Medicare and Medicaid Programs: Hospice Conditions of Participation

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-3844-P]

RIN 0938-AH27

Medicare and Medicaid Programs: Hospice Conditions of Participation

AGENCY:

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

ACTION:

Proposed rule.

SUMMARY:

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

DATES:

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

ADDRESSES:

In commenting, please refer to file code CMS-3844-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

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

1. Electronically. You may submit electronic comments to

http://www.cms.hhs.gov/regulations/ecomments

(attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word).

2. By mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3844-P, P.O. Box 8010, Baltimore, MD 21244-8010.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3.

By hand or courier.

If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850.

(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

Submission of comments on paperwork requirements.

You may submit comments on this document's paperwork requirements by mailing your comments to the addresses provided at the end of the “Collection of Information Requirements” section in this document.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

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

Danielle Shearer, (410) 786-6617.

Steve Miller, (410) 786-6656.

SUPPLEMENTARY INFORMATION:

Submitting Comments:

We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-3844-P and the specific “issue identifier” that precedes the section on which you choose to comment.

Inspection of Public Comments:

Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

I. Introduction

As the single largest payer for health care services in the United States, the Federal Government assumes a critical responsibility for the delivery and quality of care furnished under its programs. Historically, we have adopted a quality assurance approach that has been directed toward identifying health care providers that furnish poor quality care or fail to meet minimum Federal standards. These problems would either be corrected or would lead to the exclusion of the provider from participation in the Medicare or Medicaid programs. However, we have found that this problem-focused approach has inherent limits. Ensuring quality through the enforcement of prescriptive health and safety standards, rather than improving the quality of care for all patients, has resulted in our expending much of our resources on dealing with marginal providers, rather than on stimulating broad-based improvements in quality of care.

Eliciting quality health care for Federal beneficiaries from CMS-certified providers and suppliers requires taking advantage of continuing advances in the health care delivery field. As a result, we are revising the Medicare hospice requirements, which are also used by Medicaid, to focus on a 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

uncomfortable symptoms through the appropriate coordination of all aspects of care needed to maximize personal comfort and relieve distress. Hospice care allows the patient to remain at home as long as possible by providing support to the patient and family, and keeping the patient as comfortable as possible while maintaining his or her dignity and quality of life. A hospice uses an interdisciplinary approach to deliver medical, social, physical, emotional, and spiritual services through the use of a broad spectrum of caregivers.

Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Public Law 97-248, added section 1861(dd) to the Social Security Act (the Act) to provide coverage for hospice care to terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice.

Under the authority of section 1861(dd) of the Act, the Secretary has established the Conditions of Participation (CoPs) that a hospice must meet to participate in Medicare and/or Medicaid, and these are currently set forth at 42 CFR part 418. The CoPs apply to a hospice as an entity as well as to the services furnished to each individual under hospice care. Under section 1861(dd) of the Act, the Secretary is responsible for ensuring that the CoPs, and their enforcement, are adequate to protect the health and safety of individuals under hospice care and to promote the effective and efficient use of Medicare funds. To implement this requirement, State survey agencies conduct surveys of hospices to assess their compliance with the CoPs.

B. Why Revise the Conditions of Participation?

The hospice CoPs were originally promulgated on December 16, 1983 (48 FR 56008) and were amended on December 11, 1990 (55 FR 50831) largely to implement provisions of section 6005(b) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239). However, many of the current CoPs have remained unchanged since their inception.

We are proposing changes to the current CoPs based on four main considerations. First, we considered the suggestions that emerged from the Secretary's Advisory Committee on Regulatory Reform. In an effort to make regulations more predictable and responsive to relevant stakeholders, the Committee heard public testimony on a variety of hospice related topics and developed recommendations to address key issues that were highlighted. The two largest changes that resulted from the Committee's recommendations are the clarification of the relationship between nursing facilities and hospices at proposed § 418.112, and the changes to the nursing services standard at proposed § 418.110(b).

Our second consideration was the Balanced Budget Act of 1997 (Pub. L. 105-33) because it made changes to the hospice statute that need to be incorporated into the CoPs.

Our third consideration was prompted by sections 408 and 946 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173). Section 408 amended the Social Security Act to permit a nurse practitioner to be deemed a patient's attending physician when the patient elects hospice care. Section 946 amended section 1861(dd), Hospice Care: Hospice Program, of the Act to permit a hospice to enter into an arrangement with another hospice to provide core hospice services, or to provide highly specialized services of a registered professional nurse, in certain circumstances.

Finally, this revision is part of a larger effort to bring about improvements in the quality of care furnished to Medicare and Medicaid beneficiaries through an outcome-oriented approach to quality of care responsibilities. The existing hospice CoPs do not contain patient-centered, outcome-oriented standards, nor do they provide for the operation of a quality assessment and performance improvement program.

Historically, we have established requirements for participation in the Medicare program that address the structure and process of health care. These early requirements are the result of professional consensus. Enforcing structure and process requirements by identifying deficient providers has not been adequate to meet the growing challenges associated with the changing hospice care environment. For example, rather than focusing on the relationship between the needs of patients and the staff available in an inpatient facility, the current regulations require that a registered nurse be present on every shift. Hospices often contract with local nursing facilities to provide inpatient respite care, and these facilities are only required to have a registered nurse on duty for a single eight hour shift each day. A hospice would have to supplement the nursing facility's staff with its own, at a significant cost to the hospice, even if the needs and acuity of the patient do not require a registered nurse. A hospice that did not supplement the facility's staff could be cited for not meeting the requirements, even though the requirements had no relevance to the needs of the patient. Thus, revisions to the hospice CoPs are essential.

C. Transforming the Hospice Conditions of Participation

Before developing these proposed CoPs for hospices, we received advice and suggestions from the hospice industry, professional associations, practitioner communities, consumer advocates, and State and other governmental agencies with an interest in, or responsibility for, hospice regulation and oversight. Based on these suggestions, we have developed the following principles:

• Focus on the continuous, integrated health care process that a patient/family experiences across all aspects of hospice care, and on activities that center around patient assessment, care planning, service delivery, and quality assessment and performance improvement.

• Use a patient-centered, interdisciplinary approach that recognizes the contributions of various skilled professionals and other support personnel and their interaction with each other to meet the patient's needs.

• Incorporate an outcome-oriented quality assessment and performance improvement program.

• Facilitate flexibility in how a hospice meets performance expectations.

• Require that patient rights are ensured.

• Use performance measurement systems to evaluate and improve care.

Based on these principles, we are proposing to set forth four core conditions of participation: Patient Rights, Patient/Family Assessment, Interdisciplinary Care Planning and Coordination of Services, and Quality Assessment and Performance Improvement.

• The Patient Rights CoP emphasizes a hospice's responsibility to respect and promote the rights of each hospice patient.

• The comprehensive Patient/Family Assessment CoP reflects the critical nature of a comprehensive assessment in determining appropriate treatments and accomplishing desired health outcomes.

• The Care Planning and Coordination of Services CoP incorporates the interdisciplinary team approach to providing hospice care.

• The Quality Assessment and Performance Improvement CoP charges each hospice with the responsibility for carrying out a performance effort to effect continuing improvement in the

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

The last three requirements establish a cycle of individual care and hospice-wide performance improvement. First, the patient's needs are comprehensively assessed and outcome measure data are collected. Second, the interdisciplinary group, in consultation with the patient's attending physician, establishes a plan of care to address those needs. Third, the plan of care is implemented and the results of the care are evaluated through updates of the comprehensive assessment and plan of care. Fourth, the outcome measure data collected during the initial and updated comprehensive assessments are analyzed to identify practices that lead to positive outcomes as well as opportunities for improvement. Finally, the hospice uses the results of such analyses to implement performance improvement activities. These activities will influence the establishment of plans of care and their implementation, thus creating a continuous cycle of individual care and an ongoing effort to improve the hospice's performance related to identified outcomes of care for all patients.

This cycle of care adapts to changing standards of practice while addressing issues that surveyors have identified. Below is a list of the most cited deficiencies found by surveyors (year ending September 3, 2002):

1. Plan of care was not complete.

2. No written plan was established.

3. Plan was not reviewed at specific intervals.

4. Plan did not include an assessment of needs.

5. Plan was not established before providing care.

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

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

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

9. Clinical record was not maintained for every patient.

10. Interdisciplinary group did not review and update the plan of care for each patient.

We note that 8 of the 10 top deficiencies are related to plan of care, assessment, and quality assurance. Based on industry comments and our own surveys, we believe that the current plan of care condition contained in § 418.58 must be strengthened. We did this by creating a separate condition for the assessment of individual needs and for the time frames related to that assessment. We also revised the quality assurance requirement and strengthened the plan of care requirement.

These requirements would focus provider and surveyor efforts on the actual care delivered to the patient, the performance of the hospice as an organization, and the impact of the medical, physical, social, emotional, and spiritual care delivered to the patient.

We are proposing to retain some of the current process-oriented requirements when they are likely to produce desirable outcomes and/or prevent harmful outcomes. These proposed CoPs invest in hospices the responsibility for improving patient care performance, rather than relying on an externally based approach where prescriptive requirements are enforced through the punitive aspects of the survey process.

This change signals an opportunity for CMS, hospices, and States to join in a partnership for improvement. When implemented, hospice programming will reflect a patient-centered, outcome-oriented approach that will likely alter the manner in which CMS and States manage the survey process. We believe that this approach will provide opportunities for improvement in patient care that have been lacking in the past. The addition of a strong quality assessment and performance improvement requirement will stimulate the hospice to continuously monitor its performance and find opportunities for improvement.

D. Development of Outcome-Based Performance Measures for Hospices

[If you choose to comment on issues in this section, please include the caption “OUTCOME-BASED PERFORMANCE MEASURES” at the beginning of your comments.]

We are proposing to require that hospices implement an outcome-based internal performance improvement program that can be used to measure individual patient outcomes. The information a hospice gleans from its own data analysis will serve as a baseline for hospice quality improvement. Measures quantify quality and are tools for the hospice to use in assessing and improving patient care, outcomes, and satisfaction. An outcome based performance program can help hospices improve the effectiveness and efficiency of their services, improve the outcomes of care they provide, and increase patient satisfaction with their services.

Hospice outcome measures, data elements, tools, and instructions for using them have already been developed by the industry. A Task Force initiative was sponsored and convened by the National Hospice Work Group (NHWG) and the National Hospice and Palliative Care Organization (NHPCO) in 1999. We participated in the development of the measures and provided technical assistance for pilot testing of the measures. The Task Force was invited to present the results of the measurement development work and results of the pilot studies to us in November 2000.

The work of the Task Force resulted in four measures for the outcome domains of self-determination, comfort, safety, and effective grieving. The hospice industry rapidly moved to include these four measures in the data set that they encourage member hospices to use and report. The data elements and instructions for using the measures are publicly available on the NHPCO Web site at

http://www.nhpco.org.

