noncompliance is occasionally an 

obstacle for hospices in providing safe 

and effective hospice care. However, we 

have no authority to mandate patient 

compliance. It is the hospice’s 

responsibility to fully educate the 

patient and family regarding hospice 

care, as well as hospice policies and 


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procedures for handling plan of care 

disagreements, emergencies and other 

situations that may prompt patient 

noncompliance. For these reasons we 

are not adding a patient compliance 

provision. 

Comment: A single commenter 

suggested that hospices be required to 

comply with any additional State 

reporting requirements for elder abuse. 

Response: We agree that hospices 

should be required to comply with all 

health and safety related Federal, State 

and local laws and regulations, which 

would include reporting requirements 

for elder abuse. This rule finalizes 

§ 418.116, ‘‘Compliance with Federal, 

State and local laws and regulations 

related to the health and safety of 

patients,’’ which requires hospices to 

comply with State elder abuse reporting 

requirements. 

4. Condition of Participation: Initial and 

Comprehensive Assessment of the 

Patient (Proposed § 418.54) 

The proposed assessment requirement 

identified the general areas that would 

be included in a patient assessment and 

the timeframes for completing the 

assessments to help hospices ensure 

that they were identifying needs in all 

areas in a timely fashion. 

The proposed comprehensive 

assessment requirement was divided 

into five standards. The first standard, 

(a), ‘‘Initial assessment,’’ would require 

a registered nurse to make an initial 

assessment visit within 24 hours of 

receiving a physician’s admission order 

for care, unless ordered otherwise by the 

physician. The purpose of this initial 

assessment was to determine the 

patient’s immediate care and support 

needs. In the proposed rule we 

differentiated this initial assessment 

from the hospice’s evaluation of a 

patient’s appropriateness for hospice 

care. We stated that visiting a patient to 

determine his or her appropriateness for 

hospice care does not constitute an 

initial assessment. 

The second standard, (b), ‘‘Timeframe 

for the completion of the comprehensive 

assessment,’’ proposed that the hospice 

IDG and the patient’s attending 

physician complete the comprehensive 

assessment no later than four calendar 

days after the patient elected the 

hospice benefit. The four day timeframe 

was proposed because many hospice 

patients are admitted to hospice late in 

their terminal illness and often require 

intensive hospice services at the 

beginning of their hospice stay. A 

hospice must assess a patient to identify 

his or her needs before it can develop 

and implement a plan of care to meet 

those needs. Therefore, a timely 

assessment is necessary to properly care 

for a patient. 

In the third standard, (c), ‘‘Content of 

the comprehensive assessment,’’ we 

proposed that hospices identify the 

physical, psychosocial, emotional, and 

spiritual needs of the patient related to 

the terminal illness and related 

conditions. As proposed, the 

comprehensive assessment would 

include information about the terminal 

condition, complications and risk 

factors, an initial bereavement 

assessment, a drug profile review, and 

any further referrals or evaluations, as 

appropriate. We did not propose that 

hospices use a specific assessment form 

or tool. 

Under proposed standard (d), 

‘‘Update of the comprehensive 

assessment,’’ the hospice IDG would be 

required to update each patient’s 

comprehensive assessment no less 

frequently than every 14 days and at the 

time of each recertification. The 

proposed comprehensive assessment 

update would document changes that 

had occurred since the last assessment, 

including the patient’s progress toward 

desired outcomes and the patient’s 

response to the care furnished by the 

hospice. We proposed these update 

timeframes because the condition of a 

hospice patient is expected to change 

over the course of hospice care, and 

often does so quite rapidly, considering 

that the median length of a hospice stay 

is about 26 days. 

The final standard in this proposed 

CoP, (e), ‘‘Patient outcome measures,’’

would require hospices to include, as 

part of the information gathered by the 

comprehensive assessment, data 

elements to allow hospices to measure 

patient outcomes. This standard 

proposed that the data elements would 

be collected and documented in the 

same manner for all patients in order to 

ensure the accuracy and consistency of 

the data. Hospices would be required to 

use the data in individual care planning 

and the quality assessment and 

performance improvement program 

described in proposed § 418.58. We did 

not propose to require hospices to use 

any specific patient outcome measures 

or data elements. 

Comment: Many commenters 

requested that we clarify in the opening 

paragraph of the CoP that hospices are 

not required to assess a patient’s 

condition beyond the patient’s need for 

hospice care and services related to the 

terminal illness and related conditions. 

Commenters suggested that we delete 

the phrase ‘‘but is not limited to’’

because it implies that hospices are 

required to assess and address areas 

beyond the boundaries of the terminal 

illness and related conditions. 

Response: The Medicare hospice 

benefit covers all care provided by 

hospices for the palliation and 

management of an individual’s terminal 

illness and related conditions. Hospices 

are required to furnish these services; 

however, they are not required to 

furnish services for needs unrelated to 

the terminal illness and related 

conditions. Our intent in specifying that 

hospices are not limited to assessing the 

patient’s status and needs associated 

with the terminal and related conditions 

was to explicitly permit hospices to look 

beyond the terminal and related 

conditions to gain a complete picture of 

the patient. We did not intend to imply 

that hospices would be required to 

provide care for those issues that are 

outside of the scope of hospice care 

under the hospice benefit. In order to 

clarify our intent in the second sentence 

of the CoP, we have removed the phrase 

‘‘but is not limited to’’ and we have 

replaced the word ‘‘care’’ with 

‘‘assessment’’. The final sentence of the 

introductory paragraph at 418.54 now 

reads, ‘‘This assessment includes all 

areas of hospice care related to the 

palliation and management of the 

terminal illness and related conditions.’’

Modifying the requirement does not 

mean that hospices are prohibited from 

identifying and/or addressing issues and 

areas of patient need outside of the 

hospice benefit, even though hospices 

are not responsible for providing 

services for these issues. Indeed, not 

gathering the information may make it 

more difficult for hospices to effectively 

plan to care for a patient because 

important information would not be 

available when making care planning 

decisions. 

Comment: The majority of 

commenters who submitted comments 

in this section expressed concern about 

the timing of the initial assessment. 

Commenters seemed unclear about the 

proposed requirement that hospices 

would have 24 hours from the time that 

a physician order is received to make 

the assessment. Additionally, 

commenters were concerned that the 

proposed rule, as written, would not 

allow hospices to adjust the initial 

assessment timeframe based upon 

patient and family wishes. Many 

commenters specifically requested that 

we replace the term ‘‘physician’s order 

for care’’ with ‘‘physician’s 

certification’’, which would require the 

assessment to be completed after the 

physician has certified that the patient 

is terminally ill and thus an appropriate 

candidate for hospice care. A few 

commenters explicitly disagreed with 


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this suggestion. Several other 

commenters questioned the role that the 

patient’s election to receive hospice care 

played in determining when to begin 

the timeframe for completing the 

assessment. 

Response: We agree that a more 

definitive time point needs to be 

established and that patient and family 

wishes should be taken into account 

when establishing this timeframe. We 

recognize that some patients are selfreferred and therefore may not have a 

physician’s order for hospice care. 

These patients could create uncertainty 

in hospices because hospices would not 

know when to begin the 24 hour period 

for completion of the initial assessment. 

This uncertainty could lead to situations 

of non-compliance that are out of the 

hospice’s control. We do not believe 

that this would be in the best interest of 

patients or hospices; therefore, we are 

revising the timeframe language as 

requested by many commenters. 

In order to clarify the length of time 

that hospices have to complete the 

initial assessment, we have referenced 

language used in Subpart B, Eligibility, 

election and duration of benefits, of the 

existing hospice regulations, into the 

initial assessment requirement at 

§ 418.54(a). Once a hospice has obtained 

an election statement for a particular 

Medicare or Medicaid patient in 

accordance with the requirements of 

Subpart B, the hospice has 48 hours to 

complete the initial assessment, unless 

the patient, his/her representative, and/ 

or physician request an expedited 

timeframe. Since election requirement is 

particular to the Medicare and Medicaid 

hospice benefits, hospices are free to 

establish a similar starting point for 

non-Medicare and Medicaid patients in 

their own policies, based on the needs 

of the hospice, its community, and any 

applicable State and local laws and 

regulations. 

We also agree that the needs of 

patients or their representatives should 

be taken into consideration when 

completing the initial assessment. There 

are times when patients or 

representatives may want to expedite 

the initial assessment, and their wishes, 

along with the health status of the 

patient, should be taken into account 

when scheduling and completing the 

initial assessment. For example, a 

patient’s representative may request that 

the hospice complete the initial 

assessment in a shortened timeframe 

because the patient is in acute distress 

and requires immediate hospice 

assistance. We would expect the 

hospice to consider the patient’s or 

representative’s request for a change in 

the initial assessment timeframe when 

scheduling the necessary visit(s) to 

complete the initial assessment. 

Therefore, we have modified the 

language to state that the patient or 

representative may request that the 

initial assessment be completed in less 

than 48 hours. 

If a patient or representative wishes to 

delay the completion of the initial 

assessment, it would not be appropriate 

to have that patient or representative 

elect the hospice benefit. When a 

patient elects the hospice benefit she 

waives the right to receive all other 

Medicare covered services for the 

terminal illness and related conditions. 

If the patient may not receive all other 

Medicare covered services for the 

terminal illness and related conditions, 

and that patient cannot receive hospice 

services because she has not received an 

initial assessment to determine her 

immediate care needs, then the 

terminally ill patient is effectively 

without health care for the intervening 

time period. We do not believe that this 

is an acceptable situation. 

Standard (a), ‘‘Initial assessment,’’

now states, ‘‘The hospice registered 

nurse must complete an initial 

assessment within 48 hours after the 

election of hospice care in accordance 

with § 418.24 is complete (unless the 

physician, patient, or representative 

requests that the initial assessment be 

completed in less than 48 hours).’’

Comment: A few commenters 

expressed support for separating the 

initial assessment from the 

comprehensive assessment. 

Response: We agree that separating 

the assessment requirements will enable 

hospices to quickly assess the most 

critical areas of need and begin 

furnishing appropriate care while 

ensuring that all areas of need are 

assessed by the appropriate disciplines 

in a timely manner. 

Comment: Some commenters 

requested that we replace the 

requirement that hospices complete 

initial assessments within 24 hours with 

a requirement that hospices make or 

make available an initial patient contact 

within 24 hours of receiving a referral. 

In addition, commenters requested that 

any hospice employee, or at least an RN 

or social worker, be permitted to make 

this initial contact. 

Response: We understand there may 

be some confusion in the hospice 

community about the purpose of the 

initial assessment. The purpose of the 

initial assessment is to gather the 

critical information necessary to treat 

the patient’s immediate care needs. The 

initial assessment is not a ‘‘meet and 

greet’’ visit whereby the hospice 

introduces itself to the patient and 

begins to evaluate the patient’s interest 

in and appropriateness for hospice care. 

As the commenters stated, the initial 

patient contact takes place before the 

hospice assumes responsibility for the 

patient’s care. Hospices may choose the 

timeframe and appropriate individual 

for completing this initial contact. 

It is not appropriate to substitute an 

initial contact for an initial assessment. 

Merely requiring an initial contact 

within 24 hours would not be sufficient 

to meet the needs of critical patients. 

Patients often come to hospice in 

moments of crisis. An initial contact 

when a patient is in need of timely 

assistance would be a disservice to the 

patient and family and would not lead 

to effective, high quality care. Hospices 

may choose to send a social worker or 

other discipline to complete the initial 

assessment along with the RN, and this 

may lead to better patient outcomes and 

satisfaction. Because other disciplines 

do not have the skills necessary to 

independently complete the initial 

assessment, we are not incorporating the 

commenters’ suggestions. 

Comment: Several commenters 

suggested that we change the phrase 

‘‘RN must make an initial assessment 

visit’’ to ‘‘RN must complete an initial 

assessment.’’ Similarly, another 

commenter suggested that we require 

that ‘‘the hospice registered nurse must 

perform and document an initial 

assessment visit.’’ The commenters 

stated that their proposed revised 

language would clarify our intent that, 

rather than simply making a visit to 

begin the initial assessment, the initial 

assessment must be fully complete 

within the specified timeframe. 

Response: The commenters are correct 

in their assertion that the initial 

assessment must be completed, not just 

started, within the timeframe. 

Completing the initial assessment, 

which means that it is both performed 

and documented, enables the hospice to 

determine the patient’s immediate care 

and support needs in a timely manner. 

An accurate determination of care and 

support needs cannot be made until the 

initial assessment is complete; therefore, 

we agree that it is necessary that it be 

completed within 48 hours. We have 

clarified the requirement to read, ‘‘The 

hospice registered nurse must complete 

an initial assessment within 48 hours 

* * * .’’

Comment: A few commenters 

questioned the role of the hospice 

physician in completing the initial 

assessment. 

Response: The initial assessment 

completed by hospice staff must address 

the patient’s critical physical, 

psychosocial and emotional status 


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related to the terminal and related 

conditions. It is likely not the most 

efficient use of a physician’s time to 

complete a task (the initial assessment) 

that can be fully handled by a registered 

nurse. Therefore, we continue to require 

that a registered nurse complete the 

initial assessment. This requirement in 

no way prevents a hospice from using 

the knowledge and skills of both a 

registered nurse and a physician to 

complete the initial assessment. A 

physician who is employed by or under 

contract with a Medicare hospice cannot 

bill separately for the initial and 

comprehensive assessments. 

Comment: Several commenters 

requested that we revise the timeframe 

for completing the initial assessment. 

Suggestions included 48 hours, 72 

hours, the close of the day following the 

day the patient is referred, and 24 hours 

‘‘when reasonably possible.’’ Other 

commenters requested that the 

timeframe be deleted completely. 

Response: Establishing a clear and 

consistent timeframe for completing the 

initial assessment is essential to 

ensuring that patients benefit from 

hospice care early in their stay. 

Completing the initial assessment 

within 48 hours will help hospices 

gather the essential information to begin 

a plan of care that addresses the 

patient’s needs before those needs 

escalate and become extremely difficult 

to address. 

Overall, many commenters stated that 

the 24 hour timeframe for the initial 

assessment, as we proposed, was too 

restrictive. In this final rule we have 

effectively increased the length of the 

timeframe by changing its starting point 

from the time the physician’s order is 

received to the time that the election 

statement is complete in accordance 

with the applicable requirement of 

Subpart B. Under the proposed rule, 

hospices would have been required to 

complete the initial assessment within 

24 hours of the physician’s order to 

begin hospice care, even if the hospice 

was unable to schedule a visit with the 

patient and family within that 

timeframe. Under the revised final rule 

language, hospices have 48 hours after 

the patient elects the hospice benefit to 

complete the initial assessment. At 

times, a patient, representative, or 

physician may request that the 

comprehensive assessment be 

completed in a timeframe less than 48 

hours, and we expect hospices to 

accommodate such requests when they 

are made. 

Comment: Many commenters 

questioned the role of the patient’s 

attending physician in completing the 

comprehensive assessment. Some 

commenters explicitly requested that 

hospices should not be required to 

involve attending physicians. Other 

commenters requested that a provision 

be added permitting attending 

physicians to ‘‘opt out’’ of participating 

in the assessment. Still others indicated 

that we should require attending 

physicians to approve, in writing, the 

content of the comprehensive 

assessment. 

Response: The scope of public 

comments submitted regarding the role 

of the attending physician in hospice 

care suggested that there is no single 

model that applies. Some commenters 

indicated that community-based 

attending physicians provide a leading 

role in hospice care, actively 

participating in the IDG, writing orders, 

and even making visits. Some 

commenters, however, indicated that 

community-based attending physicians 

preferred to step back once a patient has 

elected hospice, typically transferring 

their patients to the hospice physician’s 

care. While we are pleased to know that 

there are many attending physicians 

who wish to stay involved in caring for 

their patients, these physicians should 

not assume that their attending 

physician service role is part of the 

hospice benefit. Likewise, while we are 

pleased to know that hospices are fully 

prepared to care for all of their patients 

needs, including those needs unrelated 

to the terminal illness and related 

conditions that the attending physician 

would be responsible for, it would be 

inappropriate for a hospice to influence 

a patient to relinquish his or her 

attending physician. 

At the same time, we are sensitive to 

the concerns expressed by the hospices. 

Some patients do not have attending 

physicians. Some patients do not want 

to continue seeing their attending 

physicians. Some attending physicians 

may be unresponsive to, or 

uncooperative with, the hospice. We do 

not want to place patients in a position 

where they must choose between 

receiving services from their attending 

physician and their hospice, nor do we 

want to place hospices in a position 

where they are forced to handle difficult 

attending physicians who disrupt their 

operations. 

In light of these considerations, we 

are maintaining the requirement that 

hospices consult with the patient’s 

attending physician when completing 

the comprehensive assessment. 

Involving the attending physician to the 

extent possible will allow hospices to 

gain additional information about the 

patient. Attending physicians can often 

provide a lengthy history of the patient’s 

disease process and family dynamics 

can help the hospice make better care 

planning decisions that result in 

improved patient outcomes. In 

recognition of the fact that not all 

patients have willing attending 

physicians, we have added a caveat that 

this consultation need only occur if 

there is an attending physician to 

consult with. In this way, attending 

physicians may, with the patient’s 

agreement, opt out of following the 

patient’s care through the patient’s 

hospice stay. We are not, as some 

commenters suggested, requiring that 

the attending physician sign a document 

approving the content of the 

comprehensive assessment. Rather, we 

leave it to hospices to define in their 

own policies and procedures how they 

will document that they have conferred 

with the attending physician. We 

believe that this will give hospices the 

ability to structure their communication 

and coordination system in a way that 

meets their needs for timely information 

sharing and documentation. 

Comment: Several commenters 

wanted to know if the consultation with 

the attending physician to complete the 

comprehensive assessment could be 

accomplished over the telephone or 

through electronic communication 

methods. 

Response: A hospice would need to 

consult with willing attending 

physicians in accordance with its own 

policies and procedures. If a hospice’s 

policies and procedures permitted it to 

consult with attending physicians on 

the telephone or through electronic 

communications, then that would be an 

acceptable practice. Rather than dictate 

what is or is not an acceptable 

communication method, this rule seeks 

to ensure that these communications 

occur. Effective communication 

between the hospice and attending 

physician in completing the 

comprehensive assessment will enable a 

hospice to develop a more complete 

understanding of the patient and family 

in order to develop a plan of care that 

addresses all areas of need related to the 

terminal illness and related conditions. 

Comment: A majority of commenters 

addressed the issue of the length of time 

necessary to complete the 

comprehensive assessment. As with the 

initial assessment, some commenters 

questioned the exact time that the 

timeframe began. Some commenters 

expressed strong support for the 

proposed four-day timeframe, with a 

few commenters even suggesting that, in 

the future, we should move to a two- or 

three-day timeframe. Other commenters 

suggested that the timeframe should be 

lengthened to five, seven, eight, or even 

14 days. Some suggested that no 


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timeframe be established at all. Still 

other commenters suggested that we 

should add a caveat that completion of 

the comprehensive assessment should 

be dependent upon the patient’s 

condition. 

Response: Completing the 

comprehensive assessment is an integral 

step in hospice care. The information 

gathered in the comprehensive 

assessment is the basis for completing 

the plan of care. If the information is not 

gathered in a timely manner, then 

completing the plan of care is delayed. 

This results in patients and families not 

receiving all of the services they need in 

order to maximize comfort and dignity 

and achieve the patient’s and family’s 

hospice care goals. Comprehensive 

assessment plays an important role in 

hospice care and a reasonable time is 

needed for its completion. The 

timeframes suggested by the 

commenters varied greatly, with some 

being so short as to potentially preclude 

hospices from conducting a truly 

thorough assessment and some being so 

long as to virtually ensure that hospices 

would never be required to complete 

comprehensive assessments for more 

than 30 percent of their patients. 

Neither extreme would successfully 

meet the needs of patients and hospices. 

In the middle are the commenters 

who suggested maintaining the four-day 

requirement, lengthening it to five days, 

or lengthening it to seven days. While 

we appreciate the support from 

commenters who agreed with the 

proposed four-day timeframe, we agree 

with those commenters who suggested 

that a longer timeframe would be more 

appropriate due to the scheduling 

demands of hospice providers. We have 

lengthened the timeframe from four 

days to five days. Allowing hospices 

another day to complete the 

comprehensive assessment will allow 

more time to schedule the necessary 

contacts. 

While we have lengthened the 

timeframe, we note that it is a 

maximum, a length of time that should 

not be exceeded. The timeframe should 

not be misinterpreted to prevent 

hospices from completing the 

comprehensive assessment earlier than 

five days after the patient or 

representative elects the hospice benefit. 

Indeed, we encourage hospices to 

complete comprehensive assessments in 

less than five days if at all possible. This 

is particularly true for patients who 

enter hospice in crisis. While the initial 

assessment will provide the necessary 

information to begin the plan of care for 

these critical patients, it is the 

comprehensive assessment that will fill 

in important pieces of information to be 

used to maximize the patient and 

family’s physical, emotional and 

spiritual comfort. While we recognize 

that a portion of patients enter hospice 

at the end stage of the disease process 

and may die in less than five days after 

electing the hospice benefit, their 

physical condition does not necessarily 

absolve hospices of the responsibility to 

comprehensively assess these patients. 

The hospice is still responsible for 

taking all appropriate steps to complete 

the comprehensive assessment as that 

assessment is tailored to the patient’s 

areas of need. The ability of hospices to 

tailor the exact content of the 

comprehensive assessment, and the 

individuals who complete it, to the 

needs of patient and families addresses 

concerns about extremely short stay 

patients who may not be contacted by 

all disciplines before death. We do not 

expect or require designated disciplines 

to complete assessments if those 

assessments are not indicated as being 

necessary during the initial assessment 

and any subsequent contacts. 

Comment: A few commenters 

suggested that we eliminate certain 

areas from the comprehensive 

assessment. In particular, commenters 

suggested that we eliminate the 

requirement that hospices assess 

spiritual or potential bereavement issues 

as part of the comprehensive 

assessment. Commenters noted that 

eliminating either of these areas from 

the comprehensive assessment would 

make it easier to complete the 

comprehensive assessment within the 

required timeframe. The commenters 

acknowledged that these areas would 

still need to be assessed, and stated that 

completing the assessments by the time 

of the first IDG meeting would be 

sufficient. 

Response: As discussed above, we 

agree that fully assessing all areas may 

require more than the four days we 

initially proposed for this process. For 

this reason, we have extended the 

timeframe from four days to five days. 

We believe that this approach, rather 

than carving out certain sections of the 

comprehensive assessment, best meets 

the flexibility needs of hospices and the 

care needs of patients. In maintaining 

both the spiritual and bereavement 

assessment requirements, hospices will 

be required to ensure that patient and 

family specific information about these 

important areas is gathered in a timely 

manner to inform the care planning 

decisions. At the same time, allowing 

hospices more time to schedule the 

necessary contacts to gather this 

information will ensure that hospices 

have the flexibility to incorporate new 

patients into existing workloads and 

schedules. We believe that this solution 

accommodates the concerns of the 

commenters without separating these 

two key areas from the comprehensive 

assessment. 

Comment: Some commenters 

requested that the final sentence of the 

introductory paragraph of standard (c) 

be revised. The commenters stated that 

characterizing the comprehensive 

assessment as a description does not 

fully capture the role of the 

comprehensive assessment. 

Commenters suggested that we use 

either the phrase, ‘‘[t]he comprehensive 

assessment must take into consideration 

the following factors,’’ or the phrase, 

‘‘[f]actors that must be considered in 

developing the individualized care plan 

interventions include’’ in its place. 

Response: We agree that more 

expressive language is useful in 

introducing the elements that the 

comprehensive assessment must 

contain. Since both of the suggested 

phrases achieve the same goal, we chose 

to incorporate the more concise 

statement because it will likely lead to 

less confusion. Therefore, the final 

sentence of the introductory paragraph 

at § 418.54(c) states, ‘‘[t]he 

comprehensive assessment must take 

into consideration the following 

factors.’’

Comment: Several commenters 

suggested that we should add a new 

element to standard 418.54(c), ‘‘Content 

of the comprehensive assessment,’’

which would address the issue of the 

patient’s functional status and the 

impact of that status on the patient’s 

ability to understand and participate in 

care planning and implementation. 

Response: We agree that the 

functional status of the patient, both 

physically and mentally, impacts the 

patient’s ability to participate in his or 

her own care and the hospice’s ability 

to furnish that care. Furthermore, we 

agree that this information should be 

collected as part of the comprehensive 

assessment. Therefore, we have added a 

new element at § 418.54(c)(3) that 

requires hospices to assess the patient’s 

‘‘[f]unctional status, including the 

patient’s ability to understand and 

participate in his or her own care.’’

Comment: Several commenters 

suggested that we add a new element to 

standard 418.54(c), ‘‘Content of the 

comprehensive assessment,’’ which 

would address the issue of the 

imminence of death. 

Response: We agree that assessing the 

imminence of the patient’s death is an 

important part of the comprehensive 

assessment. A certain portion of hospice 

patients have extremely short hospice 

stays of three days, and sometimes less 


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than that. The imminence of a patient’s 

death will often drive the type and 

frequency of services provided to a 

patient. Published studies and reports 

(Medpac, ‘‘Report to the Congress: 

Increasing the Value of Medicare,’’

Chapter 3, June 2006; Huskamp, H., 

Buntin, M.B., Wang, V., and Newhouse, 

J., ‘‘Providing Care at the End of Life: Do 

Medicare Rules Impede Good Care?’’, 

Health Affairs, 2001) have noted that 

hospice per-patient expenditures are 

highest in the last few days of life. This 

indicates that the pattern of care for a 

patient in the last days of life will likely 

be different than for a patient who is 

expected to receive hospice services for 

several weeks or months. Identifying the 

imminence of death as part of the 

comprehensive assessment will allow 

hospices to more accurately tailor the 

plan of care to the patient’s status. We 

are adding this element as new 

§ 418.54(c)(4). 

Comment: Numerous commenters 

suggested that we add a new element to 

the comprehensive assessment standard 

(c), which would address severity of 

symptoms. 

Response: We agree that the severity 

of a patient’s symptoms is an important 

aspect of the comprehensive assessment 

that should be assessed for all patients, 

and we have added this requirement as 

new § 418.54(c)(5). Gathering accurate 

information about symptom severity 

will allow hospices to make more 

accurate care planning decisions. We 

are not prescribing how hospices must 

assess symptom severity. There are 

numerous pain and distress scales 

available for use and we do not endorse 

one scale over another. Hospices have 

the discretion to identify the manner in 

which they will assess and document 

symptom severity for their patients. We 

anticipate, over time, that useful tools 

for patient assessment will emerge, and 

that the hospice industry will select the 

most effective and efficient assessment 

tools to use as part of a standard patient 

assessment practice. We may revisit the 

patient assessment requirements in the 

future to ensure that the requirements 

reflect current standards of practice. 

Comment: Many commenters 

supported our proposed requirement 

that hospices complete a medication 

review for each patient as part of the 

comprehensive assessment. The 

commenters suggested that further 

clarification was needed with regard to 

the requirement that hospices include a 

review of a patient’s prescription and 

over-the-counter drugs. Commenters 

suggested that this review should 

include all drugs and alternative 

therapies, even those unrelated to the 

terminal illness and related conditions. 

Furthermore, some commenters 

suggested that hospices should be 

required to differentiate in their 

documentation of this review which 

drugs were and were not related to the 

terminal illness and related conditions. 

Some commenters noted that hospices 

should not be held responsible for not 

being aware of drugs that they were not 

informed of by the patient, family, 

physician, or other health care provider. 

Response: We thank the commenters 

for their support and agree that the drug 

profile review should include all drugs, 

herbal remedies and other alternative 

treatments that could affect drug 

therapy, whether those drugs and 

remedies are related to the terminal 

illness and related conditions or not. 

This thorough review must document 

all substances which the patient is 

using. While we understand that 

patients and families may be unwilling 

to disclose the use of certain substances, 

we expect hospices to use all available 

and appropriate methods to develop a 

complete list. These efforts may include 

asking the patient, family, attending 

physician, and any other health care 

providers. Efforts may also include 

asking to look at all medications in the 

home, being attentive to tell-tale odors, 

and looking for medication-specific 

equipment in the home. Hospices may 

choose how to document the drug 

profile review and the efforts made to 

complete it in the manner that best suits 

their individual needs. While we agree 

that it may be helpful for hospices to 

note the relationship of a drug and 

therapy to the terminal illness and 

related conditions, we do not believe 

that it is necessary to prescribe this level 

of documentation detail in regulation. 

Comment: A few commenters 

suggested that we restructure the 

comprehensive assessment standard to 

de-emphasize the bereavement and drug 

therapy sections of the comprehensive 

assessment. The commenters 

acknowledged that these are important 

areas to assess; however, they believe 

that their placement within the standard 

appeared to place more value on these 

two elements than on the other elements 

of the standard. 

Response: We agree that neither 

bereavement nor drug therapy should 

appear to take precedence over the other 

comprehensive assessment elements. 

The drug therapy requirements, now 

referred to as drug profile requirements, 

are now codified at § 418.54(c)(6) and 

the bereavement requirements are now 

codified at § 418.54(c)(7), on par with 

the other elements of the standard. 

Comment: Many commenters 

suggested that we should rephrase the 

requirement that hospices identify 

‘‘ineffective drug therapy’’ as a 

requirement that hospices assess the 

‘‘effectiveness of drug therapy.’’ A single 

commenter suggested that this 

requirement should be removed because 

it is not within the nurse’s scope of 

practice. 

Response: We agree that the phrase 

‘‘effectiveness of drug therapy’’ is more 

inclusive and will help to capture the 

range of effectiveness of different drugs 

and therapies. For example, rather than 

noting that drug B is ineffective and 

remaining silent on the effectiveness of 

drugs A and C, this new requirement 

will require hospices to note for 

example, that drug A is fully effective, 

but only for a few hours, drug B is 

completely ineffective, and drug C is 

consistently minimally effective. The 

additional level of detail required by 

this new provision will help hospices 

develop a more complete overall 

assessment from which to make more 

accurate care planning decisions. This 

new provision is located at 

§ 418.54(c)(6)(i). If a nurse is unable to 

complete this part of the assessment, 

then it is appropriate for a hospice to 

use another discipline to complete the 

drug profile assessment. 

Comment: Some commenters 

suggested that we require hospices to 

identify all drug side effects, rather than 

only those side effects that are not 

wanted. In addition, the commenters 

suggested that we delete the term 

‘‘toxic’’ because the phrase ‘‘drug side 

effects’’ would include issues of 

toxicity. 

Response: Our original intent was to 

ensure that bothersome side effects were 

noted in the drug assessment so that 

they could be addressed in the care 

planning process. However, as the 

commenters noted, all side effects 

should be noted, even if they are 

desirable. Identifying desirable, as well 

as undesirable, side effects will help 

ensure that the desired side effects are 

not negatively impacted by other drugs 

and their side effects. Additionally, as 

the commenters noted, the term ‘‘toxic’’

is unnecessary. Any toxic effects would 

already be recorded as side effects, 

rendering the term ‘‘toxic’’ duplicative. 

Therefore, we are deleting the terms 

‘‘unwanted’’ and ‘‘toxic’’ from 

§ 418.54(c)(6)(ii), and are simply 

requiring that the hospice review the 

patient’s drug profile for side effects. 

Comment: Several commenters 

suggested that we require hospices to 

evaluate potential as well as actual drug 

interactions. 

Response: We agree that more 

specificity is needed to clarify our 

intent. We agree that hospices must 

identify drug interactions that have 


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occurred in the past or are occurring at 

the time of the assessment if at all 

possible, and must identify drug 

interactions that have the potential to 

occur if the patient continues using the 

same drugs. The lack of a drug 

interaction to date does not mean that 

an interaction will never occur as long 

as the patient continues to use the 

potentially interacting drugs. The 

individual completing the drug profile 

must document the existence of the 

potential interaction so that the entire 

IDG is made aware of the potential 

problem and can then make an informed 

decision about the patient’s drug 

regimen. For these reasons, we are 

revising the drug profile requirement at 

§ 418.54(c)(6)(iii), to require the hospice 

to evaluate both actual and potential 

drug interactions. 

Comment: A commenter suggested 

that we require hospices to determine 

whether the patient is using duplicate 

medications or medications that require 

laboratory monitoring. 

Response: We agree that adding these 

provisions will help hospices gather 

more detailed information from which 

to make accurate care decisions. 

Patients often come to hospice with a 

long list of medications prescribed by 

several different doctors. It is very 

possible that some of these medications 

have overlapping effects, in which case 

one or more medications may be safely 

and appropriately discontinued. 

Identifying unnecessary/duplicate drugs 

and subsequently eliminating them will 

make it easier for patients to follow their 

drug regimens. Identifying drugs that 

currently require laboratory monitoring 

during the assessment will also help 

patients and hospices. Some patients 

come to hospice with the explicit desire 

to forgo more laboratory tests. It is 

imperative that hospices identify any 

drugs that the patient is currently taking 

that may require these tests so that 

patients know about the situation and 

the options available to them to help 

achieve their goals. Identifying drugs 

that require laboratory testing will 

enable patients to make informed 

decisions and may lead patients to forgo 

the use of certain drugs. For these 

reasons, we have incorporated these two 

suggestions at § 418.54(c)(6)(iv) and 

§ 418.54(c)(6)(v). 

Comment: A commenter suggested 

that, as part of the drug review, hospices 

should be required to identify: 

Medications that are unnecessary or 

are not consistent with patient therapy 

goals; Medications requiring dosage 

optimization; Medications that are 

inappropriate according to evidence 

based guidelines; and Missing 

medications that are necessary to 

prevent or address symptoms 

experienced by the patient. 

Response: The purpose of the drug 

profile assessment is to gather the 

information necessary to enable the 

hospice to make appropriate care 

decisions, and it is the role of the 

individual completing this portion of 

the assessment to collect this 

information. Several of the commenter’s 

suggestions (1, 3 and 4) require the 

individual completing the drug profile 

portion of the assessment to draw 

conclusions. We believe that these 

conclusions should be made by the IDG 

during care planning, rather than by a 

single member of the IDG who is 

completing this portion of the 

assessment. Suggestion 2 is already 

captured by the requirement that 

hospices review the effectiveness of 

drug therapy at § 418.54(c)(6)(i). If a 

drug dosage needs adjustment, then that 

need will be reflected in its level of 

effectiveness. For these reasons, we are 

not incorporating these suggestions. 

Comment: Numerous commenters 

expressed concern about the role of the 

initial bereavement assessment in the 

comprehensive assessment and in the 

bereavement plan of care. In particular, 

commenters noted that the information 

gathered in the initial bereavement 

assessment may not remain accurate 

when the patient dies and may 

unintentionally result in poor decision 

making in the final bereavement plan of 

care. For this reason, some commenters 

requested clarification of the role that 

the initial bereavement assessment 

plays in the final bereavement plan of 

care. Other commenters suggested that 

we substitute the hospice plan of care 

for the bereavement plan of care. This 

would require hospices to use the 

information gathered in the initial 

bereavement assessment when 

developing the plan of care, but not 

when developing the bereavement plan 

of care. Still other commenters 

suggested that the initial bereavement 

assessment be completely removed from 

the comprehensive assessment. 

Response: We appreciate the valuable 

insight that the commenters provided 

about the role of the initial bereavement 

assessment in hospice. The comments 

validated our understanding that 

hospices already assess patients and 

families for actual and potential 

bereavement issues before the patient’s 

death rather than waiting until after 

death to begin this process. 

We also appreciate the suggestions to 

help clarify the role of the bereavement 

assessment within the comprehensive 

assessment. We agree that the 

information gained in the initial 

bereavement assessment should be 

incorporated into the hospice plan of 

care. Issues identified in the initial 

bereavement assessment such as 

anticipatory grief and previous 

experiences with loss should inform 

care planning decisions long before the 

patient dies. By requiring hospices to 

incorporate bereavement assessment 

information into the plan of care, 

hospices will be able to develop a more 

complete picture of the patient and 

family. 

Likewise, we agree that feelings can 

change over time, rendering the 

information gathered in the initial 

bereavement assessment moot at the 

time of the patient’s death. For this 

reason, we are no longer requiring that 

information gathered from the initial 

bereavement assessment be 

incorporated into the bereavement plan 

of care. Rather, we are requiring that the 

information from the initial 

bereavement assessment be considered 

in the bereavement plan of care. This 

change still requires hospices to begin 

the bereavement assessment process 

early in the patient’s stay. However, the 

change reflects that fact that the 

bereavement assessment will change as 

it is updated. Furthermore, the change 

allows hospices to use the most accurate 

bereavement assessment information, 

regardless of when it was obtained, in 

developing the bereavement plan of 

care. 

Comment: A single commenter 

suggested that we require, as part of the 

comprehensive assessment, that 

hospices assess the family’s needs along 

with the patient’s needs. 

Response: One of the most unique 

aspects of hospice, and one of the most 

valued, is that it treats the patient and 

family as a single unit of care. Hospices 

recognize that patients do not live in a 

vacuum. Rather, patients are continually 

affected by the well-being, or lack 

thereof, of the people who surround and 

care for them. We in no way want to 

discourage this holistic practice. 

However, comprehensively assessing all 

of the needs of the patient’s family, as 

we require for the patient, is beyond the 

scope of the Medicare and Medicaid 

hospice benefits. Therefore, we are not 

incorporating this suggestion. 

Comment: A few commenters 

suggested that we should add the phrase 

‘‘consistent with patient selfdetermination’’ to the description of the 

elements that must be included in the 

comprehensive assessment. The 

commenters expressed that adding this 

phrase would convey to hospices that 

the comprehensive assessment is 

patient-driven. 

Response: We agree that, within the 

broad outline provided in this rule, the 


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comprehensive assessment is a patientdriven process. Hospice has a long 

history of tailoring patient care, 

including assessments, to the needs and 

desires of the patient. We do not believe 

that the new comprehensive assessment 

requirement will alter this existing 

practice because it provides broad 

outlines that allow hospices to continue 

tailoring their care. Therefore, we do not 

believe that adding the phrase 

‘‘consistent with patient selfdetermination’’ is necessary. 

Comment: A single commenter 

suggested that we should add a new 

element to Standard (c), which would 

address the issue of the need for 

hospices to assess pain and symptom 

management as well as emotional and 

spiritual support. 

Response: We agree that these are 

important areas to be assessed; however, 

we do not agree that they need to be 

separated out as new elements. 

Standard (c) already requires hospices 

to ‘‘identify the physical, psychosocial, 

emotional, and spiritual needs’’ of the 

patient. The specific issues of pain and 

symptom management and emotional 

and spiritual support are addressed by 

these broader categories, and therefore 

do not require separate elements in the 

assessment. To do so would be 

duplicative. 

Comment: A few commenters asked 

us to specify which disciplines and 

providers within those disciplines must 

complete the comprehensive 

assessment. For example, one 

commenter asked us to specify the type 

of personnel who are qualified to 

provide a spiritual assessment. Many 

other commenters wanted us to specify 

that only certified chaplains should 

perform this function. Another 

commenter questioned whether MSWs 

should be required to complete social 

work assessments and whether, based 

on those assessments, patients could 

then be assigned to a baccalaureate 

degree prepared social worker. 

Response: A comprehensive 

assessment, in the context of this rule, 

is not a single document that all hospice 

providers are required to use. Instead, it 

is a flexible evaluative process that 

could be different for each hospice 

based on the hospice’s own needs. If a 

hospice chooses to implement a policy 

that an MSW must assess the status and 

needs of all patients, then we would 

expect the hospice to follow its own 

policy. Likewise, if a hospice chooses to 

implement a policy that certified 

chaplains must be used to assess all 

patients who do not have existing 

spiritual support systems while 

community religious leaders must be 

used to assess all patients who have 

existing spiritual support systems, then 

we would expect the hospice to follow 

its own policy. These examples 

illustrate the flexible nature of the 

assessment requirement. To prescribe 

who may or may not complete different 

elements of the comprehensive 

assessment, or even what areas of care 

must be assessed, would remove this 

flexibility. We do not believe that 

removing flexibility is in the best 

interest of patients or hospices; 

therefore we are not adopting these 

suggestions. 

Comment: A single commenter 

observed that the plan of care could not 

be completed until the comprehensive 

assessment was completed. 

Response: The commenter is correct; 

however, the initial assessment would 

already have gathered the most critical 

clinical and psychosocial information, 

which would enable the hospice to 

begin completing the plan of care. Once 

the comprehensive assessment is 

complete, the hospice must then finish 

the plan of care based on the needs 

identified in the comprehensive 

assessment. Hospices may not wait until 

the comprehensive assessment is 

complete to begin to formulate the plan 

of care and provide services, as the 

commenter seemed to imply. Such 

waiting, when the hospice has assumed 

responsibility for caring for the patient 

and the patient has forgone all other 

services related to the terminal illness, 

would be a disservice to the patient and 

would likely lead to negative patient 

outcomes, patient and family 

complaints, and numerous other 

undesirable effects. 

Comment: Several commenters 

expressed confusion about who would 

be responsible for completing the 

comprehensive assessment, how it 

would have to be completed, and who 

would review its content. Specifically, 

commenters suggested that the hospice 

registered nurse be required to complete 

the comprehensive assessment and that 

the IDG be required to review its 

content. Other commenters questioned 

whether all disciplines were required to 

make in-person visits or whether phone 

contacts could be used to complete the 

assessment. 

Response: The comprehensive 

assessment is not a single static 

document, a symptom and severity 

checklist, or a set of generic questions 

that all patients are asked. It is a 

dynamic process that needs to be 

documented in an accurate and 

consistent manner for all patients. 

While the comprehensive assessment 

often begins with a nursing assessment 

that is focused on the patient’s physical 

status and conducted by a registered 

nurse, it does not end there. The 

comprehensive assessment must also 

focus on the patient’s psychosocial and 

emotional status and needs, and this 

piece is often assessed by a social 

worker. In addition, the comprehensive 

assessment must address the patient’s 

spiritual status and needs, which is 

often the domain of the pastoral or other 

counselor who is a member of the 

patient’s IDG. Furthermore, the 

comprehensive assessment must focus 

on identifying any other needs that fall 

into the scope of the physical therapist, 

speech language pathologist, 

occupational therapist, dietitian, or any 

number of other disciplines that a 

hospice may provide. A nurse is not 

qualified to provide detailed 

assessments in all of these areas; 

therefore we cannot place the burden of 

completing the comprehensive 

assessment on the nurse alone. The 

broad nature of the comprehensive 

assessment requires the active 

involvement of all of the members of the 

IDG in order to ensure that a complete 

and accurate picture of the patient and 

family is obtained. 

The active involvement can occur in 

any number of ways depending on the 

patient’s needs and preferences. Some 

families may need a face-to-face visit 

from a social worker to help them sort 

through myriad insurance papers or 

simply provide a supportive presence, 

while other families may find it easier 

to discuss difficult issues by phone. If 

families need or prefer in person visits, 

then those needs should be met. If they 

prefer the limited anonymity afforded 

by the telephone, then their preference 

should be accommodated. We cannot 

provide the clear cut answer that 

commenters are seeking because each 

patient, family, and situation is 

different. Decisions about who assesses 

and how they assess need to be based 

on the needs of the patient and family 

and the hospice’s own policies and 

procedures. 

Comment: A single commenter 

suggested that we should create a 

separate standard for assessing patients 

with short lengths of stay. The 

commenter stated that a separate 

standard would avoid overwhelming 

patients and families. 

Response: We agree that patients and 

families should not be overwhelmed in 

the last days of life. However, we do not 

agree that a separate short stay 

assessment standard is necessary. We 

are finalizing a requirement that 

hospices complete an initial, 

abbreviated patient assessment within 

48 hours of the patient or representative 

electing the hospice benefit. This 

assessment, conducted by the hospice 


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nurse in conjunction with other 

appropriate hospice staff, will provide 

hospices with the essential information 

to formulate a plan of care to address 

the patient’s immediate care and 

support needs without overwhelming 

the patient and family. We believe that 

patients who stay for a short time in 

hospice will be well served by this 

initial assessment. Length of stay should 

not be the determinant of the quality of 

care that is to be furnished. For those 

patients who stay for a longer period of 

time, we are requiring hospices to 

complete a comprehensive assessment 

within five days of the patient or 

representative electing the hospice 

benefit. We are not prescribing what 

areas of hospice care must be assessed 

(that is, nursing, social work, therapies, 

etc.) or who must complete those 

assessments. Allowing hospices to make 

these choices allows them to strike a 

balance between the need for 

assessment information and the desire 

to not overwhelm patients and families. 

We believe that this built-in flexibility 

accomplishes the commenter’s goal 

without adding a separate short stay 

assessment standard. Therefore, we are 

not adopting the comments as 

suggested. 

Comment: A commenter suggested 

that standard (d), ‘‘Update of the 

comprehensive assessment’’ should be 

renamed ‘‘Ongoing assessment’’ to 

clarify that the entire assessment does 

not need to be redone every 15 days. 

Response: We do not believe that 

renaming the standard will accomplish 

the stated goal. Renaming the standard 

as ‘‘Ongoing assessment’’ would imply 

that every single change, regardless of 

how minute it was, would need to be 

documented on the comprehensive 

assessment, as these minute changes 

would be identified in the day-to-day 

clinical assessments of the patient. We 

believe this would add an unnecessary 

burden to hospice staff and would not 

advance patient care. 

Comment: Many commenters 

supported the goal of requiring hospices 

to regularly update the comprehensive 

assessment. Most of these commenters 

suggested changes to the proposed 14- 

day timeframe for updating the 

comprehensive assessment. Some 

commenters suggested that we delete 

the timeframe completely, while other 

commenters suggested that the 

timeframe be every two weeks or at the 

beginning of each new benefit period. 

Response: We appreciate the support 

for regularly updating the 

comprehensive assessment, as this 

support generally reflects our 

understanding that most hospices 

already update patient assessments in 

accordance with some sort of selfimposed timeframe. We believe that 

establishing a standard comprehensive 

assessment timeframe in this rule will 

help those hospices ensure that their 

update timeframe is consistent with 

patient needs and standards of practice. 

Deleting or greatly extending the 

timeframe, as a few commenters 

suggested, would be out of step with 

current standards of practice and would 

likely lead to negative patient outcomes. 

Updating the comprehensive assessment 

at reasonable regular intervals ensures 

that hospices have the most recent 

information about the patient from 

which to make accurate care planning 

decisions. Without the timely updated 

assessment information, care planning 

decisions are likely to be inaccurate, 

inappropriate, and possibly harmful to 

the patient. This is not an acceptable 

outcome. 

We also appreciate the many 

timeframe suggestions that we received. 

We agree that the proposed 14-day 

timeframe, while within reason and in 

the realm of acceptable standards of 

practice, may not be the best match 

between patient and hospice needs. 

Numerous commenters suggested that 

updating the comprehensive assessment 

at least every 15 days was the proper 

match, as the 15-day timeframe would 

correspond with the 60- and 90-day 

Medicare Hospice Benefit election 

periods described in § 418.21. 

Corresponding the update timeframe 

length to the benefit period length 

would help hospices avoid completing 

separate assessments for the routine 

comprehensive assessment update and 

the update to re-certify that the patient 

is terminally ill. Two separate 

assessments within a few days of each 

other would be overwhelming for the 

patient and burdensome for the hospice. 

Thus, we agree that requiring hospices 

to update the comprehensive 

assessment at least every 15 days is 

preferable to the proposed 14-day 

timeframe. We believe that the new 15- 

day timeframe accomplishes the 

flexibility goals of those commenters 

who suggested twice monthly, biweekly, and every 14- to 16-day updates 

as well. We note that hospices are still 

required to complete the comprehensive 

assessment update more frequently than 

every 15 days as the patient’s status 

changes. We also note that hospices are 

permitted to update the assessment 

more frequently than every 15 days if 

the 15th day falls on a holiday or if dayto-day hospice operations are scheduled 

to be suspended for any reason on the 

15th day. 

Comment: Several commenters 

suggested that we should either delete 

the requirement that hospices must 

update the comprehensive assessment at 

the time of each recertification, or allow 

a grace period at the time of each 

recertification to ensure that the 

assessment is not unnecessarily updated 

twice within a few days to meet the 

every 14-day and recertification 

timeframes. 

Response: As discussed above, we 

replaced the 14-day timeframe with a 

15-day timeframe. The 15-day 

timeframe would coincide with the 

length of the benefit periods and the 

recertification timeframes. Since the 

assessment and recertification 

timeframes are now coordinated, we 

agree that it is appropriate to delete the 

recertification assessment requirement. 

Comment: Several commenters 

expressed confusion about the nature of 

the comprehensive assessment update. 

A few commenters wanted to know if 

we expected hospices to complete an 

entire new set of comprehensive 

assessment forms each time an update is 

due. Other commenters wanted to know 

if the update of the comprehensive 

assessment referred to the regularly 

scheduled IDG meetings. Another 

commenter noted that the medical 

director should not be required to 

update the assessment. 

Response: We understand that some 

hospices are confused by the proposed 

requirement that patient-specific 

comprehensive assessments should be 

updated at regular intervals. To clarify, 

we are requiring hospices to update 

those sections of the comprehensive 

assessment that require updating. As a 

patient’s condition changes the 

comprehensive assessment must be 

updated to reflect these changes. For 

example, if a patient had a normal blood 

pressure reading at the time of the 

initial assessment and at a nursing visit 

nine days later the patient’s blood 

pressure becomes elevated for a period 

of time, this new elevated blood 

pressure must be documented. This 

becomes an update to the 

comprehensive assessment. A 

significant change in the patient’s 

condition must be documented and the 

assessment must then be updated to 

reflect the patient’s revised status. As in 

the case of the comprehensive 

assessment, hospices are not required to 

use specific forms or formats. However, 

there have to be dedicated documents 

that contain assessment information and 

that are easily identified. Hospices are 

free to choose the method that best suits 

their needs when documenting the 

comprehensive assessment and the 

updates to that assessment. The purpose 

of updating the assessment is to ensure 

that the hospice IDG has the most recent 


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accurate information about the patient 

in order to make accurate care planning 

decisions. We are not requiring hospices 

to complete, in full, those documents 

which they identified as comprising 

their comprehensive assessment every 

15 days, although hospices are free to do 

so if they choose. Likewise, we are not 

requiring hospice medical directors to 

assume total responsibility for updating 

the comprehensive assessment, 

although we do expect to see the 

physician member of the IDG actively 

involved in all aspects of furnishing 

care, including updating the 

comprehensive assessment. 

Comment: Many commenters 

expressed confusion about the role of 

patient outcome measures in the 

comprehensive assessment. Some 

commenters stated that data elements 

should be in the plan of care rather than 

in the assessments. Others stated that 

including data measures in the 

assessments may limit the amount of 

useful data available for a hospice’s 

quality assessment and performance 

improvement (QAPI) program. 

Response: In the QAPI CoP hospices 

are required to identify patient outcome 

measures that they will apply to all 

patients. These measures should help 

the hospice identify areas of strength 

and weakness in patient and family care 

delivery. Once the measures are 

identified, hospices must choose which 

data elements they will collect in order 

to measure their performance. For 

example, a hospice may choose to focus 

on pain control as one of its QAPI 

domains. Within the pain control 

domain, that hospice may choose an 

outcome measure that identifies the 

percentage of patients whose pain was 

controlled within 48 hours of admission 

to hospice. In order to measure this 

outcome, that hospice may choose to 

incorporate a data element in its initial 

assessment that identifies those patients 

who are experiencing uncontrolled pain 

upon admission as well as a data 

element in its comprehensive 

assessment to identify patients who 

experienced uncontrolled pain upon 

admission and had that pain controlled 

within 48 hours of admission. The 

information gathered by these data 

elements during the comprehensive 

assessment can then be collected, 

aggregated, and used to identify areas of 

strength and weakness within the 

hospice’s care delivery system. Without 

these individual pieces of information 

gathered during the assessments, the 

hospice does not have the information 

it needs to make effective judgments of 

its quality and to make appropriate 

performance improvement project 

decisions. Therefore, QAPI-related data 

elements must be included in the 

patient assessments completed by the 

hospice. 

At the same time, we do not expect 

hospices to limit their QAPI-related data 

collection efforts to the data collected in 

the patient assessments. Data collection 

must look beyond patient assessment 

data to examine all facets of a hospices 

operation, from contract services to 

volunteer retention rates to adverse 

events. Rather than limiting the amount 

of useful data available to hospices, this 

requirement simply ensures that patient 

level data are included as part of the 

broader data collection program. 

For additional discussion of public 

comments regarding patient outcome 

measures and the proposed QAPI CoP, 

please refer to the quality assessment 

and performance improvement section 

in the preamble of this rule. 

Comment: A commenter requested 

that we change the timing of the 

medical director’s certification of the 

terminal illness to coincide with the 

completion of the comprehensive 

assessment. 

Response: The commenter did not 

provide any particular rationale for this 

request. The timing of the certification 

of the terminal illness for Medicare 

beneficiaries is based on specific 

Medicare payment requirements. Since 

payment requirements are not within 

the scope of this rule, we are not 

accepting this suggestion. 

Comment: Numerous commenters 

expressed varying levels of confusion 

regarding the exact sequence and timing 

of the initial assessment, comprehensive 

assessment, updated assessments, plan 

of care, and updated plans of care. 

Commenters believed that some of these 

elements would occur simultaneously 

while other elements, such as orienting 

patients to hospices and evaluating 

patients for hospice appropriateness do 

not appear in the regulation at all. 

Response: We appreciate the 

opportunity to explain how the 

finalized requirements will function in 

the hospice environment. First, hospices 

will obtain a signed election statement 

in accordance with § 418.24. Next, the 

hospice registered nurse must complete 

an initial assessment of the patient’s 

physical, psychosocial and emotional 

status related to the terminal illness and 

related conditions in order to evaluate 

the patient’s immediate care and 

support needs within 48 hours of 

completing the election form. This 

assessment need not go into great detail 

in each of these areas. Rather, it needs 

to gather key information, as identified 

in the hospices policies and procedures, 

about the patient that will enable the 

hospice IDG accurately to determine 

what the patient immediately needs to 

begin or continue feeling comfortable. 

The purpose of the initial assessment is 

not to determine the patient’s eligibility 

for the hospice benefit, which is 

addressed in 418.22 and 418.24, or to 

orient the patient to the hospice benefit 

and obtain the election statement. 

Additional information regarding 

physician certification of the terminal 

illness is available in the FY 2008 

Hospice Wage Index, 72 FR 50214, 

50223, August 31, 2007. These tasks, 

which are often part of following-up on 

referrals from other providers, must 

already have been completed before the 

initial assessment is completed. This 

does not mean, however, that we expect 

hospices to conduct multiple visits to 

complete the patient admission and 

assessment. Once the initial assessment 

is complete, the hospice develops and 

implements a plan of care to address the 

immediate needs identified in the initial 

assessment. 

Next, the hospice must complete a 

comprehensive assessment within five 

days of completion of the election 

statement. The comprehensive 

assessment is defined as a thorough 

evaluation of the patient’s physical, 

psychosocial, emotional and spiritual 

status related to the terminal illness and 

related conditions. This includes a 

thorough evaluation of the caregiver’s 

and family’s willingness and ability to 

care for the patient. This comprehensive 

assessment is based on the hospice’s 

policies and procedures as well as the 

information gathered in the initial 

assessment. For example, a hospice may 

have a policy that all patients will 

receive a psychosocial assessment 

conducted by an MSW. Therefore, we 

would expect that a patient’s 

comprehensive assessment in his or her 

clinical record would include the 

information gathered by and the 

conclusions made by an MSW. The 

comprehensive assessment requirement 

is flexible to adapt to the needs of 

individual hospices and patients, and 

will help hospices gather the 

information needed to develop accurate 

and appropriate plans of care. 

Then, based on the information 

gathered in the comprehensive 

assessment, the hospice IDG, in 

collaboration with the patient’s 

attending physician (if any), the patient 

or representative, and the primary 

caregiver, must develop an 

individualized plan of care for each 

patient. The plan of care must reflect 

patient and family goals, and include all 

interventions needed to address the 

problems identified in the initial and 

comprehensive assessments. The plan of 

care is where information turns into 


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actions that will result in patient 

comfort and dignity, self-determined life 

closure, and any other goals that the 

hospice, patient, and family establish 

for the patient’s hospice care. 

Once the plan of care is established 

and all disciplines are aware of their 

respective roles in caring for the patient, 

the hospice must implement the plan of 

care. If the patient’s status in one or 

more areas changes, hospice staff must 

update the comprehensive assessment 

to reflect the change(s). We do not 

expect hospices to complete an entire 

comprehensive assessment each time a 

patient’s status changes. Rather, we 

expect that the updated assessment 

reflects status changes so that other 

disciplines furnishing services are 

aware of them. Updating the 

comprehensive assessment will ensure 

that all disciplines are providing care 

based on the most recent information 

about the patient. We require that these 

updates occur as frequently as that 

patient’s condition requires, but no less 

frequently than every 15 days. If a 

change in the patient’s status will affect 

the kind of care that needs to be 

furnished, then the plan of care needs 

to be modified. For example, 

information from a comprehensive 

assessment could indicate that a patient 

has a stage three pressure ulcer and the 

patient’s plan of care indicates that the 

hospice registered nurse will make three 

visits a week, in part, for wound care. 

The wound care provided by the 

registered nurse results in the pressure 

ulcer healing. This change in status 

would be recorded as an update to the 

comprehensive assessment. Based on 

this new information in the updated 

comprehensive assessment, the hospice 

IDG may decide to reduce registered 

nursing visits to two times per week 

because the patient’s status and needs 

no longer indicated that RN visits three 

times per week were necessary. The 

hospice IDG would then update the 

patient’s plan of care to reflect that RN 

visits will be two times per week and 

that wound care was no longer part of 

the treatment that the RN would 

provide. In this way, the patient’s 

assessment and plan of care are both 

updated to provide accurate and timely 

information to all disciplines providing 

services to the patient, and the hospice 

complies with our requirements to 

update both the comprehensive 

assessment and the plan of care. 

We believe that the timeline described 

above will help illuminate the 

timeframe requirements for both the 

assessment and plan of care 

requirements, as well as how these two 

requirements are related. 

Comment: A few commenters 

explicitly thanked us for not requiring 

hospices to use a standardized 

assessment form. Other commenters 

expressed concern that the proposed 

assessment requirement would result in 

CMS requiring hospices to use a specific 

assessment form. Several of these 

commenters specifically stated that we 

should not require hospices to use the 

OASIS data collection tool that is 

currently used by home health agencies. 

Response: We appreciate the support 

from commenters who recognized that 

we are not requiring any type of 

assessment form, standardized or 

otherwise. As we stated in the preamble 

to the proposed rule, and restate here, 

we are not requiring hospices to use any 

particular form or tool to document the 

completion of the initial assessment, 

comprehensive assessment, or updated 

assessments at this time. Hospices are 

permitted to use the written or 

electronic form or tool that best suits 

their needs and their patients’ needs, 

provided that the information gathered 

in the assessments is complete and 

available in each patient’s clinical 

record. Hospices need to choose a form 

or tool that gathers thorough 

information about the patient’s physical, 

psychosocial, emotional and spiritual 

status related to the terminal illness and 

related conditions. This form or tool 

must allow hospices to document 

information in a systematic and 

retrievable way for each patient. Within 

the framework of these broad 

guidelines, it is within each hospice’s 

discretion to choose its own patient 

assessment documentation form or tool. 

Hospices may find it beneficial to 

examine the CARE (Continuity 

Assessment Record and Evaluation) tool 

developed by CMS in choosing their 

assessment forms/tools. Under the 

Deficit Reduction Act of 2005, Section 

5008, CMS was directed to develop a 

uniform patient assessment instrument 

for use in a three year, post acute carepayment reform demonstration, to begin 

in January 2008. This uniform 

assessment instrument is now referred 

to as CARE. The purpose of the CARE 

tool is to collect standardized data on 

Medicare beneficiaries’ medical 

conditions, functional and cognitive 

impairments, and social support factors, 

affecting treatment and discharge, 

regardless of site of care. During the 

demonstration CARE will be 

administered to Medicare beneficiaries 

at time of hospital discharge, upon 

admission and discharge from post 

acute care (PAC) providers, as well as at 

interim points, if significant changes 

occur. CARE is comprised of a set of 

common assessment items administered 

to all patients across all settings, and a 

set of supplemental items only 

administered for specific conditions or 

at particular times (i.e., PAC discharge 

only). A master version of the CARE 

instrument and item matrix identifying 

common assessment items and 

supplemental items is available for 

viewing at http://www.cms.hhs.gov/

PaperworkReductionActof1995/

PRALSep2007/itemdetail.asp?

filterType=none&filterByDID=-99&

sortByDID=1&sortOrder=ascending&

itemID=CMS1205047&int

NumPerPage=10. 

If, at some time in the future, we 

determine that it is necessary to require 

hospices to use a standardized patient 

assessment tool, we will follow the 

provisions of the Administrative 

Procedure Act, which generally requires 

us to publish a notice of proposed rule 

making and solicit public comment on 

the proposal. 

4. Condition of Participation: 

Interdisciplinary Group Care Planning 

and Coordination of Services (Proposed 

§ 418.56) 

This proposed CoP elaborated on the 

existing Interdisciplinary group CoP at 

§ 418.68 and combined it with elements 

of the Plan of care CoP at § 418.58. It 

contained five standards: ‘‘(a) Approach 

to service delivery,’’ ‘‘(b) Plan of care,’’

‘‘(c) Content of the plan of care,’’ ‘‘(d) 

Review of the plan of care,’’ and ‘‘(e) 

Coordination of services.’’ Together, 

these standards would have required a 

hospice, through its IDG, to develop, 

implement, and update a 

comprehensive plan of care for each 

patient and family that addresses their 

needs as identified in the patient 

assessment. 

Standard (a), ‘‘Approach to service 

delivery,’’ would require each hospice 

to have an IDG that included at least the 

following: A doctor of medicine or 

osteopathy who is not the patient’s 

attending physician; a registered nurse; 

a social worker; and a pastoral, clergy, 

or other spiritual counselor. This IDG 

would be required to work together to 

meet the physical, medical, social, 

emotional, and spiritual needs of the 

patient and family. The IDG would also 

be required to designate a qualified 

individual to coordinate 

implementation of the plan of care and 

assessment of the patient. Paragraph 

418.68(d) of the existing rule required 

the IDG to designate a registered nurse 

to fulfill this role. In the proposed rule, 

the IDG would be required to establish 

policies governing the day-to-day 

provision of care and services. If a 

hospice has more than one IDG, one 


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would be designated in advance to 

fulfill the policy role. 

The next proposed standard, ‘‘(b) Plan 

of care,’’ would require hospices to 

provide care to patients and families in 

accordance with a written plan of care 

established by the IDG and the patient’s 

attending physician. This standard 

would also require hospices to ensure 

that patients and families received 

appropriate education and training that 

would enhance the implementation of 

the plan of care. Unlike the existing 

requirement, this proposed standard 

would incorporate families into the plan 

of care, recognizing that hospice care 

must reach beyond the patient to 

support those who surround and care 

for the patient. 

In proposed standard (c), ‘‘Content of 

the plan of care,’’ we would require 

hospices to develop a plan of care based 

on the problems identified in the 

patient’s assessments. We proposed to 

require that the plan of care include: 

Pain and symptom management 

interventions; a detailed statement of 

the scope and frequency of services; 

patient outcomes; any necessary drugs 

and treatments; any necessary medical 

supplies and equipment; and 

documentation of the patient’s and 

family’s understanding, involvement, 

and agreement with the plan of care. 

The existing plan of care requirement at 

§ 418.58(c) mandated that the hospice 

describe the scope and frequency of 

services. The remainder of the elements 

were new in the proposed rule. 

The fourth proposed standard, ‘‘(d) 

Review of the plan of care,’’ would 

require the hospice medical director or 

physician designee, along with the IDG 

and the patient’s attending physician, to 

review, revise, and document the plan 

of care at intervals specified in the plan 

of care. The review of the plan of care 

would be required to occur no less 

frequently than every 14 calendar days. 

The revised plan of care would be 

required to include information from 

the patient’s updated assessment, and 

the hospice would have to document 

any progress toward the outcomes 

specified in the plan of care. This 

proposed requirement directly linked 

the results of the updated assessment, 

including the data elements, to the 

changes that would be made in the plan 

of care. This would empower hospices 

to make care decisions based on 

evidence of the successes and failures of 

past care decisions in achieving the 

desired outcomes. 

The final proposed standard, ‘‘(e) 

Coordination of services,’’ was a new 

addition to the hospice CoPs. Hospice 

has always been based on an 

interdisciplinary care model, which 

requires frequent communication 

between care disciplines and settings, as 

well as between the hospice, the patient 

and the family. This proposed standard 

would require the hospice to maintain 

a system of communication and 

integration to enable the IDG to ensure 

that care and services are provided in 

accordance with the plan of care. This 

system would also be required to ensure 

the ongoing liaison of all disciplines 

providing care and services in the home, 

outpatient, and inpatient settings, 

notwithstanding the manner in which 

the care and services are furnished (that 

is, directly or under arrangement). 

Comment: A commenter asked us to 

clarify the meaning of the following 

sentence at § 418.56, ‘‘The plan of care 

must specify the hospice care and 

services necessary to meet the patient 

and family-specific needs identified in 

the comprehensive assessment and as it 

relates to the terminal illness and 

related conditions.’’ The commenter 

believed that this statement was 

confusing. 

Response: The intent of the sentence 

is to ensure that there is a direct link 

between the needs identified in the 

patient assessment and the plan of care 

developed by the hospice. The intent is 

also that hospices are responsible for 

including those services and treatments 

in the plan of care that are related to the 

terminal illness and related conditions, 

even if the hospice identified other 

needs in the patient assessment that are 

not related to the terminal illness and 

related conditions. We agree that minor 

grammatical changes to the statement 

are warranted to clarify our intent. 

Specifically, we are replacing the 

singular term ‘‘it’’ with the plural phrase 

‘‘such needs’’ to correspond with the 

plural ‘‘specific needs’’ identified earlier 

in the sentence. This grammatical 

change provides a direct link between 

the needs identified in the 

comprehensive assessment and those 

specific needs related to the terminal 

illness and related conditions that must 

be addressed in the plan of care. The 

revised sentence at § 418.56 now states, 

‘‘The plan of care must specify the 

hospice care and services necessary to 

meet the patient and family-specific 

needs identified in the comprehensive 

assessment as such needs relate to the 

terminal illness and related conditions.’’

We have not attempted to enumerate the 

conditions in which care outside the 

hospice would be covered under 

Medicare because we recognize that 

there are many illnesses which may 

occur when an individual is terminally 

ill which are brought on by the 

underlying condition of the patient. For 

example, it is not unusual for a 

terminally ill patient to develop 

pneumonia or some other illness as a 

result of his or her weakend condition. 

Treatment of such illnesses is 

considered a hospice service and 

payment under other Medicare benefits 

would be waived by the hospice 

election. We expect that the hospice 

interdisciplinary group will reasonably 

determine the services that the 

individual requires for palliation and 

management of his or her symptoms. 

Comment: A commenter suggested 

that, when hospices are caring for 

residents of long term care facilities, the 

long term care facility medical director 

should be the individual responsible for 

designating the members of the IDG to 

care for the patient. 

Response: It is the hospice’s 

responsibility to furnish hospice care. 

While we agree that designated long 

term care facility staff should actively 

participate in a patient’s hospice IDG, it 

is the hospice’s responsibility to decide 

what care is provided, based on the 

information gathered during the patient 

assessments. Hospices are not 

permitted, and certainly should not be 

compelled, to delegate their 

responsibilities to the long term care 

facility medical director and staff. 

Comment: Numerous commenters 

suggested that we include the term 

‘‘psychosocial’’, rather than ‘‘social’’, in 

§ 418.56(a) when detailing the types of 

patient and family needs that IDGs are 

required to address during care 

planning. The commenters stated that 

the term ‘‘psychosocial’’ is more 

consistent with the terminology used 

throughout the remainder of the rule. 

Response: We agree that the word 

‘‘psychosocial’’ is more consistent with 

the terminology in the rest of the rule 

and we have made this change. 

Comment: Numerous commenters 

made suggestions to refine our proposal 

at § 418.56(a) that ‘‘The hospice must 

designate a qualified health care 

professional that is a member of the IDG 

to provide coordination of care and to 

ensure continuous assessment of each 

patient’s and family’s needs and 

implementation of the interdisciplinary 

plan of care.’’ A few commenters 

supported our proposal to permit any 

qualified health care professional that is 

a member of the IDG to fulfill the 

coordinator role, while many other 

commenters suggested that only nurses 

and/or social workers should be 

considered qualified for this role. One 

commenter suggested that the 

coordinator should only be responsible 

for ensuring the assessment of each 

patient’s and family’s specific hospice 

care, rather than being personally 

responsible for assessing their needs. 


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Another commenter suggested that the 

individual responsible for coordinating 

the plan of care be named the 

‘‘interdisciplinary group coordinator.’’

Response: We appreciate the many 

comments that were submitted. We do 

not believe that the coordinator needs to 

be given a specific title in this rule. 

Hospices are free to refer to the 

coordinator in a manner that meets their 

needs, as long as there is an individual 

identified as being responsible for 

coordinating and implementing each 

patient’s plan of care. 

The majority of commenters noted the 

unique demands of the case coordinator 

role and the many skills that are 

necessary to successfully fulfill the role. 

Commenters described the need for the 

case coordinator to have solid 

knowledge of the biological, 

psychological and spiritual issues of 

terminally ill patients and their families. 

They also described the need for the 

case coordinator to act as an advocate, 

negotiator, and leader when dealing 

with the varied members of the IDG, the 

patient, and the patient’s family. We 

agree that the specific demands of the 

case coordinator role, as described by 

the commenters, warrant a more specific 

requirement regarding who is qualified 

to fulfill this role. Therefore, we are 

requiring the coordinator to be a 

registered nurse. A registered nurse has 

the necessary medical and interpersonal 

background to meet the demands of the 

coordinator position in a way that no 

other discipline does. Social workers are 

not educated or trained to identify 

physical issues, just as physical or 

occupational therapists are not educated 

or trained to identify psychosocial 

issues. The unique skills of registered 

nurses, who are educated to assess and 

manage the overall aspects of a patient’s 

physical and psychosocial care, can be 

used to oversee the coordination and 

implementation of the care identified by 

the IDG. 

Comment: The majority of 

commenters asked us to reconsider the 

specification in proposed 

§ 418.56(a)(1)(i) that the physician 

member of the IDG may not be the 

patient’s attending physician. The 

commenters stated that hospice 

physicians often have their own private 

practice and may, at times, be in the 

position of caring for a private practice 

patient who has chosen to receive 

hospice care from the hospice the 

physician works with. Furthermore, the 

commenters stated that this prohibition 

could create a barrier to accessing 

hospice for those patients whose 

attending physicians also work with 

hospices. One commenter suggested we 

should replace the general requirement 

that a doctor of medicine or osteopathy 

be a member of the IDG with a 

requirement that the hospice medical 

director or physician designee be a 

member of the IDG. 

Response: While it was not our intent, 

we agree that this prohibition could 

negatively impact hospice access and 

treatment. Therefore, we have removed 

the statement that the physician 

member of the IDG may not be the 

patient’s attending physician. In its 

place, we have added a statement that 

the physician member of the IDG must 

be an employee of or under contract 

with the hospice. While the physician 

member could be the hospice medical 

director or physician designee, this 

revised requirement does not mandate 

this. This new requirement 

accomplishes our original intent of 

ensuring that hospice physicians are 

actively involved in patient care 

through the IDG without the unintended 

effect of limiting access that 

accompanied the original proposal. 

Comment: Numerous commenters 

suggested that we amend the language 

discussing spiritual counselors in 

§ 418.56(a)(1)(iv). Some commenters 

noted that the terms ‘‘pastoral’’ and 

‘‘clergy’’ are Judeo-Christian terms that 

do not encompass other faiths. These 

commenters suggested that we require 

hospices to have a board certified 

chaplain as a member of the IDG 

because board certified chaplains are 

routinely educated and trained to work 

with individuals from various, nonJudeo-Christian faiths. On the other 

hand, some commenters specifically 

disagreed with the suggestion that a 

board certified chaplain be a required 

member of the IDG. Still other 

commenters suggested that we should 

use the language that appears in section 

1861(dd)(2)(B)(i) of the Act, which reads 

that a hospice must have ‘‘at least one 

pastoral or other counselor’’ as a 

member of the IDG. 

Response: Spiritual advisors play an 

important role in helping many patients 

and families achieve their end-of-life 

goals. In the proposed rule we sought to 

further assure the role of spiritual 

advisors in hospice care by specifying 

that the counselor must be capable of 

addressing a patient’s spiritual needs. 

As some commenters stated, not all 

patients need or desire the involvement 

of spiritual counselors in their care. 

These patients, the commenters 

contended, should not be compelled to 

accept the involvement, even if that 

involvement is only through the 

spiritual counselor’s participation in the 

IDG meetings. We agree that spiritual 

counselors, whether they are certified 

chaplains, clergy, pastoral counselors, 

or any other discipline, should not be 

forced upon unwilling patients. 

Therefore, we have replaced the 

proposed ‘‘pastoral, clergy, or other 

spiritual counselor’’ requirement with 

the statutory requirement of ‘‘pastoral or 

other counselor.’’ This revised 

requirement gives hospices the 

flexibility to use the counselor that best 

meets the patient’s needs. 

Nothing in this requirement prohibits 

hospices from using certified chaplains 

as the IDG member to fulfill this role. 

Indeed, some hospice patients who 

receive the services of certified 

chaplains may have better outcomes 

because certified chaplains are trained 

to work with individuals from various 

faiths and backgrounds. 

Comment: A few commenters 

suggested that we should require a 

bereavement counselor as a member of 

the IDG. The commenters stated that 

including the bereavement counselor in 

the IDG would help ensure that the 

information gathered in the 

bereavement assessment, required in 

final § 418.54(c)(7), is included in the 

plan of care. 

Response: We expect that all 

disciplines involved in caring for a 

patient and family will have a voice in 

the IDG. This voice may be reflected 

through reports given by the members of 

the patient’s care team who are not part 

of the official IDG to the individual who 

is coordinating care plan 

implementation or through IDG 

members attending IDG meetings in 

some manner. Including a bereavement 

counselor, whether as an individual 

position or as a function of the 

counselor or social worker, in the IDG 

would satisfy our expectations that all 

disciplines communicate with each 

other and have a voice in IDG meetings 

and decisions, and may result in better 

patient and family satisfaction and 

outcomes. Nothing in this rule prevents 

hospices from involving a bereavement 

counselor in the IDG. The core members 

of the IDG are identified in section 

1861(dd)(2)(B) of the Act. This section 

permits the use of another type of 

counselor instead of, or in addition to, 

the pastoral counselor. Hospices are free 

to use a bereavement counselor when 

they believe the needs of the patient and 

family require it. 

Comment: Many commenters took 

issue with the proposed requirement in 

§ 418.56(a)(2) that, if a hospice has more 

than one IDG, it must designate one IDG 

to establish policies governing the dayto-day provision of hospice care and 

services. Some commenters sought 

minor changes to the proposed 

requirement to allow hospices to create 

a special IDG, culled from all of its 


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IDGs, for the job of establishing policies. 

Other commenters suggested that the 

hospice’s administrator, clinical leaders, 

or governing body should be responsible 

for developing these policies. 

Response: Section 1861(dd)(2)(B)(iii) 

of the Act requires a hospice IDG to 

establish policies governing the 

provision of hospice care and services. 

Therefore, we believe that it is 

appropriate to maintain the IDG’s 

responsibility for developing a hospice’s 

policies. At the same time, we agree that 

the IDG that is responsible for 

developing those policies does not need 

to be the same group that works together 

to care for patients. For example, a 

hospice may choose to have a policy 

IDG comprised of the physician from 

IDG 1, the nurse from IDG 2, and the 

social worker and pastoral counselor 

from IDG 3. In order to clarify that an 

arrangement is acceptable, we have 

modified the requirement at 

§ 418.56(a)(2) to read, ‘‘[i]f the hospice 

has more than one interdisciplinary 

group, it must identify a specifically 

designated interdisciplinary group to 

establish policies governing the day-today provision of hospice care and 

services.’’

Comment: A commenter sought 

clarification of the phrase ‘‘policies 

governing day-to-day provision of 

hospice care and services’’ as it was 

used in proposed § 418.56(a)(2). 

Response: This phrase, which is also 

located in the previously existing CoPs 

at § 418.68(b)(4), refers to the hospice’s 

responsibility to establish its own 

policies and procedures to govern its 

practices within the framework of the 

CoPs. We are not prescribing the exact 

patient care, documentation, orientation 

and training, and administration 

policies and procedures that each 

hospice will use in its daily operations. 

Each hospice, through its designated 

IDG, will establish these policies and 

procedures. The policies and 

procedures established by the IDG must 

be in compliance with the CoPs and 

other applicable Federal, State, and 

local laws and regulations. 

Comment: In proposed § 418.56(b), 

many commenters sought clarification 

on the role of the patient’s attending 

physician in the IDG. Some commenters 

suggested that all mention of the 

attending physician’s involvement in 

the IDG should be deleted because not 

all patients would have attending 

physicians. Other commenters 

suggested that the involvement of the 

attending physician in the IDG should 

be qualified by statements such as ‘‘at 

his/her discretion’’, or ‘‘only to the 

extent possible.’’ Still other commenters 

suggested that the patient’s attending 

physician should actively develop the 

patient’s plan of care or even lead the 

IDG. 

Response: The role of the patient’s 

attending physician in the patient’s 

hospice care will vary from hospice to 

hospice, and from patient to patient. 

This variability is reflected in the 

diverse comments that we received on 

this subject. Some commenters 

suggested that attending physicians 

should assume a leadership role in the 

IDG, while other commenters suggested 

that the role of the attending physician 

should be excluded altogether. To 

accept either of the suggested extremes, 

that is, attending physician leadership 

or exclusion, would most certainly not 

meet the needs of all hospices. To meet 

these needs, we have chosen to qualify 

the role of the attending physician in 

the IDG by adding the phrase ‘‘if any’’

to § 418.56(b). This phrase recognizes 

that not all patients have attending 

physicians. We expect hospices to 

document their efforts to involve the 

attending physician in developing the 

hospice plan of care, as well as the 

results of those efforts. Hospices may 

determine the best method for this 

documentation in accordance with their 

own policies and procedures. 

Comment: A commenter suggested 

that hospices be required to make efforts 

to include the patient and primary 

caregiver when establishing the plan of 

care. 

Response: We agree that involving the 

patient and primary caregiver in 

developing the plan of care is an 

important step to ensuring that the plan 

of care reflects the patient’s goals. We 

have achieved this goal by adding a 

provision to § 418.56(b) that a patient or 

representative, and primary caregiver 

should be included in developing the 

plan of care if they so desire in 

accordance with the patient’s needs. If 

a patient, his or her representative, and/ 

or primary caregiver decline to 

participate in actively developing the 

plan of care, then hospices would need 

to document this. We also added a 

provision in the patient rights CoP at 

§ 418.52(c)(2) that patients have the 

right to be involved in developing their 

plan of care. In addition, we have added 

a requirement in § 418.56(c) that the 

plan of care must reflect the patient’s 

and family’s goals. These provisions 

will, we believe, ensure that the 

patient’s and family’s goals are reflected 

in the plan of care and that patients will 

have full and open access to the care 

planning process if they so desire. 

Comment: A commenter observed that 

the proposed rule did not include a 

requirement that at least two members 

of the IDG establish the initial plan of 

care. The commenter appreciated that 

this requirement was not included in 

the proposed rule. 

Response: The requirement that the 

commenter referred to is part of the 

interpretive guidelines that were issued 

for the current hospice regulations. 

While we did not include this 

requirement in the proposed rule, we do 

not recommend that a single member of 

the IDG independently develop the 

initial plan of care without input from 

other IDG members. This would violate 

the intent of the hospice 

interdisciplinary care model. 

Development of the plan of care is a 

collaborative effort involving all 

members of the IDG. We will continue 

to include this information in the new 

Interpretive Guidelines. 

Comment: A commenter suggested 

that we should include timeframes for 

completing the initial plan of care and 

the comprehensive plan of care. 

Response: We do not differentiate 

between the stages of the plan of care. 

We expect the first stage of the plan of 

care to be completed after the initial 

patient assessment has been completed. 

This preliminary plan of care must 

address the immediate care needs 

identified during the initial assessment. 

Once the comprehensive assessment is 

complete, the hospice must then update 

the plan of care to address the other care 

needs identified through the 

comprehensive assessment. We believe 

that beginning and completing the first 

iteration of the plan of care should be 

based on the needs of the patient and 

family rather than specific timeframes. 

If a patient is in crisis or is actively 

dying, then it stands to reason that the 

plan of care must be developed by the 

IDG members rather quickly. 

Comment: A commenter requested 

that, in § 418.56(b), hospices only be 

required to provide education and 

training to the patient and primary 

caregiver. In addition, the commenter 

requested that hospices be permitted to 

tailor the training and education 

provided to patients and caregivers 

based on their responsibilities for care. 

Response: We agree that requiring 

hospices to educate and train the family, 

as we proposed, is unnecessary because 

not all family members may participate 

in furnishing care to the patient. We 

also agree that hospices should be 

permitted to tailor the education and 

training provided to patients and 

caregivers based on the exact services 

that patients and caregivers will be 

providing. For example, if a caregiver is 

assessed as being competent and willing 

to care for a patient’s catheter, then we 

would expect the caregiver to be 

educated and trained on proper catheter 


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care procedures. The relevant portion of 

section 418.56(b) now reads, ‘‘The 

hospice must ensure that each patient 

and the primary caregiver(s) receive 

education and training provided by the 

hospice as appropriate to their 

responsibilities for the care and services 

identified in the plan of care.’’

Comment: A commenter suggested 

that § 418.56(b) should explicitly state 

that only one plan of care is required 

and that a separate plan of care is not 

necessary for the family’s needs. 

Response: One of the most unique and 

valuable aspects of hospice care is its 

treatment of the patient and his/her 

family as a single unit of care. It is 

current hospice practice to address the 

needs of the patient’s family as part of 

the patient’s plan of care. This standard 

practice will not change based on the 

requirements of this rule. We expect 

that this rule will reinforce this practice 

by requiring that all services provided to 

both patients and their families be 

included in the written plan of care. We 

note that the term ‘‘plan of care’’ is 

singular and in no way implies that 

there should be more than one plan. 

