Medicare and Medicaid Programs: Hospice Conditions of Participation

Part II

Department of Health and Human Services

-----------------------------------------------------------------------

Centers for Medicare & Medicaid Services

-----------------------------------------------------------------------

42 CFR Part 418

Medicare and Medicaid Programs: Hospice Conditions of Participation;

Proposed Rule

Rules

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-3844-P]

RIN 0938-AH27

Medicare and Medicaid Programs: Hospice Conditions of

Participation

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

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would revise the existing conditions of

participation that hospices must meet to participate in the Medicare

and Medicaid programs. The proposed requirements focus on the care

delivered to patients and their families by hospices and the outcomes

of that care. The proposed requirements continue to reflect an

interdisciplinary view of patient care and allow hospices flexibility

in meeting quality standards. These changes are an integral part of the

Administration's efforts to achieve broad-based improvements in the

quality of health care furnished through the Medicare and Medicaid

programs.

DATES: We will consider comments if we receive them at the appropriate

address, as provided below, no later than 5 p.m. on July 26, 2005.

ent care and allow hospices flexibility

in meeting quality standards. These changes are an integral part of the

Administration's efforts to achieve broad-based improvements in the

quality of health care furnished through the Medicare and Medicaid

programs.

DATES: We will consider comments if we receive them at the appropriate

address, as provided below, no later than 5 p.m. on July 26, 2005.

ADDRESSES: In commenting, please refer to file code CMS-3844-P. Because

of staff and resource limitations, we cannot accept comments by

facsimile (FAX) transmission.

You may submit comments in one of three ways (no duplicates,

please):

1. Electronically. You may submit electronic comments to http://www.cms.hhs.gov/regulations/ecomments (attachments should be in

Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft

Word).

2. By mail. You may mail written comments (one original and two

copies) to the following address ONLY: Centers for Medicare & Medicaid

Services, Department of Health and Human Services, Attention: CMS-3844-

P, P.O. Box 8010, Baltimore, MD 21244-8010.

Please allow sufficient time for mailed comments to be received

before the close of the comment period.

3. By hand or courier. If you prefer, you may deliver (by hand or

courier) your written comments (one original and two copies) before the

close of the comment period to one of the following addresses. If you

intend to deliver your comments to the Baltimore address, please call

telephone number (410) 786-9994 in advance to schedule your arrival

with one of our staff members. Room 445-G, Hubert H. Humphrey Building,

200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security

Boulevard, Baltimore, MD 21244-1850.

(Because access to the interior of the HHH Building is not readily

available to persons without Federal Government identification,

commenters are encouraged to leave their comments in the CMS drop slots

located in the main lobby of the building

s. Room 445-G, Hubert H. Humphrey Building,

200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security

Boulevard, Baltimore, MD 21244-1850.

(Because access to the interior of the HHH Building is not readily

available to persons without Federal Government identification,

commenters are encouraged to leave their comments in the CMS drop slots

located in the main lobby of the building. A stamp-in clock is

available for persons wishing to retain a proof of filing by stamping

in and retaining an extra copy of the comments being filed.)

Comments mailed to the addresses indicated as appropriate for hand

or courier delivery may be delayed and received after the comment

period.

Submission of comments on paperwork requirements. You may submit

comments on this document's paperwork requirements by mailing your

comments to the addresses provided at the end of the ``Collection of

Information Requirements'' section in this document.

For information on viewing public comments, see the beginning of

the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Mary Rossi-Coajou, (410) 786-6051.

Danielle Shearer, (410) 786-6617.

Steve Miller, (410) 786-6656.

SUPPLEMENTARY INFORMATION:

Submitting Comments: We welcome comments from the public on all

issues set forth in this rule to assist us in fully considering issues

and developing policies. You can assist us by referencing the file code

CMS-3844-P and the specific ``issue identifier'' that precedes the

section on which you choose to comment.

Inspection of Public Comments: Comments received timely will be

available for public inspection as they are received, generally

beginning approximately 3 weeks after publication of a document, at the

headquarters of the Centers for Medicare & Medicaid Services, 7500

Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of

each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view

public comments, phone 1-800-743-3951.

I. Introduction

able for public inspection as they are received, generally

beginning approximately 3 weeks after publication of a document, at the

headquarters of the Centers for Medicare & Medicaid Services, 7500

Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of

each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view

public comments, phone 1-800-743-3951.

I. Introduction

As the single largest payer for health care services in the United

States, the Federal Government assumes a critical responsibility for

the delivery and quality of care furnished under its programs.

Historically, we have adopted a quality assurance approach that has

been directed toward identifying health care providers that furnish

poor quality care or fail to meet minimum Federal standards. These

problems would either be corrected or would lead to the exclusion of

the provider from participation in the Medicare or Medicaid programs.

However, we have found that this problem-focused approach has inherent

limits. Ensuring quality through the enforcement of prescriptive health

and safety standards, rather than improving the quality of care for all

patients, has resulted in our expending much of our resources on

dealing with marginal providers, rather than on stimulating broad-based

improvements in quality of care.

Eliciting quality health care for Federal beneficiaries from CMS-

certified providers and suppliers requires taking advantage of

continuing advances in the health care delivery field. As a result, we

are revising the Medicare hospice requirements, which are also used by

Medicaid, to focus on a patient-centered, outcome-oriented process that

promotes patient care foremost, rather than penalizing unproductive

providers. We have developed a set of core requirements for hospice

services that encompass the following: Patient rights, comprehensive

assessment, and patient care planning and coordination by a hospice

interdisciplinary group (IDG)

ch are also used by

Medicaid, to focus on a patient-centered, outcome-oriented process that

promotes patient care foremost, rather than penalizing unproductive

providers. We have developed a set of core requirements for hospice

services that encompass the following: Patient rights, comprehensive

assessment, and patient care planning and coordination by a hospice

interdisciplinary group (IDG). Overarching these requirements is a

quality assessment and performance improvement program that builds on

the philosophy that a provider's own quality management system is key

to improved patient care performance. The objective is to achieve a

balanced regulatory approach by ensuring that a hospice furnishes

health care that meets essential health and quality standards, while

ensuring that it monitors and improves its own performance.

To achieve this objective, we are working to revise not only the

hospice requirements but the requirements for several other major

health care provider types, such as hospitals, home health agencies,

and end-stage renal disease facilities, through separate rules. All of

the revised requirements are directed towards improving patient

outcomes of care and satisfaction.

II. Background

A. The Medicare Hospice Benefit

Hospice care is an approach to caring for the terminally ill

individual that provides palliative care rather than traditional

medical care and curative treatment. Palliative care is treatment for

the relief of pain and other

parate rules. All of

the revised requirements are directed towards improving patient

outcomes of care and satisfaction.

II. Background

A. The Medicare Hospice Benefit

Hospice care is an approach to caring for the terminally ill

individual that provides palliative care rather than traditional

medical care and curative treatment. Palliative care is treatment for

the relief of pain and other

uncomfortable symptoms through the appropriate coordination of all

aspects of care needed to maximize personal comfort and relieve

distress. Hospice care allows the patient to remain at home as long as

possible by providing support to the patient and family, and keeping

the patient as comfortable as possible while maintaining his or her

dignity and quality of life. A hospice uses an interdisciplinary

approach to deliver medical, social, physical, emotional, and spiritual

services through the use of a broad spectrum of caregivers.

Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982

(TEFRA), Public Law 97-248, added section 1861(dd) to the Social

Security Act (the Act) to provide coverage for hospice care to

terminally ill Medicare beneficiaries who elect to receive care from a

Medicare-participating hospice.

Under the authority of section 1861(dd) of the Act, the Secretary

has established the Conditions of Participation (CoPs) that a hospice

must meet to participate in Medicare and/or Medicaid, and these are

currently set forth at 42 CFR part 418. The CoPs apply to a hospice as

an entity as well as to the services furnished to each individual under

hospice care. Under section 1861(dd) of the Act, the Secretary is

responsible for ensuring that the CoPs, and their enforcement, are

adequate to protect the health and safety of individuals under hospice

care and to promote the effective and efficient use of Medicare funds.

To implement this requirement, State survey agencies conduct surveys of

hospices to assess their compliance with the CoPs.

spice care. Under section 1861(dd) of the Act, the Secretary is

responsible for ensuring that the CoPs, and their enforcement, are

adequate to protect the health and safety of individuals under hospice

care and to promote the effective and efficient use of Medicare funds.

To implement this requirement, State survey agencies conduct surveys of

hospices to assess their compliance with the CoPs.

B. Why Revise the Conditions of Participation?

The hospice CoPs were originally promulgated on December 16, 1983

(48 FR 56008) and were amended on December 11, 1990 (55 FR 50831)

largely to implement provisions of section 6005(b) of the Omnibus

Budget Reconciliation Act of 1989 (Pub. L. 101-239). However, many of

the current CoPs have remained unchanged since their inception.

We are proposing changes to the current CoPs based on four main

considerations. First, we considered the suggestions that emerged from

the Secretary's Advisory Committee on Regulatory Reform. In an effort

to make regulations more predictable and responsive to relevant

stakeholders, the Committee heard public testimony on a variety of

hospice related topics and developed recommendations to address key

issues that were highlighted. The two largest changes that resulted

from the Committee's recommendations are the clarification of the

relationship between nursing facilities and hospices at proposed Sec.

418.112, and the changes to the nursing services standard at proposed

Sec. 418.110(b).

Our second consideration was the Balanced Budget Act of 1997 (Pub.

L. 105-33) because it made changes to the hospice statute that need to

be incorporated into the CoPs.

Our third consideration was prompted by sections 408 and 946 of the

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(Pub. L. 108-173). Section 408 amended the Social Security Act to

permit a nurse practitioner to be deemed a patient's attending

physician when the patient elects hospice care

made changes to the hospice statute that need to

be incorporated into the CoPs.

Our third consideration was prompted by sections 408 and 946 of the

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(Pub. L. 108-173). Section 408 amended the Social Security Act to

permit a nurse practitioner to be deemed a patient's attending

physician when the patient elects hospice care. Section 946 amended

section 1861(dd), Hospice Care: Hospice Program, of the Act to permit a

hospice to enter into an arrangement with another hospice to provide

core hospice services, or to provide highly specialized services of a

registered professional nurse, in certain circumstances.

Finally, this revision is part of a larger effort to bring about

improvements in the quality of care furnished to Medicare and Medicaid

beneficiaries through an outcome-oriented approach to quality of care

responsibilities. The existing hospice CoPs do not contain patient-

centered, outcome-oriented standards, nor do they provide for the

operation of a quality assessment and performance improvement program.

Historically, we have established requirements for participation in

the Medicare program that address the structure and process of health

care. These early requirements are the result of professional

consensus. Enforcing structure and process requirements by identifying

deficient providers has not been adequate to meet the growing

challenges associated with the changing hospice care environment. For

example, rather than focusing on the relationship between the needs of

patients and the staff available in an inpatient facility, the current

regulations require that a registered nurse be present on every shift.

Hospices often contract with local nursing facilities to provide

inpatient respite care, and these facilities are only required to have

a registered nurse on duty for a single eight hour shift each day

n focusing on the relationship between the needs of

patients and the staff available in an inpatient facility, the current

regulations require that a registered nurse be present on every shift.

Hospices often contract with local nursing facilities to provide

inpatient respite care, and these facilities are only required to have

a registered nurse on duty for a single eight hour shift each day. A

hospice would have to supplement the nursing facility's staff with its

own, at a significant cost to the hospice, even if the needs and acuity

of the patient do not require a registered nurse. A hospice that did

not supplement the facility's staff could be cited for not meeting the

requirements, even though the requirements had no relevance to the

needs of the patient. Thus, revisions to the hospice CoPs are

essential.

C. Transforming the Hospice Conditions of Participation

Before developing these proposed CoPs for hospices, we received

advice and suggestions from the hospice industry, professional

associations, practitioner communities, consumer advocates, and State

and other governmental agencies with an interest in, or responsibility

for, hospice regulation and oversight. Based on these suggestions, we

have developed the following principles:

Focus on the continuous, integrated health care process

that a patient/family experiences across all aspects of hospice care,

and on activities that center around patient assessment, care planning,

service delivery, and quality assessment and performance improvement.

Use a patient-centered, interdisciplinary approach that

recognizes the contributions of various skilled professionals and other

support personnel and their interaction with each other to meet the

patient's needs.

Incorporate an outcome-oriented quality assessment and

performance improvement program.

Facilitate flexibility in how a hospice meets performance

expectations.

Require that patient rights are ensured.

Use performance measurement systems to evaluate and

improve care

various skilled professionals and other

support personnel and their interaction with each other to meet the

patient's needs.

Incorporate an outcome-oriented quality assessment and

performance improvement program.

Facilitate flexibility in how a hospice meets performance

expectations.

Require that patient rights are ensured.

Use performance measurement systems to evaluate and

improve care.

Based on these principles, we are proposing to set forth four core

conditions of participation: Patient Rights, Patient/Family Assessment,

Interdisciplinary Care Planning and Coordination of Services, and

Quality Assessment and Performance Improvement.

The Patient Rights CoP emphasizes a hospice's

responsibility to respect and promote the rights of each hospice

patient.

The comprehensive Patient/Family Assessment CoP reflects

the critical nature of a comprehensive assessment in determining

appropriate treatments and accomplishing desired health outcomes.

The Care Planning and Coordination of Services CoP

incorporates the interdisciplinary team approach to providing hospice

care.

The Quality Assessment and Performance Improvement CoP

charges each hospice with the responsibility for carrying out a

performance effort to effect continuing improvement in the

quality of care it furnishes to its patients and their families.

The last three requirements establish a cycle of individual care

and hospice-wide performance improvement. First, the patient's needs

are comprehensively assessed and outcome measure data are collected.

Second, the interdisciplinary group, in consultation with the patient's

attending physician, establishes a plan of care to address those needs.

Third, the plan of care is implemented and the results of the care are

evaluated through updates of the comprehensive assessment and plan of

care

ovement. First, the patient's needs

are comprehensively assessed and outcome measure data are collected.

Second, the interdisciplinary group, in consultation with the patient's

attending physician, establishes a plan of care to address those needs.

Third, the plan of care is implemented and the results of the care are

evaluated through updates of the comprehensive assessment and plan of

care. Fourth, the outcome measure data collected during the initial and

updated comprehensive assessments are analyzed to identify practices

that lead to positive outcomes as well as opportunities for

improvement. Finally, the hospice uses the results of such analyses to

implement performance improvement activities. These activities will

influence the establishment of plans of care and their implementation,

thus creating a continuous cycle of individual care and an ongoing

effort to improve the hospice's performance related to identified

outcomes of care for all patients.