These outcome-based measures are part of a national reporting process created by the hospice industry. If a hospice chooses to participate in the NHCPO process, it submits its data to the NHPCO (or its contractor). Reports are then generated for a hospice to compare its performance with other hospices. The hospice may also choose to send additional information for the NHPCO reporting process in the areas of pertinent utilization data, appropriateness and effectiveness of services, and patient/family satisfaction. All hospices that participate in the NHPCO reporting process must comply with regulations mandated by the Health Insurance Portability and Accountability Act of 1996 (Pub.L. 104-191, “HIPAA”). Regulations implementing HIPAA were published on December 28, 2000 (65 FR 82462) and were amended on August 14, 2002 (67 FR 53182).

We are not proposing to require that hospices participate in the NHPCO process described above, but hospices may choose to use some of the measures the NHPCO is already using as part of its comprehensive assessment of the patient, and as part of the organization's quality assessment and performance improvement program. Hospices may also develop their own data elements and measurement processes. Participating in the NHPCO outcome measurement and reporting process would assist hospices in meeting the requirements of proposed § 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

The revised conditions would begin with existing § 418.2 that specifies the statutory authority and scope of the part for the ensuing regulations. Section 418.1 would remain unchanged.

1. Scope of the Part (Proposed § 418.2)

Section 418.2 would be revised to reflect the reorganization of the part and to include an introductory statement describing the purpose of the part.

2. Definitions (Proposed § 418.3)

Existing § 418.3 sets forth definitions for terms used in the hospice CoPs. This section is being revised in order to provide further clarification. We are proposing to move existing definitions of “physician” and “social worker” to proposed § 418.114, personnel requirements. We believe these definitions better fit in this new condition. We propose to include the following definitions:

• Attending physician (revised)

• Bereavement counseling (revised)

• Cap Period (same)

• Clinical note (new)

• Drug restraint (new)

• Employee (revised)

• Hospice (revised)

• Hospice care (new)

• Licensed professional (new)

• Palliative care (new)

• Physical restraint (new)

• Progress note (new)

• Representative (revised)

• Restraint (new)

• Satellite location (new)

• Seclusion (new)

• Terminally ill (revised)

These definitions would be revised to read as follows:

Attending physician

means a—

(a)(1) Doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he or she performs that function or action; or (2) Nurse practitioner who meets the training, education and experience requirements as the Secretary may prescribe; and

(b) Is identified by the individual, at the time he or she elects to receive hospice care, as having the most significant role in the determination and delivery of the individual's medical care.

Here after, except as indicated, the term “attending physician” includes nurse practitioners.

We modified this definition to address changes made to the Act by Congress in section 408 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (“MMA”). Nurse practitioners are often the primary medical health care professionals for some patients, particularly those residing in rural areas. For example, a nurse practitioner that works in conjunction with a doctor may be the health care professional a patient sees most often. The patient would develop a relationship with the nurse practitioner, and would like the nurse practitioner to continue to be involved in his or her care once he or she elects the hospice benefit. Under the current regulations, this is not allowed. Under the proposed regulations, we would permit a nurse practitioner to continue serving his or her patient as that patient's attending physician once that patient elects to receive hospice care. We believe that this would ensure the continuity of care and improve the quality of care because the health care professional most familiar with the patient, his or her conditions, and his or her personal situation would be involved in developing the plan of care and in making other important decisions.

Within the provisions of section 408 of the MMA nurse practitioners are prohibited from certifying or recertifying a patient's terminal illness. CMS will publish additional information regarding section 408 in a forthcoming

Federal Register

document.

Bereavement counseling

means emotional, psychosocial, and spiritual support and services provided after the death of the patient to assist with issues related to grief, loss, and adjusting.

Cap period

means the 12-month period ending October 31 used in the application of the cap on overall hospice reimbursement as specified in § 418.309.

Clinical note

means a notation of a contact with the patient that is written and dated by any person providing services, and that describes signs and symptoms, treatments and medications administered, including the patient's reaction and/or response, and any changes in physical or emotional condition.

Drug restraint

means a medication used to control behavior or to restrict the patient's freedom of movement which is not a standard treatment for a patient's medical or psychiatric condition.

Employee

means a person who works for the hospice and for whom the hospice is required to issue a W-2 form on his or her behalf, or if the hospice is a subdivision of an agency or organization, an employee of the agency or organization who is appropriately trained and assigned to the hospice or is a volunteer under the jurisdiction of the hospice.

Hospice

means a public agency or private organization or subdivision of either of these that is primarily engaged in providing hospice care as defined in this section.

Hospice care

means a comprehensive set of services described in 1861(dd)(1) of the Act, identified and coordinated by an interdisciplinary team to provide for the physical, psychosocial, spiritual, and emotional needs of a terminally ill patient and/or family members, as delineated in a specific patient plan of care.

Licensed professional

means a licensed person sanctioned by the State in which services are delivered, furnishing services such as skilled nursing care, physical therapy, speech-language pathology, occupational therapy, and medical social services.

Palliative care

means patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice.

Physical restraint

means any manual method or physical or mechanical device, material, or equipment attached to the patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body.

Progress note

means a written notation, dated and signed by any person providing services, that summarizes facts about the care furnished and the patient's response during a given period of time.

Representative

means an individual who has the authority under State law (whether by statute or pursuant to an appointment by the courts of the State) to authorize or terminate medical care or to elect or revoke the election of hospice care on behalf of a terminally ill patient who is mentally or physically incapacitated. This may include a legal guardian.

Restraint

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

Satellite location

means a Medicare-approved location from which the hospice provides hospice care and services within a portion of the total geographic area served by the hospice provider issued the provider agreement number. The satellite location is part of the hospice and shares administration, supervision, and services in a manner that renders it unnecessary for the satellite location to independently meet the conditions of participation as a hospice.

We are proposing to add this definition to recognize long-standing Medicare survey and certification policies, which allow for the operation of multiple locations by a single hospice provider. We are proposing that a hospice satellite location be approved by CMS before it begins to furnish service to patients. In the past, some hospices were found to be furnishing services from locations that had not been shown to be in compliance with applicable regulations. We envision the approval process to be consistent with determining that patients receive safe services from the satellite location in question. As is done for other appropriate providers and suppliers, we are accepting comment on applying the Medicare Appeals Procedures that affect participation in the Medicare program (42 CFR 498.3). If a hospice, including any or all satellite locations, is accredited by an accrediting organization such as JCAHO or CHAP, the hospice and each satellite location must still receive Medicare approval.

Seclusion

means the confinement of a person in a room or an area where a person is isolated and physically prevented from leaving.

Terminally ill

means that a patient has a medical prognosis that his or her life expectancy is six months or less if the illness runs its normal course.

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

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

D. Subpart C, Conditions of Participation—Patient Care

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

[If you choose to comment on issues in this section, please include the caption “PATIENTS RIGHTS” at the beginning of your comments.]

This section would replace the current condition of participation, Informed consent, laid out at § 418.62. This condition would set forth certain rights to which hospice patients would be entitled, and would require that hospices inform each patient of these rights and that hospice personnel ensure and support these rights. Among these rights would be the following, laid out at proposed § 418.52: Being informed in advance regarding the care to be provided; having an opportunity to participate in care planning; voicing grievances; being assured of confidentiality of records; having personal property respected; being informed whether services are covered or not covered, and having information provided in writing. We are proposing to specify that the patient must also be informed about factors that affect palliation and comfort. We believe that these revisions would act as an additional safeguard of patient health and safety. Open communication between hospice staff and the patient, and patient access to palliative information is vital to enhancing the patient's participation in his or her coordinated care planning. All hospices must also comply with the Privacy Rule published in the

Federal Register

on December 28, 2000 (65 FR 82461) as amended on August 14, 2002 (67 FR 53182) and contained in 45 CFR parts 160 and 164.

We are specifically soliciting public comment on this proposed condition of participation.

2. The Cycle of Care: Assessment, Planning, and Delivery (Proposed § 418.54 Through § 418.62)

The patient care assessment, planning, and palliative care process represented by the next four CoPs (§ 418.54 through § 418.62) can be seen as a cycle. Through the use of a comprehensive assessment, accurate and timely patient information is made available for use in the patient care process. The palliative care process consists of all hospice care and services furnished to the patient and family. The patient palliative care process results in an effect on the patient's condition, whether it is positive or negative. The assessment of the effectiveness of palliative care then results in subsequent care decisions, and the cycle begins anew. Through this cycle, accurate patient and family information obtained from each comprehensive assessment should yield effective and appropriate palliative care decisions, thus generating a positive effect on patient care and desired outcomes.

Condition of Participation: Comprehensive Assessment of the Patient (Proposed § 418.54)

The proposed comprehensive assessment requirement reflects our view that a patient-centered, interdisciplinary, and systematic patient assessment is essential to improving patient quality of care and patient outcomes.

In hospice care, the comprehensive assessment of the patient contributes to quality of care improvements in closely linked stages. First, the information generated from an interdisciplinary comprehensive assessment is a vital tool for developing a hospice patient's plan of care that will guide decisions on how best to determine the individual care and support needs of the patient. Second, based on updates of the comprehensive assessment, a hospice is able to track the patient's progress towards achieving the desired care outcomes, and where this does not occur, make appropriate changes to the patient's plan of care. Finally, the hospice is able to evaluate the results of its care decisions, thus yielding information to help form the hospice's future care planning process. We believe this approach reflects contemporary standard practice for many hospices, and we are proposing to revise the CoPs to support this outcome-oriented approach.

The centerpiece of this 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. The frequency with which this area is cited indicates that there are a significant number of hospices that are not doing enough to properly assess their patients.

The expanded assessment condition would guide these deficient hospices in thoroughly assessing their patients by identifying the general areas that should be included in each assessment and by identifying time frames for the completion of assessments. We believe that this proposed CoP would enable hospices to specifically identify patient care needs. Once a hospice has completed a timely and thorough assessment of the patient, it can develop an accurate plan of care that reflects the needs identified during the assessment. The accuracy and timeliness of the plan of care may lead to an improvement in the quality of the hospice experience for the patient and his or her family.

In addition, we believe that the broad assessment outline we are proposing will encourage hospices to exercise flexibility in determining how best to achieve positive outcomes. We believe that this approach is consistent with currently accepted practices in hospices.

In § 418.54(a), Initial assessment, we are proposing that a registered nurse make the initial assessment visit to determine the patient's immediate care and support needs within 24 hours after the hospice receives a physician's admission order for care (unless another date is specified by the physician). We realize that some hospices meet with patients and their families, at their request, before the actual admission for care orders are received, and this regulation would not prevent this practice. However, meeting with a patient and his or her family before the patient's physician orders hospice care would not satisfy the initial assessment requirement.

In § 418.54(b), Time frame for completion of the comprehensive assessment, we are proposing that the hospice interdisciplinary group, in consultation with the hospice medical director or physician designee and/or the individual's attending physician, complete the comprehensive assessment in a timely manner consistent with the patient's immediate needs, but no later than 4 calendar days after the patient elects the hospice benefit. We believe that most hospices already complete the assessment within this time frame and, due to the decreased length of stay, as explained in the discussion of § 418.54(d), Update of the comprehensive assessment, and the potential severity of the patient's condition, we believe it is essential to ensure that patients are assessed in a timely manner.

Section § 418.54(c), Content of the comprehensive assessment, would describe the requirements for the content of the comprehensive assessment that we believe are critical to quality hospice care. These content requirements are at the core of hospice care and are needed to evaluate the patient's need for physical, social, emotional, medical, and spiritual care.