Comment: A few commenters 

suggested that we should clarify the 

scope of the plan of care by stating that 

the plan of care must address all of a 

patient’s needs, rather than only those 

services that the hospice is capable of 

providing. Another commenter 

suggested that we should specify that 

the plan of care must be individualized 

for each patient and that it must reflect 

the patient’s hospice care goals. Still 

other commenters suggested that the 

plan of care, including drugs, durable 

medical equipment and supplies, 

should be limited to addressing those 

needs related to the terminal illness and 

related conditions. The commenters 

suggested that deleting the phrase ‘‘but 

is not limited to’’ in proposed 

§ 418.56(c) would accomplish this goal. 

Response: The plan of care is one of 

the most important documents in 

hospice care. It is the essential link 

between the needs of the patient and the 

actions of the hospice. Therefore, we 

agree with the commenters that the plan 

of care must be individualized to meet 

all of the needs of the patient and family 

related to the terminal illness and 

related conditions. In order to achieve 

this goal, we have clarified the rule in 

several places. First, we have added the 

term ‘‘individualized’’ to both 

§ 418.56(b) and § 418.56(c), to require 

hospices to develop and follow an 

‘‘individualized written plan of care.’’

Second, we have revised the final 

sentence of the stem statement in 

§ 418.56(c) from ‘‘The plan of care must 

include but not be limited to—’’ to ‘‘The 

plan of care must include all services 

necessary for the palliation and 

management of the terminal illness and 

related conditions, including * * *.’’

This revised statement more explicitly 

links the patient’s needs, as identified in 

the assessments, to the services 

furnished by the hospice. In addition, 

this revised statement clarifies that 

hospices are only responsible for 

furnishing services based on those 

needs identified in the assessments 

related to the terminal and related 

conditions. Needs that are not related to 

the terminal illness and related 

conditions are not the responsibility of 

the hospice, although the hospice may 

choose to furnish services for those 

needs regardless of responsibility. 

If a hospice does not choose to furnish 

services for those needs unrelated to the 

terminal illness and related conditions, 

we would expect the hospice to 

communicate and coordinate with those 

health care providers who are caring for 

the unrelated needs, as described in 

§ 418.56(e). In such situations where a 

hospice coordinates its care and services 

for the terminal illness and related 

conditions with care and services 

provided by other health care providers 

for unrelated conditions, we believe that 

it is essential for the hospice to be aware 

of their role within the larger 

comprehensive plan of care for that 

patient. Furthermore, we believe that it 

is essential for the hospice to be aware 

of any gaps in the overall 

comprehensive plan of care, and the 

parties responsible for filling those gaps. 

Comment: A commenter questioned 

what was meant by the phrase ‘‘initial 

comprehensive and updated 

assessment’’ as it was used in proposed 

§ 418.56(c). 

Response: Our intent was to require 

hospices to base the interventions 

described in the plan of care on 

information gathered in all of the 

assessments, that is, the initial, 

comprehensive, and updated 

assessments. We have modified the 

language in § 418.56(c) to reflect this. 

Comment: A commenter suggested 

that we should remove or define the 

terms ‘‘facilitate’’, ‘‘targeted’’, and 

‘‘anticipated’’ in § 418.56(c). Another 

commenter suggested that we should 

replace the term ‘‘measurable targeted 

outcomes’’ with ‘‘agreed-upon goals.’’

Response: Section 418.56(c) describes 

the general areas that must be included 

in each patient’s individualized plan of 

care. We agree that when describing the 

interventions necessary to manage a 

patient’s pain and symptoms in 

§ 418.56(c)(1), the language should be 

simplified. We deleted the term 

‘‘facilitate’’ in this statement and further 

refined it to require that the plan of care 

include ‘‘Interventions to manage pain 

and symptoms.’’ We also agree that in 

§ 418.56(c)(3) the language should be 

simplified. We removed the term 

‘‘targeted’’ from the statement, which 

now reads ‘‘Measurable outcomes 

anticipated from implementing and 

coordinating the plan of care.’’ We did 

not remove the term ‘‘anticipated’’ from 

this requirement, because the term 

‘‘anticipated’’ explicitly recognizes that 

the measurable outcomes are goals and 

they may or may not be achieved. For 

example, a hospice may not be able to 

control pain within 48 hours of 

admission. The hospice may have 

anticipated meeting that goal and took 

all necessary steps. However, 100 

percent success is not always 

guaranteed. The term ‘‘anticipated’’

recognizes that fact. 

We did not, as the other commenter 

suggested, replace ‘‘measurable 

outcomes’’ with ‘‘agreed-upon goals.’’

Instead, we have added a statement to 

§ 418.56(c) to state that, ‘‘[t]he plan of 

care must reflect patient and family 

goals and interventions based on the 

problems identified.* * * ’’ We believe 

that this is an appropriate way to 

include patient and family goals in the 

plan of care without excluding 

measurable outcomes, which are part of 

the individual patient care planning 

process and the hospice’s overall QAPI 

program. We expect the hospice plan of 

care to address all patient goals in some 

way. If a patient has a goal that is not 

related to the terminal illness and 

related conditions, and if the hospice 

does not intend to address this goal, 

then the hospice plan of care should 

identify the party that is responsible for 

meeting the unrelated goal. 

Furthermore, final § 418.56(e) requires 

the hospice to actively communicate 

with the outside party to ensure that the 

goal is addressed. 

Comment: Some commenters 

questioned the term ‘‘prescribed’’ as it is 

used in proposed § 418.56(c). The 

commenters stated that the term 

‘‘prescribed’’ implied that we were 

requiring a specific physician’s order for 

each intervention included in the plan 

of care. 

Response: We agree that the term 

‘‘prescribed’’ implies that all 

interventions require physician’s orders. 

Requiring physician orders for 

everything was not our intent. 

Therefore, we removed the term 

‘‘prescribed’’ from this standard. 

Comment: Some commenters 

suggested that we should delete the 

terms ‘‘detailed’’, ‘‘scope’’, and 

‘‘specific’’ as related to the services 

provided (§ 418.56(c)(2)). 


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Response: We did not delete these 

terms in this final rule. In § 418.58(c) of 

the existing hospice regulations, 

hospices are required to ‘‘state in detail 

the scope and frequency of services 

needed to meet the patient’s and 

family’s needs.’’ We note that the 

proposed requirement that the plan of 

care include, ’’[a] detailed statement of 

the scope and frequency of services 

necessary to meet the specific patient 

and family needs’’ is very similar to the 

requirement that has existed for the last 

two decades. We believe that hospices 

have already determined, and will 

continue to determine, through their 

own policies and procedures, how to 

meet this requirement. The level of 

detail established by the hospice in the 

plan of care should be clear enough to 

provide a complete picture of which 

disciplines will be furnishing which 

services, how frequently that care will 

be furnished, and what needs are being 

addressed by such care. The plan of care 

serves as a primary means of 

communication between all hospice 

disciplines, the patient, the primary care 

giver, and the family. It must contain 

enough information so that all of these 

individuals know exactly what is 

supposed to be done, by whom, at what 

time, and for what purpose. 

Comment: A commenter suggested 

that non-pharmacological interventions 

should be included, in addition to 

drugs, in § 418.56(c)(4). 

Response: We agree that nonpharmacological interventions should 

be included in the individualized 

hospice plan of care; however, we are 

not specifically referencing them in 

§ 418.56(c)(4). We believe that the 

provision of required nonpharmacological interventions are 

already strongly implied in the stem 

statement of § 418.56, and also in 

§ 418.56(c)(1), which states that the plan 

of care must include ‘‘interventions to 

manage pain and symptoms,’’ as well as 

in § 418.56(c)(5), which requires the 

plan of care to indicate the medical 

supplies and appliances necessary to 

meet the needs of the patient. 

Comment: Numerous commenters 

expressed concern regarding our 

proposal at § 418.56(c)(6) that the 

hospice document the patient’s and 

family’s understanding, involvement, 

and agreement with the content of the 

plan of care. The commenters stated that 

there are times when the patient may 

agree with the plan of care while 

members of his or her family do not. 

Commenters suggested either removing 

the term ‘‘agreement’’ or replacing the 

term ‘‘family’’ with ‘‘representative’’ or 

‘‘primary caregiver’’ to narrow the 

number of individuals who must agree, 

and to ensure that the patient’s needs 

and goals take primacy. Commenters 

also suggested that, rather than 

requiring hospices to document 

complete understanding, involvement 

and agreement on the part of patients 

and families, which may not be 

attainable, we should require hospices 

to document the level of understanding, 

involvement and agreement attained by 

the patient and family. 

Response: We understand that 

patients and families may sometimes be 

in conflict regarding the content of the 

plan of care, and we agree that it is the 

patient’s understanding, involvement 

and agreement with the plan of care that 

takes precedence. Therefore, we have 

removed the term ‘‘family’’ from this 

requirement and replaced it with the 

term ‘‘representative.’’ As defined in 

§ 418.3, a representative is the 

individual who makes decisions for a 

patient when a patient is unable to do 

so. We believe that limiting this 

requirement to patients and 

representatives will help ensure that the 

patient’s needs and goals are primary in 

the content of the plan of care. We 

continue to expect a hospice to also 

address, to the extent possible, the goals 

of the patient’s family in the plan of 

care. We do not require the entire family 

to agree to the patient’s plan of care. 

Furthermore, we agree that, rather 

than requiring hospices to document 

complete understanding, involvement 

and agreement with the plan of care, it 

is more appropriate to require hospices 

to document the level of understanding, 

involvement and agreement attained by 

the patient or representative. The 

terminal illness and numerous other 

factors may affect a patient’s or 

representative’s ability to participate in 

care planning or understand the content 

of the plan of care. Requiring hospices 

to document a level of understanding, 

involvement and agreement with the 

plan of care recognizes this fact. 

Hospices will now be required to note 

whether impediments to understanding 

are present and the degree to which 

those impediments impact the patient’s 

or representative’s participation in care 

planning. Documenting this information 

will help hospices tailor the content of 

the plan of care and their patient 

communication process to the needs of 

the patient, resulting in improved 

patient outcomes. 

Comment: A few commenters 

questioned the type of documentation 

that would be necessary in terms of a 

patient’s or representative’s 

understanding, involvement and 

agreement with the plan of care. 

Response: The documentation in the 

clinical record must be correct and 

complete, as required by § 418.104, and 

should provide sufficient detail to fully 

describe the level of understanding, 

involvement and agreement with the 

plan of care. Hospices may choose to 

include a specific form for this 

documentation in each patient’s 

medical record, include the 

documentation in the clinical notes or 

use any number of other documentation 

methods as those methods meet the 

needs and circumstances of individual 

hospices. 

Comment: A commenter suggested 

that we delete proposed § 418.56(c)(6) 

because the plan of care is a process, not 

just a single document. 

Response: While we agree that the 

plan of care is an on-going process with 

many updates along the way, we are 

retaining this regulatory element. As the 

plan of care evolves through updates by 

the IDG, patients and representatives 

should continue to be involved, and 

hospices should continue to seek their 

understanding of and agreement with 

the changes. This requirement will help 

to ensure that patients and 

representatives are involved in the care 

planning process and that hospices 

actively address the needs and goals of 

patients. 

Comment: Some commenters sought 

clarification on the obligations of the 

hospice when the family disagrees with 

the plan of care, even though the patient 

agrees. 

Response: As discussed previously, 

we have deleted the requirement that 

hospices must obtain family agreement 

with the plan of care. Although hospices 

are no longer required to obtain the 

family’s agreement, the plan of care 

must still address the family’s goals and 

will still require assistance from the 

family in its implementation. For these 

reasons, it remains essential for 

hospices to actively educate and involve 

family members to the extent possible. 

Comment: A commenter agreed with 

our proposal in § 418.56(d) that the 

patient’s attending physician should be 

involved, to the extent possible, in 

updating the plan of care. 

Response: Involving the attending 

physician to the extent possible in the 

patient’s care, including updating the 

plan of care, is an important step to help 

ensure continuity of care. We are setting 

forth this requirement at § 418.56(d). 

Comment: Many commenters 

requested that the specific reference to 

the medical director or physician 

designee’s role in updating the plan of 

care be deleted or rearranged. 

Commenters stated that the medical 

director or physician designee is often a 

member of the IDG and does not need 

to be mentioned separately. 


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Response: We agree that it is not 

necessary to specifically require the 

involvement of the medical director or 

physician designee in updating the plan 

of care because each IDG must have a 

physician member and that physician 

member provides adequate medical 

input in the updates. Therefore, we 

deleted this proposed requirement. 

Comment: We received numerous 

comments about the proposed 

timeframes for updating the plan of care 

(§ 418.56(d)). Some commenters 

requested that we delete the proposed 

requirement that the plan of care be 

updated at least every 14 days. Others 

suggested that the 14 day requirement 

be changed to every 14–16 days, every 

15 days, every 30 days, or twice per 

month. 

Response: The plan of care is the map 

that the hospice will follow when 

delivering care to a patient and family. 

It is essential that the plan of care 

accurately reflect the services that must 

be delivered in order to meet the needs 

of the patient and family. As the 

patient’s condition changes, the plan of 

care changes as well. In order to ensure 

that these updates occur, we proposed 

timeframes for both updating the 

comprehensive assessment and the plan 

of care. As previously discussed, we 

changed the timeframe for updating the 

comprehensive assessment from 14 to 

15 days. We also believe that it is 

necessary for the timeframes for 

updating the plan of care and updating 

the comprehensive assessment to 

coincide. This will help to ensure that 

there is a direct correlation between the 

two. Therefore, we have also changed 

the update timeframe for the plan of 

care from every 14 days to every 15 

days. 

Comment: Some commenters 

suggested that we should delete the 

requirement in proposed § 418.56(d) 

that hospices must update the plan of 

care at intervals specified in the plan of 

care. Commenters stated that the plan of 

care cannot project future changes in the 

patient’s needs. Commenters suggested 

that the plan of care should be updated 

based on the updates to the 

comprehensive assessment instead. 

Response: Our intent in the proposed 

rule was to tie the updates to the plan 

of care directly to changes in the 

patient’s condition. Predicting changes 

in patient status and the related plan of 

care is too difficult; therefore, we agree 

that this requirement should be deleted. 

We have deleted this requirement that 

hospices must ‘‘review, revise and 

document the plan as necessary at 

intervals specified in the plan’’, and, in 

its place, require that hospices must 

‘‘review, revise and document the 

individualized plan as frequently as the 

patient’s condition requires * * * .’’

Comment: A commenter suggested 

that IDGs should be required to meet 

once every 28 days with all team 

members and the patient and family. 

The commenter also suggested that two 

or three members of the IDG should 

meet once a week. 

Response: We do not believe that 

mandating an IDG meeting schedule 

would meet the needs of patients and 

families or would enhance overall care 

planning. A large number of patients in 

hospices die before the 28th day 

(NHPCO Facts and Figures 2005). In 

addition, the proposed smaller weekly 

meetings would lack the essential input 

of all disciplines involved in the 

patient’s care, potentially resulting in 

patient and family needs being 

overlooked or inadequately addressed. 

Section 418.56(e), Coordination of 

services, already requires an IDG system 

of communication that enables frequent 

information sharing among disciplines 

and across service locations. 

Comment: Several commenters sought 

clarification regarding the requirement 

in proposed § 418.56(e) that hospices 

must have a system of communication 

and integration. Commenters requested 

clarification on how the system might 

be documented, how the system would 

interact with contract providers, and 

how the system might be implemented. 

Other commenters expressed support 

for the new requirement and stated that 

the communication system outlined in 

the requirement is already standard 

practice in hospice agencies. 

Response: We appreciate the support 

for this standard, as it validates our 

understanding that hospices have 

already established robust 

communication systems. As an 

interdisciplinary care model, hospice 

relies on communication between and 

integration of providers to effectively 

plan and furnish care to patients and 

families. Through the years, hospices 

have developed methods to ensure that 

all members of a patient’s care team 

receive timely information about 

patients. This standard expands on the 

communication and integration systems 

that hospices have developed for their 

own uses. This standard requires 

hospices to communicate, not only with 

their employees, but also with their 

contractors. It also requires hospices to 

integrate those same contractors into the 

hospice team. Communication and 

integration with service providers 

outside of the hospice’s direct purview 

will help hospices ensure that each 

patient receives appropriate, high 

quality care in accordance with his or 

her plan of care, regardless of whether 

that care is furnished by hospice 

employees or contractors. As always, 

the hospice is ultimately responsible for 

the care furnished on its behalf and 

must actively ensure that contractors are 

fulfilling their patient care and 

communication contractual obligations. 

The exact structure of the system of 

communication and integration will 

vary depending on the unique needs of 

each hospice. Telephone, e-mail, instant 

messaging, the postal service, and any 

other form of communication may be 

used in accordance with a hospice’s 

own policies and procedures. Likewise, 

clinical notes, IDG meeting minutes, 

and any other form of documentation 

associated with the patient’s plan of 

care may be used to demonstrate 

compliance with this requirement, in 

accordance with a hospice’s own 

policies and procedures. We believe that 

allowing hospices to determine the 

structure of the system and the 

documentation necessary to ensure that 

the system is used in the best and most 

flexible method for ensuring that 

hospices are able to comply with this 

provision. 

Comment: A commenter suggested 

that we should delete the phrase 

‘‘through its designated professionals’’

from § 418.56(e)(1) because the members 

of the IDG are already defined in 

§ 418.56(a)(1). 

Response: We agree with the 

commenter that the above-referenced 

phrase is not necessary, and we have 

deleted it. 

Comment: A commenter suggested 

that the language in proposed 

§ 418.56(e)(4) be simplified by 

substituting the phrase ‘‘all facilities’’

for the list of the various settings where 

hospice care may be provided. 

Response: We agree that adopting an 

all-inclusive term will make it easier for 

hospices to understand their 

crosscutting communication 

responsibilities. Since ‘‘settings’’ is a 

broader term than ‘‘facilities’’, as the 

commenter suggested, we are modifying 

the text in § 418.56(e)(4) to require that 

the system of communication provides 

for and ensures the ongoing sharing of 

information between all disciplines in 

all settings. 

Comment: A commenter suggested 

that, in § 418.56(e), hospices should be 

required to share information with nonhospice providers who are also caring 

for a patient. 

Response: We agree with this 

suggestion. We believe that it will 

enhance patient care in the unusual 

circumstances where patients with 

multiple illnesses and conditions 

receive care from multiple providers. 

This will ensure that hospices actively 


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coordinate the care that they are 

providing with the care being furnished 

by other providers. The coordination 

will help hospices avoid a duplication 

of services as well as potentially 

dangerous drug prescribing and dosage 

problems. This new requirement is 

located at § 418.56(e)(5). As stated 

previously, when coordinating care with 

other providers, it is essential that 

hospices are aware of their role within 

the larger comprehensive plan of care, 

as well as any gaps in the 

comprehensive plan of care and the 

parties responsible for filling those gaps. 

5. Condition of Participation: Quality 

Assessment and Performance 

Improvement (Proposed § 418.58) 

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 Medicare 

surveyors nationwide. During the last 

decade the health care industry, 

including the hospice industry, has 

moved beyond the problem-oriented, 

after-the-fact corrective approach of 

quality assurance to an approach that 

focuses on a preemptive plan that 

continuously addresses QAPI. Hospice 

industry associations have indicated 

that the upgraded QAPI approach used 

by many hospice providers is 

incompatible with the existing quality 

assurance condition. On the other end 

of the spectrum some providers do not 

have any quality program. 

The proposed QAPI requirement 

would raise the performance 

expectations for hospices seeking 

entrance into the Medicare and 

Medicaid programs, as well the 

expectations of those currently 

participating in Medicare and Medicaid. 

We proposed that each hospice would 

develop, implement, and maintain an 

effective, continuous quality assessment 

and performance improvement program 

that stimulates the hospice to constantly 

monitor and improve its own 

performance, and to be responsive to the 

needs, desires, and satisfaction levels of 

the patients and families it serves. The 

desired overall outcome of this 

proposed CoP would be that the hospice 

would drive its own quality 

improvement activities and improve its 

provision of services. With an effective 

quality assessment and performance 

improvement program in place and 

operating properly, a hospice can better 

identify and reinforce the activities it is 

doing well, identify its activities that are 

leading to poor patient outcomes, and 

take actions to improve performance. A 

hospice would be free to develop a 

program that meets its needs. As 

proposed, a provider’s QAPI program 

would not be judged against a specific 

model. 

The proposed QAPI CoP was divided 

into five standards. Under standard 

§ 418.58(a), ‘‘Program scope,’’ a 

hospice’s quality assessment and 

performance improvement program 

would include, but not be limited to, an 

ongoing program that would be able to 

show measurable improvement in 

indicators that were linked to improving 

palliative outcomes and end-of-life 

support services. We expect that a 

hospice would use standards of care and 

the findings made available in current 

literature to select indicators to monitor 

its program. The hospice would 

measure, analyze, and track these 

quality indicators, including areas such 

as adverse patient events and other 

aspects of performance that assess 

processes of care, hospice services, and 

operations. (‘‘Adverse patient events,’’

as used in the field, generally refer to 

occurrences that are harmful or contrary 

to the targeted patient outcomes.) 

The second proposed standard at 

§ 418.58(b), ‘‘Program data,’’ would 

require the hospice program to 

incorporate quality indicator data, 

including patient care, administrative, 

and other relevant data, into its QAPI 

program. This would include data that 

were received from or submitted to 

hospice professional organizations. We 

did not propose to require that hospices 

use any particular process or outcome 

measures. However, a hospice that 

would choose to use the available 

quality measures would be able to 

expect an enhanced degree of insight 

into the quality of its services and 

patient satisfaction, compared to 

beginning the outcome-measure 

development process anew because 

currently existing measures have 

already been tested to some degree for 

reliability and validity. 

Proposed standard (b) also would 

require that data collected by the 

hospice, regardless of the source of the 

data elements, would be collected in 

accordance with the detail and 

frequency specifications established by 

the hospice’s governing body. Once 

collected, hospices would use the data 

to monitor the effectiveness and safety 

of services, and to identify opportunities 

for improvement. 

The third standard under the quality 

assessment and performance 

improvement program at proposed 

§ 418.58(c), ‘‘Program activities,’’ stated 

that the hospice would set priorities for 

its performance improvement activities 

that focused on high risk, high volume 

and problem-prone areas, considered 

the prevalence and severity of identified 

problems’ and gave priority to 

improvement activities that affected 

palliative care, patient safety, and 

quality of care outcomes. In § 418.58(c) 

we also proposed to require the hospice 

to track adverse patient events, analyze 

their causes, and implement preventive 

actions that would include feedback and 

learning throughout the hospice. 

We proposed at § 418.58(d), 

‘‘Performance improvement projects,’’

that the number and scope of 

improvement projects conducted 

annually would reflect the scope, 

complexity, and past performance of the 

hospice’s services and operations. The 

hospice would document what 

improvement projects were being 

conducted, the reasons for conducting 

them, and the measurable progress 

achieved on them. 

In the final proposed standard at 

§ 418.58(e), ‘‘Executive 

responsibilities,’’ a hospice’s governing 

body would be responsible and 

accountable for ensuring that the 

ongoing quality improvement program 

was defined, implemented, and 

maintained. The governing body would 

ensure that the program addressed 

priorities for improved quality of care 

and patient safety. The governing body 

would also specify the frequency and 

detail of the data collection and ensure 

that all quality improvement actions 

were evaluated for effectiveness. The 

governing body’s most important role 

would be to ensure that staff were 

furnishing, and patients were receiving, 

safe, effective, quality care. Therefore, it 

would be incumbent on the governing 

body to lend its full support to agency 

quality assessment and performance 

improvement efforts. 

Comment: A few commenters stated 

that the phrases ‘‘measurable 

improvement,’’ ‘‘palliative outcomes,’’

‘‘end of life support systems,’’ and 

‘‘quality indicators’’ as they were used 

in the QAPI CoP, were vague. 

Response: We agree that the phrase 

‘‘end of life support systems’’ is vague, 

and we have removed it in the opening 

paragraph and standard (a) because it is 

duplicative of the requirement that a 

hospice’s QAPI program must involve 

all hospice services, including those 

services furnished under contract or 

arrangement. In § 418.58(a)(1) we have 

replaced the term ‘‘end of life support 

systems’’ with ‘‘hospice services’’ to 

correspond with the ‘‘hospice services’’

described in the opening paragraph. We 

do not agree that the phrase ‘‘palliative 

outcomes’’ is vague. Outcomes are the 

results of care provided; therefore 

palliative outcomes are the results of 


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palliative care provided. Since hospices 

primarily furnish palliative care to 

patients and respond to the results of 

the care furnished, we believe that it is 

reasonable to expect hospices to include 

palliative outcomes, gathered as part of 

the comprehensive and updated 

comprehensive assessments in 

accordance with final § 418.54(e), as 

part of their QAPI programs. We 

replaced the phrase ‘‘indicators for 

which there is evidence that 

improvement in those indicators will 

improve palliative outcomes’’ in 

§ 418.58(a)(1) with the phrase 

‘‘indicators related to palliative 

outcomes.’’ We believe that this revised 

language is clearer and more precise. 

Therefore, revised § 418.58(a)(1) now 

reads, ‘‘[t]he program must at least be 

capable of showing measurable 

improvement in indicators related to 

improved palliative outcomes and 

hospice services.’’ We do not agree that 

the phrase ‘‘measurable improvement’’

is vague. Hospices are required to have 

data-driven QAPI programs. Through 

these data, hospices measure their 

current performance, implement 

performance improvement projects, and 

measure their changes in performance 

after implementing the performance 

improvement project. Based on an 

analysis of the data, we believe that 

hospices will be able to measure the 

amount of improvement, stagnation, or 

decline in their performance and adjust 

their activities accordingly. 

Comment: Numerous commenters 

asked for more clarification of the term 

‘‘adverse event’’ as it is used in 

§ 418.58(a) and § 418.58(c) of this 

Condition of Participation. Other 

commenters asked for a delay in the 

proposed requirement that hospices 

must collect and analyze adverse event 

data. 

Response: We do not define the term 

‘‘adverse event’’ because we believe 

that, as part of their QAPI programs, 

hospices should be free to define and 

implement the term in the manner that 

fits their needs. Hospices may choose to 

develop their own definition or use a 

definition developed by an accrediting 

body or industry organization. Once a 

hospice has identified the definition of 

an adverse event, it is responsible for 

adhering to the definition when tracking 

and analyzing these events and when 

implementing preventive actions. In 

general, an adverse event would be any 

action or inaction by a hospice that 

caused harm to a hospice patient. 

However, hospices are not bound to use 

this generic description. 

We believe that it is essential to a 

hospice’s QAPI program to begin 

tracking and analyzing adverse events at 

the same time that it begins collecting 

patient level outcome measure data 

elements and hospice-wide measures. 

Since adverse events generally result in 

harm to a patient, they serve as 

important indicators of areas for 

potential improvement. If hospices do 

not collect adverse event information, 

they may be missing important data 

from which to assess their performance. 

Therefore, we are not delaying the 

adverse event requirements in this final 

rule. 

Comment: Many commenters 

submitted suggestions for what hospices 

may want to consider when selecting 

the elements of their QAPI program. 

Commenters suggested that hospices 

may want to examine such issues as 

pharmacy services, bar coding, 

electronic prescribing, clinical decision 

support programs, adverse event 

reporting systems, provider education 

efforts, patient and family education 

efforts, pain, nausea, shortness of 

breath, skin integrity, constipation, the 

appropriateness of emotional and 

spiritual interventions, and the 

timeliness of meeting patient needs at 

the start of care. 

Response: We appreciate all of the 

suggested areas that hospices may 

choose to examine when developing 

their QAPI programs. In addition to 

these suggested domains, hospices may 

also want to consider issues 

surrounding patient transitions. 

Transitions from one care setting/ 

provider to a hospice, or from a hospice 

to another care setting/provider, are an 

opportunity for hospices to improve 

their relationships with their referral 

sources while improving patient care 

and safety. Hospices may want to 

consider the use of shared protocols, 

agreements to honor advance directives, 

medication reconciliation processes, 

caregiver training and support systems, 

communication arrangements, and 

feedback systems, all related to patient 

transitions, as areas to examine in their 

QAPI programs. We are not requiring 

hospices to use any of the suggested 

domains identified above at this time 

because there is no currently available 

set of standardized measures. 

Comment: A few commenters 

requested clarification about when and 

where patient care measures will be 

documented. 

Response: Different patient care 

measures require different data 

collection timeframes. While some 

measures may require data collection 

only once, other measures may require 

data collection every few days or weeks. 

The nature of the patient care measure 

will determine the timeframe for 

collecting and updating. We expect 

hospices to establish their data 

collection timeframes within the 

specific context of the measures used, 

the available literature, any nationwide 

data collection projects they may 

participate in, their own data collection 

needs and goals, as well as the needs of 

their patients. 

We require in § 418.104(a)(4) that the 

patient care outcome measure data be 

included in the patient’s clinical record 

because hospices must use such data for 

individual care planning and 

coordination of services (§ 418.54(e)(2)). 

Hospices are free to document the 

patient care measure data in other 

locations as well in order to meet their 

needs. All documentation must be in 

accordance with the data collection 

policies and procedures established by 

the hospice to ensure consistency and 

retrievability. 

Comment: Many commenters 

requested clarification on the role of 

national standardized patient outcome 

measures and their relationship to 

standardized benchmarks. Specifically, 

commenters noted that, while some 

national measures are currently 

available, there is still work to be done 

in this area. A commenter suggested that 

any measures developed should relate 

to providing physical and emotional 

support, promoting shared decisionmaking, individualizing care, and 

attending to the needs of families. In 

addition, commenters expressed 

uncertainty about how national 

benchmarks may be used to measure 

patient outcomes. Some commenters 

suggested that we should work with the 

hospice industry and quality 

improvement organizations (QIOs) to 

establish such benchmarks while other 

commenters stated that benchmarking is 

not necessary because the variances 

between hospices put the validity of the 

benchmarks into question. 

Response: We agree that more work is 

needed to establish a wide variety of 

valid patient outcome measures that 

hospices may choose from. We 

commissioned a special study, the 

PEACE project, conducted by the North 

and South Carolina QIO. This study 

created a quality-focused self-audit tool 

for hospices to use, and identified 

quality measures that focus on the 

quality of clinical care furnished to 

hospice patients. Results of the study 

are available at http://medqic.org/dcs/ 

ContentServer?pagename=Medqic/ 

MQPage/Homepage. 

In addition, the National Hospice and 

Palliative Care Organization launched a 

National Quality Initiative and Quality 

Collaborative to improve hospice and 

palliative care outcomes. This initiative 

is helping hospices develop functional 


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QAPI programs, including patient 

outcome measures. 

Furthermore, the National Quality 

Forum has issued voluntary consensus 

standards for end-of-life care of cancer 

patients, who comprise approximately 

50 percent of the hospice patient 

population (National Voluntary 

Consensus Standards for Symptom 

Management and End-of-Life Care in 

Cancer Patients, December 2006, 

www.qualityforum.org/publications/ 

reports/palliative.asp). 

The National Quality Forum also 

issued the ‘‘National Framework and 

Preferred Practices for Palliative and 

Hospice Care Quality’’ (2006, 

www.qualityforum.org). This report 

identified eight domains of quality care 

as follows: Structures and processes of 

care; physical aspects of care; 

psychological and psychiatric aspects of 

care; social aspects of care; spiritual, 

religious, and existential aspects of care; 

cultural aspects of care; care of the 

imminently dying patient; and ethical 

and legal aspects of care. Using the 

structure of these domains, the report 

identifies 38 preferred practices that 

have been endorsed as suitable for 

implementation in hospice programs. 

Furthermore, the agency for 

Healthcare Quality and Research 

(AHRQ) issued an evidence-based 

review of end-of-life care and outcomes 

(www.ahrq.gov/clinic/epcsums/ 

eolsums.htm) that may also assist 

hospices. 

We believe that these efforts, 

combined with the measures already 

identified by the NHPCO and Brown 

University (Time Toolkit, 

www.chcr.brown.edu/pcoc/toolkit.htm), 

are sufficient to provide hospices with 

patient outcome measure options that 

suit their needs. Some of the measures 

that already have been or are being 

developed relate to comfortable dying, 

self-determined life closure, and family 

satisfaction with care. 

We do not believe that these efforts 

are sufficient to establish nationwide 

benchmarks that are appropriate for 

inclusion in this rule. More time is 

needed to test, refine, and collect further 

data related to any specific measure 

before we could establish a nationwide 

benchmark that all hospices should be 

required to meet. The necessary 

information is simply not available at 

this time to establish mandatory 

benchmarks, although hospices are free 

to use existing benchmarks to measure 

their own performance against that of 

other similar hospices who use the same 

measures. 

In order to further the process of 

establishing widely-accepted, valid, 

benchmarked quality measures, CMS is 

actively pursuing additional research on 

selected quality measures. This research 

will help identify and refine measures 

that are valid, meaningful, and reliable 

for hospices. It will also help establish 

benchmarks for hospices to attain. 

Following publication of this final 

rule, CMS will issue further subregulatory guidance on QAPI. 

Comment: A few commenters 

questioned the ability or 

appropriateness of using the same 

outcome measures for each patient 

within a hospice. Some commenters 

noted that not all measures may apply 

to all patients. Likewise, the 

commenters noted that certain patients 

may need individualized measures 

unique to the patient’s needs and goals. 

Other commenters noted that measures 

may be different based on the location 

in which care is provided (that is, in the 

patient’s home or in an in-patient 

facility). Still other commenters noted 

that outcome measure data may not be 

statistically significant when the data 

are collected from extremely small 

samples due to a low patient census. 

Response: A variety of hospicespecific patient outcome measures are 

currently available. Many of these 

measures capture data about universal 

issues such as patient pain or 

discomfort. We believe that these 

universal measures can be successfully 

applied to all of a hospice’s patients, 

regardless of their diagnosis or care 

location. At the same time, we agree that 

hospices may need to add specific 

outcome measures for specific patients 

in order to gather data related to the 

individual’s needs and goals. Hospices 

may add patient-specific measures to 

the core set of standard measures that 

they choose to collect data on for all 

patients. As with the core set of 

standardized patient data, patientspecific data must be gathered and 

documented in a consistent, systematic 

and retrievable manner. 

When analyzing data on a patient 

level, sample size does not matter. To 

use the patient outcome measure of pain 

controlled within 48 hours of admission 

discussed above in the patient 

assessment section, a hospice would 

need to document for a patient the 

presence or absence of uncontrolled 

pain upon the patient’s admission to 

hospice. If a patient has uncontrolled 

pain, the hospice would then reassess 

his or her pain 48 hours after the 

patient’s admission to hospice and 

document the presence or absence of 

uncontrolled pain at that time. This 

does not mean that the hospice does not 

assess the patient’s pain between the 

initial pain assessment and the 48 hour 

pain assessment. Indeed, the hospice 

may need to assess the patient’s pain far 

more frequently in order to adjust the 

treatments being provided to control the 

patient’s pain. In completing a patientlevel analysis of the patient’s data, the 

hospice would be able to judge the 

effectiveness of the initial care 

furnished in controlling the patient’s 

pain. 

In completing the hospice-wide 

analysis, this patient’s pain control data 

would be aggregated with the pain 

control data of the other patients that 

the hospice cared for. This aggregated 

data would allow the hospice to look for 

patterns such as a high level of pain 

control success for patients with cancer 

diagnoses and lesser levels of success 

for congestive heart failure patients. 

Identifying patterns, areas of strength, 

and areas of weakness allows the 

hospice to reaffirm promising practices 

that lead to positive patient outcomes 

and re-examine practices that lead to 

inadequate or negative patient 

outcomes. 

Aggregation of data must be done in 

accordance with the policies and 

procedures established by the hospice. 

If a hospice has an extremely small 

average monthly census, then it may 

make sense for that hospice to aggregate 

several months of data. Likewise, if a 

hospice has an extremely large average 

monthly census, then it may make sense 

for them to aggregate the data more 

frequently to ensure that the amount of 

data does not become overwhelming to 

those analyzing it. The flexible nature of 

the patient outcome measure standard 

and the quality assessment and 

performance improvement CoP allow 

hospices to adapt data collection and 

analysis to their needs and goals. 

Comment: A few commenters 

expressed enthusiastic support for the 

requirement that hospices collect 

patient outcome measure data, noting 

that other health care providers have 

been collecting this data for several 

years. Other commenters, while 

expressing support for the overall goals 

of data collection and QAPI, expressed 

concern about the potential costs. 

Commenters cited the potential cost and 

availability of software to aid in data 

collection as the single largest concern. 

Response: We appreciate the overall 

support for data collection and QAPI. At 

the same time, we understand the 

concerns that some hospices have about 

implementing these new requirements. 

We note that the new regulation does 

not require hospices to use electronic 

health records or any specific software 

for data collection. Hospices are free to 

choose the data collection methods and 

tools that best suit their needs. We do 

not believe that this rule is imposing a 


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burden on hospices by requiring them to 

obtain sophisticated data collection and 

analysis computer programs. Analysis of 

patient outcome measures, as well as 

administrative data, will allow hospices 

to determine objectively what care 

results in the best outcomes for a 

particular patient or subset of patients. 

This will help hospices identify best 

practices and avoid ineffective 

practices, which may reduce hospice 

expenditures in the future. We believe 

these benefits will outweigh any costs 

associated with the process. 

Comment: A commenter suggested 

that, in § 418.58(b)(2)(ii), hospices 

should be required to use quality 

indicator data that they collected to 

identify priorities, as well as 

opportunities, for improvement. 

Response: We agree that hospices 

should use data to prioritize their areas 

for improvement, and we have 

incorporated this suggestion into the 

final rule. Section 418.58(b)(2)(ii) now 

reads, ‘‘[i]dentify opportunities and 

priorities for improvement.’’

Comment: In proposed § 418.58(b)(3), 

a commenter suggested that the 

governing body should approve, rather 

than specify, the frequency and detail of 

data collection. 

Response: We agree that the governing 

body’s general QAPI oversight 

responsibility would be more 

appropriately described by the term 

‘‘approved’’ than the proposed term 

‘‘specified,’’ and we have made this 

change. 

Comment: Some commenters 

suggested that the requirement for 

hospices to conduct performance 

improvement projects should be phased 

in. 

Response: In accordance with this 

rule, hospices are required to identify 

opportunities and priorities for 

improvement based on the data that 

they have collected. We agree that it 

would be appropriate to delay 

implementation of the performance 

improvement projects requirement to 

allow hospices time to develop and 

implement a data collection program, 

and actually amass several months of 

data. For this reason, we have added a 

240 day phase-in period. This phase-in 

period will allow hospices to gather 

several months of data before being 

required to develop and implement 

their data-driven performance 

improvement projects. Once the 240 day 

phase-in period is complete, we expect 

hospices to begin developing and 

implementing their data-driven 

performance improvement projects, 

with evaluation of those performance 

improvement projects to follow 

thereafter. 

Comment: A commenter asked us to 

specify, in § 418.58(d)(1), that the 

number and scope of performance 

improvement projects that a hospice 

undertakes should be based on the 

needs of the hospice’s population and 

its own internal organizational needs. 

Another commenter asked us to clarify 

our proposed requirement that 

performance improvement projects must 

reflect a hospice’s past performance. 

Response: While we understand that 

some hospices may want additional 

guidance on the number and scope of 

projects that must be undertaken, we 

believe that a hospice’s performance 

improvement projects should be 

required to reflect the needs of its 

patient population as well as its own 

needs, and this requirement is included 

in the final rule. We also believe that 

hospices must examine their past 

performance when developing 

performance improvement projects. If a 

hospice is aware that it had issues in a 

particular area in the past, then we 

believe that it is appropriate to reexamine that issue to assure that it has 

been remedied. Hospices should 

conduct these performance 

improvement projects that focus on 

previously existing concerns in concert 

with performance improvement projects 

that focus on more recently occurring 

issues, to ensure that they are 

consistently furnishing quality services 

to patients. Revised § 418.58(d)(1) reads, 

‘‘The number and scope of distinct 

performance improvement projects 

conducted annually, based on the needs 

of the hospice’s population and internal 

organizational needs, must reflect the 

scope, complexity, and past 

performance of the hospice’s services 

and operations.’’

Comment: A commenter suggested 

that, in § 418.58(d)(2), hospices should 

be specifically required to document 

any national quality improvement 

projects they are participating in. Other 

commenters questioned whether or not 

participation in national quality 

improvement projects would satisfy the 

QAPI requirement. 

Response: Section 418.58(d)(2) 

requires hospices to document all 

performance improvement projects they 

are conducting, including national 

performance improvement projects. 

There is no need to single out national 

performance improvement projects as 

needing to be documented separately 

because they are one part of a hospice’s 

larger performance improvement project 

plan, which must be documented. 

Hospices are free to participate in such 

national projects. We would caution 

however, that participation in such 

projects does not guarantee that 

hospices are in compliance with this 

requirement. As required by 

§ 418.58(b)(2)(ii), hospices must use the 

quality indicator data that they have 

gathered to identify and prioritize 

opportunities for improvement. In 

addition, § 418.58(a)(1) requires a 

hospice’s QAPI program to be able to 

show measurable improvement in areas 

related to improved palliative outcomes 

and hospice services. Furthermore, 

§ 418.58(d)(1) requires that the scope 

and number of a hospice’s performance 

improvement projects are to be based on 

the needs of the hospice and its patient 

population. Read together, these 

requirements require hospices to 

develop, implement, and assess 

performance improvement projects that 

reflect their areas of weakness, as 

identified through the data that they 

have collected, and the needs of their 

organizations. If a hospice participates 

in a national performance improvement 

project that does not address one or 

more of its areas of weakness, or if that 

performance improvement project will 

not enable the hospices to demonstrate 

measurable improvement in areas 

identified as needing to be addressed, 

then participation in the national 

performance improvement project 

would not meet the QAPI requirements 

of this rule. 

Comment: Numerous commenters 

stated that the proposed QAPI 

requirement at § 418.58(e) assigned a 

hospice’s governing body too much 

responsibility for the hospice’s QAPI 

program. Commenters believed that the 

hospice IDG or a professional advisory 

committee would better fulfill the 

executive responsibilities described in 

this paragraph. One commenter 

suggested that the role of the governing 

body should be augmented by requiring 

it to monitor the QAPI program rather 

than simply ensuring that is it 

functioning. Another commenter 

suggested that the role of the governing 

body should be further clarified by 

adapting leadership standards for home 

care agencies established by the Joint 

Commission. 

Response: Section 418.100(b) of this 

rule requires the hospice’s governing 

body to assume full legal authority and 

responsibility for the management of the 

hospice, including its QAPI program. 

Section 418.58(e) of the proposed rule 

specified the QAPI responsibilities of 

the governing body. It would require the 

hospice’s governing body to ensure that 

a QAPI program is defined, 

implemented, and maintained. In 

addition, the rule proposed that the 

governing body must ensure that the 

QAPI program addresses the hospice’s 

quality priorities and that its 


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effectiveness is evaluated. As the entity 

that is legally responsible for the 

hospice, we believe that it is essential 

that the hospice governing body ensures 

that the hospice’s QAPI program is 

meeting the requirements of this rule. 

We believe that our governing body 

requirements meet the intent of the Joint 

Commission leadership standards. 

Therefore we are setting forth this 

requirement as final. The governing 

body may assume hands-on control of 

the QAPI program to ensure that the 

program is in compliance with this rule, 

or it may choose to appoint one or more 

individuals to handle the structure and 

administration of the QAPI program 

while the governing body retains 

ultimate responsibility for the actions of 

the designated individual(s). 

As many commenters noted, the 

individuals who compose the governing 

body may not have significant 

experience in a hospice QAPI program 

and would therefore not be the best 

candidates to actively supervise or 

direct its activities. For this reason, it 

may not be appropriate to require the 

governing body to actively monitor the 

QAPI program if this function can be 

managed by others more knowledgeable 

in clinical and/or related fields of 

endeavor. A new provision has been 

added at § 418.58(e)(3) explicitly 

requiring the governing body to appoint 

QAPI leaders. 

Comment: A commenter asked us to 

delete the proposed § 418.58(e)(3) which 

required the governing body to ensure 

that clear expectations for patient safety 

are established. The commenter stated 

that patient safety is already addressed 

throughout the regulations, and that it is 

redundant to include this requirement 

in the QAPI CoP. 

Response: We agree that patient safety 

is already addressed throughout the rule 

and does not need to be separately 

included in the QAPI section. 

Comment: The majority of 

commenters that submitted comments 

on the proposed quality assessment and 

performance improvement CoP 

supported its overall goals. The 

commenters appreciated our recognition 

of the role that QAPI now plays in the 

hospice industry as well as its current 

limitations. The commenters requested 

assistance from CMS in implementing 

some aspects of the proposed QAPI 

requirement. Commenters sought 

additional CMS involvement in 

developing measures that hospices may 

choose to use. Commenters also sought 

assistance from the QIOs that CMS 

contracts with to provide quality 

assistance for other provider types. 

Response: In August 2006 CMS 

contracted with the North and South 

Carolina QIO to conduct a special study 

on hospice quality measures. This study 

created a quality-focused self-audit tool 

for hospices to use and identified 

quality measures that focus on the 

quality of clinical care furnished to 

hospice patients. Results of the study 

are available at http://medqic.org/dcs/ 

ContentServer?pagename=Medqic/ 

MQPage/Homepage. 

In addition to this completed project, 

CMS plans to sponsor additional 

research that will examine the validity, 

reliability, appropriateness, and 

usefulness of select quality measures. 

Furthermore, CMS plans to sponsor 

work that will develop a method for 

QIOs to actively assist interested 

hospices in developing and 

implementing QAPI programs. 

Comment: Many commenters made 

general statements in support of the 

broad framework adopted by the 

proposed QAPI requirement. These 

commenters liked the fact that we did 

not propose that hospices use any 

specific quality measures, data elements 

or benchmarks. Commenters voiced 

approval that they would be permitted 

to identify their own quality goals, 

measures and elements, and that they 

would be permitted to identify how 

many performance improvement 

projects they undertook and what those 

projects would focus upon. Conversely, 

other commenters specifically asked for 

the regulation to detail the quality 

measures and data elements that must 

be collected, the number and topics of 

performance improvement projects that 

must be undertaken, and the exact 

benchmarks or results that must be 

achieved. 

Response: The two diametrically 

opposed viewpoints expressed by 

commenters are difficult to reconcile. 

Our intent in developing the QAPI CoP 

was to ensure that hospices would 

develop a data-driven program for 

continuous quality improvement that 

reflects the needs of patients and 

hospices alike. We believe that 

prescribing specific data measures and 

improvement projects is not appropriate 

at this time because there is no currently 

available, valid, reliable, widely applied 

set of clinical and/or administrative 

quality measures. As hospice quality 

measurement and best practices 

continue to evolve, we believe that a set 

of measures and practices may be 

identified, and that such measures and 

practices may be appropriate for 

inclusion in the hospice rules. 

At the same time, we are sensitive to 

the concerns of hospice providers who 

are wary of the new and unknown. As 

described above, we conducted a special 

study through the Carolina QIO to 

identify hospice measures focusing on 

the quality of clinical care furnished to 

hospice patients. These measures are 

publicly available at no cost to hospice 

providers. In addition, the largest 

hospice industry group, the National 

Hospice and Palliative Care 

Organization, has launched a major 

quality initiative to provide hospices 

with the tools they need to begin 

collecting and analyzing QAPI data and 

to develop, implement, and analyze 

performance improvement projects. 

Furthermore, Brown University has 

made available the TIME Toolkit, which 

contains quality measures and related 

data elements that hospices may use in 

their QAPI programs. We are confident 

that these efforts, and others that may 

arise in the future, will help hospices 

transition from the quality assurance 

approach to the QAPI approach. For 

additional discussion of the former 

quality assurance requirements and the 

new QAPI requirements, see pages 

30847–30849 of the May 27, 2005 

hospice proposed rule (70 FR 30840). 

Comment: Many commenters 

expressed general concern about the 

cost of implementing a QAPI program. 

Several of these commenters suggested 

that implementing a QAPI program will 

require more staff hours and money 

than estimated in the impact analysis 

section of the proposed rule. 

Response: We recognize that moving 

from the basic QA approach to a QAPI 

approach will require some hospices to 

reallocate funds to expand and evolve 

their existing quality programs. 

However, an effective QAPI program 

will allow hospices to identify areas for 

improvement. The analysis of patient 

care and administrative data for the 

QAPI program may help hospices 

identify ineffective therapies, 

opportunities for staff improvement, 

low performing contracts for services, 

etc., and allow hospices the chance to 

improve services and efficiency. A 

vigorous QAPI program will benefit 

hospices and patients, and will help 

ensure that hospice resources are being 

used in the most effective and efficient 

manner possible. While we have 

adjusted the cost estimate for this CoP 

in the impact analysis section, we have 

not factored in the cost savings that 

hospices may achieve. 

Comment: Several commenters 

stressed the importance of ensuring that 

all hospice employees are involved in 

the QAPI program. Of these 

commenters, a few highlighted the need 

for board certified chaplain involvement 

in QAPI. 

Response: We agree that it is 

important to involve employees, both 

paid and volunteer, as well as 


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individuals furnishing services under 

contract, in the hospice’s QAPI program. 

In order to ensure such involvement, we 

require in § 418.62, that all licensed 

professionals furnishing services on 

behalf of the hospice must actively 

participate in the hospice’s QAPI 

program. Hospices have the flexibility, 

within the licensed professional 

requirement, to determine which 

individuals will lead QAPI efforts based 

on their own needs and goals. Hospices 

may choose to use the services of board 

certified chaplains in developing and 

implementing their QAPI program. 

Comment: A few commenters 

suggested that we should require 

hospices to publicly report the results of 

their data collection, while other 

commenters expressed concern that we 

may require hospices to use a data 

collection tool such as OASIS, which 

would enable public reporting of 

hospice data. Similarly, commenters 

expressed concern that we would expect 

hospices to use computerized systems 

in implementing the QAPI requirement. 

Response: Quality assessment and 

performance improvement is a fast 

growing approach to quality 

improvement in the hospice industry. 

However, there is no nationally 

standardized and accepted set of 

measures that could be used at this time 

to develop an OASIS-like tool that 

would enable public reporting. The 

intent of this rule is to establish the 

framework of QAPI in hospice, not to 

prescribe specific measures or tools. As 

such, we are not requiring hospices to 

use specific outcome or process 

measures, data elements, forms, or 

computer systems. These decisions are 

at the discretion of each hospice based 

on its own needs and goals. We caution 

that we cannot, at this time, predict 

with any certainty the future of hospice 

data collection and its relationship to 

the public reporting of data. 

Comment: Many commenters asked 

for more information about how State 

surveyors will survey hospices for 

compliance with the QAPI 

requirements. Commenters sought more 

information about how hospice 

surveyors will use hospice data and 

how they will determine a QAPI 

program’s scope, complexity and 

adequacy of improvement projects. 

Response: Hospices are required to 

collect and analyze patient care and 

administrative quality data and to use 

that data to identify, prioritize, 

implement, and evaluate performance 

improvement projects to improve the 

quality of services furnished to hospice 

patients. In order to assess compliance 

with the QAPI requirements, hospice 

surveyors will need to access, upon 

request, a hospice’s aggregated data and 

its analysis of that data. Surveyors will 

also need access to the hospice’s QAPI 

plan, any meeting minutes or notes for 

meetings concerning the development 

and implementation of the hospice’s 

QAPI program, those individuals 

responsible for the QAPI program, and 

any other necessary resources needed to 

assess a hospice’s compliance. This 

information will allow surveyors to 

match the data provided by the hospice 

with the actual experiences of hospice 

employees and patients to ensure that 

the QAPI program is prevalent 

throughout the hospice’s operations and 

services, and that it is positively 

influencing patient care. Furthermore, 

this information will enable surveyors 

to assess the adequacy and 

appropriateness of a hospice’s QAPI 

program. Surveyors will focus on areas 

such as how and why a hospice chose 

its quality measures, how it ensures 

consistent data collection, how it uses 

data in patient care planning, how it 

aggregates and analyzes data, how it 

uses the data analysis to select 

performance improvement projects, how 

it implements such projects, and its use 

of data to evaluate the effectiveness of 

those projects. We will include more 

detailed information about the QAPI 

survey process and goals in future subregulatory guidance such as the State 

Operations Manual and Interpretive 

Guidelines. 

We note that hospitals are currently 

required to comply with a very similar 

performance improvement project 

regulation and have successfully 

determined their performance 

improvement project needs and goals 

without prescribed minimums. 

Likewise, hospital surveyors have 

successfully assessed hospital 

compliance with the performance 

improvement project regulation without 

such minimums. We will use the 

knowledge gained through the hospital 

survey process to guide our 

understanding and implementation of 

surveys for hospices complying with 

this performance improvement project 

regulation. 

6. Condition of Participation: Infection 

Control (§ 418.60) 

There are no current requirements for 

infection control other than the 

requirements at § 418.100(a) that read in 

part, ‘‘each patient is to be kept 

comfortable, clean, well groomed, and 

protected from accident, injury, and 

infection,’’ and the requirement at 

§ 418.100(e) regarding isolation areas. 

We proposed a new CoP to help manage 

the seriousness and hazards of 

infectious and communicable diseases. 

We recognize that a hospice cannot be 

directly responsible for the maintenance 

of an infection-free environment in 

every setting. We proposed in 

§ 418.60(a), ‘‘Prevention,’’ that hospices 

follow accepted infection control 

standards of practice and ensure that all 

staff that provide hospice services know 

and use these current best prevention 

practices to curb the spread of infection. 

Periodic training is one way to assure 

that staff take all appropriate infection 

prevention and control precautions. 

Hospices may also consider immunizing 

their patient care staff for influenza as 

part of their infection control programs. 

Hospice staff may transmit influenza to 

patients, compromising their quality of 

life at this important time, and to 

caregivers, compromising their ability to 

effectively care for the patient. 

Furthermore, infected staff may create a 

staffing shortage, compromising the 

entire hospice’s ability to safely and 

effectively deliver care to all hospice 

patients and their families. 

In § 418.60(b), ‘‘Control,’’ we 

proposed that the hospice be required to 

engage in an ongoing system-wide 

program that focuses on the 

surveillance, identification, prevention, 

control, and investigation of infections 

and communicable disease. Where 

infection and/or communicable disease 

are identified, we expect that this 

information would be made part of the 

hospice’s quality assessment and 

performance improvement program. 

As proposed in § 418.60(c), 

‘‘Education,’’ each hospice would be 

expected to educate its staff, as well as 

patients, families, and other caregivers 

in the ‘‘current best practices’’ for 

controlling the spread of infections 

within the home during the course of 

the family/caregiver’s interactions. We 

did not propose any specific approaches 

that a hospice would be required to 

adhere to. A hospice would be expected 

to aggressively seek to minimize the 

spread of disease and infection through 

its efforts to help families and caregivers 

understand what can and should be 

done to minimize infection. 

Comment: Several commenters 

thanked us and supported the 

incorporation of this new requirement. 

Response: We appreciate the support 

from the commenters on this proposal. 

We believe that this requirement is 

necessary to ensure that patients receive 

quality care from hospices, regardless of 

the patient’s setting. Due to the potential 

negative effects on health and safety that 

are posed by infection and 

communicable diseases, we believe 

hospices need to address infection 

standards of practice and ensure all staff 

that provide hospice services know and 


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use the current best prevention practices 

to curb the spread of infection. 

Comment: One commenter requested 

that we add the word ‘‘visitor’’ to the 

list of those protected by the infection 

control program. 

Response: We agree, and the word 

‘‘visitor’’ has been added to the opening 

paragraph. The final language at 

§ 418.60 reads, ‘‘[t]he hospice must 

maintain and document an effective 

infection control program that protects, 

patients, families, visitors and hospice 

personnel by preventing and controlling 

infections and communicable diseases.’’

Comment: One commenter 

recommended that the disease 

prevention plan in § 418.60(b)(2)(ii), 

should ensure the comfort of the 

patient. 

Response: We strongly agree. The 

comfort, safety and well-being of the 

patient must always be the main 

objective when providing care and 

services. Section 418.100(a), ‘‘Serving 

the hospice patient and family,’’ already 

requires hospices to furnish all care, 

including care related to infection 

control, in a manner that optimizes 

patient comfort. 

Comment: A few commenters 

expressed concern about our proposed 

requirement at § 418.60(c) that hospices 

must provide infection control 

education to staff, patients, family and 

other caregivers. One commenter 

expressed concern that the tracking of 

infection in hospice patients, especially 

in the home setting, is difficult and that 

in many cases infection is a natural 

progression of the disease and is not 

unexpected. 

Response: We acknowledge the 

limitations hospices may encounter 

regarding infections in patients, and in 

determining the outcomes for patients 

that are terminally ill, immunesuppressed and that may have other comorbidities. However, we believe that 

this should not affect the need to 

apprise family and caregivers about 

infection control. The education 

standard in § 418.60(c) allows the 

hospice flexibility in meeting infection 

control, prevention and education 

objectives. While we would expect the 

hospice to adhere to best practices, we 

are not requiring any specific 

approaches. Due to the negative effects 

of infections on the health and safety of 

patients and staff and the potential 

financial burden on the hospice, we 

believe that it is in the best interest of 

hospices and the patients they serve to 

focus on controlling the spread of 

infections in the home. 

Comment: A few commenters asked 

how hospices should handle extremely 

short lengths of stays, where there may 

not be an opportunity to educate the 

caregivers on infection control 

procedures. 

Response: We certainly appreciate 

that hospices may encounter patients 

that elect the benefit in the last 24–72 

hours of life. We agree that, due to the 

short timeframe, there may not be time 

to educate the patient, family and 

caregiver on myriad infection control 

procedures, nor given the 

circumstances, may it be appropriate. 

Nonetheless, we believe that the 

demonstration of best practices by the 

hospice staff while caring for the patient 

and the ability of the staff to talk to the 

patient and family regarding basic 

precautions such as hand washing while 

providing care would be sufficient. This 

information will be included in future 

sub-regulatory guidance. 

7. Condition of Participation: Licensed 

Professional Services (§ 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 proposed 

to remove § 418.82, § 418.84, and 

§ 418.92, and replace them with a more 

simplified condition, ‘‘Licensed 

professional services.’’ Instead of 

identifying detailed tasks, we broadly 

described the expected contributions of 

the licensed professionals who are 

furnishing hospice services. Licensed 

professional services, for purposes of 

this section, would include, but not be 

limited to, skilled nursing care, physical 

therapy, speech language pathology, 

occupational therapy, and medical 

social services. We proposed that 

licensed professionals who provide 

services to hospice patients either 

directly or under arrangement would 

participate in coordinating all aspects of 

care, including updating the 

interdisciplinary comprehensive 

assessments, developing and evaluating 

plans of care, participating in patient 

and family counseling, participating in 

the quality assessment and performance 

improvement plan, and participating in 

in-service training. 

Comment: Several commenters 

suggested that we amend the language 

in proposed § 418.62(b) to apply to the 

coordination of the patient’s hospice 

care. One commenter stated that we 

should limit the hospice’s responsibility 

to coordination of hospice care, since 

the hospice cannot control other aspects 

of patient care that are unrelated to the 

terminal illness and related conditions. 

Response: We appreciate the 

comments and are accepting the 

suggested changes. Although we expect 

that the hospice will actively participate 

in the coordination of hospice care, it is 

unrealistic and beyond the scope of the 

hospice regulations to require hospices 

to coordinate all aspects of a patient’s 

care. Therefore, we have amended this 

provision and the final language at 

§ 418.62(b) now reads, ‘‘[l]icensed 

professionals must actively participate 

in the coordination of all aspects of the 

patient’s hospice care * * *.’’ As 

previously noted, if a hospice does not 

coordinate all aspects of a patient’s care, 

it is incumbent upon the hospice to 

know who is performing this function, 

and to actively communicate and 

coordinate with other providers to 

ensure that the patient’s needs and goals 

are met. 

Comment: One commenter asked that 

we not require contracted staff to 

participate in the hospice’s QAPI 

program. The commenter suggested that 

we amend this language so that 

contracted licensed professionals are 

encouraged to participate whenever 

possible. 

Response: For QAPI to work 

effectively for the hospice, all 

professionals must be involved in the 

quality process. This would include 

contracted licensed professionals. We 

expect all hospices to provide high 

quality care for all of the patients they 

serve, and believe that the care should 

be ‘‘seamless,’’ meaning that, whether 

the individual providing services is an 

employee or contracted licensed 

professional, the care provided to 

patients and their families must be 

provided at the same high level of 

quality. 

8. Condition of Participation: Core 

Services (§ 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 proposed to combine 

these into a single condition. We also 

proposed to incorporate the requirement 

at existing § 418.50(b)(3) which required 

that core services would be provided in 

a manner consistent with accepted 

standards of practice. This section was 

revised to reflect changes to the Act 

made by section 946 of the MMA. In 

accordance with section 946 of the 

MMA, we proposed to allow a hospice 

(the primary hospice) to enter into 

arrangements with another Medicarecertified hospice to obtain core hospice 

services. The Act provided that this 

could be done under extraordinary or 


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other nonroutine circumstances. 

Pursuant to section 1861(dd)(5)(D) of 

the Act (as amended by section 946(a) 

of the MMA) those circumstances are: 

unanticipated periods of high patient 

loads; staffing shortages due to illness or 

other short-term temporary situations 

that interrupt patient care such as 

natural disasters; and temporary travel 

of a patient outside the hospice’s service 

area. 

In the first proposed standard, ‘‘(a) 

Physician services,’’ we incorporated 

the existing requirements of § 418.86. 

The existing and proposed requirement 

states that hospice physicians, in 

conjunction with the patient’s attending 

physician, are responsible for the 

palliation and management of the 

terminal illness, conditions related to 

the terminal illness, and the general 

medical needs of the patient. As a result 

of changes made to the Act by the BBA, 

we also proposed to add a provision to 

the CoPs permitting hospices to contract 

for physician services. This proposed 

provision would align the CoPs with 

current CMS policy permitting hospices 

to contract for physician services. 

The second proposed standard, ‘‘(b) 

Nursing services,’’ incorporated the 

requirements of § 418.82 of the existing 

CoPs. We also proposed to add specific 

language to address the role of nurse 

practitioners in providing hospice care. 

The services provided by nurse 

practitioners continue to be guided by 

Medicare statutory requirements. 

Within these statutory requirements, we 

propose to allow nurse practitioners to 

perform hospice functions that are 

within the scope of their practice and 

license, as well as within the laws of the 

State in which they practice. 

We also proposed in § 418.64(b) to 

allow hospices to provide certain types 

of nursing services under contract. This 

proposed change also resulted from 

section 946 of the MMA, which 

amended the Act by adding section 

1861(dd)(5)(E). As amended, the Act 

provides that these nursing services 

must be highly specialized and 

provided non-routinely and so 

infrequently that their provision by 

hospice employees would be 

impracticable and prohibitively 

expensive. We recognize that it may be 

cost-prohibitive for a hospice to employ 

a nurse that possesses very highly 

specialized skills when he or she may 

only care for a few patients a year. By 

allowing hospices to contract with 

specialized nursing providers or others 

to provide these highly specialized 

nursing services to the few patients who 

require them, hospices would be able to 

better implement an efficient staffing 

plan and ensure proficiency in the 

skilled services being provided. 

In standard ‘‘(c) Medical social 

services,’’ we proposed to maintain the 

requirements of the current medical 

social services requirement at § 418.84. 

This standard would continue to require 

that medical social services be provided 

by a qualified social worker under the 

direction of a physician. This standard 

would also require that medical social 

services, when accepted by a patient 

and family, be based on an assessment 

of that patient’s psychosocial needs. In 

proposed standard § 418.64(d), we 

addressed the counseling services that 

would be available to hospice patients 

and their families. Those services would 

be bereavement, nutritional, and 

spiritual counseling. In the bereavement 

counseling section, we proposed that a 

hospice would be required to have an 

organized program of bereavement 

services furnished under the 

supervision of a qualified professional 

with experience in grief/loss counseling. 

These services would be required to be 

made available to individuals identified 

in the bereavement plan of care up to 

one year following the death of the 

patient, and would reflect the needs of 

those individuals. When appropriate, 

residents and staff of a SNF/NF, ICF/ 

MR, or other facility would be offered 

bereavement services. 

In the nutritional counseling section, 

we proposed to allow qualified 

individuals, such as dietitians and 

nurses to furnish this service, provided 

that it was within their scope of practice 

and expertise according to State law. We 

believed that allowing other qualified 

individuals to participate in nutritional 

counseling would give hospices greater 

flexibility and would help ensure that 

all hospice patients had access to this 

service when needed. This proposal 

conformed to a recommendation made 

by the Secretary’s Advisory Committee 

on Regulatory Reform. 

In the spiritual counseling section, we 

proposed that a hospice would be 

required to assess the patient’s and 

family’s spiritual needs and provide 

spiritual counseling to meet those 

needs, in accordance with the patient’s 

and family’s beliefs and desires. If a 

patient and family did not desire 

spiritual counseling, then they would 

not have to be provided this service. If 

a patient and family did desire spiritual 

counseling, then a hospice would be 

expected to facilitate visits by local 

clergy, pastoral counselors, or others to 

the best of its ability. 

Comment: Numerous commenters 

requested that the regulations permit 

hospices to contract for core services 

with various entities and for various 

reasons. Some of these commenters 

believed that hospices should be 

permitted to contract with hospice and 

non-hospice agencies on a routine basis 

for the provision of core services to 

hospice patients. Other commenters 

believed that, in extraordinary 

circumstances, hospices should be 

allowed to contract with non-hospice 

agencies in addition to contracting with 

other Medicare-certified hospice 

agencies, as we proposed. Still other 

commenters stated that hospices should 

be permitted to use contracted staff 

when they are providing continuous 

care to one or more patients, either 

because continuous care increases the 

amount of hours of patient care, which 

results in a period of peak patient loads, 

or because providing continuous care 

requires highly specialized nursing 

skills. 

Response: Section 1861(dd) of the Act 

requires hospices to provide 

substantially all core services directly 

(see section 1861(dd)(2)(A)(ii)(I) of the 

Act). Thus, in accordance with the Act, 

hospices are prohibited from contracting 

with other hospices and non-hospice 

agencies on a routine basis for the 

provision of core services to hospice 

patients. The Act specifically states 

‘‘substantially all’’ in recognition of the 

fact that there are times when hospices 

must contract for core services. The Act 

identifies the circumstances in which 

hospices are permitted to contract for 

core services as those that are 

‘‘extraordinary’’ or otherwise ‘‘nonroutine’’ such as unanticipated periods 

of high patient loads, temporary staffing 

shortages, and travel of a patient outside 

of the hospice’s service area. We agree 

that hospices should be permitted to 

contract with non-hospice providers as 

well as other Medicare certified 

hospices in order to meet patient needs 

in extraordinary circumstances, and we 

have amended the final rule as such. 

We also agree that simultaneously 

providing continuous home care to 

multiple patients may result in an 

unanticipated period of high patient 

load that would warrant contracting for 

core services through the extraordinary 

circumstance exception. If a hospice 

chooses to contract with another 

Medicare-certified hospice or a nonhospice entity, the contracting hospice 

must maintain professional management 

responsibility for the services provided, 

in accordance with this final rule at 

§ 418.100(e). In addition, all licensed 

professionals who provide services to 

hospice patients under contract must 

actively participate in the coordination 

of all aspects of the patient’s hospice 

care, including patient assessments; care 

planning development, delivery, and 


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evaluation; patient and family 

counseling and education; in-service 

training; and the hospice’s quality 

assessment and performance 

improvement program, to the extent 

applicable, in accordance with § 418.62. 

Comment: A commenter suggested 

that, in order to ensure the quality of 

nurses providing care under contract, 

CMS should survey nurse staffing 

agencies. 

Response: Medicare does not 

currently have the authority to survey 

nurse staffing agencies because they are 

not themselves providers under 

Medicare. We expect hospices that use 

the services of a nurse staffing agency to 

ensure that the nurses provided by such 

agency are qualified to furnish nursing 

care to hospice patients. In addition, we 

expect hospices to exercise full 

professional management responsibility 

for the services provided by contractors 

to ensure that those services are 

appropriate and are of high quality. 

Comment: Many commenters 

submitted suggestions to refine the 

proposed ‘‘Physician services’’ standard 

at § 418.64(a). One of these commenters 

suggested that this standard should be 

removed, because having a standard for 

physician services separates physician 

services from the rest of the IDG. 

Another commenter suggested that this 

standard should explicitly state that the 

hospice medical director would not be 

required personally to provide direct 

physician services to every patient. Still 

another commenter suggested that the 

role of physician assistants should be 

included in this standard. Several other 

commenters suggested that we remove 

the proposed requirement that hospice 

physicians be responsible for the 

general medical needs of the patient, 

because this responsibility would create 

a conflict with the role of the attending 

physician and/or the physicians of a 

SNF/NF. 

Response: We believe that including a 

standard for physician services under 

the umbrella of the core services CoP, 

highlights the fact that physician 

services are one piece in the larger 

interdisciplinary services model of 

hospice care. Physician services are, in 

this rule, treated as equal to nursing 

services, medical social services, and 

counseling services. These four 

disciplines are required to work together 

as the core members of the IDG, and we 

believe that it is appropriate to group 

them together under a single CoP. 

We do not believe that it is 

appropriate or necessary to state that 

medical directors are not required to 

furnish hands-on services to each 

patient. Elements of the proposed rule, 

such as the proposed requirement that 

the hospice medical director 

communicate with the medical director 

of a SNF/NF in proposed § 418.112(d), 

may have incorrectly implied that the 

hospice medical director would be 

expected to furnish direct care to every 

patient. We have removed or revised 

these elements to reflect the fact that the 

hospice IDG, including its physician 

member, is required to fulfill the role 

originally designated for the hospice 

medical director. Now that these 

implications have been removed, it is 

not necessary to explicitly state that the 

hospice medical director is not required 

to furnish care to each patient. 

We proposed the provisions 

governing the role of nurse practitioners 

in hospice because the use of nurse 

practitioner services is prevalent in the 

hospice industry, and we have received 

numerous requests for this guidance for 

several years. Conversely, we are not 

aware of any need to address the role of 

physician assistants in hospice because, 

to our knowledge, physician assistant 

services are rarely used in hospices and 

are not recognized under the Medicare 

hospice benefit. We believe that there is 

no need to regulate services that are not 

used. 

We agree that we need to revise the 

proposed rule requiring hospice 

physicians to assume responsibility for 

the general medical needs of the patient. 

This responsibility could well be 

beyond the scope of hospice physician 

services and could conflict with the 

responsibilities of other physicians 

furnishing services for needs unrelated 

to the patient’s terminal illness and 

related conditions. Therefore, this 

proposed requirement has been 

removed. We have retained the 

requirement that, when the patient’s 

attending physician is not available, a 

hospice physician is responsible for 

meeting the patient’s medical needs. We 

do not believe that this requirement 

creates a conflict because it only applies 

when the attending physician is not 

available to perform his or her duties. 

Comment: Several commenters 

suggested that requirements for nurse 

practitioner services should be included 

in the same standard as those for 

physician services. Some of these 

commenters also suggested that the 

‘‘Physician services’’ standard should be 

renamed ‘‘Medical services.’’ In 

addition, some of these commenters 

suggested that the requirements for 

nurse practitioner services, as included 

under the physician services heading, 

should be expanded to govern the role 

of all advanced practice nurses. 

Response: Section 1861(dd) of the Act 

clearly delineates those services 

provided by physicians from those 

provided by nurses. We believe that the 

services of nurse practitioners fall 

squarely into the nursing services 

category, because they are services 

provided by nurses. We also believe 

that, as such, it is not appropriate to 

relocate the regulation governing the 

services of nurse practitioners from the 

nursing services standard to the 

physician services standard. Since we 

are not placing nurse practitioner 

services into the same standard as 

physician services, it is not necessary to 

rename the standard. We agree that it is 

appropriate to replace the term ‘‘nurse 

practitioner’’ as used in proposed 

§ 418.64(b), ‘‘Nursing services,’’ and we 

have replaced it with the broader term 

‘‘registered nurse.’’ If a registered nurse, 

including a nurse practitioner, advanced 

practice nurse, etc., is permitted by 

State law and regulation to see, treat, 

and write orders, then they may perform 

this function while providing nursing 

services for hospice patients. Hospices 

are free to use the services of all types 

of advanced practice nurses within their 

respective scopes of practice to enhance 

the nursing care furnished to patients. 

The Medicare Hospice per diem 

payment includes nursing costs. A 

Nurse practitioners cannot bill 

separately for care provided to Medicare 

hospice patients, except under very 

limited circumstances. Please refer to 

the Hospice chapter of the Medicare 

Benefit Policy Manual for additional 

instructions regarding coverage and 

payment policy. 

Comment: A commenter suggested 

that we remove the proposed 

requirement that the patient’s plan of 

care describe the role and scope of 

services provided by nurse 

practitioners. 

Response: We agree that it is not 

necessary to describe the role and scope 

of services provided by nurse 

practitioners separately from the role 

and scope of general nursing services in 

the patient’s plan of care. Therefore, we 

have removed this proposed 

requirement. We continue to expect that 

the role and scope of nursing services, 

including those provided by nurse 

practitioners and other advanced 

practice nurses, will be specified in 

each patient’s plan of care in accordance 

with final § 418.56(c)(2). 

Comment: A few commenters 

suggested that we should revise the 

requirements of proposed § 418.64(b)(3). 

Some of these commenters suggested 

that we should delete the requirement 

that, in order to contract for highly 

specialized nursing services, those 

services must be provided infrequently. 

The commenters believed that the term 

‘‘infrequently’’ was not specific. Other 


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commenters suggested that we should 

clarify that the contract for highly 

specialized nursing services is not 

required to be with another Medicarecertified hospice in order to differentiate 

this contracting requirement from the 

general core services contracting 

requirement. 

Response: Section 946(a) of the MMA 

amended 1861(dd)(5) of the Act by 

adding a new subparagraph (E). That 

subparagraph states, ‘‘A hospice 

program may provide services described 

in paragraph (1)(A) other than directly 

by the program if services are highly 

specialized services of a registered 

professional nurse and are provided 

non-routinely and so infrequently so 

that the provision of such services 

directly would be impracticable and 

prohibitively expensive.’’ We believe 

that this criterion, established by the 

MMA, is sufficient for hospices to assess 

whether or not they may contract for a 

highly specialized nursing service. If 

providing the nursing service through 

direct hospice employees is impossible 

and cost-prohibitive because the service 

is provided infrequently, and if the 

service requires highly specialized 

nursing skills, then the hospice may 

contract for the service. 

We do not believe that it is necessary 

to state that the contract for highly 

specialized nursing services need not be 

with another Medicare-certified hospice 

because we have revised the 

requirements for the general core 

services contract to permit hospices to 

contract with Medicare-certified 

hospices and non-hospice providers for 

core services under certain 

circumstances. Since hospices may 

contract with hospice and non-hospice 

providers for the general core services 

contract and for the highly specialized 

nursing skills contract, there is no need 

to differentiate between the two 

contracts. 

Comment: Several commenters 

suggested that we should revise 

proposed § 418.64(c), ‘‘Medical social 

services.’’ Many of these commenters 

suggested that we should remove the 

requirement that medical social services 

be provided under the supervision of a 

physician. Others suggested that 

medical social services should be 

provided under the direction of the 

hospice medical director or the IDG. 

Another commenter suggested that this 

standard should require social workers 

to have an MSW from an institution of 

higher learning that is accredited by the 

Council on Social Work Education. Still 

another commenter suggested that the 

scope of medical social services should 

be broadened. 

Response: Effective supervision of 

medical social services is essential for 

ensuring high quality care. Section 

1861(dd)(1)(C) of the Act requires 

hospices to provide ‘‘medical social 

services under the direction of a 

physician.’’ Since the Act specifically 

requires a physician to supervise 

medical social services, it is not 

appropriate to assign supervisory 

responsibility for medical social 

services to the IDG. It is also not 

appropriate to assign supervisory 

responsibility to the medical director 

because he or she may not necessarily 

be the physician member of the IDG 

assigned to the patient. The medical 

director, if he or she is not the physician 

member of the patient’s IDG, may not 

have sufficient knowledge about the 

patient’s care to effectively supervise 

the medical social services provided to 

that patient. 

In addition to effective supervision, it 

is essential that the individuals 

providing medical social services to 

hospice patients be qualified to provide 

these services. Section 418.114 

addresses the personnel qualifications 

that social workers must meet in order 

to provide services to hospice patients. 

We have addressed the commenter’s 

suggestion of requiring an MSW for 

social workers in the section addressing 

§ 418.114 in the preamble of this final 

rule. 

Supervision and qualifications both 

affect the scope of medical social 

services that are provided to patients. 

These services are required to be based 

on the needs of patients and families as 

those needs are identified through a 

thorough psychosocial assessment. 

Since the scope of services provided is 

directly tied to the needs of the patient 

and family, it is not possible to 

generically broaden their scope. Some 

patients and families may have limited 

social work needs, and should not be 

compelled to accept broader social work 

services that do not meet their needs. 

Comment: A commenter suggested 

that medical social services should be 

included in the counseling services 

standard because social workers 

perform counseling functions in 

hospices. 

Response: While social workers do 

perform counseling functions in 

hospices, their duties and 

responsibilities go beyond counseling. 

Therefore, it is not appropriate to place 

the requirements for social workers 

under the counseling services heading. 

Comment: Many commenters 

requested that we broaden the definition 

of ‘‘counseling services’’ to address the 

purpose of counseling services rather 

than naming precisely which types of 

counseling services are included in 

hospice. 

Response: ‘‘Counseling services’’ is a 

broad category of services that has 

undergone a change from the traditional 

physical and psychological 

interventions and now includes the use 

of alternative therapies (for example, art 

therapy, yoga therapy, massage therapy, 

and light therapy). These therapies are 

now frequently used to benefit hospice 

patients and their families. We 

encourage hospices to continue to 

explore and employ alternative 

counseling services. We have adopted 

the suggestion and have incorporated a 

broader description into the 

requirements for counseling services at 

§ 418.64(d). In the proposed rule we 

stated, ‘‘Counseling services for 

adjustment to death and dying must be 

available to both the patient and the 

family.’’ This final rule now states, 

‘‘Counseling services must be available 

to the patient and family to assist the 

patient and family in minimizing the 

stress and problems that arise from the 

terminal illness, related conditions, and 

the dying process.’’ We believe that this 

revised language reflects the broad 

nature of counseling services described 

by the commenters. 

Comment: Many commenters 

suggested that hospices should be 

permitted to provide certain specialized 

counseling services under contract, 

either by inserting a provision to allow 

such contracting or by relocating the 

counseling requirements to § 418.70, 

‘‘Furnishing of non-core services.’’

Commenters suggested that the contract 

services include dietary counseling 

provided by dietitians, art therapy and 

music therapy, to name a few. 

Response: Section 

1861(dd)(2)(A)(ii)(I) of the Act requires 

hospices to routinely provide 

substantially all core services, including 

counseling services to care for the 

terminally ill patient and to assist the 

patient in adjusting to his or her 

condition. The Act permits hospices to 

contract for counseling services as well 

as other core services, only under 

extraordinary or otherwise non-routine 

circumstances such as short-term 

staffing shortages, periods of peak 

patient loads, and travel of a patient 

outside of a hospice’s service area. 

Therefore, it is not appropriate to permit 

hospices to routinely contract for 

counseling services. 

Comment: Numerous commenters 

suggested changes to the proposed 

bereavement counseling requirement at 

§ 418.64(d)(1). One of these commenters 

suggested that hospices should be 

required to incorporate bereavement 

services into their daily patient care 


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services. Another commenter suggested 

that either education or experience in 

grief/loss counseling should be an 

appropriate qualification for the 

individual supervising the bereavement 

services program. Other commenters 

pointed out a distinction between 

offering and providing bereavement 

services. They suggested that hospices 

should only be required to offer 

bereavement services because they 

cannot provide such services to 

individuals who are unwilling to 

receive them. 

Response: We appreciate the general 

support received for the bereavement 

services requirement. We agree that 

bereavement counseling must be a daily 

hospice activity for each patient and 

family. To that end, we have revised the 

definition of the term ‘‘bereavement 

counseling’’ at final § 418.3 to require 

the services to be provided before and 

after the death of the patient. We also 

require hospices to complete an initial 

bereavement assessment as part of the 

comprehensive assessment, which must 

be completed within five days of the 

completion of the hospice election 

statement and certification form. 

Furthermore, as part of the 

comprehensive assessment, the 

bereavement assessment must be 

updated in accordance with § 418.56(d). 

We believe that these requirements will 

ensure that bereavement counseling is 

incorporated into patient care 

throughout the patient’s hospice stay. 

We also believe that it is necessary to 

ensure that the individual supervising 

this thorough bereavement program is 

appropriately qualified. We agree that, 

in addition to experience, education in 

grief/loss counseling is an appropriate 

qualification for the program supervisor. 

We have made this change in 

§ 418.64(d)(1)(i). 

We also appreciate the support that 

we received regarding bereavement 

services furnished within a SNF/NF or 

ICF/MR. As we stated in the proposed 

rule preamble, there are times when 

facility staff and residents fulfill the role 

of a patient’s family, providing caregiver 

services, being companions, and 

generally supporting the patient. We 

believe it is appropriate for a hospice to 

consider the bereavement needs of these 

individuals. However, we agree with 

commenters that requiring a hospice to 

offer bereavement services to facility 

staff may create a conflict between the 

hospice and the facility, which bears 

ultimate responsibility for its staff. 

Therefore, we have separated this 

requirement into two parts. A hospice 

may offer bereavement services to 

facility residents as identified in the 

patient’s plan of care. Additionally, a 

hospice must include a provision in its 

contract with a facility that addresses 

the offering of bereavement counseling 

to facility staff. Through this contractual 

provision, hospices and facilities can 

mutually agree upon a plan that meets 

the needs of the hospice, the facility, 

and the staff (see § 418.112(c)(9)). 

Additionally, we believe that the offer 

of bereavement services, as opposed to 

providing them, is the appropriate 

requirement for hospices to meet. 