This cycle of care adapts to changing standards of practice while

addressing issues that surveyors have identified. Below is a list of

the most cited deficiencies found by surveyors (year ending September

3, 2002):

1. Plan of care was not complete.

2. No written plan was established.

3. Plan was not reviewed at specific intervals.

4. Plan did not include an assessment of needs.

5. Plan was not established before providing care.

6. RN supervisory visits were not made for home health aide

services.

7. No plan of care was included for bereavement services.

8. Hospice did not conduct a self-assessment of quality and care

provided.

9. Clinical record was not maintained for every patient.

10. Interdisciplinary group did not review and update the plan of

care for each patient.

We note that 8 of the 10 top deficiencies are related to plan of

care, assessment, and quality assurance. Based on industry comments and

our own surveys, we believe that the current plan of care condition

contained in Sec. 418.58 must be strengthened

Clinical record was not maintained for every patient.

10. Interdisciplinary group did not review and update the plan of

care for each patient.

We note that 8 of the 10 top deficiencies are related to plan of

care, assessment, and quality assurance. Based on industry comments and

our own surveys, we believe that the current plan of care condition

contained in Sec. 418.58 must be strengthened. We did this by creating

a separate condition for the assessment of individual needs and for the

time frames related to that assessment. We also revised the quality

assurance requirement and strengthened the plan of care requirement.

These requirements would focus provider and surveyor efforts on the

actual care delivered to the patient, the performance of the hospice as

an organization, and the impact of the medical, physical, social,

emotional, and spiritual care delivered to the patient.

We are proposing to retain some of the current process-oriented

requirements when they are likely to produce desirable outcomes and/or

prevent harmful outcomes. These proposed CoPs invest in hospices the

responsibility for improving patient care performance, rather than

relying on an externally based approach where prescriptive requirements

are enforced through the punitive aspects of the survey process.

This change signals an opportunity for CMS, hospices, and States to

join in a partnership for improvement. When implemented, hospice

programming will reflect a patient-centered, outcome-oriented approach

that will likely alter the manner in which CMS and States manage the

survey process. We believe that this approach will provide

opportunities for improvement in patient care that have been lacking in

the past. The addition of a strong quality assessment and performance

improvement requirement will stimulate the hospice to continuously

monitor its performance and find opportunities for improvement.

D. Development of Outcome-Based Performance Measures for Hospices

rvey process. We believe that this approach will provide

opportunities for improvement in patient care that have been lacking in

the past. The addition of a strong quality assessment and performance

improvement requirement will stimulate the hospice to continuously

monitor its performance and find opportunities for improvement.

D. Development of Outcome-Based Performance Measures for Hospices

[If you choose to comment on issues in this section, please include the

caption ``OUTCOME-BASED PERFORMANCE MEASURES'' at the beginning of your

comments.]

We are proposing to require that hospices implement an outcome-

based internal performance improvement program that can be used to

measure individual patient outcomes. The information a hospice gleans

from its own data analysis will serve as a baseline for hospice quality

improvement. Measures quantify quality and are tools for the hospice to

use in assessing and improving patient care, outcomes, and

satisfaction. An outcome based performance program can help hospices

improve the effectiveness and efficiency of their services, improve the

outcomes of care they provide, and increase patient satisfaction with

their services.

Hospice outcome measures, data elements, tools, and instructions

for using them have already been developed by the industry. A Task

Force initiative was sponsored and convened by the National Hospice

Work Group (NHWG) and the National Hospice and Palliative Care

Organization (NHPCO) in 1999. We participated in the development of the

measures and provided technical assistance for pilot testing of the

measures. The Task Force was invited to present the results of the

measurement development work and results of the pilot studies to us in

November 2000.

The work of the Task Force resulted in four measures for the

outcome domains of self-determination, comfort, safety, and effective

grieving. The hospice industry rapidly moved to include these four

measures in the data set that they encourage member hospices to use and

report

to present the results of the

measurement development work and results of the pilot studies to us in

November 2000.

The work of the Task Force resulted in four measures for the

outcome domains of self-determination, comfort, safety, and effective

grieving. The hospice industry rapidly moved to include these four

measures in the data set that they encourage member hospices to use and

report. The data elements and instructions for using the measures are

publicly available on the NHPCO Web site at http://www.nhpco.org.

These outcome-based measures are part of a national reporting

process created by the hospice industry. If a hospice chooses to

participate in the NHCPO process, it submits its data to the NHPCO (or

its contractor). Reports are then generated for a hospice to compare

its performance with other hospices. The hospice may also choose to

send additional information for the NHPCO reporting process in the

areas of pertinent utilization data, appropriateness and effectiveness

of services, and patient/family satisfaction. All hospices that

participate in the NHPCO reporting process must comply with regulations

mandated by the Health Insurance Portability and Accountability Act of

1996 (Pub.L. 104-191, ``HIPAA''). Regulations implementing HIPAA were

published on December 28, 2000 (65 FR 82462) and were amended on August

14, 2002 (67 FR 53182).

We are not proposing to require that hospices participate in the

NHPCO process described above, but hospices may choose to use some of

the measures the NHPCO is already using as part of its comprehensive

assessment of the patient, and as part of the organization's quality

assessment and performance improvement program. Hospices may also

develop their own data elements and measurement processes.

Participating in the NHPCO outcome measurement and reporting process

would assist hospices in meeting the requirements of proposed Sec.

418.54(e)

he NHPCO is already using as part of its comprehensive

assessment of the patient, and as part of the organization's quality

assessment and performance improvement program. Hospices may also

develop their own data elements and measurement processes.

Participating in the NHPCO outcome measurement and reporting process

would assist hospices in meeting the requirements of proposed Sec.

418.54(e). At this time, we are neither proposing that hospices use any

particular measures of outcomes, nor that they report data to us.

However, we may consider doing so in the future.

We invite comments from the public on this aspect of the proposed

rule.

III. Provisions of the Proposed Regulations

A. Overview

Under our proposal, the hospice conditions of participation would

continue to be set forth in regulations under 42 CFR part 418. However,

since many of the existing requirements in part 418 would be revised,

consolidated with other requirements, or eliminated, we are proposing

changes to the existing organizational scheme. A significant change

would be to group all CoPs directly related to patient care and place

them together in a separate subpart. CoPs concerning hospice

organization and administration would be contained in another subpart.

We believe that this proposed organization better reflects a patient/

family-centered orientation and helps illustrate that patient

assessment, care planning, and quality assessment and improvement

efforts are central to the delivery of high quality care.

B. Subpart A, General Provisions

te subpart. CoPs concerning hospice

organization and administration would be contained in another subpart.

We believe that this proposed organization better reflects a patient/

family-centered orientation and helps illustrate that patient

assessment, care planning, and quality assessment and improvement

efforts are central to the delivery of high quality care.

B. Subpart A, General Provisions

The revised conditions would begin with existing Sec. 418.2 that

specifies the statutory authority and scope of the part for the ensuing

regulations. Section 418.1 would remain unchanged.

1. Scope of the Part (Proposed Sec. 418.2)

Section 418.2 would be revised to reflect the reorganization of the

part and to include an introductory statement describing the purpose of

the part.

2. Definitions (Proposed Sec. 418.3)

Existing Sec. 418.3 sets forth definitions for terms used in the

hospice CoPs. This section is being revised in order to provide further

clarification. We are proposing to move existing definitions of

``physician'' and ``social worker'' to proposed Sec. 418.114,

personnel requirements. We believe these definitions better fit in this

new condition. We propose to include the following definitions:

Attending physician (revised)

Bereavement counseling (revised)

Cap Period (same)

Clinical note (new)

Drug restraint (new)

Employee (revised)

Hospice (revised)

Hospice care (new)

Licensed professional (new)

Palliative care (new)

Physical restraint (new)

Progress note (new)

Representative (revised)

Restraint (new)

Satellite location (new)

Seclusion (new)

Terminally ill (revised)

These definitions would be revised to read as follows:

Attending physician means a--

(a)(1) Doctor of medicine or osteopathy legally authorized to

practice medicine and surgery by the State in which he or she performs

that function or action; or (2) Nurse practitioner who meets the

training, education and experience requirements as the Secretary may

prescribe; and

Terminally ill (revised)

These definitions would be revised to read as follows:

Attending physician means a--

(a)(1) Doctor of medicine or osteopathy legally authorized to

practice medicine and surgery by the State in which he or she performs

that function or action; or (2) Nurse practitioner who meets the

training, education and experience requirements as the Secretary may

prescribe; and

(b) Is identified by the individual, at the time he or she elects

to receive hospice care, as having the most significant role in the

determination and delivery of the individual's medical care.

Here after, except as indicated, the term ``attending physician''

includes nurse practitioners.

We modified this definition to address changes made to the Act by

Congress in section 408 of the Medicare Prescription Drug, Improvement,

and Modernization Act of 2003 (Pub. L. 108-173) (``MMA''). Nurse

practitioners are often the primary medical health care professionals

for some patients, particularly those residing in rural areas. For

example, a nurse practitioner that works in conjunction with a doctor

may be the health care professional a patient sees most often. The

patient would develop a relationship with the nurse practitioner, and

would like the nurse practitioner to continue to be involved in his or

her care once he or she elects the hospice benefit. Under the current

regulations, this is not allowed. Under the proposed regulations, we

would permit a nurse practitioner to continue serving his or her

patient as that patient's attending physician once that patient elects

to receive hospice care. We believe that this would ensure the

continuity of care and improve the quality of care because the health

care professional most familiar with the patient, his or her

conditions, and his or her personal situation would be involved in

developing the plan of care and in making other important decisions

ent as that patient's attending physician once that patient elects

to receive hospice care. We believe that this would ensure the

continuity of care and improve the quality of care because the health

care professional most familiar with the patient, his or her

conditions, and his or her personal situation would be involved in

developing the plan of care and in making other important decisions.

Within the provisions of section 408 of the MMA nurse practitioners

are prohibited from certifying or recertifying a patient's terminal

illness. CMS will publish additional information regarding section 408

in a forthcoming Federal Register document.

Bereavement counseling means emotional, psychosocial, and spiritual

support and services provided after the death of the patient to assist

with issues related to grief, loss, and adjusting.

Cap period means the 12-month period ending October 31 used in the

application of the cap on overall hospice reimbursement as specified in

Sec. 418.309.

Clinical note means a notation of a contact with the patient that

is written and dated by any person providing services, and that

describes signs and symptoms, treatments and medications administered,

including the patient's reaction and/or response, and any changes in

physical or emotional condition.

Drug restraint means a medication used to control behavior or to

restrict the patient's freedom of movement which is not a standard

treatment for a patient's medical or psychiatric condition.

Employee means a person who works for the hospice and for whom the

hospice is required to issue a W-2 form on his or her behalf, or if the

hospice is a subdivision of an agency or organization, an employee of

the agency or organization who is appropriately trained and assigned to

the hospice or is a volunteer under the jurisdiction of the hospice.

Hospice means a public agency or private organization or

subdivision of either of these that is primarily engaged in providing

hospice care as defined in this section

ehalf, or if the

hospice is a subdivision of an agency or organization, an employee of

the agency or organization who is appropriately trained and assigned to

the hospice or is a volunteer under the jurisdiction of the hospice.

Hospice means a public agency or private organization or

subdivision of either of these that is primarily engaged in providing

hospice care as defined in this section.

Hospice care means a comprehensive set of services described in

1861(dd)(1) of the Act, identified and coordinated by an

interdisciplinary team to provide for the physical, psychosocial,

spiritual, and emotional needs of a terminally ill patient and/or

family members, as delineated in a specific patient plan of care.

Licensed professional means a licensed person sanctioned by the

State in which services are delivered, furnishing services such as

skilled nursing care, physical therapy, speech-language pathology,

occupational therapy, and medical social services.

Palliative care means patient and family-centered care that

optimizes quality of life by anticipating, preventing, and treating

suffering. Palliative care throughout the continuum of illness involves

addressing physical, intellectual, emotional, social, and spiritual

needs and to facilitate patient autonomy, access to information, and

choice.

Physical restraint means any manual method or physical or

mechanical device, material, or equipment attached to the patient's

body that he or she cannot easily remove that restricts freedom of

movement or normal access to one's body.

Progress note means a written notation, dated and signed by any

person providing services, that summarizes facts about the care

furnished and the patient's response during a given period of time.

method or physical or

mechanical device, material, or equipment attached to the patient's

body that he or she cannot easily remove that restricts freedom of

movement or normal access to one's body.

Progress note means a written notation, dated and signed by any

person providing services, that summarizes facts about the care

furnished and the patient's response during a given period of time.

Representative means an individual who has the authority under

State law (whether by statute or pursuant to an appointment by the

courts of the State) to authorize or terminate medical care or to elect

or revoke the election of hospice care on behalf of a terminally ill

patient who is mentally or physically incapacitated. This may include a

legal guardian.

Restraint means either a physical restraint or a drug used as a

restraint.

Satellite location means a Medicare-approved location from which

the hospice provides hospice care and services within a portion of the

total geographic area served by the hospice provider issued the

provider agreement number. The satellite location is part of the

hospice and shares administration, supervision, and services in a

manner that renders it unnecessary for the satellite location to

independently meet the conditions of participation as a hospice.

We are proposing to add this definition to recognize long-standing

Medicare survey and certification policies, which allow for the

operation of multiple locations by a single hospice provider. We are

proposing that a hospice satellite location be approved by CMS before

it begins to furnish service to patients. In the past, some hospices

were found to be furnishing services from locations that had not been

shown to be in compliance with applicable regulations. We envision the

approval process to be consistent with determining that patients

receive safe services from the satellite location in question

hat a hospice satellite location be approved by CMS before

it begins to furnish service to patients. In the past, some hospices

were found to be furnishing services from locations that had not been

shown to be in compliance with applicable regulations. We envision the

approval process to be consistent with determining that patients

receive safe services from the satellite location in question. As is

done for other appropriate providers and suppliers, we are accepting

comment on applying the Medicare Appeals Procedures that affect

participation in the Medicare program (42 CFR 498.3). If a hospice,

including any or all satellite locations, is accredited by an

accrediting organization such as JCAHO or CHAP, the hospice and each

satellite location must still receive Medicare approval.

Seclusion means the confinement of a person in a room or an area

where a person is isolated and physically prevented from leaving.

Terminally ill means that a patient has a medical prognosis that

his or her life expectancy is six months or less if the illness runs

its normal course.

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

Subpart B concerns eligibility, election, and duration of hospice

benefits. We are not proposing changes to this subpart at this time.

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

1. Patient's Rights, Condition of Participation (Proposed Sec. 418.52)

[If you choose to comment on issues in this section, please include the

caption ``PATIENTS RIGHTS'' at the beginning of your comments.]