Under proposed § 418.54(c)(3)(ii), Drug therapy, the patient's comprehensive assessment would have to‘ include a review of the patient’s current medication. The review and accompanying documentation would include identification of the following items:

• Ineffective drug therapy;

• Unwanted side and toxic effects; and

• Drug interactions.

This review must be repeated as necessary to ensure that the patient continues to receive drug therapy that is effective and appropriate for his or her needs. A review of a patient's drugs would be included in the initial assessment and in the development of the plan of care. This review could occur at any time, but specifically when a patient is prescribed or begins to take any new drug and/or when use of a drug is discontinued.

In § 418.54(d), Update of the comprehensive assessment, we are proposing that the comprehensive assessment be updated by the interdisciplinary group as frequently as the patient's condition requires, but no less frequently than every 14 days. We believe that these frequent reviews are necessary and predictive of quality outcomes for two reasons:

(1) In the terminal stages of care, patient status needs, circumstances, and family expectations can change greatly, affecting the type and frequency of services that should be furnished. Reassessments assist the hospice in developing a more responsive care plan. The interdisciplinary group would use assessment information to guide necessary reviews and/or changes to the patient's plan of care.

(2) We are proposing that a hospice medical director or physician designee be required to recertify a patient for hospice care at specific intervals as stated in § 418.21. We believe recertification, which occurs at the end of the initial and subsequent 90-day benefit periods (and at the end of the remaining benefit periods as described in § 418.21), serves as a logical point for updating an assessment in addition to the minimum 14 days and when the patient's condition changes.

We believe that to ensure quality and timely care for our hospice beneficiaries, timely completion of the initial assessment requirement and the comprehensive assessment update requirement is necessary. In 2001 the average length of enrollment in hospice care was 51 days (2002 Nov. Medicare National Summary for HHA, Hospice, SNF, and outpatient CY 1999-2001,

http://www.cms.hhs.gov/statistics/feeforservice/National Summary.pdf).

According to research by the NHPCO, in 2000 the average length of enrollment in hospice care was 48 days (2000 NHPCO National Data Set Summary Report, 2001 Nov.). There has been some concern regarding short lengths of stay. Hospices have been admitting patients late in their terminal illness and those patients need extensive hospice services and resources initially, and right before death. In order to ensure that patients receive the necessary services and thus begin to benefit from hospice care at the earliest time possible, we believe that it is important that the comprehensive patient assessment be completed within the time frame that we have proposed. A delay in completing the initial comprehensive assessment and the updated assessments is ultimately not as beneficial to the patient and family as if the patient had entered hospice care and received timely assessments to determine the proper care to be provided.

These requirements, though 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 § 418.54(b) and 14-day timeframe for updating the comprehensive assessment as proposed in § 418.54(d) may set higher performance expectations for some hospices then the self-imposed standards they currently utilize. We believe that if a hospice recognizes that it is not capable of furnishing services within these timeframes, new patients should not be accepted for care.

We welcome public comments on the review of our proposed timeframes for the initial comprehensive assessment and updated comprehensive assessment. We believe the timeframes are reasonable and consistent with current hospice practice.

[If you choose to comment on issues in this section, please include the caption “ASSESSMENT TIME FRAMES” at the beginning of your comments.]

Under the proposed § 418.54(e), Patient outcome measures, we are proposing that a patient's comprehensive assessment include measurement and documentation of aspects of care that are essential outcomes of optimal hospice care. Documentation is carried out in the same way for all patients through what we refer to as data elements. The hospice may develop its own data elements or use existing, externally developed data elements. However, some of the data elements should be related to the domains of self-determination, comfort, safety, and effective grieving related to bereavement services. If a hospice chooses to collect information for the data elements developed by the NHPCO, it may also choose to submit this information to the NHCPO. However, submission must be in accordance with the HIPAA privacy rule (45 CFR Parts 160 and 164). The hospice may also choose to send additional information for the NHPCO reporting process in the areas of pertinent utilization data, appropriateness and effectiveness of services, and patient/family satisfaction.

The data elements used by the hospice must be an integral part of both the initial comprehensive and updated assessments. The application of these data elements to the identified domains must be documented in a systematic and retrievable way for each patient, as the outcome measurements will be used in patient care planning and coordinating services. Measurements will also be used (in the aggregate) for the hospice quality assessment and performance improvement program.

We want to emphasize that we are not proposing that hospices use any specific data elements to measure domain outcomes. We are simply proposing that hospices collect the data necessary to evaluate the quality of care they are providing and use this information in a systematic and retrievable way. Hospices may develop their own data elements related to the aspects of care related to hospice and palliation, such as self-determination, comfort, safety, and effective grieving, or may use the data elements related to the seven outcome measures in the NHPCO data set

(http://www.nhpco.org)

.

Currently, there is insufficient evidence for a valid and reliable common set of measures (that is, data elements) for use in hospice care. We are aware that the industry is studying this area. We also know that there are many measures that are currently used to help gauge the processes of care for hospice patients and to make adjustments to care on their basis. For example, there are multiple scales for use in pain management, anxiety, and depression, and there are several quality-of-life scales appearing in the relevant literature

(http://www.nhpco.org

and

http://www.chcr.brown.edu/pcoc/toolkit.htm)

. Some measurable outcomes can be captured in single items while others require multiple items to capture the full range of measurement issues.

We welcome comments on our “outcome measures” approach to this proposed regulation. We are particularly interested in comments as to whether this approach is necessary in assessment, care planning, service delivery, and most importantly, to the hospice's quality assessment and performance improvement program.

[If you choose to comment on issues in this section, please include the caption “OUTCOME MEASURES” at the beginning of your comments.]

Condition of Participation: Interdisciplinary Group Care Planning and Coordination of Services (Proposed § 418.56)

[If you choose to comment on issues in this section, please include the caption “PLAN OF CARE” or “COORDINATION OF SERVICES” where appropriate, at the beginning of your comments.]

The existing condition of participation concerning the plan of care is set forth at § 418.58. We are proposing to revise the contents of this section and place them in a new condition, “Interdisciplinary group care planning and coordination of services” (proposed § 418.56). The proposed condition would contain five standards that reflect the interdisciplinary approach to hospice care delivery.

As proposed, each patient and family would have a written plan of care developed by the hospice interdisciplinary group in consultation with the patient's attending physician that specifies the hospice care and services necessary to meet the patient/family-specific needs identified in the comprehensive and updated assessments. All hospice services furnished to patients and their families must follow this written plan of care.

Under proposed § 418.56(a), Approach to service delivery, we are proposing that the hospice designate an interdisciplinary group or groups composed of individuals who work together to meet the physical, medical, social, emotional, and spiritual needs of the hospice patients and families facing terminal illness and bereavement. We believe that the role of the interdisciplinary group is paramount in directing and monitoring the patient care and is one of the factors that makes the hospice benefit unique. The hospice would designate a qualified health care professional who is a member of the interdisciplinary group to provide program coordination, ensure the continuous assessment of each patient's and family's needs, and ensure the implementation and revision of the plan of care.

The proposed standard at § 418.56(b), Plan of care, is the same as the existing standard at § 418.58(a), with one addition. We are including a reference to the patient's family when establishing the plan of care. We would require that all hospice services furnished to patients and their families follow a written plan of care established by the hospice interdisciplinary group in collaboration with the attending physician. Family plays an important role in the care of a hospice patient, and this change reflects that role.

Under the proposed standard at § 418.56(c), Content of the plan of care, we would require that each patient's plan of care reflect interventions for problems identified in the comprehensive and updated assessments. This requirement ensures that care and services are appropriate to the level of each patient's and family's specific needs. The plan of care must include the following:

• Interventions to facilitate the management of pain and symptoms;

• A detailed statement of the scope and frequency of services required to meet the patient's and family's specific needs;

• Measurable outcomes anticipated from implementing and coordinating the plan of care;

• Drugs and treatment necessary to meet the needs of the patient;

• Medical supplies and appliances required to meet the needs of the patient; and

• The interdisciplinary group's documentation in the clinical record indicating the patient's and family's understanding, involvement, and agreement with the plan.

As we noted in the description of the previous standard, we are proposing to add a requirement that the plan address the patient's and family's expectations, understanding, agreement, and ability to participate in the care as the patient and family desire. Since family members need to understand the importance of their role in care of the hospice patient, their input and agreement regarding care is essential in developing a productive relationship with the hospice. We would expect a hospice to document the patient's and family's understanding of and agreement to the plan of care in accordance with its own policies. This could include an attestation signed by the patient and family, a note in the clinical record, and/or another form of documentation decided upon by the hospice governing body.

Proposed standard § 418.56(d), Review of the plan of care, would require that a revised plan of care include current information from the patient's updated comprehensive assessment and information concerning the patient's progress toward achieving outcomes specified in the plan of care. The plan of care must be reviewed at intervals specified in the plan but no less frequently than every 14 calendar days. We believe that it is essential to include the requirement that actual care provided also be changed as needed, thus establishing the essential linkage between assessment information, evaluation of treatment results, and plan of care modification.

We also propose to require that the hospice take steps to involve the patient's attending physician in the review of the patient's plan of care. The attending physician often has had a lengthy relationship with the patient; and his or her input into the review of the plan of care can be invaluable. We do not have the authority in the Conditions of Participation governing hospices to require that an attending physician, an individual who is not an employee of the hospice and thus not governed by these hospice regulations, participate in this process. However, we can and are proposing that the hospice collaborate with the patient's attending physician to the extent possible when reviewing the plan of care. We believe that requiring hospices to involve interested attending physicians will benefit patients by helping to ensure that the care described in the plan of care reflects the needs and desires of patients and their families.

We are proposing to add a new standard, Coordination of services, at § 418.56(e). This standard would require that the hospice maintain a system of communication and integration to enable the interdisciplinary group to ensure the overall provision of care and the efficient implementation of the day-to-day policies. These new standards would also make it easier for the hospice to ensure that the care and services are provided in accordance with the plan of care, and that all care and services provided are based on the comprehensive and updated assessments of the patient's and family's needs. An effective communication system would also enable the hospice to ensure ongoing liaison of all disciplines providing care and services in the home, outpatient, and inpatient settings, notwithstanding the manner in which the care and services are furnished.

We believe that this standard is appropriate for two reasons. First, a hospice patient typically encounters many services delivered at different times by a variety of individuals with different skills. An efficient method of communication and integration of observations among members of the interdisciplinary group and others providing care is essential to meet and respond to the patient's and family's needs in a timely manner. Second, effective communication and coordination of services will assist a hospice in avoiding a duplication of effort or a furnishing of conflicting services.

We recognize the value of an interdisciplinary approach to the delivery of hospice services. This approach to care reflects actual industry practice, and as a result, we believe the proposed requirement is in step with the hospice industry.

We are specifically soliciting public comment on the proposed requirements for the content of the plan of care, the time frames for review of the plan of care, and the new coordination of services standard.

Condition of Participation: Quality Assessment and Performance Improvement (Proposed § 418.58)

[If you choose to comments on issues in this section, please include the caption “QAPI” at the beginning of your comments.]