Hospices cannot force bereavement 

services upon unwilling recipients; 

therefore, the bereavement plan of care 

is only able to state what services will 

be offered because it cannot predict 

what services will actually be accepted 

and provided. As such, we have revised 

§ 418.64(d)(1)(iv) to state that the 

hospice is to, ‘‘[d]evelop a bereavement 

plan of care that notes the kind of 

bereavement services to be offered and 

the frequency of service delivery 

* * *.’’

Comment: One commenter stated that 

the reference to ‘‘dietary counseling’’ in 

proposed § 418.74 is confusing because 

we use the term ‘‘nutritional 

counseling’’ in the proposed ‘‘Core 

services’’ requirement at § 418.64. 

Response: We agree with the 

commenter. Therefore to be consistent, 

we have amended the language at 

§ 418.64(d)(2) to require hospices to 

furnish ‘‘dietary counseling.’’

Comment: The majority of 

commenters that submitted comments 

concerning our proposed requirements 

for nutritional counseling supported the 

provision allowing nurses to furnish 

such counseling if appropriate. 

However, a small number of 

commenters suggested that hospices 

should be required to employ a 

registered dietitian to furnish this 

counseling. 

Response: In § 418.64(d)(2) hospices 

are required to assure that the dietary 

needs of the patient are met. If a nurse 

is capable of meeting the patient’s 

needs, then we believe that it is 

appropriate to permit the nurse to fulfill 

this task. However, if the needs of the 

patient exceed the knowledge and 

expertise of a nurse, we expect the 

hospice to have available an 

appropriately educated and trained 

individual, such as a registered dietitian 

or nutritionist, to meet the needs of the 

patient. We believe that this needsbased requirement, rather than a 

prescriptive requirement dictating the 

individuals that a hospice must employ 

for this service, will assure that patient 

needs are met and that hospices have 

the flexibility to structure their staff in 

the manner that meets their needs. 

Comment: While commenters 

generally supported the proposed 

requirement at § 418.64(d)(3) that 

hospices must assess a patient’s and 

family’s spiritual needs, and provide 

care to meet those needs in accordance 

with the patient’s and family’s 

acceptance of the hospice’s service, 

commenters expressed confusion 

regarding the statement that hospices 

are not required to go to extraordinary 

lengths to facilitate visits by individuals 

who can support the patient’s needs. 

Some of these commenters noted that 

spiritual counseling is often extremely 

important to patients and families and 

that hospices should try very hard to 

facilitate outside spiritual support. 

Other commenters stated that the phrase 

‘‘extraordinary lengths’’ is unclear and 

should be removed or replaced. Some of 

these commenters suggested that the 

requirement should read, ‘‘[t]he hospice 

must make all reasonable efforts to 

facilitate visits by local clergy, pastoral 

counselors * * *’’ or ‘‘[t]he hospice 

must facilitate visits by local clergy, 

pastoral counselors, or other individuals 

who can support the patient’s spiritual 

needs consistent with the patient’s and 

family’s wishes and the willingness of 

the designated counselors to respond.’’

Response: We agree that spiritual 

counseling is an essential hospice 

service for many patients and families, 

and that hospices should strive to 

facilitate visits and contacts by those 

spiritual supporters that the patient and 

family need. However, we realize that 

there is a limit to what hospices should 

be expected to do in order to facilitate 

such visits, as reflected by the proposed 

requirement that hospices are not 

required to go to extraordinary lengths. 

We replaced the proposed 

‘‘extraordinary lengths’’ requirement 

with a requirement that reasonable 

efforts must be made. This change 

continues to reflect the value of spiritual 

counseling without burdening hospices 

with unrealistic expectations. 

9. Condition of Participation: Nursing 

Services Waiver of Requirement That 

Substantially All Nursing Services Be 

Routinely Provided Directly by a 

Hospice (§ 418.66) 

The requirements for obtaining a 

nursing services waiver as provided by 

section 1861(dd)(5) of the Act is 

currently set forth in § 418.83, and 

remained virtually unchanged in the 

proposed rule. This condition provides 

hospices the opportunity to obtain a 

waiver from the requirement that 

substantially all nursing services be 

routinely provided directly by the 

hospice. The Act specifies that to obtain 

a waiver a hospice must be located in 


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an area that is not an urbanized area, 

must have been in operation on or 

before January 1, 1983, and must 

demonstrate a good faith effort to hire a 

sufficient number of nurse employees. 

Section 1861(dd)(5)(B) of the Act also 

specifies that if a waiver is requested by 

an organization that meets the statutory 

requirements and other provisions 

required by the Secretary, then the 

waiver will be deemed granted unless 

the request is denied within 60 days 

after the request is received by the 

Secretary. We proposed to maintain the 

existing requirement, as well as the 

regulatory timeframe that provides that 

waivers are effective for 1 year at a time, 

and that CMS may approve a maximum 

of two 1-year extensions for each initial 

waiver. 

Comment: A few commenters asked 

us to define ‘‘urban area.’’

Response: The statute at section 

8161(dd)(5)(a)(i) of the Act specifically 

references urbanized areas as defined by 

the Bureau of the Census. We refer the 

commenters to the Web site at 

HYPERLINK ‘‘http://www.census.gov’’. 

In addition, hospices may contact their 

fiscal intermediary or check the hospice 

wage index, which is updated and 

published yearly. 

Comment: Several commenters 

requested that the waiver language 

requiring a hospice to be in operation on 

or before 1983 be amended by requiring 

that hospices to be in operation a 

specific number of years in order to 

qualify. Commenters also asked that 

urban as well as rural hospices be 

eligible for the nursing waiver. 

Response: The nursing waiver 

language at § 418.66 tracks the statutory 

language and cannot be significantly 

changed absent a change in the statute. 

Therefore, we are unable to promulgate 

a regulation that would modify the 

requirements of this statutory provision. 

Comment: A few commenters stated 

that the waiver process described in 

proposed § 418.66 is complex, 

cumbersome and time-consuming. 

Other commenters urged CMS to 

streamline and simplify the process. 

One commenter asked that the waiver 

be deemed granted unless the request is 

denied within 30 days after it is 

received. Other commenters asked if it 

is CMS’ intent to limit the waiver for 

individual hospice programs to only 3 

years. 

Response: While we understand the 

waiver process may be at times a 

lengthy process, CMS is unable to 

change most of these statutorily based 

requirements. Changing the current 60- 

day timeframe to a 30-day timeframe 

would not allow the CMS Regional 

Office time to sufficiently review the 

waiver request. In the proposed rule, we 

specifically requested information on 

how frequently this waiver was being 

used. We heard back from very few 

hospices or other entities. All of those 

responding stated that they were not 

using this waiver. At the request of 

those commenters that requested 

clarification on the restriction of only 

two 1-year extensions, CMS has 

removed the first sentence in the 

requirement at § 418.66(d). We are not 

restricting the number of extensions a 

hospice can receive on its original 

waiver request. We believe that this will 

reduce the burden of requesting a 

waiver because hospices will no longer 

be required to submit a new waiver 

request every three years (original 

request + two 1-year extensions). 

Instead, a hospice can submit a single 

waiver request and an unlimited 

number of extensions as long as it 

continues to meet the waiver 

requirements. 

Comment: One commenter requested 

the waiver not impede a hospice from 

contracting with non-Medicare-certified 

hospices. Other commenters requested 

that CMS allow hospices to contract for 

continuous nursing care. 

Response: The proposed language at 

§ 418.66 does not specify with whom a 

hospice can contract, nor does it specify 

the level of nursing care for which 

contracts can be written. The purpose of 

the waiver was to allow hospices in 

rural areas, which were having 

difficulty hiring nurses, to have the 

ability to contract for overall nursing 

services. For a discussion of contracting 

for continuous nursing care, see the 

preamble language relating to core 

services at § 418.64 and existing 

regulations at 418.204 and 418.302. 

Comment: Some commenters 

confused the proposed § 418.66 with the 

nursing shortage exemption, which was 

implemented on October 14, 2004 and 

renewed on September 14, 2006 by CMS 

(S&C–05–02, www.cms.hhs.gov/ 

SurveyCertificationGenInfo/downloads/ 

SCLetter06–28.pdf). Other commenters 

stated that the proposed rule fails to 

recognize the national nursing shortage. 

Response: We understand that there 

may be some confusion about this 

nursing waiver at § 418.66, which is 

currently in regulations at § 418.83, and 

the nursing shortage exemption that has 

been in effect the past several years. The 

nursing waiver at § 418.66 is statutory 

and allows rural hospices in operation 

before 1983 the opportunity to obtain a 

waiver from the statutory requirement 

that substantially all nursing services be 

routinely provided directly by the 

hospice, thereby permitting such 

hospices to contract for nursing services 

if they meet the statutory requirements. 

The nursing shortage exemption 

implemented in 2004, and renewed in 

2006, permits all hospices that are 

having difficulty hiring nurses to apply 

for an exemption that allows the 

hospice to contract for nursing services. 

These two waivers are completely 

separate from one another. As noted, the 

nursing waiver is statutory and 

applicable only to hospices located in a 

nonurbanized area and in operation 

since 1983. By contrast, the nursing 

shortage exemption provides short-term 

relief to all hospices who qualify during 

this nursing shortage. 

Comment: One commenter requested 

that this waiver not be available to forprofit hospices, stating that ‘‘for-profit 

hospices are the fastest growing sector 

in the hospice industry, and there is no 

evidence that they need this waiver.’’

Response: The statute does not 

differentiate between for-profit or notfor-profit hospices. Therefore, this 

waiver applies to any hospice meeting 

the waiver requirements. We note that 

hospices must clearly demonstrate that 

they have made a good-faith effort to 

hire nurse employees before seeking a 

waiver. 

10. Condition of Participation: 

Furnishing of Noncore Services 

(§ 418.70) 

The current CoP governing non-core 

services is contained in § 418.90. We 

proposed to re-number the CoP and 

maintain its requirements, with slight 

language modifications. We also 

proposed to amend this CoP by adding 

language contained in § 418.50(b)(3) of 

the current rule, which states that noncore services must be provided in a 

manner consistent with current 

standards of practice. 

There were no comments received on 

this condition of participation. 

Therefore, we are finalizing it as 

proposed. 

11. Condition of Participation: Physical 

Therapy, Occupational Therapy, and 

Speech-Language Pathology (§ 418.72) 

Currently, the CoP concerning 

physical therapy, occupational therapy, 

and speech-language pathology is found 

at § 418.92(a). We proposed to recodify 

this CoP at § 418.72 without changes. 

This CoP requires hospices to make 

physical therapy, occupational therapy, 

and speech-language pathology services 

available to patients, and to ensure that 

these services are provided in a manner 

consistent with current standards of 

practice. 

Comment: Several commenters 

requested that we add dietary 

counseling provided by dietitians to the 


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list of non-core services (that is, 

physical therapy, occupational therapy, 

and speech-language pathology) 

included in proposed § 418.72. 

Response: Dietary counseling is seen 

as a core service, and therefore falls 

under the regulatory requirements 

proposed at § 418.64. Within § 418.64 

we have proposed that qualified 

individuals, including dietitians and 

nurses, may furnish dietary counseling, 

provided that it is within their scope of 

practice and expertise according to State 

law. Also within § 418.64, we allow 

hospices to contract with other 

Medicare-certified hospices and 

contracting agencies for core services 

under specific circumstances, such as 

extraordinary or other non-routine 

circumstances, unanticipated periods of 

high loads, and staffing shortages due to 

illness or other short-term temporary 

situations that interrupt patient care. 

Additionally, in § 418.74, we allow 

hospices located in non-urbanized areas 

to receive a waiver of the requirement 

that dietary counseling be provided 

directly pursuant to statutory 

authorization at 1861(dd)(5)(C). We 

believe that the staffing flexibility and 

waivers give hospices the flexibility to 

provide dietary counseling to all 

patients who require the service. 

12. Condition of Participation: Waiver of 

Requirement—Physical Therapy, 

Occupational Therapy, SpeechLanguage Pathology and Dietary 

Counseling (§ 418.74) 

We proposed a new CoP that would 

provide for a waiver of certain 

requirements. This CoP would establish 

authority to waive the requirement that 

eligible hospices must provide physical 

therapy (PT), occupational therapy (OT), 

and/or speech-language pathology (SLP) 

services as needed on a 24-hour basis as 

otherwise required by section 

1861(dd)(2)(A)(i). This CoP would also 

establish authority to waive the 

requirement that eligible hospices must 

provide dietary counseling services on a 

24-hour basis and/or that eligible 

hospices must routinely provide dietary 

counseling services directly through 

hospice employees. 

As in the case for a waiver of nursing 

services (proposed § 418.66), eligibility 

for a waiver is based on the primary 

location of a hospice. For a hospice that 

operates in multiple locations, its 

primary location is considered to be the 

location of its central office. This central 

office must be located in a nonurbanized area as determined by the 

Bureau of the Census. The hospice must 

provide evidence that it made a good 

faith effort (for example, copies of 

advertisements in local newspapers, 

documentation of competitive salaries 

and benefits, and evidence of recruiting 

activities) to hire a sufficient number of 

PTs, SLPs, OTs, and dietary counselors 

to provide services directly through 

hospice employees or under 

arrangement on a 24-hour as needed 

basis. 

Comment: Several commenters 

supported the optional waiver for PT, 

OT, SLP and dietary services, but one 

commenter stated that these services are 

so critical that it seemed inappropriate 

to provide a waiver. 

Response: We agree that these can be 

very valuable services for the care of the 

hospice patient. However, we do not 

believe that these services need to be 

offered as needed on a 24-hour basis if 

the 24-hour requirement places an 

undue burden on rural hospices. 

Because of the scarcity of those 

professionals in non-urbanized areas, 

we believe the option for a waiver is 

appropriate. We also note that the 

waiver conditions are statutory. 

Comment: A few commenters 

requested that we consider allowing 

hospices located in urban areas the 

waiver option as well. 

Response: As noted above, this waiver 

language, like the nursing waiver option 

at proposed § 418.66, is statutory. We 

are unable to promulgate a regulation 

that would contravene the statutory 

provision. 

Comment: One commenter asked if it 

is our intent to limit the waiver for 

individual hospice programs to only 

three years. 

Response: As proposed, a hospice 

would have been required to submit an 

original waiver request. The hospice 

could then request up to two extensions 

on the original request. Once those two 

extensions expired, the hospice would 

have been required to submit another 

original waiver request. Thus, while the 

proposed requirement did not limit a 

hospice to receiving a waiver for three 

years in total, it did require a hospice to 

submit substantially more paperwork 

once every three years in the form of an 

original waiver request. We believe that 

it is not necessary to require an original 

waiver request every three years. 

Therefore, we have removed the first 

sentence in the proposed requirement at 

§ 418.74(d). We are not restricting the 

amount of extensions a hospice may 

receive to the original waiver request. 

Comment: One commenter requested 

that this waiver not be available to forprofit hospices, stating that ‘‘for-profit 

hospices are the fastest growing sector 

in the hospice industry, and there is no 

evidence that they need this waiver.’’

Response: The statute does not 

differentiate between for-profit or notfor-profit hospices. Therefore, this 

waiver applies to any hospice meeting 

the waiver requirements. We believe 

that the criteria set out at 

1861(dd)(5)(C)(ii) of the Act will ensure 

that waivers are granted only on an asneeded basis. 

13. Condition of Participation: Hospice 

Aide and Homemaker Services 

(§ 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, which incorporates by 

reference the home health aide 

requirements of the home health agency 

CoPs at § 484.36. We proposed in 

§ 418.76 to use most of the substance of 

the requirements of § 484.36. The home 

health aide CoP establishes that a home 

health aide must complete a Stateestablished or other training program, 

and in § 418.76(b) we outline the 

requirements that this training must 

meet, which are similar, but not 

identical to, the provisions of § 484.36. 

In § 418.76(e) and § 418.76(f) we outline 

requirements for the individuals and 

organizations eligible to provide the 

aide training. 

We proposed that three standards be 

particularly adapted for the hospice 

conditions of participation. First, 

§ 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 no less frequently than every 28 

days while the home health aide is 

providing care. This in-person 

supervisory visit would need to be 

conducted with at least one patient to 

whom the aide is providing services at 

the time. Thorough supervision of home 

health aides is crucial to ensuring that 

the patient’s and family’s needs are 

being met, and conducting supervisory 

visits when the aide is performing his or 

her duties is a key way to provide 

thorough supervision. Onsite 

supervisory visits will still be required 

every 14 days, as in the current rule at 

§ 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 


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all patients receiving home health aide 

services were having their needs met by 

these services. 

Second, proposed § 418.76(j), 

‘‘Homemaker qualifications,’’ was 

adapted from the existing § 418.94. The 

proposed standard would define a 

qualified homemaker as a home health 

aide, as described in § 418.76, or an 

individual who 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, 

as noted in § 418.202(g), may include 

assistance in maintenance of a safe and 

healthy environment to enable the 

patient to benefit from care that is 

furnished. 

Finally, § 418.76(k) would require a 

member of the IDG to coordinate 

homemaker services, and supply 

instructions for the homemaker on 

duties to be performed. The homemaker 

would be required to report all concerns 

about the patient or family to the 

member of the IDG who was 

coordinating the homemaker services. 

We have proposed these changes to 

ensure proper training and supervision, 

and to protect the quality of the 

homemaker services provided. 

Comment: Numerous commenters 

suggested that we should change the 

term that we use to refer to aides who 

furnish hospice care. Commenters 

suggested that the phrase ‘‘nursing 

aide’’, ‘‘certified nursing assistant’’, or 

‘‘hospice aide’’ be used instead of the 

phrase ‘‘home health aide.’’

Response: We agree that it is 

appropriate to re-name aides who 

furnish hospice care in order to 

differentiate them from aides who 

furnish care in other environments. 

Therefore we have adopted the term 

‘‘hospice aide’’ as best describing that 

role. 

Comment: A commenter suggested 

that all of the hospice aide requirements 

(that is, training, education, and 

supervision) should be replaced by 

those for nurse aides, as described in 42 

CFR part 483, which sets out standards 

for long term care facilities. 

Response: We agree that nurse aide 

training and education in accordance 

with § 483.151 through § 483.154 is an 

appropriate qualification for hospice 

aides, and we have incorporated these 

provisions at new § 418.76(a)(1)(iii). 

However, we do not believe that the 

supervision requirements for nurse 

aides in long term care facilities meet 

the needs of hospices, whose hospice 

aides furnish care in the community 

rather than in a self-contained facility. 

Therefore, we are not adopting the 

supervision requirements from part 483. 

Comment: Many commenters 

suggested that, in order to adapt the 

requirements of the home health aide 

regulations to the hospice regulations, 

we should replace all references to 

home health agencies with references to 

hospice agencies. Several commenters 

singled out the reference to home health 

agencies in proposed § 418.76(f), 

‘‘Eligible training organizations,’’ which 

prohibits certain home health agencies 

from training aides, as a place where a 

reference to hospice agencies should be 

substituted. 

Response: We agree that, throughout 

most of this CoP, references to home 

health agencies should be replaced with 

references to hospice agencies, and we 

have made these changes. However, in 

§ 418.76(f), we are unable to substitute 

hospices for home health agencies. The 

provisions of standard (f) come directly 

from Section 1891(a)(3) of the Act. 

Therefore, certain home health agencies 

must be prohibited from providing aide 

training. Hospices, however, are not 

prohibited from providing aide training, 

even if they meet the exclusion criteria 

established for home health agencies. 

Although hospices are not excluded 

from providing training, we caution all 

hospices to ensure that training 

furnished by other providers meets all 

of the requirements of this rule and is 

of the highest quality. It is essential that 

aides be well trained to perform their 

patient care duties. 

Comment: A commenter suggested 

that hospice aides should be required to 

be certified in hospice and palliative 

nursing assistant care. 

Response: Hospices are free to require 

their hospice aides to be certified in 

hospice and palliative care. However, 

this certification goes beyond the 

standards of aide education and training 

that are currently in place for other 

provider types and is uncommon within 

the hospice industry. Requiring such 

certification for all hospice aides 

nationwide would likely result in a 

shortage of qualified aides, which 

would negatively impact patient care 

and outcomes. For these reasons, we are 

not adding this suggested requirement. 

Comment: A commenter suggested 

that, in the first sentence of § 418.76(c), 

we should add the word ‘‘aide’’ to state 

that ‘‘an individual may furnish home 

health aide services on behalf of a 

hospice * * *.’’

Response: We agree that adding the 

term ‘‘aide’’ will clarify our intent, and 

we have made this change. In this 

section, the term ‘‘home health aide’’

has been replaced by the term ‘‘hospice 

aide’’. 

Comment: Many commenters 

suggested changes to our proposal at 

§ 418.76(e) that would require the 

registered nurse who provides or 

supervises hospice aide training to have 

at least two years of nursing experience, 

one of which must be in home health 

care. The commenters suggested that the 

term ‘‘home health’’ be replaced with 

the term ‘‘hospice’’. 

Response: We agree that experience in 

hospice care is an appropriate source of 

knowledge for a registered nurse to 

perform or supervise practical training 

for hospice aides. We replaced the term 

‘‘home health’’ with the term ‘‘home 

care,’’ which is used broadly in this 

standard and encompasses both home 

health care and hospice care. We believe 

that this fulfills the commenters’ request 

without limiting the opportunity for the 

registered nurse to gain the necessary 

experience. 

Comment: Numerous commenters 

made suggestions regarding the 

proposed requirement at § 418.76(g)(2) 

that aide services must be ordered by a 

physician or nurse practitioner and 

included in the plan of care. 

Specifically, some commenters 

suggested that the IDG as a whole, of 

which the physician is a member, 

should be allowed to order hospice aide 

services. Other commenters supported 

our proposal to allow both nurse 

practitioners and physicians to order 

hospice aide services. Still other 

commenters suggested that the 

frequency and scope of aide services 

should not need to be detailed, as is 

required of all other services contained 

in the plan of care. A single commenter 

suggested that the proposed provisions 

regarding hospice aide assignments and 

duties should only apply in the absence 

of State requirements. 

Response: While we appreciate the 

support for our proposal that a nurse 

practitioner or physician must order 

hospice aide services, we agree that the 

IDG as a whole may order hospice aide 

services because physicians and nurse 

practitioners are already active members 

of the IDG. When ordering hospice aide 

services, we believe that it is necessary 

to detail the scope and frequency of 

such services. The purpose of the order, 

as included in the plan of care, is to 

provide a comprehensive map of which 

disciplines are providing which services 

at which time(s). Without such detailed 

information there is a lack of clarity that 

may compromise patient and family 

care. Therefore, we are keeping the 

detailed scope and frequency 

requirements. 

Comment: Many commenters 

requested clarification about what 

duties hospice aides are permitted to 


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perform. The commenters were 

particularly interested in proposed 

§ 418.76(g)(3)(iv), which would permit 

hospice aides to provide assistance in 

administering medications that are 

ordinarily self-administered. Some 

commenters wanted to know how to 

determine which medications are 

ordinarily self-administered, while 

other commenters noted that the 

hospice aide training requirement at 

proposed § 418.76(b) does not require 

aides to be trained in medication 

administration. Related to these 

comments on aide training are 

commenters who sought clarification on 

the proposed requirements of 

§ 418.76(g)(2)(iv), which stated that 

aides may only furnish services that are 

consistent with their aide training. Still 

other commenters suggested that 

medication administration requirements 

should defer to State laws. 

Response: Section 418.106 of this rule 

requires hospices to evaluate a patient’s 

and family’s ability to safely administer 

medications. This requirement is 

present because various factors may 

interfere with a patient’s ability to safely 

adhere to a medication regimen. 

Allowing hospice aides to help 

administer those medications that 

patients are typically allowed to 

administer to themselves, if they are 

competent to do so, allows hospices to 

meet the medication needs of patients 

and caregivers who are not capable of 

safely self-administering medications. 

Assistance in medication administration 

may consist of helping a patient with 

hand tremors apply or remove a 

medication patch or any number of 

other similar tasks. Allowing aides to 

fulfill this role may decrease the 

demand for nursing visits for the 

purpose of medication maintenance, 

thus allowing nurses to provided 

services where needed. 

Determining those medications that 

are appropriate for aides to help 

administer is the decision of the IDG, 

based on the needs of the patient and 

family, the training of the aide, the 

policies of the hospice, and any 

applicable State and local laws and 

regulations. We do not require all 

hospice aides to be trained in 

medication administration because not 

all hospices will choose to have aides 

perform this task. Section 418.116 of 

this rule requires hospices to comply 

with all health and safety related State 

and local laws and regulations. State or 

local rules may very well prohibit 

hospice aides from administering 

medication. However, if medication 

administration is within the bounds of 

State and local rules, and if hospices do 

choose to have aides perform this task, 

§ 418.76(b)(3)(xiii) requires those 

hospices to provide aide training for any 

other task that an aide is expected to 

perform, which would include 

medication administration. This, in 

conjunction with the requirement at 

§ 418.76(g)(2)(iv), that aide services 

furnished must be consistent with 

hospice aide training, effectively 

requires medication administration 

training for those aides who are charged 

with assisting patients in administering 

medications that are ordinarily selfadministered. 

Comment: Some commenters 

suggested that we should replace the 

proposed hospice aide supervision 

requirements with the supervisory 

requirements for home health aides 

found in the home health regulations at 

§ 484.36. Commenters also suggested 

that we should replace the every-14-day 

supervisory visit requirement, which 

was designed to ensure the adequacy 

and appropriateness of aide services for 

each hospice patient, with a 

requirement that the RN should review 

the patient’s plan of care with the aide 

at least every 60 days, and as needed. 

These commenters stated that 

supervising the aide every 14 days, as is 

currently required in the existing 

hospice regulations, is overly 

burdensome. Other commenters 

explicitly supported the 14 day 

supervision requirement. 

Response: We appreciate the support 

for this requirement among some 

commenters. We believe that 

supervising the aide every 14 days to 

ensure that aide services are adequate 

and appropriate for each hospice patient 

is appropriate, given the length of time 

that most hospice patients receive 

hospice services. Many hospice patients 

die within a few weeks of beginning 

hospice services. If we were to extend 

the supervision timeframe, the 

extension would likely result in no 

supervisory visits occurring between the 

time the patient begins receiving 

hospice care and the time the patient 

passes away (for example, a hospice 

patient begins receiving aide services on 

day three and passes away on day 24, 

without ever receiving an aide 

supervisory visit to assess the adequacy 

and appropriateness of the aide care 

provided). This lack of supervision 

would in no way benefit patients and 

families. In addition, this lack of 

supervision would likely not help 

hospices because they would remain 

completely unaware of the quality and 

adequacy of the aide services they were 

providing. This could lead to an overor under-use of aide services, low 

quality aide services, patient and family 

dissatisfaction, and a wide variety of 

other negative outcomes that hospices 

wish to avoid. In short, we believe that 

adequate frequent supervision benefits 

patient and hospices alike, and the 

requirement remains in this final rule. 

Comment: A commenter suggested 

that all hospice aide supervision 

requirements should be removed in 

favor of outcome and patient 

satisfaction measures and performance 

improvement projects when measures 

indicate inadequate performance in aide 

services. Another commenter suggested 

that all hospice aide supervision 

requirements should be removed 

because hospices are already required 

by § 418.76(b) and § 418.76(c) to ensure 

that hospice aides are trained and that 

competency evaluations are completed. 

Response: We are not deleting these 

requirements for two reasons. First, 

while hospice aide training and 

competency evaluations ensure that 

aide skills are adequate upon hiring or 

initial training, they do not ensure that 

those same skills remain adequate as 

time passes. We believe that aide skills 

should be continuously reexamined to 

ensure competency at all times. Second, 

hospice quality and outcome measures 

have not yet reached the point where 

there is consensus on a single set of 

measures that have been thoroughly 

tested and determined to be valid, 

reliable, and widely applicable. As 

quality and outcome measures continue 

to evolve we will consider this 

suggestion. Nonetheless, hospices may 

use an outcome measure that targets 

aide services as part of their QAPI 

program, however the measure could 

not replace aide supervision. Outcome 

measures and supervision can and 

should work together, rather than 

replace each other, in order to enhance 

the quality of the service provided, 

patient outcomes, and patient 

satisfaction. 

Comment: A few commenters 

requested clarification about the nursing 

personnel who may function as hospice 

aide supervisors. One commenter 

suggested that licensed vocational 

nurses (LVNs) and licensed practical 

nurses (LPNs) should be permitted to 

supervise hospice aides. Another 

commenter suggested that any nurse 

should be permitted to supervise a 

hospice aide, rather than having a 

designated nurse supervise a specific 

hospice aide’s care of a patient. 

Response: Registered nurses (RNs) 

have the education and training to 

adequately supervise hospice aide 

services. In addition to ensuring that 

hospice aides furnish the care identified 

in the plan of care, nurse supervisors 

must be able to assess the adequacy of 

the aide services in relationship to the 


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needs of the patient and family. 

Registered nurses possess the 

assessment skills necessary to fulfill this 

function to a greater degree than LVNs 

and LPNs, which makes registered 

nurses uniquely qualified to fulfill the 

hospice aide supervisory position. 

In addition to having the necessary 

assessment skills, it is important that 

registered nurses have a relationship 

both with the aide being supervised and 

the patient receiving the aide’s services. 

Ideally, the RN responsible for 

supervising the aide is the RN chiefly 

responsible for the patient’s nursing 

care. This allows the RN to develop a 

complete picture of the patient and 

family and of the aide’s services. For 

this reason, we believe that it is 

necessary for hospices to identify a 

specific RN who will serve as the aide’s 

supervisor during the care of a specific 

patient. We understand that, at times, it 

is necessary to use other RNs to fill-in 

and supervise aide services. If a 

substitute supervising RN is used, this 

should be noted. 

Comment: A large number of 

commenters expressed concern about 

our proposal in § 418.76(h) to allow 

therapists to supervise hospice aides. 

Some commenters sought clarification 

regarding the exact meaning of the term 

‘‘qualified therapist.’’ Other commenters 

suggested that therapists should only be 

allowed to supervise hospice aides 

when aides are furnishing delegated 

therapy services. Still others suggested 

that only nurses be allowed to supervise 

hospice aides. 

Response: We proposed to allow 

hospices to use therapists to supervise 

home health aides in order to provide 

more flexibility in meeting the every-28- 

day in-person supervisory visit 

requirement discussed later. We have 

changed the 28-day timeframe, thereby 

alleviating many of the related 

supervisory demands. For this reason, 

we believe that it is no longer necessary 

to allow therapists, who are not 

routinely involved in the care of most 

hospice patients, to supervise hospice 

aides. Thus, the term ‘‘therapist’’ has 

been deleted from this standard, as well 

as this CoP. 

Comment: A commenter suggested 

that the every-14-day supervisory visit 

could be conducted through a telephone 

contact with the patient or family, rather 

than through a visit to the patient’s 

home. 

Response: In-person visits by the 

supervising nurse to the patient’s home 

allow the nurse directly to observe the 

patient and the results of the aide’s care. 

Telephone contacts do not allow the 

nurse to see if the patient has been 

bathed, and patients may be hesitant to 

report these failures of duty to nurses 

for any number of reasons. In-person 

home visits simply provide nurse 

supervisors with more information than 

telephone contacts do. 

Comment: A commenter suggested 

that we should clarify the purpose of the 

every-14-day supervisory visit required 

by § 418.76(h), to state that the visit is 

designed ‘‘to assess the quality of care 

and services provided’’ by the aide. 

Response: We agree that clarifying the 

intent of the every-14-day supervisory 

visit will be helpful to hospices. We 

have added language at § 418.76(h)(1)(i) 

to reflect the intent of the suggestion. In 

addition, we have added a statement 

that the every-14-day supervisory visit 

is also meant to ensure that the services 

ordered by the hospice are sufficient to 

meet the patient’s needs. 

Comment: Numerous commenters 

submitted suggestions on the proposed 

every-28-day timeframe for in-person 

supervision of hospice aides at 

§ 418.76(h). Although some commenters 

expressed support for the 28-day 

supervision requirement, most 

suggested that the 28-day timeframe be 

changed to every 60 days, every quarter, 

every 6 months, every 12 months, or 

even every 24 months. Some 

commenters also suggested that the inperson supervision requirement be 

deleted in its entirety. 

Response: We believe that all hospice 

employees, including hospice aides, 

must be supervised. To ensure that 

aides are adequately supervised, we 

proposed that each aide would be 

supervised while he or she is furnishing 

care to a patient for the purpose of 

observing the aide’s skills. In addition, 

we proposed that this in-person 

supervision would occur at least every 

28 days. After reviewing the comments 

that we received, we agree that assuring 

aide skill competency 12 times per year 

is not necessary. In keeping with our 

desire to maintain consistency with the 

aide requirements in the home health 

regulations, we have changed the inperson supervisory visit timeframe from 

once every 28 days to once annually per 

aide. 

At the same time, we have added a 

new requirement at § 418.76(h)(1)(ii) 

that requires hospices to conduct inperson supervisory visits to observe and 

assess aide skills if a potential 

deficiency in care furnished by the aide 

is noted in the regular 14-day 

supervisory visit (during which the aide 

is not required to be present). We 

believe that linking more frequent inperson supervisory visits to the actual 

performance of the aides will ensure 

that aides furnish quality care and that 

hospices have the flexibility to 

supervise their staff in a manner that 

meets their needs. 

Comment: A few commenters 

suggested that the aide in-person 

supervision visit (proposed as occurring 

every 28 days and finalized as occurring 

annually) should be documented in the 

aide’s personnel record, rather than in 

the patient’s clinical record. 

Response: We agree that the aide’s 

personnel record is an appropriate place 

to document the annual in-person 

supervisory visit. Hospices may 

determine the appropriate location to 

document the annual aide evaluation in 

accordance with their own policies and 

procedures. 

Comment: Many commenters 

expressed confusion about the in-person 

supervisory visit to observe the aide 

furnishing care. Commenters wanted to 

know whether the observation visit 

needed to be conducted with each 

patient that the aide is caring for, or 

whether the observation visit only 

needed to be conducted with a single 

patient that the aide is caring for. The 

commenters noted that conducting an 

observation visit with each patient that 

the aide is caring for would be difficult 

to schedule and cost-prohibitive. 

Response: The intent of the proposed 

rule was to require an observation once 

every 28 days with a single patient that 

the aide was caring for at the time of the 

visit. In response to public comments, 

we changed the timeframe for the 

observation visit from once every 28 

days to once annually. In addition, we 

have changed the phrasing of this 

requirement to more clearly state our 

intent for only a visit to a single 

patient’s home. The revised requirement 

at § 418.76(h)(2) states, ‘‘A registered 

nurse must make an annual on-site visit 

to the location where a patient is 

receiving care in order to observe and 

assess each aide while he or she is 

performing care.’’ We believe that ‘‘a 

patient’’ is clearer than the language we 

originally proposed, ‘‘the patient.’’ We 

are not requiring that the aide be 

supervised with each patient annually 

to evaluate the aide’s proficiency. 

Comment: Many commenters 

addressed the relationship between 

hospice aide services, hospice 

homemaker services, and Medicaid 

personal care benefits. Specifically, 

commenters suggested that we should 

state in the regulation text that hospice 

aide and homemaker services are not 

24-hour-a-day primary caregiver 

services and are not meant to replace 

personal care aide services covered 

under Medicaid or other insurers. 

Commenters also suggested that we 

should clarify the relationship between 

the hospice and personal care aides by 


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stating that hospices may use the 

personal aides in implementing the plan 

of care only to the extent that the 

hospices would routinely use the 

services of a patient’s family in 

implementing the plan of care. 

Furthermore, commenters suggested 

that hospices should be required to 

coordinate their services with those 

furnished by personal care aides. 

Response: We understand that there 

may be confusion relative to the 

interaction between the Medicaid 

personal care aide benefit and the 

hospice benefit. The Medicaid personal 

care benefit is designed to assist eligible 

Medicaid beneficiaries with daily 

personal care tasks such as household 

chores and personal hygiene. The 

hospice aide and homemaker services 

covered under the Medicare hospice 

benefit cover many of the same tasks. 

However, hospice aide and homemaker 

services are not necessarily meant to be 

daily services, and are certainly not 

meant to be 24-hour daily services. 

Hospices are neither expected to nor 

prohibited from fulfilling the caregiver 

role for a patient. Rather, hospice aide 

and homemaker services are provided to 

supplement the primary caregiver(s). 

Since there may be occasions where a 

patient receives services through a 

personal care aide benefit while 

receiving hospice services, we agree 

with the commenters that this rule 

should address the responsibilities of 

the hospice for coordinating the care 

provided by hospice personnel and the 

Medicaid personal care aide. We have 

added new elements to address this, 

§ 418.76(i)(2) and § 418.76(i)(3). Section 

418.76(i)(2) provides that services 

furnished by the Medicaid personal care 

benefit may be used to the extent that 

the hospice would routinely use the 

services of a hospice patient’s family in 

implementing a patient’s plan of care. 

Section 418.76(i)(3) requires that a 

hospice coordinate hospice aide and 

homemaker services with the services 

furnished by the Medicaid personal care 

aide benefit to ensure that patients 

receive all the services that they require. 

Comment: Numerous commenters 

requested clarification of the 

requirements at proposed § 418.76(j), 

Homemaker qualifications. The 

commenters interpreted the proposed 

standard to mean that only those 

individuals who have completed 

hospice aide training are considered 

qualified to function as homemakers. 

The commenters disagreed with this 

policy and stated that orientation to 

hospice care should be sufficient for 

homemakers. 

Response: In § 418.76(j) we proposed 

that a homemaker be either an 

individual who has completed aide 

training or an individual who has 

successfully completed hospice 

orientation addressing the needs and 

concerns of patients and families coping 

with a terminal illness. We believe that 

the commenters misinterpreted this 

requirement, and that the 

misinterpretation led to a great deal of 

confusion. We agree with the 

commenters that homemakers do not 

need to complete hospice aide training 

in order to be qualified, which is why 

we proposed that hospice orientation is 

sufficient. We do not agree that hospice 

aide training should be completely 

removed from this standard. If an 

individual has completed hospice aide 

training, he or she should not be 

prevented from serving as a homemaker. 

Indeed, hospice aide training provides 

an extra level of education and training 

that would go above and beyond 

hospice orientation. In order to clarify 

our intent in this standard, we have 

reformatted it to place hospice 

orientation as the first option for 

homemaker qualifications and hospice 

aide training as the second option for 

homemaker qualifications. We believe 

that this reformatting will make it 

clearer that either qualification is 

acceptable. 

Comment: A commenter asked 

whether or not hospices are permitted to 

contract for homemaker services. 

Response: Section 

1861(dd)(2)(A)(ii)(I) of the Act requires 

hospices to provide substantially all 

nursing, medical social, and counseling 

services through direct employees. 

Homemaker services do not fall into any 

of these categories; therefore hospices 

may contract for homemaker services. If 

hospices choose to contract for 

homemaker services, then the 

professional management responsibility 

requirements of § 418.100(e) will apply. 

We believe that this question may have 

been prompted by a requirement in 

proposed § 418.76(h)(4) regarding 

contracting for hospice aide services. 

The inclusion of specific requirements 

for aide contracting, and the omission of 

requirements for homemaker 

contracting, seemed to imply that 

homemaker contracting would not be 

allowed. We have removed the aide 

contracting provision at § 418.76(h)(4) 

in order to remove any implication that 

homemaker services may not be 

contracted. 

Comment: A commenter suggested 

that we should explicitly state that 

homemakers can be volunteers. 

Response: Volunteers are permitted to 

fulfill many roles in hospice care, 

including providing homemaker 

services, provided that the volunteers 

meet all qualifications and personnel 

requirements established by this rule. 

We do not believe that it is necessary to 

explicitly state in this standard that 

volunteers may function as 

homemakers. We believe that making 

this statement may unintentionally 

imply that volunteers may not function 

in other capacities within a hospice 

program. The implication would 

negatively impact the role of volunteers 

in hospice and may affect the level of 

volunteer services that hospices furnish. 

Comment: A commenter sought 

clarification about who is responsible 

for supervising homemaker services. 

Response: We agree that this rule 

should explicitly require such 

supervision. We have added a provision 

at § 418.76(k)(1), stating that the 

member of the patient’s IDG group who 

is responsible for coordinating 

homemaker services must also be 

responsible for supervising those 

services. 

14. Condition of Participation: 

Volunteers (§ 418.78) 

The current CoP for volunteers is 

located at § 418.70. We proposed to 

recodify this CoP at § 418.78 with minor 

changes. We proposed to remove the 

existing § 418.70(f), regarding the 

availability of clergy, because the role of 

the pastoral, clergy, or other spiritual 

counselor would be described as part of 

the IDG at proposed § 418.56(a)(1)(iv). 

This change would not preclude the 

hospice from continuing to use or 

starting to use clergy as volunteers. We 

did not propose any changes to the 

requirements to document cost savings 

and to maintain a sufficient level of 

volunteer activity. 

Comment: A few commenters 

suggested that we should remove the 

term ‘‘day to day’’ from the proposed 

§ 418.78(b). The commenters stated that 

removing the phrase would permit 

hospices to use volunteers for special 

events that occur infrequently. 

Response: The phrase ‘‘day-to-day,’’

as used, requires hospices to incorporate 

volunteer services into their daily 

patient care and operations routine in 

order to retain the volunteer-based 

essence of hospice as it originated in the 

United States. The phrase does not 

preclude hospices from using volunteer 

services for special events or nonroutine occurrences. Hospices must use 

volunteers for day-to-day services, and 

may use volunteers for other services as 

well. 

Comment: Some commenters asked us 

to clarify that volunteer time spent in 

training, orientation, travel, direct 

patient care, and administrative services 

may be included when documenting the 


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cost savings that the hospice achieves 

through the use of volunteers. 

Response: Section 1861(dd)(2)(E)(ii) 

of the Act requires hospices to maintain 

records on the cost savings achieved 

through the use of volunteers. That is, 

hospices must document those hours 

that volunteers furnished care and 

services for which a hospice would 

otherwise have been required to pay its 

employees to furnish such care and 

services. If a hospice is training and 

orienting volunteers, it is most likely 

using its paid employees to do so. 

Therefore, no cost savings is achieved. 

However, if a hospice does pay an 

employee for time spent traveling for 

direct patient care and administrative 

purposes, and does not compensate a 

volunteer for the time, then it may 

include the volunteer’s travel time, 

direct patient care and administrative 

services in its documentation of the cost 

savings it achieves. Likewise, hospices 

may document the time that volunteers 

actually spend providing direct patient 

care and administrative services, 

because hospices would compensate 

paid employees for the time spent 

performing these duties. We note that 

travel time is not the same as direct 

patient care. Following publication of 

this final rule, we will issue further subregulatory guidance addressing the 

manner in which the cost savings needs 

to be calculated and documented. 

Comment: Several commenters 

requested clarification about what 

volunteer hours may be included in 

calculating the level of volunteer 

activity within a hospice, as required by 

proposed § 418.78(e). Commenters 

specifically suggested that time spent 

traveling, providing care or services, 

documenting, and phoning patients 

should be included in the level of 

volunteer activity calculation. 

Response: We understand that 

traveling, providing care or services, 

documenting information, and calling 

patients all consume volunteer time, 

and we agree that the time may be used 

in calculating the level of volunteer 

activity in a hospice. If a hospice 

chooses to include any of these areas 

that are directly related to providing 

direct patient care or administrative 

services in its percentage calculation of 

volunteer hours, it must ensure that the 

time spent by its paid employees and 

contractors for the same activity is also 

included in the calculation. That is, if 

a hospice chooses to count the hours 

spent by volunteers traveling to and 

from patient homes in its calculation of 

the numerator, it must count the hours 

spent by its paid employees and 

contractors in traveling to and from 

patient homes in its calculation of the 

denominator. In this way, hospices will 

be able to accurately assess the 

proportion of volunteer hours to paid 

staff and contractor hours. Upon 

issuance of this final rule, we will issue 

sub-regulatory guidance to reflect the 

potential inclusion of certain volunteer 

hours in the overall calculation. 

Comment: Some commenters 

suggested that hospices should only be 

required to provide volunteer hours 

equal to five percent of the routine 

home care level of care hours furnished 

to patients. Commenters stated that this 

would be easier for hospices to comply 

with because providing direct inpatient, 

respite, or continuous home care 

accounts for a substantial number of 

paid staff hours. Eliminating the hours 

spent providing direct inpatient, respite, 

or continuous home care would 

decrease the number of hours in the 

denominator, thereby altering the ratio 

of volunteer hours to paid hours. Other 

commenters suggested that the five 

percent goal should be completely 

eliminated. 

Response: Section 1861(dd)(2)(E)(i) of 

the Act requires the Secretary to ensure 

a continuing level of effort to use 

volunteers in providing care and 

services to hospice patients. In addition 

to serving as companions, homemakers 

and administrative staff, volunteers 

often serve as medical directors, nurses, 

alternative counselors, and spiritual 

advisors. All of these services, when 

provided by volunteers, count toward 

the five percent goal. Since we permit 

hospices the flexibility to use volunteers 

to function in such a wide variety of 

roles within hospices, we do not believe 

that it is necessary to artificially lower 

the standard for achieving continual 

volunteer use in hospice by eliminating 

the hours spent by hospices furnishing 

direct inpatient, respite, or continuous 

home care. Additionally, we note that 

hospices have not historically failed to 

meet the five percent requirement, as 

this is not a frequently cited deficiency 

during hospice surveys conducted by 

the State survey agencies. 

Comment: A commenter asked us to 

define the role of a hospice volunteer. 

Response: Hospice volunteers are 

permitted to fill any role within the 

hospice, provided that the volunteer 

filling the role meets the appropriate 

qualifications of this rule and any other 

applicable State and local requirements 

(for example, State licensure). Since 

volunteers may be used in any role, 

there is no one volunteer role that can 

be defined in this rule. Any definition 

may unintentionally limit a hospice’s 

use of volunteer services, thus 

compromising its ability to comply with 

the requirements of this rule. 

Comment: Some commenters 

suggested that board certified chaplains 

should be required to train and 

supervise hospice volunteers. 

Response: Hospices are responsible 

for ensuring that volunteers are trained, 

oriented, and supervised. While a 

designated employee must supervise 

volunteers, their training and 

orientation may be conducted by a 

person(s) of the hospice’s choosing. We 

believe that it is inappropriate to 

prescribe the qualifications for the 

person(s) responsible for training and 

supervising volunteers because hospices 

need the flexibility to make the staffing 

decisions based on their individual 

needs. If hospices choose to use board 

certified chaplains to train and/or 

supervise volunteers, they are free to do 

so. 

15. Condition of Participation: 

Organization and Administration of 

services (§ 418.100) 

We proposed to combine several 

conditions of the existing CoPs into a 

single new CoP. The proposed CoP 

included the requirements of current 

§ 418.50, ‘‘General provisions,’’

§ 418.52, ‘‘Governing body,’’ § 418.56, 

‘‘Professional management,’’ § 418.60, 

‘‘Continuation of care,’’ and § 418.64, 

‘‘In-service training.’’ We believe that 

the proposed CoP simplifies the 

structure of the requirements, making 

them easier to understand. We also 

proposed to condense the list of all 

services that hospices are required to 

furnish into a single standard. We 

believe that this single list will 

emphasize hospice’s holistic approach 

to patient and family care. 

We made minor changes to the 

‘‘General provisions,’’ ‘‘Governing 

body,’’ ‘‘In-service training,’’ and 

‘‘Continuation of care’’ requirements. In 

§ 418.100(e), ‘‘Professional management 

responsibility,’’ we proposed to revise 

some of the current requirements found 

at § 418.56(b) and § 418.56(c). This 

proposed standard would require 

written agreements for services 

furnished under arrangement, and 

would require that the hospice retain 

professional management, supervisory, 

and financial responsibility for all 

services that are provided to the patient 

and family. The hospice would be 

required to ensure that it authorizes all 

services that it provides, that they are 

furnished in a safe and effective manner 

by qualified personnel, and that items 

and/or services specified in the plan of 

care are provided. 

We proposed to add a new standard 

to address the issue of multiple service 

locations. This provision was intended 

to codify long-standing Medicare survey 


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and certification policy, which allows 

for the operation of multiple locations 

by a single hospice provider with a 

single Medicare agreement. We expect 

that any hospice that requests to 

establish a satellite location (now 

referred to as a multiple location) will 

be able to demonstrate how it is able to 

manage and monitor all of the services 

provided in its entire service area, 

including services from a multiple 

location. Patients who receive care and 

services from a hospice multiple 

location must receive the full range of 

services that are documented in the plan 

of care. 

Before operating a multiple location, 

also known as a practice location on 

CMS form 855, a hospice must enroll 

with the fiscal intermediary and notify 

the State agency and CMS of all 

currently approved multiple locations at 

the time it requests approval for any 

additional multiple locations. If a 

hospice provides care and services to 

Medicare beneficiaries from an 

unapproved or disapproved multiple 

location, these services may be 

determined to be non-covered. At the 

time of any multiple location closure 

the hospice is expected to notify the 

fiscal intermediary, State agency and 

CMS. Hospice multiple locations are 

also subject to survey by the State 

survey agency or CMS regional office. 

Deficiencies that are identified at any 

multiple location will apply to the 

entire hospice issued the provider 

agreement number. Multiple locations 

must comply with the hospice 

conditions of participation at § 418.52 

through § 418.116. 

Comment: A few commenters 

suggested that we restate the 

requirements in proposed 

§ 418.100(a)(1) to clarify that hospices 

are responsible for providing care that 

meets the patient’s needs for comfort 

and dignity, but are not responsible for 

ensuring that patient’s actually 

experience such care because patient 

perceptions are outside of the hospice’s 

control. A commenter suggested that 

this requirement should be further 

qualified by adding a statement that 

hospices should only be responsible for 

providing such care to the extent that it 

is possible within the context in which 

the patient is living. 

Response: We agree that hospices are 

responsible for providing care rather 

than ensuring experiences. We also 

believe that the term ‘‘optimizes’’

already reflects the fact that hospices 

must work within the context of the 

patient’s living situation to address the 

patient’s unique needs and goals. Rather 

than holding hospices responsible for 

actually assuring comfort and dignity, 

we are requiring hospices to optimize, 

or take all appropriate steps, to provide 

care that promotes comfort and dignity. 

The revised requirement reads, ‘‘[t]he 

hospice must provide hospice care that 

[optimizes] comfort and dignity.’’

Comment: Many commenters 

suggested that we should reexamine the 

proposed requirement at § 418.100(a)(2) 

which would require that the hospice 

must ensure ‘‘[t]hat each patient 

experiences hospice care that is 

consistent with patient and family 

needs and desires.’’ The commenters 

stated that hospices are not necessarily 

able to ensure that patients experience 

care that is consistent with their needs 

and desires. Rather, hospices are able to, 

through their actions, promote care that 

is consistent with patient needs. 

Furthermore, commenters stated that 

the term ‘‘desires’’ was too broad to be 

successfully met by hospices. The 

commenters suggested that it be deleted; 

qualified by phrases such as ‘‘consistent 

with hospice practice’’ or ‘‘that are 

reasonable and necessary’’; or replaced 

by ‘‘goals.’’ In addition, the commenters 

expressed concern about the 

requirement to meet family desires 

when those desires are in conflict with 

each other or those of the patient. 

Response: We agree with the 

commenters that hospices should be 

required to provide care consistent with 

patient and family needs rather than 

requiring hospices to ensure that 

patients and families experience care 

that is consistent with their needs and 

desires. Using the term ‘‘provide’’ holds 

hospices responsible for those things 

that are within their control in contrast 

to the term ‘‘experience,’’ which is 

subjective and out of a hospice’s 

control. We also agree that the term 

‘‘desires’’ is too broad and subjective, 

even when qualified by the suggested 

phrases. We believe that the term 

‘‘goals’’ is more objective, and it 

corresponds with the requirement at 

§ 418.56(c) that the hospice plan of care 

must reflect patient and family goals. 

Therefore, we have replaced the term 

‘‘desires’’ with ‘‘goals’’ in this 

requirement. Furthermore, we have 

added a statement in § 418.100(a)(2) 

affirming that the patient’s needs and 

goals are the hospice’s primary 

consideration in care planning and 

delivery. While hospice treats the 

patient and family as a single unit of 

care, this new statement recognizes that 

not all members of a family may agree 

about the patient’s hospice care. In 

situations where agreement cannot be 

reached regarding the goals of hospice 

care, the patient’s needs and goals must 

take precedence. 

Comment: A commenter suggested 

that the requirement for the governing 

body to assume full responsibility for 

management of the hospice may be in 

conflict with State laws regarding 

management of entities. The commenter 

stated that Boards of Directors generally 

do not perform hands-on management 

of the entity. 

Response: We believe that the 

commenter may have misunderstood 

our intent in this section. We are not 

requiring the governing body to actually 

perform day-to-day management 

functions. We clarified in proposed and 

final § 418.100(b) that the administrator, 

who is appointed by the governing 

body, is responsible for the 24-hour 

operation of the hospice. If the 

administrator is not available to fulfill 

his or her assigned duties and 

responsibilities, the hospice must 

identify another individual to assume 

those assigned duties and 

responsibilities in accordance with the 

hospice’s established policies and 

procedures. The governing body must 

assume responsibility for ensuring that 

the hospice is managed by the 

administrator and any managers that the 

administrator appoints. 

Comment: A commenter requested 

that we provide a definition for the term 

‘‘administrator’’ at § 418.100(b). 

Response: At § 418.100(b) we are 

requiring hospices to have an 

administrator who reports to the 

governing body and who is responsible 

for the day-to-day operations of the 

hospice. We have added a new 

requirement that the administrator be 

appointed by the governing body, to 

further clarify the relationship between 

the two parties. We are requiring that 

the administrator be a hospice employee 

who possesses the education and 

experience determined to be necessary 

by the governing body. We intentionally 

are not including specific personnel 

requirements or a job description for the 

administrator because this leadership 

position varies from hospice to hospice, 

based on the unique needs of each 

hospice. A hospice’s governing body, 

with knowledge of its operations and 

needs, is far better suited for making 

administrator personnel and job 

description decisions. 

Comment: A commenter suggested 

that we should add requirements related 

to advanced beneficiary notices and 

expedited determination notices to 

proposed § 418.100(d), which states that 

hospices may not discontinue or reduce 

care provided to a Medicare or Medicaid 

beneficiary because of the beneficiary’s 

inability to pay for that care. 

Response: It is not appropriate to add 

information about advanced beneficiary 


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notices and expedited determination 

notices to this rule because these notices 

are not within the scope of this 

rulemaking. 

Comment: Many commenters 

expressed concern about our proposed 

requirement at § 418.100(e) that 

hospices must retain supervisory 

responsibility for services furnished 

under arrangement. The commenters 

stated that the word ‘‘supervision’’

implies that hospices are responsible for 

providing personnel supervision for 

those individuals furnishing services. 

Personnel supervision, the commenters 

further stated, is the role of the entity 

with which the hospice has an 

arrangement. The hospice should be 

responsible for ensuring that such 

supervision occurs. Commenters 

suggested that the word ‘‘supervision’’

be deleted and replaced with 

‘‘oversight’’, ‘‘supervisory 

responsibility’’, or ‘‘continually monitor 

and manage.’’

Response: It was not our intent to 

imply that hospices must provide 

personnel supervision for contracted 

staff. We agree that the term 

‘‘supervision,’’ as used in the proposed 

regulatory standard, implies much more 

than was intended. Therefore, we are 

deleting the term ‘‘supervision’’ and 

replacing it with the term ‘‘oversight’’ to 

clarify that the hospice must be 

responsible for the services furnished 

rather than the individuals furnishing 

the services. 

Comment: Numerous commenters 

suggested that the proposed requirement 

at § 418.100(e)(2) regarding the 

qualifications of contracted personnel 

be clarified. The commenters suggested 

that the phrase ‘‘qualified personnel’’

replace the phrase ‘‘personnel having at 

least the same qualifications as hospice 

employees.’’ The commenters stated 

that for some contracted services, for 

example, durable medical equipment, 

there are no equivalent positions 

between the hospice and the contractor. 

Therefore, it would not be possible for 

the contractor’s employees to have at 

least the same qualifications as hospice 

employees. 

Response: Our intent was to ensure 

that hospice patients receive the same 

quality service regardless of whether 

that service is provided by hospice 

employees or contracted staff. We 

believe that the commenters’ suggestion 

is appropriate and we revised the 

requirement found at § 418.100(e)(2). 

This revised element requires 

contracted staff to be ‘‘qualified,’’

meaning that they must meet the 

personnel qualifications of whatever 

profession or job description they are in, 

as well as any regulatory requirements 

particular to that profession or job 

description. 

Comment: A large number of 

commenters expressed support for, or 

requested clarification regarding, our 

proposal at 418.100(f), ‘‘Hospice 

satellite locations.’’ Commenters 

appreciated our inclusion of regulations 

on this fast growing part of hospice care 

and our exclusion of mileage 

restrictions. Some commenters sought 

specific criteria that hospices must meet 

in order to open a multiple location, 

while other commenters requested more 

detailed information on the Medicare 

approval process, including what would 

constitute an ‘‘initial determination’’

under § 498.3, regarding such locations. 

A few commenters suggested that the 

entire proposed multiple location 

requirement be deleted. 

Response: We appreciate the support 

from commenters on this proposal. We 

believe that this proposed requirement 

is necessary to ensure that patients 

receive quality care from hospices, 

regardless of whether those services are 

being provided by the hospice location 

originally issued the certification 

number or by a multiple location of the 

hospice. (As noted in the discussion of 

public comments in § 418.3, the term 

‘‘multiple location’’ is more current and 

appropriate than the term ‘‘satellite 

location.’’) We also believe that the 

proposed requirement at § 418.100(f), 

coupled with the definition of ‘‘multiple 

locations’’ at § 418.3, will provide 

much-needed guidance for hospices 

considering operating one or more 

‘‘multiple locations.’’

As previously stated, we relocated the 

requirement that hospices must exercise 

supervision and management over 

multiple locations from the definition of 

the term ‘‘multiple location’’ at § 418.3 

to § 418.100(f)(1)(ii). Furthermore, we 

reorganized § 418.100(f) to group all 

requirements related to Medicare 

approval of multiple locations under a 

single regulatory element, 

§ 418.100(f)(1), ‘‘Medicare approval.’’

We believe that grouping these elements 

will clarify our expectations for 

hospices seeking to operate multiple 

locations. Revised § 418.100(f)(1)(iii) 

now requires that the lines of authority, 

and professional and administrative 

control be clearly delineated in the 

hospice’s organizational structure and 

in practice. It also requires that the lines 

of authority be traceable between the 

hospice location issued the certification 

number and all multiple locations. This 

new requirement further clarifies how a 

hospice must demonstrate supervision 

and management of the multiple 

location by the hospice issued the 

provider number. Revised 

§ 418.100(f)(1)(iv) also includes a 

provision that a determination of 

whether or not a location qualifies as a 

multiple location in accordance with 

the considerations described above is an 

‘‘initial determination’’ under § 498.3. 

An ‘‘initial determination’’ is an 

administrative action made by CMS, 

and is subject to appeal. Section 498.5 

sets out the procedures for appellate 

review of CMS administrative actions 

that qualify as initial determinations. 

Therefore, hospices may appeal an 

unfavorable multiple location 

determination in accordance with the 

procedures of § 498.5. 

In the preamble to the proposed rule, 

we described some of the factors that are 

currently examined when hospices 

apply to their CMS regional office for 

Medicare approval of a multiple 

location. The factors further explain 

what evidence must be presented by a 

hospice to CMS to demonstrate that the 

requirements of § 418.100(f)(1), such as 

supervision and management by the 

hospice issued the certification number, 

are met by the hospice. The factors, 

which will be updated in sub-regulatory 

guidance [(Pub. 100–7, Chapter 2, 

section 2081)] for this final rule, 

include, but are not limited to, the 

following: 

The hospice’s ability to supervise the 

multiple location to assure the provision 

of quality care for the patients and 

families served by the multiple location; 

The hospice’s past compliance 

history; 

Relevant state issues and 

recommendations, such as a reciprocal 

agreement between states to assure that 

at least one of the state agencies 

assumes responsibility for any necessary 

surveys of multiple locations in 

situations in which a hospice provides 

services across State lines, certificate of 

need requirements, State licensure 

requirements, etc.; and 

The ability of the hospice to ensure 

that each patient receives care from an 

assigned IDG that effectively works 

together to identify and meet the needs 

of the hospice patient and family. 

Once a hospice has received approval 

from Medicare and the State (where 

applicable) to operate multiple 

locations, § 418.100(f)(2) requires that 

supervision and management of the 

multiple locations must continually 

ensure that services delivered through 

the multiple locations are delivered in 

a safe and effective manner, and that the 

care of each patient and family is 

provided in accordance with the plan of 

care. All care and services provided by 

multiple locations must be in 

accordance with all hospice conditions 

of participation at all times. Deficiencies 


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identified at any multiple location will 

apply to all locations operating under 

the CMS-issued certification number. 

Comment: A few commenters 

suggested that existing multiple 

locations should not be required to have 

individual Medicare approval. Other 

commenters suggested that multiple 

locations, whether existing or new, 

should not be required to have Medicare 

approval. 

Response: Hospices have been 

required through a CMS policy 

memorandum from the Director of the 

Office of Chronic Care and Insurance 

Policy and the Deputy Director for 

Survey and Certification to all Regional 

Administrators on the subject of the 

Hospice Conditions of Participation 

(June 27, 1997) to obtain Medicare 

approval for multiple locations since 

1997. Thus, there is no need to exclude 

existing multiple locations from 

obtaining Medicare approval because 

they should have already received such 

approval. Furthermore, we believe that 

Medicare approval is essential for 

ensuring that hospice services furnished 

from multiple locations are in 

accordance with all Medicare 

conditions of participation and that 

hospice services meet the needs of the 

patients and families being served. 

Comment: Some commenters 

suggested that we should require 

hospices to orient each hospice 

employee to specific job duties that the 

employee is expected to perform and to 

the fundamentals of hospice 

philosophy. 

Response: We agree that employees 

and contracted staff furnishing patient 

care should be oriented in hospice 

philosophy, and this requirement has 

been added to 418.100(g)(1). We do not 

believe that it is necessary for 

employees and staff that do not have 

patient contact to be knowledgeable in 

hospice philosophy, and requiring them 

to be oriented as such would be an 

unwise use of hospice resources. We 

also agree that hospice employees 

should be oriented to their specific job 

duties, and this requirement has been 

added to § 418.100(g)(2). If hospice 

employees provide hospice care to 

patients who reside in regulated 

facilities (for example, a nursing 

facility), we believe that it would be 

beneficial to educate hospice employees 

regarding the regulatory requirements 

that the facility and its staff are required 

to meet. Such education may help 

improve hospice-facility understanding 

and cooperation to ensure consistent, 

high quality care for hospice patients 

residing in facilities. 

Comment: A commenter requested 

that we add a provision to this standard 

stating that boardπcertified chaplains 

who furnish hospice care must maintain 

national standards of practice and serve 

as teachers to other disciplines on the 

topics of patient rights, advance 

directives, ethics, and cultural and 

spiritual needs. 

Response: Hospices are permitted to 

use certified chaplains in the manner 

that best meets their needs. If a hospice 

chooses to use the services of certified 

chaplains, then we would expect the 

chaplains to maintain national 

standards of practice just as all other 

disciplines are expected to do. 

16. Condition of Participation: Medical 

Director (§ 418.102) 

We proposed to revise the existing 

medical director requirements at 

§ 418.54 in several ways. First, we 

proposed that the medical director 

could provide services under contract to 

the hospice. This proposal would have 

prohibited general contracts with 

agencies or organizations for medical 

director services, and reflected existing 

CMS policy, as permitted by section 

4445 of the BBA 1997. Second, we 

proposed that another physician would 

be identified by the medical director to 

assume the role of the medical director 

in the medical director’s absence. We 

believe that having another physician 

prepared to assume the medical director 

role would ensure continuity of care for 

the hospice’s patients, even when the 

regular medical director was 

unavailable. 

Third, in standard (a) and (b), we 

proposed to add further guidance on the 

factors that would need to be considered 

when certifying and recertifying the 

terminal illness. We believe that these 

factors, such as related diagnoses, 

current medication and treatment 

orders, and the patient’s desire to 

continue hospice care, are already 

routinely considered by most medical 

directors when certifying and 

recertifying the terminal illness. Fourth, 

we proposed to further define the role 

of the medical director. We proposed 

that the medical director coordinate 

with other physicians and health care 

professionals to ensure that patients 

receive care that is consistent with 

hospice policy. Additionally, we 

proposed that the medical director, in 

tandem with the IDG, be responsible for 

patient medical care in its entirety. 

Finally, we proposed that the medical 

director be responsible for directing the 

hospice’s QAPI program. We believed 

that these medical director 

responsibilities would ensure that the 

medical director was an active leader 

and participant in all aspects of the 

hospice’s operations and services. We 

believe active participation would lead 

to better quality care and patient 

outcomes. 

Comment: While several commenters 

expressed general support for our 

proposed medical director 

requirements, calling them 

‘‘appropriate’’ and ‘‘much needed,’’

many commenters expressed concern 

that the medical director’s role appeared 

to supersede the role of the IDG. 

Specifically, commenters stated that the 

proposed requirement at § 418.102 that, 

‘‘[t]he medical director and physician 

designee coordinate with other 

physicians and health care professionals 

to ensure that each patient experiences 

medical care that reflects hospice 

policy’’ seemed to elevate the medical 

director above the other members of the 

IDG. In addition, the commenters stated 

that making the medical director and 

physician designee responsible for this 

coordination would be burdensome for 

volunteer medical directors. Some 

commenters also stated that a patient’s 

hospice care should reflect the hospice 

philosophy rather than hospice policy. 

Response: Our intent in this proposed 

standard was to ensure that medical 

directors are actively involved in patient 

care. However, after considering 

commenter concerns, we agree that this 

level of involvement is not always 

necessary. Some larger hospices have 

several physicians who may serve on 

IDGs, and it is the physician member of 

the IDG, whether he or she is the 

medical director or not, who shares the 

responsibility with the rest of the IDG 

for communicating with other 

physicians and health care providers 

and for ensuring that the care furnished 

by the hospice reflects hospice policy. 

Since the medical director may not be 

the physician member of the IDG, we 

agree that this requirement should be 

removed. Hospices will still be required 

to have a communication system in 

place to ensure the ongoing sharing of 

information, both between all 

disciplines providing care and services 

in all settings, and with other nonhospice health care providers furnishing 

services to the patient in accordance 

with final § 418.56(e). In addition, 

hospices will still be required to 

develop and implement an 

individualized plan of care for each 

patient that addresses the patient’s and 

family’s hospice care needs and goals in 

accordance with § 418.56(c). The 

individualized plan of care and the 

services furnished to execute the plan 

should be in accordance with hospice 

policies, which should, in turn, reflect 

the individual hospice’s philosophy of 

care. 


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Comment: A few commenters wanted 

to know if a medical director could be 

a volunteer. 

Response: Medical directors may be 

volunteers, and we did not intend to 

imply otherwise. We believe that this 

question arose from the phrasing in the 

proposed rule that was used to describe 

the employment status of the medical 

director. In § 418.102 of the proposed 

rule, we stated that the medical director 

could be ‘‘employed by, or [be] under 

contract with,’’ the hospice. 

Additionally, in § 418.3 we define the 

term ‘‘employee’’ to include volunteers. 

Since the proposed phrasing did not 

explicitly use the term ‘‘employee’’, we 

believe that commenters were confused 

about our intent. We have clarified in 

this final rule that the medical director 

may be an ‘‘employee’’ of the hospice, 

which includes volunteers. 

Comment: Many commenters 

suggested that the hospice, rather than 

the medical director, should be 

responsible for identifying the physician 

designee who fulfills the role of the 

medical director in the medical 

director’s absence. A few commenters 

suggested that hospices should be 

allowed to contract with physician 

groups, without designating a specific 

physician, for medical director services, 

while still other commenters suggested 

that hospices should not be required to 

have physician designees at all. 

Response: We agree that the hospice 

is better suited than the medical director 

exclusively to choose the physician 

designee, and we have incorporated this 

suggestion in § 418.102. We are 

requiring hospices to employ or contract 

with physician designees because, in 

many hospices, the medical director 

may be the only physician employee or 

contractor in the entire hospice. It is 

essential that another physician be 

available to assume the medical 

director’s role when the medical 

director is absent to ensure continuous 

quality care for the hospice’s patients. 

Likewise, it is essential that there be a 

specific individual identified to be the 

physician designee. Allowing numerous 

physicians to fulfill the medical director 

role would likely result in inconsistent 

care and decreased accountability. 

Comment: Numerous commenters 

requested that hospices be allowed to 

contract with physicians employed by a 

professional entity or a physicians’’

group. The commenters explained that, 

for tax and paperwork purposes, it is 

often easier for the hospice and the 

physician to arrange the contract for a 

particular physician’s medical director 

services through the physician’s 

practice or professional organization. In 

such a case, a specific physician would 

fulfill the medical director position at 

the hospice, but the hospice’s contract 

for that particular physician’s services 

would be with the physicians’’ group or 

professional organization. 

Response: Our intent in this standard 

is to ensure that there is a specific 

physician who fulfills and is held 

accountable for the medical director’s 

responsibilities. We agree that there may 

be times when it is beneficial for 

hospices and physicians to handle 

contracts through established entities, 

rather than through direct individual 

contracts. For this reason, we have 

added a new standard at § 418.102(a), 

‘‘Medical director contract,’’ which 

permits hospices to contract with a selfemployed physician or a physician 

employed by a professional entity or 

physicians’’ group. The new standard at 

§ 418.102(a) establishes that, when 

contracting for medical director 

services, the contract must specify the 

name of the physician who assumes the 

responsibilities and obligations of the 

medical director. 

Comment: A commenter suggested 

that we should add attending physicians 

to proposed § 418.102(a), which requires 

the medical director or physician 

designee to review clinical information 

for each patient and provide written 

certification of the patient’s terminal 

illness. 

Response: The attending physician is 

a participant in the certification process 

pursuant to § 418.22(c)(1)(ii). Although 

regulating the actions of the attending 

physician is not within the scope to this 

rule, we agree that attending physicians 

should consider the same clinical 

information as the medical director or 

physician designee to help ensure that 

all physicians make certification 

decisions based on the same 

information. 

Comment: Many commenters sought 

clarification on our proposal at 

§ 418.102(a) that the medical director 

must consider certain factors when 

initially certifying that it is anticipated 

that a patient’s life expectancy is 6 

months or less if the illness runs its 

normal course. 

Response: We proposed that the 

medical director must consider the 

primary terminal condition, related 

diagnoses, current subjective and 

objective medical findings, current 

medication and treatment orders, and 

information about unrelated conditions 

when considering the initial 

certification of the terminal illness. In 

the proposed rule, we called these areas 

‘‘criteria’’, and we believe that this term 

may have been the source of commenter 

concern. Our intent was to ensure that 

medical directors carefully examine all 

relevant information that is gathered 

about the patient before making this 

determination in accordance with the 

requirements for establishing eligibility 

for the Medicare hospice benefit found 

at 418.22 and 418.25. The 

interdisciplinary group may consider 

the information gathered during the 

certification in and developing the 

patient specific plan of care. We have 

removed the term ‘‘criteria’’ in order to 

remove any implication that there are 

specific CMS clinical benchmarks in 

this rule that must be met in order to 

certify terminal illness. 

We believe the requirements in this 

final rule compliment and encompass 

the existing Medicare hospice 

certification requirements and may 

enhance the health and safety of 

patients by ensuring that hospices have 

all relevant information about a patient 

in the patient’s record. 

Comment: Several commenters 

suggested that the IDG as a whole, rather 

than the medical director or physician 

designee individually as we proposed, 

be responsible for reviewing the 

patient’s clinical information in 

preparation for recertifying the terminal 

illness. One commenter wanted to know 

if a review of the patient’s clinical 

information would include a review of 

the plan of care. 

Response: Certifying and recertifying 

the terminal illness is the function of 

the medical director or physician 

member of the IDG, and the patient’s 

attending physician, if any, (in 

accordance with § 418.22(c)), not the 

entire IDG. The contributions of the 

other members of the IDG should be 

considered when making the 

recertification decision. Section 

418.102(c) of the final rule requires that 

the patient’s clinical information be 

reviewed before recertification. During 

this review the physicians would 

consider all of the patient’s clinical 

information from all disciplines 

providing services to the patient. The 

review would, by definition, include the 

patient’s plan of care since we would 

deem the plan of care to be ‘‘clinical 

information.’’ The plan of care is 

required to be updated at least every 15 

days, and the 90- and 30-day benefit 

periods that require recertification 

would coincide with the plan of care 

updates. We believe that this review 

will allow the collection of the 

necessary information from which to 

make a determination. 

Comment: Many commenters asked 

for clarification of the proposed 

requirement at § 418.102(b)(2) that 

provides for review of the patient’s and 

family’s expectations and wishes for the 

continuation of hospice care. Some 


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commenters suggested that the review 

should focus on the patient’s or 

representative’s expectations and 

wishes, rather than the family’s. Others 

suggested that a review of the patient’s 

goals would be more appropriate. Some 

of these commenters contended that, 

because hospice is an elected benefit 

and patients are free to revoke their 

election at any time, this requirement is 

unnecessary. In addition, commenters 

expressed concern that reviewing the 

patient’s and family’s desire for hospice 

care may appear to patients and families 

as though they are being pressured to 

change their minds about hospice care. 

Response: We agree that the proposed 

requirement is not necessary because 

patients may choose to leave hospice at 

any time. Therefore, we are not 

finalizing this requirement. 

Comment: Numerous commenters 

expressed concern regarding the 

proposed requirement at § 418.102(c) 

that the medical director or physician 

designee and the other members of the 

IDG have joint responsibility for 

coordinating the patient’s medical care 

in its entirety. Some of the commenters 

believed that the proposed standard 

unnecessarily separated the medical 

director or physician designee from the 

rest of the IDG, thereby downplaying the 

interdisciplinary nature of hospice care. 

Other commenters believed that the 

hospice should only be responsible for 

coordinating the patient’s hospice care, 

because other care being furnished to a 

hospice patient for unrelated conditions 

is not within the hospice’s control. Still 

other commenters believe that the 

patient’s attending physician (if any) or 

the physician of the long term care 

facility where the patient resides (if 

applicable) would be the appropriate 

provider to coordinate the patient’s 

medical care in its entirety. 

Response: We agree that it is 

inappropriate to create an environment 

which separates the medical director or 

physician designee from the IDG. We 

expect that all members of the IDG, 

including the physician, will actively 

work together to ensure that a patient’s 

care is coordinated. We believe that this 

IDG approach to care is already reflected 

in final § 418.56. Section 418.56(e) of 

this final rule requires hospices to have 

a communication system that allows for 

the sharing of information with health 

care providers who are furnishing care 

to hospice patients for unrelated 

conditions. In addition, § 418.56(a)(1) of 

this final rule requires hospices to 

designate a registered nurse who is a 

member of the IDG to coordinate 

implementation of the plan of care, 

which is required to address all of a 

patient’s hospice needs. Since these 

provisions adequately ensure that each 

patient’s hospice care is coordinated 

both within the hospice and with other 

health care providers, we have removed 

the language in question. 

Comment: The majority of 

commenters expressed support for 

involving medical directors in a 

hospice’s quality assessment and 

performance improvement program, but 

expressed concern about holding 

medical directors responsible for 

directing the QAPI program. 

Commenters stated that medical 

directors may not be the individuals 

who are most qualified to direct QAPI 

programs. Commenters also stated that 

these medical director responsibilities 

would be burdensome, particularly for 

part-time and volunteer medical 

directors. Some commenters suggested 

that the IDG designated as being 

responsible for establishing a hospice’s 

day-to-day policies should have the 

responsibility for directing the QAPI 

program, while others suggested that the 

governing body or a professional 

advisory committee should have this 

responsibility. 

Response: We agree that the medical 

director may not be the individual who 

is most qualified to direct a hospice’s 

QAPI program; therefore, we have 

removed this requirement. As licensed 

professionals, § 418.62(c) requires 

medical directors to actively participate 

in a hospice’s QAPI program. We 

believe that this requirement is 

sufficient to ensure that QAPI programs 

benefit from the expertise of medical 

directors. We considered commenter 

suggestions for reassigning 

responsibility for directing the QAPI 

program. The final rule at § 418.58(e)(3) 

requires the governing body to designate 

individuals to be responsible for 

directing the hospice’s QAPI program. 

Comment: A commenter suggested 

maintaining the existing requirement at 

§ 418.54 that the medical director must 

be a hospice employee who is a doctor 

of medicine or osteopathy who assumes 

overall responsibility for the medical 

component of the hospice’s patient care 

program. 

Response: We do not believe that the 

medical director requirement in the 

current regulation is sufficient, because 

it does not address the issues of 

contracting for medical director 

services, physician designees, or the 

role of the medical director in certifying 

and recertifying terminal illness status. 

These are important areas to address, as 

they impact a hospice’s ability to obtain 

medical director services as well as 

patient care and patient eligibility. At 

the same time, we agree that it 

continues to be appropriate to require 

the hospice medical director to assume 

overall responsibility for the medical 

component of the hospice’s patient care 

program. We have incorporated this 

requirement into the final rule at new 

§ 418.102(d). 

Comment: A commenter suggested 

that we should incorporate the 

definition of the term ‘‘medical 

director’’ from the American Academy 

of Hospice and Palliative Care into the 

final rule. 

Response: No publication or policy of 

the American Academy of Hospice and 

Palliative Care defines the term 

‘‘medical director’’; therefore, we cannot 

incorporate this suggestion into the final 

rule. 

Comment: One commenter stated that 

the ‘‘Medical director’’ condition of 

participation should be deleted because 

the requirements can be incorporated 

into the physician services requirement 

at § 418.64(a). 

Response: The hospice medical 

director’s role is above and beyond that 

of general physician services because, in 

addition to furnishing physician 

services and being a member of the IDG, 

the medical director also is responsible 

for providing overall medical leadership 

in the hospice. We believe that this 

additional level of responsibility, 

coupled with the medical director’s 

supervisory role of other hospice 

physicians, warrants a separate 

condition of participation. 

Comment: Some commenters 

suggested that we should require 

hospice medical directors to have 

additional education, experience, and/ 

or training in palliative and end-of-life 

care. 

Response: We agree that hospices 

should choose a medical director with 

an appropriate set of knowledge and 

skills to meet the needs of patients and 

the hospice. We do not believe that a 

single set of personnel requirements for 

medical directors would achieve this 

goal. Hospices need the flexibility to 

determine the qualifications of the 

medical director based on the role of the 

medical director in that particular 

hospice. That is, a medical director who 

is the only physician in the hospice, and 

who is thus expected to provide direct 

patient care to each patient needs a very 

different set of skills and knowledge 

than the medical director of a large 

hospice whose job it is to manage 

numerous hospice physicians and 

perform various other administrativetype tasks. 

17. Condition of Participation: Clinical 

Records (§ 418.104) 

The proposed condition of 

participation, ‘‘Clinical records,’’ would 


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incorporate several of the existing 

requirements in § 418.74 of the current 

regulation, ‘‘Central clinical records’’

(for example, that clinical records 

contain past and current findings, be 

maintained for each patient who is 

admitted by the hospice, be protected 

from loss or unauthorized use, and be 

readily accessible). We proposed to add 

a new requirement that the clinical 

record contain accurate clinical 

information that would be available to 

the physician and hospice staff. 

At § 418.104(a), ‘‘Content,’’ we 

proposed to retain the requirement that 

the clinical record include all 

assessments (including the initial 

assessment and all updated 

assessments), plans of care, consent and 

election forms, and clinical and progress 

notes. We proposed the following 

additional requirements for the content 

of the clinical record—

• Advance directive information as 

described in proposed § 418.52(a)(3); 

• Authorization forms; 

• Responses to medications, symptom 

management, treatments and services; 

• Patient process and outcome 

measures as they relate to the plan of 

care; and 

• Physician certification of terminal 

illness as required in § 418.22(c) and 

described in proposed § 418.102(a) and 

(b) (now (b) and (c) in the final rule). 

We proposed to add a new standard 

at § 418.104(b), ‘‘Authentication,’’ to 

require authentication of clinical 

records. This proposed standard was 

similar to a requirement in the 

conditions of participation for hospitals. 

We proposed that all entries be legible, 

clear, complete, and appropriately 

authenticated and dated. Authentication 

would include verification of 

handwritten and/or electronic 

signatures by signature logs or a 

computer secure entry of a unique 

identifier for a primary author who has 

reviewed and approved the entry. This 

new standard would address 

technological changes in information 

management, such as the 

computerization of records and 

electronic signatures. 

Under § 418.104(d), ‘‘Retention of 

records,’’ we proposed to ensure 

protection of patient information by 

adding a new requirement that patient 

records be retained for five years after 

the death or discharge of the patient, 

unless State law stipulated a longer 

period of time. 

Under § 418.104(e), ‘‘Discharge or 

transfer of care,’’ we proposed a new 

requirement that Medicare/Medicaidapproved hospice facilities forward a 

copy of the patient’s clinical record and 

hospice discharge summary to the 

facility or provider to which the patient 

was being transferred. We believe that 

this would help to ensure that the 

information flow between the hospice 

and the transfer facility/provider would 

be smooth, and that appropriate care 

would continue without being 

compromised. Furthermore, we 

proposed that the hospice discharge 

summary would include information 

that accurately described the patient’s 

stay; current plan of care; recent 

treatment, symptom, and pain 

management information; most recent 

physician orders; and any other 

documentation that would assist in 

post-discharge continuity of care. 

Comment: One commenter requested 

that we clarify the term ‘‘accurate’’ as it 

pertained to the information contained 

in the clinical record. 

Response: CMS expects that the 

hospice will ensure that information 

placed into the clinical record is correct 

and we have replaced the term 

‘‘accurate’’ with the term ‘‘correct’’ to 

reflect this expectation. This would 

include providing correct information in 

appropriate sections of the clinical 

record in accordance with accepted 

hospice documentation policies. 

Comment: One commenter suggested 

that updated plans of care as well as 

assessments should be included in the 

clinical record requirement because 

updated plans of care are better to use 

than progress notes. 