This section would replace the current condition of participation,

Informed consent, laid out at Sec. 418.62. This condition would set

forth certain rights to which hospice patients would be entitled, and

would require that hospices inform each patient of these rights and

that hospice personnel ensure and support these rights. Among these

rights would be the following, laid out at proposed Sec

his section would replace the current condition of participation,

Informed consent, laid out at Sec. 418.62. This condition would set

forth certain rights to which hospice patients would be entitled, and

would require that hospices inform each patient of these rights and

that hospice personnel ensure and support these rights. Among these

rights would be the following, laid out at proposed Sec. 418.52: Being

informed in advance regarding the care to be provided; having an

opportunity to participate in care planning; voicing grievances; being

assured of confidentiality of records; having personal property

respected; being informed whether services are covered or not covered,

and having information provided in writing. We are proposing to specify

that the patient must also be informed about factors that affect

palliation and comfort. We believe that these revisions would act as an

additional safeguard of patient health and safety. Open communication

between hospice staff and the patient, and patient access to palliative

information is vital to enhancing the patient's participation in his or

her coordinated care planning. All hospices must also comply with the

Privacy Rule published in the Federal Register on December 28, 2000 (65

FR 82461) as amended on August 14, 2002 (67 FR 53182) and contained in

45 CFR parts 160 and 164.

We are specifically soliciting public comment on this proposed

condition of participation.

2. The Cycle of Care: Assessment, Planning, and Delivery (Proposed

Sec. 418.54 Through Sec. 418.62)

The patient care assessment, planning, and palliative care process

represented by the next four CoPs (Sec. 418.54 through Sec. 418.62)

can be seen as a cycle. Through the use of a comprehensive assessment,

accurate and timely patient information is made available for use in

the patient care process. The palliative care process consists of all

hospice care and services furnished to the patient and family

care assessment, planning, and palliative care process

represented by the next four CoPs (Sec. 418.54 through Sec. 418.62)

can be seen as a cycle. Through the use of a comprehensive assessment,

accurate and timely patient information is made available for use in

the patient care process. The palliative care process consists of all

hospice care and services furnished to the patient and family. The

patient palliative care process results in an effect on the patient's

condition, whether it is positive or negative. The assessment of the

effectiveness of palliative care then results in subsequent care

decisions, and the cycle begins anew. Through this cycle, accurate

patient and family information obtained from each comprehensive

assessment should yield effective and appropriate palliative care

decisions, thus generating a positive effect on patient care and

desired outcomes.

Condition of Participation: Comprehensive Assessment of the Patient

(Proposed Sec. 418.54)

The proposed comprehensive assessment requirement reflects our view

that a patient-centered, interdisciplinary, and systematic patient

assessment is essential to improving patient quality of care and

patient outcomes.

In hospice care, the comprehensive assessment of the patient

contributes to quality of care improvements in closely linked stages.

First, the information generated from an interdisciplinary

comprehensive assessment is a vital tool for developing a hospice

patient's plan of care that will guide decisions on how best to

determine the individual care and support needs of the patient. Second,

based on updates of the comprehensive assessment, a hospice is able to

track the patient's progress towards achieving the desired care

outcomes, and where this does not occur, make appropriate changes to

the patient's plan of care. Finally, the hospice is able to evaluate

the results of its care decisions, thus yielding information to help

form the hospice's future care planning process

ond,

based on updates of the comprehensive assessment, a hospice is able to

track the patient's progress towards achieving the desired care

outcomes, and where this does not occur, make appropriate changes to

the patient's plan of care. Finally, the hospice is able to evaluate

the results of its care decisions, thus yielding information to help

form the hospice's future care planning process. We believe this

approach reflects contemporary standard practice for many hospices, and

we are proposing to revise the CoPs to support this outcome-oriented

approach.

The centerpiece of this outcome-oriented approach is that each

patient receives a patient-specific comprehensive assessment that

identifies the patient's need for medical, nursing, psychosocial,

emotional and spiritual care. The care needs identified in the

assessment would include, but not be limited to, those necessary for

palliation and management of the terminal illness and related medical

conditions. The comprehensive assessment would be completed by the

interdisciplinary group in consultation with the individual's attending

physician to ensure that each member of the interdisciplinary group

provided input within the scope of that individual's practice. We

believe that the patient-specific comprehensive assessment requirement

we are proposing is already recognized and practiced by the hospice

industry in general.

The existing CoPs contain few requirements that address the need

for patient assessment; therefore, we are emphasizing the importance of

the comprehensive assessment by establishing it as a separate CoP. In

hospice surveys nationwide, we have identified a pattern of healthcare

related deficiencies that indicate that the current assessment

requirements are not sufficient. The fourth most frequently cited

deficiency is that the plan of care did not include an assessment of

the patient's needs

e are emphasizing the importance of

the comprehensive assessment by establishing it as a separate CoP. In

hospice surveys nationwide, we have identified a pattern of healthcare

related deficiencies that indicate that the current assessment

requirements are not sufficient. The fourth most frequently cited

deficiency is that the plan of care did not include an assessment of

the patient's needs. The frequency with which this area is cited

indicates that there are a significant number of hospices that are not

doing enough to properly assess their patients.

The expanded assessment condition would guide these deficient

hospices in thoroughly assessing their patients by identifying the

general areas that should be included in each assessment and by

identifying time frames for the completion of assessments. We believe

that this proposed CoP would enable hospices to specifically identify

patient care needs. Once a hospice has completed a timely and thorough

assessment of the patient, it can develop an accurate plan of care that

reflects the needs identified during the assessment. The accuracy and

timeliness of the plan of care may lead to an improvement in the

quality of the hospice experience for the patient and his or her

family.

In addition, we believe that the broad assessment outline we are

proposing will encourage hospices to exercise flexibility in

determining how best to achieve positive outcomes. We believe that this

approach is consistent with currently accepted practices in hospices.

In Sec. 418.54(a), Initial assessment, we are proposing that a

registered nurse make the initial assessment visit to determine the

patient's immediate care and support needs within 24 hours after the

hospice receives a physician's admission order for care (unless another

date is specified by the physician)

elieve that this

approach is consistent with currently accepted practices in hospices.

In Sec. 418.54(a), Initial assessment, we are proposing that a

registered nurse make the initial assessment visit to determine the

patient's immediate care and support needs within 24 hours after the

hospice receives a physician's admission order for care (unless another

date is specified by the physician). We realize that some hospices meet

with patients and their families, at their request, before the actual

admission for care orders are received, and this regulation would not

prevent this practice. However, meeting with a patient and his or her

family before the patient's physician orders hospice care would not

satisfy the initial assessment requirement.

In Sec. 418.54(b), Time frame for completion of the comprehensive

assessment, we are proposing that the hospice interdisciplinary group,

in consultation with the hospice medical director or physician designee

and/or the individual's attending physician, complete the comprehensive

assessment in a timely manner consistent with the patient's immediate

needs, but no later than 4 calendar days after the patient elects the

hospice benefit. We believe that most hospices already complete the

assessment within this time frame and, due to the decreased length of

stay, as explained in the discussion of Sec. 418.54(d), Update of the

comprehensive assessment, and the potential severity of the patient's

condition, we believe it is essential to ensure that patients are

assessed in a timely manner.

Section Sec. 418.54(c), Content of the comprehensive assessment,

would describe the requirements for the content of the comprehensive

assessment that we believe are critical to quality hospice care. These

content requirements are at the core of hospice care and are needed to

evaluate the patient's need for physical, social, emotional, medical,

and spiritual care.

Under proposed Sec

manner.

Section Sec. 418.54(c), Content of the comprehensive assessment,

would describe the requirements for the content of the comprehensive

assessment that we believe are critical to quality hospice care. These

content requirements are at the core of hospice care and are needed to

evaluate the patient's need for physical, social, emotional, medical,

and spiritual care.

Under proposed Sec. 418.54(c)(3)(ii), Drug therapy, the patient's

comprehensive assessment would have to` include a review of the

patient's current medication. The review and accompanying documentation

would include identification of the following items:

Ineffective drug therapy;

Unwanted side and toxic effects; and

Drug interactions.

This review must be repeated as necessary to ensure that the

patient continues to receive drug therapy that is effective and

appropriate for his or her needs. A review of a patient's drugs would

be included in the initial assessment and in the development of the

plan of care. This review could occur at any time, but specifically

when a patient is prescribed or begins to take any new drug and/or when

use of a drug is discontinued.

In Sec. 418.54(d), Update of the comprehensive assessment, we are

proposing that the comprehensive assessment be updated by the

interdisciplinary group as frequently as the patient's condition

requires, but no less frequently than every 14 days. We believe that

these frequent reviews are necessary and predictive of quality outcomes

for two reasons:

(1) In the terminal stages of care, patient status needs,

circumstances, and family expectations can change greatly, affecting

the type and frequency of services that should be furnished.

Reassessments assist the hospice in developing a more responsive care

plan. The interdisciplinary group would use assessment information to

guide necessary reviews and/or changes to the patient's plan of care.

) In the terminal stages of care, patient status needs,

circumstances, and family expectations can change greatly, affecting

the type and frequency of services that should be furnished.

Reassessments assist the hospice in developing a more responsive care

plan. The interdisciplinary group would use assessment information to

guide necessary reviews and/or changes to the patient's plan of care.

(2) We are proposing that a hospice medical director or physician

designee be required to recertify a patient for hospice care at

specific intervals as stated in Sec. 418.21. We believe

recertification, which occurs at the end of the initial and subsequent

90-day benefit periods (and at the end of the remaining benefit periods

as described in Sec. 418.21), serves as a logical point for updating

an assessment in addition to the minimum 14 days and when the patient's

condition changes.

We believe that to ensure quality and timely care for our hospice

beneficiaries, timely completion of the initial assessment requirement

and the comprehensive assessment update requirement is necessary. In

2001 the average length of enrollment in hospice care was 51 days (2002

Nov. Medicare National Summary for HHA, Hospice, SNF, and outpatient CY

1999-2001, http://www.cms.hhs.gov/statistics/feeforservice/National

Summary.pdf). According to research by the NHPCO, in 2000 the average

length of enrollment in hospice care was 48 days (2000 NHPCO National

Data Set Summary Report, 2001 Nov.). There has been some concern

regarding short lengths of stay. Hospices have been admitting patients

late in their terminal illness and those patients need extensive

hospice services and resources initially, and right before death. In

order to ensure that patients receive the necessary services and thus

begin to benefit from hospice care at the earliest time possible, we

believe that it is important that the comprehensive patient assessment

be completed within the time frame that we have proposed

in their terminal illness and those patients need extensive

hospice services and resources initially, and right before death. In

order to ensure that patients receive the necessary services and thus

begin to benefit from hospice care at the earliest time possible, we

believe that it is important that the comprehensive patient assessment

be completed within the time frame that we have proposed. A delay in

completing the initial comprehensive assessment and the updated

assessments is ultimately not as beneficial to the patient and family

as if the patient had entered hospice care and received timely

assessments to determine the proper care to be provided.

These requirements, though process-oriented in part, are predictive

of good patient care and safety. Our rationale for requiring the

completion of the initial comprehensive assessment is that a new

patient being referred to a hospice for initiation of services is at a

point of immediate need and often in crisis. Likewise, maintaining an

ineffective plan of care could jeopardize patient health and safety.

Regular assessment updates would minimize this possibility.

We believe that the comprehensive assessment requirements pose

little or no burden for hospices because it is a current standard of

practice to

comprehensively assess hospice patients. However, we recognize that the

proposed 4-day timeframe for completing the initial comprehensive

assessment as proposed in Sec. 418.54(b) and 14-day timeframe for

updating the comprehensive assessment as proposed in Sec. 418.54(d)

may set higher performance expectations for some hospices then the

self-imposed standards they currently utilize. We believe that if a

hospice recognizes that it is not capable of furnishing services within

these timeframes, new patients should not be accepted for care.

We welcome public comments on the review of our proposed timeframes

for the initial comprehensive assessment and updated comprehensive

assessment

ance expectations for some hospices then the

self-imposed standards they currently utilize. We believe that if a

hospice recognizes that it is not capable of furnishing services within

these timeframes, new patients should not be accepted for care.

We welcome public comments on the review of our proposed timeframes

for the initial comprehensive assessment and updated comprehensive

assessment. We believe the timeframes are reasonable and consistent

with current hospice practice.

[If you choose to comment on issues in this section, please include the

caption ``ASSESSMENT TIME FRAMES'' at the beginning of your comments.]

Under the proposed Sec. 418.54(e), Patient outcome measures, we

are proposing that a patient's comprehensive assessment include

measurement and documentation of aspects of care that are essential

outcomes of optimal hospice care. Documentation is carried out in the

same way for all patients through what we refer to as data elements.

The hospice may develop its own data elements or use existing,

externally developed data elements. However, some of the data elements

should be related to the domains of self-determination, comfort,

safety, and effective grieving related to bereavement services. If a

hospice chooses to collect information for the data elements developed

by the NHPCO, it may also choose to submit this information to the

NHCPO. However, submission must be in accordance with the HIPAA privacy

rule (45 CFR Parts 160 and 164). The hospice may also choose to send

additional information for the NHPCO reporting process in the areas of

pertinent utilization data, appropriateness and effectiveness of

services, and patient/family satisfaction.

The data elements used by the hospice must be an integral part of

both the initial comprehensive and updated assessments

ce with the HIPAA privacy

rule (45 CFR Parts 160 and 164). The hospice may also choose to send

additional information for the NHPCO reporting process in the areas of

pertinent utilization data, appropriateness and effectiveness of

services, and patient/family satisfaction.

The data elements used by the hospice must be an integral part of

both the initial comprehensive and updated assessments. The application

of these data elements to the identified domains must be documented in

a systematic and retrievable way for each patient, as the outcome

measurements will be used in patient care planning and coordinating

services. Measurements will also be used (in the aggregate) for the

hospice quality assessment and performance improvement program.

We want to emphasize that we are not proposing that hospices use

any specific data elements to measure domain outcomes. We are simply

proposing that hospices collect the data necessary to evaluate the

quality of care they are providing and use this information in a

systematic and retrievable way. Hospices may develop their own data

elements related to the aspects of care related to hospice and

palliation, such as self-determination, comfort, safety, and effective

grieving, or may use the data elements related to the seven outcome

measures in the NHPCO data set (http://www.nhpco.org).

Currently, there is insufficient evidence for a valid and reliable

common set of measures (that is, data elements) for use in hospice

care. We are aware that the industry is studying this area. We also

know that there are many measures that are currently used to help gauge

the processes of care for hospice patients and to make adjustments to

care on their basis. For example, there are multiple scales for use in

pain management, anxiety, and depression, and there are several

quality-of-life scales appearing in the relevant literature (http://www.nhpco.org and http://www.chcr.brown.edu/pcoc/toolkit.htm)

there are many measures that are currently used to help gauge

the processes of care for hospice patients and to make adjustments to

care on their basis. For example, there are multiple scales for use in

pain management, anxiety, and depression, and there are several

quality-of-life scales appearing in the relevant literature (http://www.nhpco.org and http://www.chcr.brown.edu/pcoc/toolkit.htm). Some

measurable outcomes can be captured in single items while others

require multiple items to capture the full range of measurement issues.