The existing § 418.66, Condition of participation—Quality assurance, relies on a problem-oriented approach to identify and resolve patient care issues. Failure to meet the quality assurance condition is consistently one of the top 10 deficiencies cited by surveyors nationwide. According to the hospice industry associations, hospices are no longer using the quality assurance model. During the last decade the health care industry, including the hospice industry, has moved beyond the problem-oriented, after-the-fact corrective approach of quality assurance to an approach that focuses on a pre-emptive plan that continuously addresses quality assessment and performance improvement (QAPI). Hospice industry associations have indicated that their upgraded QAPI systems are incompatible with the existing quality assurance condition. Therefore, the providers who have moved beyond quality assurance in order to make meaningful and sustained quality improvements in their own programs are actually in violation of the outdated quality assurance condition.

On the other end of the spectrum are providers who are truly deficient because they do not have any quality program. These providers would find more guidance in the proposed regulation. In the following section of this preamble we will discuss two publicly available resources for data measures, an integral part of the proposed QAPI requirement. In the proposed regulation we have outlined when those should be collected and what role they play in the proposed QAPI condition. In addition, we have described the scope of the proposed QAPI program requirement, the guidelines for identifying performance improvement activities, and the individuals responsible for ensuring that a hospice has a QAPI program. The proposed regulations provide hospices that are unsure of what is expected of them with the guidelines to begin tailoring a QAPI program that meets their needs and circumstances.

Therefore, we believe that this proposed condition will reduce the number of deficient providers by recognizing those who are practicing QAPI and guiding reluctant providers to meet current standards of practice. The proposed QAPI requirement would raise the performance expectations for hospices seeking entrance into the Medicare program, as well the expectations of those currently participating in Medicare. We are proposing that each hospice develop,

implement, and maintain an effective, continuous quality assessment and performance improvement program that stimulates the hospice to constantly monitor and improve its own performance, and to be responsive to the needs, desires, and satisfaction levels of the patients and families it serves.

The desired overall outcome of this proposed CoP is that the hospice will drive its own quality improvement activities and improve its provision of services. With an effective quality assessment and performance improvement program in place and operating properly, the hospice can better identify and reinforce the activities it is doing well, identify its activities that are leading to poor patient outcomes, and take actions to improve performance.

This proposed condition requires the hospice to develop, implement, and maintain an effective data driven quality assessment and performance improvement program (QAPI). The program establishes a planned approach to quality improvement and takes into account the complexity of the hospice's organization and services, including those provided directly or under arrangement. The hospice must take whatever actions are necessary to implement improvements in its performance as identified by its quality assessment and performance improvement program. The hospice is also responsible for ensuring that the professional services it offers are carried out within current clinical practice guidelines as well as professional practice standards applicable to hospice care.

In the first proposed standard under this condition at § 418.58(a), Standard: Program scope, we are proposing that the hospice's quality assessment and performance improvement program must include, but not be limited to, an ongoing program that is able to show measurable improvement in indicators that are linked to improving palliative outcomes and end-of-life support services. We expect that a hospice will use standards of care and the findings made available in current literature to select indicators to monitor its program. The hospice must measure, analyze, and track these quality indicators, including areas such as adverse patient events and other aspects of performance that assess processes of care, hospice services, and operations. Adverse patient events, as used in the field, are occurrences that are harmful or contrary to the targeted patient outcomes.

The second proposed standard under § 418.58(b) Program data, would require the hospice program to incorporate quality indicator data, including patient care data and other relevant data, into its QAPI program. This would include data that are received from or submitted to hospice professional organizations. A fundamental barrier in identifying quality care at the end of life is the lack of measurement tools. Measurement tools can identify opportunities for improving medical care and examining the impact of interventions.

CMS does not currently require the submission of data from hospices to calculate quality measures but is interested in the development of a set of measures. Hospice measures were submitted and discussed as part of the recent National Quality Forum process identifying home health measures but were withdrawn and added to the more focused end of life discussions. CMS would be interested in comments regarding clinical measures, patient experience of care measures, and systems measures (use of information technology, staffing, follow up mechanisms) specific to hospice care. These comments should include existing measures in use, measures to be developed, data collection methods and issues, and how measures are currently being used. We are especially interested in the feasibility, usability, if the measures presented are proprietary or publicly available, and burden of collecting and reporting the measures.

An example of available measurement tools would be the hospice outcome measures, data elements, tools, and instructions developed by a hospice industry task force in which the CMS participated as a stakeholder. A Task Force initiative was sponsored and convened by the National Hospice Work Group (NHWG) and the National Hospice and Palliative Care Organization (NHPCO) in 1999. We participated in developing the measures and provided technical assistance for pilot testing the measures. In addition to the work that has already been done in this area, we are committed to working with all relevant interest groups and associations as they develop and provide hospices with model quality assessment and performance improvement programs and other services.

The work of the Task Force resulted in measures addressing the outcome domains of self-determined life closure, comfortable dying, safe dying, and effective grieving. The hospice industry moved to include these measures in the data set that they encourage member hospices to use and report. The data elements, tools, and instructions for using the measures are publicly available on the NHPCO website

http://www.nhpco.org.

If a hospice chooses to participate in this voluntary process as described in the NHPCO web site, it would collect the specified data elements, analyze the data to assess its performance, and implement performance improvement projects to address weaknesses while reinforcing strengths. A hospice may also choose to submit its data to the NHPCO or its contractor. The national reporting process includes pertinent utilization data, appropriateness and effectiveness of services, and patient and family satisfaction. Reports are then generated by the NHPCO for hospices to compare their performance with other hospices.

All hospices that choose to utilize the NHPCO reporting process will need to follow the HIPAA Privacy Rule. We believe that participating in the NHPCO reporting process in order to improve the quality of care delivered to patients would probably be deemed to be part of the hospice's health care operations under the HIPAA Privacy Rule. The NHPCO would be doing work on behalf of the hospice. Therefore, it appears that the hospice and the NHPCO would be required to have a business associate agreement, ensuring that the NHPCO would protect the health information submitted by the hospice. Sample business associate language is available at

http://www.hhs.gov/ocr/hipaa/contractprov.html.

Hospices should confer with their legal counsel to ensure that their disclosures are in compliance with the Department's rules. Once the business associate agreement was in place and the hospice began to submit its data, it would not need individual authorization to disclose protected health information to the NHPCO. In addition, the hospice would not need to account for the disclosures to the NHPCO.

We are not proposing to require that hospices use any particular process or outcome measures. However, a hospice that uses the available quality measures may be able to expect an enhanced degree of insight into the quality of its services and patient satisfaction than if it began the outcome-measure development process anew. In addition to the NHPCO measures, there are many other resources available. One of these resources, for example, is the “TIME: Toolkit of Instruments to Measure End of life care,” developed by Brown University. It can be found at

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

This Toolkit takes steps toward crossing the measurement barrier by creating patient-focused, family-centered survey instruments that address the needs and

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

The hospice could also develop its own data elements and measurement process as part of its quality assessment and performance improvement program. A hospice is free to develop a program that meets its needs. We recognize the diversity of provider needs and concerns with respect to QAPI programs. As such, a provider's QAPI program will not be judged against a specific model.

Under the proposed standard, Program data, found at § 418.58(b), the hospice is expected to monitor the effectiveness of services and be able to target areas for improvement. The main goal of the quality assessment and performance improvement standard is to identify and correct ineffective and/or unsafe care. We expect hospices to assess their patient load and identify circumstances that could lead to significant patient care issues and concentrate quality assessment and performance improvement energies in these areas. For example, patients with minimal support care, those experiencing frequent exacerbations of symptoms, and those whose diagnosis and care may be unique to the hospice, may be the subject of more intense quality assessment and performance improvement activity. We expect a hospice to be able to demonstrate consistent performance progress in successful quality assessment and performance improvement interventions.

The third standard under the quality assessment and performance improvement program at proposed § 418.58(c), Program activities, states that the hospice must set priorities for its performance improvement activities that: focus on high risk, high volume and problem-prone areas; consider the prevalence and severity of identified problems; and give priority to improvement activities that affect palliative, patient safety, and quality of care outcomes. We expect that a hospice would take immediate action to correct any identified problems that directly or potentially threatened the care and safety of patients. Prioritizing areas of improvement is essential for the hospice to gain a strategic view of its operating environment and to ensure the consistent quality of care provided over time.

In § 418.58(c) we are also proposing to require the hospice to track adverse patient events, analyze their causes, and implement preventive actions that include feedback and learning throughout the hospice. The hospice's quality assessment and performance improvement program is expected to view staff as full partners in quality improvement. Because staff members are in a unique position to provide the hospice with structured feedback on its performance and suggestions on how performance can be improved, we expect the hospice to demonstrate how staff contribute to its quality improvement program.

We are proposing at § 418.58(d), Performance improvement projects, to require that the number and scope of improvement projects conducted annually must reflect the scope, complexity, and past performance of the hospice's services and operations. The hospice must document what improvement projects are being conducted, the reasons for conducting them, and the measurable progress achieved on these projects. We believe that giving hospices the flexibility to review their own organization and quality performance and improvement program may improve the effectiveness and efficiency of their services, improve the outcomes of care they provide, and potentially improve beneficiary satisfaction with their services.

We are proposing at § 418.58(e), Executive responsibilities, to require the hospice's governing body to be responsible and accountable for ensuring that the ongoing quality improvement program is defined, implemented, and maintained. The governing body must ensure that the program addresses priorities for improved quality of care and patient safety. The governing body must also specify the frequency and detail of the data collection and ensure that all quality improvement actions are evaluated for effectiveness. The governing body's most important role is to ensure that staff are furnishing and patients are receiving the most appropriate level of care. Therefore, it is incumbent on the governing body to lend its full support to agency quality improvement and performance improvement efforts.

We are specifically soliciting public comments on this proposed condition of participation.

Condition of Participation: Infection Control (Proposed § 418.60)

[If you choose to comments on issues in this section, please include the caption “INFECTION CONTROL” at the beginning of your comments.]

There is no current requirement for infection control other than the requirement at § 418.100(a) that “* * * each patient is to be kept comfortable, clean, well groomed, and protected from accident, injury, and infection.” We are now proposing a new CoP due to the seriousness and hazards of infectious and communicable diseases. There is a substantial amount of research from government agencies and private organizations regarding the effect of infections and communicable diseases in the inpatient environment. This research documents their widespread prevalence. While there is less research that examines infections and communicable diseases in the home, the effect of both on the health and safety of patients and the cost of patient care cannot be dismissed. In response, the health care industry has developed guidelines and recommendations for managing preventative programs. For example, the Association for Professionals in Infection Control and Epidemiology, Inc. have published “Requirements for infrastructure and essential activities of infection control and epidemiology in out-of-hospital settings: A Consensus Panel report” (

http://www.apic.org/pdf/cpinfra2.pdf

). The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) responded to the issue by designing new infection control standards for, among others, home care providers. These standards will become effective in 2005. Due to the negative effects on patient health and safety that are posed by infections and communicable diseases, and due to the significant amount of public, industry, and government attention that this issue has generated, we believe that hospices need to address infection control in a more complete manner.