Response: We agree with the 

commenter’s suggestion and have 

amended the language at § 418.104(a)(1) 

to indicate that the patient’s clinical 

record must include, ‘‘the initial plan of 

care, updated plans of care, initial 

assessment, comprehensive assessment, 

updated comprehensive assessments, 

and clinical notes.’’

Comment: Several commenters asked 

CMS to clarify what is meant by the 

term ‘‘authorization’’ in proposed 

418.104(a)(2). Another commenter asked 

that we amend the language to read 

‘‘election statement, which is required 

to include consent to start hospice 

services as well as patient rights.’’

Response: We agree that the word 

‘‘authorization’’ was confusing in this 

context. We also agree that ‘‘election 

statement’’ should be added to this 

section. Therefore we have removed 

‘‘authorization’’ and have added 

‘‘election statement’’ to the regulatory 

text. The election statement must be 

completed in accordance with the 

requirements of § 418.24, which is not a 

part of these conditions of participation. 

The new § 418.104(a)(2) now requires 

the patient’s clinical record to include 

signed copies of the notice of patient 

rights and election statement. 

Comment: The majority of 

commenters believed that proposed 

§ 418.104(b) was too broad and held 

hospices to a higher standard than home 

health agencies. They recommended 

that we consider using the language in 

the home health CoPs regarding 

authentication issues. Another 

commenter recommended that we 

mirror the home health requirements by 

not having a signature requirement. The 

commenter stated that making a home 

health agency and a hospice conform to 

the same requirements would offer 

entities that have both a hospice and a 

home health agency an administrative 

advantage. For example clinical record 

software could be utilized by both 

entities. One commenter believed that 

the proposed language looked too much 

like the hospital conditions of 

participation. The majority of 

commenters strongly recommended that 

this section be excluded from the 

hospice conditions of participation. 

Response: We do not believe it is the 

best interest of the hospice to exclude 

this requirement, nor do we believe the 

clinical record requirement of the home 

health agency conditions of 

participation meets the needs of 

hospices. We agree that the proposed 

language could be difficult for the 

hospice to comply with; therefore we 

have amended the language to allow 

greater flexibility. We believe that a 

hospice should have the authority to 

create its own policy on authentication 

of clinical records. We have modified 

the proposed rule to reflect this change. 

Hospices will follow State laws 

regarding authentication of clinical 

records, and, within this context, alter 

their policies as often as necessary to 

adapt to changing technologies and 

practices. 

Comment: One commenter asked if a 

unique user name and password that 

would allow access to, and creation of, 

an electronic health record would 

constitute authentication. One 

commenter stated that electronic 

medical records already have multiple 

protections in place, such as frequently 

changed passwords, making the 

proposed signature requirement 

duplicative and unnecessary. Some 

commenters stated that hospices have 

no mechanism to authenticate a 

signature of a covering physician 

beyond the initial verbal order taken by 

the registered nurse. Another 

commenter suggested that we require 

authentication of documents, not 

signatures. One commenter asked if 

authentication requirements apply to 

consulting physicians and covering 

physicians. Another asked whether they 

would be required to maintain a sample 


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signature on file as proof of the 

legitimacy of an authentication. An 

additional commenter suggested that 

hospices should only be required to 

authenticate handwritten and electronic 

signatures made by hospice employees. 

Response: It will be up to the 

individual hospice to decide how it will 

handle authentication of entries made 

by employees, contracted staff, 

attending physicians, and any other 

individuals who input information in a 

patient’s clinical record. Hospices must 

first decide on who is permitted to enter 

information into a clinical record. If the 

hospice is using electronic medical 

records, electronic authentication must 

have a user ID and frequently changed 

passwords. Every entry, both written 

and electronic must be signed and 

dated. Hospices must continue to 

comply with any applicable State laws 

regarding record authentication. 

Comment: Many commenters asked 

what we meant by ‘‘primary author’’ in 

proposed 418.104(b). Commenters asked 

whether faxed signatures would meet 

the authentication requirement, and 

who (if anyone) would be required to 

authenticate a faxed signature. 

Commenters also asked if we were 

requiring hospices to be held 

accountable for signature logs for 

attending physicians not employed by 

the hospice, or whether we were 

requiring a signature log for everyone. 

Finally, they asked whether this 

standard would apply to contracted 

entities. 

Response: ‘‘Primary author,’’ a term 

that has been removed from this final 

rule, referred to the person who wrote 

the entry. For information that is 

transcribed, we would require both the 

physician’s and transcriber’s signatures. 

Faxed signatures supporting orders and 

documentation, or care and services 

delivered would be acceptable, and we 

will provide sub-regulatory guidance to 

that effect. The hospice would need to 

make its own decision as to how it 

wanted to approach authentication; it 

will be up to the hospice to make 

decisions regarding signature logs. 

Comment: Several commenters noted 

that there were differences between the 

hospice proposed record retention 

standard and Health Insurance 

Portability and Accountability Act 

(HIPAA) requirements as set out at 45 

CFR 164.530(j)(2). 

Response: We thank the commenters 

for pointing out the different timeframe 

requirements under HIPAA. It was an 

oversight by us. To ensure consistency 

between these two regulations, we have 

changed the language at § 418.104 (d) to 

read: ‘‘Patient clinical records must be 

retained for 6 years after the death or 

discharge of the patient, unless State 

law stipulates a longer period of time.’’

Comment: Several commenters 

requested that we amend the discharge 

summary language by stating that we 

prefer the use of electronic methods for 

sending discharge summaries and/or 

clinical records when a patient is 

discharged. 

Response: We believe that when 

electronic clinical records are available, 

sharing of discharge summaries and/or 

clinical record information through an 

electronic format would be acceptable if 

agreed upon by both the sender and the 

receiver. Electronic sharing of 

information may include access to a 

record through a secure internet access 

portal. We understand that many 

hospices may not have this capability. 

We are not mandating this as a 

requirement. Paper copies of the 

discharge summary and clinical record 

are acceptable. 

Comment: One commenter requested 

that we amend the language at 

§ 418.104(e) so that it does not apply to 

patients discharged as a result of their 

death. 

Response: We have amended the 

regulatory text to indicate that a 

discharge summary is only necessary for 

patients discharged under § 418.26. We 

agree with the commenter that a 

discharge summary need not be 

completed for deceased patients; we do 

not deem a patient’s death to be a 

discharge within the meaning of 

§ 418.26. 

Comment: Several commenters 

requested language changes under 

§ 418.104(e); for example, commenters 

requested that ‘‘Medicare/Medicaid 

approved’’ be changed to ‘‘Medicare/ 

Medicaid certified’’; that we add the 

phrase ‘‘as requested’’ to the end of 

proposed § 418.104(e)(3)(iv); and that 

we add the phrase ‘‘patient’s written 

consent’’ to the same element. Others 

commented on the unnecessary 

requirement that both the clinical record 

and discharge summary be sent. Many 

commenters believed that the discharge 

summary contains enough information 

to maintain continuity of care, and 

believed that a copy of the clinical 

record should only be sent upon request 

of the receiving entity. One commenter 

questioned whether sending the 

discharge summary would violate the 

HIPAA ‘‘minimum necessary’’

standards. 

Response: In response to these 

suggestions we have decided to amend 

the language under § 418.104(e). We 

have changed ‘‘Medicare/Medicaid 

approved’’ to ‘‘Medicare/Medicaid 

certified,’’ and have added the term ‘‘if 

requested’’ when forwarding the clinical 

record. Pursuant to the HHS privacy 

rule at 45 CFR 164.502(a)(1)(i), 

164.502(b)(2), and 164.506 the 

‘‘minimum necessary’’ standard does 

not apply to disclosures to or requests 

by a health care provider for treatment. 

The transfer of patient information is 

permitted when the patient transfers 

from one provider to another. 

In the reorganization of § 418.104(e) 

we believe we captured the 

commenters’ concerns in the area of 

discharge summary. We recognize that 

the discharge summary and clinical 

record are very important, and have 

amended the language to specify that 

the discharge summary will be sent 

automatically, but that a copy of the 

patient’s entire clinical record will only 

be sent if requested. When patients 

transition from a hospice to another 

provider, it is important for hospices to 

establish communication channels with 

receiving providers. The 

communication channels give hospices 

to opportunity to receive feedback from 

receiving providers regarding the 

adequacy and appropriateness of the 

hospice’s discharge process. This 

feedback, which can be incorporated 

into a hospice’s QAPI program, gives 

hospices the opportunity to improve 

patient transitions to ensure that 

patients receive safe and effective care 

at all times during the transfer process. 

Comment: A commenter asked us to 

elaborate on the proposed requirement 

at § 418.104(f), ‘‘Retrieval of clinical 

records.’’

Response: Clinical records, either in 

electronic or hard copy form, must be 

made available to the appropriate 

requestor, such as the State survey 

agency or and accrediting body, within 

a reasonable amount of time. Access 

needs to be granted to any and all 

patient related documentation that the 

hospice maintains. If the hospice 

maintains electronic clinical records, 

equipment must be available to allow 

access to the clinical record 

information. 

Comment: Many commenters 

responded to our request for 

information and input on the use of 

electronic health records. The 

overwhelming consensus at this time 

was that electronic health records (EHR) 

would be burdensome and cost 

prohibitive, especially for smaller 

hospices. A few commenters stated that 

financial assistance may be necessary to 

achieve EHR standards, and one 

commenter suggested that at the very 

least, EHR standards would need to be 

phased in. 

Response: Given the potential 

financial constraints, we are not 

amending the final rule to mandate 


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EHRs. Hospices may use EHRs if they 

choose, and would need to ensure 

trouble-free record retrieval. 

Comment: A few commenters 

requested that Federal regulations as a 

whole need to address the development 

of EHRs that can be accessed and used 

in multiple care sites, including the 

patient’s home. One commenter 

included the specific pieces of 

information that should be in the EHR. 

Some commenters commented on the 

advantages of the EHR, such as: 

improved coordination of care, 

increased communication, increased 

accuracy, accessibility from any 

computer, easy portability and 

legibility, with documentation available 

to others much more rapidly. 

Response: We acknowledge and 

appreciate the comments. The overall 

goal of the EHR is to achieve and 

improve collaborative practice among 

all care providers and to ensure 

continuity of care as patients move 

across the care continuum. 

Promoting the use of health 

information technology (HIT) is a major 

health initiative of the President and the 

Secretary of the Department of Health 

and Human Services (HHS). The 

President has made implementation of 

interoperable HIT a national priority 

and has expressed a goal that most 

Americans have an electronic health 

record (EHR) by 2014. While this rule 

does not require hospice providers to 

use specific health information 

technology solutions, including EHRs, 

we encourage hospice providers to 

become knowledgeable about ongoing 

HHS activities and actively participate 

in efforts to develop and implement 

cost-effective HIT. For example, one 

activity recently undertaken by the 

Secretary has been the formation of the 

American Health Information 

Community (AHIC), a public-private 

sector federal advisory body charged 

with providing advice on accelerating 

the adoption of interoperable EHRs. In 

another effort, the Health Information 

Technology Standards Panel (HITSP) 

has identified widely accepted, 

consensus-based HIT standards to 

enable and support the development 

and use of interoperable HIT products 

in several healthcare domains. While 

HITSP did not focus on the quality 

measures that are typically important to 

hospice providers, several of the 

identified standards could be used to 

support the development of 

interoperable quality measurement and 

reporting HIT products needed by 

hospice providers. 

Comment: Some commenters noted 

the disadvantages of EHRs. For example, 

software requirements to meet 

regulatory requirements and quality 

initiatives have not been finalized, EHRs 

may be less flexible that paper records, 

EHRs can be time consuming to 

computer challenged staff, and EHR 

systems may be more prone to failures. 

Commenters believed that one of the 

biggest barriers to the EHR was the 

potential to allow personal health 

records to automatically be left available 

to the patient/caregiver. The 

commenters stated that clear safeguards 

need to be in place to ensure the 

security and appropriate use of personal 

health records in the home. A 

commenter believed that caregivers 

might be less likely to record certain 

procedures or observations because of 

open access in the EHR. 

Response: We acknowledge the 

disadvantages the commenters listed. 

Because of these and other issues, we 

are not abandoning the traditional 

clinical record keeping process in favor 

of the EHR at this time. 

18. Condition of Participation: Drugs 

and Biologicals, Medical Supplies, and 

Durable Medical Equipment (§ 418.106) 

This proposed condition of 

participation would revise the current 

general requirement, found at § 418.96, 

that durable medical equipment, 

supplies, appliances, and drugs and 

biologicals related to the palliation and 

management of the terminal illness and 

related conditions, as identified in the 

hospice plan of care, must be provided 

by the hospice while the patient is 

under hospice care. 

Section 418.106(a)(1), 

‘‘Administration of drugs and 

biologicals,’’ would have required that 

all drugs and biologicals be 

administered in accordance with 

accepted hospice and palliative care 

standards of practice and according to 

the patient’s plan of care. In 

§ 418.106(a)(2) we proposed to add a 

new requirement that the IDG be 

responsible for reviewing the plan of 

care to determine whether the patient 

and/or family has and continues to have 

the ability to safely administer drugs 

and biologicals. 

In § 418.106(b), we proposed that the 

hospice would have a written policy for 

tracking, collecting and disposing of 

controlled drugs that are maintained in 

a patient’s home. We proposed that this 

policy would be discussed with patients 

and their families during the initial 

assessment to ensure that patients and 

families were educated about the uses 

and potential dangers of controlled 

drugs. We believe that the hospice’s 

policy, coupled with patient and family 

education, would result in shared 

responsibility for these beneficial, but 

potentially dangerous, drugs. 

Standard 418.106(c) proposed that 

hospices assume responsibility for the 

use and maintenance of durable medical 

equipment and supplies. This standard 

proposed that hospices, either directly 

or under contract, would be responsible 

for ensuring the maintenance and repair 

of durable medical equipment in a 

manner that conformed to manufacturer 

recommendations. If no manufacturer 

recommendations existed for a piece of 

equipment, then repair and routine 

maintenance policies and procedures 

would have to be established. This 

standard also proposed that the hospice 

ensure that the patient, family, and all 

other caregivers receive instruction in 

the safe use of equipment and supplies. 

Likewise, the hospice would have to 

ensure that the patient, family, and 

other caregivers could demonstrate the 

safe use of such equipment and supplies 

to the satisfaction of hospice staff. We 

believe that proper maintenance and 

education are essential to ensuring the 

patients benefit from fully functional 

equipment and supplies that they are 

able to use in a safe and effective 

manner. 

Comment: A commenter asked us to 

define the term ‘‘controlled drugs.’’

Response: In this regulation we intend 

controlled drugs to mean those 

substances identified under schedules 

II, III, IV, and V of the Federal 

Controlled Substances Act (Pub. L. 91–

513) and FDA regulations (see 21 CFR 

part 290) issued thereunder. 

Comment: A few commenters 

suggested that we should require 

hospices to use pharmacists to 

participate in the drug review. Other 

commenters suggested that we should 

require a pharmacist as a member of the 

IDG to help identify and prevent drugrelated complications such as 

duplication, improper dosing, and drug 

interactions. Still other commenters 

suggested that the requirements for 

pharmacist and pharmaceutical services 

at proposed § 418.110(m) and 

§ 418.110(n) should apply to the entire 

hospice, rather than only to the hospice 

inpatient facility. The commenters 

stated that, since drugs are prescribed to 

virtually all hospice patients, these 

patients should benefit from the 

expertise of a pharmacist and the 

additional level of drug oversight 

required by these regulatory standards. 

One commenter suggested that we 

should retain the existing requirements 

for drugs found at § 418.96(b), which 

requires the hospice to have a policy for 

the disposal of controlled drugs 

maintained in the patient’s home when 


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those drugs are no longer needed by the 

patient. 

Response: Many hospices, 

particularly those with hospice 

inpatient facilities, have already 

realized the benefits of actively 

involving pharmacists in patient care 

planning. Hospices are seeking to use 

drugs more effectively and efficiently to 

improve patient outcomes and reduce 

costs. In the last years of life, patients 

typically use five drugs or more at any 

one time, increasing the risk of 

duplicative drug therapy, drug 

interactions, or drug side effects, as well 

as the risk of dispensing or dosing 

errors. (Steinman, M., Landefeld, C.S., 

Rosenthal, G., Berthenthal, D., Sen, S., 

et al., ‘‘Polypharmacy and prescribing 

quality in older people,’’ Journal of the 

American Geriatrics Society, 2006; Koh, 

N.Y., Koo, W.H., ‘‘Polypharmacy in 

palliative care: Can it be reduced,’’

Singapore Medical Journal, 2002; 

Meredith, S., Feldman, P., Frey, D., Hall, 

K., Arnold, K., et al., ‘‘Possible 

medication errors in home healthcare 

patients,’’ Journal of the American 

Geriatrics Society, 2001; Twycross, R., 

Bergl, S., John, S., and Lewis, K., 

‘‘Monitoring drug use in palliative 

care,’’ Palliative Medicine, 1994.) The 

need for the use of drugs in caring for 

hospice patients, coupled with the risk 

of negative patient outcomes, warrants 

an additional focus on drug 

management for all hospice patients, 

regardless or whether they receive care 

in their place of residence or in an 

inpatient facility. Therefore, we have 

moved and modified the requirements 

of proposed § 418.110(m) and 

§ 418.110(n) to § 418.106 and have 

reorganized the requirements in 

standards (a) through (e). 

In new standard (a), ‘‘Managing drugs 

and biologicals,’’ we combined some of 

the requirements of proposed 

§ 418.110(m) and § 418.110(n), such as 

the proposed requirement that a 

qualified licensed pharmacist direct the 

inpatient hospice’s pharmaceutical 

services, including evaluation of a 

patient’s response to drug therapy, and 

identification of adverse drug reactions. 

New standard (a) requires the hospice to 

ensure that the interdisciplinary group 

confers with an individual with 

education and training in drug 

management as defined in hospice 

policies and procedures and State law, 

who is an employee of or under contract 

with the hospice to ensure that drugs 

and biologicals meet each patient’s 

needs. 

Hospices may choose to use a 

licensed pharmacist, an individual who 

has an extensive and up-to-date 

knowledge of drugs, to fulfill this role. 

Approximately 1,600 hospices already 

contract with pharmacy benefit 

management companies to provide 

drugs and pharmacist services to each of 

their patients. Hospices may also choose 

to use other individuals with 

specialized education and training in 

drug management, including evaluating 

the effectiveness of drug therapies, 

identifying drug side effects, identifying 

actual or potential drug interactions, 

identifying redundant drugs, and taking 

appropriate corrective actions. All 

hospices must be able to demonstrate an 

individual’s knowledge, skills, and 

abilities in managing the use of drugs in 

accordance with accepted standards of 

practice and all applicable State and 

local requirements, including State 

licensure requirements. 

Standard (a)(2) also incorporates the 

proposed requirements of § 418.110(m) 

and § 418.110(n) that a pharmacist must 

oversee an inpatient hospice’s pharmacy 

program. The provided pharmacist 

services must include evaluation of a 

patient’s response to medication 

therapy, identification of potential 

adverse drug reactions, and 

recommended appropriate corrective 

action. New standard (b), ‘‘Ordering of 

drugs,’’ relocates the requirements of 

proposed § 418.110(n)(1). This new 

standard indicates who may order drugs 

for a hospice patient and how verbal or 

electronic drug orders should be 

documented. New standard (c), 

‘‘Dispensing of drugs and biologicals,’’

combines some of the requirements of 

proposed § 418.110(m), with proposed 

§ 418.110(n)(4)(ii). This new standard 

requires a hospice to have a written 

policy that promotes dispensing 

accuracy, to maintain current and 

accurate records of the receipt and 

disposition of all controlled drugs, and 

to obtain drugs and biologicals from 

community or institutional pharmacists 

or from its own stock. New standard (d), 

‘‘Administration of drugs and 

biologicals,’’ combines the requirements 

of proposed § 418.106(a)(2) and 

§ 418.110(n)(2). The new standard 

addresses drug administration in both 

the home and hospice inpatient facility 

environments to ensure that drugs and 

biologicals are administered to a patient 

by an individual who is competent to do 

so, regardless of the patient’s current 

environment. 

New standard (e), ‘‘Labeling, 

disposing, and storing of drugs and 

biologicals,’’ combines and revises the 

requirements of proposed § 418.106(b) 

and § 418.110(n)(3), (n)(4)(i), (n)(4)(iii), 

and (n)(5). This new standard ensures 

that drugs are safely labeled, stored, and 

disposed of in accordance with accepted 

standards of practice and applicable 

Federal and State laws and regulations. 

It also ensures that patients and families 

are properly educated about drug 

disposal. 

We understand that the revised drug 

requirements may have some financial 

impact on hospices. However the cost 

saving achieved through a more efficient 

and effective use of drugs in the 

hospice, as well as improved patient 

outcomes and satisfaction, will, we 

believe, offset a portion of this financial 

impact. Additionally, we believe that 

the new standards (for example, 

development of hospice-wide policies 

and procedures, patient and family 

education) will help hospices create 

partnerships with patients and families 

to ensure that controlled drugs are used 

and disposed of in a safe manner. 

Comment: Numerous commenters 

suggested that we should address the 

issue of hospice patients bringing their 

own drugs from their homes into a 

hospice inpatient facility. 

Response: This rule does not prohibit 

patients from bringing their own drugs 

into a hospice inpatient facility. If 

patients do so, the transportation and 

use of these drugs must be in 

accordance with any applicable Federal, 

State, and local laws and regulations, as 

well as with the hospice’s own policies 

and procedures. 

Comment: A commenter suggested 

that we should delete the requirement 

that drugs and biologicals must be 

obtained from a community or 

institutional pharmacist or stocked by 

the hospice. 

Response: We assume that the 

commenter seeks to obtain drugs and 

biologicals from sources outside of the 

United States. Due to concerns about the 

safety of drugs and biologicals obtained 

from sources that are outside of the 

purview of the Food and Drug 

Administration, we believe it it 

necessary to continue to require 

hospices to obtain drugs and biologicals 

from a community or institutional 

pharmacist or from its own stocks. 

Comment: A commenter requested 

that the following statement be added to 

proposed § 418.106(a) (now located at 

§ 418.106(d)(1)): 

‘‘If the patient and/or family are 

determined to be unable to safely 

administer drugs and biologicals, the 

patient and family will be encouraged to 

relocate the patient to a setting where 

administration assistance can be 

routinely offered. However, it is 

recognized that the patient, if 

competent, and the patient’s surrogate if 

the patient is not competent, can refuse 

to relocate. Given patient rights and the 

home setting, [the] hospice will be 

expected to provide reasonable 


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assistance. [The] hospice will not be 

expected to restrict the provision of 

medications unless there is a blatant 

safety issue for non-competent adults or 

children in the home.’’

Response: If a patient and all family 

members are unable to safely administer 

drugs themselves, then it is incumbent 

upon the hospice to identify alternatives 

to ensure safe administration. 

Depending on the circumstances, 

alternatives may include friends and 

neighbors of the patient and family who 

are competent to administer 

medications with appropriate training 

from the hospice, the hospice’s own 

paid employees and volunteers, paid 

caregivers, and, lastly, patient 

relocation. We do not believe that it is 

necessary to include the suggested 

language because the options mentioned 

above are already available to hospices. 

Furthermore, we do not believe that it 

is necessary to establish in this 

regulation criteria for restricting the 

placement of drugs in a patient’s home. 

We believe that hospices should be able 

to assume the responsibility to 

determine when it is or is not 

appropriate to place drugs in a patient’s 

home. 

Comment: A few commenters 

suggested changes regarding who is 

permitted to administer medications to 

patients in a hospice inpatient facility. 

One commenter suggested that licensed 

practical nurses (LPN) and licensed 

vocational nurses (LVN) should be 

allowed to administer medications, 

while other commenters suggested that 

the patient’s family or caregiver should 

be allowed to administer medications. 

Response: In accordance with 

§ 418.106(d)(2) of this final rule, 

licensed nurses are permitted to 

administer medications in accordance 

with their scope of practice. If an LPN’s 

or LVN’s scope of practice permits him 

or her to administer medications, then 

it is appropriate to allow them to 

administer medications in accordance 

with this rule. However, it is not 

appropriate to allow the family or 

primary care giver of a patient to 

administer medications in an inpatient 

facility. Patients enter hospice inpatient 

facilities for two primary reasons, 

respite and general inpatient care. If a 

patient is in an inpatient facility for 

respite care, it is because the family/care 

giver needs a temporary break from care 

giving duties. It would not be 

appropriate to expect the family/ 

caregiver to administer medications to 

the patient in the inpatient facility. If a 

patient is in an inpatient facility for 

general inpatient care, it is because the 

patient is experiencing pain or 

symptoms which cannot be managed in 

the patient’s home by the patient’s 

caregivers in conjunction with the 

hospice staff, in which case it is not 

appropriate to expect the family/ 

caregiver to handle the complex 

medication regimen the patient likely 

requires. This is the job of the hospice 

inpatient staff. 

Comment: Numerous commenters 

expressed concern regarding our 

proposal in § 418.52(a)(3) that hospices 

inform patients and families about their 

drug policies before hospice care is 

furnished. Commenters believed that 

providing the drug policy information at 

that time would overwhelm patients 

and families with information that was 

not urgent. Some commenters suggested 

that a hospice should be required to 

provide information about its drug 

policy in the admission package of 

information that is left with the patient. 

The content of the admission package, 

including the drug policy, could be 

discussed with the patient and family at 

some time during the comprehensive 

assessment period. Other commenters 

suggested that hospices be required to 

discuss their drug policies when 

patients are prescribed drugs to which 

the hospice’s policy applies. Other 

commenters requested clarification 

regarding the form of the drug policy 

notice, noting the difficulties involved 

in furnishing the notice in obscure or 

otherwise uncommon languages. As 

with the general notice of patient rights 

in § 418.52, many commenters 

requested that we explicitly allow the 

use of translators when providing the 

drug policy notice. Additionally, as 

with the general notice of patient rights, 

a few commenters requested that we 

clarify how hospices should document 

the fact that patients and families were 

informed of the hospice’s drug policies. 

Response: We agree that providing 

controlled drug policy information 

before the start of care may not be 

appropriate in all cases because not all 

patients are taking controlled drugs at 

the start of care. We also agree that 

providing such information may 

unnecessarily overwhelm patients and 

families. Therefore, we have replaced 

the proposed requirement at 

§ 418.52(a)(3), with a requirement set 

out at § 418.106(e)(2) that, at the initial 

time that controlled drugs are ordered 

by the hospice for the patient’s use at 

home, the hospice must provide a copy 

of its written policies and procedures on 

the management and disposal of 

controlled drugs to the patient or 

representative, and the family. 

While we are requiring hospices to 

provide drug policy and procedure 

information to patients and families, we 

are not prescribing the manner in which 

they must document this information 

sharing. The drug policy and procedure 

information, unlike the notice of patient 

rights in § 418.52, is more of an 

educational effort. The hospice’s drug 

policies and procedures will help 

patients learn how to safely use 

controlled substances and avoid 

negative outcomes. The drug policies 

and procedures will also help the 

hospice explain its own role in 

controlled drug management. We do not 

believe that it is necessary to dictate the 

method for educating patients and 

families about the hospice’s drug 

policies and procedures, nor is it 

necessary to prescribe how hospices 

should document that patients and 

families have received such education. 

Hospices should decide for themselves, 

in their own policies and procedures, 

how staff will document the discussion 

of the hospice’s drug policies and 

procedures. Obtaining a patient or 

family member signature would be 

appropriate, as would any number of 

other documentation methods. 

As previously discussed in the notice 

of patient rights section, it is acceptable 

to use translators, either professional or 

family members, to ensure that patients 

and families fully understand the 

hospice’s controlled drugs policies and 

procedures. 

Comment: In § 418.106(b) we 

proposed that hospices have a written 

policy for tracking, collecting, and 

disposing of controlled drugs 

maintained in the patient’s home. The 

majority of commenters who submitted 

comments on this CoP asked us to 

remove this requirement. The 

commenters were concerned that the 

tracking requirement would require 

hospice staff to conduct pill counts. 

They were also concerned that these 

proposed requirements would compel 

hospice employees to remove drugs 

from the patient’s home, which 

employees are prohibited from doing 

because the drugs are the patient’s 

property. 

Response: While it was not our intent 

to imply that hospices would be 

required to conduct pill counts or 

remove drugs from patient homes, we 

understand that the terms ‘‘tracking’’, 

‘‘collecting’’ and ‘‘disposing’’ implied 

precisely that. Therefore, we have 

removed these terms and replaced them 

with a requirement at new 

§ 418.106(e)(2) that hospices have 

written policies and procedures for 

management and disposal of controlled 

drugs maintained in the patient’s home. 

The intent of this revised requirement is 

to ensure that hospices have a clear 

picture of what drugs have been 

prescribed and delivered to the patient, 


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and are therefore present in the patient’s 

home, at any time. Through the written 

policies and procedures, hospices will 

have a plan detailing how they can 

assist a family in safely disposing of 

controlled drugs after a patient’s death. 

Comment: The majority of 

commenters who submitted comments 

on this CoP asked us to replace the 

proposed requirement that hospices 

must discuss the potential dangers of 

controlled drugs with a requirement that 

hospices must discuss the ‘‘safe use,’’

‘‘appropriate use,’’ or ‘‘risks/benefits’’ of 

controlled drugs. 

Response: Our intent in the proposed 

standard was to ensure that hospices 

educate patients and families on how 

controlled drugs are used and the risks 

associated with abusing and/or 

improperly disposing of them. We agree 

that requiring hospices to discuss the 

‘‘safe use’’ of controlled drugs 

accomplishes this intent without the 

negative connotations that may be 

associated with the language of the 

proposed rule. The safe disposal of 

controlled drugs should also be part of 

the patient and family education effort. 

Therefore, we revised § 418.106(e)(2)(B) 

to require that, when controlled drugs 

are first ordered for use in the patient’s 

home, the hospice must, ‘‘[d]iscuss the 

hospice policies and procedures for 

managing the safe use and disposal of 

controlled drugs with the patient or 

representative and the family in a 

language and manner that they 

understand to ensure that these parties 

are educated regarding the safe use and 

disposal of controlled drugs.’’

Comment: A commenter suggested 

that we should require hospices to 

educate patients and families about drug 

policies in a language and manner that 

the patient and family understand. 

Response: HHS guidance on Title VI, 

‘‘Guidance to Federal Financial 

Assistance Recipients Regarding Title 

VI, Prohibition Against National Origin 

Discrimination Affecting Limited 

English Proficient Persons,’’ August 8, 

2003 (68 FR 47311), related to limited 

English proficiency persons, presents 

guidelines for developing and 

implementing communication strategies 

in a variety of settings, including 

hospice. Since hospices are already 

expected to meet these guidelines, we 

agree that it is appropriate to re-enforce 

the existing guidance by requiring the 

discussion of drug policies to occur in 

a language and manner that the patient 

and family understand. 

Comment: A few commenters wanted 

to know where drug discrepancy 

investigation reports should be sent to. 

One of these commenters suggested that 

sending drug discrepancy investigation 

reports to State and Federal officials 

should be done only when required by 

law. 

Response: We agree that such reports 

should only be sent to the appropriate 

agencies when required by a specific 

Federal or State law or regulation. These 

State specific laws and regulations may 

vary, and describe the appropriate 

reporting mechanism, timeframe, and 

recipient. We have added the phrase ‘‘if 

required by law or regulation’’ to the 

end of the reporting requirement, which 

is now located at § 418.106(e)(3)(ii). 

Comment: A commenter asked us to 

clarify the relationship between the 

requirement that hospices must provide 

drugs for patients and the Medicare Part 

D benefit. 

Response: Hospices are required by 

section 1861(dd)(1)(E) of the Act to 

furnish all drugs and supplies related to 

the terminal illness and related 

conditions. Hospices may not expect 

patients to obtain drugs related to the 

terminal illness and related conditions 

through the Medicare Part D benefit. If 

a patient requires drugs that are not 

related to the terminal illness and 

related conditions, then it may be 

possible for the patient to obtain those 

unrelated drugs through the Medicare 

Part D benefit. 

Comment: A commenter suggested 

that hospices should note in the 

patient’s clinical record any drugs that 

are prescribed for the patient that are 

not standard treatment for that patient’s 

symptoms. The commenter further 

suggested that the patient’s clinical 

record should include an explanation 

for such unconventional use. 

Response: Hospices are free to 

determine the type, dose and 

administration methods for any drugs 

that they choose to prescribe. We would 

expect hospices to confer with an 

individual with education and training 

in drug management and use current 

practices to select the most appropriate 

drugs for a particular patient, and to be 

able to explain drug choices to those 

providing patient care, the patient or 

representative, the family, and any 

authorities having jurisdiction, as 

necessary. Hospices may find it 

appropriate to document those drugs 

that are prescribed for uncommon or 

unconventional reasons, and the 

rationale behind such decisions; 

however, we do not believe that it is 

necessary to require such additional 

documentation. 

Comment: Numerous commenters 

stated that, when durable medical 

equipment (DME) is provided under 

contract, the contracted DME provider is 

responsible for DME maintenance. As 

such, the commenters stated that 

hospices should not be held responsible 

for DME maintenance when it is 

provided under contract. 

Response: We understand that the 

majority of hospices contract with 

outside entities for DME equipment. We 

also understand that, as part of that 

contract, most hospices require the DME 

company to provide maintenance 

services. This is an acceptable 

arrangement. However, requiring a DME 

company to maintain the equipment 

that it provides does not absolve the 

hospice of its ultimate responsibility to 

ensure that all services provided on its 

behalf, whether by its employees or 

through a contract, are safe and 

effective. An improperly or 

inadequately maintained piece of DME 

is neither safe nor effective. Thus, it is 

the hospice’s ultimate responsibility (as 

it is with respect to all of its contracted 

services) to ensure that maintenance is 

performed on DME equipment, 

regardless of the source of such 

equipment. A written statement from 

the DME supplier and signed by a 

person of authority stating that 

equipment has been serviced according 

to manufacturer recommendations or 

other comparable standards would be 

one way that the hospice could assure 

that the equipment is safe and performs 

as required. If a hospice does not ensure 

that such maintenance is performed, it 

is not in compliance with the 

requirement that it must maintain 

professional management responsibility 

for all services provided or this 

requirement at new § 418.106(f)(1). 

At the same time, we understand that 

the proposed requirements should be 

clarified to ensure that hospices may 

provide DME maintenance services 

under contract. We have revised new 

§ 418.106(f)(1) to state that hospices 

must ensure that manufacturer 

maintenance recommendations are 

followed. If there are no manufacturer 

recommendations, hospices must ensure 

that maintenance policies are 

developed. We believe that adding the 

term ‘‘ensure’’ will clarify that hospices 

must make sure that such maintenance 

is complete, but that hospices are not 

necessarily required to handle 

maintenance through their employees. 

Comment: Numerous commenters 

stated that the contracted entity that 

supplies the DME is best suited to 

instruct the patient and family in the 

safe use of the DME provided. 

Response: In the proposed rule at 

§ 418.106(c)(2), we stated that hospices 

must ensure that patients and families 

receive DME instruction. Our intent was 

to allow hospices to provide such 

instruction through a contracted DME 

supplier. We agree that this intent 


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should be further clarified. We have 

added a provision to the final rule at 

§ 418.106(f)(2) to clarify that, ‘‘[t]he 

hospice may use persons under contract 

to ensure patient and family 

instruction.’’

Comment: A few commenters asked 

for clarification about the role of the 

Medicare Supplier Standards and 

accreditation in contracting for DME 

services. Some of these commenters 

suggested that any DME supplier who 

furnished DME equipment as part of the 

Medicare hospice benefit be required to 

meet the Medicare Supplier Standards 

and be accredited by a national 

accrediting body. Another commenter 

suggested that by contracting with a 

DME supplier that met the Medicare 

Supplier Standards, hospices would 

have more assurance that the DME 

provider would safely and effectively 

perform its maintenance and instruction 

duties. 

Response: We believe that Medicare 

beneficiaries should receive the same 

high quality DME service whether they 

receive such DME through Medicare 

Part B or through the Medicare hospice 

benefit. In order to ensure continuous 

DME service quality, we agree that 

hospices should contract with those 

DME suppliers who meet the Medicare 

Supplier Quality and Accreditation 

Standards. A provision to this effect has 

been added at new § 418.106(f)(3). 

Comment: A commenter suggested 

that the National Safety Council should 

be involved in conducting site 

inspections of DME suppliers to 

determine compliance with the 

Medicare Supplier Standards. 

Response: As part of the effort to 

ensure quality DME services for 

Medicare beneficiaries, the Medicare 

Supplier Quality and Accreditation 

Standards require DME suppliers to be 

accredited by national accrediting 

organizations. (See 42 CFR 424.58.) 

Accreditation requires regular surveys 

by CMS-approved accrediting bodies. 

The existing DME accreditation 

regulations, we believe, respond to the 

commenter’s concern. 

Other Issues 

We are aware that the appearance of 

a conflict of interest or an actual conflict 

of interest could exist when a 

pharmacist or pharmacist service under 

contract to the hospice recommends one 

brand name drug over another, favors 

one drug in a therapeutic class over 

another, or recommends an increase in 

the utilization of a specific drug. For 

example, a conflict of interest exists 

when a pharmacist under contract to the 

hospice is employed by the pharmacy 

that supplies drugs to the hospice and 

that pharmacy accepts access/ 

performance rebates or other price 

concessions designed to or likely to 

influence or impact utilization of drugs 

in the hospice. The term ‘‘access/ 

performance rebates’’ refers to rebates 

manufacturers provide to pharmacies 

that are designed to prefer, protect, or 

maintain that manufacturer’s product 

selection by the pharmacy or to increase 

the volume of that manufacturer’s 

products that are dispensed by the 

pharmacy under its formulary (referred 

to as ‘‘moving market share’’). If a 

conflict of interest exists, it has the 

potential to compromise the judgment 

of the pharmacist which could affect the 

care of a patient. The hospice IDG 

retains responsibility for all patient care 

decisions independent of others, and it 

is inappropriate for a pharmacist or any 

other member or consultant of the IDG 

to drive patient care decisions based on 

financial or business incentives. It is 

incumbent upon a hospice to obtain 

assurance that a contracted pharmacist 

or pharmacist service is free of any 

potential or real conflicts of interest or 

financial incentives. 

19. Condition of Participation: ShortTerm Inpatient Care (§ 418.108) 

Under § 418.108, we proposed to 

retain the requirement that hospices 

make inpatient care available for pain 

control, symptom management, and 

respite purposes, and that care be 

provided either in the hospice or in a 

participating Medicare or Medicaid 

facility. We proposed to recodify the 

current standard found at § 418.98(a), 

‘‘Inpatient care for symptom control,’’ as 

§ 418.108(a), ‘‘Inpatient care for 

symptom management and pain 

control.’’ We proposed to recodify the 

current standard found at § 418.98(b), 

‘‘Inpatient care for respite purpose’’, as 

§ 418.108(b), with the same title and 

only minor terminology changes. 

We proposed to eliminate the existing 

requirement found at § 418.100(a)(2), 

requiring that a registered nurse provide 

direct patient care on each shift. In its 

place, we proposed that the patient’s 

plan of care and the patient’s condition 

should determine the amount and skill 

level of nursing care required, as well as 

the skill level and State licensing 

requirements of the staff required to 

provide requisite care. 

Under proposed § 418.108(c), 

‘‘Inpatient care provided under 

arrangement,’’ we proposed to 

incorporate the requirements of existing 

standard 418.56(e), ‘‘Inpatient care.’’ In 

particular, we proposed to require that, 

if a hospice chose to contract with 

another type of facility to provide 

inpatient care, the hospice would have 

to include in its contract a provision 

that it would train the personnel who 

would be providing hospice patient care 

in the inpatient facility (currently at 

§ 418.56(e)(5)). We believe the training 

is necessary because the hospice 

palliative model of patient care is very 

different from the curative model of 

patient care in which medical personnel 

are routinely trained. We also proposed 

that, as part of the contract, a copy of 

the inpatient clinical record and 

discharge summary would have to be 

available to the hospice at the time of 

discharge from the inpatient facility. 

Under proposed § 418.108(d), 

‘‘Inpatient care limitation,’’ and 

§ 418.108(e), ‘‘Exemption from 

limitation,’’ we proposed to re-codify 

the existing parallel requirements at 

§ 418.98(c) and (d) respectively, without 

changes, because these requirements are 

derived directly from section 1861(dd) 

of the Act. 

Comment: Many commenters believe 

that a reference to the psychosocial/ 

family crisis situations should be added 

to the opening paragraph of the CoP as 

an additional reason to admit a patient 

to inpatient care. Adding psychosocial 

and family crisis situations would, 

according to the commenters, conform 

to the requirements of Chapter 9, section 

40.1.5 of the Medicare benefit policy 

manual. Another commenter asked that 

we allow inpatient care to be used for 

acute caregiver breakdown. One 

commenter stated that the hospice 

should have the option of placing the 

patient in a general inpatient level of 

care for a short period of time while 

developing a more appropriate plan of 

care. 

Response: We believe that caregiver 

and family status should be considered 

in the comprehensive assessment 

process. This allows families and 

hospices time to develop back-up plans 

for any family or caregiver breakdowns 

that may occur in the future. As this 

issue primarily relates to Medicare 

payment rules, we refer readers to the 

FY 2008 hospice wage index (72 FR 

50214, August 31, 2007) for additional 

discussion of the appropriate use of the 

respite and general inpatient levels of 

care in situations where a caregiver 

breakdown has occurred. 

Comments: One commenter requested 

that we change the language in 

proposed § 418.108(b)(2) from 

‘‘Medicare/Medicaid approved’’ to 

‘‘Medicare/Medicaid participating.’’

Two commenters requested that we use 

the phrase ‘‘Medicare certified.’’

Response: We have amended the 

language to read ‘‘Medicare or 

Medicaid-certified.’’


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Comment: One commenter asked for 

clarification of whether or not a 

freestanding hospice inpatient facility 

operated by a Medicare-certified 

hospice would qualify as a participating 

Medicare or Medicaid facility. 

Response: Yes, the facility would 

qualify if it met all applicable 

requirements of the hospice regulations 

at 42 CFR part 418. 

Comment: One commenter stated that 

a hospice should not be able to send its 

own nursing staff to supplement 

contracted facility staff to meet inpatient 

care staffing requirements. 

Response: We understand the 

commenter’s view; however, this issue 

is related to a hospice’s contractual 

agreement with its providers. A hospice 

must set up its own polices and 

guidelines, as well as its own written 

contract with an inpatient provider. We 

would not prohibit a hospice from 

sending in its own staff to care for the 

hospice patient, if it is permitted within 

the provisions of its contractual 

arrangement and the statutory and 

regulatory requirements applicable to 

the contracted inpatient provider. 

Comment: One commenter requested 

that we allow up to four patients per 

room for inpatient respite purposes. 

Response: We do not agree with the 

commenter. The level of care provided 

to the patient should not determine the 

level of patient and family privacy. 

Therefore, we believe that no more than 

two patients per room should be 

permitted. 

Comment: Many commenters thanked 

us for proposing to remove the 24 hour 

nursing requirement for respite care. 

The commenters felt it was not always 

necessary to have an RN on duty 24 

hours a day for respite care and that the 

proposed nurse staffing requirement 

allowed for greater staffing flexibility 

and improved coordination of care 

between hospices and nursing homes 

where respite care may be provided. 

Response: We agree that it is not 

automatically necessary to have a 

registered nurse on every shift to 

provide direct patient care if the only 

hospice patients in a facility are 

receiving the respite level of care. We 

believe that respite care is meant to give 

the family time to rest and re-energize 

before the patient returns to the home. 

The care needs of a respite patient are 

equivalent to those of the patient in his 

or her home and therefore may not 

necessitate registered nursing care on a 

24-hour basis. Rather, staffing for a 

facility solely providing the respite level 

of care to hospice patients should be 

based on each patient’s care needs. The 

requirements for nursing services for 

respite care are now at § 418.108(b)(2). 

Comment: A few commenters 

requested that that we define nursing 

services in inpatient facilities as care 

provided by an RN or LPN. 

Response: Because Congress was not 

specific about what level of nursing 

services were required, we believe that 

the intent of section 1861(dd) of the Act 

has always been for hospices to furnish 

nursing services from a variety of 

different categories of nurses, ranging 

from nurse practitioners to licensed 

vocational nurses to registered nurses. 

Since hospices have not, to our 

knowledge, had any difficulty in 

determining what constitutes nursing 

services, we see no reason to establish 

a definition for the term at this time. 

Comment: One commenter stated that 

the respite level of care should be able 

to be provided in any facility that meets 

the general nursing requirements that 

apply to all hospice care; that is, that the 

nursing services provided must meet 

patient needs without CMS issuing 

specific regulations prescribing the 

exact level of nursing services that must 

be available at all times (such as 24-hour 

RN services). A few commenters 

requested that assisted living facilities 

and licensed group homes providing 24- 

hour care (but not necessarily nursing 

care) that meet the needs of the patient 

should be authorized for inpatient 

respite purposes. 

Response: To meet each patient’s 

nursing needs the facility would need to 

be a Medicare/Medicaid certified 

nursing facility, a Medicare-certified 

hospice or a Medicare-certified hospital 

or skilled nursing facility because these 

facilities already maintain the requisite 

staff to meet hospice patient’s needs at 

the respite level of care. 

While we understand that care of the 

respite patient is much different than 

care of the general inpatient, we do not 

have regulatory authority over assisted 

living facilities or group homes. 

Therefore, to maintain continuity and 

safe care of the respite patient, we 

require that all respite care be provided 

in Medicare or Medicaid certified 

inpatient facilities. This in no way 

prohibits a hospice patient from 

residing in an assisted living facility or 

licensed group home. 

Comment: One commenter requested 

that we add language that states that 

general inpatient care and respite care 

are coordinated by the hospice in a 

Medicare or Medicaid facility. 

Response: We agree with the 

commenter in that care of the general 

inpatient and respite patient must be 

coordinated by the hospice. The 

standard at § 418.108(c), ‘‘Inpatient care 

provided under arrangements’’ has been 

modified to read: ‘‘If the hospice has an 

arrangement with a facility to provide 

for short-term inpatient care, the 

arrangement is described in a legally 

binding written agreement, coordinated 

by the hospice * * *.’’

Comment: A few commenters 

suggested that the inpatient clinical 

record should be provided by the 

inpatient facility only if requested by 

the hospice, and that a discharge 

summary would be routinely provided 

to the hospice at the time of discharge. 

Response: We agree with the 

commenters, and the amended language 

at § 418.108(c)(3) requires the written 

agreement to specify, ‘‘[t]hat the hospice 

patient’s inpatient clinical record 

includes a record of all inpatient 

services furnished and events regarding 

care that occurred at the facility; that a 

copy of the discharge summary be 

provided to the hospice at the time of 

discharge; and that a copy of the 

inpatient clinical record is available to 

the hospice at the time of discharge.’’

Comment: One commenter requested 

that we replace the word ‘‘individual’’

with ‘‘position’’ in proposed 

§ 418.108(c)(4). This would have the 

effect of permitting more than 

individual holding that position to 

implement the provisions of the 

agreement. 

Response: Identifying a single 

individual, rather than a position that 

may be shared by more than one 

individual, in the inpatient facility that 

is responsible for implementing the 

contract, ensures that accountability is 

clearly assigned. Therefore, we are not 

accepting the commenter’s suggestion 

and are finalizing this requirement as 

proposed. 

Comment: A few commenters stated 

that, since inpatient facilities provide 

services to more than one hospice, the 

hospice should retain responsibility for 

ensuring the training of all personnel 

who will be providing care to the 

patients in facilities for which it has 

responsibility, rather than the hospice 

actually arranging such training. In 

addition, a description of the training 

and the names of those giving the 

training would be documented. Another 

commenter noted that hospices have no 

control over the staff of facilities, and 

therefore, requiring hospice 

responsibility for training will pose 

problems for hospices. 

Response: The training of personnel 

who will be furnishing care must be 

specified in the contractual agreement. 

The hospice must ensure that facility 

personnel are trained. Through the 

contractual agreement, the hospice is 

responsible for ensuring that the facility 

makes its staff available for these 

trainings. We agree with the 


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commenters that hospices are 

responsible for ensuring that training 

occurs, but not necessarily arranging for 

or providing such training; therefore, we 

are amending the language at 

§ 418.108(c)(5) and § 418.108(c)(6) to 

require the agreement between the 

hospice and the inpatient facility to 

state: ‘‘that the hospice retains 

responsibility for ensuring that the 

training of personnel who will be 

providing the patient’s care in the 

inpatient facility has been provided and 

that a description of the training and the 

names of those giving the training is 

documented; and (6) A method for 

verifying that the requirements in 

paragraphs (c)(1) through (c)(5) of this 

section are met.’’

Comment: A few comments were 

submitted regarding the proposed 

requirement in § 418.108(d), ‘‘Inpatient 

care limitation.’’ The commenters stated 

that the 20 percent limitation is 

problematic because patients who reside 

a great distance from the hospice must 

be admitted to the hospice, making their 

entire hospice stay an inpatient stay. 

Response: We believe that there may 

be some confusion about the proposal in 

this section. Hospices are permitted to 

admit patients to their own facilities if 

the patient lives a long distance from 

the hospice, cannot stay at home, or for 

any number of other reasons. However, 

if the patient is admitted for a reason 

other than the need for short-term 

respite care, or for symptom 

management or pain ---control, then the 

patient is not receiving an inpatient 

level of care that counts toward the 20 

percent inpatient cap. atients admitted 

for reasons other than short-term respite 

care, symptom management, or pain 

control receive the routine home care 

level of payment. 

20. Condition of Participation: Hospices 

That Provide Inpatient Care Directly 

(§ 418.110) 

We proposed to recodify most of the 

requirements of existing § 418.100 at 

§ 418.110, with some revisions. We 

proposed to recodify, without change, 

the requirements of § 418.100(d), ‘‘Fire 

protection,’’ at § 418.110(d); 

§ 418.100(e), ‘‘Patient areas,’’ at 

§ 418.110(e); § 418.100(f), ’’Patient 

rooms and toilet facilities,’’ at 418.110(f) 

and (g); § 418.100(g), ‘‘Bathroom 

facilities,’’ at § 418.110(h); § 418.100(h), 

‘‘Linen,’’ at § 418.110(k); and 

§ 418.100(k), ‘‘Pharmaceutical services,’’

at § 418.110(m) and (n). 

We proposed to replace existing 

§ 418.100(a) with § 418.110(a), 

‘‘Staffing,’’ and § 418.110(b), ‘‘24-hour 

nursing services.’’ The existing 

regulation requires that a registered 

nurse must provide direct patient care 

on each shift. The two proposed 

standards provide some flexibility and 

would require hospices that provide 

inpatient care in their own inpatient 

facilities to ensure that staffing for all 

services, including nursing services, is 

adequate, based on the volume of 

patients, their acuity, and the level of 

services they need. These standards 

further proposed that staffing must meet 

the needs of patients to ensure that each 

patient’s plan of care is adhered to and 

that the outcomes described in each 

patient’s plan of care are achieved. 

Finally, these standards proposed that 

nursing services must be adequate to 

ensure that each patient is kept 

comfortable, clean, well-groomed, and 

protected from accident, injury, and 

infection. We believe that this outcomebased approach meets the needs of 

patients and hospices without using 

prescriptive requirements. 

At § 418.110(c), ‘‘Physical 

environment,’’ we proposed that the 

hospice maintain a safe physical 

environment that was free of hazards for 

patients, staff, and visitors. In 

§ 418.110(c)(1), ‘‘Safety management,’’

we proposed that the hospice prevent 

situations that posed a real or potential 

threat to the health and safety of the 

patients, others, and property. The 

hospice would be required to promptly 

investigate, correct, and report to 

appropriate State and local bodies with 

jurisdiction all breaches of safety. The 

hospice would be required to take steps 

to prevent equipment failures, and 

correct and report any equipment 

failures promptly. 

In addition, § 418.110(c)(1)(iii) 

proposed to retain 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. In developing and rehearsing their 

disaster preparedness plans, we believe 

that it is important for hospices to be 

engaged with their local and state 

disaster preparedness planning 

counterparts. Although this disaster 

preparedness requirement applies only 

to hospice inpatient facilities, we 

encourage all hospices to be aware of 

the need for disaster planning at the 

hospice, local, and State levels, and to 

actively engage in the planning process. 

We also proposed, at § 418.110(c)(2), 

that the hospice develop procedures for 

managing trash and medical waste 

disposal; light, temperature and 

ventilation; emergency gas and water 

supplies; and equipment maintenance 

and repairs. We believe that these basic 

precautions and actions will help the 

hospice ensure that buildings, as well as 

the equipment inside of them, are fully 

and safely functioning at all times to 

ensure patient and family comfort and 

satisfaction. 

Proposed § 418.110(f), ‘‘Patient 

rooms,’’ would recodify and revise the 

requirements of existing 418.100(f). We 

proposed in § 418.110(f)(3)(iv) that each 

room accommodate no more than two 

patients because we believe that hospice 

patients and families need the 

additional privacy that a two-patient 

room affords them in order to help 

preserve the patient’s comfort and 

dignity during the dying process. We 

believe this is the standard 

accommodation in most facilities. We 

proposed to allow existing hospice 

facilities with more than two patients in 

each room to receive a waiver of this 

requirement. This waiver would be 

based on whether the hospice was 

already providing direct inpatient care 

in a non-compliant facility when this 

regulation became effective. That is, if a 

hospice was providing direct inpatient 

care in a non-compliant building on the 

day before the effective date of the final 

rule and could demonstrate that the 

imposition of a two-patient-per-room 

requirement would result in 

unreasonable hardship or jeopardize its 

ability to continue to participate in 

Medicare or Medicaid, then the hospice 

operating in the non-compliant building 

could qualify for a waiver of the 

proposed requirement. A hospice would 

have to demonstrate to CMS that the 

waiver served the needs of its patients 

and did not adversely affect their health 

and safety. If that same hospice moved 

into a non-compliant building after the 

effective date of this final rule, then the 

hospice would be deemed out of 

compliance with our rules. If a hospice 

chose to begin operating its own 

inpatient unit after the effective date of 

this final rule, then it would not qualify 

for the proposed waiver, and would be 

required to have no more than two 

patients per room. The remaining 

paragraphs in this standard would be 

virtually the same as in the current 

requirement, with only minor revisions 

to the language that would not change 

the substantive requirements of the 

regulation. 

In § 418.110(i), ‘‘Infection control,’’

we proposed to revise the infection 

control standards to conform to those 

required of other provider types, such as 

home health agencies and hospitals. We 

proposed to require a hospice to 

establish an infection control program 

that would protect patients, families, 

and staff against communicable diseases 

and would prevent and control the 


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spread of infections. The infection 

control program would be required to 

follow professionally established 

infection control standards and be part 

of the hospice’s overall quality 

assurance and performance 

improvement and education program. 

We did not propose any specific 

approaches to meeting the infection 

control requirement. 

In § 418.110(l), ‘‘Meal service and 

menu planning,’’ we proposed to revise 

the existing § 418.100(j). We proposed to 

make this standard less restrictive by 

eliminating several structural 

requirements, such as serving at least 

three meals at regular times, with no 

more than 14 hours between substantial 

evening and breakfast meals, and having 

a staff member trained in food 

management or nutrition. In place of 

these prescriptive requirements, we 

proposed that a hospice should focus on 

meeting the individual patient’s 

nutritional and plan of care needs. 

We proposed a new standard at 

§ 418.110(o) to address the use of 

seclusion and restraints in hospice 

inpatient facilities. Anecdotal evidence 

indicates that seclusion and restraints 

are occasionally used in hospice 

inpatient facilities ostensibly to protect 

patients, visitors, and/or staff. The 

proposed requirements, modeled on 

those for hospitals issued by CMS in 

1999, and on the requirements of 

section 3207 of the Children’s Health 

Act (Pub. L. 106–310), would ensure 

that, when seclusion or restraints are 

used, they are used in a safe manner for 

the shortest time necessary to ensure 

patient and staff safety. 

The proposed standard, divided into 

seven elements, focused on the proper 

use of seclusion and restraints, and on 

the need for hospice personnel to 

receive training and education both in 

the proper use of seclusion and restraint 

application and techniques, and in the 

use of alternative methods for handling 

situations that arise. The standard 

proposed specific requirements for 

physician orders for seclusion or 

restraint (for example, consultation with 

the hospice medical director, 1 hour 

face-to-face evaluation of the patient, 

and time limits on the length of orders). 

The proposed standard also included a 

requirement that a hospice would have 

to report to its CMS regional office any 

death that occurs while a patient is 

restrained or in seclusion, or that 

occurred within 24 hours of a patient 

being removed from seclusion or 

restraint. 

Comment: A commenter asked us to 

clarify that the requirements in 

§ 418.110 would apply only to facilities 

operated by the hospice and not to 

nursing facilities or hospitals with 

which the hospice has a contract for 

inpatient care. 

Response: The commenter is correct 

that, with the exception of § 418.110(b) 

and § 418.110(f), the requirements of 

this CoP only apply to hospice operated 

inpatient facilities. These facilities may 

be in a building owned wholly by the 

hospice, or may be in space leased from 

a company or health care provider, such 

as a designated hospice inpatient 

facility leasing and occupying a floor in 

a hospital. In order to clarify our 

longstanding intent that this CoP only 

applies to inpatient facilities operated 

by a hospice, we have added the term 

‘‘in its own facility’’ to the stem 

statement, which now reads, ‘‘[a] 

hospice that provides inpatient care 

directly in its own facility must 

demonstrate compliance with all of the 

following standards.’’ We believe that 

restricting the majority of the 

requirements of § 418.110 to hospiceoperated inpatient facilities, and 

permitting contracted facilities to 

comply with their own applicable 

regulations, will help avoid and 

potential regulatory conflicts between 

the hospice regulations and the 

regulations pertaining to a contracted 

facility (for example, a hospital or 

skilled nursing facility). A contracted 

facility would nonetheless be required 

to comply with (b) and (f), because these 

requirements are necessary to ensure 

appropriate staffing levels to care for 

seriously ill patients receiving the 

general inpatient level of hospice care 

and to ensure that hospice patients and 

families receive the care in a 

comfortable environment. 

Comment: A commenter suggested 

that we should define the term ‘‘nursing 

services’’ as it is used in proposed 

§ 418.110(b) to include the services of 

licensed practical nurses within their 

scope of practice. 

Response: The nursing services, as 

well as all other services, furnished by 

a hospice inpatient facility must meet 

the needs of the patients in the facility. 

Hospices may choose to use registered 

nurses, licensed practical nurses, 

licensed vocational nurses, and any 

other level of nurse to meet the needs 

of their patients. We expect all nurses, 

as well as other professionals, to always 

act within the scope of their training 

and licensure. We do not believe that a 

statement to this effect needs to be in 

regulation because we require in 

§ 418.114 that all professionals must 

obtain the license offered by their State. 

In order to obtain and maintain the 

license, these providers are required by 

their State to practice only within the 

scope of their license. 

Comment: The majority of 

commenters who submitted comments 

on this CoP made suggestions regarding 

the 24-hour nursing services 

requirement at proposed § 418.110(b). 

An overwhelming number of 

commenters suggested that, if a hospice 

is providing general inpatient care, the 

hospice should be required to have a 

registered nurse (RN) on duty at all 

times. These same commenters stated 

that it is not necessary to have a 

registered nurse on duty at all times if 

the hospice is only providing respite 

care. Other commenters agreed with our 

proposal to require that the nursing 

services provided by the hospice must 

meet patient needs rather than requiring 

hospices to have a registered nurse on 

duty at all times. Still other commenters 

suggested that, if a registered nurse is 

not present in the facility, one must be 

available for on-call consultation and 

direct care, if needed. 

Response: We proposed to eliminate 

the 24-hour registered nurse 

requirement in order to make it easier 

for providers to care for respite patients. 

We continue to believe that it is not 

necessary to require a registered nurse 

on duty for all shifts if patients in the 

facility are receiving respite care only, 

and we therefore did not include a 24- 

hour RN requirement in § 418.108(b)(2), 

which pertains to nurse staffing levels 

in facilities that are only providing 

respite level care to hospice patients. At 

the same time, we agree that the needs 

of patients receiving general inpatient 

care, who are in distress to such a 

degree that their pain and symptoms 

cannot be managed in their homes, 

necessarily require care from a 

registered nurse on all shifts. Therefore, 

we have incorporated a requirement for 

24-hour RN services at § 418.110(b)(2), 

and have cross-referenced this 

requirement at § 418.108(a)(2). All 

facilities providing the general inpatient 

level of care, whether operated by the 

hospice or under arrangement with the 

hospice, must provide 24-hour RN care 

if at least one hospice patient is 

receiving general inpatient care. 

Comment: Numerous commenters 

asked us to define and provide 

examples of the terms ‘‘breach of safety’’

and ‘‘equipment failures’’ as they are 

used in proposed § 418.110(c)(1) (i) and 

(ii), respectively. Commenters asked us 

to clarify the relationship between the 

requirements for equipment failures and 

the requirements of the Safe Medical 

Devices Act of 1990 (Pub. L. 101–629). 

Furthermore, commenters asked us to 

clarify which State and local bodies 

should receive reports of safety breaches 

and equipment failures. 


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Response: The intent of these 

proposed requirements was to ensure 

that the proper authorities were alerted 

by hospices regarding situations that 

may jeopardize patient health and 

safety. We agree that this goal has 

already been accomplished both 

through the requirements of the Safe 

Medical Devices Act, with which health 

care providers are required to comply 

(21 U.S.C. § 360L), and the requirements 

of final § 418.110(c)(2)(iv), which 

requires hospices to have procedures for 

controlling the reliability and quality of 

their emergency maintenance and repair 

program for their equipment. Therefore, 

we have deleted the proposed 

requirements. 

Comment: A commenter was 

confused about the requirements for 

chapter 9 of the Life Safety Code, as 

included in proposed § 418.110(d)(4). 

Response: In January 2003 we 

published a final rule adopting the 2000 

edition of the Life Safety Code. The 

2000 edition of the Life Safety Code 

requires health care facilities, including 

hospices, to have emergency lighting 

systems meeting certain specifications. 

We allowed hospices a 3-year phase-in 

period after the effective date of the Life 

Safety Code rule to purchase and install 

their emergency lighting systems. That 

phase-in period expired March 13, 2006. 

Therefore all hospices must now have 

emergency lighting systems that comply 

with the specifications of chapter 9 of 

the 2000 edition of the Life Safety Code. 

Since the phase-in date has now passed, 

we have removed the phase-in language 

in this final hospice rule. We believe 

that removing the phase-in language 

will make it clearer that hospices must 

comply with all of the requirements of 

the 2000 edition of the Life Safety Code. 

Comment: Some commenters 

suggested that we should define the 

terms ‘‘home-like’’ and ‘‘equipped for 

nursing care’’ as they are used in 

proposed § 418.110(e) and (f). 

Response: Hospice inpatient facilities 

have been required, since the inception 

of the Medicare hospice benefit, to have 

a home-like environment for patients 

and families to enjoy. Hospices should 

take all appropriate steps to minimize a 

cold, clinically sterile environment by 

incorporating materials and items 

typically found in private residences 

where appropriate. We understand that 

certain standards of hygiene may 

preclude the use of certain materials or 

objects. We also understand that certain 

machines and devices needed to 

provide medical care to patients may 

need to be present and that such 

machines and equipment may not 

appear ‘‘home-like.’’ We expect 

hospices to take appropriate steps, 

where feasible, to create a soothing, 

inviting atmosphere within the context 

of creating an environment where 

nurses and other hospice staff are able 

to effectively provide care and services. 

Comment: Many commenters 

submitted comments regarding our 

proposal at § 418.110(f), ‘‘Patient 

rooms.’’ Some suggested that hospices 

should be allowed to have more than 

two patients in a room during 

community disasters or evacuations. 

Others suggested that patient rooms 

should be required to accommodate 

families as well as patients. Still others 

supported our proposal to waive the 

maximum two patients per room 

requirement for existing hospice 

facilities. 

Response: We appreciate the support 

and thoughtful comments that we 

received in this area. We agree that the 

two-patient rooms should accommodate 

patients and family members, and we 

have specified this in revised 

§ 418.110(f)(3)(iv). We also agree that 

hospices should be allowed to place 

more than two patients in a room during 

community disasters or evacuations. 

This situation is already addressed 

through separate waiver authority in 

section 1135 of the Act. Furthermore, 

we agree that the two-patient-per-room 

waiver for existing facilities should 

remain. Requiring a hospice to reduce 

the number of beds per room without 

the opportunity for a waiver may reduce 

the number of overall beds available and 

could create a hardship for affected 

facilities and problems for patients 

requiring access to inpatient care. 

Comment: All commenters who 

submitted comments on proposed 

§ 418.110(l), ‘‘Meal service and menu 

planning,’’ supported our proposal to 

replace prescriptive food planning and 

service requirements with requirements 

based on patient needs and goals. 

Response: We thank the commenters 

for their support of this change. The 

final rule will require that food service 

in a hospice inpatient facility be based 

on the needs and wants of the patient 

in the facility, rather than on 

prescriptive regulatory requirements. 

Comment: Numerous commenters 

who submitted comments on our 

proposed seclusion and restraint 

requirements at § 418.110(o) were 

confused about the applicability of the 

proposed standard. Commenters seemed 

to believe that the proposed standard 

would apply to patients in their homes 

or to hospice patients who reside in 

long term care facilities. 

Response: This standard is located in 

the CoP that governs hospice inpatient 

facilities operated by the hospice. It 

only applies to care furnished to 

hospice patients in the hospice’s 

inpatient facility. This requirement does 

not apply to care furnished to hospice 

patients outside of the hospice’s 

inpatient facility. If a hospice contracts 

with another facility (for example, 

hospital, or SNF) for inpatient care, we 

believe that it is preferable for the 

seclusion and restraint requirements for 

that provider to apply to the hospice 

patient. 

Comment: A single commenter 

suggested that we should convene an 

expert task force to examine the use of 

drug restraints in hospice care. 

Response: Under the revised 

definition of ‘‘drug restraints’’

previously described, we believe that it 

will be a rare situation for a hospice to 

use a drug restraint on a patient. Since 

the situation is likely to be very rare, we 

do not believe that it is necessary to 

convene an expert panel to examine the 

issue. Moreover, we are following the 

statutory definition, which applies to 

hospices through the Children’s Health 

Act (42 U.S.C. 290ii(d)(1)(B)). 

Comment: Many commenters made 

suggestions to modify proposed 

§ 418.110(o)(3)(ii) regarding orders for 

seclusion and restraint. One commenter 

sought clarification about the 

prohibition on standing or as needed 

orders for seclusion and restraint. Other 

commenters stated that it would be 

difficult for a hospice physician to get 

to the inpatient facility in time to 

complete the one-hour visit and 

evaluation of a patient in seclusion or 

restraint. A commenter questioned the 

role and responsibility of the attending 

physician ordering restraints or 

seclusion. Other commenters suggested 

that orders be allowed to be written for 

eight or even 24-hour periods, rather 

than only for four hours as proposed. 

One commenter suggested that there 

should be no maximum length of time 

for a seclusion or restraint order. 

Response: An order for seclusion or 

restraint must be specific to the patient, 

time, and place where the intervention 

will be used. A physician may not order 

restraint for a patient unless the patient 

requires such intervention at that very 

moment. In other words, orders based 

on future contingencies are not 

acceptable. 

Hospices may authorize their medical 

director, physician designee, other 

hospice physician employees, and/or 

attending physicians to issue restraint or 

seclusion orders. If an order for 

seclusion or restraint is not ordered by 

the attending physician, medical 

director, or physician designee, then the 

medical director or physician designee 

must be consulted as soon as possible 

after the order is issued. 


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Once an order for seclusion or 

restraint is issued and implemented, the 

patient must be seen within one hour to 

evaluate the need for continuing the 

intervention. We agree that it may be 

difficult for a hospice physician to 

arrive at the inpatient facility and 

actually see the patient within this onehour window. Therefore, we have added 

a provision permitting a registered nurse 

trained in the proper use of seclusion 

and restraint to conduct the one-hour 

face-to-face evaluation of the patient. 

In addition to the one-hour 

evaluation, we believe that it is 

necessary to regularly re-evaluate the 

patient’s status and need for the ordered 

intervention. To ensure a thorough reevaluation, we are requiring orders for 

seclusion or restraint to last no more 

than four hours each for a total of up to 

24 hours. We believe that frequently reordering the intervention will ensure 

that patients remain in seclusion or 

restraint for the shortest time possible to 

control their distress. 

Comment: A commenter asked us to 

clarify the meaning of the term 

‘‘continually’’ as it is used in proposed 

§ 418.110(o)(4)(i). The commenter 

specifically asked if this term meant that 

patients would need to be constantly 

monitored when restraint and seclusion 

are used simultaneously. 

Response: If restraint and seclusion 

are used simultaneously, the patient 

must be continually monitored, face-toface, by an assigned, trained staff 

member or continually monitored by 

trained staff using both video and audio 

equipment. This monitoring must be in 

close proximity to the patient. For the 

purposes of this provision, 

‘‘continually’’ means ongoing without 

interruption. 

Comment: Some commenters 

expressed concern that the presence of 

seclusion and restraint requirements 

would seem to discourage their use, 

even when medically necessary and 

appropriate. Other commenters 

suggested that the requirement proposed 

at § 418.110(o)(7), regarding the 

reporting of seclusion and/or restraintrelated deaths, would discourage the 

use of seclusion and/or restraint because 

hospices would fear that the reports 

would result in State surveys. They 

therefore suggested deleting the 

seclusion and restraint requirements in 

their entirety, while other comments 

suggested that hospices should only be 

required to report unexpected deaths or 

deaths that occur by hanging due to 

physical restraints. 

Response: Seclusion and restraint 

requirements are needed to protect a 

patient from harm by ensuring that 

professionals will be able to 

appropriately use seclusion and 

restraint methods. These regulations 

also implement sections 591–593 of the 

Public Health Service Act, as added by 

section 3207 of the Children’s Health 

Act. In order to further the goal of safe 

and appropriate implementation of 

seclusion and restraint techniques, we 

clarified the training requirements for 

hospice inpatient staff. Staff must be 

trained in techniques to identify 

behaviors, events, and environmental 

factors that may trigger the need for 

seclusion and restraint techniques. Staff 

must also be trained in the following: 

using nonphysical intervention skills, 

choosing the least restrictive 

intervention, safely implementing all 

types of restraint and seclusion, 

recognizing and responding to distress 

signs, identifying behavioral changes 

that indicate that seclusion and restraint 

are no longer necessary, monitoring 

patient well-being, and using first aid 

and cardiopulmonary resuscitation 

techniques. We believe that this staff 

training will minimize the likelihood of 

a patient death related to the use of 

seclusion or restraint for a patient, and 

will thus minimize the number of 

deaths that hospices must report. These 

regulations are similar to those that we 

plan for other facility types, as required 

by section 593(b) of the PHS Act. 

Should a seclusion or restraint-related 

death occur, our intent is to ensure that 

hospices fully investigate the death and 

notify CMS of the death and the 

investigation findings. We have clarified 

that the seclusion and restraint 

investigation and reporting 

requirements in final standard 

§ 418.110(o), ‘‘Death reporting 

requirements,’’ only apply to those 

patients who die unexpectedly. 

Section 592 of the PHS Act requires 

facilities to report all deaths within 24 

hours after a patient is removed from 

restraint or seclusion, or where it is 

reasonable to assume that a patient’s 

death is a result of such seclusion or 

restraint. Therefore, we have also 

clarified that unexpected deaths 

occurring within 24 hours of a patient 

being removed from seclusion and/or 

restraints would need to be investigated. 

We believe that unexpected deaths 

require a full investigation by the 

hospice to determine the presence or 

lack of a relationship between the 

seclusion and/or restraint and the 

patient’s death. We also believe that 

CMS must be apprised of such 

situations because a patient death 

related to seclusion and/or restraint use 

may indicate the presence of patient 

safety issues within the hospice that 

require additional guidance from the 

State or CMS. It is important to 

remember that we are in no way seeking 

to discourage the use of seclusion and 

restraint if, within these regulatory 

boundaries, their use will benefit a 

patient. Our goal is to ensure that 

seclusion and restraint, when used, are 

used in a safe manner for the shortest 

amount of time necessary, as required 

by the PHS Act. 

21. Condition of Participation: Hospices 

That Provide Hospice Care to Residents 

of a SNF/NF or ICF/MR (§ 418.112) 

We currently do not separately 

address the provision of hospice care to 

a hospice-eligible resident of a facility. 

This includes hospice care provided to 

residents who choose to live in skilled 

nursing facilities, nursing facilities, 

intermediate care facilities, and many 

other types of facilities. The provision 

of, and questions related to, hospice 

care for residents of those facilities has 

come under scrutiny as a result of a 

variety of report findings, including 

Operation Restore Trust (ORT) 

activities, Inspector General (OIG) 

reports from 1996, 1997, and 1998, and 

a 2000 report from the Department’s 

Assistant Secretary for Planning and 

Evaluation (ASPE) Office of Disability, 

Aging and Long-Term Care Policy and 

the Urban Institute. (U.S. D.H.H.S. OIG, 

‘‘Hospice and Nursing Home 

Contractual Relationships,’’ Nov. 1997, 

OEI–05–95–00251; OIG Special Fraud 

Alert, ‘‘Fraud and Abuse, Nursing Home 

Arrangements with Hospices,’’ Mar. 

1998; ‘‘Synthesis and Analysis of 

Medicare Hospice Benefit Executive 

Summary and Recommendations.’’

(Harvell, J.; Jackson, B.; Gage, B.; Miller, 

S.; and Mor, V., Mar. 2000)). The 

relationship between hospices and 

nursing facilities was also addressed by 

the Secretary’s Advisory Committee on 

Regulatory Reform. The committee 

focused on clarifying the 

responsibilities of each provider and on 

patient access to the hospice benefit 

while residing in a facility. 

Based on the recommendations of the 

committee, as well as the reports from 

Operation Restore Trust, the Office of 

the Inspector General, and ASPE, we 

proposed to add a new condition at 

§ 418.112, ‘‘Hospices that provide care 

to residents of a SNF/NF, ICF/MR, or 

other facilities.’’ We are also preparing 

a separate regulatory document to 

address long-term care facility 

obligations regarding residents receiving 

hospice services. 

Under § 418.112(a), ‘‘Resident 

eligibility, election and duration of 

benefits,’’ we proposed that the hospice 

ensure that the resident met all the same 

Medicare eligibility requirements for 

hospice care (found at § 418.20 to 


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§ 418.30), as a patient who resides in his 

or her home in the community. 

At § 418.112(b), ‘‘Professional 

management,’’ we proposed that the 

hospice assume full responsibility for 

all of the hospice care provided to the 

patient. This would include making 

arrangements for any inpatient care that 

the patient would require in accordance 

with § 418.100. This standard would 

reinforce the necessity of continuity of 

care for patients who reside in a SNF/ 

NF, ICF/MR, or other facility. In 

§ 418.112(c), ‘‘Core services,’’ (and in 

accordance with sections 1861(dd)(1) 

and (2)(A) of the Act), we proposed that 

the hospice be required to provide all 

necessary core services to its patients 

residing in a SNF/NF, ICF/MR, or other 

facility in the same manner that it 

would provide such core services to a 

patient residing in a home in the 

community. It is not reasonable for the 

hospice to delegate any of its standard 

hospice core services to the nursing or 

residential facility staff. 

In § 418.112(d), ‘‘Medical director,’’

we proposed that a hospice medical 

director would be expected to 

communicate with all facility 

physicians, including the facility’s 

medical director, and the attending 

physician and other professionals 

involved in developing and/or 

implementing the patient’s plan of care. 

This standard was designed to ensure 

that all physicians, including those in 

leadership positions, were in agreement 

regarding the patient’s care to ensure 

that duplicative and/or conflicting 

physician orders are not issued for 

patient care. 

Under § 418.112(e), ‘‘Written 

agreement,’’ we proposed that a 

comprehensive written agreement be 

developed between the hospice and 

facility, and that it be in effect before 

any hospice care was provided to a 

facility resident. The purpose of the 

written agreement would be to ensure 

that the duties and responsibilities of 

the hospice and facility were clearly 

articulated and executed in a manner 

that ensured that the patient would 

receive quality hospice care. The 

written agreement would be required to 

include the following: 

(1) Written consent and 

documentation of the patient or the 

representative’s desire for hospice 

services. 

(2) Identification of the services that 

the hospice and the facility would 

provide. 

(3) The manner in which the facility 

and the hospice would communicate to 

ensure that the needs of the patient were 

addressed and met 24 hours a day. 

(4) A requirement that the facility 

immediately notify the hospice when: 

(A) A significant change in the 

patient’s physical, mental, social or 

emotional status occurred; 

(B) Clinical complications appeared 

that suggested a need to alter the plan 

of care; 

(C) A life threatening condition(s) 

appeared; 

(D) A need to transfer the patient from 

the facility arose; or 

(E) The patient died. 

(5) A provision stating that the 

hospice assumed responsibility for 

determining the appropriate course of 

care, including the determination to 

change the level of services provided. 

(An agreement that it was the facility’s 

primary responsibility to furnish room 

and board.) 

(6) A delineation of the hospice’s 

responsibilities, which would include, 

but not be limited to, providing medical 

direction and management of the 

patient, nursing, counseling (including 

spiritual and dietary counseling), social 

work, bereavement counseling, 

provision of medical supplies and 

durable medical equipment, provision 

of drugs necessary for the palliation of 

pain and symptoms associated with the 

terminal illness and related conditions, 

as well as all other hospice services that 

might be necessary for the care of the 

resident’s terminal illness and related 

conditions. 

(7) A provision that the hospice could 

use the facility’s nursing personnel 

where permitted by law and as specified 

by the facility to assist in the 

administration of prescribed therapies 

included in the plan of care, but only to 

the extent that the hospice would 

routinely use the services of a hospice 

patient’s family in implementing the 

plan of care. 

These would be mandatory agreement 

provisions, but would not otherwise 

limit the scope or content of the 

relationship between the hospice and 

the facility. Additional provisions could 

be added subject to mutual agreement. 

Under § 418.112(f), ‘‘Hospice plan of 

care,’’ we proposed that the content of 

the plan of care for a patient residing in 

a SNF/NF, ICF/MR, or other residential 

facility would be similar to the content 

of the plan of care for a patient residing 

in a home in the community. The plan 

would have to reflect the hospice 

philosophy in all aspects, be based on 

an assessment of the patient’s needs and 

unique living situation in the facility, 

and be updated at least every 14 

calendar days. In addition to the 

standard plan of care requirements, the 

plan of care for a patient residing in a 

SNF/NF, ICF/MR, or other facility 

would be required to be coordinated 

with and developed by the hospice IDG 

and SNF/NF, ICF/MR, or other facility 

in collaboration with the attending 

physician. Furthermore, the plan of care 

would have to specify which provider 

would be responsible for providing a 

particular form of care. The performance 

of the functions would reflect the 

participation of the hospice, SNF/NF, 

ICF/MR, or other facility, and the 

patient and family to the extent 

possible. 

At § 418.112(g), ‘‘Coordination of 

services,’’ we proposed that the hospice 

designate a member of the IDG to 

coordinate the implementation of the 

plan. The hospice would provide the 

residential facility with the plan of care, 

hospice consent form, contact 

information for hospice personnel 

involved in the care of the resident, 

instructions on accessing the hospice 

24-hour on-call system, medication 

information specific to the patient, 

physician orders, and any advance 

directives. We believe that these 

requirements would ensure effective 

communication between the hospice 

and the facility. 

Under § 418.112(h), ‘‘Transfer, 

revocation, or discharge from hospice 

care,’’ we proposed to cross-reference 

the proposed requirement for discharge 

or revocation at § 418.104(e). In 

addition, we proposed that discharge or 

revocation of the hospice care would 

not impact the eligibility to continue to 

reside in a SNF/NF, ICF/MR, or other 

facility. 

At § 418.112(i), ‘‘Orientation and 

training of staff,’’ we proposed that the 

hospice staff would be required to train 

facility staff who provided care to 

hospice patients on aspects of the 

hospice philosophy and unique program 

features, including policies and 

procedures, methods of comfort, pain 

control and symptom management, 

general principles about death and 

dying and individual responses, patient 

rights, appropriate forms, and record 

keeping requirements. 

Comment: Many commenters 

suggested that the phrase ‘‘other 

facilities’’ be removed from the title and 

text of this CoP. The commenters stated 

that this phrase was too broad and 

imprecise to enable hospices to 

effectively determine when they would 

have to comply with the additional 

requirements of this CoP. Some 

commenters suggested that ‘‘other 

facilities’’ should only apply to those 

that were Medicare-or Medicaidapproved, while others suggested that 

assisted living facilities could be 

included as well. 


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Response: We agree that the phrase 

‘‘other facilities’’ is ambiguous and 

difficult to objectively determine. We 

also agree that this requirement should 

be limited to those facilities that can be 

Medicare-certified so as not to impose a 

de facto burden upon facilities that do 

not receive Medicare funds. Therefore, 

this final requirement applies only to 

those types of residential facilities that 

are eligible to be Medicare-certified, that 

is SNFs, NFs, and ICFs/MR. Hospices 

are permitted to use the structure and 

content of this section when 

establishing and managing their 

relationships with other facility types 

such as assisted living facilities. 

Comment: A commenter asked us to 

clarify that the requirement of proposed 

§ 418.112(a) regarding eligibility criteria 

would apply to residents of ICFs/MR in 

addition to residents of SNFs and NFs. 

Response: We agree that this 

clarification would be helpful, and we 

have made the suggested change. 

Comment: Many commenters asked 

us to specify in § 418.112(b) that 

hospices would only be responsible for 

making the necessary arrangements for 

inpatient care related to a patient’s 

hospice care (that is, the terminal illness 

and related conditions). 

Response: We agree that is it helpful 

to clarify that the hospice is responsible 

for hospice-related inpatient care for the 

patient, and we have made this change. 

In addition, we have clarified that the 

arrangements for hospice inpatient care 

must be in accordance with the 

requirements of § 418.108, ‘‘Short term 

inpatient care,’’ as well as the 

requirements of § 418.100(e), 

‘‘Professional management 

responsibility.’’ We believe that the new 

reference to the requirements of 

§ 418.108 will ensure that hospices 

make arrangements with the appropriate 

facilities and ensure proper staffing to 

meet the needs of the patient. 