We welcome comments on our ``outcome measures'' approach to this

proposed regulation. We are particularly interested in comments as to

whether this approach is necessary in assessment, care planning,

service delivery, and most importantly, to the hospice's quality

assessment and performance improvement program.

[If you choose to comment on issues in this section, please include the

caption ``OUTCOME MEASURES'' at the beginning of your comments.]

Condition of Participation: Interdisciplinary Group Care Planning and

Coordination of Services (Proposed Sec. 418.56)

[If you choose to comment on issues in this section, please include the

caption ``PLAN OF CARE'' or ``COORDINATION OF SERVICES'' where

appropriate, at the beginning of your comments.]

The existing condition of participation concerning the plan of care

is set forth at Sec. 418.58. We are proposing to revise the contents

of this section and place them in a new condition, ``Interdisciplinary

group care planning and coordination of services'' (proposed Sec.

418.56). The proposed condition would contain five standards that

reflect the interdisciplinary approach to hospice care delivery

ting condition of participation concerning the plan of care

is set forth at Sec. 418.58. We are proposing to revise the contents

of this section and place them in a new condition, ``Interdisciplinary

group care planning and coordination of services'' (proposed Sec.

418.56). The proposed condition would contain five standards that

reflect the interdisciplinary approach to hospice care delivery.

As proposed, each patient and family would have a written plan of

care developed by the hospice interdisciplinary group in consultation

with the patient's attending physician that specifies the hospice care

and services necessary to meet the patient/family-specific needs

identified in the comprehensive and updated assessments. All hospice

services furnished to patients and their families must follow this

written plan of care.

Under proposed Sec. 418.56(a), Approach to service delivery, we

are proposing that the hospice designate an interdisciplinary group or

groups composed of individuals who work together to meet the physical,

medical, social, emotional, and spiritual needs of the hospice patients

and families facing terminal illness and bereavement. We believe that

the role of the interdisciplinary group is paramount in directing and

monitoring the patient care and is one of the factors that makes the

hospice benefit unique. The hospice would designate a qualified health

care professional who is a member of the interdisciplinary group to

provide program coordination, ensure the continuous assessment of each

patient's and family's needs, and ensure the implementation and

revision of the plan of care.

The proposed standard at Sec. 418.56(b), Plan of care, is the same

as the existing standard at Sec. 418.58(a), with one addition. We are

including a reference to the patient's family when establishing the

plan of care

y group to

provide program coordination, ensure the continuous assessment of each

patient's and family's needs, and ensure the implementation and

revision of the plan of care.

The proposed standard at Sec. 418.56(b), Plan of care, is the same

as the existing standard at Sec. 418.58(a), with one addition. We are

including a reference to the patient's family when establishing the

plan of care. We would require that all hospice services furnished to

patients and their families follow a written plan of care established

by the hospice interdisciplinary group in collaboration with the

attending physician. Family plays an important role in the care of a

hospice patient, and this change reflects that role.

Under the proposed standard at Sec. 418.56(c), Content of the plan

of care, we would require that each patient's plan of care reflect

interventions for problems identified in the comprehensive and updated

assessments. This requirement ensures that care and services are

appropriate to the level of each patient's and family's specific needs.

The plan of care must include the following:

Interventions to facilitate the management of pain and

symptoms;

A detailed statement of the scope and frequency of

services required to meet the patient's and family's specific needs;

Measurable outcomes anticipated from implementing and

coordinating the plan of care;

Drugs and treatment necessary to meet the needs of the

patient;

Medical supplies and appliances required to meet the needs

of the patient; and

The interdisciplinary group's documentation in the

clinical record indicating the patient's and family's understanding,

involvement, and agreement with the plan.

As we noted in the description of the previous standard, we are

proposing to add a requirement that the plan address the patient's and

family's expectations, understanding, agreement, and ability to

participate in the care as the patient and family desire

roup's documentation in the

clinical record indicating the patient's and family's understanding,

involvement, and agreement with the plan.

As we noted in the description of the previous standard, we are

proposing to add a requirement that the plan address the patient's and

family's expectations, understanding, agreement, and ability to

participate in the care as the patient and family desire. Since family

members need to understand the importance of their role in care of the

hospice patient, their input and agreement regarding care is essential

in developing a productive relationship with the hospice. We would

expect a hospice to document the patient's and family's understanding

of and agreement to the plan of care in accordance with its own

policies. This could include an attestation signed by the patient and

family, a note in the clinical record, and/or another form of

documentation decided upon by the hospice governing body.

Proposed standard Sec. 418.56(d), Review of the plan of care,

would require that a revised plan of care include current information

from the patient's updated comprehensive assessment and information

concerning the patient's progress toward achieving outcomes specified

in the plan of care. The plan of care must be reviewed at intervals

specified in the plan but no less frequently than every 14 calendar

days. We believe that it is essential to include the requirement that

actual care provided also be changed as needed, thus establishing the

essential linkage between assessment information, evaluation of

treatment results, and plan of care modification.

We also propose to require that the hospice take steps to involve

the patient's attending physician in the review of the patient's plan

of care. The attending physician often has had a lengthy relationship

with the patient; and his or her input into the review of the plan of

care can be invaluable

between assessment information, evaluation of

treatment results, and plan of care modification.

We also propose to require that the hospice take steps to involve

the patient's attending physician in the review of the patient's plan

of care. The attending physician often has had a lengthy relationship

with the patient; and his or her input into the review of the plan of

care can be invaluable. We do not have the authority in the Conditions

of Participation governing hospices to require that an attending

physician, an individual who is not an employee of the hospice and thus

not governed by these hospice regulations, participate in this process.

However, we can and are proposing that the hospice collaborate with the

patient's attending physician to the extent possible when reviewing the

plan of care. We believe that requiring hospices to involve interested

attending physicians will benefit patients by helping to ensure that

the care described in the plan of care reflects the needs and desires

of patients and their families.

We are proposing to add a new standard, Coordination of services,

at Sec. 418.56(e). This standard would require that the hospice

maintain a system of communication and integration to enable the

interdisciplinary group to ensure the overall provision of care and the

efficient implementation of the day-to-day policies. These new

standards would also make it easier for the hospice to ensure that the

care and services are provided in accordance with the plan of care, and

that all care and services provided are based on the comprehensive and

updated assessments of the patient's and family's needs. An effective

communication system would also enable the hospice to ensure ongoing

liaison of all disciplines providing care and services in the home,

outpatient, and inpatient settings, notwithstanding the manner in which

the care and services are furnished.

We believe that this standard is appropriate for two reasons

comprehensive and

updated assessments of the patient's and family's needs. An effective

communication system would also enable the hospice to ensure ongoing

liaison of all disciplines providing care and services in the home,

outpatient, and inpatient settings, notwithstanding the manner in which

the care and services are furnished.

We believe that this standard is appropriate for two reasons.

First, a hospice patient typically encounters many services delivered

at different times by a variety of individuals with different skills.

An efficient method of communication and integration of observations

among members of the interdisciplinary group and others providing care

is essential to meet and respond to the patient's and family's needs in

a timely manner. Second, effective communication and coordination of

services will assist a hospice in avoiding a duplication of effort or a

furnishing of conflicting services.

We recognize the value of an interdisciplinary approach to the

delivery of hospice services. This approach to care reflects actual

industry practice, and as a result, we believe the proposed requirement

is in step with the hospice industry.

We are specifically soliciting public comment on the proposed

requirements for the content of the plan of care, the time frames for

review of the plan of care, and the new coordination of services

standard.

Condition of Participation: Quality Assessment and Performance

Improvement (Proposed Sec. 418.58)

[If you choose to comments on issues in this section, please include

the caption ``QAPI'' at the beginning of your comments.]

The existing Sec. 418.66, Condition of participation--Quality

assurance, relies on a problem-oriented approach to identify and

resolve patient care issues. Failure to meet the quality assurance

condition is consistently one of the top 10 deficiencies cited by

surveyors nationwide. According to the hospice industry associations,

hospices are no longer using the quality assurance model

ments.]

The existing Sec. 418.66, Condition of participation--Quality

assurance, relies on a problem-oriented approach to identify and

resolve patient care issues. Failure to meet the quality assurance

condition is consistently one of the top 10 deficiencies cited by

surveyors nationwide. According to the hospice industry associations,

hospices are no longer using the quality assurance model. During the

last decade the health care industry, including the hospice industry,

has moved beyond the problem-oriented, after-the-fact corrective

approach of quality assurance to an approach that focuses on a pre-

emptive plan that continuously addresses quality assessment and

performance improvement (QAPI). Hospice industry associations have

indicated that their upgraded QAPI systems are incompatible with the

existing quality assurance condition. Therefore, the providers who have

moved beyond quality assurance in order to make meaningful and

sustained quality improvements in their own programs are actually in

violation of the outdated quality assurance condition.

On the other end of the spectrum are providers who are truly

deficient because they do not have any quality program. These providers

would find more guidance in the proposed regulation. In the following

section of this preamble we will discuss two publicly available

resources for data measures, an integral part of the proposed QAPI

requirement. In the proposed regulation we have outlined when those

should be collected and what role they play in the proposed QAPI

condition. In addition, we have described the scope of the proposed

QAPI program requirement, the guidelines for identifying performance

improvement activities, and the individuals responsible for ensuring

that a hospice has a QAPI program. The proposed regulations provide

hospices that are unsure of what is expected of them with the

guidelines to begin tailoring a QAPI program that meets their needs and

circumstances

have described the scope of the proposed

QAPI program requirement, the guidelines for identifying performance

improvement activities, and the individuals responsible for ensuring

that a hospice has a QAPI program. The proposed regulations provide

hospices that are unsure of what is expected of them with the

guidelines to begin tailoring a QAPI program that meets their needs and

circumstances.

Therefore, we believe that this proposed condition will reduce the

number of deficient providers by recognizing those who are practicing

QAPI and guiding reluctant providers to meet current standards of

practice. The proposed QAPI requirement would raise the performance

expectations for hospices seeking entrance into the Medicare program,

as well the expectations of those currently participating in Medicare.

We are proposing that each hospice develop,

implement, and maintain an effective, continuous quality assessment and

performance improvement program that stimulates the hospice to

constantly monitor and improve its own performance, and to be

responsive to the needs, desires, and satisfaction levels of the

patients and families it serves.

The desired overall outcome of this proposed CoP is that the

hospice will drive its own quality improvement activities and improve

its provision of services. With an effective quality assessment and

performance improvement program in place and operating properly, the

hospice can better identify and reinforce the activities it is doing

well, identify its activities that are leading to poor patient

outcomes, and take actions to improve performance.

This proposed condition requires the hospice to develop, implement,

and maintain an effective data driven quality assessment and

performance improvement program (QAPI). The program establishes a

planned approach to quality improvement and takes into account the

complexity of the hospice's organization and services, including those

provided directly or under arrangement

o improve performance.

This proposed condition requires the hospice to develop, implement,

and maintain an effective data driven quality assessment and

performance improvement program (QAPI). The program establishes a

planned approach to quality improvement and takes into account the

complexity of the hospice's organization and services, including those

provided directly or under arrangement. The hospice must take whatever

actions are necessary to implement improvements in its performance as

identified by its quality assessment and performance improvement

program. The hospice is also responsible for ensuring that the

professional services it offers are carried out within current clinical

practice guidelines as well as professional practice standards

applicable to hospice care.

In the first proposed standard under this condition at Sec.

418.58(a), Standard: Program scope, we are proposing that the hospice's

quality assessment and performance improvement program must include,

but not be limited to, an ongoing program that is able to show

measurable improvement in indicators that are linked to improving

palliative outcomes and end-of-life support services. We expect that a

hospice will use standards of care and the findings made available in

current literature to select indicators to monitor its program. The

hospice must measure, analyze, and track these quality indicators,

including areas such as adverse patient events and other aspects of

performance that assess processes of care, hospice services, and

operations. Adverse patient events, as used in the field, are

occurrences that are harmful or contrary to the targeted patient

outcomes.

The second proposed standard under Sec. 418.58(b) Program data,

would require the hospice program to incorporate quality indicator

data, including patient care data and other relevant data, into its

QAPI program. This would include data that are received from or

submitted to hospice professional organizations

ld, are

occurrences that are harmful or contrary to the targeted patient

outcomes.

The second proposed standard under Sec. 418.58(b) Program data,

would require the hospice program to incorporate quality indicator

data, including patient care data and other relevant data, into its

QAPI program. This would include data that are received from or

submitted to hospice professional organizations. A fundamental barrier

in identifying quality care at the end of life is the lack of

measurement tools. Measurement tools can identify opportunities for

improving medical care and examining the impact of interventions.

CMS does not currently require the submission of data from hospices

to calculate quality measures but is interested in the development of a

set of measures. Hospice measures were submitted and discussed as part

of the recent National Quality Forum process identifying home health

measures but were withdrawn and added to the more focused end of life

discussions. CMS would be interested in comments regarding clinical

measures, patient experience of care measures, and systems measures

(use of information technology, staffing, follow up mechanisms)

specific to hospice care. These comments should include existing

measures in use, measures to be developed, data collection methods and

issues, and how measures are currently being used. We are especially

interested in the feasibility, usability, if the measures presented are

proprietary or publicly available, and burden of collecting and

reporting the measures.

An example of available measurement tools would be the hospice

outcome measures, data elements, tools, and instructions developed by a

hospice industry task force in which the CMS participated as a

stakeholder. A Task Force initiative was sponsored and convened by the

National Hospice Work Group (NHWG) and the National Hospice and

Palliative Care Organization (NHPCO) in 1999. We participated in

developing the measures and provided technical assistance for pilot

testing the measures

ts, tools, and instructions developed by a

hospice industry task force in which the CMS participated as a

stakeholder. A Task Force initiative was sponsored and convened by the

National Hospice Work Group (NHWG) and the National Hospice and

Palliative Care Organization (NHPCO) in 1999. We participated in

developing the measures and provided technical assistance for pilot

testing the measures. In addition to the work that has already been

done in this area, we are committed to working with all relevant

interest groups and associations as they develop and provide hospices

with model quality assessment and performance improvement programs and

other services.

The work of the Task Force resulted in measures addressing the

outcome domains of self-determined life closure, comfortable dying,

safe dying, and effective grieving. The hospice industry moved to

include these measures in the data set that they encourage member

hospices to use and report. The data elements, tools, and instructions

for using the measures are publicly available on the NHPCO website

http://www.nhpco.org.

If a hospice chooses to participate in this voluntary process as

described in the NHPCO web site, it would collect the specified data

elements, analyze the data to assess its performance, and implement

performance improvement projects to address weaknesses while

reinforcing strengths. A hospice may also choose to submit its data to

the NHPCO or its contractor. The national reporting process includes

pertinent utilization data, appropriateness and effectiveness of

services, and patient and family satisfaction. Reports are then

generated by the NHPCO for hospices to compare their performance with

other hospices.