In this proposed CoP, we are requiring hospices to take specific actions to address the prevention and control of infections and disease, and to educate patients, staff, and caregivers on their hazards, prevention, and control. It is essential that agencies consider the devastating effects of rampant communicable disease as they carry out their quality assessment and performance improvement programs. As a result, we expect the hospice to maintain an effective and up-to-date infection control program that may be part of its overall quality assessment and performance improvement program.

We recognize that a hospice cannot be directly responsible for the maintenance of an infection-free environment in an individual's home or inpatient setting. We are proposing in § 418.60(a), Prevention, that hospices follow accepted infection control standards of practice and ensure that all staff that provide hospice services know and use these current best prevention practices to curb the spread of infection. Periodic

training is one way to assure staff understanding.

In § 418.60(b),Control, we are proposing that the hospice engage in an ongoing system-wide program that focuses on the surveillance, identification, prevention, control, and investigation of infections and communicable disease. We expect the hospice to use best control practices in this endeavor. We are also expecting that each hospice educate its staff, as well as patients, families, and other caregivers in the “current best practices” for controlling the spread of infections within the home during the course of the family/care givers' interactions. Where infection and/or communicable disease is identified, we expect that this information is made part of the hospice's quality assessment and performance improvement program.

In § 418.60(c), Education, we are proposing a standard allowing the hospice flexibility in meeting its infection control, prevention and education objectives. For example, the amount of training in infection control necessary for the hospice's personnel would depend on the patient mix and experience of the staff. While we would expect that established best practices be adhered to, we are not proposing any specific approaches to meeting this requirement. However, all staff and family will be educated on the use of standard precautions for the safety of the patient, family and caregivers. We will expect to see clear evidence that the hospice aggressively seeks to minimize the spread of disease and infection through the use of effective techniques by its staff and through its efforts to help families and care givers understand what can and should be done to minimize infection.

We are specifically soliciting public comments on this proposed condition of participation.

Condition of Participation: Licensed Professional Services (Proposed § 418.62)

Sections of current regulations at § 418.82, Nursing services; § 418.84, Medical social services; and § 418.92, Physical therapy, occupational therapy and speech-language pathology, identify detailed tasks that must be performed by agency staff.

We are proposing to delete § 418.82, § 418.84, and § 418.92, and replace them with a more simplified condition, licensed professional services. Instead of identifying detailed tasks, we are broadly describing the expected contributions of the licensed professionals who are furnishing hospice services.

We are proposing that licensed professionals who provide services to hospice patients either directly or under arrangement must participate in coordinating all aspects of care, including updating the interdisciplinary comprehensive assessments, developing and evaluating plans of care, participating in patient and family counseling, participating in the quality assessment and performance improvement plan, and participating in in-service training. The expected outcome is the coordinated, comprehensive, interdisciplinary delivery of appropriate and effective licensed professional services delivered and supervised by health care professionals who practice under State licensure requirements and the hospice's policies and procedures. Licensed professional services, for purposes of this section, include skilled nursing care, physical therapy, 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 § 418.64 and the non-core services condition at § 418.70.

Medicare makes a distinction between providing services directly, as opposed to providing services under arrangement. The most common way services are provided directly is through the use of employees. The common law definition of “employee” fundamentally relates to whether a person is under control by the entity or individual providing the services. The “physician referral provisions” at section 1877(h)(2) of the Act references the Internal Revenue Service (IRS) “employee” definition. Section 1877(h)(2) provides that an individual is considered to be “employed by” or an “employee” of an entity if the individual would be considered to be an employee of the entity under the usual common law rules applicable in determining the employer-employee relationship (as applied for purposes of section 3121(d)(2) of the Internal Revenue Code of 1986).

Condition of Participation: Core Services (Proposed § 418.64)

The conditions of participation containing the current core services requirements are in § 418.80, Furnishing of core services; § 418.82, Nursing services; § 418.84, Medical social services; § 418.86, Physician services; and § 418.88, Counseling services. We are proposing to combine these into a single condition. We are also proposing to incorporate the requirement at existing § 418.50(b)(3) that core services be provided in a manner consistent with accepted standards of practice.

This section has been revised to reflect changes to the Act made by section 946 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”). In accordance with that provision, we are proposing to allow a hospice (the primary hospice) to enter into arrangements with another Medicare certified hospice to obtain core hospice services. This could be done under extraordinary or other non-routine circumstances. Pursuant to Section 1861(dd)(5)(D) of the Act, as added by section 946(a) of the MMA, those circumstances are: Unanticipated periods of high patient loads; staffing shortages due to illness or other short-term temporary situations that interrupt patient care such as natural disasters; and temporary travel of a patient outside the hospice's service area. We believe that the new MMA provision authorizes us to propose that hospices may not routinely contract for a specific level of care (

e.g.

, continuous care) or for specific hours of care (

e.g.

, evenings and week-ends), as these are regularly occurring situations that hospices are able to plan staffing for.

We propose to require that contractual arrangements under the provision be set forth in a legally binding written agreement between the hospices. The written agreement would ensure that contracted staff meet all hospice personnel qualifications and receive necessary training. The primary hospice would be responsible for enforcing the contractual provisions. This would ensure that the primary hospice maintains professional management responsibility for the service(s) being provided and the individual(s) providing such service(s), as described in sections 418.62, Skilled professional services and 418.100, Organization and administration of services. These sections require contracted services to be provided according to professional standards and practices. Finally, contracted individuals would be required to actively participate in the coordination of care, including patient assessment and care planning, and in the primary hospice's in-service training and quality assessment and performance improvement programs.

The physician services requirement would be changed to allow the use of contracted physicians, including the medical director (see proposed 418.102).

In proposed § 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.

As with all other contracting arrangements, the hospice would be required to maintain professional management responsibility for the service(s) being provided under arrangement as well as the individual(s) providing them. The responsibilities of both the primary hospice and the “lending” nursing provider would need to be outlined in the written agreement, and there would have to be a mechanism in place to ensure that the terms of the agreement were met. To that end, the contracted individual(s) would have to provide care in accordance with professional standards of practice; actively participate in the coordination of care, including the comprehensive patient assessment and the formulation of the plan of care; and actively participate in the hospice's inservice training and quality assessment and performance improvement programs.

In proposed § 418.64(c), we are proposing to maintain the current medical social services requirement found at § 418.84. This standard would continue to require that medical social services be provided by a qualified social worker under the direction of a physician. This standard would also require that medical social services, when accepted by a patient and family, be based on an assessment of that patient's psychosocial needs.

In proposed § 418.64(d), we address the counseling services that would be available to hospice patients. Those services would be bereavement, nutritional, and spiritual counseling. In the bereavement counseling section, we propose that a hospice would be required to have an organized program of bereavement services furnished under the supervision of a qualified professional with experience in grief/loss counseling. These services would be required to be made available to individuals identified in the bereavement plan of care up to one year following the death of the patient and would reflect the needs of those individuals. When appropriate, residents and staff of a SNF/NF, ICF/MR, or other facility would be offered bereavement services.

In the nutritional counseling section, we propose to alter the standard to allow qualified individuals such as dietitians and nurses to furnish this service, provided that it is within their scope of practice and expertise according to State law. We believe that allowing other qualified individuals to participate in nutritional counseling will give hospices greater flexibility and will help ensure that all hospice patients have access to this service when needed. This proposal for increased flexibility is a result of recommendations made by the Secretary's Advisory Committee on Regulatory Reform.

In the spiritual counseling section we propose that a hospice would be required to assess the patient's and family's spiritual needs and provide spiritual counseling to meet those needs in accordance with the patient's and family's beliefs and desires. If a patient and family do not desire spiritual counseling, then they would not have to be provided this service. If a patient and family do desire spiritual counseling, then a hospice would be expected to facilitate visits by local clergy, pastoral counselors, or others to the best of its ability. We have examined the relevant jurisprudence regarding the provision of spiritual counseling by Medicare certified hospices (Kong v. Scully

et al.

341 F.3d 1132 (9th Cir. 2003) reh. den. as amended, 357 F.3d 895 (9th Cir. 2004). We do not see any impediment to requiring hospices to offer spiritual services if a patient and family so desire.

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

[If you choose to comment on issues in this section, please include the caption “STATUTORY NURSING WAIVER” at the beginning of your comments.]

The requirements for obtaining a nursing services waiver as provided by section 1861(dd)(5) of the Act is currently set forth in § 418.83, and remains virtually unchanged in this proposal. This condition provides hospices the opportunity to obtain a waiver from the requirement that substantially all nursing services be routinely provided directly by the hospice. The Act specifies that to obtain a waiver a hospice must be located in an area that is not an urbanized area, must have been in operation on or before January 1, 1983, and must demonstrate a good faith effort to hire a sufficient number of nurse employees. Section 1861(dd)(5)(B) of the Act specifies that if a waiver is requested by an organization that meets the statutory requirements, and if it is submitted in the form and contains the information required by the Secretary, the waiver will be deemed granted unless the request is denied in 60 days after the request is received by the Secretary.

This waiver, set in statute, may be obsolete. We do not know how many hospices meet the criteria for the waiver, nor do we know if any hospices actually use the waiver. We request comments on the use of this waiver.

Condition of Participation: Furnishing of Non-Core Services (Proposed § 418.70)

The current CoP governing the provision of other services is contained in § 418.90. The hospice must ensure that the services described in § 418.72 through § 418.78 are provided directly by employees of the hospice or by others under an arrangement with the hospice. This is discussed further in proposed § 418.100. As with core services, non-core services should be provided in a manner consistent with current standards of practice.

Condition of Participation: Physical Therapy, Occupational Therapy, and Speech-Language Pathology (Proposed § 418.72)

Currently, the CoP concerning physical therapy, occupational therapy, and speech language pathology is laid out at § 418.92. We are proposing to recodify this CoP at § 418.72 without changes.

Condition of Participation: Waiver of Requirement—Physical Therapy, Occupational Therapy, Speech-Language Pathology, and Dietary Counseling (Proposed § 418.74)

We are proposing a new CoP that provides for a waiver of the requirement that physical therapy (PT), occupational therapy (OT), speech-language pathology (SLP) and dietary counseling services be provided as needed on a 24-hour basis. In addition, the waiver allows the hospice to provide the above services directly or under arrangements made by the hospice, as specified in current § 418.56.

We may approve a hospice's request for a waiver of the requirement that it furnish PT, OT, SLP and/or dietary counseling services if it is located in a nonurbanized area and can demonstrate that it has been unable, despite diligent efforts, to recruit appropriate personnel. Hospices will be required to submit evidence of their efforts to hire. We will apply similar requirements as are used for the nursing services waiver requests found in proposed § 418.66. As in the case for a waiver of nursing services, eligibility for a waiver is based on the primary location of a hospice. For a hospice that operates in several areas, its primary location is considered to be the location of its central office. The hospice must provide evidence that it made a good faith effort to hire a sufficient number of PTs, SLPs, OTs, and dietary counselors to provide services directly through hospice employees or under arrangement.

Condition of Participation: Home Health Aide and Homemaker Services (Proposed § 418.76)

Section 1861(dd)(1)(D) of the Act requires Medicare covered home health aide services to be furnished by an individual who has successfully completed training or a competency evaluation program that meets the requirements established by the Secretary. This section also provides for coverage of “homemaker” services.