Comment: Numerous commenters 

sought clarification on proposed 

§ 418.112(b), ‘‘Professional 

management.’’ Commenters were 

confused by the proposed requirement 

that the hospice must assume full 

responsibility for professional 

management of the resident’s hospice 

care. They believed that this 

requirement could create conflicts with 

long term care facility responsibilities. 

One commenter suggested that, in order 

to further clarify the hospice’s 

responsibility, we should add a 

statement that the hospice is responsible 

for those services that are included in 

the hospice plan of care. Another 

commenter suggested that deleting the 

word ‘‘full’’ would clarify the scope of 

the hospice’s responsibility. 

Response: We agree that further 

clarification is warranted in this 

standard. Hospices are only responsible 

for furnishing and managing a patient’s 

hospice care related to the terminal 

illness and related conditions. They are 

not responsible for managing all of a 

patient’s care. We believe that requiring 

hospices to take responsibility for the 

care they furnish is not in conflict with 

the long term care facility regulations at 

42 CFR part 483. To ensure that our 

intent is clear in the requirement, we 

have removed the word ‘‘full’’ and have 

added a provision that the hospice is 

responsible for services provided in 

accordance with the plan of care. 

Revised standard (b) now reads, ‘‘[t]he 

hospice must assume responsibility for 

professional management of the 

resident’s hospice services provided, in 

accordance with the hospice plan of 

care and the hospice conditions of 

participation, and make any 

arrangements necessary for hospicerelated inpatient care in a participating 

Medicare/Medicaid facility according to 

§ 418.100 and § 418.108.’’

Comment: A commenter sought 

additional clarification on the 

distinction between coordination of care 

and responsibility for the provision of 

care as the latter appears in the 

proposed rule at § 418.112(b). 

Response: Hospices are responsible 

for furnishing all care and services 

related to the terminal illness and 

related conditions as those services are 

identified in the plan of care, regardless 

of where the patient resides. Hospices 

are required by section 1861(dd) of the 

Act to provide some of these services 

directly, while other services may be 

provided under arrangement. Regardless 

of whether the hospice services are 

provided directly or under arrangement, 

hospices are required to assume full 

professional management responsibility 

for those services. In addition, hospices 

are required to designate a registered 

nurse who is a member of the hospice’s 

IDG to coordinate the implementation of 

the patient’s hospice care and services. 

Furthermore, hospices are required to 

have a system of communication to 

ensure that all disciplines furnishing 

hospice care to patients communicate 

with each other about patient needs. 

This system of communication must 

also include a sharing of information 

with health care providers that are 

simultaneously caring for the same 

patients that the hospice is caring for to 

ensure that the hospice is able to 

coordinate its care with that being 

provided by others. 

Through these mechanisms, the 

hospice maintains responsibility for all 

of its care and services for all of its 

patients and ensures that the care it is 

providing complements the care being 

provided by others. In addition to these 

mechanisms used for all patients, 

hospices are required to establish 

written agreements and communication 

systems with SNFs, NFs, and ICFs/MR 

when hospices are furnishing hospice 

care to residents of those facilities. Clear 

communication between the hospice 

and the SNF/NF or ICF/MR will help 

hospices ensure that they are meeting 

their responsibility to furnish the care 

necessary to meet the needs of its 

patients. 

Comment: Many commenters 

suggested that we should revise or 

remove the proposed requirement at 

§ 418.112(e)(4)(iii) that the written 

agreement between a hospice and a 

SNF/NF or ICF/MR must contain a 

provision that the facility notifies the 

hospice if a life-threatening condition 

appears in a hospice patient. Some 

commenters stated that this should be 

clarified to state that the life-threatening 

condition is only required to be reported 

if it is unrelated to the terminal illness 

and related conditions. Other 

commenters stated that this should be 

removed because the requirement at 

proposed § 418.112(e)(4)(i), stating that 

the facility must notify the hospice if a 

significant change in a patient’s status 

occurs, would apply to life-threatening 

conditions as well. 

Response: We agree that proposed 

§ 418.112(e)(4)(i), now located at 

418.112(c)(2)(i), applies to life 

threatening conditions, and, as a result, 

we have deleted the proposed 

requirement at § 418.112(e)(4)(iii). 

Comment: Many commenters asked 

us to clarify or remove the proposed 

requirements of § 418.112(e)(6), which 

would require the agreement between 

the hospice and the residential facility 

to state that it would be the residential 

facility’s primary responsibility to 

furnish room and board. Commenters 

stated that, although SNFs/NFs and 

ICFs/MR do provide room and board, 

describing these functions as their 

primary responsibility ignores the other 

functions that the facilities perform. 

Commenters also stated that the services 

provided by the SNF/NF or ICF/MR 

should not be assumed by the hospice. 

Rather, the commenters stated, the SNF/ 

NF or ICF/MR should furnish services 

in the role of the primary caregiver at 

the same level that would have been 

provided if the resident had not elected 

to receive hospice care. 

Response: We agree that the term 

‘‘primary’’ unnecessarily excludes the 

other functions that SNFs/NFs and 

ICFs/MR perform for their residents, 

and it has been deleted. Nonetheless, 


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the responsibility of room and board 

will be deemed to be that of the 

residential facility. In addition, we have 

expanded this requirement to clarify 

that hospices should not be expected to 

assume the functions of the SNF/NF or 

ICF/MR. The revised requirement, 

located at new § 418.112(c)(4), requires 

the agreement to state that ‘‘it is the 

SNF/NF or ICF/MR’s responsibility to 

continue to furnish 24-hour room and 

board care, meeting the personal care 

and nursing needs that would have been 

provided by the primary caregiver at 

home at the same level of care provided 

before hospice care was elected.’’ This 

expanded requirement clarifies that 

hospices are not required to assume the 

functions that the SNF/NF or ICF/MR 

performed for the patient before the 

patient elected to receive hospice care. 

This requirement is not, however, meant 

to imply that the SNF/NF or ICF/MR is 

required to automatically increase its 

level of services simply because the 

resident has elected to receive hospice 

care. All Medicare and Medicaid 

approved facilities, be they SNFs/NFs or 

ICFs/MR are responsible for providing 

services to their residents in accordance 

with their respective laws and 

regulations. 

Comment: Numerous commenters 

suggested that the written agreement 

between the hospice and the SNF/NF or 

ICF/MR should contain a provision that 

the SNF/NF or ICF/MR will continue to 

provide services at the same level as 

those services would have been 

provided before the patient elected the 

hospice benefit. 

Response: We agree that it is 

beneficial for hospice patients to 

continue to receive the same level of 

services provided by the SNF/NF or 

ICF/MR upon entry into the hospice 

program. These facilities often function 

as a patient’s family, and, just as 

hospices are not expected to replace the 

role of the family in caring for hospice 

patients, we do not expect hospices to 

replace the role of the SNF/NF or ICF/ 

MR staff in caring for hospice patients 

who reside in those facilities. We have 

clarified proposed § 418.112(e)(6) to this 

effect, and have relocated the 

requirement to new § 418.112(c)(4). To 

further clarify this issue, we have also 

added a new requirement for the written 

agreement, located at § 418.112(c)(5), 

that it is the hospice’s responsibility to 

provide services to residents of a SNF/ 

NF or ICF/MR at the same level and to 

the same extent as those services would 

be provided to patients residing in their 

own private homes. Regardless of where 

a patient resides, a hospice is 

continually responsible for furnishing 

core services, and may not delegate 

these services to the staff of a SNF/NF 

or ICF/MR. We believe that this new 

requirement will help to ensure 

consistent, high quality hospice care for 

all hospice patients, regardless of their 

place of residence. 

Comment: Numerous commenters 

sought clarification on our proposal at 

§ 418.112(e)(8) that a hospice may use 

the nursing personnel of the SNF/NF or 

ICF/MR, where permitted by law and as 

specified by the facility, to assist in 

administering hospice care, to the extent 

that the hospice would routinely use a 

patient’s family to implement the plan 

of care. Some commenters suggested 

that hospices should be allowed to use 

the nursing personnel of SNFs/NFs or 

ICFs/MR to a greater extent than family 

members would be used, because the 

nursing personnel have more training 

and education in furnishing medical 

care than family caregivers typically do. 

Other commenters wanted to know how 

this provision would affect the long 

term care facility requirement that long 

term care facility staff must provide care 

to residents as needed to maintain 

resident well-being. Other commenters 

were concerned that utilizing facility 

nursing personnel could be a ‘‘slippery 

slope’’ whereby hospices would 

delegate essential tasks to the facility’s 

personnel. Still other commenters 

sought clarification regarding which 

laws would apply to hospices utilizing 

facility personnel to implement the plan 

of care. These commenters suggested 

that State laws would most 

appropriately apply. A single 

commenter suggested that the personnel 

of the SNF/NF or ICF/MR should be 

expected to provide all nursing care 

unless the facility specifically asks the 

hospice to perform a nursing function. 

Response: The utilization of SNF/NF 

or ICF/MR personnel in implementing 

the hospice plan of care for a patient is 

difficult to address because both 

hospices and these facilities provide 

varying levels of care based on the 

needs of the patient/resident. We agree 

that State laws are best suited to 

governing the use of facility personnel 

by hospice staff, and we have specified 

this in the final rule. This provision is 

not intended to preempt any State laws 

that may apportion duties between 

hospice and residential facility staff. 

We proposed that hospices may only 

use the staff of the SNF/NF or ICF/MR 

as specified in the written agreement 

signed by the SNF/NF or ICF/MR. This 

is being retained in the final rule at 

§ 418.112(c)(7). It recognizes that 

facilities must give consent for their 

staff to be used in caring for the hospice 

patient and must determine the extent 

of staff involvement. This consent 

allows facilities and hospices to match 

their corresponding levels of available 

personnel service to the needs of the 

patients being served. As stated above, 

hospices are not responsible for 

assuming the functions that the SNF/NF 

or ICF/MR performed for the patient 

before the patient elected to receive 

hospice care. Likewise, SNFs/NFs and 

ICFs/MR are not responsible for 

assuming the functions that the hospice 

would provide for a patient residing in 

his or her own home. 

The hospice benefit is not designed so 

that hospice personnel routinely 

provide 24-hour care or serve as the 

patient’s primary caregiver. Hospice 

patients in their private homes have 

private caregivers, be they family 

members, friends, hospice volunteers, 

paid assistants, or any of a number of 

other combinations. These caregivers 

are trained by the hospice to administer 

care in accordance with the patient’s 

plan of care. Caregivers may help 

patients with a variety of duties, such as 

medication administration, bathing, and 

housekeeping. 

Hospice patients in SNFs/NFs and 

ICFs/MR depend, at least in part, on 

facility staff to provide caregiver 

services. As such, we believe that it is 

reasonable to allow hospices to use 

facility staff who act as caregivers in the 

same manner and to the same extent 

that hospices would use family 

members, friends or other caregivers 

who care for patients in their private 

residences. For example, hospices 

typically instruct home caregivers in 

how and when to administer 

medications to hospice patients. 

Therefore, it would be appropriate to 

instruct facility staff caregivers in how 

and when to administer medications. 

Hospices typically do not instruct home 

caregivers in how to draw blood to 

monitor medication levels; thus it 

would not be appropriate to expect 

facility staff to draw blood, even though 

some members of the facility’s staff may 

be competent to do so. Hospices are to 

use facility staff in the same way that 

they would use home caregivers to 

implement the patient’s plan of care. 

While facility staff presumably possess 

more sophisticated health care skills 

than home caregivers, they may not be 

used to perform functions more 

frequently, or with a greater degree of 

complexity, than the hospice would 

utilize home caregivers under similar 

circumstances. 

We understand that, in times of crisis, 

it may be necessary for a hospice to 

direct staff of the SNF/NF or ICF/MR to 

perform more sophisticated functions 

than caregivers would typically perform 

in order to ensure patient comfort while 


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the hospice staff are in route to the 

patient. A hospice should, in the 

contract between it and the facility, 

address potential crisis situations, and 

how they would be handled, with 

facility staff. Potential crisis situations 

specific to the circumstances of 

individual patients should also be 

included in individual plans of care. 

The temporary emergency measures 

should be undertaken at the direction of 

the hospice, which maintains 

responsibility for ensuring that all 

hospice care is provided in accordance 

with the patient’s plan of care. 

We understand that this does not 

provide the exact specificity of what 

functions may or may not be performed 

by facility caregivers that some 

commenters sought. We cannot provide 

an absolute list because such a list is 

subject to many variables (for example, 

patient needs, provisions of the written 

agreement, staff skill levels, etc.). 

Comment: Some commenters 

supported, while others demurred, on 

our proposal, originally at § 418.64(d), 

to require hospices to provide 

bereavement services to facility 

personnel when appropriate and 

identified in the patient’s plan of care. 

Response: We appreciate the support 

that we received regarding bereavement 

services furnished to facility personnel. 

There are times when facility employees 

fulfill the role of a patient’s family, 

providing caregiver services, being 

companions, and generally supporting 

the patient. In order to ensure that the 

needs of these individuals are met in a 

manner that accommodates the needs 

and responsibilities of the hospice and 

the SNF/NF or ICF/MR, we moved the 

requirements concerning bereavement 

care for staff from 418.64, ‘‘Core 

services,’’ to 418.112(c), which governs 

the written agreement between a 

hospice and a facility. The relocated 

requirement at 418.112(c)(9) requires 

the written agreement to include a 

provision delineating the 

responsibilities of the hospice and the 

facility with regard to providing 

bereavement services to facility staff 

that fulfill the role of a hospice patient’s 

family. 

Comment: Numerous commenters 

suggested that the proposed written 

agreement requirements at § 418.112(e) 

should be clarified. A primary concern 

of the commenters was the proposed 

requirement that the written agreement 

must include the written consent of the 

patient or the patient’s representative 

that hospice services are desired. 

Commenters stated that this proposed 

requirement implies that a new written 

agreement must be developed for each 

resident who receives hospice services. 

Commenters then noted that, if a written 

agreement is necessary per patient, it 

may be difficult to secure the agreement 

before furnishing care to the patient. 

Response: We agree that the proposed 

requirement implied that a new written 

agreement must be developed for each 

resident who receives hospice services. 

We also agree that such a requirement 

would be difficult to fulfill before any 

hospice services are furnished to a 

specific patient. As a proxy for the 

written consent of the patient or 

representative, we will use the 

requirement at new § 418.112(e)(3)(ii), 

which requires hospices to provide 

SNFs/NFs, ICFs/MR, and assisted living 

facilities with each patient’s hospice 

election form, to ensure that each 

provider is aware of the patient’s choice 

to receive hospice care. In this way, the 

election form is not linked to the 

content of the written agreement. We 

believe that this will help to clarify that 

the written agreement does not need to 

be completed for each and every patient 

who is a resident of an SNF/NF or ICF/ 

MR. In addition, we believe that this 

will make it easier for hospices to secure 

agreements before furnishing care to the 

patient because they will be required to 

secure the agreements less often than 

was implied. 

We would like to clarify that the 

written agreement requirements only 

apply to hospice patients who are 

residents of SNFs/NFs and ICFs/MR. 

The written agreement, and the 

remaining requirements of § 418.112, do 

not apply to hospice patients who are 

placed in SNFs/NFs for general 

inpatient or respite care by the hospice 

itself. Rather, the requirements for the 

written agreement between a hospice 

and a facility that furnishes general 

inpatient or respite care are described in 

§ 418.108(c). 

Comment: Several commenters 

suggested that we should add a 

provision requiring the written 

agreement to contain information about 

the services to be provided by the SNF/ 

NF or ICF/MR. 

Response: The services provided by 

the SNF/NF or ICF/MR will vary based 

on the plan of care which will identify 

the resident’s needs. The written 

agreement established between the 

hospice and the SNF/NF or ICF/MR is 

not the appropriate place for a list of the 

services to be provided by the SNF/NF 

or ICF/MR. The services provided by the 

facility are included in the plan of care 

and coordinated by the hospice and the 

facility in accordance with new 

§ 418.112(d). 

Comment: Some commenters 

expressed confusion about the proposed 

hospice plan of care requirements at 

proposed § 418.112(f). Commenters 

questioned if the standard required 

hospices and SNFs/NFs and ICFs/MR to 

have a single plan of care that applied 

to both providers. If so, commenters 

stated that updating the plan of care 

every 14 days would be burdensome to 

long term care facilities that otherwise 

would be required to update the 

resident’s plan of care only every three 

months. 

Response: Hospices and SNFs/NFs 

and ICFs/MR must have a single plan 

for each patient. We would expect the 

hospice and the facility to develop and 

update this plan in full consultation 

with each other. The hospice portion of 

the plan of care governs the actions of 

the hospice and describes the services 

that are needed to care for the patient. 

The patient’s single, coordinated plan of 

care must identify which provider 

(hospice or facility) is responsible for 

performing a specific service. The plan 

of care may be divided into two 

portions, one of which is maintained by 

the long term care facility and the other 

of which is maintained by the hospice. 

These two sections must work together 

to ensure that the needs of the patient 

for both hospice care and long term care 

facility care are met at all times. The 

facility is required to update its portion 

of the plan of care in accordance with 

any Federal, State or local laws and 

regulations governing the particular 

facility just as hospices would need to 

update their plans of care according to 

§ 418.56(d) of these CoPs. 

Comment: As with the proposed 

update of the plan of care requirements 

in § 418.56, many commenters 

suggested changes to the update 

timeframe for the hospice plan of care 

for residents of SNFs/NFs and ICFs/MR. 

Commenters suggested that the update 

timeframe be changed from ‘‘at least 

every 14 days’’ to ‘‘at least every 15 

days’’ or ‘‘at least twice a month.’’

Response: We agree that the update 

timeframe should be lengthened to at 

least every 15 days to correspond with 

the lengths of the Medicare hospice 

benefit periods. This change has been 

made by referencing the requirements of 

§ 418.56, which includes an every-15- 

day update timeframe. 

Comment: A commenter suggested 

that we should clarify that the hospice 

plan of care must be based on a 

comprehensive assessment of the 

patient’s needs. 

Response: We agree that the plan of 

care must address those needs identified 

in the comprehensive assessment of the 

patient. This requirement is included in 

§ 418.56, and the revised hospice plan 

of care standard at new § 418.112(d) 

references the requirements of § 418.56. 


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Comment: Numerous commenters 

suggested that the proposed requirement 

at § 418.112(f)(4) should be clarified. 

Specifically, these commenters 

expressed concern about the proposed 

requirement that changes in the plan of 

care must be discussed ‘‘among all 

caregivers.’’ These commenters stated 

that the phrase ‘‘among all caregivers’’

was very broad, considering that 

multiple facility staff may act as 

caregivers for a resident on any given 

day. Some commenters suggested that 

‘‘between both providers’’ or ‘‘discussed 

by the IDG, facility representatives and 

the patient/family’’ should replace the 

phrase ‘‘among all caregivers.’’

Response: We agree that discussing 

plan of care changes with ‘‘all 

caregivers’’ should be replaced by a 

more definite requirement. Therefore, 

the final rule at § 418.112(d)(3) requires 

changes in the hospice portion of the 

plan of care to be ‘‘discussed with the 

patient or representative, and SNF/NF 

or ICF/MR representatives* * *’’ This 

revised requirement allows the facility 

to identify those with whom plan of 

care discussions must occur and 

provides hospices with a defined list of 

those individuals who must be 

consulted before a change in the hospice 

portion of the plan of care is 

implemented. The revised requirement 

still states that the hospice must 

approve any changes to the hospice 

portion of the plan of care before those 

changes are implemented. We believe 

that this enables hospices to maintain 

control over the hospice portion of the 

plan of care while allowing facilities to 

have their voices heard before final 

decisions are made about hospice care. 

Comment: A commenter wanted to 

know what forms of communication are 

acceptable between the hospice and the 

residential facility concerning care 

planning. 

Response: Hospices are free to use any 

form of communication that best suits 

their needs in accordance with their 

established system of communication as 

required by § 418.56(e). In accordance 

with 418.112(c)(1) of this final rule, 

hospices must document that this 

communication has occurred to ensure 

that the hospice has made all necessary 

efforts to consult facility representatives 

in hospice care planning activities. 

Comment: A large number of 

commenters requested clarification of 

the proposed medical director 

requirement at proposed § 418.112(d). 

The overall response of commenters was 

that the proposed requirements were 

overly burdensome. Many of these 

commenters suggested that the medical 

director requirement should be entirely 

deleted. Others suggested that the 

communication responsibilities 

assigned to the hospice medical director 

would be more appropriately handled 

by all physicians in the hospice, the 

hospice IDG, or the RN member of the 

IDG who is assigned the care plan 

coordinator role. Still others expressed 

concern that the proposed medical 

director communication requirement 

would overwhelm SNF/NF and ICF/MR 

medical directors with information 

about the care of patients that they are 

not actively involved with. 

Response: Our intent in proposing the 

medical director requirement was to 

ensure that there was communication 

and agreement among the clinical 

leadership of both providers. The 

purpose of this communication was to 

ensure that these senior physicians did 

not issue incompatible care orders for 

the same patient or otherwise disagree 

on the approach to patient care. 

However, as some commenters noted, 

hospice and facility medical directors 

are not necessarily involved in actively 

caring for all patients and facility 

residents. Some hospices and facilities 

have multiple physicians, and one of 

these physicians, rather than the 

medical director, could potentially be 

the most knowledgeable with respect to 

the care of a particular patient or 

resident. For this reason, we agree that 

it is appropriate to remove the medical 

director requirement. We also agree that 

it is appropriate to reassign 

communication responsibilities to the 

IDG responsible for caring for the 

resident of a SNF/NF or ICF/MR. New 

§ 418.112(e) requires the hospice IDG to 

designate one of its members to 

coordinate the patient’s hospice care 

with representatives of the SNF/NF or 

ICF/MR. The designated IDG member 

must also communicate with 

representatives of the SNF/NF or ICF/ 

MR and any other health care providers 

to ensure quality care for the patient. 

Additionally, the designated IDG 

member must ensure that the hospice 

IDG communicates with the SNF/NF or 

ICF/MR medical director, the patient’s 

attending physician, and any other 

physicians caring for the patient as 

needed to coordinate the patient’s 

hospice care with the care provided by 

other entities. We believe that this new 

requirement will alleviate the demand 

on the hospice and facility medical 

directors while actively involving all 

members of the patient’s care team, both 

within the hospice and the facility, in 

care planning and delivery. 

Comment: Commenters expressed 

general support for the coordination of 

services requirement at proposed 

§ 418.112(g), stating that it would have 

the greatest potential for strengthening 

the partnerships between hospices and 

SNFs/NFs and ICFs/MR. Several 

commenters suggested that we specify 

that the hospice provide the SNF/NF or 

ICF/MR with a copy of the hospice plan 

of care. 

The commenters believe that 

requiring this would reinforce the fact 

that the hospice and the facility have 

separate, but coordinated plans of care 

for each patient. Other commenters 

suggested that, in addition to the 

original hospice plan of care, facilities 

should also be provided with updated 

plans of care. Still other commenters 

suggested that hospices should provide 

SNFs/NFs and ICFs/MR copies of each 

patient’s initial certification and 

recertification of terminal illness forms. 

Response: We appreciate the general 

support of this requirement. We agree 

that this standard, now at § 418.112(e), 

should specify that hospices provide 

facilities with the most recent hospice 

plan of care. This will ensure that 

facilities have the most current plan for 

what services the hospice is providing 

as well as what services they are 

committed to providing. We also agree 

that it is helpful for the hospice to 

provide the facility with a patient’s 

certification and recertification forms. 

Having these forms on file will serve as 

a reminder to the facility that the patient 

is terminally ill and that he or she is a 

Medicare hospice beneficiary. 

Comment: A few commenters sought 

clarification about what kind of 

physician orders hospices would 

provide to facilities. Other commenters 

suggested that we should take action to 

require SNFs/NFs and ICFs/MR to 

accept hospice physician orders. 

Response: Although a large amount of 

the care decided upon by the hospice 

IDG does not require specific physician 

orders, certain elements of the plan of 

care, such as medications and laboratory 

work, do require physician orders. 

Whenever physician orders are issued, 

whether by the hospice physician or the 

attending physician in coordination 

with the hospice, a copy of those orders 

must be provided to the SNF/NF or ICF/ 

MR in a timely manner. Providing a 

copy of physician orders to the SNF/NF 

or ICF/MR allows the staff of the facility 

to implement any portions of the order 

for which they may be responsible. 

Providing a copy of orders is simply 

another way in which the hospice keeps 

the SNF/NF or ICF/MR abreast of its 

hospice care activities. In the final rule 

at § 418.112(e)(3)(vii) we clarified that 

the ‘‘physician orders’’ supplied by the 

hospice are those issued by the hospice 

physician(s) and the patient’s attending 

physician (if any). The acceptance of 

hospice physician orders by residential 


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facility staff is not within the purview 

of this rule. In its contract with the 

residential facility, the hospice is 

responsible for ensuring that the 

management of the residential facility 

communicates with its staff regarding 

the acceptability of hospice physician 

orders. 

Comment: A majority of commenters 

who submitted recommendations on 

this CoP recommended that we revise 

the proposed requirement at § 418.112(i) 

regarding the training of staff of a SNF/ 

NF or ICF/MR in hospice philosophy. 

Most of these commenters noted that a 

SNF/NF or ICF/MR may work with 

several different hospices and that 

facility staff should not be required to be 

oriented to hospice philosophy by every 

hospice. The commenters suggested that 

hospices be required to assure that the 

staff of the SNF/NF or ICF/MR has 

received the required training, rather 

than requiring each hospice to provide 

the training. One commenter suggested 

that the responsibility for orienting 

facility staff in hospice philosophy 

should fall to the facility, rather than the 

hospice. 

Response: The intent of this proposed 

standard was to ensure that facility staff 

who furnish care to patients are 

provided information on the hospice 

philosophy and approach to care, much 

in the same way that home caregivers 

are routinely provided information on 

the hospice philosophy and approach to 

care. We agree that facility staff should 

not be oriented multiple times using the 

same basic information. Therefore, we 

have amended this requirement at new 

§ 418.112(f) of the final rule to state that 

hospices must assure the orientation of 

facility staff. 

At the same time, we note that the 

entire purpose for using outside 

hospices to furnish hospice care to 

facility residents is to fulfill a need that 

the facility is not able to fulfill on its 

own. If a facility is unable to provide 

hospice care because it lacks the 

capability to do so, then the facility is 

certainly not qualified to orient its staff 

in hospice philosophy. Furthermore, the 

facility would not be qualified to orient 

its staff in a particular hospice’s policies 

and procedures, patient rights, forms, 

and record keeping requirements. In 

that case, the hospice working with the 

facility needs to provide information, 

guidance and/or staff to assure 

orientation of the facility staff. 

Comment: Several commenters asked 

how frequently hospices are to be 

involved in offering training to facility 

staff, considering the high staff turnover 

rates of some facilities. Commenters also 

questioned who might be in the best 

position to coordinate the training 

sessions. 

Response: It is the hospice’s 

responsibility to coordinate the 

trainings with representatives of the 

facility. It is also the hospice’s 

responsibility to determine how 

frequently training needs to be offered 

in order to ensure that the staff 

furnishing care to hospice patients are 

oriented to the philosophy of hospice 

care. Facility staff turnover rates should 

certainly be a consideration in 

determining training frequency. 

Comment: A commenter disagreed 

with our proposed requirement that 

facility staff should be trained by 

hospices in hospice philosophy and 

care. The commenter stated that there is 

a ‘‘spillover effect,’’ whereby the 

training received by staff affects the care 

furnished to non-hospice patients as 

well as hospice patients. The 

commenter further stated that this 

‘‘spillover effect’’ may not be desirable 

for those patients who do not choose to 

receive hospice care. 

Response: While there may be a 

‘‘spillover effect’’ when facility staff are 

oriented to hospice philosophy, we do 

not believe that the effect is inherently 

negative. The hospice philosophy 

focuses on using multiple treatment 

modes to make patients physically, 

emotionally, and spiritually 

comfortable. Providing comfort to 

residents, regardless of whether those 

residents receive hospice care or not, 

would positively impact their wellbeing. Therefore, we do not view a 

‘‘spillover effect’’ as a problem that 

would warrant removal of the proposed 

facility staff orientation requirements. 

Comment: A commenter suggested 

that hospices be required to educate the 

facility staff regarding the 

individualized plan of care for each 

hospice patient who resides in the 

facility. 

Response: We agree with this 

suggestion. Section 418.56(b) of this 

rule, ‘‘Plan of care,’’ requires hospices to 

ensure that each patient and his or her 

primary caregiver(s) receives education 

and training provided by the hospice as 

appropriate to their responsibilities for 

the care and services identified in the 

plan of care. Facility staff members 

acting as the patient’s primary 

caregivers are expected to receive 

education specific to each patient’s 

hospice plan of care and the caregiver’s 

role in implementing the content of the 

hospice portion of the plan of care. 

Comment: A commenter suggested 

that hospices should be required to 

orient facility administrative staff as 

well as the staff who furnish care to 

hospice patients that reside in the 

facility. 

Response: With the facility’s consent, 

hospices may orient facility 

administrative staff as well as hands-on 

care staff. However, we do not believe 

that this orientation should be required 

because it is unlikely to improve patient 

care or outcomes. 

Comment: A commenter asked for a 

definition of the term ‘‘nursing facility.’’

Response: Our use of the abbreviation 

‘‘SNF/NF’’ refers to the long term care 

facilities referenced at 42 CFR part 483, 

where skilled nursing facilities (SNF) 

and nursing facilities (NF) are 

described. 

Comment: Many commenters stated 

that this section of the rule should 

require SNFs/NFs and ICFs/MR to 

contract with any hospice that a 

resident chooses. Many other 

commenters stated that hospices should 

be prohibited from contracting with 

SNFs/NFs and ICFs/MR that do not 

contract with all interested hospices. 

Response: As noted above, these CoPs 

regulate hospices, not SNFs/NFs and 

ICFs/MR. We are not proposing 

mirroring requirements for Medicare/ 

Medicaid facilities at this time. We also 

note that we do not have jurisdiction or 

authority to regulate facilities that do 

not participate in Medicare or Medicaid. 

In addition, even though these CoPs do 

regulate hospices, we do not believe that 

it is appropriate to preclude hospices 

from contracting with certain SNFs/NFs 

or ICFs/MR because the facility chooses 

to be selective in its contracting 

decisions. Indeed prohibiting hospices 

from contracting with selective SNFs/ 

NFs and ICFs/MR could deny residents 

of those facilities any access to hospice 

care furnished by Medicare-approved 

hospices. We believe that this would be 

a disservice to those residents. 

Comment: Some commenters took 

issue with the requirement that, when 

hospice services are furnished to 

Medicaid eligible SNF/NF residents, the 

hospice receives payment from 

Medicaid for room and board care and 

is responsible for paying the SNF/NF for 

this service. 

Response: Payment and billing 

procedures are not within the scope of 

these CoPs. We have shared this 

comment with the appropriate officials 

within CMS, and it will be taken under 

advisement. 

Comment: A commenter suggested 

that hospices should be required to 

notify hospice patients who reside in a 

SNF/NF or ICF/MR that Medicare does 

not pay for room and board for a patient 

who is receiving the routine home care 

level of hospice care. 


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Response: The commenter is correct 

that Medicare does not pay for room and 

board. We believe that Medicare 

coverage of services under the hospice 

benefit is already addressed by 

§ 418.52(c)(7), stating that patients have 

the right to ‘‘[r]eceive information about 

the services covered under the hospice 

benefit.’’ We do not believe that it is 

necessary to require hospices to provide 

a separate notice in writing regarding 

Medicare non-coverage of a patient’s 

room and board in a SNF/NF or ICF/ 

MR. 

Comment: Many commenters had 

questions about the proposed core 

services requirement at § 418.112(c), 

which would have required hospices to 

routinely provide all core services to 

hospice patients who are residents of 

SNFs/NFs or ICFs/MR. Some 

commenters wanted to know if this 

requirement was the same as proposed 

§ 418.64, ‘‘Core Services.’’ If so, the 

commenters suggested that it should be 

deleted because it is duplicative and 

unnecessary. Other commenters asked if 

it would be permissible to use staff of 

the SNFs/NFs or ICFs/MR to furnish 

core services to hospice patients. A 

single commenter suggested that, for 

clarity, we should add the word ‘‘work’’

to the term ‘‘medical social’’ to clarify 

that hospices must provide medical 

social work services to patients who 

reside in SNFs, NFs, or ICFs/MR. 

Response: Hospices that furnish 

hospice services to residents of a SNF/ 

NF or ICF/MR are required to furnish 

core services to those residents under 

the same requirements and in the same 

manner as those services are furnished 

to patients residing in their own homes. 

The core services requirement at 

§ 418.64 applies equally to both facility 

and community residents. We agree that 

it is not necessary to state the same 

requirements in both § 418.64 and 

§ 418.112. Therefore, the core services 

standard in § 418.112 has been removed. 

Since the core services requirement at 

§ 418.64 applies, regardless of where 

services are provided, hospices are not 

permitted to routinely delegate hospice 

services to the staff of a SNF/NF or ICF/ 

MR. Hospices are required to routinely 

provide substantially all core services 

directly. Hospices may only provide 

core services under arrangement if they 

meet the conditions for an extraordinary 

circumstance exemption described in 

§ 418.64, the nursing services waiver 

described in § 418.66, or the nursing 

shortage waiver described in CMS S&C 

letter 05–02. 

Comment: Numerous commenters 

asked us to clarify or delete the 

proposed requirement at § 418.112(h), 

‘‘Transfer, revocation, or discharge from 

hospice care.’’ Most of these 

commenters stated that this requirement 

should be deleted because hospices 

have no authority to govern the 

discharge actions of SNFs/NFs and 

ICFs/MR, thereby making it very 

difficult for hospices to comply with the 

requirement. Some commenters 

suggested that the intent of the standard 

should be clarified. One commenter 

suggested that we should add the 

following statement to the end of the 

requirement: ‘‘It is believed that patients 

should not experience the trauma of an 

external move because they perhaps 

have stabilized and may not continue to 

be eligible for hospice.’’

Response: We agree that resident 

eligibility is not within the control of 

the hospice, and this requirement has 

been removed. Absent this requirement, 

the discharge requirement set forth in 

§ 418.104(e) continues to apply to any 

hospice patients who reside in a SNF/ 

NF or ICF/MR. The requirements of 

§ 418.104(e) do not place any 

requirements on residential facilities 

serving as a patient’s home. 

Comment: A large number of 

commenters stated that it would be 

difficult for hospices to implement the 

requirements of this CoP without the 

inclusion of complementary 

requirements in the long term care CoPs 

at 42 CFR part 483. Some commenters 

suggested that we should not issue this 

CoP until the complementary 

requirements are included in the long 

term care CoPs, while other commenters 

suggested that we should add a phasein period for this CoP to allow the long 

term care CoPs to ‘‘catch-up’’ to this 

hospice CoP. Still other commenters 

suggested that this CoP should be issued 

as planned, but that survey enforcement 

of its requirements should understand 

that not all provisions can be adequately 

implemented until the long term care 

CoPs agree with those for hospices. 

Response: Upon issuance of this final 

rule we intend to issue a proposed rule 

to add a new requirement to the long 

term care CoPs at § 483.75(r). This 

proposed rule would describe: 

• The manner in which long term 

care facilities may furnish hospice 

services to their residents; 

• The minimum content of the 

written agreement between the long 

term care facility and the hospice; 

• The conditions under which the 

long term care facility must contact the 

hospice; 

• The participation and coordination 

of the long term care facility in care 

planning and delivery; and 

• The information that the long term 

care facility must obtain from the 

hospice. 

We agree that, without this 

requirement in the long term care 

facility regulations, it will be 

challenging for hospices to comply with 

the requirements of this CoP. We will 

work with the hospice and long term 

care industries to address any situations 

that may occur during the intervening 

time period. 

Comment: Several commenters sought 

clarification about how surveyors would 

determine accountability for negative 

patient outcomes when patients were 

both hospice patients and residents of a 

SNF/NF or ICF/MR. 

Response: Hospices are responsible 

for all hospice care and services 

provided to a patient, regardless of 

where that patient resides. Hospices are 

also responsible for coordinating the 

plan of care for a particular patient with 

representatives of the facility where the 

patient resides to ensure that both the 

hospice and facility are aware of their 

respective patient care responsibilities. 

Furthermore, hospices are responsible 

for ensuring that the terms of the 

arrangement established between the 

hospice and the facility are met to 

ensure patient care and safety at all 

times. We expect hospices to fulfill their 

responsibilities at all times and for all 

patients. If a hospice does not fulfill its 

responsibility and take all appropriate 

actions to ensure the health and safety 

of its patient in accordance with the 

requirements of this final rule, then that 

hospice will be held accountable for its 

actions. We note that these final 

provisions do not propose to judge 

hospices on ‘‘negative patient 

outcomes’’ except to the extent that 

those outcomes are connected with 

regulatory non-compliance. 

Comment: Several commenters noted 

that the interpretive guidelines that 

surveyors will use to ensure compliance 

with this CoP needs to provide further 

detail regarding provider 

responsibilities for individual aspects of 

hospice care. 

Response: We agree that additional 

detail is needed and we will take this 

suggestion under advisement as we 

develop interpretive guidelines for this 

regulation. 

Comment: A commenter suggested 

that frequent onsite verification of 

hospice agency compliance with this 

proposed CoP is the best way to ensure 

that hospices are fulfilling their 

regulatory obligations. 

Response: State surveyors are 

required to survey long term care 

facilities annually. These surveyors 

have already been directed to report 

issues involving long term care facility 

residents who are hospice patients to 

their hospice surveyor counterparts for 


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follow-up with the hospice. We believe 

that using hospice survey resources to 

focus on potential problems is 

preferable to randomly surveying 

hospices where issues involving long 

term care facility residents have not 

appeared. 

Comment: Several commenters 

suggested that we address the 

responsibilities of the attending 

physician in caring for residents of a 

SNF/NF or ICF/MR who receive hospice 

services. The commenters suggested that 

the attending physician be responsible 

for coordinating the patient’s care and 

communicating with hospice and 

facility physicians. 

Response: We do not have the 

authority to regulate the actions of a 

patient’s attending physician who is not 

an employee of or under contract with 

the hospice through this hospice rule. If 

a patient has an attending physician 

who is actively involved in his or her 

care, then the hospice is required to 

consult the attending physician in 

developing and updating the patient’s 

hospice plan of care. The hospice may 

use this consultation with the attending 

physician to gather information about 

other care and services the patient is 

receiving from the facility where the 

patient resides and from any other 

health care providers. The hospice may 

not delegate its responsibility to 

coordinate the patient’s hospice care to 

the attending physician. 

Comment: A commenter asked if the 

medical director of a SNF/NF or ICF/MR 

may also be the medical director of a 

hospice. 

Response: These regulations do not 

prohibit this arrangement. 

Comment: A commenter suggested 

that the interpretive guidelines should 

allow the medical director of the SNF/ 

NF to relinquish or assume secondary 

professional responsibility for 

coordinating the medical care for 

residents who elect the hospice benefit. 

Response: As discussed above, we 

have deleted the proposed medical 

director requirement at proposed 

§ 418.112(d), including the requirement 

that the hospice medical director must 

provide overall coordination of the 

medical care of the hospice patient 

residing in a SNF/NF or ICF/MR. We 

have replaced it with the requirement of 

the final rule at § 418.112(e)(1) that a 

member of the IDG coordinate the 

patient care and services with the 

facility. 

22. Condition of Participation: 

Personnel Qualifications (§ 418.114) 

We proposed significant revisions to 

the personnel qualifications for hospice 

employees. Specifically, we proposed to 

provide that in cases where personnel 

requirements are not statutory, or do not 

relate to a specific payment provision, 

personnel would only be required to 

meet State certification or licensure 

requirements. 

In § 418.114(a), ‘‘General 

qualifications,’’ we proposed that 

licensed professionals who provide 

hospice services directly, either as 

employees or under individual contract, 

or under arrangement with a hospice 

must be licensed, certified, or registered 

to practice by the State in which they 

perform the functions, as applicable. All 

personnel who fall into this category 

must act exclusively within the scope of 

the State license, certification or 

registration. In proposed § 418.114(b), 

‘‘Personnel qualifications for 

physicians, speech-language 

pathologists, and home health aides,’’

we proposed to include those personnel 

requirements that are included in the 

Act. 

When a State does not have a 

licensure, certification, or registration 

requirement, the hospice would apply 

the qualifications in proposed 

§ 418.114(c), ‘‘Personnel qualifications 

when no State licensing laws or State 

certification or registration requirements 

exist.’’ This category would consist of 

all personnel qualifications specified in 

existing § 418.3, ‘‘Definitions,’’

including a requirement that a social 

worker have a baccalaureate degree from 

a school of social work accredited by the 

Council on Social Work Education 

(proposed § 418.114(c)(7)). 

In § 418.114(d), we proposed a new 

requirement that a hospice obtain a 

criminal background check for all 

hospice and contract employees before 

employment at the hospice. We believe 

that this is an important safety measure 

to protect both patients and the hospice. 

We did not propose any specific type, 

scope, or frequency requirements for 

completing the background check. 

Comment: A commenter noted that 

the proposed title of this CoP is 

‘‘Personnel qualifications for licensed 

professionals,’’ and that this title could 

be interpreted as to apply only to those 

individuals for whom licensure is 

available. As such, the commenter 

reasoned, the criminal background 

check requirement would not apply to 

unlicensed individuals. 

Response: Our intent, as stated in the 

proposed rule, is for all appropriate 

individuals to have background checks. 

We have removed the phrase ‘‘for 

licensed professionals’’ from the title of 

this CoP to avoid any confusion in this 

area. 

Comment: Several commenters 

supported the proposed requirement 

that, if a State offers licensure for any 

discipline, including social workers, the 

individuals practicing within that 

discipline must obtain State licensure. 

One commenter even suggested that 

social workers should be required to 

obtain the highest level of State 

licensure available to them. However, a 

few commenters disagreed, stating that 

social workers should not be required to 

obtain State licensure. 

Response: The existing hospice 

requirements at § 418.72 require 

employees who provide services to be 

licensed, certified, or registered in 

accordance with applicable Federal and 

State laws. We believe that it is 

necessary to maintain this requirement 

in this final rule to ensure that the 

individuals furnishing services to 

hospice patients are legally authorized 

to furnish care in their respective 

disciplines. We believe that State 

licensure, certification and/or 

registration, where required by State law 

or regulation, help to ensure that 

individuals are qualified to furnish safe 

and effective care to patients and 

families. As professionals and equals 

among the IDG members, we believe 

that it is necessary to require social 

workers to meet the same licensure 

qualifications that all other hospice 

professionals are required to meet. 

Comment: The majority of 

commenters who submitted comments 

on our proposed personnel 

qualifications section made suggestions 

to revise the requirements for social 

workers. While some of these 

commenters agreed with our proposal to 

defer to State requirements for social 

workers, the majority of commenters 

believed that all hospice social workers 

should be required to meet the same 

basic qualifications. Of these 

commenters, many suggested that 

hospice social workers should be 

required to have a baccalaureate degree 

in social work from an accredited higher 

education institution. Other 

commenters suggested that a 

baccalaureate or higher degree in a field 

related to social work, such as 

psychology, would be an appropriate 

qualification for hospice social workers, 

while some commenters explicitly 

disagreed with this suggestion. 

Numerous other commenters suggested 

that hospice social workers should be 

required to have a Master of Social 

Work (MSW) degree from an accredited 

university. Of these commenters, several 

suggested that a waiver should be 

granted for hospices in rural areas to 

allow them to use the services of a 

social worker with a baccalaureate 

degree under the supervision of an 

MSW or a licensed mental health 


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professional with a graduate degree. 

Still other commenters suggested that, 

regardless of the degree that the social 

worker holds, he or she should be 

required to have one or two years of 

social work experience in a health care 

setting. Some commenters explicitly 

disagreed with this suggestion. 

Response: The large number of public 

comments submitted in reference to the 

personnel requirements for social 

workers, coupled with the divergent 

views expressed in the comments, leads 

us to believe that there is no standard 

or consensus in the hospice industry on 

this issue. Our goal is to balance the 

needs of patients and families at a very 

stressful time and the needs of hospices 

that may have difficulty employing 

personnel who meet appropriate 

personnel standards. We believe that all 

hospices should strive to employ the 

most qualified individuals possible to 

provide social work services to patients 

and families. In order to ensure that 

hospices employ a qualified individual 

as a social worker, we are requiring that 

a hospice social worker must at least 

meet one of the following options: 

• Have a Master of Social Work 

(MSW) degree from a school of social 

work accredited by the Council on 

Social Work Education, and one year of 

experience in a health care setting; 

• Have a baccalaureate degree in 

social work (BSW) from a school of 

social work accredited by the Council 

on Social Work Education, and one year 

of experience in a health care setting; or 

• Have a baccalaureate degree in 

psychology, sociology, or other field 

related to social work, and at least one 

year of social work experience in a 

health care setting. 

If a hospice chooses to employ a 

social worker with a baccalaureate 

degree in social work, psychology, 

sociology, or other field related to social 

work, the services of that baccalaureate 

social worker must be provided under 

the supervision of a social worker with 

an MSW from a school of social work 

accredited by the Council on Social 

Work Education and one year of 

experience in a health care setting. We 

believe that requiring MSW supervision 

of BSW services will help ensure that 

patient and family needs are met in a 

complete and timely manner. The MSW 

supervisor role is that of an active 

advisor, consulting with the BSW on 

assessing the needs of patients and 

families, developing and updating the 

social work portion of the plan of care, 

and delivering care to patients and 

families. This supervision may occur in 

person, over the telephone, through 

electronic communication, or any 

combination thereof. 

Social workers with a baccalaureate 

degree from a school of social work 

accredited by the Council on Social 

Work Education and who are employed 

by the hospice before the effective date 

of this final rule are exempted from the 

MSW supervision requirement. 

Therefore, if a hospice currently 

employs a BSW, unsupervised by an 

MSW, it is not required to hire an MSW 

to supervise the BSW. If a hospice hires 

a new social worker with a 

baccalaureate degree and one year of 

experience in a health care setting, then 

the new baccalaureate social worker 

must be supervised by an MSW who has 

one year of experience in a health care 

setting. 

Comment: Many commenters 

suggested that the final rule should 

include personnel qualifications for 

chaplains. Commenters suggested that 

education (that is, a baccalaureate and 

graduate-level divinity or theological 

degree from a university accredited by 

the Council of Higher Education 

Accreditation and/or 4 units of clinical 

pastoral education), experience in the 

medical field, certification from a 

national organization, or any 

combination thereof would be 

appropriate to qualify a chaplain to care 

for hospice patients. Other commenters 

explicitly disagreed with this 

suggestion, stating that the final rule 

should not include personnel 

qualifications for chaplains or require 

them to be licensed or certified. 

Response: Hospices may choose to 

employ the individual(s) best suited to 

meet the needs of the hospice and its 

patients. If a hospice chooses to employ 

a chaplain, it may choose to use any 

criteria in selecting the appropriate 

candidate. We do not believe that it is 

appropriate to require hospices to use 

specific criteria to guide the selection of 

a spiritual counselor. Rather, the needs 

of the hospice’s patient population 

should drive the selection of the 

appropriate person. 

Comment: A commenter suggested 

that, if physical therapist assistants 

furnish care to hospice patients, they 

should be required to be under the 

supervision of a physical therapist. 

Response: As a general statement, 

hospices are required to furnish 

physical therapy services in a manner 

consistent with accepted standards of 

practice. In addition, physical therapists 

and assistants are required to act only 

within the scope of their State license, 

certification, or registration. We believe 

that these requirements ensure that 

physical therapy services are provided 

in a safe and effective manner by and 

under the supervision of the appropriate 

personnel. 

In this final rule we are incorporating 

changes made by a separate final rule 

(72 FR 66222, 66406, November 27, 

2007) to the personnel qualifications for 

physical therapists, physical therapist 

assistants, occupational therapists, 

occupational therapist assistants, and 

speech-language pathologists. That final 

rule amended § 418.92 of the existing 

hospice regulations to cross reference 

the revised personnel requirements 

contained in 42 CFR 484.4, thereby 

requiring physical therapists, physical 

therapist assistants, occupational 

therapists, occupational therapist 

assistants, and speech-language 

pathologists subject to the requirements 

of the hospice conditions of 

participation to meet the same 

personnel requirements as therapists 

subject to the requirements of the home 

health agency conditions of 

participation. In this final rule, we 

continue to require therapists who are 

subject to the requirements of the 

hospice conditions of participation to 

meet the same personnel requirements 

as therapists subject to the requirements 

of the home health agency conditions of 

participation, as was required by the 

November 27, 2007 final rule. 

We believe that these revised 

requirements, which went through the 

notice-and-comment rulemaking 

process separate from and more recently 

than the hospice conditions of 

participation continue to allow hospices 

the flexibility to employ or contract 

with individuals who are well qualified 

to provide therapy services to hospice 

patients. However, we are replacing the 

cross reference to the requirements of 42 

CFR part 484 with a duplicate of the 

requirements of § 484.4. We believe that 

duplicating the relevant requirements of 

§ 484.4 in § 418.114(b)(4)–(8) will make 

it easier for hospices to know the 

personnel requirements that their 

therapists must meet in order to be 

considered qualified to provide services 

to hospice patients. 

Comment: A commenter suggested 

that we should incorporate the 

definition of the term ‘‘licensed 

professionals’’ from the home health 

regulations at 42 CFR part 484 in the 

personnel requirements for registered 

nurses at § 418.114(c). 

Response: The home health 

regulations at 42 CFR part 484 do not 

define the term ‘‘licensed 

professionals’’; therefore we cannot 

incorporate this suggestion into the final 

rule. 

Comment: Some commenters 

suggested that we should add personnel 

qualifications for nurse practitioners. 

Response: Section 1861(aa)(5) of the 

Act describes a nurse practitioner for 


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purposes of Medicare as an individual 

‘‘who performs such services as such 

individual is legally authorized to 

perform (in the State in which the 

individual performs such services) in 

accordance with State law (or the State 

regulatory mechanism provided by State 

law), and who meets such training, 

education, and experience requirements 

(or any combination thereof) as the 

Secretary may prescribe in regulations.’’

A Medicare-participating hospice that 

employs a nurse practitioner is expected 

to comply with these statutory 

requirements, and we believe that they 

are sufficient. 

Comment: Numerous commenters 

sought clarification about who was 

required to have a criminal background 

check. Some commenters suggested that 

volunteers should not be required to 

have a background check, while others 

suggested that only those individuals 

who provide direct patient care and/or 

who have access to patient financial 

information should be required to have 

background checks. Furthermore, some 

commenters suggested that only 

unlicensed hospice personnel should be 

required to have criminal background 

checks. Other commenters wanted to 

know if hospices would be required to 

obtain background checks on current 

employees, or only for employees hired 

after the effective date of this final rule. 

Still other commenters wanted to know 

if background checks were needed for 

individuals employed by a DME 

supplier or pharmacy that the hospice 

has a contract with. Some commenters 

suggested that, if background checks are 

required for contractors, the contracted 

entity would be the most appropriate 

entity to complete criminal background 

checks for its employees. 

Response: We believe that any 

individual who has direct patient 

contact or has access to a patient’s 

records, clinical, financial or otherwise, 

should have a criminal background 

check because these individuals are in 

a position that enables them to violate 

patient rights to both safety and privacy. 

This includes all current paid hospice 

employees, volunteers, and contracted 

employees, as well as any new 

employees. If an office employee, such 

as a receptionist, does not have access 

to patient records, and does not make 

patient visits, then that employee is not 

required to have a criminal background 

check. If a volunteer is a homemaker, 

and thus has direct patient contact, he 

or she is required to have a background 

check. We understand that hospices 

would likely not actually conduct 

background checks on contracted 

employees. We have added a statement 

to § 418.114(d)(1) that hospices must 

require, as part of their written 

agreement with a contractor, that the 

contractor provides the hospice a 

background check for each contracted 

employee who has direct hospice 

patient contact or access to hospice 

patient records. We believe that 

requiring all individuals who have 

direct patient contact or access to 

patient records to have background 

checks will help hospices assure that 

patient rights are protected at all times. 

Comment: Many commenters 

suggested that the requirements for 

criminal background checks (that is, 

scope, frequency, timing, etc.) should 

apply only in the absence of State 

requirements. Other commenters 

suggested that the timeframe for 

completing a criminal background 

check should be lengthened because it 

may take a few weeks to receive a 

background check from the State police 

and/or FBI. Still other commenters 

suggested that the scope of this 

requirement should be clarified. 

Response: We agree that if a State has 

particular laws or regulations requiring 

criminal background checks for hospice 

employees and contractors, then 

hospice compliance with such State 

requirements satisfies the intent of this 

requirement. If a State does not have 

any requirements, or does not have 

requirements for a specific discipline, 

then the requirements of this final rule 

must be met. In this final rule, we 

require hospices to obtain a criminal 

background check within three months 

of the date of employment for all states 

that the individual has lived or worked 

in for the past three years. We believe 

that it is essential to gather information 

on the individual’s activities in several 

states to ensure that the criminal 

background check presents a complete 

and accurate picture of the individual’s 

compliance with the law. In order to 

gather such information while allowing 

hospices to fill vacant positions in a 

timely fashion, we believe that it is 

necessary to alter the proposed 

timeframe from ‘‘before employment’’ to 

‘‘within three months of the date of 

employment. * * *’’ Therefore, if a 

State requires a registered nurse to have 

a State police background check 

completed within six months of 

employment, and the hospice complies 

with this State requirement when 

conducting background checks on its 

nurses, then the hospice is in 

compliance with this final rule even 

though the state standard is not as 

stringent. If that same State does not 

have requirements for background 

checks of physicians, then the hospice 

must obtain a criminal background 

check within three months of the date 

of employment for all states that the 

physician (paid, volunteer, or 

contracted) has lived or worked in for 

the past three years. 

Comment: A few commenters sought 

clarification on the relationship between 

the background check obtained by the 

hospice and the background check 

conducted by the State licensing body. 

Response: Many States require a 

criminal background check before a 

health care practitioner can obtain a 

State license, and some of these states 

require background checks to be 

updated when the license is renewed. 

However, not all states have a 

background check requirement in place 

for licensing. As described above, if a 

State has criminal background check 

requirements for a specific discipline, 

and the hospice complies with the State 

requirements for that discipline, then 

the hospice is in compliance with this 

Federal criminal background check 

requirement. This means an individual 

does not need a criminal background 

check if his or her license is current and 

State licensure requires a background 

check. If a State does not have such 

criminal background check 

requirements, then the hospice must 

comply with the Federal requirements 

described above. 

Comment: One commenter suggested 

that we should delay implementing the 

criminal background check requirement 

until completion of the background 

check demonstration project called for 

by the MMA. 

Response: While the results of the 

MMA background check demonstration 

project may provide further clarification 

on the particulars of implementing 

background check requirements in 

health care, we do not believe that it is 

appropriate to delay this important 

requirement. Hospices must make 

informed decisions regarding the staff 

(paid, volunteer, and contracted) that 

they use to care for patients. Without 

such vital information patients become 

vulnerable, and this can lead to negative 

patient outcomes. 

Comment: Some commenters noted 

that obtaining background checks will 

have a financial impact on hospices, 

while others noted that requiring 

volunteers to submit to background 

checks may decrease the number of 

willing volunteers. 

Response: We understand that 

obtaining background checks will have 

some degree of financial impact on 

hospices. We believe that this impact 

will be offset by a decreased level of 

hospice liability. Hospices will be able 

to exclude those individuals who may 

pose a threat to hospice patients, 

thereby decreasing the likelihood of 


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patient’s rights violations and/or 

criminal and civil litigation. 

We also understand that some 

volunteers may perceive a criminal 

background check as an affront. 

However, we believe that explaining 

that background checks are a precaution 

that everyone must take, and that 

background checks are not meant to 

single anyone out, will ease volunteer 

concerns and not deter them from 

offering their time and services to 

hospices. 

Comment: A few commenters asked 

us to prescribe the exact offenses that 

would preclude a hospice from 

employing a certain individual. A 

commenter also asked us to include a 

waiver for individuals who have been 

reformed as well as protections for 

hospices to choose to terminate an 

individual’s employment based on the 

results of the criminal background 

check. 

Response: We do not believe that it is 

appropriate to prescribe the 

circumstances under which an 

individual must be precluded from 

hospice employment on the basis of his 

or her criminal background check 

results. Hospices should consult 

applicable labor laws and regulations 

when developing their own policies and 

procedures for implementing the 

criminal background check requirement. 

In addition, hospices should inform 

current and prospective direct 

employees (including volunteers) and 

contracted employees about their 

criminal background check policy. We 

believe that a well-designed and openly 

implemented policy will help hospices 

choose the individuals best suited for 

hospice employment and service. 

Comment: A commenter suggested 

that the section for personnel 

requirements should be re-located to the 

beginning of the rule, rather than its 

proposed location at the end of the rule. 

Response: This rule is organized into 

two subparts, Subpart C—Patient Care, 

and Subpart D—Organizational 

environment. Subpart C contains the 

conditions of participation related to 

providing direct patient care, while 

Subpart D contains the conditions of 

participation related to the 

administration of a hospice. Since the 

requirements for personnel 

qualifications relate more to the 

administration of a hospice than to the 

delivery of direct patient care, we 

believe that it is appropriate to keep the 

personnel qualifications section in its 

proposed location. 

23. Condition of Participation: 

Compliance With Federal, State, and 

Local Laws and Regulations Related to 

the Health and Safety of Patients 

(§ 418.116) 

The provisions concerning licensure 

requirements for hospices are currently 

located at § 418.72, ‘‘Condition of 

participation: Licensure.’’ We proposed 

to expand this condition by making a 

minor revision to the language at 

existing § 418.72(a), requiring the 

hospice and its staff to operate and 

furnish services in compliance with all 

Federal, State, and local laws and 

regulations applicable to hospices 

related to the health and safety of 

patients. 

Under § 418.116(b), ‘‘Satellite 

locations,’’ we proposed to continue to 

require that the hospice comply with 

the requirements of § 420.206 regarding 

disclosure of ownership and control 

information. We also proposed that the 

hospice and any other satellite locations 

operated under the same provider 

number be licensed in accordance with 

applicable State licensure laws before 

the hospice could be reimbursed for 

Medicare services. This proposed 

provision would apply to the hospice as 

an entity, as well as to any personnel 

furnishing services to hospice patients. 

We proposed to recodify the current 

requirements at § 418.92(b), regarding 

laboratory services, at § 418.116(c). 

Comment: We received a minimal 

number of comments on the proposed 

rule concerning multiple location 

requirements in this section. The 

commenters requested that hospices be 

allowed to have multiple locations 

(previously known as satellite locations) 

and also asked about the procedures for 

the approval of such locations. 

Response: As previously noted in this 

preamble, we have deleted the term 

‘‘satellite’’ and replaced it with 

‘‘multiple locations.’’ Hospices are 

permitted to operate in multiple 

locations if they meet the requirements 

set forth in § 418.3 and § 418.100(f). The 

definition of ‘‘multiple location’’ as 

defined in § 418.3 is ‘‘a Medicareapproved location from which the 

hospice provides the same full range of 

hospice care and services that is 

required of the hospice issued the 

certification number. A multiple 

location must meet all of the conditions 

of participation applicable to hospices.’’

The multiple location is part of the 

hospice and shares administration, 

supervision, and services with the 

hospice that was issued the certification 

number. In § 418.100(f) we state that all 

multiple locations must be approved by 

Medicare before providing hospice care 

and services to Medicare patients. The 

hospice must continually monitor and 

manage all services provided at all of its 

locations to ensure that services are 

delivered in a safe and effective manner 

and to ensure that each patient and 

family receives the necessary care and 

services outlined in the plan of care. 

Procedures for requesting CMS approval 

of a multiple location will be set forth 

in the hospice interpretive guidelines, 

which will be made available after this 

final rule has been published. The 

interpretive guidelines will provide subregulatory instructions and parameters 

which will apply to multiple locations. 

III. Provisions of the Final Regulations 

In this final rule we are adopting the 

provisions as set forth in the May 27, 

2005 proposed rule with the following 

revisions. We have—

1. Definitions (§ 418.3) 

• Deleted proposed revisions to the 

definition of the term ‘‘attending 

physician.’’

• Amended the definition of 

‘‘bereavement counseling’’ by adding 

the term ‘‘before and’’. 

• Revised the definition of ‘‘clinical 

note.’’

• Added a definition of the term 

‘‘comprehensive assessment.’’

• Added a definition of the term 

‘‘dietary counseling.’’

• Deleted the definition of the term 

‘‘drug restraint.’’

• Added a definition of the term 

‘‘initial assessment.’’

• Amended the definition of 

‘‘licensed professional.’’

• Amended the name and definition 

of ‘‘satellite location,’’ now referred to 

as ‘‘multiple location.’’

• Added a definition of the term 

‘‘physician.’’

• Added a definition of the term 

‘‘physician designee.’’

• Revised the definition of 

‘‘restraint,’’ incorporating definitions of 

the terms ‘‘restraint’’, ‘‘drug restraint’’, 

and ‘‘physical restraint’’ into a single 

definition. 

• Revised the definition of 

‘‘seclusion.’’

• Deleted the definitions of the terms 

‘‘physical restraint’’ and ‘‘progress 

note.’’

2. Condition of Participation: Patient’s 

Rights (§ 418.52) 

• Renamed 418.52(a) ‘‘Notice of rights 

and responsibilities.’’

• Revised the phrasing of 

§ 418.52(a)(1). 

• Redesignated and revised proposed 

§ 418.52(a)(3) to § 418.106(e)(2)(i). 

• Redesignated and revised proposed 

§ 418.52(a)(4) as § 418.52(a)(3). 


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• Revised § 418.52(b)(4) to clarify the 

hospice’s responsibility for investigating 

and reporting violations of patient 

rights. 

• Renamed and revised section 

418.52(c) ‘‘Rights of the patient’’ to 

include several new patient rights. 

• Deleted § 418.52(d) ‘‘Confidentiality 

of clinical records’’ (now at 418.52(c)) 

and § 418.52(e), ‘‘Patient liability.’’

3. Condition of Participation: Initial and 

Comprehensive Assessment of the 

Patient (§ 418.54) 

Revised the stem statement. 

Revised § 418.54(a) to clarify the 

assessment timeframe. 

Revised § 418.54(b) to clarify the role 

of the patient’s attending physician, and 

expand the timeframe for completing 

the comprehensive assessment. 

Revised § 418.54(c) to include new 

factors that must be considered during 

all comprehensive assessments. The 

new factors are functional status, 

imminence of death, and severity of 

symptoms. 

Renumbered § 418.54(c)(3)(ii) as 

§ 418.54(c)(6), and revised the title of 

this section as ‘‘Drug Profile.’’ We also 

revised the factors that hospices must 

consider in the drug profile assessment. 

Revised the requirements for the 

‘‘bereavement assessment’’ now at 

§ 418.54(c)(7) to require that a hospice 

incorporate information gathered from 

the initial assessment into the patient’s 

plan of care and consider such 

information when developing the 

bereavement plan of care. 

Revised § 418.54(d) to require an 

update of the comprehensive 

assessment at least every 15 days. We 

also deleted the requirement that the 

comprehensive assessment be updated 

at the time of each recertification. 

4. Condition of Participation: 

Interdisciplinary Group, Care Planning, 

and Coordination of Services (§ 418.56) 

Revised the stem statement. 

Revised § 418.56(a)(1) to maintain 

consistent terminology throughout the 

rule. In addition, we retained the 

existing hospice rule provision that 

requires the hospice to designate a 

registered nurse that is a member of the 

IDG to coordinate patient care, 

assessment, and care plan 

implementation. 

Revised the IDG requirements at 

§ 418.56(a)(1)(i) to require that the 

physician member of the IDG be 

an employee of or under contract 

with the hospice. We also revised 

§ 418.56 (a)(1)(iv), to retain the existing 

hospice requirement that the hospice 

IDG must include a pastoral or other 

counselor. 

Revised § 418.56(a)(2) regarding the 

members of the IDG responsible for 

developing day-to-day hospice policies 

and procedures. 

Revised § 418.56(b) to clarify that a 

patient’s plan of care must be 

individualized to his or her needs and 

circumstances. Additionally, we revised 

this section to require a hospice to 

involve the patient and primary 

caregiver in developing the plan of care 

in accordance with the patient’s needs. 

We also clarified which individuals 

must be educated and trained by the 

hospice in implementing the plan of 

care, as well as the extent of that 

education and training. 

Revised § 418.56(c) to specify that the 

written plan of care must be 

individualized. We also added a 

provision that the plan of care must 

reflect patient and family goals. 

Revised § 418.56(c)(1) to simplify the 

phrasing of the requirement. 

Removed the term ‘‘targeted’’ from 

§ 418.56(c)(3) to simplify its phrasing. 

Revised § 418.56(c)(6) by changing 

‘‘family’’ to ‘‘representative.’’

Revised § 418.56(d). We removed 

specific mention of the role of the 

hospice medical director or physician 

designee in updating each patient’s plan 

of care. We also revised the timeframes 

for updating the plan of care to at least 

every 15 days. Additionally, we added 

a requirement that the IDG must note 

the patient’s progress toward specified 

goals when updating in the plan of care. 

Made several minor revisions to 

§ 418.56(e) that do not change the intent 

of the proposed and added a new 

requirement that hospice coordination 

and communication systems must 

ensure that information is shared with 

non-hospice health care providers 

furnishing services to patient. 

5. Condition of Participation: Quality 

Assessment and Performance 

Improvement (§ 418.58) 

Removed the phrase ‘‘focuses on the 

end-of-life support services provided’’

from § 418.58. 

Replaced the phrase ‘‘end-of-life 

support services’’ with ‘‘hospice 

service’’ in § 418.58(a). In addition, we 

replaced the phrase ‘‘for which there is 

evidence that improvement in those 

indicators will improve palliative 

outcomes’’ with the phrase ‘‘related to 

improved palliative outcomes.’’

Revised § 418.58(b) to clarify our 

intent. In § 418.58(b)(2)(ii), we 

incorporated a requirement that quality 

indicator data must be used to identify 

priorities, as well as opportunities, for 

improvement. In § 418.58(b)(3), we 

replaced the term ‘‘specified’’ with the 

term ‘‘approved’’ to clarify that the 

governing body is not necessarily the 

entity that establishes data collection 

specifications. 

Added a 240-day phase-in period to 

§ 418.58(d) to allow hospices more time 

to collect the initial program data. 

Revised § 418.58(e) by adding a 

requirement that the governing body 

annually evaluates the hospice’s QAPI 

program. We also added a requirement 

that the hospice governing body must 

identify at least one individual who is 

responsible for operating the QAPI 

program. Deleted proposed 

§ 418.58(e)(3) regarding expectations for 

patient safety. 

6. Condition of Participation: Infection 

Control (§ 418.60) 

Expanded the scope of the hospice’s 

infection control program to protect 

visitors as well as patients, families and 

hospice personnel. 

Replaced the term ‘‘staff’’ in proposed 

§ 418.60(c) with the terms ‘‘employees’’

and ‘‘contracted providers.’’

7. Condition of Participation: Licensed 

Professional Services (§ 418.62) 

Revised § 418.62(b) to clarify that 

licensed professionals providing care to 

hospice patients must actively 

participate in the coordination of all 

aspects of the patient’s hospice care. 

8. Condition of Participation: Core 

Services (§ 418.64) 

Revised § 418.64 to permit hospices to 

utilize contracted staffing sources under 

extraordinary or other non-routine 

circumstances (for example, 

unanticipated periods of peak patient 

loads, short-term staffing shortages that 

interrupt patient care, and patient 

travel). Deleted the proposed 

requirement at § 418.64(a) that hospice 

physicians be responsible for meeting a 

patient’s general (that is, non-hospice) 

medical needs. 

Replaced the term ‘‘nurse 

practitioner’’ with ‘‘registered nurse’’ in 

§ 418.64(b)(2). We also deleted the 

proposed requirement at § 418.64(b)(2) 

that the role and scope of nurse 

practitioner services be separately 

specified in the plan of care. 

Revised the requirements in 

§ 418.64(d) to clarify the role of 

counseling services, requiring that 

hospices make available counseling 

services, ‘‘* * * to assist the patient 

and family in minimizing the stress and 

problems that arise from the terminal 

illness, related conditions, and the 

dying process.’’

Revised § 418.64(d)(1)(i) to permit 

individuals with education (as well as 

experience) in grief/loss counseling to 

supervise a hospice’s bereavement 


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program. Furthermore, we revised 

§ 418.64(d)(1)(ii) by removing the term 

‘‘other facility’’ and removing the 

requirement that hospices must offer 

bereavement services to facility staff. 

We also revised § 418.64(d)(1)(iv) by 

changing ‘‘provided’’ to ‘‘offered.’’

Revised § 418.64(d)(2), renaming it 

‘‘Dietary counseling,’’ to be more 

consistent with the terminology used 

throughout the rest of the rule. 

Revised section 418.64(d)(3)(iii) by 

removing the statement that hospices 

are not required to go to extraordinary 

lengths to facilitate clergy, pastoral, or 

other visits from this section. We added 

language that indicates that hospices 

must make all reasonable efforts to 

facilitate such visits. 

9. Condition of Participation: Nursing 

Services—Waiver of Requirement That 

Substantially All Nursing Services Be 

Routinely Provided Directly by a 

Hospice (§ 418.66) 

Removed the requirement at proposed 

§ 418.66(d) that CMS may approve a 

maximum of two 1-year extensions for 

each initial waiver. 

10. Condition of Participation: Waiver of 

Requirement—Physical Therapy, 

Occupational Therapy, SpeechLanguage Pathology, and Dietary 

Counseling (§ 418.74) 

Revised § 418.74(d) by removing the 

requirement at 418.66(d) that CMS may 

approve a maximum of two 1-year 

extensions for each initial waiver. 

11. Condition of Participation: Hospice 

Aide and Homemaker Services 

(§ 418.76) 

Revised § 418.76 by changing its name 

from ‘‘Home health aide and 

homemaker services’’ to ‘‘Hospice aide 

and homemaker services.’’

Revised § 418.76(a)(ii) to clarify that 

the evaluation program used to measure 

aide competency must meet the specific 

requirements of § 418.76(c) of this 

section. Clarified that the training or 

competency evaluation programs 

referred to in § 418.76(a)(2) are those 

programs described in § 418.76(a)(1). 

Added an option in § 418.76(a)(1), 

that a hospice aide may be considered 

qualified if the aide has completed a 

training and competency evaluation 

program in accordance with the content 

and specifications of the nurse aide 

training program requirements for long 

term care facilities at 42 CFR part 483. 

Revised the language in § 418.76(b)(1) 

to describe the training that hospice 

aides must complete. The revised 

requirement states that, ‘‘[h]ospice aide 

training must include classroom and 

supervised practical training.’’

Revised § 418.76(c)(1) to clarify that a 

competency evaluation program is 

required to address the areas identified 

in § 418.76(b)(3) of this section, rather 

than the requirements of § 418.76(b)(1) 

through § 418.76(b)(3). Revised the 

requirement in § 418.76(c)(4) to specify 

that an aide is not considered to have 

successfully completed a competency 

evaluation if the aide has an 

‘‘unsatisfactory’’ rating in more than one 

required area. 

Deleted the proposed requirement in 

§ 418.76(d) that an organization 

excluded by § 418.76(f) would be 

excluded from offering in-service 

training to hospice aides. This 

paragraph continues to exclude certain 

organizations from initially training 

hospice aides. 

Revised § 418.76(e) to clarify that the 

requirements of this section apply to 

instructors providing both classroom 

and supervised practical training. We 

are no longer applying the requirements 

of this standard to those individuals 

performing competency evaluations or 

in-service trainings. Third, we clarified 

the description of the training instructor 

by rearranging the language and 

clarifying that one year of the trainer’s 

health care experience would be in the 

broad home care environment (that is, 

hospice or home health care), rather 

than in the more specific home health 

care environment. 

Revised § 418.76(f) to state that any 

home health agency that, within the last 

two years, was out of compliance with 

the requirements of paragraphs 

§ 418.76(b) or § 418.76(c) of this section 

was not eligible to train hospice aides, 

except with respect to in-service 

training. 

Deleted the proposed language in 

418.76(g)(1) that an appropriate 

qualified therapist may make hospice 

aide assignments or supervise hospice 

aides. Also in section 418.76(g)(1), we 

added a new specification requiring the 

nurse who makes aide assignments for 

a specific aide and patient to be a 

member of that patient’s hospice IDG. 

Revised § 418.76(g)(2) to indicate that 

the hospice IDG as a whole may order 

aide services. 

Revised § 418.76(h) by removing 

references to qualified therapists. 

Clarified the purpose of the every 14 

day aide supervision visit in 

§ 418.76(h)(1)(i). 

Added a provision in § 418.76(h)(1)(ii) 

stating that if during the supervision 

visit the nurse supervisor notes a 

potential area of concern regarding the 

way in which hospice aide services are 

being furnished, then the supervising 

registered nurse must make an on-site 

visit to the patient when the hospice 

aide is present, to observe and assess the 

aide while he or she is performing care. 

Added § 418.76(h)(1)(iii) to clarify 

these problems identified during any 

hospice aide supervisory visits that 

cannot be resolved at that time by the 

supervising registered nurse, the 

hospice aide must complete a 

competency evaluation in accordance 

with § 418.76(c). We also redesignated 

§ 418.76(h)(2) as § 418.76(h)(3). We 

added a new section 418.76(h)(2) to 

require a hospice registered nurse to 

make an annual on-site visit to observe 

each hospice aide furnishing aide 

services to at least one patient. Hospices 

may determine the appropriate location 

to document this annual aide evaluation 

in accordance with their own policies 

and procedures. 

Deleted proposed 418.76(h)(3). 

Added a provision in § 418.76(i)(2) 

that the individuals providing Medicaid 

personal care aide services may only be 

used by the hospice in implementing a 

patient’s plan of care to the same extent 

that the hospice would routinely use a 

patient’s family in implementing the 

plan of care. 

Added a provision in § 418.76(i)(3) 

that a hospice must coordinate its 

hospice aide and homemaker services 

with the personal care aide services 

provided by Medicaid to ensure that 

patient needs are met. 

Reorganized § 418.76(j) to clarify that 

homemakers must either meet the 

standards of § 418.202(g) (in 42 CFR 418 

Subpart F Covered Services) and 

complete hospice orientation, or meet 

the requirements for hospice aides at 

§ 418.76 as indicated in revised 

§ 418.76(j)(2). There are no substantive 

changes to this paragraph. 

Revised the qualifications for the 

supervision of homemakers in 

§ 418.76(k) to require that such services 

be supervised by the same member of 

the IDG who coordinates the services. 

12. Condition of Participation: 

Organization and Administration of 

Services (§ 418.100) 

Revised the requirements of 

§ 418.100(a) and § 418.100 (a)(1) to make 

clear that hospices must structure their 

operations to fully serve patients and 

families at the end of life. 

Clarified then relationship between a 

hospice’s governing body and 

administrator in § 418.100(b) by adding 

a provision that the administrator must 

be appointed by the governing body. 

Revised the requirement in 

§ 418.100(e) to state that hospices must 

maintain oversight responsibility for 

services furnished under contract. 

Revised the requirement in 

§ 418.100(e)(2) that contracted services 


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be provided by personnel having at least 

the same qualifications as hospice 

employees with a requirement that 

contracted services by provided by 

qualified personnel. 

Revised and reorganized § 418.100(f) 

by replacing the term ‘‘satellite 

location’’ with the term ‘‘multiple 

location,’’ and adding new requirements 

for Medicare approval. 

Revised § 418.100(g) by adding (g)(1) 

and (2) to address the orientation of 

patient care employees in the hospice 

philosophy and the initial orientation of 

a hospice employee to his or her 

specific job duties. We also redesignated 

proposed paragraph (g) as (g)(3). 

13. Condition of Participation: Medical 

Director (§ 418.102) 

Revised § 418.102 by describing the 

employment relationship between the 

medical director and the hospice. We 

clarified that the medical director is 

either an employee of the hospice (paid 

or volunteer) or is an individual under 

contract with the hospice. We also 

revised the requirement to state that the 

hospice is responsible for designating 

the individual who fulfills the physician 

designee role in the medical director’s 

absence. 

Inserted a new § 418.102(a) to address 

contracting for medical director 

services, and redesignated the other 

paragraphs accordingly. The new 

paragraph specifies that hospices may 

choose to make arrangements for 

medical director services to be met 

through a contract with a self-employed 

doctor or through a contract with a 

professional entity or physicians group. 

Revised § 418.102 (a)(2) specifies that if 

a hospice chooses to contract with a 

professional entity or physicians group 

for medical director services, the 

contract must identify a particular 

physician who will fulfill the hospice 

medical director’s role and 

responsibilities. 

Redesignated § 418.102(a) as 

§ 418.102(b) and revised it to delete the 

term ‘‘criteria.’’

Deleted proposed § 418.102(b)(2), 

which would have required the medical 

director to review the patient’s and 

family’s expectations and wishes for the 

continuation of hospice care at the time 

of each recertification. 

Redesignated and revised § 418.102(c) 

as § 418.102(d). The revision requires 

the hospice medical director to assume 

responsibility for the medical 

component of the hospice’s patient care 

program. We deleted references to the 

joint responsibility of the IDG. 

13. Condition of Participation: Clinical 

Records (§ 418.104) 

Revised § 418.104(a) to clarify which 

documents must be included in the 

clinical record. 

Revised § 418.104(a) to specify that all 

versions of the plan of care (initial and 

updated) must be in the clinical record. 

Likewise, we clarified that all 

assessments (initial, comprehensive, 

and updated comprehensive) must be 

included in the patient’s clinical record. 

In addition, we removed the language 

that separate progress notes must be 

included in the clinical record because 

all notes, including notes that document 

a patient’s progress, are included under 

the broad heading of ‘‘clinical notes.’’

Furthermore, we removed the 

requirement that the clinical record 

must contain a patient’s informed 

consent from this section. In its place, 

we require that the clinical record 

contain a copy of the notice of patient 

rights (in accordance with 

§ 418.52(a)(3)), which requires a hospice 

to obtain the patient’s or 

representative’s signature confirming 

that he or she has received a copy of the 

notice of rights. Deleted the requirement 

in section § 418.104(b) that, ‘‘[a]ll 

entries must be signed, and the hospice 

must be able to authenticate each 

handwritten and electronic signature of 

a primary author who has reviewed and 

approved the entry.’’ We are requiring 

authentication and dating in accordance 

with hospice policy and accepted 

standards of practice. 

Revised § 418.104(d) to specify the 

length of time that a hospice is required 

to retain a patient’s clinical record after 

death or discharge from five years to six 

years in accordance with the HIPAA 

requirements. 

Revised § 418.104(e) by replacing the 

term ‘‘Medicare/Medicaid-approved 

facility’’ with ‘‘Medicare/Medicaidcertified facility.’’

Revised § 418.104(e)(1) and (2) by 

requiring only that the discharge 

summary be sent to the receiving 

facility/physician, and that the clinical 

record be made available only upon 

request. 

14. Condition of Participation: Drugs 

and Biologicals, Medical Supplies, and 

Durable Medical Equipment (§ 418.106) 

Revised this CoP by combining the 

requirements of proposed § 418.106 and 

proposed § 418.110(m) and § 418.110(n). 

Revised § 418.106(a) to now require 

the hospice to ensure that the IDG 

confers with a qualified individual with 

education and training in drug 

management who is an employee of, or 

under contract with, the hospice to 

ensure that drugs and biologicals meet 

each patient’s needs. This section also 

requires a hospice that provides 

inpatient care directly in its own facility 

to provide pharmacy services under the 

direction of a qualified licensed 

pharmacist who is an employee of, or 

under contract with, the hospice. 

Incorporated the proposed requirements 

of § 418.110(n) in section 418.106(b). 

Drug orders must only be given by a 

physician or nurse practitioner. If a drug 

order is given verbally or electronically, 

it must be given to a licensed nurse, 

nurse practitioner, pharmacist, or 

physician, and must be recorded and 

signed immediately by the receiver. The 

prescribing individual must sign the 

order in accordance with State and 

Federal regulations. 

Inserted new section 418.106(c), 

‘‘Dispensing of drugs and biologicals,’’

to incorporate elements of proposed 

§ 418.110(m) and (n). This new standard 

requires a hospice to have a written 

policy to promote dispensing accuracy, 

maintain current and accurate records of 

the receipt and disposition of all 

controlled drugs, and obtain drugs and 

biologicals from community or 

institutional pharmacists or its own 

stock. Some of these requirements (that 

is, policy for dispensing accuracy and 

controlled drug records) only apply to 

those hospices that choose to maintain 

their own drug and biological stocks. 

Revised § 418.106(d) to combine 

proposed standards § 418.106(a)(2) and 

§ 418.110(n)(2). Revised § 418.106(d) is 

divided into two elements, one for 

patients receiving care in their home 

and another for patients receiving care 

in a hospice inpatient facility. If a 

patient is receiving care in his or her 

home, the hospice IDG must determine 

the patient’s and/or family’s ability to 

safely administer drugs and biologicals 

in the home. If a patient is receiving 

care in an inpatient facility operated by 

the hospice, then drugs may only be 

administered to the patient by a 

designated list of individuals working in 

the inpatient facility. 

Revised § 418.106(e) to combine and 

revise the requirements of § 418.106(b) 

and § 418.110(n)(3), § 418.110(n)(4), and 

§ 418.110(n)(5). A hospice must ensure 

that all drugs and biologicals are labeled 

with appropriate use and cautionary 

instructions, as well as an expiration 

date, in accordance with accepted 

standards of practice. In addition, a 

hospice must have written policies and 

procedures for the management and 

disposal of controlled drugs in a 

patient’s home, and must provide and 

discuss them with the patient and 

family at the time when controlled 

drugs are initially ordered. Furthermore, 


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a hospice that operates its own inpatient 

facility must dispose of controlled drugs 

in compliance with State and Federal 

requirements and its own policies and 

procedures. It must also store drugs and 

biologicals in a secure area. Certain 

controlled drugs must be stored in 

locked compartments within the secure 

area, and access to those locked 

compartments must be restricted to 

those individuals who are permitted to 

administer these drugs. Any 

discrepancies in the acquisition, storage, 

dispensing, administration, disposal, or 

return of controlled drugs in the 

hospice’s inpatient facility must be 

investigated immediately, and reported, 

if necessary. An investigation report 

must be made available to State and/or 

federal officials, if required. 