All hospices that choose to utilize the NHPCO reporting process

will need to follow the HIPAA Privacy Rule

to

the NHPCO or its contractor. The national reporting process includes

pertinent utilization data, appropriateness and effectiveness of

services, and patient and family satisfaction. Reports are then

generated by the NHPCO for hospices to compare their performance with

other hospices.

All hospices that choose to utilize the NHPCO reporting process

will need to follow the HIPAA Privacy Rule. We believe that

participating in the NHPCO reporting process in order to improve the

quality of care delivered to patients would probably be deemed to be

part of the hospice's health care operations under the HIPAA Privacy

Rule. The NHPCO would be doing work on behalf of the hospice.

Therefore, it appears that the hospice and the NHPCO would be required

to have a business associate agreement, ensuring that the NHPCO would

protect the health information submitted by the hospice. Sample

business associate language is available at http://www.hhs.gov/ocr/hipaa/contractprov.html. Hospices should confer with their legal

counsel to ensure that their disclosures are in compliance with the

Department's rules. Once the business associate agreement was in place

and the hospice began to submit its data, it would not need individual

authorization to disclose protected health information to the NHPCO. In

addition, the hospice would not need to account for the disclosures to

the NHPCO.

We are not proposing to require that hospices use any particular

process or outcome measures. However, a hospice that uses the available

quality measures may be able to expect an enhanced degree of insight

into the quality of its services and patient satisfaction than if it

began the outcome-measure development process anew. In addition to the

NHPCO measures, there are many other resources available. One of these

resources, for example, is the ``TIME: Toolkit of Instruments to

Measure End of life care,'' developed by Brown University. It can be

found at http://www.chcr.brown.edu/pcoc/toolkit.htm

nto the quality of its services and patient satisfaction than if it

began the outcome-measure development process anew. In addition to the

NHPCO measures, there are many other resources available. One of these

resources, for example, is the ``TIME: Toolkit of Instruments to

Measure End of life care,'' developed by Brown University. It can be

found at http://www.chcr.brown.edu/pcoc/toolkit.htm. This Toolkit takes

steps toward crossing the measurement barrier by creating patient-

focused, family-centered survey instruments that address the needs and

concerns of patients and their families, as defined by them.

The hospice could also develop its own data elements and

measurement process as part of its quality assessment and performance

improvement program. A hospice is free to develop a program that meets

its needs. We recognize the diversity of provider needs and concerns

with respect to QAPI programs. As such, a provider's QAPI program will

not be judged against a specific model.

Under the proposed standard, Program data, found at Sec.

418.58(b), the hospice is expected to monitor the effectiveness of

services and be able to target areas for improvement. The main goal of

the quality assessment and performance improvement standard is to

identify and correct ineffective and/or unsafe care. We expect hospices

to assess their patient load and identify circumstances that could lead

to significant patient care issues and concentrate quality assessment

and performance improvement energies in these areas. For example,

patients with minimal support care, those experiencing frequent

exacerbations of symptoms, and those whose diagnosis and care may be

unique to the hospice, may be the subject of more intense quality

assessment and performance improvement activity. We expect a hospice to

be able to demonstrate consistent performance progress in successful

quality assessment and performance improvement interventions

nts with minimal support care, those experiencing frequent

exacerbations of symptoms, and those whose diagnosis and care may be

unique to the hospice, may be the subject of more intense quality

assessment and performance improvement activity. We expect a hospice to

be able to demonstrate consistent performance progress in successful

quality assessment and performance improvement interventions.

The third standard under the quality assessment and performance

improvement program at proposed Sec. 418.58(c), Program activities,

states that the hospice must set priorities for its performance

improvement activities that: focus on high risk, high volume and

problem-prone areas; consider the prevalence and severity of identified

problems; and give priority to improvement activities that affect

palliative, patient safety, and quality of care outcomes. We expect

that a hospice would take immediate action to correct any identified

problems that directly or potentially threatened the care and safety of

patients. Prioritizing areas of improvement is essential for the

hospice to gain a strategic view of its operating environment and to

ensure the consistent quality of care provided over time.

In Sec. 418.58(c) we are also proposing to require the hospice to

track adverse patient events, analyze their causes, and implement

preventive actions that include feedback and learning throughout the

hospice. The hospice's quality assessment and performance improvement

program is expected to view staff as full partners in quality

improvement. Because staff members are in a unique position to provide

the hospice with structured feedback on its performance and suggestions

on how performance can be improved, we expect the hospice to

demonstrate how staff contribute to its quality improvement program.

We are proposing at Sec

essment and performance improvement

program is expected to view staff as full partners in quality

improvement. Because staff members are in a unique position to provide

the hospice with structured feedback on its performance and suggestions

on how performance can be improved, we expect the hospice to

demonstrate how staff contribute to its quality improvement program.

We are proposing at Sec. 418.58(d), Performance improvement

projects, to require that the number and scope of improvement projects

conducted annually must reflect the scope, complexity, and past

performance of the hospice's services and operations. The hospice must

document what improvement projects are being conducted, the reasons for

conducting them, and the measurable progress achieved on these

projects. We believe that giving hospices the flexibility to review

their own organization and quality performance and improvement program

may improve the effectiveness and efficiency of their services, improve

the outcomes of care they provide, and potentially improve beneficiary

satisfaction with their services.

We are proposing at Sec. 418.58(e), Executive responsibilities, to

require the hospice's governing body to be responsible and accountable

for ensuring that the ongoing quality improvement program is defined,

implemented, and maintained. The governing body must ensure that the

program addresses priorities for improved quality of care and patient

safety. The governing body must also specify the frequency and detail

of the data collection and ensure that all quality improvement actions

are evaluated for effectiveness. The governing body's most important

role is to ensure that staff are furnishing and patients are receiving

the most appropriate level of care. Therefore, it is incumbent on the

governing body to lend its full support to agency quality improvement

and performance improvement efforts.

We are specifically soliciting public comments on this proposed

condition of participation

for effectiveness. The governing body's most important

role is to ensure that staff are furnishing and patients are receiving

the most appropriate level of care. Therefore, it is incumbent on the

governing body to lend its full support to agency quality improvement

and performance improvement efforts.

We are specifically soliciting public comments on this proposed

condition of participation.

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

[If you choose to comments on issues in this section, please include

the caption ``INFECTION CONTROL'' at the beginning of your comments.]

There is no current requirement for infection control other than

the requirement at Sec. 418.100(a) that ``* * * each patient is to be

kept comfortable, clean, well groomed, and protected from accident,

injury, and infection.'' We are now proposing a new CoP due to the

seriousness and hazards of infectious and communicable diseases. There

is a substantial amount of research from government agencies and

private organizations regarding the effect of infections and

communicable diseases in the inpatient environment. This research

documents their widespread prevalence. While there is less research

that examines infections and communicable diseases in the home, the

effect of both on the health and safety of patients and the cost of

patient care cannot be dismissed. In response, the health care industry

has developed guidelines and recommendations for managing preventative

programs. For example, the Association for Professionals in Infection

Control and Epidemiology, Inc. have published ``Requirements for

infrastructure and essential activities of infection control and

epidemiology in out-of-hospital settings: A Consensus Panel report''

(http://www.apic.org/pdf/cpinfra2.pdf). The Joint Commission on

Accreditation of Healthcare Organizations (JCAHO) responded to the

issue by designing new infection control standards for, among others,

home care providers

Inc. have published ``Requirements for

infrastructure and essential activities of infection control and

epidemiology in out-of-hospital settings: A Consensus Panel report''

(http://www.apic.org/pdf/cpinfra2.pdf). The Joint Commission on

Accreditation of Healthcare Organizations (JCAHO) responded to the

issue by designing new infection control standards for, among others,

home care providers. These standards will become effective in 2005. Due

to the negative effects on patient health and safety that are posed by

infections and communicable diseases, and due to the significant amount

of public, industry, and government attention that this issue has

generated, we believe that hospices need to address infection control

in a more complete manner.

In this proposed CoP, we are requiring hospices to take specific

actions to address the prevention and control of infections and

disease, and to educate patients, staff, and caregivers on their

hazards, prevention, and control. It is essential that agencies

consider the devastating effects of rampant communicable disease as

they carry out their quality assessment and performance improvement

programs. As a result, we expect the hospice to maintain an effective

and up-to-date infection control program that may be part of its

overall quality assessment and performance improvement program.

We recognize that a hospice cannot be directly responsible for the

maintenance of an infection-free environment in an individual's home or

inpatient setting. We are proposing in Sec. 418.60(a), Prevention,

that hospices follow accepted infection control standards of practice

and ensure that all staff that provide hospice services know and use

these current best prevention practices to curb the spread of

infection. Periodic

ot be directly responsible for the

maintenance of an infection-free environment in an individual's home or

inpatient setting. We are proposing in Sec. 418.60(a), Prevention,

that hospices follow accepted infection control standards of practice

and ensure that all staff that provide hospice services know and use

these current best prevention practices to curb the spread of

infection. Periodic

training is one way to assure staff understanding.

In Sec. 418.60(b),Control, we are proposing that the hospice

engage in an ongoing system-wide program that focuses on the

surveillance, identification, prevention, control, and investigation of

infections and communicable disease. We expect the hospice to use best

control practices in this endeavor. We are also expecting that each

hospice educate its staff, as well as patients, families, and other

caregivers in the ``current best practices'' for controlling the spread

of infections within the home during the course of the family/care

givers' interactions. Where infection and/or communicable disease is

identified, we expect that this information is made part of the

hospice's quality assessment and performance improvement program.

In Sec. 418.60(c), Education, we are proposing a standard allowing

the hospice flexibility in meeting its infection control, prevention

and education objectives. For example, the amount of training in

infection control necessary for the hospice's personnel would depend on

the patient mix and experience of the staff. While we would expect that

established best practices be adhered to, we are not proposing any

specific approaches to meeting this requirement. However, all staff and

family will be educated on the use of standard precautions for the

safety of the patient, family and caregivers

infection control necessary for the hospice's personnel would depend on

the patient mix and experience of the staff. While we would expect that

established best practices be adhered to, we are not proposing any

specific approaches to meeting this requirement. However, all staff and

family will be educated on the use of standard precautions for the

safety of the patient, family and caregivers. We will expect to see

clear evidence that the hospice aggressively seeks to minimize the

spread of disease and infection through the use of effective techniques

by its staff and through its efforts to help families and care givers

understand what can and should be done to minimize infection.

We are specifically soliciting public comments on this proposed

condition of participation.

Condition of Participation: Licensed Professional Services (Proposed

Sec. 418.62)

Sections of current regulations at Sec. 418.82, Nursing services;

Sec. 418.84, Medical social services; and Sec. 418.92, Physical

therapy, occupational therapy and speech-language pathology, identify

detailed tasks that must be performed by agency staff.

We are proposing to delete Sec. 418.82, Sec. 418.84, and Sec.

418.92, and replace them with a more simplified condition, licensed

professional services. Instead of identifying detailed tasks, we are

broadly describing the expected contributions of the licensed

professionals who are furnishing hospice services.

We are proposing that licensed professionals who provide services

to hospice patients either directly or under arrangement must

participate in coordinating all aspects of care, including updating the

interdisciplinary comprehensive assessments, developing and evaluating

plans of care, participating in patient and family counseling,

participating in the quality assessment and performance improvement

plan, and participating in in-service training

de services

to hospice patients either directly or under arrangement must

participate in coordinating all aspects of care, including updating the

interdisciplinary comprehensive assessments, developing and evaluating

plans of care, participating in patient and family counseling,

participating in the quality assessment and performance improvement

plan, and participating in in-service training. The expected outcome is

the coordinated, comprehensive, interdisciplinary delivery of

appropriate and effective licensed professional services delivered and

supervised by health care professionals who practice under State

licensure requirements and the hospice's policies and procedures.

Licensed professional services, for purposes of this section, include

skilled nursing care, physical therapy, speech-language pathology,

occupational therapy, and medical social services. The services of

these licensed professionals are described in more detail under the

core services condition proposed at Sec. 418.64 and the non-core

services condition at Sec. 418.70.

Medicare makes a distinction between providing services directly,

as opposed to providing services under arrangement. The most common way

services are provided directly is through the use of employees. The

common law definition of ``employee'' fundamentally relates to whether

a person is under control by the entity or individual providing the

services. The ``physician referral provisions'' at section 1877(h)(2)

of the Act references the Internal Revenue Service (IRS) ``employee''

definition. Section 1877(h)(2) provides that an individual is

considered to be ``employed by'' or an ``employee'' of an entity if the

individual would be considered to be an employee of the entity under

the usual common law rules applicable in determining the employer-

employee relationship (as applied for purposes of section 3121(d)(2) of

the Internal Revenue Code of 1986).

Condition of Participation: Core Services (Proposed Sec

es that an individual is

considered to be ``employed by'' or an ``employee'' of an entity if the

individual would be considered to be an employee of the entity under

the usual common law rules applicable in determining the employer-

employee relationship (as applied for purposes of section 3121(d)(2) of

the Internal Revenue Code of 1986).

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

The conditions of participation containing the current core

services requirements are in Sec. 418.80, Furnishing of core services;

Sec. 418.82, Nursing services; Sec. 418.84, Medical social services;

Sec. 418.86, Physician services; and Sec. 418.88, Counseling

services. We are proposing to combine these into a single condition. We

are also proposing to incorporate the requirement at existing Sec.

418.50(b)(3) that core services be provided in a manner consistent with

accepted standards of practice.

This section has been revised to reflect changes to the Act made by

section 946 of the Medicare Prescription Drug, Improvement, and

Modernization Act of 2003 (``MMA''). In accordance with that provision,

we are proposing to allow a hospice (the primary hospice) to enter into

arrangements with another Medicare certified hospice to obtain core

hospice services. This could be done under extraordinary or other non-

routine circumstances. Pursuant to Section 1861(dd)(5)(D) of the Act,

as added by section 946(a) of the MMA, those circumstances are:

Unanticipated periods of high patient loads; staffing shortages due to

illness or other short-term temporary situations that interrupt patient

care such as natural disasters; and temporary travel of a patient

outside the hospice's service area. We believe that the new MMA

provision authorizes us to propose that hospices may not routinely

contract for a specific level of care (e.g., continuous care) or for

specific hours of care (e.g., evenings and week-ends), as these are

regularly occurring situations that hospices are able to plan staffing

for

atural disasters; and temporary travel of a patient

outside the hospice's service area. We believe that the new MMA

provision authorizes us to propose that hospices may not routinely

contract for a specific level of care (e.g., continuous care) or for

specific hours of care (e.g., evenings and week-ends), as these are

regularly occurring situations that hospices are able to plan staffing

for.