Currently, the condition of participation concerning home health aide and homemaker services is set forth at § 418.94. We are proposing in § 418.76 that a home health aide completes a State-established or other training program, and in § 418.76(b) we outline requirements that this training must meet. Except for minor reorganization, these training requirements are consistent with existing home health aide requirements in § 484.36.

For example, we would continue to permit a home health aide to meet the proposed § 418.76(a), Home health aide qualifications, requirement in one of three ways: by completing a training and competency evaluation program that meets the proposed training requirements, by completing a competency evaluation program, or by completing a State licensure program that meets the proposed training requirements. We propose to include three separate ways to meet the proposed requirement because we understand that home health aides come to hospices with various levels of experience and qualifications. We would expect that, if a State licenses home health aides, then an aide would meet those licensure requirements and would, in fact, be licensed by that State. If a State does not have licensure requirements, then we would expect that a home health aide who had not previously participated in a training program that meets the proposed requirements would be trained in a program that meets the proposed requirements. In addition, we would expect that, following such training, that aide would be evaluated in a systematic way to assess his or her skills and competencies before performing patient care. If, however, a home health aide has already completed a training program that meets the proposed requirements while employed at another provider, then we would only expect the aide to complete a competency evaluation program at his or her new employer. We believe that this would make it easier for aides to change employers and faster for hospices to get qualified new employees out in the field. One of the skills a home health aide would be required to master is the ability to observe, report, and document patient status and the care or service furnished. We believe that clear and effective communication between the many providers of hospice care is an important part of ensuring high quality patient care. We believe that a home health aide should be able to both verbally report and document in writing what he or she observes and does at a patient's home.

Three standards have been particularly adapted for the hospice conditions of participation. First, § 418.76(j), homemaker qualifications, has been adapted from the existing § 418.94. The proposed standard clarifies that a qualified homemaker is a home health aide as described in § 418.76 or an individual who has met the standards in § 418.202(g) and has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness. Homemaker services may include assistance in maintenance of a safe and healthy environment to enable the patient to benefit from care that is furnished.

Second, § 418.76(h), Supervision of home health aides, would be revised from the current § 484.36(d) to require that a registered nurse or appropriate qualified therapist conduct an on-site supervisory visit every 28 days while the home health aide is providing care. Thorough supervision of home health aides is crucial to ensuring that the patient's and family's needs are being met, and conducting supervisory visits when the aide is present and performing his or her duties is the only way to provide such thorough supervision. On-site supervisory visits will still be required every 14 days as in the current rule at § 484.36(d)(2), but the aide would not be required to be present for these visits. This supervision schedule would allow hospices to maintain control over the quality and continuity of care being provided, and would help ensure that all patients receiving home health aide services are having their needs met by such services.

Finally, § 418.76(k) would require a member of the interdisciplinary group to coordinate homemaker services, and supply instructions for the homemaker on duties to be performed. The homemaker would be required to report all concerns about the patient or family to the member of the IDG who was coordinating the homemaker services. We have proposed these changes to ensure proper training and supervision, and to protect the quality of the homemaker services provided.

Condition of Participation: Volunteers (Proposed § 418.78)

The current CoP for volunteers is located at § 418.70. We are proposing to recodify this CoP at § 418.78 with minor changes. We are removing the existing § 418.70(f), regarding the availability of clergy, because the role of the pastoral, clergy, or other spiritual counselor is described in proposed § 418.56(a)(1)(iv), Interdisciplinary group, care planning and coordination of services. This change does not preclude the hospice from continuing to use or starting to use clergy as volunteers.

Subpart D, Conditions of Participation, Organizational Environment

Condition of Participation: Organization and Administration of Services (Proposed § 418.100)

[If you choose to comment on issues in this section, please include the caption “ORGANIZATION AND

ADMINISTRATION” at the beginning of your comments.]

We are proposing to revise existing regulations at § 418.50, General provisions, § 418.52, Governing body, and § 418.56, Professional management, by creating a new condition. This new condition would simplify the structure of these current requirements and clarify new performance expectations for the governing body. We believe the structure of the current requirements does not establish clear performance expectations for the operation of all services. The overall goal of the revised requirement would be to ensure a management structure that is organized and accountable. We believe that a 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, § 418.100), we have taken the current CoPs and proposed changing them to standards:

• Governing body and administrator (existing § 418.52).

• Continuation of care (existing § 418.60).

• Professional management responsibility (existing § 418.56).

• In-service training (existing § 418.64).

We would also include a standard clearly listing the services that the statute requires hospices to furnish. We are also proposing to add a new standard for in-service training that would require a hospice to provide 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, § 418.50(b)(3), Required services; § 418.52, Governing body; § 418.82(c), Acceptable standards of practice; § 418.92(a), PT, OT and SLP; and § 418.96(a), Administration of drugs and biologics, all exist as separate standards. To emphasize the importance of continuity of care and the focus on quality, regardless of the site of service, we are proposing to move these existing provisions and incorporate their performance expectation into the quality assessment and performance improvement program that is proposed at § 418.58.

We have long used the term “in accordance with accepted standards of practice,” in various provider and supplier requirements, (such as in the existing § 418.82(c)) to set a performance expectation and to be able to employ regulatory authority to shed light on inappropriate and/or dangerous practices. We are proposing to retain this authority and move the existing § 418.82(c) into § 418.64, Core services and § 418.70, Furnishing of non-core services.

In the proposed governing body and administrator standard at § 418.100(b) we emphasize the responsibility of the hospice governing body (or designated persons so functioning) for the management and provision of all hospice services including fiscal operations, quality assessment, performance improvement, and the appointment of the administrator. The actual approach to the administration of the hospice is left to the discretion of the governing body, thereby affording the hospice management flexibility. The proposed governing body standard reflects our goal of promoting the effective management and administration of the hospice as an organizational entity without dictating prescriptive requirements for how a hospice must meet that goal.

Section 418.100(c), Services, includes nursing, medical social services, physician services, counseling services, home health aide and homemaker services, therapy services, short-term inpatient care and medical supplies. The nursing services, physician services, and drugs/biologicals as specified in § 418.100(c)(2) must be routinely available on a 24-hour basis. All other covered services must be available on a 24-hour basis when reasonable and necessary to meet the needs of the patient and family.

In § 418.100(d), Continuation of care, the current standard is at § 418.60. We are proposing to recodify this section at § 418.100(d) without change.

In § 418.100(e), Professional management responsibility, we are proposing to revise some of the current requirements found at § 418.56(b) and (c). This standard would require written agreements for services furnished under arrangement, and would require that the hospice retain professional management and supervisory and financial responsibility for all services that are provided to the patient and family. The hospice would be required to ensure that all services provided are authorized by the hospice, are furnished in a safe and effective manner by qualified personnel, and that items and/or services specified in the plan of care are provided.

In § 418.100(f)(1), we are proposing a new standard to address the issue of multiple service locations. Our goal is to establish clear requirements in order to ensure patient comfort, patient safety, and the provision of a consistent level of care throughout the hospice organization. This provision is intended to codify long-standing Medicare survey and certification policy, which allows for the operation of multiple locations by a single hospice provider with a single Medicare agreement.

We are adding the definition of a hospice satellite location. The way in which hospices are organized has changed since the original regulations were promulgated. Today, unlike small community based hospices that were operating when the Medicare hospice benefit first began, it is common to find large hospice organizations serving a patient population widely dispersed throughout a sizeable geographic area. Some existing hospices operate from multiple locations. We believe it is appropriate to develop a basis in regulation to better clarify this organizational structure and we have been asked by hospices to more fully consider the nature of the relationship between a hospice and a satellite location.

We expect that any hospice that requests to establish a satellite location will be able to demonstrate how it is able to manage and monitor all of the services provided in its entire service area, including services from a satellite location. Patients who receive care and services from a hospice satellite location must receive the full range of services that are documented in the plan of care. We will consider the following factors in our review of a hospice's request to establish a satellite location:

• The hospice's ability to supervise the satellite location to ensure the timely provision of quality care for patients and families receiving care.

• The hospice's past compliance history.

• Relevant State issues and recommendations including a reciprocal agreement between the States to assure that at least one of the State agencies assumes responsibility for any necessary surveys of the satellite location in situations in which a hospice provides services in satellite locations across state lines.

• The hospice's assurance that each patient receives care from an assigned interdisciplinary group that works effectively together to identify and meet the physical, social, emotional, and spiritual needs of the hospice patients and families receiving care.

Before operating a satellite location, a hospice must enroll with the fiscal intermediary and notify the State agency

and CMS of all currently approved satellite locations at the time it requests approval for any additional satellite locations. If a hospice provides care and services to Medicare beneficiaries at an unapproved or disapproved satellite location, such services may be determined to be non-covered. At the time of any satellite location closure the hospice is expected to notify the fiscal intermediary, State agency and CMS.

Hospice satellite locations are also subject to survey by the State survey agency or CMS regional office. Deficiencies that are identified at any satellite location will apply to the entire hospice issued the provider agreement number. Satellite locations must comply with the hospice conditions of participation at § 418.52 through § 418.116.

Proposed § 418.100(g), Inservice training, applies to volunteers and employees, including those employed under arrangement or contract. We are expecting a hospice to take steps to develop appropriate inservice programs or to arrange to acquire training from others.

We are not dictating a specific inservice training program, but rather we expect each hospice to determine the scope of its own program, including the manner in which it chooses to assess competence levels, determine training content, and determine the duration and frequency of training.

We are specifically soliciting public comment on this proposed condition of participation.

Condition of Participation: Medical Director (Proposed § 418.102)

[If you choose to comment on issues in this section, please include the caption “MEDICAL DIRECTOR” at the beginning of your comments.]

We would revise the existing medical director CoP at § 418.54 by incorporating current requirements and expanding it to illustrate the importance of having a medical director or physician designee coordinate the activities of physicians and other health care professionals to ensure that care is appropriate and reflects the hospice philosophy. To maintain patient care and coordination of services, the medical director or physician designee appointed by the medical director, must either be a hospice employee or under contract with the hospice. A contractual arrangement with another agency or organization is not permitted.

Section 418.102(a), Initial certification of terminal illness, would incorporate the provisions of current § 418.22, and require that the medical director or physician designee review the patient's clinical information and provide written certification that the individual has a medical prognosis that his/her life expectancy is 6 months or less if the illness runs its normal course. The certification would have to be based on the medical director's or physician designee's clinical judgment regarding the normal course of the individual's illness.

In the second standard, § 418.102(b), Recertification of the terminal illness, we would require that the medical director or physician designee review the clinical information and the patient and family's expectations and wishes for hospice care on an ongoing basis and before each updated assessment. Assessments would be required to be updated at least every 14 calendar days according to § 418.54(d). In addition, this standard would also require that the assessment be updated at the time of each recertification. The timeframes for recertification are described in § 418.21.

Within § 418.102(c), Coordination of medical care, we are proposing that the medical director or physician designee and the hospice interdisciplinary group maintain responsibility for coordinating a patient's medical care in all settings, even when multiple physicians are participating in the care. This level of coordination ensures that the patient receives continuous medical care and services that are consistent with the hospice philosophy.

We are also proposing to require that the medical director or physician designee be responsible for the hospice's quality assessment and performance improvement program. This program and implementation of its findings are critical to ensuring that patients receive effective and meaningful care.