Revised § 418.106(f) to clarify the 

hospice’s responsibility for durable 

medical equipment and medical 

supplies and the hospice’s contractual 

relationship with a durable medical 

equipment supplier. Specifically, 

section 418.106(f)(1) and (2) have been 

revised to state that, regardless of 

whether the hospice provides durable 

medical equipment and medical 

supplies directly or under contract, the 

hospice must ensure the following: That 

manufacturer recommendations for 

routine and preventive maintenance are 

followed; that maintenance policies are 

developed when no manufacturer 

recommendations exist; that equipment 

is safe; that equipment works as 

intended; that patients, families, and 

other caregivers receive instruction in 

the safe use of equipment and supplies; 

and that patients, families, and other 

caregivers are able to demonstrate the 

safe and appropriate use of equipment 

and supplies. 

Added § 418.106(f)(3) to state that, if 

a hospice chooses to contract with an 

entity for durable medical equipment, it 

may only contract with a durable 

medical equipment supplier that meets 

the Medicare Supplier Quality and 

Accreditation Standards at 42 CFR 

424.57. 

15. Condition of Participation: ShortTerm Inpatient Care (§ 418.108) 

Revised 418.108(b)(2) to require a 

facility providing only the respite level 

of care to meet the 24-hour nursing 

needs of all patients in accordance with 

each patient’s plan of care. A facility 

providing only the respite level of care 

is not required to automatically have 

registered nurse present on all shifts to 

provide direct patient care. 

16. Condition of Participation: Hospices 

That Provide Inpatient Care Directly 

(§ 418.110) 

Revised the opening paragraph of this 

CoP to clarify that the requirements of 

§ 418.110 apply only to those inpatient 

facilities operated by a hospice. Where 

a hospice has its ‘‘own inpatient 

facility,’’ either in a freestanding 

building or as a section located in the 

building of another provider type, the 

requirements of § 418.110 apply to the 

building or applicable portion thereof as 

if it were physically located with the 

hospice administrative offices, as well 

as to the hospice patients receiving care 

within that building. 

Added a requirement at 

§ 418.110(b)(2), originally at § 418.100(a) 

of the existing hospice regulations, that 

at least one registered nurse must 

provide direct patient care on each shift. 

However, unlike the current 

§ 418.100(a), this requirement only 

applies if the hospice inpatient facility 

is providing general inpatient care to 

one or more patients. 

Removed the proposed requirements 

§ 418.110(c)(1)(i) and (ii), that a hospice 

must report safety breaches and that 

hospices must prevent, report, and 

correct equipment failures. 

Deleted § 418.110(d)(4) and 

§ 418.110(d)(5), the phase-in provisions 

requiring hospices to comply with 

certain emergency lighting and door 

latching requirements as of March 13, 

2006. 

Redesignated proposed paragraph 

§ 418.110(d)(6) as paragraph 

§ 418.110(d)(4). 

Added an exception to 

§ 418.110(f)(1)(iv) with respect to the 

number of patients that may occupy a 

single room. Redesignated proposed 

§ 418.110(o) as § 418.110(m), and 

revised it to correspond with the 

seclusion and restraint requirements for 

hospitals. 

Revised proposed § 418.110(o)(6) as 

§ 418.110(n) to provide more detailed 

guidance regarding the role of staff 

training in safely and successfully 

implementing restraint or seclusion 

techniques. These changes conform to 

the requirements of the hospital 

conditions of participation. 

Redesignated proposed 

§ 418.110(o)(7) as § 418.110(o) to 

provide more detailed requirements 

regarding death reporting requirements. 

16. Condition of Participation: Hospices 

That Provide Hospice Care to Residents 

of a SNF/NF or ICF/MR (§ 418.112) 

Deleted the term ‘‘other facilities’’

throughout this section. 

Revised § 418.112(b) to clarify a 

hospice’s responsibility for care 

furnished to hospice patients who 

reside in a SNF/NF or ICF/MR. A 

hospice assumes all responsibility for 

the professional management of all 

hospice services furnished to residents, 

including hospice-related inpatient care. 

All services furnished by the hospice 

must be in accordance with the 

individualized plans of care. 

Deleted § 418.112 (c) and (d), and 

redesignated the remaining sections 

accordingly. 

Redesignated § 418.112(e) as 

§ 418.112(c), deleted some provisions, 

clarified other provisions, and 

incorporated new provisions regarding 

the written agreement between a 

hospice and a SNF/NF or ICF/MR. 

Redesignated § 418.112(f) as 

§ 418.112(d) and replaced some of the 

detailed plan of care requirements 

included in the proposed standard with 

a cross reference to the requirements of 

§ 418.56. We also clarified that the 

hospice must discuss changes in a 

patient’s plan of care with the patient or 

the patient’s representative, as well as 

with representatives of the SNF/NF or 

ICF/MR where the patient resides. 

Revised § 418.112(g) (redesignated as 

§ 418.112(e)) to clarify the hospice’s 

patient care coordination responsibility. 

Deleted proposed § 418.112(h). 

Revised § 418.112(i) and redesignated 

it as § 418.112(f) to clarify that a hospice 

is not required to provide orientation 

training itself if another hospice has 

already done so. 

17. Condition of Participation: 

Personnel Qualifications (§ 418.114) 

Revised § 418.114(a) by combining the 

requirements of proposed standards 

§ 418.114(a) and § 418.116(a). The 

revised § 418.114 requires that all 

professionals who furnish hospice 

services be currently licensed, certified 

or registered to provide services in 

accordance with applicable Federal, 

State, and local laws. Furthermore, all 

professionals must act only within the 

scope of their license, certification, or 

registration. 

Revised § 418.114(b) by replacing the 

proposed term ‘‘home health aides’’

with the final term ‘‘hospice aides.’’ We 

also added revised personnel 

requirements for social workers at 

§ 418.114(b)(3). 

Revised personnel requirements for 

physical therapists, physical therapy 

assistants, occupational therapists, 

occupational therapy assistants, and 

speech-language pathologists to 

incorporate changes made to these 

sections in a separate final rule (72 FR 

66222, November 27, 2007) Revised 

§ 418.114(d) to provide more specificity 


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about the timing and scope of the 

criminal background check requirement. 

18. Condition of Participation: 

Compliance With Federal, State, and 

Local Laws and Regulations Related to 

the Health and Safety or Patients 

(§ 418.116) 

Moved proposed § 418.116(a) to a 

similar provision at final § 418.114(a). 

Replaced the term ‘‘satellite 

locations’’ with the term ‘‘multiple 

locations’’ in final § 418.116(a) 

(proposed § 418.116(b)) to conform to 

other sections of the final rule. 

IV. Crosswalk 

Provisions Not Cited in the Crosswalk 

are Unchanged in the Final Rule 

Proposed citation Proposed condition Final citation Final condition 

418.3 .................................. Definitions ................................................................. Same .................................. Definitions. 

New ........................................................................... 418.3 .................................. Initial assessment, Comprehensive assessment, 

Physician designee, and Dietary counseling. 

Satellite location ....................................................... Same .................................. Multiple location, New and amended language. 

Bereavement counseling, Clinical note, Employee, 

Hospice care, Licensed professional, Restraint, 

Seclusion.

Same .................................. New and amended language. 

Attending physician, Cap period, Drug restraint, 

Physical restraint, Progress note, Terminally ill.

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

418.52 ................................ Patient Rights ........................................................... Same .................................. Patient Rights. 

418.52(a)(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.

Same .................................. New and amended language. 

418.52(a)(3) ........................ The hospice must inform the patient and family of 

the hospice’s drug policies and procedures, including the policies and procedures regarding the 

tracking and disposing of controlled substances.

418.106(e)(2)(i) .................. Relocated and amended language. 

418.52(a)(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.

418.52(a)(3) ....................... New and amended language. 

418.52(b)(4)(i) .................... The hospice must—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.

418.52(b)(4)(i) and 

418.52(b)(4)(iv).

New and amended language. 

418.52(b)(4)(ii) .................... Immediately investigate all alleged violations and 

immediately take action to prevent further potential abuse while the alleged violation is being 

verified.

Same .................................. New and amended language. 

418.52(4)(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.

418.52(b)(4)(ii) ................... Amended language. 

418.52(c) ............................ Pain management and symptom control ................. 418.52(c)(1) ....................... New and amended language. 

New ........................................................................... 418.52(c)(2) ....................... New. 

New ........................................................................... 418.52(c)(3) ....................... New. 

418.52(c)(4) ....................... New. 

418.52(c)(6) ....................... New. 

New ........................................................................... 418.52(c)(7) ....................... New. 

418.52(c)(8) ....................... New. 

418.52(d) ............................ Confidentiality of clinical records .............................. 418.52(c)(5) ....................... Same. 

418.52(e) ............................ Patient liability ........................................................... Deleted ............................... Deleted. 

418.54 ................................ Initial and Comprehensive Assessment of the Patient.Same .................................. Same. 

418.54(a) ............................ 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.

Same .................................. New and amended language. 

418.54(b) ............................ Timeframe 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.

Same .................................. New and amended language. 


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418.54(c) ............................ 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—

Same .................................. New and amended language. 

418.54(c)(1) ........................ The nature and condition causing admission (including the presence or lack of objective data 

and subjective complaints); 

Same .................................. New and amended language. 

418.54(c)(3) ........................ Factors that must be considered in developing individualized care plan interventions, including—Same .................................. New and amended language. 

418.54(c)(3)(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.

418.54(c)(7) ....................... New and amended language. 

418.(c)(3)(ii) ........................ Drug therapy. A review of the patient’s prescription 

and over-the-counter drug profile, including but 

not limited to identification of the following—

418.54(c)(6) ....................... New and amended language. 

418.54(c)(3)(ii)(A) ............... Ineffective drug therapy; ........................................... 418.54(c)(6)(i) .................... New and amended language. 

418.54(c)(3)(ii)(B) ............... Unwanted drug side and toxic effects; and 418.54(c)(6)(ii) ................... New and amended language. 

418.54(c)(3)(ii)(C) ............... Drug interactions ...................................................... 418.54(c)(6)(iii) ................... New and amended language. 

New ........................................................................... 418.54(c)(6)(iv) .................. Duplicate therapy. 

New ........................................................................... 418.54(c)(6)(v) ................... Laboratory monitoring. 

418.54(c)(4) ........................ The need for referrals and further evaluation by appropriate health professionals.418.54(c)(8) ....................... Same. 

418.54(d) ............................ Update of the comprehensive assessment .............. Same .................................. New and amended language. 

418.54(d)(1) ........................ As frequently as the patient requires, but no less 

frequently than every 14 days; and 

418.54(d) ............................ Amended language. 

418.54(d)(2) ........................ At the time of each recertification ............................ Deleted ............................... Deleted. 

418.56 ................................ § 418.56 Condition of participation: Interdisciplinary 

group care planning and coordination of services.

Same .................................. Amended language. 

The hospice must designate an interdisciplinary 

group or groups as specified in paragraph (a) of 

this section which, in consultation with the patient’s attending physician, must prepare a written plan of care for each patient. The plan of 

care must specify the hospice care and services 

necessary to meet the patient and family-specific 

needs identified in the comprehensive assessment and as it relates to the terminal illness and 

related conditions.

418.56(a)(1) ........................ Standard: Approach to 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: 

Same .................................. New and amended language. 

418.54(a)(1)(i) .................... A doctor of medicine or osteopathy (who is not the 

patient’s attending physician).

Same .................................. Amended language. 

418.54(a)(1)(iv) ................... A pastoral, clergy, or other spiritual counselor ........ Same .................................. Amended language. 

418.56(a)(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.

Same .................................. Amended language. 

418.56(b) ............................ 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.

Same .................................. New and amended language. 


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418.56(c) ............................ 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—

Same .................................. New and amended language. 

418.56(c)(1) ........................ Interventions to facilitate the management of pain 

and symptoms; 

Same .................................. Amended language. 

418.56(c)(3) ........................ Measurable targeted outcomes anticipated from implementing and coordinating the plan of care; Same .................................. Amended language, 

418.56(c)(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.

Same .................................. Amended language. 

418.56(d) ............................ Review of the plan: 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.

Same .................................. Amended language. 

418.56(e) ............................ 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—

Same .................................. New and amended language. 

418.56(e)(1) ........................ Ensure the interdisciplinary group, through its designated professionals, maintains responsibility for 

directing, coordinating, and supervising the care 

and services provided; 

Same .................................. Amended language. 

418.56(e)(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.

Same .................................. Amended language. 

New ........................................................................... New 418.56(e)(5) ............... New. 

418.58 ................................ Quality assessment and performance improvement: 

The hospice must develop, implement, and maintain an effective, ongoing, hospice-wide datadriven 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.

Same .................................. New and amended language. 

418.58(a)(1) ........................ 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.

Same .................................. Amended language. 

418.58(b)(2)(ii) .................... Identify opportunities for improvement ..................... Same .................................. Amended language. 

418.58(b)(3) ........................ The frequency and detail of the data collection 

must be specified by the hospice’s governing 

body.

Same .................................. Amended language. 

418.58(d)(1)–(d)(2) ............. Performance improvement projects: (1) The number and scope of distinct improvement projects 

conducted annually must reflect the scope, complexity, and past performance of the hospice’s 

services and operations. (2) The hospice must 

document what quality improvement projects are 

being conducted, the reasons for conducting 

these projects, and the measurable progress 

achieved on these projects.

Same .................................. New and amended language. 

418.58(e)–(e)(1) ................. 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; 

Same .................................. Amended language. 


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418.58(e)(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 

Same .................................. Amended language. 

418.58(e)(3) ........................ That clear expectations for patient safety are established.Deleted ............................... Deleted. 

New ........................................................................... 418.58(e)(3) ....................... New. 

418.60 ................................ 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.

Same .................................. Amended language. 

418.60(b)(2)(ii) .................... A plan for the appropriate actions that are expected 

to result in improvement and disease prevention.

Same .................................. Amended language. 

418.62 ................................ Licensed professional services ................................ Same .................................. Same. 

418.62(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 

Same .................................. Amended language. 

418.64 ................................ 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.

Same .................................. New and amended language. 

Circumstances under which a hospice may enter 

into a written arrangement for the provision of 

core services include: Unanticipated periods of 

high patient loads, staffing shortages due to illness or other short-term temporary situations that 

interrupt patient care; and temporary travel of a 

patient outside of the hospice’s service area.

418.64(a) ............................ Physician services: The 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.

Same .................................. Amended language. 

(1) All physician employees and those under contract, must function under the supervision of the 

hospice medical director.

(2) All physician employees and those under contract shall meet this requirement by either providing the services directly or through coordinating patient care with the attending physician.

(3) If the attending physician is unavailable, the 

medical director, contracted physician, and/or 

hospice physician employee is responsible for 

meeting the medical needs of the patient.

418.64(b) ............................ Nursing services: (1) 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.

Same .................................. Amended language. 

(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.


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418.64(d) ............................ 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: 

Same .................................. New and amended language. 

418.64(d)(1)(i) .................... Bereavement counseling. The hospice must: Have 

an organized program for the provision of bereavement services furnished under the supervision of a qualified professional with experience 

in grief/loss counseling.

Same .................................. Amended language. 

418.64(d)(1)(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.

Same .................................. Amended language. 

418.64(d)(1)(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).

Same .................................. Amended. 

418.64(d)(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.

Same .................................. Renamed: Dietary Counseling. 

418.64(d)(3)(i)–(iv) ............. Spiritual counseling. The hospice must: Same .................................. Amended language. 

(i) Provide an assessment of the patient’s and 

family’s spiritual needs; 

(ii) Provide spiritual counseling to meet these 

needs in accordance with the patient’s and 

family’s acceptance of this service, and in a 

manner consistent with patient and family 

beliefs and desires; 

(iii) Facilitate visits by local clergy, pastoral 

counselors, or other individuals who can 

support the patient’s spiritual needs to the 

best of its ability. The hospice is not required 

to go to extraordinary lengths to do so; and 

(iv) Advise the patient and family of this service.

418.66 ................................ Nursing services—Waiver of requirement that substantially all nursing services be routinely provided directly by a hospice.

Same .................................. Same. 

418.66(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: 

Same .................................. Amended language. 

(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 


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(iv) Evidence of any other recruiting activities 

(for example, recruiting efforts at health fairs 

and contacts with nurses at other providers 

in the area).

418.66(d) ............................ CMS may approve a 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.

Same .................................. Amended language. 

418.74 ................................ Waiver of requirement—Physical therapy, occupational therapy, speech-language pathology, and 

dietary counseling.

Same .................................. Same. 

418.74(a) ............................ A hospice located in a non-urbanized area may 

submit a written request for a waiver of the requirement for providing physical therapy, occupational therapy, speech-language pathology, and 

dietary counseling services. The hospice may 

seek a waiver of the requirement that it make 

physical therapy, occupational therapy, 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.

Same .................................. Amended language. 

The hospice must provide evidence that it has 

made a good faith effort to meet the requirements for these services before it seeks a waiver. CMS may approve a waiver application on 

the basis of the following criteria: (1) The hospice 

is located in a non-urbanized area as determined 

by the Bureau of the Census.

(2) The hospice provides evidence that it had made 

a good faith effort to make available physical 

therapy, occupational therapy, speech-language 

pathology, and dietary counseling services on a 

24-hour basis and/or to hire a dietary counselor 

to furnish services directly. This evidence must 

include—

(i) Copies of advertisements in local newspapers that demonstrate recruitment efforts; 

(ii) Physical therapy, occupational therapy, 

speech-language pathology, and dietary 

counselor job descriptions; 

(iii) Evidence that salary and benefits are competitive for the area; and 

(iv) Evidence of any other recruiting activities 

(for example, recruiting efforts at health fairs 

and contact discussions with physical therapy, occupational therapy, speech-language 

pathology, and dietary counseling service 

providers in the area).

418.74(d) ............................ CMS may approve a 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.

Same .................................. Amended language. 

418.76 ................................ 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.

Same .................................. New and amended language. 

418.76(a)(1) ........................ Home health aide qualifications: .............................. Same .................................. New and amended language. 

(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 Same .................................. New and amended language. 

(iii) A State licensure program that meets the 

requirements of paragraphs (b) and (c) of 

this section.

418.76(a)(1)(iv) .................. Same. 

New .................................... New ........................................................................... 418.76(a)(1)(iii) .................. New. 


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418.76(a) ............................ (2) A home health aide is not considered to have 

completed a training program, or a competency 

evaluation program if, since the individual’s most 

recent completion of the program(s), there has 

been a continuous period of 24 consecutive 

months during which none of the services furnished by the individual as described in § 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.

Same .................................. New and amended language. 

418.76(b) ............................ 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.

Same .................................. Amended language. 

(2) A minimum of 16 hours of classroom training 

must precede a minimum of 16 hours of supervised practical training as part of the 75 hours.

(3) A home health aide training program must address each of the following subject areas: 

(4) The hospice must maintain documentation that 

demonstrates that the requirements of this standard are met.

418.76(c) ............................ Competency evaluation: 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.

Same .................................. Amended language. 

418.76(c)(1) ........................ (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.

Same .................................. Amended language. 

418.76(c)(2) ........................ (2) A home health aide competency evaluation program may be offered by any organization, except 

as specified in paragraph (f) of this section.

Same .................................. Amended language. 

418.76(c)(4) ........................ (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.

Same .................................. New and amended language. 

418.76(d) ............................ In-service training: A home health aide must receive at least 12 hours of in-service training during each 12-month period. In-service training 

may occur while an aide is furnishing care to a 

patient.

Same .................................. Amended language. 

(1) In-service training may be offered by any organization except one that is excluded by paragraph (f) of this section, and must be supervised 

by a registered nurse.

(2) The hospice must maintain documentation that 

demonstrates the requirements of this standard 

are met.

418.76(e) ............................ Qualifications for instructors conducting classroom 

supervised practical training, competency evaluations and in-service training: 

Same .................................. Amended language. 

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.


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418.76(f) ............................. 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—

Same .................................. Amended language. 

(1) Was out of compliance with the requirements of 

paragraphs (b) or (c) of this section; 

(2) Permitted an individual that does not meet the 

definition of a ‘‘qualified home health aide’’ as 

specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); 

(3) Was subjected to an extended (or partial extended) survey as a result of having been found 

to have furnished substandard care (or for other 

reasons at the discretion of CMS or the State); 

(4) Was assessed a civil monetary penalty of 

$5,000 or more as an intermediate sanction; 

(5) Was found by CMS to have compliance deficiencies that endangered the health and safety of 

the home health agency’s patients and had temporary management appointed to oversee the 

management of the home health agency; 

(6) Had all or part of its Medicare payments suspended; or 

(7) Was found by CMS or the State under any Federal or State law to have: 

418.76(g) ............................ Home health aide assignments and duties: A registered nurse or the appropriate qualified therapist that is a member of the interdisciplinary team 

makes home health aide assignments.

Deleted ............................... Deleted stem. 

418.76(g)(1) ........................ 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, speechlanguage pathologist, or occupational therapist) 

who is responsible for the supervision of a home 

health aide as specified under paragraph (h) of 

this section.

Same .................................. New and amended language. 

418.76(g)(2) ........................ A home health aide provides services that are: Same .................................. Amended language. 

(i) Ordered by the physician or nurse practitioner; 

(ii) Included in the plan of care; 

(iii) Permitted to be performed under State law 

by such home health aide; and 

(iv) Consistent with the home health aide training.

418.76(g)(3) ........................ The duties of a home health aide include: Same .................................. Amended language. 

(i) The provision of hands on personal care; 

(ii) The performance of simple procedures as 

an extension of therapy or nursing services; 

(iii) Assistance in ambulation or exercises; and 

(iv) Assistance in administering medications 

that are ordinarily self administered.

418.76(g)(4) ........................ Home health aides must 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.

Same .................................. Amended language. 

418.76(h) ............................ Supervision of home health aides: (l) 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.

418.76(h)(1) and (h)(2) ...... New and amended language. 

418.76(h)(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—

418.76(h)(3) ....................... Amended language. 

(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; 


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(ii) Creating successful interpersonal relationships with the patient and family; 

(iii) Demonstrating competency with assigned 

tasks; 

(iv) Complying with infection control policies 

and procedures; and 

(v) Reporting changes in the patient’s condition. 

418.76(h)(3) ........................ If the hospice chooses to provide home health aide 

services under contract with another organization, the hospice’s responsibilities include, but 

are not limited to—

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

(i) Ensuring the overall quality of care provided 

by an aide; 

(ii) Supervising an aide’s services as described 

in paragraphs (h)(l) and (h)(2) of this section; 

and 

(iii) Ensuring that home health aides who provide services under arrangement have met 

the training and/or competency evaluation 

requirements of this condition. 

New ........................................................................... 418.76(h)(3) ....................... New language. 

418.76(i) ............................. Individuals furnishing Medicaid personal care aideonly 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.

418.76(i) and (i)(1) ............. Amended language. 

418.76(i)(2) ........................ New language. 

418.76(i)(3) ........................ New language. 

418.76(j) ............................. 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.

Same .................................. New and amended language. 

418.76(k) ............................ Homemaker supervision and duties ......................... Same .................................. New and amended language. 

(1) Homemaker services must be coordinated by a 

member of the interdisciplinary group. 

(2) Instructions for homemaker duties must be prepared by a member of the interdisciplinary group. 

(3) Homemakers must report all concerns about the 

patient or family to the member of the interdisciplinary group who is coordinating homemaker services. 

Subpart D Conditions of Participation: Organizational Environment 

418.100 .............................. Organization and 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.

Same .................................. New and amended language. 

418.100(a) .......................... 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.

Same .................................. New and amended language. 

418.100(c) .......................... 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: 

Same .................................. Amended language. 

(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.


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(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.

418.100(e) .......................... 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—

Same .................................. Amended language. 

(1) Authorized by the hospice; 

(2) Furnished in a safe and effective manner 

by personnel having at least the same qualifications as hospice employees; and 

(3) Delivered in accordance with the patient’s 

plan of care.

418.100(f) ........................... Hospice satellite 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.

Same .................................. Renamed. Amended language. 

(2) The hospice must continually monitor and manage all services provided at all of its locations to 

ensure that services are delivered in a safe and 

effective manner and to ensure that each patient 

and family receives the necessary care and services outlined in the plan of care.

418.100(g) .......................... In-service training: A hospice must assess the skills 

and competence of all individuals furnishing care, 

including volunteers furnishing services, and, as 

necessary, provide in-service training and education programs where required. The hospice 

must have written policies and procedures describing its method(s) of assessment of competency and maintain a written description of the 

in-service training provided during the previous 

12 months.

Same .................................. Renamed. New and amended language. 

418.102 .............................. 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.

Same .................................. Amended language. 

418.102(a) .......................... 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: 

418.102(b) .......................... Amended language. 

(1) The primary terminal condition.

(2) Related diagnosis(es), if any.

(3) Current subjective and objective medical 

findings.

(4) Current medication and treatment orders.

(5) Information about the medical management 

of any of the patient’s conditions unrelated to 

the terminal illness.

New .................................... 418.102(a) .......................... New. 

418.102(b) .......................... Recertification of the terminal illness. Before the recertification period for each patient, as described 

in § 418.21(a), the medical director or physician 

designee must review: 

418.102(c) .......................... Amended language. 

(1) The patient’s clinical information; and 

(2) The patient’s and family’s expectations and 

wishes for the continuation of hospice care.

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


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418.102(c) .......................... 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.

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

New .................................... New ........................................................................... 418.102(d) .......................... New. 

418.104(a) .......................... Clinical records. Content. Each patient’s record 

must include the following: 

Same .................................. New and amended language. 

(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).

418.104(b) .......................... 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.

Same .................................. New and amended language. 

418.104(d) .......................... 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.

Same .................................. Amended language. 

418.104(e) .......................... 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.

Same .................................. New and amended language. 

(2) If a patient revokes the election of hospice care, 

or is discharged from hospice because eligibility 

criteria are no longer met, the hospice must provide a copy of the clinical record and the hospice 

discharge summary of this section to the patient’s attending physician.

(3) The hospice discharge summary must include—

(i) A summary of the patient’s stay including 

treatments, symptoms and pain management; 

(ii) The patient’s current plan of care; 

(iii) The patient’s latest physician orders; and 

(iv) Any other documentation that will assist in 

post-discharge continuity of care.

418.106(a) .......................... Drugs and biologicals, medical supplies, and durable medical equipment. Administration of Drugs 

and biologicals: (1) All drugs and biologicals 

must be administered in accordance with accepted hospice and palliative care standards of practice and according to the patient’s plan of care.

418.106(d) .......................... Partially deleted and moved to stem. 

418.106(a) .......................... (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.

418.106(d)(1) ..................... Renamed. New and amended language. 

New .................................... New ........................................................................... 418.106(a) .......................... Renamed. New and amended language. 

418.106(b) .......................... Controlled drugs: 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.

418.106(e) .......................... Renamed. New and amended language. 


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418.110(n)(1) ...................... New ........................................................................... 418.106(b) .......................... Renamed. New and amended language. 

418.106(c) .......................... 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.

418.106(f) ........................... New and amended language. 

(2) The hospice must ensure that the patient, 

where appropriate, as well as the family and/or 

other caregiver(s), receive instruction in the safe 

use of durable medical equipment and supplies. 

The patient, family, and/or caregiver must be 

able to demonstrate the appropriate use of durable medical equipment to the satisfaction of the 

hospice staff.

418.110(m) ......................... ................................................................................... 418.106(c) .......................... Renamed. New and amended language. 

418.110(n)(2) ...................... ................................................................................... 418.106(d)(2) ..................... Renamed. New and amended language. 

418.106(b) and 

418.110(n)(3)–(5).

................................................................................... 418.106(e) .......................... Renamed. New and amended language. 

New .................................... New ........................................................................... 418.106(f)(3) ...................... Amended language. 

418.108(a) .......................... Inpatient care for 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.

Same .................................. Amended language. 

418.108(b) .......................... Inpatient care for respite purposes: Inpatient care 

for respite purposes must be provided by one of 

the following: 

Same .................................. New and amended language. 

(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).

418.108(c) .......................... 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—

Same .................................. Amended language. 

(1) That the hospice supplies the inpatient provider a copy of the patient’s plan of care and 

specifies the inpatient services to be furnished; 

(2) That the inpatient provider has established 

patient care policies consistent with those of 

the hospice and agrees to abide by the palliative care protocols and plan of care established by the hospice for its patients; 

(3) That the hospice patient’s inpatient clinical 

record includes a record of all inpatient services furnished, events regarding care that 

occurred at the facility, and that a copy of 

the inpatient clinical record and discharge 

summary is available to the hospice at the 

time of discharge; 

(4) That the inpatient facility has identified a individual within the facility who is responsible 

for the implementation of the provisions of 

the agreement; 

(5) That the hospice retains responsibility for 

arranging the training of personnel who will 

be providing the patient’s care in the inpatient facility and that a description of the 

training and the names of those giving the 

training is documented; and 

(6) That a way to verify that requirements in 

paragraphs (c)(1) through (c)(5) of this section have been met is established. 

418.110 .............................. Hospices that provide inpatient care directly.

418.110 .............................. A hospice that provides inpatient care directly must 

demonstrate compliance with all of the following 

standards: 

Same .................................. New language. 


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418.110(b) .......................... Twenty-four hour nursing services: The hospice facility must provide 24-hour nursing services that 

meet the nursing needs of all patients and are 

furnished in accordance with each patient’s plan 

of care. Each patient must receive all nursing 

services as prescribed and must be kept comfortable, clean, well-groomed, and protected from 

accident, injury, and infection.

Same .................................. New language. 

418.110(c) .......................... Physical environment. The hospice must maintain a 

safe physical environment free of hazards for patients, staff, and visitors.

Same .................................. Amended language. 

(1) Safety management. (i) The hospice must address real or potential threats to the health and 

safety of the patients, others, and property. The 

hospice must report a breach of safety to appropriate State and local bodies having regulatory 

jurisdiction and correct it promptly.

(ii) The hospice must take steps to prevent 

equipment failure and when a failure occurs, 

report it to the appropriate State and local 

bodies having regulatory jurisdiction and correct it promptly.

(iii) The hospice must have a written disaster 

preparedness plan in effect for managing the 

consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. The 

plan must be periodically reviewed and rehearsed with staff (including non-employee 

staff) with special emphasis placed on carrying out the procedures necessary to protect patients and others.

418.110(c) .......................... (2) Physical plant and equipment. The hospice 

must develop procedures for managing the control, reliability, and quality of—

Same .................................. Amended language. 

(i) The routine storage and prompt disposal of 

trash and medical waste; 

(ii) Light, temperature, and ventilation/air exchanges throughout the hospice; 

418.110(d) .......................... Fire protection ........................................................... Same .................................. Amended language. 

418.110(f) ........................... Patient rooms: (1) The hospice must ensure that 

patient rooms are designed and equipped for 

nursing care, as well as the dignity, comfort, and 

privacy of patients.

Same .................................. New and amended language. 

(2) The hospice must accommodate a patient and 

family request for a single room whenever possible.

(3) Each patient’s room must—

(i) Be at or above grade level; 

(ii) Contain a suitable bed and other appropriate furniture for each patient; 

(iii) Have closet space that provides security 

and privacy for clothing and personal belongings; 

(iv) Accommodate no more than two patients; 

(v) Provide at least 80 square feet for each residing patient in a double room and at least 

100 square feet for each patient residing in a 

single room; and 

(vi) Be equipped with an easily-activated, functioning device accessible to the patient, that 

is used for calling for assistance.

418.110(f)(4) ....................... For an existing 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 jeopardize its ability to continue to participate in the 

Medicare program; and 

Same .................................. New and amended language. 

418.110(m) ......................... 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.

418.106(a) .......................... New and amended language. 

418.110(m) ......................... The hospice will evaluate a patient’s response to 

the medication therapy, identify adverse drug reactions, and take appropriate corrective action.

418.54(a)(6) ....................... New and amended language. 

418.110(m) ......................... Drugs and biologicals must be obtained from community or institutional pharmacists or stocked by 

the hospice.

418.106(c) .......................... New and amended language. 


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418.110(m) ......................... The hospice must furnish the drugs and biologicals 

for each patient, as specified in each patient’s 

plan care.

418.106 Stem .................. New and amended language. 

418.110(m) ......................... The use of drugs and biologicals must be provided 

in accordance with accepted professional principles and appropriate Federal, State, and local 

laws.

418.100(c) and 418.116 .... New and amended language. 

418.110(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.

418.106(a) .......................... New and amended language. 

418.110(n)(1) ...................... Orders for medications ............................................. 418.106(b) .......................... New and amended language. 

(i) A physician as defined by section 1861(r)(1) of 

the Act, or a nurse practitioner in accordance 

with the plan of care and State law, must order 

all medications for the patient.

(ii) If the medication order is verbal or given by or 

through electronic transmission—

(A) The physician must give it only to a licensed 

nurse, nurse practitioner (where appropriate), 

pharmacist, or another physician; and 

(B) The individual receiving the order must record 

and sign it immediately and have the prescribing 

physician sign it in accordance with State and 

Federal regulations.

418.110(n)(2) ...................... Administration of medications. Medications must be 

administered by only the following individuals: 

418.106(d)(2) ..................... New and amended language. 

(i) A licensed nurse, physician, or other health 

care professional in accordance with their 

scope of practice.

(ii) An employee who has completed a Stateapproved training program in medication administration.

(iii) The patient, upon approval by the attending physician.

418.110(n)(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).

418.106(e)(1) ..................... New and amended language. 

418.110(n)(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.

418.106(e)(3) ..................... New and amended language. 

(ii) The hospice must keep current and accurate 

records of the receipt and disposition of all controlled drugs.

(iii) Any discrepancies in the acquisition, storage, 

use, disposal, or return of controlled drugs must 

be investigated immediately by the pharmacist 

and hospice administrator and where required reported to the appropriate State agency. A written 

account of the investigation must be made available to State and Federal officials.

418.110(n)(5) ...................... Drug disposal. 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.

418.106(e)(2)(ii) ................. New and amended language. 

418.110(o)(1) ...................... 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.

418.110(m) ......................... Same. 

418.110(o)(1) ...................... The term restraint includes either a physical restraint or a drug that is being used as a restraint. 

A physical restraint is any manual method or 

physical or mechanical device, material or equipment attached or adjacent to the patient’s body 

that he or she cannot easily remove, that restricts free movement of, normal function of, or 

normal access to one’s body.


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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.

418.3 .................................. Same. 

418.110(o)(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.

418.110(m) and 

418.110(m)(1).

Same. 

418.110(o)(3)(i) .................. The use of restraint and seclusion must be— 418.110(m)(2) .................... New and amended language. 

(i) Selected only when less restrictive measures 

have been found ineffective to protect the patient 

or others from harm; 

418.110(o)(3)(ii) .................. Carried out in accordance with the order of a physician. The following will be superseded by more 

restrictive State laws: 

418.110(m)(4) and 

418.110(m)(7).

New and amended language. 

418.110(o)(3)(ii)(A) ............. Orders for seclusion or restraints must never be 

written as a standing order or an as needed 

basis (that is, PRN).

418.110(m)(5) .................... Amended language. 

418.110(o)(3)(ii)(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.

418.110(m)(6) .................... Amended language. 

418.110(o)(3)(ii)(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.

418.110(m)(11) and 

418.110(m)(12).

New and amended language. 

418.110(o)(3)(ii)(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 issuing another seclusion and restraint order.

418.110(m)(7) .................... New and amended language. 

418.110(o)(3)(iii) ................. In accordance with the interdisciplinary group and a 

written modification to the patient’s plan of care; 

418.110(m)(3)(i) ................. Amended language. 

418.110(o)(3)(iv) ................. Implemented in the least restrictive manner possible not to interfere with the palliative care being 

provided; 

418.110(m)(2) .................... Amended language. 

418.110(o)(3)(v) ................. In accordance with safe, appropriate restraining 

techniques.

418.110(m)(3)(ii) ................ Amended language. 

418.110(o)(3)(vi) ................. Ended at the earliest possible time; and 418.110(m)(8) .................... Amended language. 

418.110(o)(3)(vii) ................ Supported by medical necessity and the patient’s 

response or outcome, and documented in the patient’s clinical record.

418.110(m)(15) .................. New and amended language. 

418.110(o)(4) ...................... A restraint and seclusion may not be used simultaneously unless the patient is—418.110(m)(14) .................. Amended language. 

(i) Continually monitored face to face by an assigned staff member; or 

(ii) Continually monitored by staff using video 

and audio equipment. Staff must be in immediate response proximity to the patient.

418.110(o)(5) ...................... The condition of the patient who is in a restraint or 

in seclusion must continually be assessed, monitored, and reevaluated by an assigned staff 

member.

418.110(m)(9) .................... New and amended language. 

418.110(o)(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.

418.110(n) .......................... New and amended language. 

418.110(o)(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.

418.110(o) .......................... New and amended language. 

418.112 .............................. 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.

Same .................................. New and amended language. 


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418.112(a) .......................... 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.

Same .................................. New and amended language. 

418.112(b) .......................... 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.

Same .................................. New and amended language. 

418.112(c) .......................... Core services: A hospice must routinely provide all 

core services. These services include nursing 

services, medical social services, and counseling 

services.

418.64 ................................ New and amended language. 

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.

418.112(d) .......................... 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.

418.112(e) .......................... New and amended language. 

418.112(e) .......................... 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.

418.112(c) .......................... New and amended language. 

418.112(e)(1) and (e)(2) .... The written agreement must include at least the following: Deleted ............................... Deleted. 

(1) The written consent of the patient or the 

patient’s representative that hospice services 

are desired.

(2) The services that the hospice will furnish 

and that the facility will furnish.

418.112(e)(3) ...................... The manner in which the facility and the hospice 

are to communicate with each other to ensure 

that the needs of the patient are addressed and 

met 24 hours a day.

418.112(c)(1) ..................... Amended language. 

418.112(e)(4)(i) and (ii) ...... A provision that the facility immediately notifies the 

hospice if—

418.112(c)(2), 

418.112(c)(2)(i) and 

418.112(c)(2)(ii).

Amended language. 

(i) A significant change in the patient’s physical, mental, social, or emotional status occurs; 

(ii) Clinical complications appear that suggest a 

need to alter the plan of care; 

418.112(e)(4)(iii) ................. A life threatening condition appears; Deleted ............................... Deleted. 

418.112(e)(4)(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 

418.112(c)(2)(iii) ................. Amended language. 

418.112(e)(4)(v) ................. The patient dies ........................................................ 418.112(c)(2)(iv) ................ Amended language. 

418.112(e)(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.

418.112(c)(3) ..................... Amended language. 

418.112(e)(6) ...................... An agreement that it is the facility’s primary responsibility to furnish room and board.418.112(c)(4) ..................... New and amended language. 

New .................................... New ........................................................................... 418.112(c)(5) ..................... New. 


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418.112(e)(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.

418.112(c)(6) ..................... New and amended language. 

418.112(e)(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.

418.112(c)(7) ..................... Amended language. 

New .................................... New ........................................................................... 418.112(c)(8) ..................... New. 

New .................................... New ........................................................................... 418.112(c)(9) ..................... New. 

418.112(f) ........................... 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.

418.112(d) .......................... New and amended language. 

418.112(f) ........................... 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.

418.56(b) and (c) ............... New and amended language. 

418.112(f)(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.

418.112(d)(1) ..................... Amended language. 

418.112(f)(2) ....................... The plan of care reflects the participation of the 

hospice, the facility, and the patient and family to 

the extent possible.

418.112(d)(2) ..................... Amended language. 

418.112(f)(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.

418.56(d) ............................ New and amended language. 

418.112(f)(4) ....................... Any changes in the plan of care must be discussed 

among all caregivers and must be approved by 

the hospice before implementation.

418.112(d)(3) ..................... Amended language. 

418.112(g) .......................... 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: 

418.112(e)(1) ..................... New and amended language. 

(1) Plan of care.

418.112(g)(2)–(g)(6) ........... (2) Patient or patient’s representative hospice consent form and advance directives.418.112(e)(3) ..................... New and amended language. 

(3) Names and contact information for hospice personnel involved in hospice care of the patient.

(4) Instructions on how to access the hospice’s 24- 

hour on-call system.

(5) Medication information specific to the patient.

(6) Physician orders.

418.112(h) .......................... Transfer, revocation, 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.

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

418.112(i) ........................... Orientation and training: Hospice staff must orient 

facility staff furnishing care to hospice patients in 

the hospice philosophy, including hospice policies and procedures regarding methods of comfort, pain control, symptom management, as well 

as principles about death and dying, individual 

responses to death, patient rights, appropriate 

forms, and record keeping requirements.

418.112(f) ........................... Amended language. 

418.114 .............................. Personnel qualifications for licensed professionals Same .................................. Renamed. 


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418.114(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.

Same .................................. New and amended language. 

418.114(b) .......................... Personnel qualifications for physicians, speech-language pathologists, and home health aides: The 

following qualifications must be met: 

Same .................................. Renamed. New and amended language. 

418.114(b)(1) ...................... Physicians ................................................................. Same and 418.3 ................ New and amended language. 

418.114(b)(2) ...................... Speech language pathologists ................................. 418.114(b)(4) ..................... New and amended language. 

418.114(b)(3) ...................... Home health aides ................................................... 418.114(b)(2) ..................... Renamed. New and amended language. 

418.114(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: 

Same .................................. New and amended language. 

418.114(c)(1) ...................... Occupational therapist .............................................. 418.114(b)(5) ..................... New and amended language. 

418.114(c)(2) ...................... Occupational therapy assistant ................................ 418.114(b)(6) ..................... New and amended language. 

418.114(c)(3) ...................... Physical therapist ..................................................... 418.114(b)(7) ..................... New and amended language. 

418.114(c)(4) ...................... Physical therapist assistant ...................................... 418.114(b)(8) ..................... New and amended language. 

418.114(c)(5) ...................... Registered nurse. A graduate of a school of professional nursing.418.114(c)(1) ..................... New and amended language. 

418.114(c)(6) ...................... Licensed practical nurse. A person who has completed a practical nursing program.418.114(c)(2) ..................... New and amended language. 

418.114(c)(7) ...................... Social worker ............................................................ 418.114(b)(3) ..................... New and amended language. 

418.114(d) .......................... Criminal background checks: The hospice must obtain a criminal background check on each hospice employee and contracted employee before 

employment at the hospice.

Same .................................. New and amended language. 

418.116(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.

418.114(a) .......................... Relocated and amended. 

418.116(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.

418.116(a) .......................... Amended language. 

V. Collection of Information 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

The accuracy of our estimate of the 

information collection burden. 

The quality, utility, and clarity of the 

information to be collected. 

Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

Therefore, we are soliciting public 

comment on each of these issues for the 

following sections of this document that 

contain information collection 

requirements. 

Condition of Participation: Patient’s 

Rights (§ 418.52) 

Section 418.52(a)(1) states that a 

hospice must provide the patient or 

representative with verbal and written 

notice of the patient’s right and 

responsibilities. The notification must 

be presented in a manner and language 

consistent with the patient’s ability to 

comprehend the information. Section 

418.52(a)(2) requires a hospice to inform 

and distribute written information on its 

policies concerning advance directives. 

The information must include a 

description of applicable State laws. 

Section 418.52(a)(3) states that a hospice 

must obtain the patient’s or 

representative’s signature confirming 

that he or she has received a copy of the 

notice of rights. 

The burden associated with the 

notification requirements contained in 

§ 418.52(a) is the time and effort 

necessary for a hospice to: develop the 

notification form; provide, both verbally 

and in writing, the patient or the 

patient’s representative with a notice of 

patient’s rights; inform and distribute 

information pertaining to its policies on 

advance directives and applicable State 

laws; obtain signatures from either the 

patient or representative confirming 

receipt of a copy of the notice of rights. 

There are 2,872 hospices that must 

comply with the aforementioned 

requirements. We estimate that it will 

take each hospice 8 hours to develop the 

form and 5 minutes to meet the 

requirements in § 418.52(a)(1–3). We 

estimate that each hospice will on 

average provide 303 notifications per 

year for a total one time burden of 

22,976 hours and annual burden of 

72,518 hours. 

Section 418.52(b) sets out the right of 

the patients to exercise these patient 

rights and requires hospices to show 

respect for property and person. 

Specifically, § 418.52(b)(4)(i) states that 

a hospice is accountable for ensuring 


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that all alleged violations involving 

mistreatment, neglect or verbal, mental, 

sexual, and physical abuse, including 

injuries of unknown source, and 

misappropriation of patient property by 

anyone furnishing services on behalf of 

the hospice are reported immediately to 

the hospice administrator. Section 

418.52(b)(4)(ii) requires a hospice to 

immediately investigate all alleged 

violations involving anyone furnishing 

services on behalf of the hospice and 

immediately take preventative action to 

avoid additional violations. As part of 

the investigation, the hospice must 

document and maintain all records 

associated with the alleged violations in 

accordance with established procedures. 

Section 418.52(b)(4)(iv) further requires 

that a hospice report all confirmed 

violations to the State and local bodies 

having jurisdiction within 5 working 

days of becoming aware of the violation. 

The burden associated with the 

recordkeeping and reporting 

requirements described in § 418.52(b) is 

the time and effort necessary to report 

all alleged violations to the hospice 

administrator, to conduct and document 

an investigation and to maintain record 

of the documented investigation. There 

is also burden associated with reporting 

all verified allegations to the State and 

local bodies that have jurisdiction. We 

anticipate that each of the 2,872 

hospices will investigate, document, 

and report 15 violations per year. We 

estimate that it will take each hospice 

60 minutes per event to satisfy the 

requirements contained in § 418.52(b). 

The estimated annual burden associated 

with the requirements contained in 

§ 418.52(b) is 43,080 hours. 

Condition of Participation: Initial and 

Comprehensive Assessment of the 

Patient (§ 418.54) 

Section 418.54 contains the 

information collection requirements 

associated with the initial and 

comprehensive assessment of the 

patient. Section 418.54(a) requires a 

hospice to conduct the initial patient 

assessment within 48 hours after the 

patient or representative elects the 

hospice benefit. Section 418.54(b) states 

that the hospice IDG must complete the 

patient’s comprehensive assessment no 

later than 5 calendar days after the 

patient or representative elects the 

hospice benefit. Section 418.54(c) sets 

out the content of the assessment. 

Section 418.54(d) requires that the 

comprehensive patient assessment be 

updated as needed based on the 

patient’s condition, but no less 

frequently than every 15 days. 

The burden associated with the 

requirements in § 418.54 is the time and 

effort necessary to document and 

maintain the patient assessment. While 

these requirements are subject to the 

PRA, the associated burden is exempt as 

stated in 5 CFR 1320.3(b)(2); conducting 

patient assessments is a usual and 

customary business practice. The time, 

effort, and financial resources necessary 

to comply with a collection of 

information that would be incurred by 

a person in the normal course of their 

activities are considered to be usual and 

customary and is exempt from the PRA. 

Condition of Participation: 

Interdisciplinary Group Care Planning 

and Coordination of Services (§ 418.56) 

Section 418.56(a) requires a hospice 

that has more than one IDG to designate 

a group to establish policies governing 

the day-to-day provision of hospice care 

and services. The burden associated 

with this requirement is the time and 

effort necessary to draft, implement, and 

maintain the policies governing the dayto-day provision of hospice care 

services. While this requirement is 

subject to the PRA, the burden is 

considered to be usual and customary 

and is exempt as stated under 5 CFR 

1320.3(b)(2). 

Section 418.56(b) requires all hospice 

care and services furnished to patients 

and their families to follow an 

established plan of care established by 

the hospice IDG and the patient’s 

caregivers. In addition, a hospice must 

ensure that each patient and the primary 

caregiver(s) receive education and 

training provided by the hospice. The 

education and training must be specific 

to the individual’s responsibilities with 

respect to the care and services outlined 

in the plan of care. The burden 

associated with this requirement is the 

time and effort associated with 

educating and training the patient and 

patient caregiver(s). This requirement is 

currently approved under OMB control 

number 0938–0302. The expiration date 

for the approval is August 31, 2009. 

Section 418.56(c) requires hospices to 

develop an individualized written plan 

of care for each patient. The plan of care 

must contain the information described 

in § 418.56(c)(1)–(6). Section 418.56(d) 

states that the hospice interdisciplinary 

team must review, revise, and document 

the individualized plan of care as 

frequently as the patient’s condition 

warrants, but no less frequently than 

every 15 days. The burden associated 

with these requirements is the time and 

effort associated with drafting, 

reviewing, revising, and maintaining the 

plan of care. This requirement is 

currently approved under OMB control 

number 0938–0302, with an expiration 

date of August 31, 2009. 

Section 418.56(e) describes the 

standard for the coordination of hospice 

services. Specifically, it states that a 

hospice must develop and maintain a 

system of communication and 

integration to ensure the information 

contained in § 418.56(e)(1)–(5). The 

burden associated with this requirement 

is the time and effort required to 

develop and maintain the system of 

communication in accordance with the 

hospice’s policies and procedures. 

While this requirement is subject to the 

PRA, the associated burden is 

considered to be usual and customary as 

stated in 5 CFR 1320.3(b)(2). 

Condition of Participation: Quality 

Assessment and Performance 

Improvement (§ 418.58) 

Section 418.58 states that a hospice 

must develop, implement, and maintain 

an effective, ongoing, hospice-wide 

data-driven quality assessment and 

performance improvement (QAPI) 

program. In addition, the hospice must 

maintain documentary evidence of its 

quality assessment and performance 

improvement program and be able to 

demonstrate its operation to CMS. 

Section 418.58(a) describes the required 

scope of the QAPI program. Specifically, 

§ 418.58(a)(1) discusses the 

documentation requirements. The QAPI 

program must be able to demonstrate 

measurable improvement in indicators 

related to improved palliative outcomes 

and hospice services. Section 

418.58(a)(2) states that the hospice must 

measure, analyze, and track quality 

indicators. 

Section 418.58(b)(2) states that a 

hospice must use the data to monitor 

the effectiveness and safety of services 

and quality of care. As part of the 

monitoring process, the data must be 

used to identify improvement 

opportunities. The data must also be 

used to assist in the prioritization of the 

aforementioned opportunities for 

improvement. 

Section 418.58(c)(2) states that as part 

of performance improvement activities, 

a hospice must track adverse patient 

events, analyze their causes, and 

implement preventative actions and 

mechanisms that include feedback and 

learning throughout the hospice. 

Section 418.58(c)(3) requires a hospice 

to measure its success and track 

performance in its performance 

improvement initiatives to ensure that 

the improvements are continuous. 

Section 418.58(d) discusses that 

standard for performance improvement 

projects. Hospices are responsible for 

developing, implementing, and 

evaluating performance improvement 

projects. Section 418.58(d)(2) requires 


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hospices to document their performance 

improvement projects, the reason for 

conducting each project, and the 

measurable progress achieved as a result 

of the projects. 

The burden associated with the 

requirements contained in § 418.58 is 

the time and effort necessary to develop, 

draft, and implement a QAPI program. 

As part of the QAPI program, there is 

also burden associated with recording 

quality data for performance 

improvement initiatives. We estimate 

that for all 2,872 hospices, 1 hour per 

hospice will be required to comply with 

the documentation of the domains and 

measures, 91 hours per hospice for data 

entry and 48 hours to aggregate the data. 

This is an annual burden of 140 hours 

per hospice to meet the requirement of 

this section. The estimated annual 

burden associated with the 

requirements in § 418.58 is 402,080 

hours annually. 

Condition of Participation: Infection 

Control (§ 418.60) 

Section 418.60(a) requires hospices to 

maintain and document an effective 

infection control program. The goal of 

the program is to protect patients, 

families, visitors, and hospice staff by 

preventing and controlling infectious 

and communicable diseases. Section 

418.60(b) provides the standard for 

effective hospice infection control 

programs. Section 418.60(c) describes 

the standard for education with respect 

to infection control. Hospices must 

provide infection control education to 

employees, contracted providers, 

patients, and family members and other 

care givers. 

The burden associated with the 

requirements in § 418.60(a)–(c) is the 

time and effort associated with 

developing, implementing, 

documenting, and maintaining an 

effective infection control program. 

There is also burden associated with 

providing infection control education. 

While these requirements are subject to 

the PRA, the burden is exempt as stated 

in 5 CFR 1320.3(b)(2). The existence of 

an effective infection control program is 

a usual and customary business practice 

in the hospice care industry. 

Condition of Participation: Core 

Services (§ 418.64) 

Section 418.64 states that hospices 

may contract for the physician services 

contained in § 418.64(a). A hospice may 

also enter into a written agreement with 

another Medicare-certified hospice 

program for the provision of the core 

services. The burden associated with 

these requirements is the time and effort 

necessary to develop, draft, sign, and 

maintain contracts and written 

agreements. The burden associated with 

these requirements is exempt from the 

PRA as stated in 5 CFR 1320.3(b)(2); the 

use of contracted physicians and the use 

of written agreements between two 

Medicare certified hospice programs for 

the provision of core services 

constitutes a usual and customary 

business practice. 

Section 418.64(d) describes the 

standard for counseling services. 

Hospices are required to make 

counseling services available to patients 

and families to provide comfort and 

assistance with coping and stress 

management associated with the dying 

process. Specifically, section 

§ 418.64(d)(1)(iv) states that as part of 

bereavement counseling, a hospice must 

develop a bereavement plan of care that 

notes the kind of bereavement services 

to be offered and the frequency of 

service delivery. Section 418.64(d)(3) 

states that a hospice must provide an 

assessment of the patient’s and family’s 

spiritual needs, provide spiritual 

counseling to meet those needs in a 

manner that is accepted by the patient 

and family and is consistent with their 

respective beliefs, facilitate visits by 

individuals that can meet the patient’s 

spiritual needs, and advise the patient 

and family of the availability of the 

aforementioned bereavement counseling 

services. We believe the requirements in 

§ 418.64(d) are usual and customary 

business practices; and therefore, the 

burden is not subject to the PRA as 

stipulated in 5 CFR 1320.3(b)(2). 

Condition of Participation: Nursing 

Services—Waiver of Requirement That 

Substantially All Nursing Services Be 

Routinely Provided Directly by a 

Hospice (§ 418.66) 

Section 418.66(a) allows CMS to 

waive the requirement in § 418.64(b) 

that a hospice provide nursing services 

directly, if the hospice is located in a 

nonurbanized area. To obtain a waiver, 

the hospice must provide evidence to 

CMS that it made good faith efforts to 

hire a sufficient number of nurses to 

provide services. As part of CMS’

review process, the hospice must meet 

the criteria outlined in § 418.66(a)(1)–

(3). To obtain an extension for a 

currently approved waiver, a hospice 

must submit its request to CMS prior to 

the expiration of the waiver period and 

certify that the conditions under which 

the hospice originally requested the 

waiver have not changed. The burden 

associated with this requirement is the 

time and effort associated with a 

hospice demonstrating good faith efforts 

for its staffing process and submitting a 

certified extension request to CMS 

stating that the circumstances that 

caused the original waiver request have 

not changed. We believe this 

requirement and the associated burden 

is exempt from the PRA under 5 CFR 

1320.3(c)(4). We believe the requirement 

will affect less than 10 entities on an 

annual basis. 

Waiver of Requirement—Physical 

Therapy, Occupational Therapy, 

Speech-Language Pathology, and 

Dietary Counseling (§ 418.74) 

Section 418.74(a) allows CMS to 

waive the requirement for providing 

physical therapy, occupational therapy, 

speech-language pathology, and dietary 

counseling services (as needed) on a 24- 

hour basis for hospices located in nonurbanized areas. In addition, CMS can 

waive the requirement that a hospice 

provide dietary counseling directly. To 

obtain a waiver, a hospice must provide 

evidence to CMS that it made good faith 

efforts to meet the requirements for the 

aforementioned services prior to 

submitting a waiver request. As part of 

CMS’ review process, a hospice’s waiver 

request must meet the criteria outlined 

in § 418.74(a)(1)–(2). To obtain an 

extension for a currently approved 

waiver as stated in § 418.74(d), a 

hospice must submit its request to CMS 

prior to the expiration of the waiver 

period and certify that the conditions 

under which the hospice originally 

requested the waiver have not changed. 

The burden associated with this 

requirement is the time and effort 

associated with a hospice demonstrating 

good faith efforts for its staffing process 

and submitting a certified extension 

request to CMS stating that the 

circumstances that caused the original 

waiver request have not changed. We 

believe this requirement and the 

associated burden is exempt from the 

PRA under 5 CFR 1320.3(c)(4). We 

believe the requirement will affect less 

than 10 entities on an annual basis. 

Condition of Participation: Hospice 

Aide and Homemaker Services 

(§ 418.76) 

Section 418.76(b) outlines the 

standard for the content and duration of 

hospice aide classroom and supervised 

practical training. A hospice aide 

training program must meet the criteria 

in § 418.76(b)(1)–(3). Section 

418.76(b)(4) requires that a hospice 

maintain documentation demonstrating 

that its training program meets the 

requirement of the standard contained 

in § 418.76(b). We estimate that it will 

take each hospice 5 minutes to 

document and maintain records that its 

hospice aide training program met all of 

the requirements contained in this 


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section, for a total annual burden of 239 

hours. 

Section 418.76(c) describes the 

standard for competency evaluations. In 

particular, § 418.76(c)(5) states that a 

hospice must maintain documentation 

that all individuals furnishing hospice 

aide services on behalf of a hospice 

successfully completed a competency 

evaluation program. The competency 

evaluation program must meet the 

requirements specified under 

§ 418.76(b)(3). The burden associated 

with this requirement is the time and 

effort necessary to maintain 

documentation that demonstrates all 

individuals furnishing hospice aide 

services on behalf of a hospice 

successfully completed a competency 

evaluation program. We estimate it will 

take each hospice 5 minutes to meet this 

requirement, for a total annual burden 

of 239 hours. 

Section 418.76(d) discusses the 

standard for in-service training. 

Hospices are required to maintain 

documentation that all hospice aides 

have received at least 12 hours of inservice training during each 12-month 

period. The burden associated with this 

requirement is the time and effort 

necessary to document and maintain 

record of the required in-service 

training. We estimate it will take each 

hospice 2 hours annually to meet this 

requirement. The estimate total annual 

burden for this requirement is 5,744 

hours. 

Section 418.76(g) describes the 

standard for hospice aide assignments 

and duties. Specifically, § 418.76(g)(1) 

states that written patient care 

instructions for a hospice aide must be 

drafted by a registered nurse responsible 

for the supervision of a hospice aide. 

The burden associated with this 

requirement is the time and effort 

necessary for a registered nurse 

responsible for supervising a hospice 

aide to draft written patient care 

instructions for the hospice aide. We 

believe this is a usual and customary 

business practice and is thereby exempt 

from the PRA under 5 CFR 1320.3(b)(2). 

Section 418.76(h) explains the 

standard for the supervision of hospice 

aides. In particular, § 418.76(h)(1)(i) 

stated that a registered nurse must make 

an onsite visit to a patient’s home no 

less frequently than every 14 days to 

assess and document the quality of care 

and services provided by the hospice 

care aide and to ensure that the services 

ordered by the hospice’s IDG meet the 

patient’s needs. The burden associated 

with this requirement is the time and 

effort necessary for a nurse to conduct 

an onsite evaluation of a hospice care 

aide in the patient’s home, to document 

the quality of care provided by the 

hospice care aide, and to evaluate the 

services ordered by the IDG to ensure 

that they are consistent with the 

patient’s needs. We believe this is a 

usual and customary business practice 

and is thereby exempt from the PRA 

under 5 CFR 1320.3(b)(2). 

Section 418.76(h)(2) states that a 

registered nurse must also make an 

annual onsite visit to the location to the 

location where a patient is receiving 

care to observe and evaluate each aide 

while he or she is performing care. 

Section 418.76(h)(3) details the contents 

of the registered nurse’s assessment 

required in 418.76(h)(3). The burden 

associated with this requirement is the 

time and effort necessary for a registered 

nurse to make an annual on site visit to 

observe and evaluate each hospice aide 

while they perform care. In addition, 

they must document the evaluation. We 

estimate to meet this requirement that 5 

supervisory visits will be conducted on 

an annual basis per hospice with a total 

of 14,360 visits annually. We believe it 

will take each nurse 5 minutes to 

document the onsite visit. The 

estimated total annual burden 

associated with this requirement is 

1,197 hours. 

Section 418.76(i)(1) contains the 

standard for individuals furnishing 

Medicaid personal care aide-only 

services under a Medicaid personal care 

benefit. Prior to furnishing personal care 

services, an individual must 

demonstrate competency in the services 

they are required to furnish. The burden 

associated with this requirement is the 

time and effort necessary to demonstrate 

competency. While this requirement is 

subject to the PRA, we believe the 

associated burden is exempt stated in 5 

CFR 1320.3(b)(2). We believe this is a 

usual and customary business practice. 

Section 418.76(k)(2) requires the 

instructions for homemaker duties to be 

prepared by a member of the hospice 

IDG. The burden associated with this 

requirement is the time and effort 

necessary for a member of the IDG to 

develop and draft instructions for 

homemaker duties. We believe this is a 

usual and customary business practice 

and is thereby exempt from the PRA 

under 5 CFR 1320.3(b)(2). 

Section 418.76(k)(3) states that 

homemakers must report all concerns 

about the patient or family to the 

member of the IDG who is coordinating 

the homemaker’s services. The burden 

associated with this requirement is the 

time and effort needed for the 

homemaker to report all concerns. We 

believe the burden is exempt as stated 

in 5 CFR 1320.3(b)(2); this is a usual and 

customary business practice. 

Conditions of Participation—Volunteers 

(§ 418.78) 

Section 418.78(a) states that a hospice 

must document, maintain, and provide 

volunteer orientation and training that 

is consistent with hospice industry 

standards. We estimate on average that 

a hospice would provide orientation 

and training six times per year; we 

estimate that it will take no longer than 

five minutes to document each 

orientation section for a total of 30 

minutes per year per hospice. The total 

annual burden associated with this 

requirement is 1,436 hours. 

Section 418.78(c) requires hospices to 

document and demonstrate viable and 

ongoing efforts to recruit and retain 

volunteers. The burden associated with 

this requirement is the time and effort 

necessary to document and demonstrate 

the recruitment and retention efforts. 

We estimate that it will take each 

hospice 3 hours to document and 

demonstrate its recruitment and 

retention efforts, for a total annual 

burden of 8,616 hours. 

The cost-saving standard in 

§ 418.78(d) requires hospices to 

document the cost savings achieved 

through the use of volunteers. We 

estimate that complying with this 

requirement will take 3 hours per 

hospice per year, or 8,616 annual hours. 

Section 418.78(e) requires hospices to 

document and maintain records on the 

use of volunteers for patient care and 

administrative services, including the 

type of services and time worked. The 

burden associated with this requirement 

is the time and effort necessary to 

document and maintain the volunteer 

records. We estimate that recording 

these examples would take 

approximately 600 hours per hospice for 

a total annual burden of 1,723,200 

hours. 

Condition of Participation: Organization 

and Administration of Services 

(§ 418.100) 

Section 418.100(e) describes the 

standard for professional management 

responsibilities. A hospice that has a 

written agreement with another agency, 

individual, or organization to furnish 

any services under arrangement, must 

retain administrative and financial 

management, and oversight of staff and 

services for all arranged services, to 

ensure the provision of quality care. The 

burden associated with this requirement 

is the time and effort necessary to 

develop, draft, execute and maintain the 

written agreements. We believe these 

written agreements are part of the usual 

and customary business practices of 


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hospices and are thereby exempt from 

the PRA under 5 CFR 1320.3(b)(2). 

Section 418.100(f)(2) states that a 

hospice must continually monitor and 

manage all services provided at all of its 

locations. The burden associated with 

this requirement is the time and effort 

necessary to monitor and manage all of 

the services provided at all of its 

locations. The burdens associated with 

this requirement is considered to be 

usual and customary as stated in 5 CFR 

1320.3(b)(2) and is thereby exempt from 

the PRA. 

Section 418.100(g) describes the 

standard for training. In particular, 

§ 418.100(g)(2) requires a hospice to 

provide an initial orientation for each 

employee that addresses the employee’s 

specific job duties. Section 418.100(g)(3) 

requires a hospice to have written 

policies and procedures describing its 

method(s) of assessment of competency. 

In addition, the hospice must maintain 

a written description of the in-service 

training provided during the previous 

12 months. The burden associated with 

the requirements of this section is 

considered to be usual and customary 

under 5 CFR 1320.3(b)(2); usual and 

customary burdens are exempt from the 

PRA. 

Condition of Participation: Medical 

Director (§ 418.102) 

Section 418.102(b) requires hospice 

medical directors or physician 

designees to review the clinical 

information for each hospice patient 

and provide written certification that it 

is anticipated that the patient’s life 

expectancy is 6 months or less if the 

illness runs its normal course. Prior to 

making a certification statement, the 

medical director or physician designee 

must consider the issues discussed in 

§ 418.102(b)(1)–(5). Section 418.102(c) 

states that before the recertification 

period for each patient, as described in 

§ 418.21(a), the medical director or 

physician designee must review the 

patient’s clinical information. 

The burden associated with the 

requirements contained in § 418.102(b)–

(c) is the time and effort necessary to 

review the written certification. We 

estimate this process requires 10 

minutes per patient. We estimate the 

burden for each hospice to be 50 hours 

annually. The total annual burden 

associated with the requirements of this 

section is 143,600 hours. 

Condition of Participation: Clinical 

Records (§ 418.104) 

Section 418.104 requires a hospice to 

maintain a clinical record for each 

patient. The required contents of the 

record are listed in § 418.104(a). The 

burden associated with the requirement 

is the time and effort necessary to 

document and maintain the information 

listed in § 418.104(a). The maintenance 

of clinical records is a usual and 

customary business practice; the burden 

associated with maintaining a clinical 

record is exempt form the PRA under 5 

CFR 1320.3(b)(2). 

Section 418.104(b) requires that all of 

the entries in a clinical record be 

authenticated. The entries must be 

legible, clear, complete, and consistent 

with hospice policy. The burden 

associated with this requirement is 

considered to be usual and customary 

under 5 CFR 1320.3(b)(2). This usual 

and customary burden is therefore 

exempt from the PRA. 

Section 418.104(d) describes the 

standard for the retention of records. 

Clinical records must be retained for 6 

years after the death or discharge of the 

patient, unless State law stipulates a 

longer period of time. If the hospice 

discontinues operation, hospice policies 

must provide for retention and storage 

of clinical records. The burden 

associated with these requirements is 

the time and effort necessary to 

maintain records for 6 years after the 

death or discharge of the patient, and to 

draft, implement, and maintain the 

record retention policy in the event that 

the HHA discontinues operation. While 

this requirement is subject to the PRA, 

we believe the associated burden is 

exempt as stated in 5 CFR 1320.3(b)(2). 

The development and maintenance of a 

record retention policy is a usual and 

customary business practice. 

Section 418.104(f) describes the 

standard for the retrieval of clinical 

records. Clinical records, whether in 

hard copy or electronic form, must be 

made readily available on request by an 

appropriate authority. The burden 

associated with this requirement is the 

time and effort required to disclose a 

clinical record to an appropriate 

authority. While this requirement is 

subject to the PRA, we believe the 

associated burden is exempt as stated in 

5 CFR 1320.3(b)(2). Making clinical 

records available to the appropriate 

authority is part of the survey and 

certification process and imposes no 

additional burden as a usual and 

customary business practice. 

Condition of Participation: Drugs, 

Controlled Drugs and Biologicals, 

Medical Supplies, and Durable Medical 

Equipment (§ 418.106) 

Section 418.106(b) describes the 

standard for the ordering of drugs. In 

particular, § 418.106(b)(2)(ii) states that 

the individual receiving a drug order 

must record and sign it immediately and 

have the prescribing person sign it in 

accordance with State and Federal 

regulations. The burden associated with 

this requirement is the time and effort 

necessary for the recipient of the order 

record and sign the order and to have 

the prescribing person sign the 

prescription. The burden associated 

with this requirement is exempt under 

both 5 CFR 1320.3(b)(2) and 5 CFR 

1320.3(b)(3). As defined in 5 CFR 

1320.3(b)(2), this process is a usual and 

customary business practice. As defined 

in 5 CFR 1320.3(b)(3), a State 

requirement would exist even in the 

absence of the Federal requirement. The 

associated burden is thereby exempt 

from the PRA. 

Section 418.106(c)(2) states that a 

hospice that provides inpatient care 

directly in its own facility must have a 

written policy in place that promotes 

dispensing accuracy. Additionally, this 

section requires that a hospice that 

provides inpatient care directly must 

maintain current and accurate records of 

the receipt and disposition of all 

controlled drugs. The burden associated 

with this requirement is the time and 

effort necessary to develop, draft, 

implement, and maintain a written 

policy that promotes dispensing 

accuracy and to maintain controlled 

drug records. The existence of this type 

of policy and these records are usual 

and customary business practices. The 

burden associated with this section is 

exempt from the PRA under 5 CFR 

1320.3(b)(2). 

Section 418.106(e) discusses the 

standard for labeling, disposing and 

storing of drugs and biologicals. 

Specifically, § 418.106(e)(2)(i) states that 

a hospice must have a written policy for 

the management and disposal of 

controlled drugs in the patient’s home. 

As required by § 418.106(e)(2)(i)(A), a 

hospice must provide a copy of the 

written policy required in 

§ 418.106(e)(2)(i) to the patient, and his/ 

her representative and family. 

Additionally, the hospice must discuss 

the hospice policy for managing the safe 

use and disposal of controlled drugs 

with the patient or representative and 

the family in a language and manner 

they can understand to ensure that these 

parties are educated regarding the safe 

use and disposal of controlled drugs, as 

required by § 418.106(e)(2)(i)(B). Section 

418.106(e)(2)(i)(C) requires a hospice to 

document in a patient’s clinical record 

that the written policy for managing 

controlled drugs was provided and 

discussed. Section 418.106(e)(2)(ii) 

states that a hospice maintain current 

and accurate records of the receipt and 

disposition of all controlled drugs. 


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The burden associated with the 

requirements contained in 

§ 418.106(e)(2) is the time and effort 

necessary to provide a written copy of 

the policy on the management and 

disposal of controlled drugs in the 

patient’s home to the patient 

representative and family. There is also 

some burden associated with the 

hospice explaining the policy to the 

patient or representative and the family. 

In addition, there is a burden associated 

with documenting in the patient’s 

clinical record that the written policy 

for managing and controlled drugs was 

provided and discussed. We believe the 

burden associated with the 

aforementioned requirements is exempt 

from the PRA under 5 CFR 1320.3(b)(2), 

as they are part of the usual and 

customary business practice for 

hospices. 

Section 418.106(e)(3)(ii) states that the 

hospice pharmacist and the hospice 

administrator are required to 

immediately investigate any 

discrepancies in the acquisition, storage, 

dispensing, administration, disposal, or 

return of controlled drugs. The event 

must be reported to the appropriate 

State authority. A written account of the 

investigation must be made available to 

State and Federal officials if required by 

law or regulation. The burden 

associated with this requirement is 

exempt under both 5 CFR 1320.3(b)(2) 

and 5 CFR 1320.3(h)(6). As defined in 

5 CFR 1320.3(b)(2), documenting an 

investigation and reporting the 

investigation to the appropriate State 

authority is a usual and customary 

business practice. Additionally, the 

burden associated with making a 

written account of the investigation 

available to State and Federal officials 

upon request is exempt from the PRA 

under 5 CFR 1320.3(h)(6); the 

information will be collected from 

individual hospices on a case by case 

basis. As stated under in 5 CFR 

1320.3(h)(6), information collection 

requests addressed to a single ‘‘person’’

as defined in 5 CFR 1320.3(b)(4), are 

exempt from the PRA. 

Section 418.106(f)(1) states that a 

hospice must ensure that repair and 

routine maintenance policies are 

developed in situations when a 

manufacturer’s recommendation for a 

piece of equipment is nonexistent. 

Section 418.106(f)(2) requires a hospice 

to ensure that the patient, family, and 

other caregivers receive instruction in 

the safe use of durable medical 

equipment and supplies. After 

providing instruction, the patient, 

family, and/or caregiver must be able to 

demonstrate the appropriate use of 

durable medical equipment. The burden 

associated with the requirements in 

§ 418.106(f)(1)–(2) is the time and effort 

necessary to develop, draft, implement, 

and maintain repair and routine 

maintenance policies. There is also 

burden associated with providing 

proper instruction on the use of durable 

medical equipment to patient, family 

members, and caregivers. As defined in 

5 CFR 1320.3(b)(2), providing proper 

instruction on the use of durable 

medical equipment to patient, family 

members, and caregivers is a usual and 

customary business practice. 

Condition Of Participation—Short-Term 

Inpatient Care (§ 418.108) 

Section 418.108(c) requires the use of 

a written agreement if a hospice has an 

arrangement with a facility to provide 

short-term inpatient care. At a 

minimum, the agreement must address 

the issues outlined in § 418.108(c)(1)–

(6). The burden associated with this 

requirement is the time and effort 

necessary to develop, draft, execute, and 

maintain the written agreement. While 

this requirement is subject to the PRA, 

the burden is exempt under 5 CFR 

1320.2(b)(2). The use of the written 

agreements between facilities is a usual 

and customary business practice. 

Condition Of Participation: Hospices 

That Provide Inpatient Care Directly 

(§ 418.110) 

Section 418.110(c)(1)(ii) states that a 

hospice must have a written disaster 

preparedness plan in effect to manage 

emergencies that might compromise the 

hospice’s ability to provide care. 

Additionally, the plan must be 

periodically reviewed. The burden 

associated with this requirement is the 

time and effort necessary to develop, 

draft, implement, maintain, and 

periodically review the disaster 

preparedness plan. Section 

418.110(c)(2) requires hospices to 

develop procedures for managing 

physical plant issues. 

The burden associated with the 

requirements in § 418.108(c) is the time 

and effort necessary to draft, implement, 

maintain, and review the facility’s 

disaster preparedness plans and 

procedures to address physical plant 

issues. While these requirements are 

subject to the PRA, we believe the 

associated burden is exempt as stated in 

5 CFR 1320.3(b)(2). 

Section 418.110(m)(3)(i) specifies that 

the use of restraint and seclusion must 

be used in accordance with a written 

modification to the plan of care. The use 

of restraint and seclusion must be 

implemented in accordance with safe 

and appropriate restraint and seclusion 

techniques as determined by hospice 

policy in accordance with State law. 

The burden associated with this 

requirement is the time and effort 

necessary to modify the plan of care in 

writing to include the physician order 

for restraint and seclusion. 

Section 418.110(m)(4) states that the 

use or restraint or seclusion must be 

done in accordance with a physician’s 

orders. There is a burden associated 

with creating a physician’s order. 

However, we believe the burden 

associated with the aforementioned 

requirements is exempt from the PRA 

under 5 CFR 1320.3(b)(2), as they are 

part of the usual and customary 

business practice for hospices. 

Section 418.110(m)(7)(ii) states that 

prior to writing a new order for the use 

of restraint or seclusion, a physician 

must see and assess the patient. The 

burden associated with this requirement 

is the time and effort necessary for the 

ordering physician to see and assess the 

patient. 

Section 418.110(m)(15) states that 

when restraint or seclusion is used, a 

patient’s clinical record must contain 

the documentation outlined in 

§ 418.110(m)(15)(i)–(v). The burden 

associated with this requirement is the 

time and effort necessary to compile the 

documentation specified in 

§ 418.110(m)(15)(i)–(v) in the patient’s 

clinical record. We estimate the 

collective burden associated with the 

requirements contained in 

418.110(m)(3)(i), 418.110(m)(7)(ii), and 

418.110(m)(15) to be 45 minutes per 

event per hospice for a total of 8,702 

events annually. The annual burden 

associated with the aforementioned 

information collection requirements is 

6,527 hours. 

Section 418.110(n) discusses the 

standard for restraint or seclusion staff 

training requirements. Specifically, 

§ 418.110(n)(1) states that all patient 

care staff working in the hospice 

inpatient facility must be trained and 

able to demonstrate competency in the 

application of restraints, 

implementation of seclusion, 

monitoring, assessment and providing 

care for a patient in restraint or 

seclusion. Section 418.110(n)(4) states 

that a hospice must document in the 

personnel records that each employee 

successfully completed the restraint and 

seclusion training and demonstrated 

competency. We estimate that it will 

take 96 hours to comply with these 

requirements. The estimated total 

annual burden associated with these 

requirements is 275,512 hours. 

Section 418.110(o) states that 

hospices must report deaths associated 

with the use of restraint or seclusion. 

The hospice staff must document in the 


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decedents clinical record the date and 

time the death was reported to CMS. We 

cannot accurately estimate the number 

of deaths that would occur annually as 

a result of restraint or seclusion. 

However, we believe the number is less 

than 10 per year. While this requirement 

is subject to the PRA, we believe the 

burden is exempt under 5 CFR 

1320.3(c)(4), as it would affect less than 

10 entities. 

Condition of Participation: Hospices 

That Provide Hospice Care To Residents 

of a SNF/NF or ICF/MR (§ 418.112) 

Section 418.112(c) discusses the 

requirement that a hospice and SNF/NF 

or ICF/MR must have a written 

agreement that specifies the provision of 

hospice services in the facility. The 

agreement must be signed by authorized 

representatives of the hospices and the 

SNF/NF or ICF/MR prior to the 

provision of hospice care services. At a 

minimum, the written agreements must 

address the issues listed in 

§ 418.112(c)(1)–(8). The burden 

associated with this requirement is the 

time and effort necessary to develop, 

draft, sign, and maintain the written 

agreement. However, the use of this type 

of written agreement is a usual and 

customary business practice; the 

associated burden is exempt from the 

PRA under 5 CFR 1320.3(b)(2). 

Section 418.112(d) discusses the 

standard for the hospice plan of care. A 

written plan of care must be established 

and maintained in consultation with 

SNF/NF or ICF/MR representatives. The 

burden associated with this requirement 

is discussed in detail under our 

discussion of § 418.56(c). 

Condition of Participation: Personnel 

Qualifications (§ 418.114) 

Section 418.114(d)(1) requires 

hospices to obtain criminal background 

checks on all hospice employees who 

have direct patient contact or access to 

patient records. Additionally, all 

hospice contracts must require that all 

contracted entities obtain criminal 

background checks on contracted 

employees who have direct patient 

contact or access to patient records. The 

burden associated with this requirement 

is the time and effort necessary to 

conduct background checks and the 

time and effort necessary to develop, 

draft, and maintain contracts that 

require all contracted staff to obtain 

background checks. While this 

requirement is subject to the PRA, we 

believe the associated burden is exempt 

as stated in 5 CFR 1320.3(b)(2). While 

fulfilling these requirements, a hospice 

will not incur any burden above and 

beyond its usual and customary 

business practice. 

TABLE XX.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Regulation section(s) OMB control No. Respondents Responses Total annual 

burden (hours) 

§ 418.52(a) ...................................................... 0938–New ...................................................... 2,872 870,216 72,518 

§ 418.52(b) ...................................................... 0938–New ...................................................... 2,872 43,080 43,080 

§ 418.56(b–c) .................................................. 0938–0302 ..................................................... 2,874 2,874 9,930,912 

§ 418.58 ........................................................... 0938–New ...................................................... 2,872 2,872 402,080 

§ 418.76(b)(4) .................................................. 0938–New ...................................................... 2,872 2,872 239 

§ 418.76(c) ...................................................... 0938–New ...................................................... 2,872 2,872 239 

§ 418.76(d) ...................................................... 0938–New ...................................................... 2,872 2,872 5,744 

§ 418.76(h)(2) .................................................. 0938–New ...................................................... 2,872 14,360 1,197 

§ 418.78(a) ...................................................... 0938–New ...................................................... 2,872 2,872 1,436 

§ 418.78(c) ...................................................... 0938–New ...................................................... 2,872 2,872 8,616 

§ 418.78(d) ...................................................... 0938–New ...................................................... 2,872 2,872 8,616 

§ 418.78(e) ...................................................... 0938–New ...................................................... 2,872 2,872 1,723,200 

§ 418.102(b–c) ................................................ 0938–New ...................................................... 2,872 2,872 143,600 

§ 418.110(m)(15) ............................................. 0938–New ...................................................... 2,872 8,702 6,527 

§ 418.110(n)(1–4) ............................................ 0938–New ...................................................... 2,872 2,872 275,512 

Total ......................................................... ......................................................................... 2,874 967,952 12,623,516 

We have submitted a copy of this final 

rule to OMB for its review of the 

information collection requirements 

contained within this document. These 

requirements are not effective until they 

are approved by OMB. 

VI. Regulatory Impact Analysis 

A. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 16, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132. 

Executive Order 12866 (as amended 

by Executive Order 13258, which 

merely reassigns responsibility of 

duties) directs agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($110 million or more in any 1 year). 

This is not a major rule, since the 

overall economic impact for all 

proposed new Conditions of 

Participation is estimated to be $40.7 

million in the first year. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

government jurisdictions. Individuals 

and States are not included in the 

definition of a small entity. For 

purposes of the RFA, most hospices 

(approximately 82% of Medicare 

certified facilities) are considered to be 

small entities, either by virtue of their 

nonprofit or government status or by 

having revenues of less than $12.5 

million in any one year (for details, see 

the Small Business Administration’s 

regulation that sets forth size standards 

for health care industries at 65 FR 

69432). We estimate there are 

approximately 2,872 hospices with 

average admissions of approximately 

303 patients per hospice (based on the 

number of patients in 2005 divided by 

the number of hospices in 2005). The 

National Hospice and Palliative Care 


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Organization (Facts and Figures—2005 

Findings) estimates that 82.4 percent of 

hospice patients are Medicare 

beneficiaries; thus we have not 

considered other sources of revenue in 

this analysis. 