We propose to require that contractual arrangements under the

provision be set forth in a legally binding written agreement between

the hospices. The written agreement would ensure that contracted staff

meet all hospice personnel qualifications and receive necessary

training. The primary hospice would be responsible for enforcing the

contractual provisions. This would ensure that the primary hospice

maintains professional management responsibility for the service(s)

being provided and the individual(s) providing such service(s), as

described in sections 418.62, Skilled professional services and

418.100, Organization and administration of services. These sections

require contracted services to be provided according to professional

standards and practices. Finally, contracted individuals would be

required to actively participate in the coordination of care, including

patient assessment and care planning, and in the primary hospice's in-

service training and quality assessment and performance improvement

programs.

The physician services requirement would be changed to allow the

use of contracted physicians, including the medical director (see

proposed 418.102).

In proposed Sec. 418.64(b), Nursing services, we would add

specific language to address the role of nurse practitioners in

providing hospice care. The services provided by nurse practitioners

continue to be guided by

nce improvement

programs.

The physician services requirement would be changed to allow the

use of contracted physicians, including the medical director (see

proposed 418.102).

In proposed Sec. 418.64(b), Nursing services, we would add

specific language to address the role of nurse practitioners in

providing hospice care. The services provided by nurse practitioners

continue to be guided by

Medicare statutory requirements. Within these statutory requirements,

we propose to allow nurse practitioners to perform many other hospice

functions that are in the scope of their practice and license, as well

as within the laws of the State in which they practice.

In this standard we have also proposed to allow hospices to provide

certain types of nursing services under a legally binding written

contract. This change also results from section 946 of the Medicare

Prescription Drug, Improvement, and Modernization Act of 2003, which

added new 1861(dd)(5)(E) to the Act. These nursing services must be

highly specialized and provided non routinely and so infrequently that

their provision by hospice employees would be impracticable and

prohibitively expensive. We recognize that it may be cost-prohibitive

for a hospice to employ a nurse that possesses very highly specialized

skills when he or she may only care for a few patients a year. By

allowing hospices to contract with specialized nursing providers or

others to provide these highly specialized nursing services to the few

patients who require them, hospices will be able to better implement an

efficient staffing plan and ensure proficiency in the skilled service

being provided. Highly specialized services, as described, would not

include continuous care because, while time intensive, such care does

not require highly specialized nursing skills

hers to provide these highly specialized nursing services to the few

patients who require them, hospices will be able to better implement an

efficient staffing plan and ensure proficiency in the skilled service

being provided. Highly specialized services, as described, would not

include continuous care because, while time intensive, such care does

not require highly specialized nursing skills.

As with all other contracting arrangements, the hospice would be

required to maintain professional management responsibility for the

service(s) being provided under arrangement as well as the

individual(s) providing them. The responsibilities of both the primary

hospice and the ``lending'' nursing provider would need to be outlined

in the written agreement, and there would have to be a mechanism in

place to ensure that the terms of the agreement were met. To that end,

the contracted individual(s) would have to provide care in accordance

with professional standards of practice; actively participate in the

coordination of care, including the comprehensive patient assessment

and the formulation of the plan of care; and actively participate in

the hospice's inservice training and quality assessment and performance

improvement programs.

In proposed Sec. 418.64(c), we are proposing to maintain the

current medical social services requirement found at Sec. 418.84. This

standard would continue to require that medical social services be

provided by a qualified social worker under the direction of a

physician. This standard would also require that medical social

services, when accepted by a patient and family, be based on an

assessment of that patient's psychosocial needs.

In proposed Sec. 418.64(d), we address the counseling services

that would be available to hospice patients. Those services would be

bereavement, nutritional, and spiritual counseling

al worker under the direction of a

physician. This standard would also require that medical social

services, when accepted by a patient and family, be based on an

assessment of that patient's psychosocial needs.

In proposed Sec. 418.64(d), we address the counseling services

that would be available to hospice patients. Those services would be

bereavement, nutritional, and spiritual counseling. In the bereavement

counseling section, we propose that a hospice would be required to have

an organized program of bereavement services furnished under the

supervision of a qualified professional with experience in grief/loss

counseling. These services would be required to be made available to

individuals identified in the bereavement plan of care up to one year

following the death of the patient and would reflect the needs of those

individuals. When appropriate, residents and staff of a SNF/NF, ICF/MR,

or other facility would be offered bereavement services.

In the nutritional counseling section, we propose to alter the

standard to allow qualified individuals such as dietitians and nurses

to furnish this service, provided that it is within their scope of

practice and expertise according to State law. We believe that allowing

other qualified individuals to participate in nutritional counseling

will give hospices greater flexibility and will help ensure that all

hospice patients have access to this service when needed. This proposal

for increased flexibility is a result of recommendations made by the

Secretary's Advisory Committee on Regulatory Reform.

In the spiritual counseling section we propose that a hospice would

be required to assess the patient's and family's spiritual needs and

provide spiritual counseling to meet those needs in accordance with the

patient's and family's beliefs and desires. If a patient and family do

not desire spiritual counseling, then they would not have to be

provided this service

mittee on Regulatory Reform.

In the spiritual counseling section we propose that a hospice would

be required to assess the patient's and family's spiritual needs and

provide spiritual counseling to meet those needs in accordance with the

patient's and family's beliefs and desires. If a patient and family do

not desire spiritual counseling, then they would not have to be

provided this service. If a patient and family do desire spiritual

counseling, then a hospice would be expected to facilitate visits by

local clergy, pastoral counselors, or others to the best of its

ability. We have examined the relevant jurisprudence regarding the

provision of spiritual counseling by Medicare certified hospices (Kong

v. Scully et al. 341 F.3d 1132 (9th Cir. 2003) reh. den. as amended,

357 F.3d 895 (9th Cir. 2004). We do not see any impediment to requiring

hospices to offer spiritual services if a patient and family so desire.

Condition of Participation: Nursing Services Waiver of Requirement That

Substantially All Nursing Services Be Routinely Provided Directly by a

Hospice (Proposed Sec. 418.66)

[If you choose to comment on issues in this section, please include the

caption ``STATUTORY NURSING WAIVER'' at the beginning of your

comments.]

The requirements for obtaining a nursing services waiver as

provided by section 1861(dd)(5) of the Act is currently set forth in

Sec. 418.83, and remains virtually unchanged in this proposal. This

condition provides hospices the opportunity to obtain a waiver from the

requirement that substantially all nursing services be routinely

provided directly by the hospice. The Act specifies that to obtain a

waiver a hospice must be located in an area that is not an urbanized

area, must have been in operation on or before January 1, 1983, and

must demonstrate a good faith effort to hire a sufficient number of

nurse employees

opportunity to obtain a waiver from the

requirement that substantially all nursing services be routinely

provided directly by the hospice. The Act specifies that to obtain a

waiver a hospice must be located in an area that is not an urbanized

area, must have been in operation on or before January 1, 1983, and

must demonstrate a good faith effort to hire a sufficient number of

nurse employees. Section 1861(dd)(5)(B) of the Act specifies that if a

waiver is requested by an organization that meets the statutory

requirements, and if it is submitted in the form and contains the

information required by the Secretary, the waiver will be deemed

granted unless the request is denied in 60 days after the request is

received by the Secretary.

This waiver, set in statute, may be obsolete. We do not know how

many hospices meet the criteria for the waiver, nor do we know if any

hospices actually use the waiver. We request comments on the use of

this waiver.

Condition of Participation: Furnishing of Non-Core Services (Proposed

Sec. 418.70)

The current CoP governing the provision of other services is

contained in Sec. 418.90. The hospice must ensure that the services

described in Sec. 418.72 through Sec. 418.78 are provided directly by

employees of the hospice or by others under an arrangement with the

hospice. This is discussed further in proposed Sec. 418.100. As with

core services, non-core services should be provided in a manner

consistent with current standards of practice.

Condition of Participation: Physical Therapy, Occupational Therapy, and

Speech-Language Pathology (Proposed Sec. 418.72)

Currently, the CoP concerning physical therapy, occupational

therapy, and speech language pathology is laid out at Sec. 418.92. We

are proposing to recodify this CoP at Sec. 418.72 without changes.

hould be provided in a manner

consistent with current standards of practice.

Condition of Participation: Physical Therapy, Occupational Therapy, and

Speech-Language Pathology (Proposed Sec. 418.72)

Currently, the CoP concerning physical therapy, occupational

therapy, and speech language pathology is laid out at Sec. 418.92. We

are proposing to recodify this CoP at Sec. 418.72 without changes.

Condition of Participation: Waiver of Requirement--Physical Therapy,

Occupational Therapy, Speech-Language Pathology, and Dietary Counseling

(Proposed Sec. 418.74)

We are proposing a new CoP that provides for a waiver of the

requirement that physical therapy (PT), occupational therapy (OT),

speech-language pathology (SLP) and dietary counseling services be

provided as needed on a 24-hour basis. In addition, the waiver allows

the hospice to provide the above services directly or under

arrangements made by the hospice, as specified in current Sec. 418.56.

We may approve a hospice's request for a waiver of the requirement

that it furnish PT, OT, SLP and/or dietary counseling services if it is

located in a nonurbanized area and can demonstrate that it has been

unable, despite diligent efforts, to recruit appropriate personnel.

Hospices will be required to submit evidence of their efforts to hire.

We will apply similar requirements as are used for the nursing services

waiver requests found in proposed Sec. 418.66. As in the case for a

waiver of nursing services, eligibility for a waiver is based on the

primary location of a hospice. For a hospice that operates in several

areas, its primary location is considered to be the location of its

central office. The hospice must provide evidence that it made a good

faith effort to hire a sufficient number of PTs, SLPs, OTs, and dietary

counselors to provide services directly through hospice employees or

under arrangement.

Condition of Participation: Home Health Aide and Homemaker Services

(Proposed Sec

tes in several

areas, its primary location is considered to be the location of its

central office. The hospice must provide evidence that it made a good

faith effort to hire a sufficient number of PTs, SLPs, OTs, and dietary

counselors to provide services directly through hospice employees or

under arrangement.

Condition of Participation: Home Health Aide and Homemaker Services

(Proposed Sec. 418.76)

Section 1861(dd)(1)(D) of the Act requires Medicare covered home

health aide services to be furnished by an individual who has

successfully completed training or a competency evaluation program that

meets the requirements established by the Secretary. This section also

provides for coverage of ``homemaker'' services.

Currently, the condition of participation concerning home health

aide and homemaker services is set forth at Sec. 418.94. We are

proposing in Sec. 418.76 that a home health aide completes a State-

established or other training program, and in Sec. 418.76(b) we

outline requirements that this training must meet. Except for minor

reorganization, these training requirements are consistent with

existing home health aide requirements in Sec. 484.36.

For example, we would continue to permit a home health aide to meet

the proposed Sec. 418.76(a), Home health aide qualifications,

requirement in one of three ways: by completing a training and

competency evaluation program that meets the proposed training

requirements, by completing a competency evaluation program, or by

completing a State licensure program that meets the proposed training

requirements. We propose to include three separate ways to meet the

proposed requirement because we understand that home health aides come

to hospices with various levels of experience and qualifications. We

would expect that, if a State licenses home health aides, then an aide

would meet those licensure requirements and would, in fact, be licensed

by that State

t meets the proposed training

requirements. We propose to include three separate ways to meet the

proposed requirement because we understand that home health aides come

to hospices with various levels of experience and qualifications. We

would expect that, if a State licenses home health aides, then an aide

would meet those licensure requirements and would, in fact, be licensed

by that State. If a State does not have licensure requirements, then we

would expect that a home health aide who had not previously

participated in a training program that meets the proposed requirements

would be trained in a program that meets the proposed requirements. In

addition, we would expect that, following such training, that aide

would be evaluated in a systematic way to assess his or her skills and

competencies before performing patient care. If, however, a home health

aide has already completed a training program that meets the proposed

requirements while employed at another provider, then we would only

expect the aide to complete a competency evaluation program at his or

her new employer. We believe that this would make it easier for aides

to change employers and faster for hospices to get qualified new

employees out in the field. One of the skills a home health aide would

be required to master is the ability to observe, report, and document

patient status and the care or service furnished. We believe that clear

and effective communication between the many providers of hospice care

is an important part of ensuring high quality patient care. We believe

that a home health aide should be able to both verbally report and

document in writing what he or she observes and does at a patient's

home.

Three standards have been particularly adapted for the hospice

conditions of participation. First, Sec. 418.76(j), homemaker

qualifications, has been adapted from the existing Sec. 418.94. The

proposed standard clarifies that a qualified homemaker is a home health

aide as described in Sec

e to both verbally report and

document in writing what he or she observes and does at a patient's

home.

Three standards have been particularly adapted for the hospice

conditions of participation. First, Sec. 418.76(j), homemaker

qualifications, has been adapted from the existing Sec. 418.94. The

proposed standard clarifies that a qualified homemaker is a home health

aide as described in Sec. 418.76 or an individual who has met the

standards in Sec. 418.202(g) and has successfully completed hospice

orientation addressing the needs and concerns of patients and families

coping with a terminal illness. Homemaker services may include

assistance in maintenance of a safe and healthy environment to enable

the patient to benefit from care that is furnished.

Second, Sec. 418.76(h), Supervision of home health aides, would be

revised from the current Sec. 484.36(d) to require that a registered

nurse or appropriate qualified therapist conduct an on-site supervisory

visit every 28 days while the home health aide is providing care.

Thorough supervision of home health aides is crucial to ensuring that

the patient's and family's needs are being met, and conducting

supervisory visits when the aide is present and performing his or her

duties is the only way to provide such thorough supervision. On-site

supervisory visits will still be required every 14 days as in the

current rule at Sec. 484.36(d)(2), but the aide would not be required

to be present for these visits. This supervision schedule would allow

hospices to maintain control over the quality and continuity of care

being provided, and would help ensure that all patients receiving home

health aide services are having their needs met by such services.

Finally, Sec. 418.76(k) would require a member of the

interdisciplinary group to coordinate homemaker services, and supply

instructions for the homemaker on duties to be performed

ld allow

hospices to maintain control over the quality and continuity of care

being provided, and would help ensure that all patients receiving home

health aide services are having their needs met by such services.

Finally, Sec. 418.76(k) would require a member of the

interdisciplinary group to coordinate homemaker services, and supply

instructions for the homemaker on duties to be performed. The homemaker

would be required to report all concerns about the patient or family to

the member of the IDG who was coordinating the homemaker services. We

have proposed these changes to ensure proper training and supervision,

and to protect the quality of the homemaker services provided.

Condition of Participation: Volunteers (Proposed Sec. 418.78)

The current CoP for volunteers is located at Sec. 418.70. We are

proposing to recodify this CoP at Sec. 418.78 with minor changes. We

are removing the existing Sec. 418.70(f), regarding the availability

of clergy, because the role of the pastoral, clergy, or other spiritual

counselor is described in proposed Sec. 418.56(a)(1)(iv),

Interdisciplinary group, care planning and coordination of services.