We are specifically soliciting public comment on this proposed condition.

Condition of Participation: Clinical Records (Proposed § 418.104)

[If you choose to comment on issues in this section, please include the caption “CLINICAL RECORDS” at the beginning of your comments.]

The proposed condition of participation, Clinical records, would incorporate several of the existing requirements in § 418.74 of the current regulation, Central clinical records. We are proposing to add a new requirement that the clinical record contain accurate clinical information that is available to the physician and hospice staff.

The proposed condition continues to require that all clinical records contain past and current findings and that they are maintained for each patient who is admitted by the hospice.

We are also providing an opportunity for the hospice to choose to maintain clinical records electronically if it desires and recognize that some hospices are beginning to maintain electronic records. The use of electronic health records (EHRs) has the potential to improve patient care and improve efficiency. We anticipate that the use of electronic health records will become widespread, and will be required in future hospice conditions of participation.

We also recognize that there may be significant barriers for hospices that are interested in maintaining electronic health records (EHRs) for their patients. We are interested in learning how the final hospice CoPs and/or other future regulations can reduce or eliminate those barriers.

We are interested in public comments on the following areas:

1. What are the components of an electronic health record (EHR)? What are the advantages and disadvantages of using an EHR in a hospice setting?

2. Should an EHR include a personal health record which is accessible to the patient? What are the positive and negative consequences (

e.g.

caregivers less likely to record certain procedures or observations) of personal health records?

3. What are the barriers (

e.g.

technical, clinical) to implementing an EHR system in a hospice?

It is obvious that there are many different issues regarding the institutionalization of EHRs. We are aware that some hospices have already chosen to pursue this option to one degree or another. We are interested in knowing what their experience has been thus far. How have electronic health records impacted the way they allocate and deliver patient care, and how has this, in turn, impacted patient outcomes?

At § 418.104(a), Content, we would retain the requirement that the record include all assessments (including the initial assessment and all updated assessments), plan of care, consent and election forms, and clinical and progress notes. We are proposing the following requirements for the content of the clinical record—

• Advance directive information as described in proposed § 418.52(a)(3);

• Informed consent, authorization and election forms;

• Responses to medications, symptom management, treatments and services;

• Patient process and outcome measures as they relate to the plan of care; and

• Physician certification of terminal illness as required in § 418.22(c) and

described in proposed § 418.102(a) and (b).

We recognize that there has been some confusion between the meaning of clinical note and progress note. To eliminate this confusion, we have defined “clinical note” and “progress note” in the definitions section. The key differences between clinical and progress notes are that:

1. Clinical notes summarize an actual patient encounter (as this term is used in the field) while progress notes do not necessarily have to; and

2. Clinical notes comprehensively describe the care provided during that encounter while progress notes briefly summarize care furnished (which could cover a span of time) and the patient's response. We believe that these definitions, adopted from the current conditions of participation for home health agencies (42 CFR part 484) will provide needed clarity and will ensure that the records contain information necessary to provide high quality patient care.

We are proposing to add a new standard at § 418.104(b), Authentication, that requires authentication of clinical records. All entries must be legible, clear, complete, and appropriately authenticated and dated. Authentication would include verification of handwritten and/or electronic signatures by signature logs or a computer secure entry of a unique identifier for a primary author who has reviewed and approved the entry. This new standard addresses technological changes in information management such as the computerization of records as well as electronic signatures. A similar requirement is in the conditions of participation for hospitals.

We are proposing to re-codify the existing requirement found in § 418.74(b) as § 418.104(c), Protection of information. This re-codified provision would require that all patient information, including the clinical record and its contents, be safeguarded against loss or unauthorized use. The text would also be revised to reflect that all hospices must also comply with the Privacy Rule published in the

Federal Register

on December 28, 2000 (65 FR 82461) as amended on August 14, 2002 (67 FR 53182) and contained in 45 CFR parts 160 and 164.

Under § 418.104(d), Retention of records, we propose to ensure protection of the patients information by adding a new requirement that patient records be retained for 5 years after the death or discharge of the patient, unless State law stipulates a longer period of time. If the hospice discontinues operation, hospice policies would be required to provide for the retention and storage of clinical records. The hospice would be required to notify the State agency and its CMS regional office where the clinical records would be stored.

Under proposed § 418.104(e)(1), Discharge or transfer of care, we have proposed a new requirement that Medicare/ Medicaid-approved hospice facilities forward a copy of the patient's clinical record and hospice discharge summary to the facility to which the patient is being transferred. This would help to ensure that the information flow between the hospice and the transfer facility is smooth, so that the level of care will continue without being compromised.

Under § 418.104(e)(2), we would add a new requirement that the hospice provide a copy of the patient's clinical record and hospice discharge summary to the attending physician if the patient revoked the election of hospice care or was discharged from hospice because eligibility criteria were no longer met. This requirement was added to ensure that the patient's attending physician would be aware of the most current clinical information.

The hospice discharge summary requirement proposed at § 418.104(e)(3) would be a new requirement and would detail what would be required to be contained in the discharge summary. The purpose of the discharge summary is to provide important clinical information to those medical and other health professionals who will be assuming the care of the patient upon discharge from the hospice. At a minimum, the discharge summary would contain information that accurately describes the patient's stay, current plan of care, recent treatment, symptom, and pain management information, most recent physician orders, and any other documentation that would assist in post-discharge continuity of care.

Under § 418.104(f), Retrieval of clinical records, we would require that clinical records, whether in hard copy or electronic form, be made readily available to, and retrievable by, an appropriate authority.

We are specifically soliciting public comment on this proposed condition of participation.

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

[If you choose to comment on issues in this section, please include the caption “DRUGS, SUPPLIES, and DME” at the beginning of your comments.]

This condition of participation revises the current requirement, found at § 418.96, and would clarify that durable medical equipment, supplies, appliances, and drugs and biologicals related to the palliation and management of the terminal illness and related conditions, as identified in the plan of care, must be provided by the hospice while the patient is under hospice care.

In addition, restrictions regarding the use of controlled substances in the patient's home would be conveyed more clearly. We believe that the hospice, as well as the patient and family, need to share in the responsibility and accountability for maintaining controlled substances in the home. Primary responsibility rests with the hospice, and the hospice must assume responsibility to educate the family about the proper use and disposal of drugs and biologicals and the consequences of misuse.

Section 418.106(a)(1), Administration of drugs and biologicals, would require that all drugs and biologicals be administered in accordance with accepted hospice and palliative care standards of practice and according to the patient's plan of care. In § 418.106(a)(2) we are proposing to add a new requirement that the interdisciplinary group be responsible for periodically reviewing the plan of care to determine whether the patient and/or family continues to have the ability to safely administer drugs and biologicals.

Under proposed § 418.106(b), Controlled drugs in the patient's home, the hospice would ensure the safe delivery and accountability of controlled drugs in the patient's home. The hospice would have to have a policy for the tracking, collecting, and disposing of controlled drugs maintained in the patient's home. During the initial assessment, the hospice policy regarding the use and disposal of controlled drugs would be required to be discussed with the patient and family, and the hospice nurse would be required to document that the policy had been discussed with the patient and family. Because controlled drugs can pose significant danger to patients if improperly ingested or abused, educating patients and families may prevent unwanted complications.

In § 418.106(c), Use and maintenance of equipment and supplies, a hospice would be responsible for overseeing the use of durable medical equipment and supplies in the patient's home. Through the Medicare survey process and beneficiary complaints, we have found

that equipment that is not properly maintained does not perform properly and may harm the patient. Under this proposal, the hospice would be responsible for making certain that equipment being furnished under the plan of care is operating safely. The hospice may carry out this responsibility through a contractual arrangement with others, but would continue to maintain primary responsibility.

Stressing the importance of providing families with information and levels of comfort relative to the care being furnished to family members, we are proposing a new medical equipment and supplies requirement. The hospice would be required to take action to ensure that the family received instruction in the safe use of equipment and supplies. In order for the family to participate in providing quality care to the patient, the family members would need to understand how and when to use equipment and supplies.

We are specifically soliciting public comment on this proposed condition of participation.

Condition of Participation: Short-Term Inpatient Care (Proposed § 418.108)

[If you choose to comment on issues in this section, please include the caption “SHORT TERM INPATIENT CARE” at the beginning of your comments.]

Under proposed § 418.108, we would retain the requirement that hospices make inpatient care available for pain control, symptom management, and respite purposes, and that care be provided either in the hospice or in a participating Medicare or Medicaid facility.

We would recodify the current requirement found at § 418.98(a), Short-term inpatient care, as § 418.108(a), Inpatient care for symptom management and pain control.

The references to the condition at § 418.108(b), Inpatient care for respite purposes, would no longer focus on process as in the existing § 418.98. Rather, the updated standards reflect expected outcomes of care.

We would eliminate the existing requirement found at § 418.100(a)(2), requiring a registered nurse to provide direct patient care on each shift. We believe that the patient's plan of care and the patient's condition should determine the amount and skill level of nursing care required, as well as the skill level and State licensing requirements of the staff to provide requisite care. If the patient does not need care by a registered nurse, imposing a requirement on a hospice that mandates a registered nurse to be in attendance on a particular shift to serve the patient will have no effect on the patient's care.

Under proposed § 418.108(c), Inpatient care provided under arrangement, we would incorporate many of the existing requirements in existing § 418.56(e). In particular, we would require that a hospice train the personnel who would be providing patient care in an inpatient facility. The hospice model of patient care is very different from the curative model of patient care that medical personnel are trained in. Therefore, in order to ensure that patients in inpatient facilities continue to receive care that is consistent with the hospice philosophy (

i.e.

, proactive pain management, interdisciplinary care), it is important that inpatient facility personnel be trained to understand the hospice philosophy and model of care.

Under proposed § 418.108(d), Inpatient care limitation, and § 418.108(e), Exemption from limitation, we are proposing to re-codify the existing requirements at § 418.98(c) and (d), respectively, without changes.

Condition of Participation: Hospices That Provide Inpatient Care Directly (Proposed § 418.110)

[If you choose to comment on issues in this section, please include the caption “INPATIENT CARE” at the beginning of your comments.]

Under proposed § 418.110, we are proposing to revise the existing requirements, currently located at § 418.100, as follows:

Under § 418.110(a), Staffing, we would include the expectation that staffing for all services provided by the hospice reflect the volume of patients, patient acuity, and the level of intensity of the services as reflected in the plan of care to ensure that expected outcomes of care are achieved and negative outcomes are avoided. We also would eliminate our requirement that a registered nurse provide direct patient care each shift when the condition of the patient does not require the care of a registered nurse on each shift. This change would reduce the staffing burden for hospices and is a result of recommendations made by the Secretary's Advisory Committee on Regulatory Reform.We are proposing to remove the requirement in the existing § 418.100(a)(2) that each shift include a registered nurse that provides direct patient care for those patients who are receiving short-term inpatient care for symptom management. We are proposing in § 418.110(b), 24-hour nursing services, that the hospice facility provide 24-hour nursing services that meet the nursing needs of all patients and are furnished in accordance with each patient's plan of care, as well as the skill level of the staff that provides care, in accordance with State licensing requirements. We would require that each patient be kept comfortable, clean, well-groomed and protected from accident, injury, and infection.