We certify that this rule would not 

have a significant impact on a 

substantial number of small entities 

because the cost of this rule is less than 

1 percent of total hospice Medicare 

revenue. According to the CMS 2005 

national expenditure data, Medicare 

paid $8.2 billion to providers for 

hospice care in FY 2005. We estimate 

this rule will cost hospices 

approximately $40.7 million or 

approximately $32,223 per average 

hospice (operating its own inpatient 

unit and requiring the supervisory 

services of an MSW) in the first year. An 

average hospice that does not operate its 

own inpatient unit and does not need to 

hire an MSW, accounting for the vast 

majority of hospices, will expend 

$11,151 to comply with this final rule 

in the first year. While we understand 

that a few very small hospices 

(described below) may expend a larger 

percentage of their revenue to comply 

with this rule, we believe that this group 

of hospices is quite small. 

We understand that there are different 

sizes of hospices and that the burden for 

hospices of different sizes will vary. 

Therefore, we have assessed the burden 

for hospices that are smaller than the 

statistically average hospice used for 

calculations in part B of this section, 

Anticipated Effects on Hospices. The 

smaller hospices have been broken up 

into two categories based on the number 

of routine home care days, the most 

common level of hospice care provided. 

The categories are group 1 hospices 

providing 0 to 1,754 routine home care 

days, and group 2 hospices providing 

1,755 to 4,373 routine home care days. 

Group 1 hospices, averaging 67 patients 

per year, would spend approximately 

$18,980 or $5,980, depending on the 

need to hire and MSW supervisor, to 

comply with these regulations. The 

average hospice in this group received 

$229,406 from Medicare for routine 

home care days under the 2005 hospice 

payment rates. Group 2 hospices, 

averaging 167 patients per year, would 

spend approximately $21,191 or $8,191, 

also depending on the need to hire an 

MSW supervisor, to comply with these 

regulations. The average hospice in this 

group received $571,945 from Medicare 

for routine home care days under the 

2005 rates. 

The time and cost burden for these 

providers is less than that of the average 

hospice used in part B of this section 

because a portion of the burden 

associated with these regulations is 

directly related to patient care and the 

staff necessary to provide care. 

Therefore, a consistently smaller patient 

census leads to reduced burden because 

the smaller hospices have less staff, 

complete less data collection and less 

patient rights orientation etc. These 

estimates of the annual burden for 

smaller hospices make only minor 

adjustments to the estimated quality 

assessment and performance 

improvement burden described in part 

B of this section in the area of patient 

level data collection. Additionally, these 

figures do not include the time and cost 

burden estimates associated with a 

hospice inpatient facility because it is 

very uncommon for a hospice with a 

small annual patient census to operate 

its own inpatient facility. We estimate 

that the financial burden for group 1 

hospices would be approximately 8.25 

or 2.5 percent of the payment received 

for routine home care days, depending 

on whether or not the hospice needs to 

hire an MSW supervisor. For group 2 

hospices, the financial burden would be 

3.75 or 1.5 percent of the payment 

received for routine home care days, 

also depending on whether or not the 

hospice needs to hire an MSW 

supervisor. Since employing an MSW is 

considered the standard within the 

hospice industry, we believe that very 

few group 1 and 2 hospices will incur 

the additional expense of hiring an 

MSW above their present level of 

staffing (see B., Anticipated Effects on 

Hospices, Personnel qualifications for a 

more detailed discussion). These 

percentages do not include amounts 

paid by Medicare for continuous home 

care days, respite care days, and regular 

inpatient care days. The percentages 

also do not include amounts paid by 

Medicaid, private insurers, and 

individual patients, which account for 

approximately 18 percent of hospice 

revenue. Additionally, these 

percentages do not include additional 

income from fundraising, donations, 

foundations, etc. that hospices routinely 

use to finance operations and programs. 

Therefore, we believe that the actual 

cost incurred by a group 1 or a group 2 

hospice accounts for a significantly 

smaller portion of hospice’s overall 

revenue, and does not have a significant 

impact on a substantial number of small 

entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a metropolitan statistical area and has 

fewer than 100 beds. We believe that 

this rule would not have a significant 

impact on the operations of a substantial 

number of small rural hospitals, since 

there are few hospice programs in those 

facilities. Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any one year of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold level is currently 

approximately $127 million. This final 

rule does not contain mandates that will 

impose spending costs on State, local, or 

tribal governments in the aggregate, or 

by the private sector of $127 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

compliance costs on State or local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This rule has no Federalism 

implications. 

B. Anticipated Effects on Hospices 

As described in the preamble, this 

final rule contains both new provisions 

and provisions that are carried over 

from the existing hospice regulations. 

For purposes of this section, we have 

assessed the impact of all provisions 

that may present a burden to a hospice. 

Within this section, we have made 

several assumptions and estimates in 

order to assess the time that it would 

take for a hospice to comply with the 

provisions and the associated costs of 

compliance. We have detailed these 

assumptions and estimates in the table 

below. We have also detailed many, but 

not all, of the standards within each 

CoP, and have noted whether or not 

there is an impact for each. However, 

the requirements contained in many 

provisions are already standard medical 

or business practices. These 

requirements would, therefore, not 

provide additional burden to hospice 

providers. 

Our assumptions are based on the 

idea of an average hospice, culled from 

national averages. While we understand 

that there is no average hospice, the idea 

of an average hospice allows us to 

quantify the impact of this final rule on 

a hospice’s resources. For purposes of 

this section only, we describe an 

average hospice as one that is: 

Freestanding; 

Not-for-profit; 


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26 day median length of stay (NHPCO 

Facts & Figures 2005); 

303 annual admissions; 

40 employees and volunteers; 

27% of patients residing in a SNF/NF, 

ICF/MR or assisted living facility; and 

TABLE 1.—ASSUMPTIONS AND ESTIMATES USED THROUGHOUT THE IMPACT ANALYSIS SECTION

# of Medicare hospices nationwide 2,872 

# of hospice patients nationwide .... 869,201 

# of patients per average hospice .. 303 

Hourly rate of registered nurse ...... $35 

Hourly rate of office employee ....... $14 

Hourly rate of administrator ............ $49 

Hourly rate of home health aide ..... $19 

Hourly rate of MSW ........................ $25 

Hourly rate of pharmacist ............... $56 

Hourly rate of clinical manager ...... $36 

Hourly rate of QAPI coordinator ..... $35 

Hourly rate of medical director ....... $114 

Note: All salary estimates include benefits 

package worth 30% of the fringe base salary. 

Patient Rights (§ 418.52) 

The final rule expands 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 is required to provide patients 

or their representatives with written and 

verbal notice of the patient’s rights and 

responsibilities during the initial 

assessment visit. A hospice is also 

required to document that the notice of 

rights was provided by obtaining the 

patient’s or representative’s signature. A 

hospice must also inform and distribute 

written information to the patient 

regarding its policies on advance 

directives. We estimate that it will take 

eight hours on a one-time basis for a 

hospice to develop a patient rights form, 

at a cost of $392, based on the 

assumption that an administrator will 

develop the form. We estimate that it 

will take approximately five minutes 

per patient to incorporate this 

information into the existing informed 

consent process. At the average hourly 

rate for a registered nurse, it will cost 

$2.92 per patient to fulfill the 

requirement. 

8 hours x $49 an hour = $392 

$35 hour/60 minutes = $0.58 minute x 5 

minutes = $3 

(b) Standard: Exercise of rights and 

respect for property and person. A 

hospice is required to investigate and 

document all allegations of abuse, 

unexplained injuries, and 

misappropriations of patient property 

involving hospice employees and 

contractors. Hospice employees and 

contractors must report alleged patient 

rights violations to the hospice 

administrator, and must report verified 

violations to appropriate State and local 

bodies having jurisdiction. A hospice 

must also take action to correct 

problems once they are identified. 

We expect that a hospice 

administrator will investigate alleged 

patient rights violations. We estimate 

that as many as 5% (15) of an average 

hospice’s patients would require a onehour-long investigational session, for a 

total of 15 hours per hospice. The cost 

for the entire hospice industry would be 

$2,110,920 a year, while the cost for an 

average hospice would be $735 a year. 

15 investigations per hospice x 1 hour per 

investigation = 15 hours per hospice 

$49 hour x 15 hours per hospice = $735 per 

average hospice 

15 hours per hospice x 2872 hospices = 

43,080 hours nationwide 

$735 per average hospice x 2872 hospices = 

$2,110,920 

(c) Standard: Rights of the patient. 

There is no burden associated with this 

standard. 

TABLE 2.—PATIENT RIGHTS BURDEN ASSESSMENT

Standard 

Time per 

patient 

(minutes) 

Time per 

hospice 

(hours) 

Total time 

(hours) 

Cost per 

patient 

Cost per 

average 

hospice 

Total cost 

Develop form (1st year) ........................... N/A 8 22,976 N/A $392 $1,125,824 

Notice of rights (annual) .......................... 5 25.25 72,433 $3 885 2,538,130 

Exercise of rights (annual) ....................... N/A 15 43,080 N/A 735 2,110,920 

Totals ................................................ 5 48.25 138,489 3 2,012 4,649,379 

Comprehensive Patient Assessment 

(§ 418.54) 

(a) Standard: Initial assessment and 

(b) Standard: Timeframe for completion 

of the comprehensive assessment. 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 final 

rule goes beyond this by specifying the 

time for completing the assessment, the 

factors to be included in the assessment, 

and the time for updating the 

assessment. However, we do not believe 

this will add any additional burden, 

since this section of the proposed rule 

reflects the contemporary standard 

practice of hospice programs. 

(c) Standard: Content of the 

comprehensive assessment. The 

assessment must identify the physical, 

psychosocial, emotional, and spiritual 

needs related to the terminal illness and 

related conditions that must be 

addressed in order to promote a hospice 

patient’s well-being, comfort and 

dignity throughout the dying process. 

The assessment will include factors 

such as the patient’s physical and 

nutritional needs, pain status, and 

psychological state. The assessment will 

also address complications and risk 

factors, functional status, imminence of 

death, severity of symptoms, drug 

profile and bereavement. This differs 

from the current rule in that it describes 

what must be included in the 

assessment. The factors of the 

comprehensive assessment were 

identified by the hospice industry and 

reflect standard industry practice. 

(d) Standard: Update of the 

comprehensive assessment. Updates of 

the patient’s comprehensive assessment 

must be conducted at least every 15 

days or as frequently as the condition of 

the patient requires. The current 

regulation allows the plan of care to 

determine the frequency of updates. 

However, due to the rapidly changing 

status of hospice patients, it is standard 

practice for a hospice to update a 

patient assessment at least every 15 

days, and often more frequently. This 

15-day requirement is also in line with 

the recertification periods, at which 

time a hospice must review the patient’s 

clinical information to determine 

whether a patient continues to be 

terminally ill with a prognosis of 6 

months or less if the illness runs its 

usual course. This new standard simply 

codifies current industry practice and 

does not present a burden. 

(e) Standard: Patient outcome 

measures. The comprehensive 


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assessment must include consistent, 

pre-determined data elements that allow 

for the measurement of patient care 

outcomes. (Note: There is no data 

reporting element.) We believe this 

standard will pose a burden on the 

hospice provider. However, the burden 

of collecting information related to these 

outcome measures is calculated as part 

of a hospice’s quality assessment and 

performance improvement program. 

Interdisciplinary Group, Care Planning 

and Coordination of Services (§ 418.56) 

The final rule makes several changes 

to the existing rule to improve patient 

care and lessen burden. 

(a) Standard: Approach to service and 

delivery. This standard describes the 

members of the IDG and its role in 

patient care planning and delivery. 

There is no burden associated with this 

standard. 

(b) Standard: Plan of care and (c) 

Standard: Content of the plan of care. 

This section describes the general 

content areas of each patient’s plan of 

care. The items that are required under 

the final rule are already included in the 

standard industry patient plan of care. 

(d) Standard: Review of the plan of 

care. The existing rule states that a 

patient’s plan of care must be reviewed 

at intervals specified in the initial plan 

of care. The final rule requires that the 

plan of care be reviewed at least every 

15 days. Several commenters noted that 

documenting an update to a patient’s 

plan of care takes 1–2 hours of a nurse’s 

time per update. We agree that updating 

a patient’s plan of care requires a fair 

amount of nursing time. However, we 

do not believe that requiring a hospice 

to update a patient’s plan of care on a 

regularly scheduled and as needed basis 

will present a burden because these are 

already standard practices within the 

hospice industry. 

Quality Assessment and Performance 

Improvement (§ 418.58) 

The quality assessment and 

performance improvement (QAPI) 

requirement builds off of the existing 

quality assurance requirement. Indeed, 

quality assurance is already part of 

standard hospice practice. This rule 

requires a data-driven approach to 

assessing and improving quality in all 

aspects of hospice care, from clinical 

services to staffing to contracts, that 

enables hospices to develop a clear 

understanding of their strengths and 

weaknesses in a wide variety of areas. 

However, at this time we do not 

prescribe the precise areas that each 

hospice must examine, nor do we 

prescribe the precise mechanisms for 

these examinations. Rather, we provide 

a basic outline of what QAPI is and how 

we expect it to function in the hospice 

environment. Each hospice is free to 

decide how to implement the QAPI 

requirement in a manner that reflects its 

own unique needs and goals. 

In response to public comments 

stating that we underestimated the 

impact of the QAPI CoP on the average 

hospice, we have significantly revised 

our impact assessment methodology. 

Rather than describing the impact in 

proportion to the impact that this same 

CoP had on hospitals, we have 

described the impact in three general 

phases that we believe an average 

hospice will go through. These phases 

are based off of our experience in 

implementing the QAPI requirements of 

the proposed rule in the Rural Hospice 

Demonstration project required by 

section 409 of the MMA, and from 

discussions with hospice industry 

representatives who are active in 

implementing QAPI programs 

nationwide. The description of these 

phases, and the hour and dollar 

estimates that accompany them were 

not available at the time that the 

proposed hospice rule was published. 

We believe that this new information 

more accurately reflects the hospice 

environment. 

While we have outlined these phases 

below, we stress that a hospice is not 

required to approach QAPI in this 

manner. We are not requiring a hospice 

to collect data for a specific domain; use 

specific quality measures, policies and 

procedures, or forms; submit data to an 

outside body; or conduct a specified 

number of performance improvement 

projects. A hospice may choose to 

implement a data-driven, 

comprehensive QAPI program that 

meets the requirements of this rule in 

any way that meets its individual needs. 

These phases described below simply 

provide a framework for assessing the 

potential impact of the QAPI 

requirement upon an average hospice. 

In phase one, we believe that a 

hospice will: 

Identify quality domains and 

measurements that reflect its 

organizational complexity; involve all 

hospice services; affect palliative 

outcomes, patient safety, and quality of 

care; focus on high risk, high volume, or 

problem-prone areas; and track adverse 

patient events; 

Develop policies and procedures to 

ensure that data is consistently 

collected, documented, retrieved, and 

analyzed in an accurate manner; and 

Educate hospice employees and 

contractors about the QAPI requirement, 

philosophy, policies, and procedures. 

In phase two, we believe that a 

hospice will: 

Enter data into patient clinical records 

during patient assessments and IDG 

meetings; 

Aggregate data by collecting the same 

pieces of data from patient clinical 

records and other sources (for example, 

human resource records, pharmacy 

records, etc.); 

Analyze the data that is aggregated 

through charts, graphs, and various 

other methods to identify patterns, 

anomalies, areas of concern, etc. that 

may be useful in targeting areas for 

improvement; and 

Develop, implement, and evaluate 

major and minor performance 

improvement projects based on a 

thorough analysis of the data collected. 

In phase three, we believe that a 

hospice will: 

Identify new domains and measures 

that may replace or be in addition to the 

domains and measures already being 

monitored by the hospice; 

Develop and/or revise policies and 

procedures to accommodate the new 

domains and measures; and 

Educate hospice employees and 

contractors on the new domains and 

measures, as well as the policies and 

procedures for them. 

In addition to these three phases, a 

hospice will likely allocate resources to 

an individual responsible for the general 

overall coordination of its QAPI 

program. For simplicity, we refer to this 

individual as the QAPI coordinator; 

however, a hospice is not required to 

use this title. 

Based on these three phases, we have 

anticipated the impact of the QAPI 

requirement on a hospice’s resources. In 

phase one, we anticipate that a hospice 

will use 12 hours to identify quality 

domains and measures. These hours 

will be distributed among the three 

members of the hospice’s QAPI 

committee. While we do not require a 

hospice to have a QAPI committee, we 

believe that most hospices will choose 

to do so. The hospice model is based on 

the idea of an interdisciplinary group of 

people working together, and we believe 

that hospices will choose to use this 

group decision-making model in the 

QAPI process as well. We believe that 

the QAPI committee will include the 

QAPI coordinator, the hospice 

administrator, and a clinical manager. 

We estimate that the QAPI committee 

will meet four times quarterly for 1 hour 

each meeting to identify appropriate 

quality domains and measures. The total 

cost for an average hospice to identify 

the domains and measures, then, is 

$480. 


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4 meetings × 1 hour per meeting × $35/hour 

for QAPI coordinator = $140 

4 meetings × 1 hour per meeting × $49/hour 

for administrator = $196 

4 meetings × 1 hour per meeting × $36/hour 

for clinical manager = $144 

While we anticipate that a hospice 

will use resources to develop policies 

and procedures and educate staff, we 

believe that these activities are part of 

standard business practice and do not 

pose an additional burden to a hospice. 

For example, a hospice already 

conducts a regular in-service training 

program for its employees in accordance 

with the in-service training requirement 

at existing § 418.64. A hospice can 

incorporate QAPI training into this 

existing in-service training program 

with no associated increase in burden. 

In phase two, we anticipate that a 

hospice will use 91 hours to enter data 

(at the time of each assessment, 40.4 

hours + at the time of each IDG meeting, 

50.5 hours), 48 hours to aggregate data, 

and 12 hours to analyze data. Although 

thoroughly assessing a patient is already 

standard practice, we believe that 

collecting quality measure data during 

the patient assessment will be a new 

practice for many hospices. We estimate 

that a hospice will spend 40.4 hours a 

year to collect patient-level quality data 

during patient assessments, and that a 

registered nurse is the most likely 

person to perform this data collection. 

4 minutes per patient assessment to collect 

quality data × 2 assessments per patient × 

303 patients = 40.4 hours × $35/hr for a 

registered nurse = $1,414 

The QAPI CoP requires a hospice to 

use the quality data collected during the 

patient assessment during the IDG 

meeting to monitor the effectiveness of 

interventions in helping the patient and 

family achieve desired outcomes. While 

a hospice IDG already makes decisions 

based on the information contained in 

the patient’s clinical record, they may 

not be systematically documenting this 

analysis and its results. We believe that 

documenting the results of the data 

analysis (for example, any changes to 

the plan of care based on the specific 

quality measure data) during the IDG 

meeting will require additional time for 

each patient. We estimate that this 

activity will require 50.5 hours for an 

average hospice, based on an assumed 

five minutes per patient to document 

quality measure analysis. We believe 

that the registered nurse assigned to 

coordinate the patient’s plan of care is 

the individual most likely to document 

this information. 

5 minutes per patient to document during 

IDG meeting × 2 IDG meetings per patient 

× 303 patients = 50.5 hours × $35/hour for 

a registered nurse = $1,768 

In addition to using quality measure 

data on a patient level, a hospice must 

gather the patient-level data and other 

data. Once gathered, a hospice must 

organize the data in a meaningful way. 

We estimate that, in order to ensure that 

the volume of gathered data is 

manageable, a hospice will gather its 

data once a month. A hospice may 

choose to gather data on a more or less 

frequent basis to suit its needs and 

circumstances. Some hospices may 

choose to gather all patient-level data, 

while others may choose to gather data 

from a sample of all patient-level data. 

Likewise, some hospices may choose to 

gather data from a wide variety of 

administrative files, while others may 

choose to select only a few 

administrative data sources. There are 

many combinations that a hospice may 

choose to use when it comes to 

gathering data, and no single approach 

is considered preferable to another. 

Given this variability, it is difficult to 

estimate how long an average hospice 

may spend gathering and organizing 

data. For purposes of this analysis only, 

we assume that an average hospice will 

use four hours per month to gather data, 

for a total of 48 hours a year. We believe 

that an office employee will perform the 

data aggregation and organization. 

4 hours a month to gather and organize data 

× 12 months = 48 hours × $14/hr for an 

office employee = $672 

Following data gathering and 

organization, a hospice must analyze the 

data to identify trends, patterns, 

anomalies, areas of strength and 

concern, etc. We believe that this data 

analysis will be done by the QAPI 

committee described previously. In 

order to identify trends and patterns, the 

committee would need to examine 

several months of data at the same time. 

Therefore, we assume that the 

committee will meet once every quarter 

to examine the data and make decisions 

based off of it. We assume that these 

meetings will be one hour each, for a 

total cost of $480. 

4 meetings × 1 hour per meeting × $35/hour 

for QAPI coordinator = $140 

4 meetings × 1 hour per meeting × $49/hour 

for administrator = $196 

4 meetings × 1 hour per meeting × $36/hour 

for clinical manager = $144 

Performance improvement projects 

follow all of the data entry, gathering, 

organization, and analysis. A hospice 

must conduct projects to improve its 

performance in areas where a weakness 

is identified. Performance improvement 

projects must reflect the hospice’s 

scope, complexity, and past 

performance. They must also be datadriven, and affect palliative outcomes, 

patient safety, and quality of care. 

Although this final rule more clearly 

describes a performance improvement 

project, its basis, and its purpose, are 

fundamentally the same as the current 

requirement at § 418.66, ‘‘Quality 

assurance.’’ That requirement states 

that, ‘‘A hospice must * * * correct 

identified problems and * * * revise 

hospice policies if necessary * * * 

[and] [m]ake suggestions for improving 

patient care.’’ Since a hospice already 

makes an organized effort to improve 

patient care in all of its facets, and since 

providing safe and effective care at all 

times for all patients is the essential 

charge of all health care providers, 

including hospices, we believe that 

conducting both major and minor 

performance improvement projects is 

already a standard of practice within the 

hospice industry. Therefore there is no 

additional burden associated with this 

provision. 

Phase three of the QAPI process 

builds upon the QAPI program that a 

hospice already has in place. We 

estimate that a hospice will use three 

hours a year to identify new domains 

and quality measures, and we believe 

that the QAPI committee will perform 

this task. Just as in phase one, we 

believe that the tasks of developing and/ 

or updating the hospice’s policies and 

procedures and educating the hospice’s 

staff and contractors are standard 

practice within the hospice industry. 

1 meeting × 1 hour per meeting × $35/hour 

for QAPI coordinator = $35 

1 meeting × 1 hour per meeting × $49/hour 

for administrator = $49 

1 meeting × 1 hour per meeting × $36/hour 

for clinical manager = $36 

In order to ensure the adequate 

functioning of a hospice’s QAPI 

program, a hospice must designate an 

individual to be responsible for its QAPI 

program. We estimate that a QAPI 

coordinator will spend 1.5 hours per 

week overseeing the QAPI program, 

performing various functions as needed, 

for a total of 78 hours per year. 

1.5 hours/week × 52 weeks = 78 hours × $35/ 

hour = $2,730 


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TABLE 3.—QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT BURDEN ASSESSMENT

Standard 

Time per 

hospice 

(hours) 

Total time 

(hours) 

Cost per 

hospice Total cost 

Identify domains and measures (1st year) ...................................................... 12 34,464 $480 $1,378,560 

Enter data 1 (1st year and annual) .................................................................. 91 261,352 3,182 9,138,704 

Aggregate data 1 (1st year and annual) .......................................................... 48 137,856 672 1,929,984 

Data analysis (1st year and annual) ................................................................ 12 34,464 480 1,378,560 

QAPI coordinator (1st year and annual) .......................................................... 78 224,016 2,730 7,840,560 

Update domains and measures (annual) ........................................................ 3 8,616 120 344,640 

Total 1st year ............................................................................................ 241 * 692,152 7,544 * 21,666,368 

Total annually ........................................................................................... 232 * 666,304 7,184 * 20,632,448 

* Note: The overall national estimates are based on the assumption that every hospice will begin to develop and implement a QAPI program 

upon the effective date of this final rule. Anecdotal evidence suggests that many hospices began developing and implementing QAPI programs 

upon publication of the proposed hospice rule, and therefore will not be impacted to the same extent as we have estimated above. Thus, we expect that the actual impact of this final requirement will be less than estimated in this section. 

Infection Control (§ 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 

final regulation reinforces those positive 

infection control practices and 

addresses the serious nature of 

infectious and communicable diseases. 

Infection control and standard 

precautions are long-standing clinical 

practices that are standard throughout 

the medical industry. 

This final CoP requires a hospice to 

continue to take specific and 

appropriate actions to address the 

prevention and control of infections, 

including patient, staff, and caregiver 

education. We acknowledge that this is 

a new focus; however, we do not believe 

this will add any regulatory burden, 

since this section of the final rule 

reflects contemporary standard practice 

in hospice programs. 

Core Services (§ 418.64) 

The final rule allows core services to 

be provided under contract in certain 

extraordinary or other non-routine 

circumstances as described, allowing 

hospices more flexibility. One specific 

provision allows a hospice to contract 

for highly specialized nursing services, 

providing even more staffing flexibility. 

The option to contract out for highly 

specialized nursing services allows a 

hospice to provide such highly 

specialized services at a lower cost than 

if it directly employed an individual(s) 

to perform such services. A hospice that 

chooses to contract for core services or 

highly specialized nursing services must 

have a contract with the entity 

providing the contracted services. 

Negotiating, documenting and signing a 

business contract is standard business 

practice and does not impose a burden. 

(d) Standard: Counseling services. 

The final rule also requires a hospice to 

offer bereavement services to 

appropriate residents of a SNF/NF or 

ICF/MR. Residents of a facility often act 

as a patient’s family, providing care, 

support, and companionship throughout 

the terminal illness. In such cases, we 

believe that it is appropriate for a 

hospice to offer bereavement services to 

the affected residents in the same 

manner that bereavement services are 

offered to a patient’s family. Since 

offering and subsequently providing 

bereavement services to a patient’s 

family is standard practice, we do not 

believe that extending such services to 

those who act as a patient’s family in a 

SNF/NF or ICF/MR imposes an 

additional burden upon a hospice 

relative to the burden of providing 

bereavement services to a patient’s 

family. 

Waiver of Requirement—Physical 

Therapy, Occupational Therapy, 

Speech-Language Pathology, and 

Dietary Counseling (§ 418.74) 

This waiver, currently implemented 

through a memorandum from CMS’s 

Center for Medicaid and State 

Operations, will reduce the compliance 

burden on hospices located in nonurbanized areas. If the hospice program 

demonstrates that recruitment efforts 

were unsuccessful, it may request 

certain waivers with respect to PT, OT, 

speech-language pathology, and dietary 

counseling. There have been no 

applications for this waiver in the past 

5 years; therefore we believe that the 

burden is negligible. 

Hospice Aide and Homemaker Services 

(§ 418.76) 

Hospice aide and homemaker services 

are an integral part of hospice care, yet 

they receive little attention in the 

current regulation. These services are 

briefly addressed in § 418.94 with a 

standard regarding the supervision of 

home health aide services and a 

standard regarding written patient care 

instructions. These two standards 

appear in the final regulation, with 

some minor alterations. The final 

regulation also adds several new 

requirements. 

(b) Standard: Content and duration of 

hospice aide classroom and supervised 

practical training; (c) Standard: 

Competency evaluation; (d) Standard: 

In-service training. 

These three standards describe the 

ways in which a hospice aide can meet 

the qualification requirements. All of 

these standards require the hospice to 

maintain documentation that each 

hospice aide meets these qualifications. 

The burden associated with these 

standards is the time to complete the 

required documentation. We estimate 

that it will take five minutes to 

document the information and that an 

office employee will complete this task. 

In addition, we have calculated the 

burden based on an employee turnover 

rate of 30% (2002 NHPCO National Data 

Set Summary Report), meaning that we 

expect that the average hospice would 

replace 30% of its hospice aides in a 

given year, or roughly one hospice aide 

a year based on the employment of 5 

hospice aides. Based on the abovementioned estimates and assumptions, 

we estimate that will cost an average 

hospice $1.17 to document that its 

hospice aides meet the qualification 


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requirements, for a total cost of $3,360 

nationwide. 

$14 an hour for an office employee to 

document compliance/60 minutes = $0.23 

minute × 5 minutes per aide to document 

compliance = $1.17 × 1 document per year 

= $1.17 per hospice 

$1.17 per hospice × 2,872 hospices = $3,360 

5 min to document × 2872 hospices = 14,360/ 

60min = 239 hours 

(g) Standard: Hospice aide 

assignments and duties. The hospice 

aide is required to report changes in the 

patient’s needs to a registered nurse, 

and complete appropriate records in 

compliance with the hospice’s policies 

and procedures. This new requirement 

reflects the standard industry practice of 

maintaining communication between all 

healthcare providers and maintaining a 

complete patient record. 

(h) Standard: Supervision of hospice 

aides. This standard retains the current 

rule’s requirement that a registered 

nurse visit the patient’s home to assess 

hospice aide services every 14 days. 

This standard also requires that a 

registered nurse visit the patient’s home 

annually or more frequently when there 

are care/performance issues, when the 

aide is providing services in the home. 

We believe that thoroughly supervising 

employees is standard practice and does 

not increase burden. 

(j) Standard: Homemaker 

qualifications. The final regulation 

requires homemakers to complete a 

hospice orientation program addressing 

the needs and concerns of patients and 

families coping with a terminal illness. 

We believe that this standard does not 

impose any additional regulatory 

burden because hospices train all of 

their employees, including 

homemakers, to deal with the realities 

of hospice care. 

(k) Standard: Homemaker supervision 

and duties. A member of the IDG is 

required to develop written instructions 

for the homemaker. We have also added 

a requirement that a member of the IDG 

must coordinate and supervise the 

homemaker services. We believe that 

providing patient care instructions, 

coordinating care, and supervising 

homemakers are usual and customary 

practice; therefore, this requirement 

would not impose any additional 

regulatory burden. 

TABLE 4.—HOSPICE AIDE AND HOMEMAKER SERVICES BURDEN ASSESSMENT

Standard Time per aide 

(minutes) 

Time per 

hospice 

(minutes) 

Total time 

(hours) Cost per aide 

Cost per 

average 

hospice 

Total cost 

Documentation (based on 1 new hospice 

aide per year) ....................................... 5 5 239 $1.17 $1.17 $3,360 

Totals ................................................ 5 5 239 1.17 1.17 3,360 

Organization and Administration of 

Services (§ 418.100) 

The revised requirements for the 

organization and administration of 

services are essentially the same as 

those in the previous conditions of 

participation. We added a requirement 

to clarify the relationship between the 

hospice governing body and the hospice 

administrator. This clarification 

presents no burden for a hospice. 

(f) Standard: Hospice multiple 

locations. We also added a requirement 

that a hospice must apply to CMS to 

receive authorization for the opening of 

a multiple location. This practice is 

currently mandated through a June 1997 

memorandum from CMS’ Center for 

Medicaid and State Operations. 

Requesting approval from CMS to 

provide services to Medicare and 

Medicaid patients from a particular 

location is standard practice in the 

industry and does not present a burden 

for a hospice. 

(g) Standard: Training. Finally, we 

added two employee training 

requirements. First, we added a 

requirement that a hospice must provide 

an initial orientation for each employee 

that addresses the employee’s specific 

job duties. Second, we added a 

specification for the maintenance of inservice training records to help a 

hospice document its compliance with 

the provision of in-service training 

requirement. These additions reflect 

standard practice in the industry and 

present no additional burden. 

Medical Director (§ 418.102) 

This rule includes a new requirement 

that a hospice must designate a 

physician to assume the role and 

responsibilities of the medical director 

when the medical director is not 

available. All hospices routinely meet 

the medical needs of their patients 24 

hours a day, including the need for 

physician services. As such, they must 

already have a physician available at all 

times. A single physician cannot fulfill 

this 24-hour a day hospice physician 

role; therefore hospices already have 

more than one physician available. We 

believe that identifying the alternative 

physician as the physician designee, 

ready and able to fulfill the medical 

director role in the medical director’s 

absence, does not pose a burden to a 

hospice. 

(a) Standard: Medical director 

contract. We added a provision 

permitting the medical director to work 

under a contractual arrangement, 

reducing the program and hiring burden 

on the hospice. If a hospice chooses to 

secure medical director services through 

a contract, this rule requires the contract 

to specify the physician who will serve 

as the medical director. Identifying a 

single individual to serve as the hospice 

medical director is standard practice in 

the hospice industry and does not 

present a burden. 

(b) Standard: Initial certification of 

terminal illness and (c) Standard: 

Recertification of the terminal illness. 

This rule codifies the current standards 

of practice to which medical directors 

adhere for certifying and recertifying a 

patient’s terminally ill status. 

(d) Standard: Medical director 

responsibility. This rule re-codifies the 

requirement that the medical director or 

designee has responsibility for the 

medical component of the hospice’s 

patient care program. It is standard 

practice for the hospice medical director 

to lead, and thus bear responsibility for, 

the medical component of the hospice’s 

patient care services. Therefore, this recodified provision does not impose a 

burden upon a hospice. 

Clinical Records (§ 418.104) 

This rule adds specificity in regard to 

content, authentication, retrievability, 

retention, and transfer of records. It 

requires a hospice to include all 

relevant patient care information in 

each patient’s clinical record in order to 

facilitate communication and 

coordination among all disciplines 

involved in a patient’s care. It also 

requires a hospice to ensure that clinical 

record entries are legible, clear, 

complete, and authenticated in 


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accordance with its own policies. 

Furthermore, this rule requires a 

hospice to protect and retain the 

information contained in the clinical 

record in accordance with the 

Department’s rules regarding personal 

health information at 45 CFR parts 160 

and 164. All of these requirements 

reflect standard hospice practices and 

do not pose a burden. 

(e) Standard: Discharge or transfer of 

care. This rule requires a hospice to 

prepare and send a comprehensive 

discharge summary for all patients that 

are discharged alive. The discharge 

summary must include a summary of 

the patient’s stay, the patient’s current 

plan of care, the most recent physician 

orders, and any other documentation to 

aid in post-discharge care of the patient. 

These are standard elements for 

discharge summaries in the health care 

industry, including the hospice 

industry. This rule also requires a 

hospice to send a copy of the patient’s 

clinical record to the provider assuming 

care of the patient, if the provider 

assuming care requests a copy of the 

clinical record. A comprehensive 

discharge summary should remove any 

reason for the provider assuming care to 

request a copy of the patient’s clinical 

record. Therefore, we do not believe that 

this requirement will pose a burden to 

a hospice. We believe that these 

discharge requirements reflect standard 

industry practice and add no burden. 

Drugs, Medical Supplies and Durable 

Medical Equipment (§ 418.106) 

(a) Standard: Managing drugs and 

biologicals. We added a requirement 

that a hospice must ensure that its 

IDG(s) confers with an individual with 

education and training in drug 

management to ensure that drugs and 

biologicals meet each patient’s needs. A 

hospice may meet this requirement in a 

variety of ways that is, by hiring or 

contracting with a pharmacist(s), by 

contracting with a pharmacy benefit 

management company, by hiring or 

contracting with a physician or other 

clinician with the necessary education 

and training in drug management (for 

example, a physician who is board 

certified in palliative care once board 

certification is available in October 

2008), or by ensuring the appropriate 

education and training of one or more 

existing hospice employees. 

For purposes of our analysis only, we 

are estimating the impact of this 

provision based on the assumption that 

an average hospice will choose to use a 

pharmacist to meet this requirement. 

We have made this assumption based on 

two factors. First, pharmacists are 

relatively easier to access in most parts 

of the country as compared to clinicians 

who have specialized drug management 

education and training. Second, 

pharmacist services can be easily 

accessed by phone and electronic 

communications through a local 

pharmacy or a pharmacy benefit 

management company. Hospices are in 

no way required to use a pharmacist to 

fulfill this role. We estimate that an 

average hospice already spends 

$123,842 annually to provide drugs and 

biologicals for its patients ($15.72 per 

patient day (dollar figure is not adjusted 

for inflation) for drugs and biologicals 

based on 2001 Millman USA report 

titled ‘‘The Costs of Hospice Care: An 

Actuarial Evaluation of the Medicare 

Hospice Benefit’’ and consistent with 

the 2002 NHPCO National Data Set). 

Based on discussions with the leading 

hospice pharmacy benefit management 

company, for approximately this same 

price ($12–18 per patient day), a 

hospice may contract with a pharmacy 

benefit management company to 

provide all drugs and biologicals for its 

patients. In addition, the pharmacy 

benefit management company allows a 

hospice IDG to speak with a pharmacist 

on a 24-hour basis to gather information, 

input, and advice from the pharmacist 

regarding an individual patient’s drug 

and biological profile. Contracting with 

a pharmacy benefit management 

company and utilizing its pharmacists 

satisfies the new requirement without 

increasing a hospice’s expenditures 

beyond what it is currently spending to 

provide drugs and biologicals alone. 

Since hospices currently have the 

option of contracting with a pharmacy 

benefit management company to comply 

with this requirement without 

increasing overall pharmacy costs, we 

do not believe that this new requirement 

poses a burden to a hospice. As of 

January 2008 approximately 1,600 

hospices currently use the services of 

pharmacy benefit management 

companies. 

If a hospice decides not to use a 

pharmacy benefit management 

company, it may also choose to employ 

or contract with a pharmacist(s) for 

pharmacist advisement services. A 

hospice that chooses to use the services 

of a pharmacist (or other individual 

with specialized education and training 

in drug management) in lieu of a 

pharmacy benefit management company 

retains the responsibility and flexibility 

of managing the purchase of drugs and 

biologicals. We estimate that it requires 

30 minutes for an individual such as a 

pharmacist to initially review a patient’s 

drug and biologicals profile and advise 

the IDG during the time of the patient’s 

comprehensive assessment and 

development of the plan of care. 

Additionally, we estimate that it 

requires 15 minutes of a individual’s 

time to review updates to the patient’s 

drug profile and advise the IDG about 

updates to the patient’s plan of care. 

Based on a 26 day median length of 

stay, patients would likely receive two 

updates to their plans of care. Using 

these estimates, a hospice would 

expend $56 per patient to secure 

pharmacist advisement services. An 

average hospice would expend $16,968 

annually to secure pharmacist 

advisement services for all of its 

patients. We have not estimated the cost 

associated with a hospice using an 

individual from another clinical 

discipline who has specialized 

education and training in drug 

management because we are unsure of 

what disciplines would be used in this 

role, depending upon the needs of each 

hospice. 

30 minute initial advisement per patient at 

$28 + 15 minute update advisement per 

patient at $14 + 15 minute update 

advisement per patient at $14 = $56 per 

patient for all pharmacists advisement 

services 

$56 per patient × 303 patients = $16,968 

(b) Standard: Ordering of drugs, (c) 

Standard: Dispensing of drugs and 

biologicals and (d) Standard: 

Administration of drugs and biologicals. 

We added requirements governing the 

ordering, dispensing, and 

administration of drugs and biologicals. 

Having written policies and procedures 

in place to manage drugs and 

biologicals, and educating patients and 

families about these policies and 

procedures is standard practice in the 

hospice industry. Therefore, these 

requirements pose no burden to a 

hospice. 

(e) Standard: Labeling, disposing and 

storing of drugs and biologicals. This 

standard requires a hospice to ensure 

safe labeling of all drugs and biologicals 

in accordance with current standards of 

practice. This standard also requires a 

hospice-operated inpatient facility to 

investigate discrepancies involving 

controlled drugs and to document an 

account of the investigation. Of the 

2,533 deficiencies issued by State 

surveyors in 1,161 surveys in 2006, two 

were potentially related to controlled 

drug discrepancies. The 1,161 surveys 

in 2006 represent approximately 30 

percent of all hospices. Therefore, we 

can expect that if all hospices were 

surveyed, six deficiencies would be 

issued that are potentially related 

controlled drug discrepancies. We do 

not expect a significant increase in 


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discrepancies, and estimate that six 

investigations would be conducted and 

documented throughout the hospice 

industry. 

The rule requires the hospice’s 

pharmacist and administrator to 

conduct controlled drug investigations. 

We estimate that a thorough 

investigation, including an examination 

of the records of incoming and outgoing 

drugs and biologicals, and report would 

require one hour per incident. The 

entire industry would thus spend six 

hours annually at a cost of $624 to fulfill 

this requirement. Maintaining inventory 

records incoming and outgoing drugs 

and biologicals is a usual and customary 

business practice and is not a burden. 

$55 hour + $49 hour = $104 hour × 1 hour 

investigation = $104 per investigation 

$104 per investigation × 6 investigations = 

$624 industry wide 

In addition, we added a requirement 

regarding documentation of patient and 

family drug education. A hospice must 

document in the patient’s clinical 

record that it provided a copy of its 

controlled drug policy to the patient and 

family at the time when a controlled 

drug is first ordered. A hospice must 

also document that it discussed the 

controlled drug policy with the patient 

and family. Documenting the provision 

of the material and the education 

session requires approximately five 

minutes, and will likely be completed 

by a registered nurse. Fulfilling the 

requirement would cost $2.25 per 

patient based upon the average hourly 

rate for a registered nurse. 

$27 hour/60 minutes = $0.45 minute × 5 

minutes = $2.25 

$2.25 per patient × 303 patients = $682 

$2.25 per patient × 303 patients × 2872 

hospices = $1,957,986 

(f) Standard: Use and maintenance of 

equipment and supplies. We added a 

requirement that a hospice must ensure 

that manufacturer recommendations for 

routine and preventive maintenance of 

equipment are followed. If manufacturer 

recommendations do not exist, a 

hospice must ensure that maintenance 

policies are developed. A hospice must 

also ensure that the patient and family 

receive instruction regarding the use of 

equipment and supplies, and that the 

patient and family can safely 

demonstrate the use of the equipment 

and supplies. Hospices already require 

their equipment and supply vendors to 

properly maintain the equipment 

supplied to hospice patients. Therefore, 

we believe that this maintenance 

requirement does not impose a burden. 

Additionally, hospices already assure 

that patients and families can operate 

the supplied equipment. When a patient 

and family safely and effectively use 

equipment, the hospice does not need to 

continually send its staff to the patient’s 

home for equipment problems. Since 

this routine education already occurs, 

benefiting both the patient and the 

hospice, this requirement does not 

impose a burden. 

The vast majority of hospices provide 

durable medical equipment and 

supplies under contract with one or 

more vendors. For this reason, we added 

a requirement that a hospice may only 

contract with a durable medical 

equipment supplier that meets the 

Medicare DMEPOS Supplier Standards 

at 42 CFR 424.57. We do not believe that 

this requirement will compromise a 

hospice’s ability to secure a contract or 

significantly increase the cost of that 

contract because most vendors choose to 

meet the Medicare Supplier Standards 

in order to furnish equipment and 

supplies to Medicare beneficiaries. 

Therefore, there is sufficient 

competition among vendors to provide 

high quality services at a reasonable cost 

to hospices seeking contracts. 

TABLE 5.—DRUGS, MEDICAL SUPPLIES AND DURABLE MEDICAL EQUIPMENT BURDEN ASSESSMENT

Standard 

Time per patient 

(minutes) 

Time per average hospiace 

(hours) 

Total industry 

time 

(hours) 

Cost per patient Cost per average hospice Total industry 

cost 

Drug Policy Education ............................. 5 25.25 72,518 $2.25 $681.75 $1,957,986 

Drug Discrepancy Investigation ............... N/A N/A 6 N/A N/A 624 

Total .................................................. 5 25.25 72,524 2.25 681.75 1,958,610 

Short Term Inpatient Care (§ 418.108) 

(b) Standard: Inpatient care for respite 

purposes. This rule allows a hospice to 

contract for respite care with a facility 

that does not have a registered nurse onduty providing direct patient care 24- 

hours a day. This provision will make 

it easier for hospices to contract with 

long term care facilities. 

(c) Standard: Inpatient care provided 

under arrangements. This rule provides 

additional guidance with respect to the 

substance of the written agreement 

between a hospice and an inpatient 

facility, which we believe is a usual and 

customary business practice. Therefore, 

this provision therefore does not 

increase regulatory burden. 

(d) Standard: Inpatient care limitation 

and (e) Standard: Exemption from 

limitation. This rule also maintains the 

20 percent limitation on inpatient days 

and the exemption to this limitation. 

These requirements are statutory and 

have been in place since the inception 

of the Medicare hospice benefit. They 

reflect the goal of the hospice movement 

and benefit to keep patients in their 

home, where most patients prefer to 

stay. Therefore, they are standard 

practice. 

Hospices That Provide Inpatient Care 

Directly (§ 418.110) 

(b) Standard: Twenty-four hour 

nursing services. This rule includes the 

24-hour nursing requirement from the 

existing rule. In short, a hospice that 

provides general inpatient care directly 

must have a registered nurse who 

provides direct patient care on each 

shift. This requirement has been in 

place since the inception of the 

Medicare hospice Conditions of 

Participation. As such, it is standard 

practice and does not pose a burden. 

(c) Standard: Physical environment 

through (l) Standard: Meal service and 

menu planning. This rule requires a 

hospice to maintain a safe physical 

environment in its inpatient facility. A 

hospice must: 

Have and rehearse a disaster 

preparedness plan; 

Manage all aspects of the building 

(that is, waste, water supply, and 

ventilation); 

Comply with applicable fire safety 

requirements; 

Have a home-like atmosphere with 

sufficient space and amenities; 

Have an adequate infection control 

program; 

Have clean linens and properly 

handle soiled ones; and 

Serve meals to meet patient needs. 

These requirements are standard 

practice in hospice-operated inpatient 

facilities and pose no additional burden. 

(m) Standard: Restraint or seclusion, 

(n) Standard: Restraint or seclusion staff 

training requirements and (o) Standard: 


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Death reporting requirements. This rule 

adds considerable detail in regard to 

seclusion and restraint. This section is 

adapted from the language of the 

Patient’s Rights Condition of 

Participation for hospitals published as 

a Final Rule in the Federal Register in 

December 2006, and codified at 42 CFR 

482.13. While we anticipate that 

hospices with their own inpatient 

facilities will be impacted by this rule, 

we do not have the benefit of several 

key pieces of information. For example, 

we do not have reliable data on the 

prevalence of restraint and seclusion 

use, data on the volume of staff in 

inpatient hospices, or data on the 

varying levels and qualifications of 

hospice staff who may be involved in 

restraint and seclusion use. Factors such 

as size, services rendered, staffing, and 

patient populations vary as well. We are 

hesitant to make impact estimates in 

this final rule that may not account for 

these and other unforeseen variations. 

Thus, we reserve the right to provide 

estimates when feasible. Below we 

discuss the anticipated effects on 

providers of the standards related to 

restraints and seclusion. 

(m) Standard: Restraint or seclusion. 

Standard 418.110(m) sets out the 

patient’s rights in the event he or she is 

restrained or secluded, and limits when 

and by whom restraint or seclusion can 

be implemented. We recognize that 

there will be some impact associated 

with performing patient assessment and 

monitoring to ensure that seclusion and 

restraint are only used when necessary 

and are implemented in a safe and 

effective manner. However, patient 

assessment and monitoring are standard 

components of patient care, and this 

requirement does not pose a burden to 

a hospice. 

Section 418.110(m)(6) requires that 

the medical director or physician 

designee must be consulted as soon as 

possible if the attending physician did 

not order the restraint or seclusion. 

Although this may minimally increase 

burden to hospices, we believe it is a 

best practice for patient safety. 

We have added elements at 

§ 418.110(m)(14) that monitoring must 

occur face-to-face by trained staff or by 

using both video and audio equipment, 

when there is simultaneous use of 

restraint and seclusion. We have added 

elements at § 418.110(m)(15) regarding 

the documentation that must be 

included in the patient’s medical record 

when the patient is restrained or 

secluded, including the 1-hour face-toface medical and behavioral evaluation 

if restraint or seclusion is used to 

manage violent or self-destructive 

behavior, the patient’s behavior and 

intervention used, alternatives or other 

less restrictive interventions attempted 

(as applicable), the patient’s condition 

or symptom(s) that warranted restraint 

or seclusion use, and the patient’s 

response to the use of the restraint or 

seclusion intervention, including the 

need for continued use of restraint or 

seclusion. We do not believe additional 

burdens are imposed by this 

requirement since it is a routine and 

customary practice to document the 

circumstances surrounding such an 

event for comprehensiveness of patient 

care. 

In response to the December 19, 1997 

proposed rule that we published 

concerning the use of seclusion and 

restraint in hospitals, the National 

Association of Psychiatric Health 

Systems (NAPHS) supplied data from 

fifty members for the time and cost of 

complying with the CMS requirements 

that a physician evaluate a patient faceto-face within 1 hour of the initiation of 

restraint or seclusion. The NAPHS 

stated their respondents reported it took 

an estimated 30 minutes to 1 hour to 

document all the specific elements 

required by CMS after a restraint or 

seclusion episode. This included several 

elements unique to the rule such as 

physician notification if the restraint 

was ordered by someone other than the 

patient’s attending physician. 

We believe that the time associated 

with documenting seclusion or restraint 

episode in a hospice is similar to that in 

a hospital. Thus, our burden estimate is 

based on a median timeframe (that is, 45 

minutes) that we believe it takes to 

complete the required documentation in 

the patient’s clinical record. However, 

since we are unable to estimate the 

prevalence of restraint and seclusion, 

we can not apply this estimate to assess 

the associated burden across hospices. 

(n) Standard: Restraint or seclusion 

staff training requirements. Standard 

418.110(n) identifies the training 

requirements for all staff involved in the 

use of seclusion and restraint in the 

hospice inpatient facility. While we 

have tried to minimize the burden 

which will be placed on hospices in 

order to meet this requirement, we 

believe it is important for the provision 

of safe and effective restraint or 

seclusion use. We require that before 

staff apply restraints, implement 

seclusion, perform associated 

monitoring and assessment of the 

restrained or secluded patient, or 

provide care for a restrained or secluded 

patient, the staff must be trained and 

able to demonstrate competency in the 

performance of these actions. The staff 

training requirements address the 

following broad areas: Training 

intervals, training contents, trainer 

requirements, and trainer 

documentation. 

To reduce burden and create a 

reasonable requirement while assuring 

patient safety, we have mandated that 

only those staff who are involved in the 

application of restraint or seclusion or 

performing associated monitoring and 

assessment of, or providing care for 

restrained or secluded patients have this 

training. While we expect physicians to 

be trained in the proper use of restraint 

or seclusion, we do not expect that they 

will be trained with the other hospice 

staff. Thus, we have not included 

physicians in the burden associated 

with these requirements. Instead, we 

require the remaining hospice staff who 

have direct contact with patients must 

be trained in restraint or seclusion use. 

In this final rule, we have specified 

broad topics to be covered in training, 

and have not required that staff be 

trained by an outside organization. We 

believe that in-house training may be 

more economical than sending staff offsite for instruction. However, hospices 

have the option of sending either 

selected or all staff to outside training if 

they believe that this is warranted. 

Thus, we have based our burden 

estimate on having the actual number of 

trainers attend the training from an 

outside organization one time. We 

believe that most hospices would, in 

turn, have these trained individuals 

function as program developers and 

trainers of the appropriate hospice staff. 

We believe in most instances this 

professional will be a registered nurse. 

Train-the-trainer programs are the 

way many hospices provide staff 

instruction. The four day instructor 

certification program given by the Crisis 

Prevention Institute (CPI, INC.) costs 

$1,200 dollars in tuition plus travel, 

lodging, and participant salary 

(HYPERLINK ‘‘http:// 

www.crisisprevention.com’’

www.crisisprevention.com). 

We estimate, on average, that 

roundtrip travel for each nurse will cost 

approximately $400 to cover the need 

for either local or distant travel, lodging 

for each nurse will costs approximately 

$120 per night × 3 nights, and the meals 

and incidental expenses (M&IE) will be 

approximately $50 per day depending 

upon the location within the designated 

state. Thus, we anticipate the cost to 

train one nurse would be $3,280. If all 

906 hospices (estimate based on March 

2006 Hospice Facts & Statistics report 

from the Hospice Association of 

America that 31.54 percent of hospices 

have their own inpatient facilities) with 

inpatient facilities were to send one 


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nurse to such training, the total cost for 

the 906 hospices would be $2,971,680. 

$1,200 for instructor certification program + 

$400 airfare + $360 for 3 days lodging + 

$200 for 4 days M&IE + $1120 for nurse 

salary at $35 per hour × 8 hours per day 

× 4 days = $3,280 per nurse per hospice 

inpatient facility. 

$3,280 per nurse per hospice × 906 hospices 

= $2,971,680 

We believe that hospices will add 

seclusion and restraint training onto 

their existing in-service training 

programs. The train-the-trainer program 

described above will provide hospices 

with the necessary personnel and 

materials to implement a staff-wide 

seclusion and restraint training 

program. We estimate that developing 

this staff-wide training program will 

require 40 hours of the trainer’s time on 

a one-time basis for all affected 

hospices, at a cost of $1,400 per hospice 

inpatient facility. 

We require that each individual who 

will potentially be involved in restraint 

and seclusion of a patient have training 

in the proper techniques. According to 

the NAPHS, initial training in deescalation techniques, restraint and 

seclusion policies and procedures, and 

restraint and seclusion techniques range 

from 7 to 16 hours of staff and instructor 

time. 

Using data from a March 2006 

Hospice Association of America report, 

there were 116,148 total hospice 

employees and volunteers in 2005. Of 

these employees and volunteers, 32,412 

employees and volunteers were nurses 

and physicians. Thus the average 

hospice operating its own inpatient 

facility has 11 nurse and physician 

employees and volunteers. We realize 

that some hospices will have more or 

less employees and volunteers to train. 

Based on one nurse trainer conducting 

an 8 hour training course for 11 hospice 

inpatient employees and volunteers, we 

estimate that this requirement will cost 

$3,360. 

8 trainer hours at $35/hr = $280 

88 trainee hours at $35/hr = $3080 

$280 trainer cost + $3080 trainee costs = 

$3,360 

We require that each individual will 

receive annual updates to the training 

and that the annual training will also be 

documented. Again, according to 

NAPHS, annual updates are about 4 

hours of staff and instructor time per 

each employee who has direct patient 

contact. Again, an average size hospice 

has 11 employees who have direct 

patient contact that must to be trained 

in de-escalation techniques. Therefore, 

we estimate that it will cost $1,680 

annually to update each person’s 

training. 

4 trainer hours at $35/hr = $140 

44 trainee hours at $35/hr = $1540 

$140 trainer costs + $1540 trainee costs = 

$1,680 

Additionally, we required 

recordkeeping for documenting in each 

trained individual’s personnel record 

that he or she has successfully 

completed training. We estimate that it 

will take the trainer 5 minutes per 

trainee to document each participant’s 

completion of the training. As described 

above, we estimate that 11 hospice 

employees and volunteers will be 

trained. 

5 minutes per trainee × 11 trainees = 55 

minutes annually 

55 minutes × $35/hr = $32 annually 

55 minutes per hospice × 906 hospices = 

830.5 hours industry wide 

830.5 hours industry wide × $35/hr = 

$29,067.5 industry wide 

Finally, we require that each hospice 

revise its training program annually as 

needed. We estimate this task, 

completed by the trainer, to take 

approximately 4 hours annually per 

hospice. 

4 hours × $35/hr = $140 per hospice 

$140 per hospice × 906 hospices = $126,840 

industry wide 

(o) Standard: Death reporting 

requirements. This requirement applies 

to all deaths associated with the use of 

restraint or seclusion throughout the 

hospice inpatient facility. A hospice 

must report to CMS each death that 

occurs while a patient is in restraint or 

seclusion at the hospice inpatient 

facility, each death that occurs within 

24 hours after the patient has been 

removed from restraint or seclusion, and 

the hospice must report each death 

known to the hospice that occurs within 

1 week after restraint or seclusion where 

it is reasonable to assume that the use 

of restraint seclusion contributed 

directly or indirectly to a patient’s 

death. 

Each death referenced in this section 

must be reported to CMS by telephone 

no later than the close of business the 

next business day following knowledge 

of the patient’s death. We have no data 

from which to base an estimate on the 

number of deaths in hospice that may be 

related to the use of seclusion and 

restraint. However, based on a lack of 

family complaints to State agencies or 

CMS we believe such deaths to be a rare 

occurrence. Although our goal is to 

ensure the safe and appropriate use of 

seclusion and restraint and reduce 

associated deaths, we are aware that the 

actual number of reported deaths from 

seclusion and restraint may increase 

due to these reporting requirements. 

Thus, we anticipate there will be 

burden associated with this requirement 

due to the increased number of deaths 

that will be reported by the hospice 

industry. Given the lack of historical 

data, we assume the number of reports 

certainly should average less than one 

per hospice inpatient facility per year. 

Thus, we believe the impact associated 

with this provision (that is, making a 

telephone call and filling in a written 

report) to be negligible. 

TABLE 6.—HOSPICES THAT PROVIDE INPATIENT CARE DIRECTLY BURDEN ASSESSMENT (ONE TIME) 

Standard Time per 

average hospice 

Total time 

(hours) 

Cost per 

average 

hospice 

Total # of 

hospice 

inpatient 

facilities 

Total cost 

4 day trainer training ................................. 32 hours ................................................... 16,896 $3,280 906 $2,971,680 

Staff training program development ......... 40 hours ................................................... 21,120 1,400 906 1,268,400 

Staff training .............................................. 96 hours ................................................... 50,688 3,360 906 3,044.160 

Staff training records ................................. 55 minutes ................................................ 830.5 32 906 29,068 

Totals 1st year ................................... 169 hours ................................................. 89,535 $8,072 906 $7,313,308 


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TABLE 7.—HOSPICES THAT PROVIDE INPATIENT CARE DIRECTLY BURDEN ASSESSMENT (ANNUAL) 

Standard Time per average hospice Total time 

(hours) 

Total # of 

hospice inpatient facilities 

Cost per average hospice 

Total cost 

Staff training update ................................. 48 hours ................................................... 43,488 906 $1,680 $1,522,080 

Staff training records ................................. 55 minutes ................................................ 830.5 906 32 29,068 

Staff training program update ................... 4 hours ..................................................... 3,624 906 140 126,840 

Totals annually ................................... 53 hours ................................................... 47,943 906 1,852 1,677,988 

Hospices That Provide Hospice Care to 

Residents of a SNF/NF or ICF/MR 

(§ 418.112) 

(c) Standard: Written agreement. This 

rule establishes the minimum content of 

the written agreement that a hospice 

provider must have with a SNF/NF or 

ICF/MR if the hospice is caring for a 

resident of the facility. Establishing a 

contract with another provider to 

coordinate patient care is standard 

practice and does not pose a burden to 

a hospice that chooses to care for 

patients in these settings. 

(d) Standard: Hospice plan of care. 

This rule also includes several 

requirements for a patient’s plan of care 

that are in addition to the plan of care 

requirements in § 418.56(b), (c), and (d). 

If a hospice patient is a resident of a 

SNF/NF or ICF/MR, the hospice plan of 

care for the patient must reflect the 

participation of the hospice, the facility, 

the patient, and the family to the extent 

possible. In addition, the hospice plan 

of care must identify which provider 

(the hospice or the facility) is 

responsible for each activity identified 

in the plan of care. Any changes in the 

hospice plan of care must be discussed 

by the hospice with the patient or 

representative, and facility 

representatives. The hospice must 

approve all changes to the hospice plan 

of care before the changes are 

implemented. 

(e) Standard: Coordination of services. 

In addition to the plan of care 

requirements, we added a coordination 

of services standard. This new standard 

requires a hospice to designate an IDG 

member to coordinate a patient’s care 

with facility representatives, and 

communicate with facility 

representatives and other health care 

providers. The standard also requires 

the hospice IDG to communicate with 

all physicians involved in the care of a 

particular patient. These 

communication and coordination 

requirements are essential to providing 

safe, quality patient care. 

Any additional effort by hospice 

personnel to meet these requirements 

will, we believe, be offset by the 

reduced costs associated with the 

provision of more effective and efficient 

patient care. For example, by 

communicating and coordinating with a 

facility, a hospice can avoid situations 

where duplicative or contradictory 

orders are issued by the hospice 

physician and the facility physician. If 

duplicative orders are avoided, the 

hospice may be able to eliminate the 

duplicative service, thereby decreasing 

hospice expenditures while maintaining 

quality patient care. If contradictory 

orders are avoided, a hospice can avoid 

furnishing care that is rendered 

ineffective by the opposing care 

furnished by the facility. This, too, 

would decrease hospice expenditures, 

while at the same time improving the 

patient’s well being. 

Furthermore, the standard requires a 

hospice to provide a facility with 

specified information about the patient’s 

care. With the exception of the election 

and advanced directives forms, 

certification forms, and physician 

orders, all of the specified information 

is routinely provided to a patient’s 

caregiver(s). Since the facility is the 

caregiver, providing this information 

presents no burden to a hospice. We 

estimate that providing the facility with 

the election and advanced directives 

forms, certification forms, and physician 

orders for each patient would cost $2.33 

per patient, based on 10 minutes of an 

office employee’s time to fax the 

required documents to the facility. 

According to a March 2006 report from 

the Hospice Association of America 

(‘‘Hospice Facts & Statistics’’), 27.19 

percent of hospice patients nationwide 

resided in a SNF or other long term care 

facility. Therefore, we estimate that 

hospices will provide forms to SNFs/ 

NFs and ICFs/MR for 236,336 hospice 

patients residing in those facilities. We 

also estimate that the average hospice 

will provide care to 82 patients residing 

in a SNF/NF or ICF/MR (236,336 

patients nationwide / 2,872 hospices). 

82 patients in a facility × 10 minutes per 

patient to provide forms / 60 minutes = 

13.7 hours per hospice 

13.7 hours × office employee at $14/hr = 

$192 

10 minutes per patient × 236,336 patients 

nationwide / 60 minutes = 39,389 hours 

industry wide 

39,389 hours × $14/hr = $551,446 

$551,446/236,336 patients = $2.33 per 

patient 

(f) Standard: Orientation and training 

of staff. Finally, this rule requires a 

hospice to assure the orientation of 

SNF/NF and ICF/MR staff caring for 

hospice patients. Staff orientation must 

address the following topics: hospice 

philosophy; hospice policies regarding 

patient comfort methods, pain control, 

and symptom management; principles 

about death and dying; individual 

responses to death; patient rights; 

appropriate forms; and record keeping 

requirements. As many commenters 

noted, not every hospice will conduct 

the orientation itself because several 

hospices may serve residents of a single 

facility. Rather, many hospices will rely 

on the orientation already provided by 

another hospice. We do not know 

exactly how many hospices serve 

patients residing in a SNF/NF or ICF/ 

MR, or how many of those facilities are 

served by multiple hospices. Therefore, 

we cannot estimate the number of 

hospices that will conduct orientation 

sessions for SNF/NF and ICF/MR staff. 

We believe that any burden associated 

with orienting SNF/NF and ICF/MR will 

be minimal because hospices already 

orient patients and families/caregivers 

about many of the topics covered in this 

standard (that is, hospice philosophy 

and principles about death and dying). 

Since the SNF/NF or ICF/MR staff act as 

the patient’s care giver, orienting them 

would be very similar to orienting the 

patient’s family/caregiver. 


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TABLE 8.—HOSPICES THAT PROVIDE HOSPICE CARE TO RESIDENTS OF A SNF/NF OR ICF/MR BURDEN ASSESSMENT

Standard 

Time per 

patient 

(minutes) 

Time per 

average 

hospice 

(hours) 

Total time 

(hours) 

Cost per patient 

Cost per average hospice 

Total cost 

Providing forms to facility ................................................. 10 13.7 39,389 $2.33 $192 $551,446 

Totals ........................................................................ 10 13.7 39,389 2.33 192 551,446 

Personnel Qualifications (§ 418.114) 

(b) Standard: Personnel qualifications 

for certain disciplines and (c) Standard: 

Personnel qualifications when no State 

licensing, certification or registration 

requirements exist. The final rule 

establishes personnel qualifications for 

a variety of positions within a hospice. 

In particular, this rule establishes the 

personnel qualifications for hospice 

social workers. A social worker in a 

hospice must meet one of the following 

qualifications: 

• Have a Master of Social Work 

(MSW) degree from a school of social 

work accredited by the Council on 

Social Work Education and one year of 

experience in a health care setting; 

• Have a baccalaureate degree in 

social work (BSW) from a school of 

social work accredited by the Council 

on Social Work Education and one year 

of experience in a health care setting; or 

• Have a baccalaureate degree in 

psychology, sociology, or other field 

related to social work and at least one 

year of social work experience in a 

health care setting. 

If a hospice chooses to employ a 

social worker with a baccalaureate 

degree in social work, psychology, 

sociology, or other field related to social 

work, the services of the baccalaureate 

social worker (BSW) must be provided 

under the supervision of a social worker 

with an MSW from a school of social 

work accredited by the Council on 

Social Work Education and one year of 

experience in a health care setting. The 

MSW supervisor role is that of an active 

advisor, consulting with the BSW on 

assessing the needs of patients and 

families, developing and updating the 

social work portion of the plan of care, 

and delivering care to patients and 

families. This supervision may occur in 

person, over the telephone, through 

electronic communication, or any 

combination thereof. 

Social workers with a baccalaureate 

degree from a school of social work 

accredited by the Council on Social 

Work Education and who are employed 

by the hospice before the effective date 

of this final rule are exempted from the 

MSW supervision requirement. 

Therefore, if a hospice currently 

employs a BSW, it is not required to 

hire an MSW to supervise the BSW. If 

a hospice hires a new social worker 

with a baccalaureate degree and one 

year of experience in a health care 

setting, then the new baccalaureate 

social worker must be supervised by an 

MSW who has one year of experience in 

a health care setting. 

The impact associated with this social 

work qualification requirement is the 

expense of employing an MSW to 

supervise a BSW. By virtue of the 

personnel qualifications for social 

workers in hospice that have been in 

effect since 1983, all hospices are 

already required to have, at minimum, 

a social worker with a baccalaureate 

degree in social work from a school of 

social work accredited by the Council 

on Social Work Education. Therefore, 

all hospices should qualify for the 

exemption for MSW supervision 

described above. 

We are aware that many hospices 

already employ at least one MSW to 

provide direct patient care. In fact, 

when tracking the number of social 

workers serving hospice patients, the 

Hospice Association of America only 

reports the number of MSWs (6,177 in 

2005) working in the hospice industry, 

rather than the number of BSWs, 

precisely because an MSW is the 

standard level of care within hospice. 

Thus, we believe that the number of 

hospices currently solely relying on 

BSWs is relatively low. We do not know 

the precise number of hospices without 

an MSW. For purposes of this estimate 

only, we assume that 33 percent of 

hospices (944) rely solely on BSWs to 

provide social work services to patients. 

Of the 944 hospices without an MSW, 

we estimate that 25 percent will hire a 

social worker after the effective date of 

this rule (based on a 25% social worker 

turnover rate described in the ‘‘Hospice 

Salary & Benefits Report 2006–2007’’

issued by the Hospital & Healthcare 

Compensation Service and the ‘‘2002 

NHPCO National Data Set Summary 

Report’’). Therefore, an estimated 236 

hospices a year would be required to 

employ an MSW on a part-time basis to 

supervise the services of a BSW. 

Based on information from the 

‘‘Hospice Facts & Statistics 2006’’

report, the ‘‘Assuring the Sufficiency of 

Frontline Workforce: A National Study 

of Licensed Social Workers’’ report, and 

the ‘‘Licensed Social Workers in the 

United States, 2004’’ report, we estimate 

that the annual compensation for a fulltime, supervisory, MSW working in the 

hospice industry is $52,811 ($25/hr). 

Furthermore, we estimate that a hospice 

would employ an MSW for 10 hours a 

week to supervise the care and services 

provided by a BSW. As such, we 

estimate that an affected hospice would 

spend $13,000 annually to employ a 

part-time supervisory MSW to meet the 

requirements of this rule. 

10 hours per week for MSW at $25/hour × 

52 weeks = $13,000 

$13,000 × 236 hospices = $3,068,000 

10 hours per week × 52 weeks = 520 hours 

annually 

520 hours × 236 hospices = 122,720 hours 

industry wide 

(d) Standard: Criminal background 

checks. Additionally, this final rule 

requires a background check for each 

employee providing direct patient 

contact or accessing patient records. In 

2006, 40 states required criminal 

background checks for hospice 

employees. In these states, 

approximately 92,920 hospice 

employees already received a criminal 

background check, thus greatly reducing 

the overall potential burden. We 

estimate that hospices that have not 

previously performed background 

checks, accounting for approximately 

23,228 hospice employees, will each 

obtain 40 criminal background checks 

initially. Each background check request 

form will take 6 minutes to prepare and 

send, for a total of 4 hours per hospice 

the first year. For each year thereafter, 

we estimate that hospices in states that 

do not require background checks will 

complete background checks on 

approximately 10 new employees per 

year, for a total of 1 hour per affected 

hospice per year, and 582 hours 

nationally per year. 

116,148 employees in 2005 according to 

National Association for Home Care 2005 

Hospice Facts and Statistics/50 states = 

2,323 average number of employees per 


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state × 40 states already requiring 

background checks = 92,920 already 

required to have background checks 

116,148 total employees ¥ 92,920 already 

required to have background checks = 

23,228 employees not already required to 

have background checks 

116,148 employees/2,872 hospices in 2005 = 

40 employees per average hospice 

40 employees × 6 minutes per check = 4 

hours per hospice 

23,228 employees × 6 minutes per check = 

2,323 hours nationwide 

2,872 hospices nationwide/50 states = 57.4 

average number of hospices per state × 10 

states not currently requiring background 

checks = 574 affected hospices. 

574 affected hospice × 10 new employees 

requiring background checks per year × 6 

minutes per check/60 minutes = 96 hours 

We researched a wide variety of 

agencies that perform criminal 

background checks and determined that 

the average cost for an individual 

background check is $17.00 plus $1 for 

6 minutes of clerical time per 

background check to process the paper 

work. We understand that some 

agencies or states may charge more or 

less than this fee to conduct a 

background check. In addition, some 

hospices may choose to conduct more 

extensive background checks that may 

cost more. 

We are not requiring that hospices 

conduct a specific type of background 

check (that is, State or Federal) or obtain 

such a check from a specific source (that 

is, State police or FBI). The flexibility of 

the requirement will allow hospices to 

identify the most cost efficient method 

of meeting the requirement. 

$18 per check × 40 employees requiring 

checks = $720 

$18 per check × 23,228 employees not 

already requiring checks = $418,104 

$18 per check × 10 new employees requiring 

checks = $180.00 per hospice 

$180 per hospice × 574 affected hospices = 

$103,320 

TABLE 9.—PERSONNEL QUALIFICATIONS BURDEN ASSESSMENT

Standard 

Time per 

average 

hospice 

Total industry time 

Total # 

of affected 

hospices 

Total cost per average 

hospice Total industry cost 

MSW supervisor .............. 520 hours ...................... 122,720 hours ............... 236 ..... $13,000 .......................... $3,068,000 

Criminal background 

check.

1st year—4 hours—annually 1 hour.1st year—2,323 hours—

annually 96 hours.

574 ..... 1st year—$720—annually $180.1st year—$418,104—

annually $103,320 

Total ......................... 1st year—524 hours—

Annually 521 hours.

1st year—125,043 

hours—Annually 

122,816 hours.

N/A ..... 1st year—$13,720—Annually $13,180.1st Year—$3,486,104—

Annually $3,171,320 

Compliance with Federal, State, and 

Local Laws and Regulations Related to 

the Health and Ssafety of Patients 

(§ 418.116) 

This final condition of participation 

requires that the hospice operate and 

furnish services in compliance with 

applicable Federal, State, and local laws 

and regulations related to the health and 

safety of patients. We do not believe this 

will add any regulatory burden, since 

this section of the final rule reflects 

current requirements and contemporary 

standard practice in hospice. 

TABLE 10.—TOTAL BURDEN ASSESSMENT FOR ALL REQUIREMENTS IN THE FIRST YEAR COP 

Total time per 

patient 

Total time per 

average 

hospice 

Total industry time 

Total cost 

per 

patient 

Total cost per 

average hospice Total industry cost 

Patient rights ........... 5 minutes ................ 48.25 hours ............. 138,489 hours ......... $3 ........... 2,012 4,649,379 

QAPI ........................ N/A .......................... 241 hours ................ 692,152 hours ......... N/A ......... 7,544 21,666,368 

Hospice aide ............ N/A .......................... 5 minutes ................ 239 hours ................ N/A ......... 1.17 3,360 

Drugs and DME ....... 5 minutes ................ 25.25 hours ............. 72,524 hours ........... 2.25 ........ 681.75 1,958,610 

Inpatient care directly.N/A .......................... 169 hours ................ 89,535 hours ........... N/A ......... 8,072 7,313,308 

SNF/NF or ICF/MR .. 10 minutes .............. 13.7 hours ............... 39,389 hours ........... 2.33 ........ 192 551,446 

Personnel qualifications.N/A .......................... 524 hours ................ 125,043 hours ......... N/A ......... 13,720 3,486,104 

Total ................. 20 minutes .............. 1,021.3 hours .......... 1,157,371 hours ...... 7.58 ........ *32,222.92 40,754,007 

* Includes cost of operating an inpatient facility and hiring a MSW supervisor. Most hospices will not incur these expenses. Therefore, this rule 

will cost most hospices $11,151 in the first year. 

We believe that the burden associated 

with this rule is reasonable and 

necessary to ensure the health and 

safety of all hospice patients. In 

accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and budget. 

2. Effects on other providers: 

Effects on other providers: We do not 

expect this regulation to affect any other 

provider. 

List of Subjects in 42 CFR Part 418 

Health Facilities, Hospice Care, 

Medicare, Incorporation by reference, 

Reporting and record keeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

Chapter IV as set forth below: 


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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). 

Subpart A—General Provision and 

Definitions 

■ 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 amended by: 

■ a. Revising the definitions of 

‘‘Bereavement counseling,’’

‘‘Employee,’’ ‘‘Hospice,’’ ‘‘Physician,’’

‘‘Representative,’’ and ‘‘Terminally ill’’; 

and 

■ b. Adding the definitions of ‘‘Clinical 

note,’’ ‘‘Comprehensive assessment,’’

‘‘Dietary counseling,’’ ‘‘Hospice care,’’

‘‘Initial assessment,’’ ‘‘Licensed 

professional’’ ‘‘Multiple location,’’

‘‘Palliative care,’’ ‘‘Physician designee,’’

‘‘Restraint,’’ and ‘‘Seclusion.’’

The revisions and additions read as 

follows: 

§ 418.3 Definitions. 

For the purposes of this part—

* * * * * 

Bereavement counseling means 

emotional, psychosocial, and spiritual 

support and services provided before 

and after the death of the patient to 

assist with issues related to grief, loss, 

and adjustment. 

* * * * * 

Clinical note means a notation of a 

contact with the patient and/or the 

family that is written and dated by any 

person providing services and that 

describes signs and symptoms, 

treatments and medications 

administered, including the patient’s 

reaction and/or response, and any 

changes in physical, emotional, 

psychosocial or spiritual condition 

during a given period of time. 

Comprehensive assessment means a 

thorough evaluation of the patient’s 

physical, psychosocial, emotional and 

spiritual status related to the terminal 

illness and related conditions. This 

includes a thorough evaluation of the 

caregiver’s and family’s willingness and 

capability to care for the patient. 

Dietary counseling means education 

and interventions provided to the 

patient and family regarding appropriate 

nutritional intake as the patient’s 

condition progresses. Dietary counseling 

is provided by qualified individuals, 

which may include a registered nurse, 

dietitian or nutritionist, when identified 

in the patient’s plan of care. 

Employee means a person who: (1) 

Works for the hospice and for whom the 

hospice is required to issue a W–2 form 

on his or her behalf; (2) if the hospice 

is a subdivision of an agency or 

organization, an employee of the agency 

or organization who is assigned to the 

hospice; or (3) is a volunteer under the 

jurisdiction of the hospice. 

Hospice means a public agency or 

private organization or subdivision of 

either of these that is primarily engaged 

in providing hospice care as defined in 

this section. 

Hospice care means a comprehensive 

set of services described in 1861(dd)(1) 

of the Act, identified and coordinated 

by an interdisciplinary group to provide 

for the physical, psychosocial, spiritual, 

and emotional needs of a terminally ill 

patient and/or family members, as 

delineated in a specific patient plan of 

care. 

Initial assessment means an 

evaluation of the patient’s physical, 

psychosocial and emotional status 

related to the terminal illness and 

related conditions to determine the 

patient’s immediate care and support 

needs. 

Licensed professional means a person 

licensed to provide patient care services 

by the State in which services are 

delivered. 

Multiple location means a Medicareapproved location from which the 

hospice provides the same full range of 

hospice care and services that is 

required of the hospice issued the 

certification number. A multiple 

location must meet all of the conditions 

of participation applicable to hospices. 

Palliative care means patient and 

family-centered care that optimizes 

quality of life by anticipating, 

preventing, and treating suffering. 

Palliative care throughout the 

continuum of illness involves 

addressing physical, intellectual, 

emotional, social, and spiritual needs 

and to facilitate patient autonomy, 

access to information, and choice. 

Physician means an individual who 

meets the qualifications and conditions 

as defined in section 1861(r) of the Act 

and implemented at § 410.20 of this 

chapter. 

Physician designee means a doctor of 

medicine or osteopathy designated by 

the hospice who assumes the same 

responsibilities and obligations as the 

medical director when the medical 

director is not available. 

Representative means an individual 

who has the authority under State law 

(whether by statute or pursuant to an 

appointment by the courts of the State) 

to authorize or terminate medical care 

or to elect or revoke the election of 

hospice care on behalf of a terminally ill 

patient who is mentally or physically 

incapacitated. This may include a legal 

guardian. 

Restraint means—(1) Any manual 

method, physical or mechanical device, 

material, or equipment that immobilizes 

or reduces the ability of a patient to 

move his or her arms, legs, body, or 

head freely, not including devices, such 

as orthopedically prescribed devices, 

surgical dressings or bandages, 

protective helmets, or other methods 

that involve the physical holding of a 

patient for the purpose of conducting 

routine physical examinations or tests, 

or to protect the patient from falling out 

of bed, or to permit the patient to 

participate in activities without the risk 

of physical harm (this does not include 

a physical escort); or 

(2) A drug or medication when it is 

used as a restriction to manage the 

patient’s behavior or restrict the 

patient’s freedom of movement and is 

not a standard treatment or dosage for 

the patient’s condition. 

Seclusion means the involuntary 

confinement of a patient alone in a room 

or an area from which the patient is 

physically prevented from leaving. 

Terminally ill means that the 

individual has a medical prognosis that 

his or her life expectancy is 6 months 

or less if the illness runs its normal 

course. 

■ 4. Subparts C and D are revised and 

Subpart E is removed and reserved to 

read as follows: 

Subpart C—Conditions of Participation: 

Patient Care 

Sec. 

418.52 Condition of participation: Patient’s 

rights. 

418.54 Condition of participation: Initial 

and comprehensive assessment of the 

patient. 


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418.56 Condition of participation: 

Interdisciplinary group, care planning, 

and coordination of services. 

418.58 Condition of participation: Quality 

assessment and performance 

improvement. 

418.60 Condition of participation: Infection 

control. 

418.62 Condition of participation: Licensed 

professional services. 

CORE SERVICES 

418.64 Condition of participation: Core 

services. 

418.66 Condition of participation: Nursing 

services waiver of requirement that 

substantially all nursing services be 

routinely provided directly by a hospice. 

NON-CORE SERVICES 

418.70 Condition of participation: 

Furnishing of non-core services. 

418.72 Condition of participation: Physical 

therapy, occupational therapy, and 

speech-language pathology. 

418.74 Waiver of requirement—Physical 

therapy, occupational therapy, speechlanguage pathology and dietary 

counseling. 

418.76 Condition of participation: Hospice 

aide and homemaker services. 

418.78 Condition of participation: 

Volunteers. 

Subpart D—Conditions of Participation: 

Organizational Environment 

418.100 Condition of participation: 

Organization and administration of 

services. 

418.102 Condition of participation: Medical 

director. 

418.104 Condition of participation: Clinical 

records. 

418.106 Condition of participation: Drugs 

and biologicals, medical supplies, and 

durable medical equipment. 

418.108 Condition of participation: 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 or ICF/MR. 

418.114 Condition of participation: 

Personnel qualifications. 

418.116 Condition of participation: 

Compliance with Federal, State, and 

local laws and regulations related to the 

health and safety of patients. 

Subpart E—[Removed and Reserved] 

Subpart C—Conditions of 

Participation: Patient Care 

§ 418.52 Condition of participation: 

Patient’s rights. 

The patient has the right to be 

informed of his or her rights, and the 

hospice must protect and promote the 

exercise of these rights. 

(a) Standard: Notice of rights and 

responsibilities. 

(1) During the initial assessment visit 

in advance of furnishing care the 

hospice must provide the patient or 

representative with verbal (meaning 

spoken) and written notice of the 

patient’s rights and responsibilities in a 

language and manner that the patient 

understands. 

(2) The hospice must comply with the 

requirements of subpart I of part 489 of 

this chapter regarding advance 

directives. The hospice must inform and 

distribute written information to the 

patient concerning its policies on 

advance directives, including a 

description of applicable State law. 

(3) The hospice must obtain the 

patient’s or representative’s signature 

confirming that he or she has received 

a copy of the notice of rights and 

responsibilities. 

(b) Standard: Exercise of rights and 

respect for property and person. (1) The 

patient has the right: 

(i) To exercise his or her rights as a 

patient of the hospice; 

(ii) To have his or her property and 

person treated with respect; 

(iii) To voice grievances regarding 

treatment or care that is (or fails to be) 

furnished and the lack of respect for 

property by anyone who is furnishing 

services on behalf of the hospice; and 

(iv) To not be subjected to 

discrimination or reprisal for exercising 

his or her rights. 

(2) If a patient has been adjudged 

incompetent under state law by a court 

of proper jurisdiction, the rights of the 

patient are exercised by the person 

appointed pursuant to state law to act 

on the patient’s behalf. 

(3) If a state court has not adjudged a 

patient incompetent, any legal 

representative designated by the patient 

in accordance with state law may 

exercise the patient’s rights to the extent 

allowed by state law. 