This change does not preclude the hospice from continuing to use or

starting to use clergy as volunteers.

Subpart D, Conditions of Participation, Organizational Environment

Condition of Participation: Organization and Administration of Services

(Proposed Sec. 418.100)

[If you choose to comment on issues in this section, please include the

caption ``ORGANIZATION AND

coordination of services.

This change does not preclude the hospice from continuing to use or

starting to use clergy as volunteers.

Subpart D, Conditions of Participation, Organizational Environment

Condition of Participation: Organization and Administration of Services

(Proposed Sec. 418.100)

[If you choose to comment on issues in this section, please include the

caption ``ORGANIZATION AND

ADMINISTRATION'' at the beginning of your comments.]

We are proposing to revise existing regulations at Sec. 418.50,

General provisions, Sec. 418.52, Governing body, and Sec. 418.56,

Professional management, by creating a new condition. This new

condition would simplify the structure of these current requirements

and clarify new performance expectations for the governing body. We

believe the structure of the current requirements does not establish

clear performance expectations for the operation of all services. The

overall goal of the revised requirement would be to ensure a management

structure that is organized and accountable. We believe that a well-

managed hospice will be more likely to allocate resources so that

patients maintain their highest functional capacity.

In the proposed organization and administration of services

condition (that is, Sec. 418.100), we have taken the current CoPs and

proposed changing them to standards:

Governing body and administrator (existing Sec. 418.52).

Continuation of care (existing Sec. 418.60).

Professional management responsibility (existing Sec.

418.56).

In-service training (existing Sec. 418.64).

We would also include a standard clearly listing the services that

the statute requires hospices to furnish. We are also proposing to add

a new standard for in-service training that would require a hospice to

provide in-service training to all individuals, including volunteers,

to address identified skill and competency gaps. The hospice would be

required to have written policies and procedures describing its methods

for assessing skills and competency

that

the statute requires hospices to furnish. We are also proposing to add

a new standard for in-service training that would require a hospice to

provide in-service training to all individuals, including volunteers,

to address identified skill and competency gaps. The hospice would be

required to have written policies and procedures describing its methods

for assessing skills and competency. It would also be required to

maintain a written description of in-service trainings offered during

the previous 12 months.

Currently, Sec. 418.50(b)(3), Required services; Sec. 418.52,

Governing body; Sec. 418.82(c), Acceptable standards of practice;

Sec. 418.92(a), PT, OT and SLP; and Sec. 418.96(a), Administration of

drugs and biologics, all exist as separate standards. To emphasize the

importance of continuity of care and the focus on quality, regardless

of the site of service, we are proposing to move these existing

provisions and incorporate their performance expectation into the

quality assessment and performance improvement program that is proposed

at Sec. 418.58.

We have long used the term ``in accordance with accepted standards

of practice,'' in various provider and supplier requirements, (such as

in the existing Sec. 418.82(c)) to set a performance expectation and

to be able to employ regulatory authority to shed light on

inappropriate and/or dangerous practices. We are proposing to retain

this authority and move the existing Sec. 418.82(c) into Sec. 418.64,

Core services and Sec. 418.70, Furnishing of non-core services.

In the proposed governing body and administrator standard at Sec.

418.100(b) we emphasize the responsibility of the hospice governing

body (or designated persons so functioning) for the management and

provision of all hospice services including fiscal operations, quality

assessment, performance improvement, and the appointment of the

administrator

ec. 418.70, Furnishing of non-core services.

In the proposed governing body and administrator standard at Sec.

418.100(b) we emphasize the responsibility of the hospice governing

body (or designated persons so functioning) for the management and

provision of all hospice services including fiscal operations, quality

assessment, performance improvement, and the appointment of the

administrator. The actual approach to the administration of the hospice

is left to the discretion of the governing body, thereby affording the

hospice management flexibility. The proposed governing body standard

reflects our goal of promoting the effective management and

administration of the hospice as an organizational entity without

dictating prescriptive requirements for how a hospice must meet that

goal.

Section 418.100(c), Services, includes nursing, medical social

services, physician services, counseling services, home health aide and

homemaker services, therapy services, short-term inpatient care and

medical supplies. The nursing services, physician services, and drugs/

biologicals as specified in Sec. 418.100(c)(2) must be routinely

available on a 24-hour basis. All other covered services must be

available on a 24-hour basis when reasonable and necessary to meet the

needs of the patient and family.

In Sec. 418.100(d), Continuation of care, the current standard is

at Sec. 418.60. We are proposing to recodify this section at Sec.

418.100(d) without change.

In Sec. 418.100(e), Professional management responsibility, we are

proposing to revise some of the current requirements found at Sec.

418.56(b) and (c). This standard would require written agreements for

services furnished under arrangement, and would require that the

hospice retain professional management and supervisory and financial

responsibility for all services that are provided to the patient and

family

Professional management responsibility, we are

proposing to revise some of the current requirements found at Sec.

418.56(b) and (c). This standard would require written agreements for

services furnished under arrangement, and would require that the

hospice retain professional management and supervisory and financial

responsibility for all services that are provided to the patient and

family. The hospice would be required to ensure that all services

provided are authorized by the hospice, are furnished in a safe and

effective manner by qualified personnel, and that items and/or services

specified in the plan of care are provided.

In Sec. 418.100(f)(1), we are proposing a new standard to address

the issue of multiple service locations. Our goal is to establish clear

requirements in order to ensure patient comfort, patient safety, and

the provision of a consistent level of care throughout the hospice

organization. This provision is intended to codify long-standing

Medicare survey and certification policy, which allows for the

operation of multiple locations by a single hospice provider with a

single Medicare agreement.

We are adding the definition of a hospice satellite location. The

way in which hospices are organized has changed since the original

regulations were promulgated. Today, unlike small community based

hospices that were operating when the Medicare hospice benefit first

began, it is common to find large hospice organizations serving a

patient population widely dispersed throughout a sizeable geographic

area. Some existing hospices operate from multiple locations. We

believe it is appropriate to develop a basis in regulation to better

clarify this organizational structure and we have been asked by

hospices to more fully consider the nature of the relationship between

a hospice and a satellite location

ganizations serving a

patient population widely dispersed throughout a sizeable geographic

area. Some existing hospices operate from multiple locations. We

believe it is appropriate to develop a basis in regulation to better

clarify this organizational structure and we have been asked by

hospices to more fully consider the nature of the relationship between

a hospice and a satellite location.

We expect that any hospice that requests to establish a satellite

location will be able to demonstrate how it is able to manage and

monitor all of the services provided in its entire service area,

including services from a satellite location. Patients who receive care

and services from a hospice satellite location must receive the full

range of services that are documented in the plan of care. We will

consider the following factors in our review of a hospice's request to

establish a satellite location:

The hospice's ability to supervise the satellite location

to ensure the timely provision of quality care for patients and

families receiving care.

The hospice's past compliance history.

Relevant State issues and recommendations including a

reciprocal agreement between the States to assure that at least one of

the State agencies assumes responsibility for any necessary surveys of

the satellite location in situations in which a hospice provides

services in satellite locations across state lines.

The hospice's assurance that each patient receives care

from an assigned interdisciplinary group that works effectively

together to identify and meet the physical, social, emotional, and

spiritual needs of the hospice patients and families receiving care.

Before operating a satellite location, a hospice must enroll with

the fiscal intermediary and notify the State agency

across state lines.

The hospice's assurance that each patient receives care

from an assigned interdisciplinary group that works effectively

together to identify and meet the physical, social, emotional, and

spiritual needs of the hospice patients and families receiving care.

Before operating a satellite location, a hospice must enroll with

the fiscal intermediary and notify the State agency

and CMS of all currently approved satellite locations at the time it

requests approval for any additional satellite locations. If a hospice

provides care and services to Medicare beneficiaries at an unapproved

or disapproved satellite location, such services may be determined to

be non-covered. At the time of any satellite location closure the

hospice is expected to notify the fiscal intermediary, State agency and

CMS.

Hospice satellite locations are also subject to survey by the State

survey agency or CMS regional office. Deficiencies that are identified

at any satellite location will apply to the entire hospice issued the

provider agreement number. Satellite locations must comply with the

hospice conditions of participation at Sec. 418.52 through Sec.

418.116.

Proposed Sec. 418.100(g), Inservice training, applies to

volunteers and employees, including those employed under arrangement or

contract. We are expecting a hospice to take steps to develop

appropriate inservice programs or to arrange to acquire training from

others.

We are not dictating a specific inservice training program, but

rather we expect each hospice to determine the scope of its own

program, including the manner in which it chooses to assess competence

levels, determine training content, and determine the duration and

frequency of training.

We are specifically soliciting public comment on this proposed

condition of participation.

Condition of Participation: Medical Director (Proposed Sec

aining program, but

rather we expect each hospice to determine the scope of its own

program, including the manner in which it chooses to assess competence

levels, determine training content, and determine the duration and

frequency of training.

We are specifically soliciting public comment on this proposed

condition of participation.

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

[If you choose to comment on issues in this section, please include the

caption ``MEDICAL DIRECTOR'' at the beginning of your comments.]

We would revise the existing medical director CoP at Sec. 418.54

by incorporating current requirements and expanding it to illustrate

the importance of having a medical director or physician designee

coordinate the activities of physicians and other health care

professionals to ensure that care is appropriate and reflects the

hospice philosophy. To maintain patient care and coordination of

services, the medical director or physician designee appointed by the

medical director, must either be a hospice employee or under contract

with the hospice. A contractual arrangement with another agency or

organization is not permitted.

Section 418.102(a), Initial certification of terminal illness,

would incorporate the provisions of current Sec. 418.22, and require

that the medical director or physician designee review the patient's

clinical information and provide written certification that the

individual has a medical prognosis that his/her life expectancy is 6

months or less if the illness runs its normal course. The certification

would have to be based on the medical director's or physician

designee's clinical judgment regarding the normal course of the

individual's illness.

In the second standard, Sec

he patient's

clinical information and provide written certification that the

individual has a medical prognosis that his/her life expectancy is 6

months or less if the illness runs its normal course. The certification

would have to be based on the medical director's or physician

designee's clinical judgment regarding the normal course of the

individual's illness.

In the second standard, Sec. 418.102(b), Recertification of the

terminal illness, we would require that the medical director or

physician designee review the clinical information and the patient and

family's expectations and wishes for hospice care on an ongoing basis

and before each updated assessment. Assessments would be required to be

updated at least every 14 calendar days according to Sec. 418.54(d).

In addition, this standard would also require that the assessment be

updated at the time of each recertification. The timeframes for

recertification are described in Sec. 418.21.

Within Sec. 418.102(c), Coordination of medical care, we are

proposing that the medical director or physician designee and the

hospice interdisciplinary group maintain responsibility for

coordinating a patient's medical care in all settings, even when

multiple physicians are participating in the care. This level of

coordination ensures that the patient receives continuous medical care

and services that are consistent with the hospice philosophy.

We are also proposing to require that the medical director or

physician designee be responsible for the hospice's quality assessment

and performance improvement program. This program and implementation of

its findings are critical to ensuring that patients receive effective

and meaningful care.

We are specifically soliciting public comment on this proposed

condition.

Condition of Participation: Clinical Records (Proposed Sec

hat the medical director or

physician designee be responsible for the hospice's quality assessment

and performance improvement program. This program and implementation of

its findings are critical to ensuring that patients receive effective

and meaningful care.

We are specifically soliciting public comment on this proposed

condition.

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

[If you choose to comment on issues in this section, please include the

caption ``CLINICAL RECORDS'' at the beginning of your comments.]

The proposed condition of participation, Clinical records, would

incorporate several of the existing requirements in Sec. 418.74 of the

current regulation, Central clinical records. We are proposing to add a

new requirement that the clinical record contain accurate clinical

information that is available to the physician and hospice staff.

The proposed condition continues to require that all clinical

records contain past and current findings and that they are maintained

for each patient who is admitted by the hospice.

We are also providing an opportunity for the hospice to choose to

maintain clinical records electronically if it desires and recognize

that some hospices are beginning to maintain electronic records. The

use of electronic health records (EHRs) has the potential to improve

patient care and improve efficiency. We anticipate that the use of

electronic health records will become widespread, and will be required

in future hospice conditions of participation.

We also recognize that there may be significant barriers for

hospices that are interested in maintaining electronic health records

(EHRs) for their patients. We are interested in learning how the final

hospice CoPs and/or other future regulations can reduce or eliminate

those barriers.

We are interested in public comments on the following areas:

1

future hospice conditions of participation.

We also recognize that there may be significant barriers for

hospices that are interested in maintaining electronic health records

(EHRs) for their patients. We are interested in learning how the final

hospice CoPs and/or other future regulations can reduce or eliminate

those barriers.

We are interested in public comments on the following areas:

1. What are the components of an electronic health record (EHR)?

What are the advantages and disadvantages of using an EHR in a hospice

setting?

2. Should an EHR include a personal health record which is

accessible to the patient? What are the positive and negative

consequences (e.g. caregivers less likely to record certain procedures

or observations) of personal health records?

3. What are the barriers (e.g. technical, clinical) to implementing

an EHR system in a hospice?

It is obvious that there are many different issues regarding the

institutionalization of EHRs. We are aware that some hospices have

already chosen to pursue this option to one degree or another. We are

interested in knowing what their experience has been thus far. How have

electronic health records impacted the way they allocate and deliver

patient care, and how has this, in turn, impacted patient outcomes?

At Sec. 418.104(a), Content, we would retain the requirement that

the record include all assessments (including the initial assessment

and all updated assessments), plan of care, consent and election forms,

and clinical and progress notes. We are proposing the following

requirements for the content of the clinical record--

Advance directive information as described in proposed

Sec. 418.52(a)(3);

Informed consent, authorization and election forms;

Responses to medications, symptom management, treatments

and services;

Patient process and outcome measures as they relate to the

plan of care; and

Physician certification of terminal illness as required in

Sec. 418.22(c) and

or the content of the clinical record--

Advance directive information as described in proposed

Sec. 418.52(a)(3);

Informed consent, authorization and election forms;

Responses to medications, symptom management, treatments

and services;

Patient process and outcome measures as they relate to the

plan of care; and

Physician certification of terminal illness as required in

Sec. 418.22(c) and

described in proposed Sec. 418.102(a) and (b).

We recognize that there has been some confusion between the meaning

of clinical note and progress note. To eliminate this confusion, we

have defined ``clinical note'' and ``progress note'' in the definitions

section. The key differences between clinical and progress notes are

that:

1. Clinical notes summarize an actual patient encounter (as this

term is used in the field) while progress notes do not necessarily have

to; and

2. Clinical notes comprehensively describe the care provided during

that encounter while progress notes briefly summarize care furnished

(which could cover a span of time) and the patient's response. We

believe that these definitions, adopted from the current conditions of

participation for home health agencies (42 CFR part 484) will provide

needed clarity and will ensure that the records contain information

necessary to provide high quality patient care.