(4) The hospice must: 

(i) Ensure that all alleged violations 

involving mistreatment, neglect, or 

verbal, mental, sexual, and physical 

abuse, including injuries of unknown 

source, and misappropriation of patient 

property by anyone furnishing services 

on behalf of the hospice, are reported 

immediately by hospice employees and 

contracted staff to the hospice 

administrator; 

(ii) Immediately investigate all alleged 

violations involving anyone furnishing 

services on behalf of the hospice and 

immediately take action to prevent 

further potential violations while the 

alleged violation is being verified. 

Investigations and/or documentation of 

all alleged violations must be conducted 

in accordance with established 

procedures; 

(iii) Take appropriate corrective 

action in accordance with state law if 

the alleged violation is verified by the 

hospice administration or an outside 

body having jurisdiction, such as the 

State survey agency or local law 

enforcement agency; and 

(iv) Ensure that verified violations are 

reported to State and local bodies 

having jurisdiction (including to the 

State survey and certification agency) 

within 5 working days of becoming 

aware of the violation. 

(c) Standard: Rights of the patient. 

The patient has a right to the following: 

(1) Receive effective pain management 

and symptom control from the hospice 

for conditions related to the terminal 

illness; 

(2) Be involved in developing his or 

her hospice plan of care; 

(3) Refuse care or treatment; 

(4) Choose his or her attending 

physician; 

(5) Have a confidential clinical record. 

Access to or release of patient 

information and clinical records is 

permitted in accordance with 45 CFR 

parts 160 and 164. 

(6) Be free from mistreatment, neglect, 

or verbal, mental, sexual, and physical 

abuse, including injuries of unknown 

source, and misappropriation of patient 

property; 

(7) Receive information about the 

services covered under the hospice 

benefit; 

(8) Receive information about the 

scope of services that the hospice will 

provide and specific limitations on 

those services. 

§ 418.54 Condition of participation: Initial 

and comprehensive assessment of the 

patient. 

The hospice must conduct and 

document in writing a patient-specific 

comprehensive assessment that 

identifies the patient’s need for hospice 

care and services, and the patient’s need 

for physical, psychosocial, emotional, 

and spiritual care. This assessment 

includes all areas of hospice care related 

to the palliation and management of the 

terminal illness and related conditions. 

(a) Standard: Initial assessment. The 

hospice registered nurse must complete 

an initial assessment within 48 hours 

after the election of hospice care in 

accordance with § 418.24 is complete 

(unless the physician, patient, or 

representative requests that the initial 

assessment be completed in less than 48 

hours.) 

(b) Standard: Timeframe for 

completion of the comprehensive 

assessment. The hospice 

interdisciplinary group, in consultation 

with the individual’s attending 

physician (if any), must complete the 

comprehensive assessment no later than 


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5 calendar days after the election of 

hospice care in accordance with 

§ 418.24. 

(c) Standard: Content of the 

comprehensive assessment. 

The comprehensive assessment must 

identify the physical, psychosocial, 

emotional, and spiritual needs related to 

the terminal illness that must be 

addressed in order to promote the 

hospice patient’s well-being, comfort, 

and dignity throughout the dying 

process. The comprehensive assessment 

must take into consideration the 

following factors: 

(1) The nature and condition causing 

admission (including the presence or 

lack of objective data and subjective 

complaints). 

(2) Complications and risk factors that 

affect care planning. 

(3) Functional status, including the 

patient’s ability to understand and 

participate in his or her own care. 

(4) Imminence of death. 

(5) Severity of symptoms. 

(6) Drug profile. A review of all of the 

patient’s prescription and over-thecounter drugs, herbal remedies and 

other alternative treatments that could 

affect drug therapy. This includes, but is 

not limited to, identification of the 

following: 

(i) Effectiveness of drug therapy. 

(ii) Drug side effects. 

(iii) Actual or potential drug 

interactions. 

(iv) Duplicate drug therapy. 

(v) Drug therapy currently associated 

with laboratory monitoring. 

(7) Bereavement. An initial 

bereavement assessment of the needs of 

the patient’s family and other 

individuals focusing on the social, 

spiritual, and cultural factors that may 

impact their ability to cope with the 

patient’s death. Information gathered 

from the initial bereavement assessment 

must be incorporated into the plan of 

care and considered in the bereavement 

plan of care. 

(8) The need for referrals and further 

evaluation by appropriate health 

professionals. 

(d) Standard: Update of the 

comprehensive assessment. 

The update of the comprehensive 

assessment must be accomplished by 

the hospice interdisciplinary group (in 

collaboration with the individual’s 

attending physician, if any) and must 

consider changes that have taken place 

since the initial assessment. It must 

include information on the patient’s 

progress toward desired outcomes, as 

well as a reassessment of the patient’s 

response to care. The assessment update 

must be accomplished as frequently as 

the condition of the patient requires, but 

no less frequently than every 15 days. 

(e) Standard: Patient outcome 

measures. (1) The comprehensive 

assessment must include data elements 

that allow for measurement of 

outcomes. The hospice must measure 

and document data in the same way for 

all patients. The data elements must 

take into consideration aspects of care 

related to hospice and palliation. 

(2) The data elements must be an 

integral part of the comprehensive 

assessment and must be documented in 

a systematic and retrievable way for 

each patient. The data elements for each 

patient must be used in individual 

patient care planning and in the 

coordination of services, and must be 

used in the aggregate for the hospice’s 

quality assessment and performance 

improvement program. 

§ 418.56 Condition of participation: 

Interdisciplinary group, care planning, and 

coordination of services. 

The hospice must designate an 

interdisciplinary group or groups as 

specified in paragraph (a) of this section 

which, in consultation with the 

patient’s attending physician, must 

prepare a written plan of care for each 

patient. The plan of care must specify 

the hospice care and services necessary 

to meet the patient and family-specific 

needs identified in the comprehensive 

assessment as such needs relate to the 

terminal illness and related conditions. 

(a) Standard: Approach to service 

delivery. (1) The hospice must designate 

an interdisciplinary group or groups 

composed of individuals who work 

together to meet the physical, medical, 

psychosocial, emotional, and spiritual 

needs of the hospice patients and 

families facing terminal illness and 

bereavement. Interdisciplinary group 

members must provide the care and 

services offered by the hospice, and the 

group, in its entirety, must supervise the 

care and services. The hospice must 

designate a registered nurse that is a 

member of the interdisciplinary group 

to provide coordination of care and to 

ensure continuous assessment of each 

patient’s and family’s needs and 

implementation of the interdisciplinary 

plan of care. The interdisciplinary group 

must include, but is not limited to, 

individuals who are qualified and 

competent to practice in the following 

professional roles: 

(i) A doctor of medicine or osteopathy 

(who is an employee or under contract 

with the hospice). 

(ii) A registered nurse. 

(iii) A social worker. 

(iv) A pastoral or other counselor. 

(2) If the hospice has more than one 

interdisciplinary group, it must identify 

a specifically designated 

interdisciplinary group to establish 

policies governing the day-to-day 

provision of hospice care and services. 

(b) Standard: Plan of care. All hospice 

care and services furnished to patients 

and their families must follow an 

individualized written plan of care 

established by the hospice 

interdisciplinary group in collaboration 

with the attending physician (if any), 

the patient or representative, and the 

primary caregiver in accordance with 

the patient’s needs if any of them so 

desire. The hospice must ensure that 

each patient and the primary care 

giver(s) receive education and training 

provided by the hospice as appropriate 

to their responsibilities for the care and 

services identified in the plan of care. 

(c) Standard: Content of the plan of 

care. The hospice must develop an 

individualized written plan of care for 

each patient. The plan of care must 

reflect patient and family goals and 

interventions based on the problems 

identified in the initial, comprehensive, 

and updated comprehensive 

assessments. The plan of care must 

include all services necessary for the 

palliation and management of the 

terminal illness and related conditions, 

including the following: 

(1) Interventions to manage pain and 

symptoms. 

(2) A detailed statement of the scope 

and frequency of services necessary to 

meet the specific patient and family 

needs. 

(3) Measurable outcomes anticipated 

from implementing and coordinating 

the plan of care. 

(4) Drugs and treatment necessary to 

meet the needs of the patient. 

(5) Medical supplies and appliances 

necessary to meet the needs of the 

patient. 

(6) The interdisciplinary group’s 

documentation of the patient’s or 

representative’s level of understanding, 

involvement, and agreement with the 

plan of care, in accordance with the 

hospice’s own policies, in the clinical 

record. 

(d) Standard: Review of the plan of 

care. The hospice interdisciplinary 

group (in collaboration with the 

individual’s attending physician, if any) 

must review, revise and document the 

individualized plan as frequently as the 

patient’s condition requires, but no less 

frequently than every 15 calendar days. 

A revised plan of care must include 

information from the patient’s updated 

comprehensive assessment and must 

note the patient’s progress toward 

outcomes and goals specified in the 

plan of care. 

(e) Standard: Coordination of services. 

The hospice must develop and maintain 


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a system of communication and 

integration, in accordance with the 

hospice’s own policies and procedures, 

to—

(1) Ensure that the interdisciplinary 

group maintains responsibility for 

directing, coordinating, and supervising 

the care and services provided. 

(2) Ensure that the care and services 

are provided in accordance with the 

plan of care. 

(3) Ensure that the care and services 

provided are based on all assessments of 

the patient and family needs. 

(4) Provide for and ensure the ongoing 

sharing of information between all 

disciplines providing care and services 

in all settings, whether the care and 

services are provided directly or under 

arrangement. 

(5) Provide for an ongoing sharing of 

information with other non-hospice 

healthcare providers furnishing services 

unrelated to the terminal illness and 

related conditions. 

§ 418.58 Condition of participation: Quality 

assessment and performance improvement. 

The hospice must develop, 

implement, and maintain an effective, 

ongoing, hospice-wide data-driven 

quality assessment and performance 

improvement program. The hospice’s 

governing body must ensure that the 

program: Reflects the complexity of its 

organization and services; involves all 

hospice services (including those 

services furnished under contract or 

arrangement); focuses on indicators 

related to improved palliative outcomes; 

and takes actions to demonstrate 

improvement in hospice performance. 

The hospice must maintain 

documentary evidence of its quality 

assessment and performance 

improvement program and be able to 

demonstrate its operation to CMS. 

(a) Standard: Program scope. (1) The 

program must at least be capable of 

showing measurable improvement in 

indicators related to improved palliative 

outcomes and hospice services. 

(2) The hospice must measure, 

analyze, and track quality indicators, 

including adverse patient events, and 

other aspects of performance that enable 

the hospice to assess processes of care, 

hospice services, and operations. 

(b) Standard: Program data. (1) The 

program must use quality indicator data, 

including patient care, and other 

relevant data, in the design of its 

program. 

(2) The hospice must use the data 

collected to do the following: 

(i) Monitor the effectiveness and 

safety of services and quality of care. 

(ii) Identify opportunities and 

priorities for improvement. 

(3) The frequency and detail of the 

data collection must be approved by the 

hospice’s governing body. 

(c) Standard: Program activities. (1) 

The hospice’s performance 

improvement activities must: 

(i) Focus on high risk, high volume, 

or problem-prone areas. 

(ii) Consider incidence, prevalence, 

and severity of problems in those areas. 

(iii) Affect palliative outcomes, 

patient safety, and quality of care. 

(2) Performance improvement 

activities must track adverse patient 

events, analyze their causes, and 

implement preventive actions and 

mechanisms that include feedback and 

learning throughout the hospice. 

(3) The hospice must take actions 

aimed at performance improvement 

and, after implementing those actions, 

the hospice must measure its success 

and track performance to ensure that 

improvements are sustained. 

(d) Standard: Performance 

improvement projects. Beginning 

February 2, 2009 hospices must 

develop, implement, and evaluate 

performance improvement projects. 

(1) The number and scope of distinct 

performance improvement projects 

conducted annually, based on the needs 

of the hospice’s population and internal 

organizational needs, must reflect the 

scope, complexity, and past 

performance of the hospice’s services 

and operations. 

(2) The hospice must document what 

performance improvement projects are 

being conducted, the reasons for 

conducting these projects, and the 

measurable progress achieved on these 

projects. 

(e) Standard: Executive 

responsibilities. The hospice’s 

governing body is responsible for 

ensuring the following: 

(1) That an ongoing program for 

quality improvement and patient safety 

is defined, implemented, and 

maintained, and is evaluated annually. 

(2) That the hospice-wide quality 

assessment and performance 

improvement efforts address priorities 

for improved quality of care and patient 

safety, and that all improvement actions 

are evaluated for effectiveness. 

(3) That one or more individual(s) 

who are responsible for operating the 

quality assessment and performance 

improvement program are designated. 

§ 418.60 Condition of participation: 

Infection control. 

The hospice must maintain and 

document an effective infection control 

program that protects patients, families, 

visitors, and hospice personnel by 

preventing and controlling infections 

and communicable diseases. 

(a) Standard: Prevention. The hospice 

must follow accepted standards of 

practice to prevent the transmission of 

infections and communicable diseases, 

including the use of standard 

precautions. 

(b) Standard: Control. The hospice 

must maintain a coordinated 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 the following: 

(i) A method of identifying infectious 

and communicable disease problems; 

and 

(ii) A plan for implementing the 

appropriate actions that are expected to 

result in improvement and disease 

prevention. 

(c) Standard: Education. The hospice 

must provide infection control 

education to employees, contracted 

providers, patients, and family members 

and other caregivers. 

§ 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 hospice 

care, in accordance with current 

professional standards and practice, 

including participating in ongoing 

interdisciplinary comprehensive 

assessments, developing and evaluating 

the plan of care, and contributing to 

patient and family counseling and 

education; and 

(c) Licensed professionals must 

participate in the hospice’s quality 

assessment and performance 

improvement program and hospice 

sponsored in-service training. 

Core Services 

§ 418.64 Condition of participation: Core 

services. 

A hospice must routinely provide 

substantially all core services directly 

by hospice employees. These services 

must be provided in a manner 

consistent with acceptable standards of 

practice. These services include nursing 

services, medical social services, and 

counseling. The hospice may contract 

for physician services as specified in 

paragraph (a) of this section. A hospice 


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may use contracted staff, if necessary, to 

supplement hospice employees in order 

to meet the needs of patients under 

extraordinary or other non-routine 

circumstances. A hospice may also enter 

into a written arrangement with another 

Medicare certified hospice program for 

the provision of core services to 

supplement hospice employee/staff to 

meet the needs of patients. 

Circumstances under which a hospice 

may enter into a written arrangement for 

the provision of core services include: 

Unanticipated periods of high patient 

loads, staffing shortages due to illness or 

other short-term temporary situations 

that interrupt patient care; and 

temporary travel of a patient outside of 

the hospice’s service area. 

(a) Standard: Physician services. The 

hospice medical director, physician 

employees, and contracted physician(s) 

of the hospice, in conjunction with the 

patient’s attending physician, are 

responsible for the palliation and 

management of the terminal illness and 

conditions related to the terminal 

illness. 

(1) All physician employees and those 

under contract, must function under the 

supervision of the hospice medical 

director. 

(2) All physician employees and those 

under contract shall meet this 

requirement by either providing the 

services directly or through 

coordinating patient care with the 

attending physician. 

(3) If the attending physician is 

unavailable, the medical director, 

contracted physician, and/or hospice 

physician employee is responsible for 

meeting the medical needs of the 

patient. 

(b) Standard: Nursing services. (1) 

The hospice must provide nursing care 

and services by or under the supervision 

of a registered nurse. Nursing services 

must ensure that the nursing needs of 

the patient are met as identified in the 

patient’s initial assessment, 

comprehensive assessment, and 

updated assessments. 

(2) If State law permits registered 

nurses to see, treat, and write orders for 

patients, then registered nurses may 

provide services to beneficiaries 

receiving hospice care. 

(3) Highly specialized nursing 

services that are provided so 

infrequently that the provision of such 

services by direct hospice employees 

would be impracticable and 

prohibitively expensive, may be 

provided under contract. 

(c) Standard: Medical social services. 

Medical social services must be 

provided by a qualified social worker, 

under the direction of a physician. 

Social work services must be based on 

the patient’s psychosocial assessment 

and the patient’s and family’s needs and 

acceptance of these services. 

(d) Standard: Counseling services. 

Counseling services must be available to 

the patient and family to assist the 

patient and family in minimizing the 

stress and problems that arise from the 

terminal illness, related conditions, and 

the dying process. Counseling services 

must include, but are not limited to, the 

following: 

(1) Bereavement counseling. The 

hospice must: 

(i) Have an organized program for the 

provision of bereavement services 

furnished under the supervision of a 

qualified professional with experience 

or education in grief or loss counseling. 

(ii) Make bereavement services 

available to the family and other 

individuals in the bereavement plan of 

care up to 1 year following the death of 

the patient. Bereavement counseling 

also extends to residents of a SNF/NF or 

ICF/MR when appropriate and 

identified in the bereavement plan of 

care. 

(iii) Ensure that bereavement services 

reflect the needs of the bereaved. 

(iv) Develop a bereavement plan of 

care that notes the kind of bereavement 

services to be offered and the frequency 

of service delivery. A special coverage 

provision for bereavement counseling is 

specified in § 418.204(c). 

(2) Dietary counseling. Dietary 

counseling, when identified in the plan 

of care, must be performed by a 

qualified individual, which include 

dietitians as well as nurses and other 

individuals who are able to address and 

assure that the dietary needs of the 

patient are met. 

(3) Spiritual counseling. The hospice 

must: 

(i) Provide an assessment of the 

patient’s and family’s spiritual needs. 

(ii) Provide spiritual counseling to 

meet these needs in accordance with the 

patient’s and family’s acceptance of this 

service, and in a manner consistent with 

patient and family beliefs and desires. 

(iii) Make all reasonable efforts to 

facilitate visits by local clergy, pastoral 

counselors, or other individuals who 

can support the patient’s spiritual needs 

to the best of its ability. 

(iv) Advise the patient and family of 

this service. 

§ 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 non-urbanized area. The 

location of a hospice that operates in 

several areas is considered to be the 

location of its central office. The 

hospice must provide evidence to CMS 

that it has made a good faith effort to 

hire a sufficient number of nurses to 

provide services. CMS may waive the 

requirement that nursing services be 

furnished by employees based on the 

following criteria: 

(1) The location of the hospice’s 

central office is in a non-urbanized area 

as determined by the Bureau of the 

Census. 

(2) There is evidence that a hospice 

was operational on or before January 1, 

1983 including the following: 

(i) Proof that the organization was 

established to provide hospice services 

on or before January 1, 1983. 

(ii) Evidence that hospice-type 

services were furnished to patients on or 

before January 1, 1983. 

(iii) Evidence that hospice care was a 

discrete activity rather than an aspect of 

another type of provider’s patient care 

program on or before January 1, 1983. 

(3) By virtue of the following evidence 

that a hospice made a good faith effort 

to hire nurses: 

(i) Copies of advertisements in local 

newspapers that demonstrate 

recruitment efforts. 

(ii) Job descriptions for nurse 

employees. 

(iii) Evidence that salary and benefits 

are competitive for the area. 

(iv) Evidence of any other recruiting 

activities (for example, recruiting efforts 

at health fairs and contacts with nurses 

at other providers in the area). 

(b) Any waiver request is deemed to 

be granted unless it is denied within 60 

days after it is received. 

(c) Waivers will remain effective for 1 

year at a time from the date of the 

request. 

(d) If a hospice wishes to receive a 1- 

year extension, it must submit a request 

to CMS before the expiration of the 

waiver period, and certify that the 

conditions under which it originally 

requested the initial waiver have not 

changed since the initial waiver was 

granted. 

Non-Core Services 

§ 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. 


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§ 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 the following: 

(i) Copies of advertisements in local 

newspapers that demonstrate 

recruitment efforts. 

(ii) Physical therapy, occupational 

therapy, speech-language pathology, 

and dietary counselor job descriptions. 

(iii) Evidence that salary and benefits 

are competitive for the area. 

(iv) Evidence of any other recruiting 

activities (for example, recruiting efforts 

at health fairs and contact discussions 

with physical therapy, occupational 

therapy, speech-language pathology, 

and dietary counseling service providers 

in the area). 

(b) Any waiver request is deemed to 

be granted unless it is denied within 60 

days after it is received. 

(c) An initial waiver will remain 

effective for 1 year at a time from the 

date of the request. 

(d) If a hospice wishes to receive a 1- 

year extension, it must submit a request 

to CMS before the expiration of the 

waiver period and certify that 

conditions under which it originally 

requested the waiver have not changed 

since the initial waiver was granted. 

§ 418.76 Condition of participation: 

Hospice aide and homemaker services. 

All hospice aide services must be 

provided by individuals who meet the 

personnel requirements specified in 

paragraph (a) of this section. 

Homemaker services must be provided 

by individuals who meet the personnel 

requirements specified in paragraph (j) 

of this section. 

(a) Standard: Hospice aide 

qualifications. (1) A qualified hospice 

aide is a person who has successfully 

completed one of the following: 

(i) A training program and 

competency evaluation as specified in 

paragraphs (b) and (c) of this section 

respectively. 

(ii) A competency evaluation program 

that meets the requirements of 

paragraph (c) of this section. 

(iii) A nurse aide training and 

competency evaluation program 

approved by the State as meeting the 

requirements of § 483.151 through 

§ 483.154 of this chapter, and is 

currently listed in good standing on the 

State nurse aide registry. 

(iv) A State licensure program that 

meets the requirements of paragraphs 

(b) and (c) of this section. 

(2) A hospice aide is not considered 

to have completed a program, as 

specified in paragraph (a)(1) of this 

section, if, since the individual’s most 

recent completion of the program(s), 

there has been a continuous period of 24 

consecutive months during which none 

of the services furnished by the 

individual as described in § 409.40 of 

this chapter were for compensation. If 

there has been a 24-month lapse in 

furnishing services, the individual must 

complete another program, as specified 

in paragraph (a)(1) of this section, before 

providing services. 

(b) Standard: Content and duration of 

hospice aide classroom and supervised 

practical training. (1) Hospice aide 

training must include classroom and 

supervised practical training in a 

practicum laboratory or other setting in 

which the trainee demonstrates 

knowledge while performing tasks on an 

individual under the direct supervision 

of a registered nurse, or a licensed 

practical nurse, who is under the 

supervision of a registered nurse. 

Classroom and supervised practical 

training combined must total at least 75 

hours. 

(2) A minimum of 16 hours of 

classroom training must precede a 

minimum of l6 hours of supervised 

practical training as part of the 75 hours. 

(3) A hospice aide training program 

must address each of the following 

subject areas: 

(i) Communication skills, including 

the ability to read, write, and verbally 

report clinical information to patients, 

care givers, and other hospice staff. 

(ii) Observation, reporting, and 

documentation of patient status and the 

care or service furnished. 

(iii) Reading and recording 

temperature, pulse, and respiration. 

(iv) Basic infection control 

procedures. 

(v) Basic elements of body functioning 

and changes in body function that must 

be reported to an aide’s supervisor. 

(vi) Maintenance of a clean, safe, and 

healthy environment. 

(vii) Recognizing emergencies and the 

knowledge of emergency procedures 

and their application. 

(viii) The physical, emotional, and 

developmental needs of and ways to 

work with the populations served by the 

hospice, including the need for respect 

for the patient, his or her privacy, and 

his or her property. 

(ix) Appropriate and safe techniques 

in performing personal hygiene and 

grooming tasks, including items on the 

following basic checklist: 

(A) Bed bath. 

(B) Sponge, tub, and shower bath. 

(C) Hair shampoo (sink, tub, and bed). 

(D) Nail and skin care. 

(E) Oral hygiene. 

(F) Toileting and elimination. 

(x) Safe transfer techniques and 

ambulation. 

(xi) Normal range of motion and 

positioning. 

(xii) Adequate nutrition and fluid 

intake. 

(xiii) Any other task that the hospice 

may choose to have an aide perform. 

The hospice is responsible for training 

hospice aides, as needed, for skills not 

covered in the basic checklist, as 

described in paragraph (b)(3)(ix) of this 

section. 

(4) The hospice must maintain 

documentation that demonstrates that 

the requirements of this standard are 

met. 

(c) Standard: Competency evaluation. 

An individual may furnish hospice aide 

services on behalf of a hospice only after 

that individual has successfully 

completed a competency evaluation 

program as described in this section. 

(1) The competency evaluation must 

address each of the subjects listed in 

paragraph (b)(3) of this section. Subject 

areas specified under paragraphs 

(b)(3)(i), (b)(3)(iii), (b)(3)(ix), (b)(3)(x) 

and (b)(3)(xi) of this section must be 


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evaluated by observing an aide’s 

performance of the task with a patient. 

The remaining subject areas may be 

evaluated through written examination, 

oral examination, or after observation of 

a hospice aide with a patient. 

(2) A hospice aide competency 

evaluation program may be offered by 

any organization, except as described in 

paragraph (f) of this section. 

(3) The competency evaluation must 

be performed by a registered nurse in 

consultation with other skilled 

professionals, as appropriate. 

(4) A hospice aide is not considered 

competent in any task for which he or 

she is evaluated as unsatisfactory. An 

aide must not perform that task without 

direct supervision by a registered nurse 

until after he or she has received 

training in the task for which he or she 

was evaluated as ‘‘unsatisfactory,’’ and 

successfully completes a subsequent 

evaluation. A hospice aide is not 

considered to have successfully 

completed a competency evaluation if 

the aide has an ‘‘unsatisfactory’’ rating 

in more than one of the required areas. 

(5) The hospice must maintain 

documentation that demonstrates the 

requirements of this standard are being 

met. 

(d) Standard: In-service training. A 

hospice aide must receive at least 12 

hours of in-service training during each 

12-month period. In-service training 

may occur while an aide is furnishing 

care to a patient. 

(1) In-service training may be offered 

by any organization, and must be 

supervised by a registered nurse. 

(2) The hospice must maintain 

documentation that demonstrates the 

requirements of this standard are met. 

(e) Standard: Qualifications for 

instructors conducting classroom and 

supervised practical training. Classroom 

and supervised practical training must 

be performed by a registered nurse who 

possesses a minimum of 2 years nursing 

experience, at least 1 year of which 

must be in home care, or by other 

individuals under the general 

supervision of a registered nurse. 

(f) Standard: Eligible competency 

evaluation organizations. A hospice 

aide competency evaluation program as 

specified in paragraph (c) of this section 

may be offered by any organization 

except by a home health agency that, 

within the previous 2 years: 

(1) Had been of compliance with the 

requirements of § 484.36(a) and (b) of 

this chapter. 

(2) Permitted an individual that does 

not meet the definition of a ‘‘qualified 

home health aide’’ as specified in 

§ 484.36(a) of this chapter to furnish 

home health aide services (with the 

exception of licensed health 

professionals and volunteers). 

(3) Had been subjected to an extended 

(or partial extended) survey as a result 

of having been found to have furnished 

substandard care (or for other reasons at 

the discretion of CMS or the State). 

(4) Had been assessed a civil 

monetary penalty of $5,000 or more as 

an intermediate sanction. 

(5) Had been found by CMS to have 

compliance deficiencies that 

endangered the health and safety of the 

home health agency’s patients and had 

temporary management appointed to 

oversee the management of the home 

health agency. 

(6) Had all or part of its Medicare 

payments suspended. 

(7) Had been found by CMS or the 

State under any Federal or State law to 

have: 

(i) Had its participation in the 

Medicare program terminated. 

(ii) Been assessed a penalty of $5,000 

or more for deficiencies in Federal or 

State standards for home health 

agencies. 

(iii) Been subjected to a suspension of 

Medicare payments to which it 

otherwise would have been entitled. 

(iv) Operated under temporary 

management that was appointed by a 

governmental authority to oversee the 

operation of the home health agency 

and to ensure the health and safety of 

the home health agency’s patients. 

(v) Been closed by CMS or the State, 

or had its patients transferred by the 

State. 

(g) Standard: Hospice aide 

assignments and duties. 

(1) Hospice aides are assigned to a 

specific patient by a registered nurse 

that is a member of the interdisciplinary 

group. Written patient care instructions 

for a hospice aide must be prepared by 

a registered nurse who is responsible for 

the supervision of a hospice aide as 

specified under paragraph (h) of this 

section. 

(2) A hospice aide provides services 

that are: 

(i) Ordered by the interdisciplinary 

group. 

(ii) Included in the plan of care. 

(iii) Permitted to be performed under 

State law by such hospice aide. 

(iv) Consistent with the hospice aide 

training. 

(3) The duties of a hospice aide 

include the following: 

(i) The provision of hands-on personal 

care. 

(ii) The performance of simple 

procedures as an extension of therapy or 

nursing services. 

(iii) Assistance in ambulation or 

exercises. 

(iv) Assistance in administering 

medications that are ordinarily selfadministered. 

(4) Hospice aides must report changes 

in the patient’s medical, nursing, 

rehabilitative, and social needs to a 

registered nurse, as the changes relate to 

the plan of care and quality assessment 

and improvement activities. Hospice 

aides must also complete appropriate 

records in compliance with the 

hospice’s policies and procedures. 

(h) Standard: Supervision of hospice 

aides. (1) A registered nurse must make 

an on-site visit to the patient’s home: 

(i) No less frequently than every 14 

days to assess the quality of care and 

services provided by the hospice aide 

and to ensure that services ordered by 

the hospice interdisciplinary group 

meet the patient’s needs. The hospice 

aide does not have to be present during 

this visit. 

(ii) If an area of concern is noted by 

the supervising nurse, then the hospice 

must make an on-site visit to the 

location where the patient is receiving 

care in order to observe and assess the 

aide while he or she is performing care. 

(iii) If an area of concern is verified by 

the hospice during the on-site visit, then 

the hospice must conduct, and the 

hospice aide must complete a 

competency evaluation in accordance 

with § 418.76(c). 

(2) A registered nurse must make an 

annual on-site visit to the location 

where a patient is receiving care in 

order to observe and assess each aide 

while he or she is performing care. 

(3) The supervising nurse must assess 

an aide’s ability to demonstrate initial 

and continued satisfactory performance 

in meeting outcome criteria that 

include, but is not limited to—

(i) Following the patient’s plan of care 

for completion of tasks assigned to the 

hospice aide by the registered nurse. 

(ii) Creating successful interpersonal 

relationships with the patient and 

family. 

(iii) Demonstrating competency with 

assigned tasks. 

(iv) Complying with infection control 

policies and procedures. 

(v) Reporting changes in the patient’s 

condition. 

(i) Standard: Individuals furnishing 

Medicaid personal care aide-only 

services under a Medicaid personal care 

benefit. An individual may furnish 

personal care services, as defined in 

§ 440.167 of this chapter, on behalf of a 

hospice agency. 

(1) Before the individual may furnish 

personal care services, the individual 

must be found competent by the State 

(if regulated by the State) to furnish 

those services. The individual only 


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needs to demonstrate competency in the 

services the individual is required to 

furnish. 

(2) Services under the Medicaid 

personal care benefit may be used to the 

extent that the hospice would routinely 

use the services of a hospice patient’s 

family in implementing a patient’s plan 

of care. 

(3) The hospice must coordinate its 

hospice aide and homemaker services 

with the Medicaid personal care benefit 

to ensure the patient receives the 

hospice aide and homemaker services 

he or she needs. 

(j) Standard: Homemaker 

qualifications. A qualified homemaker 

is—

(1) An individual who meets the 

standards in § 418.202(g) and has 

successfully completed hospice 

orientation addressing the needs and 

concerns of patients and families coping 

with a terminal illness; or 

(2) A hospice aide as described in 

§ 418.76. 

(k) Standard: Homemaker supervision 

and duties. 

(1) Homemaker services must be 

coordinated and supervised by a 

member of the interdisciplinary group. 

(2) Instructions for homemaker duties 

must be prepared by a member of the 

interdisciplinary group. 

(3) Homemakers must report all 

concerns about the patient or family to 

the member of the interdisciplinary 

group who is coordinating homemaker 

services. 

§ 418.78 Conditions of participation—

Volunteers. 

The hospice must use volunteers to 

the extent specified in paragraph (e) of 

this section. These volunteers must be 

used in defined roles and under the 

supervision of a designated hospice 

employee. 

(a) Standard: Training. The hospice 

must maintain, document, and provide 

volunteer orientation and training that 

is consistent with hospice industry 

standards. 

(b) Standard: Role. Volunteers must 

be used in day-to-day administrative 

and/or direct patient care roles. 

(c) Standard: Recruiting and 

retaining. The hospice must document 

and demonstrate viable and ongoing 

efforts to recruit and retain volunteers. 

(d) Standard: Cost saving. The 

hospice must document the cost savings 

achieved through the use of volunteers. 

Documentation must include the 

following: 

(1) The identification of each position 

that is occupied by a volunteer. 

(2) The work time spent by volunteers 

occupying those positions. 

(3) Estimates of the dollar costs that 

the hospice would have incurred if paid 

employees occupied the positions 

identified in paragraph (d)(1) of this 

section for the amount of time specified 

in paragraph (d)(2) of this section. 

(e) Standard: Level of activity. 

Volunteers must provide day-to-day 

administrative and/or direct patient care 

services in an amount that, at a 

minimum, equals 5 percent of the total 

patient care hours of all paid hospice 

employees and contract staff. The 

hospice must maintain records on the 

use of volunteers for patient care and 

administrative services, including the 

type of services and time worked. 

Subpart D—Conditions of 

participation: Organizational 

Environment 

§ 418.100 Condition of Participation: 

Organization and administration of 

services. 

The hospice must organize, manage, 

and administer its resources to provide 

the hospice care and services to 

patients, caregivers and families 

necessary for the palliation and 

management of the terminal illness and 

related conditions. 

(a) Standard: Serving the hospice 

patient and family. 

The hospice must provide hospice 

care that—

(1) Optimizes comfort and dignity; 

and 

(2) Is consistent with patient and 

family needs and goals, with patient 

needs and goals as priority. 

(b) Standard: Governing body and 

administrator. A governing body (or 

designated persons so functioning) 

assumes full legal authority and 

responsibility for the management of the 

hospice, the provision of all hospice 

services, its fiscal operations, and 

continuous quality assessment and 

performance improvement. A qualified 

administrator appointed by and 

reporting to the governing body is 

responsible for the day-to-day operation 

of the hospice. The administrator must 

be a hospice employee and possess 

education and experience required by 

the hospice’s governing body. 

(c) Standard: Services. (1) A hospice 

must be primarily engaged in providing 

the following care and services and 

must do so in a manner that is 

consistent with accepted standards of 

practice: 

(i) Nursing services. 

(ii) Medical social services. 

(iii) Physician services. 

(iv) Counseling services, including 

spiritual counseling, dietary counseling, 

and bereavement counseling. 

(v) Hospice aide, volunteer, and 

homemaker services. 

(vi) Physical therapy, occupational 

therapy, and speech-language pathology 

services. 

(vii) Short-term inpatient care. 

(viii) Medical supplies (including 

drugs and biologicals) and medical 

appliances. 

(2) Nursing services, physician 

services, and drugs and biologicals (as 

specified in § 418.106) must be made 

routinely available on a 24-hour basis 7 

days a week. Other covered services 

must be available on a 24-hour basis 

when reasonable and necessary to meet 

the needs of the patient and family. 

(d) Standard: Continuation of care. A 

hospice may not discontinue or reduce 

care provided to a Medicare or Medicaid 

beneficiary because of the beneficiary’s 

inability to pay for that care. 

(e) Standard: Professional 

management responsibility. A hospice 

that has a written agreement with 

another agency, individual, or 

organization to furnish any services 

under arrangement must retain 

administrative and financial 

management, and oversight of staff and 

services for all arranged services, to 

ensure the provision of quality care. 

Arranged services must be supported by 

written agreements that require that all 

services be—

(1) Authorized by the hospice; 

(2) Furnished in a safe and effective 

manner by qualified personnel; and 

(3) Delivered in accordance with the 

patient’s plan of care. 

(f) Standard: Hospice multiple 

locations. 

If a hospice operates multiple 

locations, it must meet the following 

requirements: 

(1) Medicare approval. 

(i) All hospice multiple locations 

must be approved by Medicare before 

providing hospice care and services to 

Medicare patients. 

(ii) The multiple location must be part 

of the hospice and must share 

administration, supervision, and 

services with the hospice issued the 

certification number. 

(iii) The lines of authority and 

professional and administrative control 

must be clearly delineated in the 

hospice’s organizational structure and 

in practice, and must be traced to the 

location that issued the certification 

number. 

(iv) The determination that a multiple 

location does or does not meet the 

definition of a multiple location, as set 

forth in this part, is an initial 

determination, as set forth in § 498.3. 

(2) The hospice must continually 

monitor and manage all services 


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provided at all of its locations to ensure 

that services are delivered in a safe and 

effective manner and to ensure that each 

patient and family receives the 

necessary care and services outlined in 

the plan of care, in accordance with the 

requirements of this subpart and 

subparts A and C of this section. 

(g) Standard: Training. 

(1) A hospice must provide 

orientation about the hospice 

philosophy to all employees and 

contracted staff who have patient and 

family contact. 

(2) A hospice must provide an initial 

orientation for each employee that 

addresses the employee’s specific job 

duties. 

(3) A hospice must assess the skills 

and competence of all individuals 

furnishing care, including volunteers 

furnishing services, and, as necessary, 

provide in-service training and 

education programs where required. 

The hospice must have written policies 

and procedures describing its method(s) 

of assessment of competency and 

maintain a written description of the 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 an 

employee, or is under contract with the 

hospice. When the medical director is 

not available, a physician designated by 

the hospice assumes the same 

responsibilities and obligations as the 

medical director. 

(a) Standard: Medical director 

contract. (1) A hospice may contract 

with either of the following—

(i) A self-employed physician; or 

(ii) A physician employed by a 

professional entity or physicians group. 

When contracting for medical director 

services, the contract must specify the 

physician who assumes the medical 

director responsibilities and obligations. 

(b) Standard: Initial certification of 

terminal illness. The medical director or 

physician designee reviews the clinical 

information for each hospice patient 

and provides written certification that it 

is anticipated that the patient’s life 

expectancy is 6 months or less if the 

illness runs its normal course. The 

physician must consider the following 

when making this determination: 

(1) The primary terminal condition; 

(2) Related diagnosis(es), if any; 

(3) Current subjective and objective 

medical findings; 

(4) Current medication and treatment 

orders; and 

(5) Information about the medical 

management of any of the patient’s 

conditions unrelated to the terminal 

illness. 

(c) Standard: Recertification of the 

terminal illness. Before the 

recertification period for each patient, as 

described in § 418.21(a), the medical 

director or physician designee must 

review the patient’s clinical 

information. 

(d) Standard: Medical director 

responsibility. The medical director or 

physician designee has responsibility 

for the medical component of the 

hospice’s patient care program. 

§ 418.104 Condition of participation: 

Clinical records. 

A clinical record containing past and 

current findings is maintained for each 

hospice patient. The clinical record 

must contain correct clinical 

information that is available to the 

patient’s attending physician and 

hospice staff. The clinical record may be 

maintained electronically. 

(a) Standard: Content. Each patient’s 

record must include the following: 

(1) The initial plan of care, updated 

plans of care, initial assessment, 

comprehensive assessment, updated 

comprehensive assessments, and 

clinical notes. 

(2) Signed copies of the notice of 

patient rights in accordance with 

§ 418.52 and election statement in 

accordance with § 418.24. 

(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 § 418.25 and 

described in § 418.102(b) and 

§ 418.102(c) respectively, if appropriate. 

(6) Any advance directives as 

described in § 418.52(a)(2). 

(7) Physician orders. 

(b) Standard: Authentication. All 

entries must be legible, clear, complete, 

and appropriately authenticated and 

dated in accordance with hospice policy 

and currently accepted standards of 

practice. 

(c) Standard: Protection of 

information. The clinical record, its 

contents and the information contained 

therein must be safeguarded against loss 

or unauthorized use. The hospice must 

be in compliance with the Department’s 

rules regarding personal health 

information as set out at 45 CFR parts 

160 and 164. 

(d) Standard: Retention of records. 

Patient clinical records must be retained 

for 6 years after the death or discharge 

of the patient, unless State law 

stipulates a longer period of time. If the 

hospice discontinues operation, hospice 

policies must provide for retention and 

storage of clinical records. The hospice 

must inform its State agency and its 

CMS Regional office where such clinical 

records will be stored and how they 

may be accessed. 

(e) Standard: Discharge or transfer of 

care. (1) If the care of a patient is 

transferred to another Medicare/ 

Medicaid-certified facility, the hospice 

must forward to the receiving facility, a 

copy of—

(i) The hospice discharge summary; 

and 

(ii) The patient’s clinical record, if 

requested. 

(2) If a patient revokes the election of 

hospice care, or is discharged from 

hospice in accordance with § 418.26, the 

hospice must forward to the patient’s 

attending physician, a copy of—

(i) The hospice discharge summary; 

and 

(ii) The patient’s clinical record, if 

requested. 

(3) The hospice discharge summary as 

required in paragraph (e)(1) and (e)(2) of 

this section must include—

(i) A summary of the patient’s stay 

including treatments, symptoms and 

pain management. 

(ii) The patient’s current plan of care. 

(iii) The patient’s latest physician 

orders. and 

(iv) Any other documentation that 

will assist in post-discharge continuity 

of care or that is requested by the 

attending physician or receiving facility. 

(f) Standard: Retrieval of clinical 

records. The clinical record, whether 

hard copy or in electronic form, must be 

made readily available on request by an 

appropriate authority. 

§ 418.106 Condition of participation: 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: Managing drugs and 

biologicals. 

(1) The hospice must ensure that the 

interdisciplinary group confers with an 

individual with education and training 

in drug management as defined in 

hospice policies and procedures and 

State law, who is an employee of or 


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under contract with the hospice to 

ensure that drugs and biologicals meet 

each patient’s needs. 

(2) A hospice that provides inpatient 

care directly in its own facility must 

provide pharmacy services under the 

direction of a qualified licensed 

pharmacist who is an employee of or 

under contract with the hospice. The 

provided pharmacist services must 

include evaluation of a patient’s 

response to medication therapy, 

identification of potential adverse drug 

reactions, and recommended 

appropriate corrective action. 

(b) Standard: Ordering of drugs. 

(1) Only a physician as defined by 

section 1861(r)(1) of the Act, or a nurse 

practitioner in accordance with the plan 

of care and State law, may order drugs 

for the patient. 

(2) If the drug order is verbal or given 

by or through electronic transmission—

(i) It must be given only to a licensed 

nurse, nurse practitioner (where 

appropriate), pharmacist, or physician; 

and 

(ii) The individual receiving the order 

must record and sign it immediately and 

have the prescribing person sign it in 

accordance with State and Federal 

regulations. 

(c) Standard: Dispensing of drugs and 

biologicals. 

The hospice must—

(1) Obtain drugs and biologicals from 

community or institutional pharmacists 

or stock drugs and biologicals itself. 

(2) The hospice that provides 

inpatient care directly in its own facility 

must: 

(i) Have a written policy in place that 

promotes dispensing accuracy; and 

(ii) Maintain current and accurate 

records of the receipt and disposition of 

all controlled drugs. 

(d) Standard: Administration of drugs 

and biologicals. 

(1) The interdisciplinary group, as 

part of the review of the plan of care, 

must determine the ability of the patient 

and/or family to safely self-administer 

drugs and biologicals to the patient in 

his or her home. 

(2) Patients receiving care in a hospice 

that provides inpatient care directly in 

its own facility may only be 

administered medications by the 

following individuals: 

(i) A licensed nurse, physician, or 

other health care professional in 

accordance with their scope of practice 

and State law; 

(ii) An employee who has completed 

a State-approved training program in 

medication administration; and 

(iii) The patient, upon approval by the 

interdisciplinary group. 

(e) Standard: Labeling, disposing, and 

storing of drugs and biologicals. 

(1) Labeling. Drugs and biologicals 

must be labeled in accordance with 

currently accepted professional practice 

and must include appropriate usage and 

cautionary instructions, as well as an 

expiration date (if applicable). 

(2) Disposing. (i) Safe use and 

disposal of controlled drugs in the 

patient’s home. The hospice must have 

written policies and procedures for the 

management and disposal of controlled 

drugs in the patient’s home. At the time 

when controlled drugs are first ordered 

the hospice must: 

(A) Provide a copy of the hospice 

written policies and procedures on the 

management and disposal of controlled 

drugs to the patient or patient 

representative and family; 

(B) Discuss the hospice policies and 

procedures for managing the safe use 

and disposal of controlled drugs with 

the patient or representative and the 

family in a language and manner that 

they understand to ensure that these 

parties are educated regarding the safe 

use and disposal of controlled drugs; 

and 

(C) Document in the patient’s clinical 

record that the written policies and 

procedures for managing controlled 

drugs was provided and discussed. 

(ii) Disposal of controlled drugs in 

hospices that provide inpatient care 

directly. The hospice that provides 

inpatient care directly in its own facility 

must dispose of controlled drugs in 

compliance with the hospice policy and 

in accordance with State and Federal 

requirements. The hospice must 

maintain current and accurate records of 

the receipt and disposition of all 

controlled drugs. 

(3) Storing. The hospice that provides 

inpatient care directly in its own facility 

must comply with the following 

additional requirements—

(i) All drugs and biologicals must be 

stored in secure areas. All controlled 

drugs listed in Schedules II, III, IV, and 

V of the Comprehensive Drug Abuse 

Prevention and Control Act of 1976 

must be stored in locked compartments 

within such secure storage areas. Only 

personnel authorized to administer 

controlled drugs as noted in paragraph 

(d)(2) of this section may have access to 

the locked compartments; and 

(ii) Discrepancies in the acquisition, 

storage, dispensing, administration, 

disposal, or return of controlled drugs 

must be investigated immediately by the 

pharmacist and hospice administrator 

and where required reported to the 

appropriate State authority. A written 

account of the investigation must be 

made available to State and Federal 

officials if required by law or regulation. 

(f) Standard: Use and maintenance of 

equipment and supplies. 

(1) The hospice must ensure that 

manufacturer recommendations for 

performing routine and preventive 

maintenance on durable medical 

equipment are followed. The equipment 

must be safe and work as intended for 

use in the patient’s environment. Where 

a manufacturer recommendation for a 

piece of equipment does not exist, the 

hospice must ensure that repair and 

routine maintenance policies are 

developed. The hospice may use 

persons under contract to ensure the 

maintenance and repair of durable 

medical equipment. 

(2) The hospice must ensure that the 

patient, where appropriate, as well as 

the family and/or other caregiver(s), 

receive instruction in the safe use of 

durable medical equipment and 

supplies. The hospice may use persons 

under contract to ensure patient and 

family instruction. The patient, family, 

and/or caregiver must be able to 

demonstrate the appropriate use of 

durable medical equipment to the 

satisfaction of the hospice staff. 

(3) Hospices may only contract for 

durable medical equipment services 

with a durable medical equipment 

supplier that meets the Medicare 

DMEPOS Supplier Quality and 

Accreditation Standards at 42 CFR 

§ 424.57. 

§ 418.108 Condition of participation: 

Short-term inpatient care. 

Inpatient care must be available for 

pain control, symptom management, 

and respite purposes, and must be 

provided in a participating Medicare or 

Medicaid facility. 

(a) Standard: Inpatient care for 

symptom management and pain 

control. Inpatient care for pain control 

and symptom management must be 

provided in one of the following: 

(1) A Medicare-certified hospice that 

meets the conditions of participation for 

providing inpatient care directly as 

specified in § 418.110. 

(2) A Medicare-certified hospital or a 

skilled nursing facility that also meets 

the standards specified in § 418.110(b) 

and (e) regarding 24-hour nursing 

services and patient areas. 

(b) Standard: Inpatient care for respite 

purposes. 

(1) Inpatient care for respite purposes 

must be provided by one of the 

following: 

(i) A provider specified in paragraph 

(a) of this section. 

(ii) A Medicare or Medicaid-certified 

nursing facility that also meets the 

standards specified in § 418.110(f). 

(2) The facility providing respite care 

must provide 24-hour nursing services 


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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: Inpatient care provided 

under arrangements. If the hospice has 

an arrangement with a facility to 

provide for short-term inpatient care, 

the arrangement is described in a 

written agreement, coordinated by the 

hospice, and at a minimum specifies—

(1) That the hospice supplies the 

inpatient provider a copy of the 

patient’s plan of care and specifies the 

inpatient services to be furnished; 

(2) That the inpatient provider has 

established patient care policies 

consistent with those of the hospice and 

agrees to abide by the palliative care 

protocols and plan of care established 

by the hospice for its patients; 

(3) That the hospice patient’s 

inpatient clinical record includes a 

record of all inpatient services furnished 

and events regarding care that occurred 

at the facility; that a copy of the 

discharge summary be provided to the 

hospice at the time of discharge; and 

that a copy of the inpatient clinical 

record is available to the hospice at the 

time of discharge; 

(4) That the inpatient facility has 

identified an individual within the 

facility who is responsible for the 

implementation of the provisions of the 

agreement; 

(5) That the hospice retains 

responsibility for ensuring that the 

training of personnel who will be 

providing the patient’s care in the 

inpatient facility has been provided and 

that a description of the training and the 

names of those giving the training are 

documented; and 

(6) A method for verifying that the 

requirements in paragraphs (c)(1) 

through (c)(5) of this section are met. 

(d) Standard: Inpatient care 

limitation. The total number of inpatient 

days used by Medicare beneficiaries 

who elected hospice coverage in a 12- 

month period in a particular hospice 

may not exceed 20 percent of the total 

number of hospice days consumed in 

total by this group of beneficiaries. 

(e) Standard: Exemption from 

limitation. Before October 1, 1986, any 

hospice that began operation before 

January 1, 1975, is not subject to the 

limitation specified in paragraph (d) of 

this section. 

§ 418.110 Condition of participation: 

Hospices that provide inpatient care 

directly. 

A hospice that provides inpatient care 

directly in its own facility must 

demonstrate compliance with all of the 

following standards: 

(a) Standard: Staffing. The hospice is 

responsible for ensuring that staffing for 

all services reflects its volume of 

patients, their acuity, and the level of 

intensity of services needed to ensure 

that plan of care outcomes are achieved 

and negative outcomes are avoided. 

(b) Standard: Twenty-four hour 

nursing services. (1) The hospice facility 

must provide 24-hour nursing services 

that meet the nursing needs of all 

patients and are furnished in 

accordance with each patient’s plan of 

care. Each patient must receive all 

nursing services as prescribed and must 

be kept comfortable, clean, wellgroomed, and protected from accident, 

injury, and infection. 

(2) If at least one patient in the 

hospice facility is receiving general 

inpatient care, then each shift must 

include a registered nurse who provides 

direct patient care. 

(c) Standard: Physical environment. 

The hospice must maintain a safe 

physical environment free of hazards for 

patients, staff, and visitors. 

(1) Safety management. 

(i) The hospice must address real or 

potential threats to the health and safety 

of the patients, others, and property. 

(ii) The hospice must have a written 

disaster preparedness plan in effect for 

managing the consequences of power 

failures, natural disasters, and other 

emergencies that would affect the 

hospice’s ability to provide care. The 

plan must be periodically reviewed and 

rehearsed with staff (including 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 

controlling the reliability and quality 

of—

(i) The routine storage and prompt 

disposal of trash and medical waste; 

(ii) Light, temperature, and 

ventilation/air exchanges throughout 

the hospice; 

(iii) Emergency gas and water supply; 

and 

(iv) The scheduled and emergency 

maintenance and repair of all 

equipment. 

(d) Standard: Fire protection. (1) 

Except as otherwise provided in this 

section—

(i) The hospice must meet the 

provisions applicable to nursing homes 

of the 2000 edition of the Life Safety 

Code (LSC) of the National Fire 

Protection Association (NFPA). The 

Director of the Office of the Federal 

Register has approved the NFPA 101

2000 edition of the Life Safety Code, 

issued January 14, 2000, for 

incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51. A copy of the code is 

available for inspection at the CMS 

Information Resource Center, 7500 

Security Boulevard, Baltimore, MD or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federalregister/codeoffederal

regulations/ibrlocations.html. Copies 

may be obtained from the National Fire 

Protection Association, 1 Batterymarch 

Park, Quincy, MA 02269. If any changes 

in the edition of the Code are 

incorporated by reference, CMS will 

publish a notice in the Federal Register 

to announce the changes. 

(ii) Chapter 19.3.6.3.2, exception 

number 2 of the adopted edition of the 

LSC does not apply to hospices. 

(2) In consideration of a 

recommendation by the State survey 

agency, CMS may waive, for periods 

deemed appropriate, specific provisions 

of the Life Safety Code which, if rigidly 

applied would result in unreasonable 

hardship for the hospice, but only if the 

waiver would not adversely affect the 

health and safety of patients. 

(3) The provisions of the adopted 

edition of the Life Safety Code do not 

apply in a State if CMS finds that a fire 

and safety code imposed by State law 

adequately protects patients in hospices. 

(4) Notwithstanding any provisions of 

the 2000 edition of the Life Safety Code 

to the contrary, a hospice may place 

alcohol-based hand rub dispensers in its 

facility if—

(i) Use of alcohol-based hand rub 

dispensers does not conflict with any 

State or local codes that prohibit or 

otherwise restrict the placement of 

alcohol-based hand rub dispensers in 

health care facilities; 

(ii) The dispensers are installed in a 

manner that minimizes leaks and spills 

that could lead to falls; 

(iii) The dispensers are installed in a 

manner that adequately protects against 

access by vulnerable populations; and 

(iv) The dispensers are installed in 

accordance with chapter 18.3.2.7 or 

chapter 19.3.2.7 of the 2000 edition of 

the Life Safety Code, as amended by 

NFPA Temporary Interim Amendment 

00–1(101), issued by the Standards 

Council of the National Fire Protection 

Association on April 15, 2004. The 

Director of the Office of the Federal 


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Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Rules and Regulations 32215 

Register has approved NFPA Temporary 

Interim Amendment 00–1(101) for 

incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51. A copy of the code is 

available for inspection at the CMS 

Information Resource Center, 7500 

Security Boulevard, Baltimore, MD or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/codeof

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. 

(e) Standard: Patient areas. The 

hospice must provide a home-like 

atmosphere and ensure that patient 

areas are designed to preserve the 

dignity, comfort, and privacy of 

patients. 

(1) The hospice must provide—

(i) Physical space for private patient 

and family visiting; 

(ii) Accommodations for family 

members to remain with the patient 

throughout the night; and 

(iii) Physical space for family privacy 

after a patient’s death. 

(2) The hospice must provide the 

opportunity for patients to receive 

visitors at any hour, including infants 

and small children. 

(f) Standard: Patient rooms. (1) The 

hospice must ensure that patient rooms 

are designed and equipped for nursing 

care, as well as the dignity, comfort, and 

privacy of patients. 

(2) The hospice must accommodate a 

patient and family request for a single 

room whenever possible. 

(3) Each patient’s room must—

(i) Be at or above grade level; 

(ii) Contain a suitable bed and other 

appropriate furniture for each patient; 

(iii) Have closet space that provides 

security and privacy for clothing and 

personal belongings; 

(iv) Accommodate no more than two 

patients and their family members; 

(v) Provide at least 80 square feet for 

each residing patient in a double room 

and at least 100 square feet for each 

patient residing in a single room; and 

(vi) Be equipped with an easilyactivated, functioning device accessible 

to the patient, that is used for calling for 

assistance. 

(4) For a facility occupied by a 

Medicare-participating hospice on 

December 2, 2008, CMS may waive the 

space and occupancy requirements of 

paragraphs (f)(2)(iv) and (f)(2)(v) of this 

section if it determines that—

(i) Imposition of the requirements 

would result in unreasonable hardship 

on the hospice if strictly enforced; or 

jeopardize its ability to continue to 

participate in the Medicare program; 

and 

(ii) The waiver serves the needs of the 

patient and does not adversely affect 

their health and safety. 

(g) Standard: Toilet and bathing 

facilities. Each patient room must be 

equipped with, or conveniently located 

near, toilet and bathing facilities. 

(h) Standard: Plumbing facilities. The 

hospice must—

(1) Have an adequate supply of hot 

water at all times; and 

(2) Have plumbing fixtures with 

control valves that automatically 

regulate the temperature of the hot 

water used by patients. 

(i) Standard: Infection control. The 

hospice must maintain an infection 

control program that protects patients, 

staff and others by preventing and 

controlling infections and 

communicable disease as stipulated in 

§ 418.60. 

(j) Standard: Sanitary environment. 

The hospice must provide a sanitary 

environment by following current 

standards of practice, including 

nationally recognized infection control 

precautions, and avoid sources and 

transmission of infections and 

communicable diseases. 

(k) Standard: Linen. The hospice must 

have available at all times a quantity of 

clean linen in sufficient amounts for all 

patient uses. Linens must be handled, 

stored, processed, and transported in 

such a manner as to prevent the spread 

of contaminants. 

(l) Standard: Meal service and menu 

planning. The hospice must furnish 

meals to each patient that are—

(1) Consistent with the patient’s plan 

of care, nutritional needs, and 

therapeutic diet; 

(2) Palatable, attractive, and served at 

the proper temperature; and 

(3) Obtained, stored, prepared, 

distributed, and served under sanitary 

conditions. 

(m) Standard: Restraint or seclusion. 

All patients have the right to be free 

from physical or mental abuse, and 

corporal punishment. All patients have 

the right to be free from restraint or 

seclusion, of any form, imposed as a 

means of coercion, discipline, 

convenience, or retaliation by staff. 

Restraint or seclusion may only be 

imposed to ensure the immediate 

physical safety of the patient, a staff 

member, or others and must be 

discontinued at the earliest possible 

time. 

(1) Restraint or seclusion may only be 

used when less restrictive interventions 

have been determined to be ineffective 

to protect the patient, a staff member, or 

others from harm. 

(2) The type or technique of restraint 

or seclusion used must be the least 

restrictive intervention that will be 

effective to protect the patient, a staff 

member, or others from harm. 

(3) The use of restraint or seclusion 

must be—

(i) In accordance with a written 

modification to the patient’s plan of 

care; and 

(ii) Implemented in accordance with 

safe and appropriate restraint and 

seclusion techniques as determined by 

hospice policy in accordance with State 

law. 

(4) The use of restraint or seclusion 

must be in accordance with the order of 

a physician authorized to order restraint 

or seclusion by hospice policy in 

accordance with State law. 

(5) Orders for the use of restraint or 

seclusion must never be written as a 

standing order or on an as needed basis 

(PRN). 

(6) The medical director or physician 

designee must be consulted as soon as 

possible if the attending physician did 

not order the restraint or seclusion. 

(7) Unless superseded by State law 

that is more restrictive—

(i) Each order for restraint or 

seclusion used for the management of 

violent or self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others may only be renewed in 

accordance with the following limits for 

up to a total of 24 hours: 

(A) 4 hours for adults 18 years of age 

or older; 

(B) 2 hours for children and 

adolescents 9 to 17 years of age; or 

(C) 1 hour for children under 9 years 

of age; and 

After 24 hours, before writing a new 

order for the use of restraint or seclusion 

for the management of violent or selfdestructive behavior, a physician 

authorized to order restraint or 

seclusion by hospice policy in 

accordance with State law must see and 

assess the patient. 

(ii) Each order for restraint used to 

ensure the physical safety of the nonviolent or non-self-destructive patient 

may be renewed as authorized by 

hospice policy. 

(8) Restraint or seclusion must be 

discontinued at the earliest possible 

time, regardless of the length of time 

identified in the order. 

(9) The condition of the patient who 

is restrained or secluded must be 


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monitored by a physician or trained 

staff that have completed the training 

criteria specified in paragraph (n) of this 

section at an interval determined by 

hospice policy. 

(10) Physician, including attending 

physician, training requirements must 

be specified in hospice policy. At a 

minimum, physicians and attending 

physicians authorized to order restraint 

or seclusion by hospice policy in 

accordance with State law must have a 

working knowledge of hospice policy 

regarding the use of restraint or 

seclusion. 

(11) When restraint or seclusion is 

used for the management of violent or 

self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others, the patient must be seen face-toface within 1 hour after the initiation of 

the intervention—

(i) By a—

(A) Physician; or 

(B) Registered nurse who has been 

trained in accordance with the 

requirements specified in paragraph (n) 

of this section. 

(ii) To evaluate—

(A) The patient’s immediate situation; 

(B) The patient’s reaction to the 

intervention; 

(C) The patient’s medical and 

behavioral condition; and 

(D) The need to continue or terminate 

the restraint or seclusion. 

(12) States are free to have 

requirements by statute or regulation 

that are more restrictive than those 

contained in paragraph (m)(11)(i) of this 

section. 

(13) If the face-to-face evaluation 

specified in § 418.110(m)(11) is 

conducted by a trained registered nurse, 

the trained registered nurse must 

consult the medical director or 

physician designee as soon as possible 

after the completion of the 1-hour faceto-face evaluation. 

(14) All requirements specified under 

this paragraph are applicable to the 

simultaneous use of restraint and 

seclusion. Simultaneous restraint and 

seclusion use is only permitted if the 

patient is continually monitored—

(i) Face-to-face by an assigned, trained 

staff member; or 

(ii) By trained staff using both video 

and audio equipment. This monitoring 

must be in close proximity to the 

patient. 

(15) When restraint or seclusion is 

used, there must be documentation in 

the patient’s clinical record of the 

following: 

(i) The 1-hour face-to-face medical 

and behavioral evaluation if restraint or 

seclusion is used to manage violent or 

self-destructive behavior; 

(ii) A description of the patient’s 

behavior and the intervention used; 

(iii) Alternatives or other less 

restrictive interventions attempted (as 

applicable); 

(iv) The patient’s condition or 

symptom(s) that warranted the use of 

the restraint or seclusion; and the 

patient’s response to the intervention(s) 

used, including the rationale for 

continued use of the intervention. 

(n) Standard: Restraint or seclusion 

staff training requirements. The patient 

has the right to safe implementation of 

restraint or seclusion by trained staff. 

(1) Training intervals. All patient care 

staff working in the hospice inpatient 

facility must be trained and able to 

demonstrate competency in the 

application of restraints, 

implementation of seclusion, 

monitoring, assessment, and providing 

care for a patient in restraint or 

seclusion—

(i) Before performing any of the 

actions specified in this paragraph; 

(ii) As part of orientation; and 

(iii) Subsequently on a periodic basis 

consistent with hospice policy. 

(2) Training content. The hospice 

must require appropriate staff to have 

education, training, and demonstrated 

knowledge based on the specific needs 

of the patient population in at least the 

following: 

(i) Techniques to identify staff and 

patient behaviors, events, and 

environmental factors that may trigger 

circumstances that require the use of a 

restraint or seclusion. 

(ii) The use of nonphysical 

intervention skills. 

(iii) Choosing the least restrictive 

intervention based on an individualized 

assessment of the patient’s medical, or 

behavioral status or condition. 

(iv) The safe application and use of all 

types of restraint or seclusion used in 

the hospice, including training in how 

to recognize and respond to signs of 

physical and psychological distress (for 

example, positional asphyxia). 

(v) Clinical identification of specific 

behavioral changes that indicate that 

restraint or seclusion is no longer 

necessary. 

(vi) Monitoring the physical and 

psychological well-being of the patient 

who is restrained or secluded, including 

but not limited to, respiratory and 

circulatory status, skin integrity, vital 

signs, and any special requirements 

specified by hospice policy associated 

with the 1-hour face-to-face evaluation. 

(vii) The use of first aid techniques 

and certification in the use of 

cardiopulmonary resuscitation, 

including required periodic 

recertification. 

(3) Trainer requirements. Individuals 

providing staff training must be 

qualified as evidenced by education, 

training, and experience in techniques 

used to address patients’ behaviors. 

(4) Training documentation. The 

hospice must document in the staff 

personnel records that the training and 

demonstration of competency were 

successfully completed. 

(o) Standard: Death reporting 

requirements. Hospices must report 

deaths associated with the use of 

seclusion or restraint. 

(1) The hospice must report the 

following information to CMS: 

(i) Each unexpected death that occurs 

while a patient is in restraint or 

seclusion. 

(ii) Each unexpected death that occurs 

within 24 hours after the patient has 

been removed from restraint or 

seclusion. 

(iii) Each death known to the hospice 

that occurs within 1 week after restraint 

or seclusion where it is reasonable to 

assume that use of restraint or 

placement in seclusion contributed 

directly or indirectly to a patient’s 

death. ‘‘Reasonable to assume’’ in this 

context includes, but is not limited to, 

deaths related to restrictions of 

movement for prolonged periods of 

time, or death related to chest 

compression, restriction of breathing or 

asphyxiation. 

(2) Each death referenced in this 

paragraph must be reported to CMS by 

telephone no later than the close of 

business the next business day 

following knowledge of the patient’s 

death. 

(3) Staff must document in the 

patient’s clinical record the date and 

time the death was reported to CMS. 

§ 418.112 Condition of participation: 

Hospices that provide hospice care to 

residents of a SNF/NF or ICF/MR. 

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 or 

ICF/MR 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 

ICF/MR are subject to the Medicare 

hospice eligibility criteria set out at 

§ 418.20 through § 418.30. 

(b) Standard: Professional 

management. The hospice must assume 

responsibility for professional 

management of the resident’s hospice 

services provided, in accordance with 

the hospice plan of care and the hospice 

conditions of participation, and make 


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any arrangements necessary for hospicerelated inpatient care in a participating 

Medicare/Medicaid facility according to 

§ 418.100 and § 418.108. 

(c) Standard: Written agreement. The 

hospice and SNF/NF or ICF/MR must 

have a written agreement that specifies 

the provision of hospice services in the 

facility. The agreement must be signed 

by authorized representatives of the 

hospice and the SNF/NF or ICF/MR 

before the provision of hospice services. 

The written agreement must include at 

least the following: 

(1) The manner in which the SNF/NF 

or ICF/MR and the hospice are to 

communicate with each other and 

document such communications to 

ensure that the needs of patients are 

addressed and met 24 hours a day. 

(2) A provision that the SNF/NF or 

ICF/MR immediately notifies the 

hospice if—

(i) A significant change in a 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 need to transfer a patient from 

the SNF/NF or ICF/MR, and the hospice 

makes arrangements for, and remains 

responsible for, any necessary 

continuous care or inpatient care 

necessary related to the terminal illness 

and related conditions; or 

(iv) A patient dies. 

(3) A provision stating that the 

hospice assumes responsibility for 

determining the appropriate course of 

hospice care, including the 

determination to change the level of 

services provided. 

(4) An agreement that it is the SNF/ 

NF or ICF/MR responsibility to continue 

to furnish 24 hour room and board care, 

meeting the personal care and nursing 

needs that would have been provided by 

the primary caregiver at home at the 

same level of care provided before 

hospice care was elected. 

(5) An agreement that it is the 

hospice’s responsibility to provide 

services at the same level and to the 

same extent as those services would be 

provided if the SNF/NF or ICF/MR 

resident were in his or her own home. 

(6) A delineation of the hospice’s 

responsibilities, which include, but are 

not limited to the following: Providing 

medical direction and management of 

the patient; nursing; counseling 

(including spiritual, dietary and 

bereavement); social work; provision of 

medical supplies, durable medical 

equipment and drugs necessary for the 

palliation of pain and symptoms 

associated with the terminal illness and 

related conditions; and all other hospice 

services that are necessary for the care 

of the resident’s terminal illness and 

related conditions. 

(7) A provision that the hospice may 

use the SNF/NF or ICF/MR nursing 

personnel where permitted by State law 

and as specified by the SNF/NF or ICF/ 

MR to assist in the administration of 

prescribed therapies included in the 

plan of care only to the extent that the 

hospice would routinely use the 

services of a hospice patient’s family in 

implementing the plan of care. 

(8) A provision stating that the 

hospice must report all alleged 

violations involving mistreatment, 

neglect, or verbal, mental, sexual, and 

physical abuse, including injuries of 

unknown source, and misappropriation 

of patient property by anyone unrelated 

to the hospice to the SNF/NF or ICF/MR 

administrator within 24 hours of the 

hospice becoming aware of the alleged 

violation. 

(9) A delineation of the 

responsibilities of the hospice and the 

SNF/NF or ICF/MR to provide 

bereavement services to SNF/NF or ICF/ 

MR staff. 

(d) Standard: Hospice plan of care. In 

accordance with § 418.56, a written 

hospice plan of care must be established 

and maintained in consultation with 

SNF/NF or ICF/MR representatives. All 

hospice care provided must be in 

accordance with this hospice plan of 

care. 

(1) The hospice 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 

hospice plan of care. 

(2) The hospice plan of care reflects 

the participation of the hospice, the 

SNF/NF or ICF/MR, and the patient and 

family to the extent possible. 

(3) Any changes in the hospice plan 

of care must be discussed with the 

patient or representative, and SNF/NF 

or ICF/MR representatives, and must be 

approved by the hospice before 

implementation. 

(e) Standard: Coordination of services. 

The hospice must: 

(1) Designate a member of each 

interdisciplinary group that is 

responsible for a patient who is a 

resident of a SNF/NF or ICF/MR. The 

designated interdisciplinary group 

member is responsible for: 

(i) Providing overall coordination of 

the hospice care of the SNF/NF or ICF/ 

MR resident with SNF/NF or ICF/MR 

representatives; and 

(ii) Communicating with SNF/NF or 

ICF/MR representatives and other health 

care providers participating in the 

provision of care for the terminal illness 

and related conditions and other 

conditions to ensure quality of care for 

the patient and family. 

(2) Ensure that the hospice IDG 

communicates with the SNF/NF or ICF/ 

MR medical director, the patient’s 

attending physician, and other 

physicians participating in the 

provision of care to the patient as 

needed to coordinate the hospice care of 

the hospice patient with the medical 

care provided by other physicians. 

(3) Provide the SNF/NF or ICF/MR 

with the following information: 

(i) The most recent hospice plan of 

care specific to each patient; 

(ii) Hospice election form and any 

advance directives specific to each 

patient; 

(iii) Physician certification and 

recertification of the terminal illness 

specific to each patient; 

(iv) Names and contact information 

for hospice personnel involved in 

hospice care of each patient; 

(v) Instructions on how to access the 

hospice’s 24-hour on-call system; 

(vi) Hospice medication information 

specific to each patient; and 

(vii) Hospice physician and attending 

physician (if any) orders specific to each 

patient. 

(f) Standard: Orientation and training 

of staff. Hospice staff must assure 

orientation of SNF/NF or ICF/MR 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. 

(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) in accordance 

with applicable Federal, State and local 

laws, 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 certain 

disciplines. 

The following qualifications must be 

met: 

(1) Physician. Physicians must meet 

the qualifications and conditions as 

defined in section 1861(r) of the Act and 

implemented at § 410.20 of this chapter. 


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(2) Hospice aide. Hospice aides must 

meet the qualifications required by 

section 1891(a)(3) of the Act and 

implemented at § 418.76. 

(3) Social worker. A person who—

(i)(A) Has a Master of Social Work 

(MSW) degree from a school of social 

work accredited by the Council on 

Social Work Education; or 

(B) Has a baccalaureate degree in 

social work from an institution 

accredited by the Council on Social 

Work Education; or a baccalaureate 

degree in psychology, sociology, or 

other field related to social work and is 

supervised by an MSW as described in 

paragraph (b)(3)(i)(A) of this section; 

and 

(ii) Has 1 year of social work 

experience in a healthcare setting; or 

(iii) Has a baccalaureate degree from 

a school of social work accredited by the 

Council on Social Work Education, is 

employed by the hospice before 

December 2, 2008, and is not required 

to be supervised by an MSW. 

(4) Speech language pathologist. A 

person who meets either of the 

following requirements: 

(i) The education and experience 

requirements for a Certificate of Clinical 

Competence in speech-language 

pathology granted by the American 

Speech-Language-Hearing Association. 

(ii) The educational requirements for 

certification and is in the process of 

accumulating the supervised experience 

required for certification. 

(5) Occupational therapist. A person 

who—

(i)(A) Is licensed or otherwise 

regulated, if applicable, as an 

occupational therapist by the State in 

which practicing, unless licensure does 

not apply; 

(B) Graduated after successful 

completion of an occupational therapist 

education program accredited by the 

Accreditation Council for Occupational 

Therapy Education (ACOTE) of the 

American Occupational Therapy 

Association, Inc. (AOTA), or successor 

organizations of ACOTE; and 

(C) Is eligible to take, or has 

successfully completed the entry-level 

certification examination for 

occupational therapists developed and 

administered by the National Board for 

Certification in Occupational Therapy, 

Inc. (NBCOT). 

(ii) On or before December 31, 2009—

(A) Is licensed or otherwise regulated, 

if applicable, as an occupational 

therapist by the State in which 

practicing; or 

(B) When licensure or other regulation 

does not apply—

(1) Graduated after successful 

completion of an occupational therapist 

education program accredited by the 

accreditation Council for Occupational 

therapy Education (ACOTE) of the 

American Occupational Therapy 

Association, Inc. (AOTA) or successor 

organizations of ACOTE; and 

(2) Is eligible to take, or has 

successfully completed the entry-level 

certification examination for 

occupational therapists developed and 

administered by the National Board for 

Certification in Occupational Therapy, 

Inc., (NBCOT). 

(iii) On or before January 1, 2008—

(A) Graduated after successful 

completion of an occupational therapy 

program accredited jointly by the 

committee on Allied Health Education 

and Accreditation of the American 

Medical Association and the American 

Occupational Therapy Association; or 

(B) Is eligible for the National 

Registration Examination of the 

American Occupational Therapy 

Association or the National Board for 

Certification in Occupational Therapy. 

(iv) On or before December 31, 1977—

(A) Had 2 years of appropriate 

experience as an occupational therapist; 

and 

(B) Had achieved a satisfactory grade 

on an occupational therapist proficiency 

examination conducted, approved, or 

sponsored by the U.S. Public Health 

Service. 

(v) If educated outside the United 

States—

(A) Must meet both of the following: 

(1) Graduated after successful 

completion of an occupational therapist 

education program accredited as 

substantially equivalent to occupational 

therapist assistant entry level education 

in the United States by one of the 

following: 

(i) The Accreditation Council for 

Occupational Therapy Education 

(ACOTE). 

(ii) Successor organizations of 

ACOTE. 

(iii) The World Federation of 

Occupational Therapists. 

(iv) A credentialing body approved by 

the American Occupational Therapy 

Association. 

(v) Successfully completed the entry 

level certification examination for 

occupational therapists developed and 

administered by the National Board for 

Certification in Occupational Therapy, 

Inc. (NBCOT). 

(2) On or before December 31, 2009, 

is licensed or otherwise regulated, if 

applicable, as an occupational therapist 

by the State in which practicing. 

(6) Occupational therapy assistant. A 

person who 

(i) Meets all of the following: 

(A) Is licensed or otherwise regulated, 

if applicable, as an occupational therapy 

assistant by the State in which 

practicing, unless licensure does apply. 

(B) Graduated after successful 

completion of an occupational therapy 

assistant education program accredited 

by the Accreditation Council for 

Occupational Therapy Education 

(ACOTE) of the American Occupational 

Therapy Association, Inc. (AOTA) or its 

successor organizations. 

(C) Is eligible to take or successfully 

completed the entry-level certification 

examination for occupational therapy 

assistants developed and administered 

by the National Board for Certification 

in Occupational Therapy, Inc. (NBCOT). 

(ii) On or before December 31, 2009—

(A) Is licensed or otherwise regulated 

as an occupational therapy assistant, if 

applicable, by the State in which 

practicing; or any qualifications defined 

by the State in which practicing, unless 

licensure does not apply; or 

(B) Must meet both of the following: 

(1) Completed certification 

requirements to practice as an 

occupational therapy assistant 

established by a credentialing 

organization approved by the American 

Occupational Therapy Association. 

(2) After January 1, 2010, meets the 

requirements in paragraph (b)(6)(i) of 

this section. 

(iii) After December 31, 1977 and on 

or before December 31, 2007—

(A) Completed certification 

requirements to practice as an 

occupational therapy assistant 

established by a credentialing 

organization approved by the American 

Occupational Therapy Association; or 

(B) Completed the requirements to 

practice as an occupational therapy 

assistant applicable in the State in 

which practicing. 

(iv) On or before December 31, 1977—

(A) Had 2 years of appropriate 

experience as an occupational therapy 

assistant; and 

(B) Had achieved a satisfactory grade 

on an occupational therapy assistant 

proficiency examination conducted, 

approved, or sponsored by the U.S. 

Public Health Service. 

(v) If educated outside the United 

States, on or after January 1, 2008—

(A) Graduated after successful 

completion of an occupational therapy 

assistant education program that is 

accredited as substantially equivalent to 

occupational therapist assistant entry 

level education in the United States 

by—

(1) The Accreditation Council for 

Occupational Therapy Education 

(ACOTE). 

(2) Its successor organizations. 

(3) The World Federation of 

Occupational Therapists. 


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(4) By a credentialing body approved 

by the American Occupational Therapy 

Association; and 

(5) Successfully completed the entry 

level certification examination for 

occupational therapy assistants 

developed and administered by the 

National Board for Certification in 

Occupational Therapy, Inc. (NBCOT). 

(7) Physical therapist. A person who 

is licensed, if applicable, by the State in 

which practicing, unless licensure does 

not apply and meets one of the 

following requirements: 

(i) Graduated after successful 

completion of a physical therapist 

education program approved by one of 

the following: 

(A) The Commission on Accreditation 

in Physical Therapy Education 

(CAPTE). 

(B) Successor organizations of CAPTE. 

(C) An education program outside the 

United States determined to be 

substantially equivalent to physical 

therapist entry level education in the 

United States by a credentials 

evaluation organization approved by the 

American Physical Therapy Association 

or an organization identified in 8 CFR 

212.15(e) as it relates to physical 

therapists. 

(D) Passed an examination for 

physical therapists approved by the 

State in which physical therapy services 

are provided. 

(ii) On or before December 31, 2009—

(A) Graduated after successful 

completion of a physical therapy 

curriculum approved by the 

Commission on Accreditation in 

Physical Therapy Education (CAPTE); 

or 

(B) Meets both of the following: 

(1) Graduated after successful 

completion of an education program 

determined to be substantially 

equivalent to physical therapist entry 

level education in the United States by 

a credentials evaluation organization 

approved by the American Physical 

Therapy Association or identified in 8 

CFR 212.15(e) as it relates to physical 

therapists. 

(2) Passed an examination for 

physical therapists approved by the 

State in which physical therapy services 

are provided. 

(iii) Before January 1, 2008—

(A) Graduated from a physical therapy 

curriculum approved by one of the 

following: 

(1) The American Physical Therapy 

Association. 

(2) The Committee on Allied Health 

Education and Accreditation of the 

American Medical Association. 

(3) The Council on Medical Education 

of the American Medical Association 

and the American Physical Therapy 

Association. 

(iv) On or before December 31, 1977 

was licensed or qualified as a physical 

therapist and meets both of the 

following: 

(A) Has 2 years of appropriate 

experience as a physical therapist. 

(B) Has achieved a satisfactory grade 

on a proficiency examination 

conducted, approved, or sponsored by 

the U.S. Public Health Service. 

(v) Before 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; and 

(C) Graduated from a physical therapy 

curriculum in a 4-year college or 

university approved by a State 

department of education. 

(vi) Before January 1, 1966 was 

licensed or registered, and before 

January 1, 1970, had 15 years of fulltime 

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. 

(vii) If trained outside the United 

States before January 1, 2008, meets the 

following requirements: 

(A) Was 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. 

(8) Physical therapist assistant. A 

person who is licensed, registered or 

certified as a physical therapist 

assistant, if applicable, by the State in 

which practicing, unless licensure does 

not apply and meets one of the 

following requirements: 

(i) Graduated from a physical 

therapist assistant curriculum approved 

by the Commission on Accreditation in 

Physical Therapy Education of the 

American Physical Therapy 

Association; or if educated outside the 

United States or trained in the United 

States military, graduated from an 

education program determined to be 

substantially equivalent to physical 

therapist assistant entry level education 

in the United States by a credentials 

evaluation organization approved by the 

American Physical Therapy Association 

or identified at 8 CFR 212.15(e); and 

(ii) Passed a national examination for 

physical therapist assistants. 

(A) On or before December 31, 2009, 

meets one of the following: 

(1) Is licensed, or otherwise regulated 

in the State in which practicing. 

(2) In States where licensure or other 

regulations do not apply, graduated 

before December 31, 2009, from a 2-year 

college-level program approved by the 

American Physical Therapy Association 

and after January 1, 2010, meets the 

requirements of paragraph (b)(8) of this 

section. 

(3) Before January 1, 2008, where 

licensure or other regulation does not 

apply, graduated from a 2-year college 

level program approved by the 

American Physical Therapy 

Association. 

(4) On or before December 31, 1977, 

was licensed or qualified as a physical 

therapist assistant and has achieved a 

satisfactory grade on a proficiency 

examination conducted, approved, or 

sponsored by the U.S. Public Health 

Service. 

(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) Registered nurse. A graduate of a 

school of professional nursing. 

(2) Licensed practical nurse. A person 

who has completed a practical nursing 

program. 

(d) Standard: Criminal background 

checks. (1) The hospice must obtain a 

criminal background check on all 

hospice employees who have direct 

patient contact or access to patient 

records. Hospice contracts must require 

that all contracted entities obtain 

criminal background checks on 

contracted employees who have direct 

patient contact or access to patient 

records. 

(2) Criminal background checks must 

be obtained in accordance with State 

requirements. In the absence of State 

requirements, criminal background 

checks must be obtained within three 

months of the date of employment for 

all states that the individual has lived or 

worked in the past 3 years. 

§ 418.116 Condition of participation: 

Compliance with Federal, State, and local 

laws and regulations related to the 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: Multiple locations. 

Every hospice must comply with the 


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32220 Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Rules and Regulations 

requirements of § 420.206 of this 

chapter regarding disclosure of 

ownership and control information. All 

hospice multiple locations must be 

approved by Medicare and licensed in 

accordance with State licensure laws, if 

applicable, before providing Medicare 

reimbursed services. 

(b) 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. 

Subpart E [Removed and Reserved] 

§ 418.200 [Amended] 

■ 5. Section 418.200 is amended by 

revising the reference ‘‘§ 418.58’’ to read 

‘‘§ 418.56’’. 

§ 418.202 [Amended] 

■ 6. 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: December 19, 2007. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: May 23, 2008. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 08–1305 Filed 5–27–08; 4:00 pm] 

BILLING CODE 4120–01–P 


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