We are proposing to add a new standard at Sec. 418.104(b),

Authentication, that requires authentication of clinical records. All

entries must be legible, clear, complete, and appropriately

authenticated and dated. Authentication would include verification of

handwritten and/or electronic signatures by signature logs or a

computer secure entry of a unique identifier for a primary author who

has reviewed and approved the entry. This new standard addresses

technological changes in information management such as the

computerization of records as well as electronic signatures. A similar

requirement is in the conditions of participation for hospitals

handwritten and/or electronic signatures by signature logs or a

computer secure entry of a unique identifier for a primary author who

has reviewed and approved the entry. This new standard addresses

technological changes in information management such as the

computerization of records as well as electronic signatures. A similar

requirement is in the conditions of participation for hospitals.

We are proposing to re-codify the existing requirement found in

Sec. 418.74(b) as Sec. 418.104(c), Protection of information. This

re-codified provision would require that all patient information,

including the clinical record and its contents, be safeguarded against

loss or unauthorized use. The text would also be revised to reflect

that all hospices must also comply with the Privacy Rule published in

the Federal Register on December 28, 2000 (65 FR 82461) as amended on

August 14, 2002 (67 FR 53182) and contained in 45 CFR parts 160 and

164.

Under Sec. 418.104(d), Retention of records, we propose to ensure

protection of the patients information by adding a new requirement that

patient records be retained for 5 years after the death or discharge of

the patient, unless State law stipulates a longer period of time. If

the hospice discontinues operation, hospice policies would be required

to provide for the retention and storage of clinical records. The

hospice would be required to notify the State agency and its CMS

regional office where the clinical records would be stored.

Under proposed Sec. 418.104(e)(1), Discharge or transfer of care,

we have proposed a new requirement that Medicare/ Medicaid-approved

hospice facilities forward a copy of the patient's clinical record and

hospice discharge summary to the facility to which the patient is being

transferred. This would help to ensure that the information flow

between the hospice and the transfer facility is smooth, so that the

level of care will continue without being compromised.

Under Sec

d a new requirement that Medicare/ Medicaid-approved

hospice facilities forward a copy of the patient's clinical record and

hospice discharge summary to the facility to which the patient is being

transferred. This would help to ensure that the information flow

between the hospice and the transfer facility is smooth, so that the

level of care will continue without being compromised.

Under Sec. 418.104(e)(2), we would add a new requirement that the

hospice provide a copy of the patient's clinical record and hospice

discharge summary to the attending physician if the patient revoked the

election of hospice care or was discharged from hospice because

eligibility criteria were no longer met. This requirement was added to

ensure that the patient's attending physician would be aware of the

most current clinical information.

The hospice discharge summary requirement proposed at Sec.

418.104(e)(3) would be a new requirement and would detail what would be

required to be contained in the discharge summary. The purpose of the

discharge summary is to provide important clinical information to those

medical and other health professionals who will be assuming the care of

the patient upon discharge from the hospice. At a minimum, the

discharge summary would contain information that accurately describes

the patient's stay, current plan of care, recent treatment, symptom,

and pain management information, most recent physician orders, and any

other documentation that would assist in post-discharge continuity of

care.

Under Sec. 418.104(f), Retrieval of clinical records, we would

require that clinical records, whether in hard copy or electronic form,

be made readily available to, and retrievable by, an appropriate

authority.

We are specifically soliciting public comment on this proposed

condition of participation.

Condition of Participation: Drugs, Controlled Drugs, Biologicals,

Medical Supplies, and Durable Medical Equipment (Proposed Sec

clinical records, we would

require that clinical records, whether in hard copy or electronic form,

be made readily available to, and retrievable by, an appropriate

authority.

We are specifically soliciting public comment on this proposed

condition of participation.

Condition of Participation: Drugs, Controlled Drugs, Biologicals,

Medical Supplies, and Durable Medical Equipment (Proposed Sec.

418.106)

[If you choose to comment on issues in this section, please include the

caption ``DRUGS, SUPPLIES, and DME'' at the beginning of your

comments.]

This condition of participation revises the current requirement,

found at Sec. 418.96, and would clarify that durable medical

equipment, supplies, appliances, and drugs and biologicals related to

the palliation and management of the terminal illness and related

conditions, as identified in the plan of care, must be provided by the

hospice while the patient is under hospice care.

In addition, restrictions regarding the use of controlled

substances in the patient's home would be conveyed more clearly. We

believe that the hospice, as well as the patient and family, need to

share in the responsibility and accountability for maintaining

controlled substances in the home. Primary responsibility rests with

the hospice, and the hospice must assume responsibility to educate the

family about the proper use and disposal of drugs and biologicals and

the consequences of misuse.

Section 418.106(a)(1), Administration of drugs and biologicals,

would require that all drugs and biologicals be administered in

accordance with accepted hospice and palliative care standards of

practice and according to the patient's plan of care. In Sec.

418.106(a)(2) we are proposing to add a new requirement that the

interdisciplinary group be responsible for periodically reviewing the

plan of care to determine whether the patient and/or family continues

to have the ability to safely administer drugs and biologicals.

Under proposed Sec

ted hospice and palliative care standards of

practice and according to the patient's plan of care. In Sec.

418.106(a)(2) we are proposing to add a new requirement that the

interdisciplinary group be responsible for periodically reviewing the

plan of care to determine whether the patient and/or family continues

to have the ability to safely administer drugs and biologicals.

Under proposed Sec. 418.106(b), Controlled drugs in the patient's

home, the hospice would ensure the safe delivery and accountability of

controlled drugs in the patient's home. The hospice would have to have

a policy for the tracking, collecting, and disposing of controlled

drugs maintained in the patient's home. During the initial assessment,

the hospice policy regarding the use and disposal of controlled drugs

would be required to be discussed with the patient and family, and the

hospice nurse would be required to document that the policy had been

discussed with the patient and family. Because controlled drugs can

pose significant danger to patients if improperly ingested or abused,

educating patients and families may prevent unwanted complications.

In Sec. 418.106(c), Use and maintenance of equipment and supplies,

a hospice would be responsible for overseeing the use of durable

medical equipment and supplies in the patient's home. Through the

Medicare survey process and beneficiary complaints, we have found

that equipment that is not properly maintained does not perform

properly and may harm the patient. Under this proposal, the hospice

would be responsible for making certain that equipment being furnished

under the plan of care is operating safely. The hospice may carry out

this responsibility through a contractual arrangement with others, but

would continue to maintain primary responsibility.

Stressing the importance of providing families with information and

levels of comfort relative to the care being furnished to family

members, we are proposing a new medical equipment and supplies

requirement

the plan of care is operating safely. The hospice may carry out

this responsibility through a contractual arrangement with others, but

would continue to maintain primary responsibility.

Stressing the importance of providing families with information and

levels of comfort relative to the care being furnished to family

members, we are proposing a new medical equipment and supplies

requirement. The hospice would be required to take action to ensure

that the family received instruction in the safe use of equipment and

supplies. In order for the family to participate in providing quality

care to the patient, the family members would need to understand how

and when to use equipment and supplies.

We are specifically soliciting public comment on this proposed

condition of participation.

Condition of Participation: Short-Term Inpatient Care (Proposed Sec.

418.108)

[If you choose to comment on issues in this section, please include the

caption ``SHORT TERM INPATIENT CARE'' at the beginning of your

comments.]

Under proposed Sec. 418.108, we would retain the requirement that

hospices make inpatient care available for pain control, symptom

management, and respite purposes, and that care be provided either in

the hospice or in a participating Medicare or Medicaid facility.

We would recodify the current requirement found at Sec. 418.98(a),

Short-term inpatient care, as Sec. 418.108(a), Inpatient care for

symptom management and pain control.

The references to the condition at Sec. 418.108(b), Inpatient care

for respite purposes, would no longer focus on process as in the

existing Sec. 418.98. Rather, the updated standards reflect expected

outcomes of care.

We would eliminate the existing requirement found at Sec.

418.100(a)(2), requiring a registered nurse to provide direct patient

care on each shift

anagement and pain control.

The references to the condition at Sec. 418.108(b), Inpatient care

for respite purposes, would no longer focus on process as in the

existing Sec. 418.98. Rather, the updated standards reflect expected

outcomes of care.

We would eliminate the existing requirement found at Sec.

418.100(a)(2), requiring a registered nurse to provide direct patient

care on each shift. We believe that the patient's plan of care and the

patient's condition should determine the amount and skill level of

nursing care required, as well as the skill level and State licensing

requirements of the staff to provide requisite care. If the patient

does not need care by a registered nurse, imposing a requirement on a

hospice that mandates a registered nurse to be in attendance on a

particular shift to serve the patient will have no effect on the

patient's care.

Under proposed Sec. 418.108(c), Inpatient care provided under

arrangement, we would incorporate many of the existing requirements in

existing Sec. 418.56(e). In particular, we would require that a

hospice train the personnel who would be providing patient care in an

inpatient facility. The hospice model of patient care is very different

from the curative model of patient care that medical personnel are

trained in. Therefore, in order to ensure that patients in inpatient

facilities continue to receive care that is consistent with the hospice

philosophy (i.e., proactive pain management, interdisciplinary care),

it is important that inpatient facility personnel be trained to

understand the hospice philosophy and model of care.

Under proposed Sec. 418.108(d), Inpatient care limitation, and

Sec. 418.108(e), Exemption from limitation, we are proposing to re-

codify the existing requirements at Sec. 418.98(c) and (d),

respectively, without changes.

Condition of Participation: Hospices That Provide Inpatient Care

Directly (Proposed Sec

facility personnel be trained to

understand the hospice philosophy and model of care.

Under proposed Sec. 418.108(d), Inpatient care limitation, and

Sec. 418.108(e), Exemption from limitation, we are proposing to re-

codify the existing requirements at Sec. 418.98(c) and (d),

respectively, without changes.

Condition of Participation: Hospices That Provide Inpatient Care

Directly (Proposed Sec. 418.110)

[If you choose to comment on issues in this section, please include the

caption ``INPATIENT CARE'' at the beginning of your comments.]

Under proposed Sec. 418.110, we are proposing to revise the

existing requirements, currently located at Sec. 418.100, as follows:

Under Sec. 418.110(a), Staffing, we would include the expectation

that staffing for all services provided by the hospice reflect the

volume of patients, patient acuity, and the level of intensity of the

services as reflected in the plan of care to ensure that expected

outcomes of care are achieved and negative outcomes are avoided. We

also would eliminate our requirement that a registered nurse provide

direct patient care each shift when the condition of the patient does

not require the care of a registered nurse on each shift. This change

would reduce the staffing burden for hospices and is a result of

recommendations made by the Secretary's Advisory Committee on

Regulatory Reform.We are proposing to remove the requirement in the

existing Sec. 418.100(a)(2) that each shift include a registered nurse

that provides direct patient care for those patients who are receiving

short-term inpatient care for symptom management. We are proposing in

Sec. 418.110(b), 24-hour nursing services, that the hospice facility

provide 24-hour nursing services that meet the nursing needs of all

patients and are furnished in accordance with each patient's plan of

care, as well as the skill level of the staff that provides care, in

accordance with State licensing requirements

ving

short-term inpatient care for symptom management. We are proposing in

Sec. 418.110(b), 24-hour nursing services, that the hospice facility

provide 24-hour nursing services that meet the nursing needs of all

patients and are furnished in accordance with each patient's plan of

care, as well as the skill level of the staff that provides care, in

accordance with State licensing requirements. We would require that

each patient be kept comfortable, clean, well-groomed and protected

from accident, injury, and infection.

When assessing a facility's compliance with this proposed

regulation, we would expect to see that the staffing level met the

needs of the patients. For example, if a patient experiences unexpected

break-through pain and needs additional pain management, we would

expect that a staff member with the appropriate skills be available to

care for that patient. If a staff member with the appropriate skills,

and knowledge is not available to care for that patient and assure that

his or her pain is effectively managed, then the hospice would be

considered to be out of compliance with this proposed regulation.

In Sec. 418.110(c), Physical environment, we are proposing that

the hospice maintain a safe physical environment that is free of

hazards for patients, staff, and visitors. In Sec. 418.110(c)(1),

Safety management, in paragraphs (c)(1)(i) and (c)(1)(ii), we are

proposing that the hospice prevent situations that pose a threat to the

health and safety of the patients, others, or property whenever

possible. The hospice would be required to promptly report and

investigate all incidents that involve injury to patients, staff or

visitors, or that involve damage to property. The hospice would be

required to report such incidents to the appropriate State and local

bodies having regulatory jurisdiction. The hospice would also be

required to take action to correct the problems promptly

never

possible. The hospice would be required to promptly report and

investigate all incidents that involve injury to patients, staff or

visitors, or that involve damage to property. The hospice would be

required to report such incidents to the appropriate State and local

bodies having regulatory jurisdiction. The hospice would also be

required to take action to correct the problems promptly. The hospice

would be required to take steps to prevent equipment failures and

correct and report any equipment failures promptly. In Sec.

418.110(c)(1)(iii) we have retained the existing requirement at Sec.

418.100(b) that the hospice periodically rehearse with staff a disaster

preparedness plan for managing the consequences of natural disasters

and other emergencies that affect the hospice's ability to provide

care. We believe that special emphasis should be placed on carrying out

the procedures necessary to protect the patients and others.

In Sec. 418.110(c)(2), Physical plant and equipment, paragraphs

(c)(2)(i) through (c)(2)(iv), we are proposing that there be procedures

for the management of light, temperature, and ventilation controls

throughout the hospice (including air exchange) for patient care. The

hospice

would be required to make battery lamps and flashlights available in

all areas not served by an emergency electrical supply source. The

hospice would be required to make available an emergency gas and water

supply. All equipment would be required to be properly maintained.

In Sec. 418.110(d), Fire protection, we are proposing to recodify,

without change, the existing provisions in Sec. 418.100(d). These

provisions were amended on January 10, 2003 (68 FR 1374) to adopt the

year 2000 version of the Life Safety Code. They were also amended on

August 11, 2004 to clarify the effective date of the roller latch

prohibition (69 FR 49266). In addition, they were amended on March 25,

2005 (70 FR 15229) to address the use and placement of alcohol-based

hand rubs.

Proposed Sec

n Sec. 418.100(d). These

provisions were amended on January 10, 2003 (68 FR 1374) to adopt the

year 2000 version of the Life Safety Code. They were also amended on

August 11, 2004 to clarify the effective date of the roller latch

prohibition (69 FR 49266). In addition, they were ame

This text is long and has been trimmed here. Open the source document for the complete record.