When assessing a facility's compliance with this proposed regulation, we would expect to see that the staffing level met the needs of the patients. For example, if a patient experiences unexpected break-through pain and needs additional pain management, we would expect that a staff member with the appropriate skills be available to care for that patient. If a staff member with the appropriate skills, and knowledge is not available to care for that patient and assure that his or her pain is effectively managed, then the hospice would be considered to be out of compliance with this proposed regulation.

In § 418.110(c), Physical environment, we are proposing that the hospice maintain a safe physical environment that is free of hazards for patients, staff, and visitors. In § 418.110(c)(1), Safety management, in paragraphs (c)(1)(i) and (c)(1)(ii), we are proposing that the hospice prevent situations that pose a threat to the health and safety of the patients, others, or property whenever possible. The hospice would be required to promptly report and investigate all incidents that involve injury to patients, staff or visitors, or that involve damage to property. The hospice would be required to report such incidents to the appropriate State and local bodies having regulatory jurisdiction. The hospice would also be required to take action to correct the problems promptly. The hospice would be required to take steps to prevent equipment failures and correct and report any equipment failures promptly. In § 418.110(c)(1)(iii) we have retained the existing requirement at § 418.100(b) that the hospice periodically rehearse with staff a disaster preparedness plan for managing the consequences of natural disasters and other emergencies that affect the hospice's ability to provide care. We believe that special emphasis should be placed on carrying out the procedures necessary to protect the patients and others.

In § 418.110(c)(2), Physical plant and equipment, paragraphs (c)(2)(i) through (c)(2)(iv), we are proposing that there be procedures for the management of light, temperature, and ventilation controls throughout the hospice (including air exchange) for patient care. The hospice

would be required to make battery lamps and flashlights available in all areas not served by an emergency electrical supply source. The hospice would be required to make available an emergency gas and water supply. All equipment would be required to be properly maintained.

In § 418.110(d), Fire protection, we are proposing to recodify, without change, the existing provisions in § 418.100(d). These provisions were amended on January 10, 2003 (68 FR 1374) to adopt the year 2000 version of the Life Safety Code. They were also amended on August 11, 2004 to clarify the effective date of the roller latch prohibition (69 FR 49266). In addition, they were amended on March 25, 2005 (70 FR 15229) to address the use and placement of alcohol-based hand rubs.

Proposed § 418.110(e), Patient areas, would be recodified from § 418.100(e) without change.

Proposed § 418.110(f), Patient rooms, would be revised. We are proposing in § 418.110(f)(3)(iv) that each room accommodate no more than two patients. We are proposing the two patients per room requirement in recognition of the fact that hospice patients in the inpatient setting are critically ill and may be actively dying. These patients and their families need the additional privacy that a two patient room affords them in order to help preserve the patient's comfort and dignity during the dying process. We believe this is the standard accommodation in most facilities.

Due to the potentially high cost of retrofitting older buildings, the proposed rule would allow existing hospice facilities with more than two patients in each room to receive a waiver of this requirement. This waiver would be based on whether or not the hospice was already providing direct inpatient care when this regulation would become effective. That is, if a hospice is providing direct inpatient care in a building on the day before the effective date of a final rule, and they had more than two patients in each room, then the hospice would qualify for a waiver of the proposed requirement. If a hospice chose to begin operating its own inpatient unit after the effective date of a final rule, then it would not qualify for the proposed waiver, and would thus be required to have no more than two patients per room.

The remaining paragraphs in this standard would be virtually the same as in the current requirement (§ 418.100(f), with only minor language changes that would not change the substantive requirements of the regulation.

Proposed § 418.110(g), Toilet/bathing facilities, is linked with patient rooms in the current requirement found at § 418.100(f). We are proposing to revise this requirement as a stand-alone standard. As such, it would highlight our concern for the adequacy of toilet and bathing facilities, and would provide more flexibility for State agency surveyors in evaluating the appropriateness of these facilities. We believe it is important for the privacy and comfort of the patient and family to have toilet and bathing facilities in each patient room, or conveniently located near the patient's room.

We are proposing no changes to existing § 418.100(g) bathroom facilities, except to recodify it at § 418.110(h) and rename it, Plumbing facilities.

In § 418.110(i), Infection control, we are proposing to revise infection control standards to conform to those required of other provider types, such as home health agencies and hospitals. We would require a hospice to establish an infection control program that protects patients, families, and staff against communicable diseases and would prevent and control the spread of infections. The infection control program would be required to follow national infection control standards and be part of the hospice's overall quality assurance and performance improvement and education program. We also propose to retain the requirement that hospices provide a sanitary environment by following accepted standards of practice.

We are not proposing any specific approaches to meeting the infection control requirement, but we would expect to see clear evidence that the hospice aggressively sought to minimize the spread of infection through the use of infection control techniques, such as standard precautions by its staff, and through the efforts made by the hospice to help families and caregivers minimize the spread of infection.

We are proposing to re-codify the current requirement § 418.100(h), Linen, as § 418.110(k) without substantive change.

In proposed § 418.110(l), Meal service and menu planning, we are proposing to revise the existing § 418.100(j). We would make this standard less restrictive, and would emphasize the need for a hospice to focus more on outcomes rather than process. Specifically, we believe that a hospice should focus on meeting the patient's nutritional and plan of care needs. We would eliminate several structural requirements, such as serving at least three meals at regular times, with no more than 14 hours between substantial evening and breakfast meals, and having a staff member trained in food management or nutrition.

In § 418.110(m), Pharmaceutical services, we are proposing to re-codify the existing requirement found at § 418.100(k) without substantive change.

In § 418.110(n), Pharmacist, we would assign this requirement a higher level of importance by making it a standard. However, we would retain the essential elements of the current requirement.

[If you choose to comment on the issues contained in paragraph (o) of this section, please include the caption “SECLUSION AND RESTRAINT” at the beginning of your comments.]

Section 418.110(o), Seclusion and restraint, would be a new standard. A number of accidental injuries and deaths across inpatient providers due to the use of seclusion and restraints have been documented. Therefore, we discourage the use of seclusion and restraints, but are aware that their application may be warranted for brief periods or in rare instances. In response to the accidental deaths and injuries, we published (in 1999) a new condition in the hospital CoPs that included a new standard at § 482.13(f), Standard: Seclusion and restraint for behavior management.

The hospital seclusion and restraint CoP was the basis for the proposed hospice seclusion and restraint CoP. We also considered the seclusion and restraint language in section 3207 of the Children's Health Act (CHA), Public Law 106-310, codified at section 591 of the Public Health Service Act (42 U.S.C. 290ii). The CHA provision requires that any health care facility that receives Federal funds, including Medicare approved hospices, protect and promote every patient's right to be free from “any restraints or involuntary seclusions imposed for purposes of discipline or convenience.” The CHA clearly described the circumstances in which restraints or seclusion may be appropriate. The proposed seclusion and restraint requirement for hospices would codify the changes made to the Act by the CHA. We believe that adding this new requirement to the hospice CoPs may promote safe use of seclusion and restraints and may prevent accidental injury or death while a patient is receiving care as an inpatient in a hospice.

We have focused this standard on the proper use of seclusion and restraints, the need for hospice personnel to receive training and education in the proper use of seclusion and restraint application and techniques, and the

need for hospice personnel to receive training and education in alternative methods for handling situations that arise. We emphasize that seclusion and restraint may only be used if needed to improve the resident's well-being or protect him or her or others from harm, and only when less restrictive interventions have been determined ineffective. We encourage the public to comment on this standard, especially with respect to instances where seclusion and restraint are appropriate and inappropriate.

Condition of Participation: Hospices That Provide Hospice Care to Residents of a SNF/NF, ICF/MR, or Other Facilities (Proposed § 418.112)

[If you choose to comment on issues in this section, please include the caption “RESIDENTS RESIDING IN A FACILITY” at the beginning of your comments.]

Hospice care is an approach to treatment that recognizes that the impending death of an individual warrants a change in the focus from curative care to palliative care (relief of pain and other uncomfortable symptoms). The goal of hospice care is to help terminally ill individuals to continue life with minimal disruption to normal activities while remaining primarily in the home environment.

A participating hospice may provide care to an eligible patient in an environment that the patient chooses to be his or her home. This includes hospice care provided to residents who choose to live in skilled nursing facilities, nursing facilities, intermediate care facilities, mental retardation facilities, and other facilities.

The provision of hospice care to residents of those facilities has come under scrutiny as a result of Operation Restore Trust (ORT) activities and Inspector General (OIG) reports from 1996, 1997, and 1998. An OIG report released in 1997 found that “contractual arrangements between hospices and nursing homes present vulnerabilities for inappropriate use of excessive Medicare and Medicaid payments being made to hospices or to nursing homes” (U.S. D.H.H.S. OIG,

Hospice and Nursing Home Contractual Relationships,

Nov. 1997, OEI-05-95-00251. See also, OIG Special Fraud Alert,

Fraud and Abuse, Nursing Home Arrangements with Hospices,

Mar. 1998). In addition, in 2000 the Assistant Secretary for Planning and Evaluation (ASPE) Office of Disability, Aging and Long-Term Care Policy and the Urban Institute published a report entitled “Synthesis and Analysis of Medicare Hospice Benefit Executive Summary and Recommendations” (Harvell, Jennie; Jackson, Beth; Gage, Barbara; Miller, Susan; and Mor, Vincent, 2000 March). This report made several recommendations, some of which related to training and hospice care outcome measurement.

The relationship between hospices and nursing facilities was also addressed by the Secretary's Advisory Committee on Regulatory Reform. The committee focused on clarifying the responsibilities of each provider and on the patients accessing the hospice benefit while they are facility residents. Based on the recommendations of the committee, as well as the reports from Operation Restore Trust, the Office of Inspector General, and the Assistant Secretary for Planning and Evaluation, we would add this new condition of participation. We are preparing a separate regulatory document to address long-term care facility obligations regarding residents receiving hospice services.

To ensure that quality hospice care is provided to eligible patients, we are proposing a new condition at § 418.112, Hospices that provide care to residents of a SNF/NF, ICF/MR or other facility. Regardless of where the hospice patient resides, the responsibility for developing and implementing an appropriate plan of care rests with the hospice.

Under proposed § 418.112(a), Resident eligibility, election and duration of benefits, we would specify that it is incumbent upon the hospice to ensure that the resident meets all the same Medicare eligibility requirements for hospice care (found at § 418.20 to § 418.30), as a patient who resides in his or her home in the community.

At proposed § 418.112(b), Professional management, the hospice would be expected to assume full responsibility for all of the hospice care provided to the resident. This would include making arrangements for any inpatient care that the patient would require in accordance with § 418.100. This standard reinforces our belief that continuity of care is crucial for hospice care in any setting.

In proposed § 418.112(c), Core services, (and in accordance with sections 1861(dd)(1) and (2)(A) of the Act), the hospice would be required to provide all necessary core services to its patients in the same manner that it would provide core services to a patient residing in a home in the community. The plan of care would have to identify the care and services that were needed and specify which provider would be responsible for providing that care. It is not reasonable to expect the hospice to delegate any of its standard hospice core services to the nursing or residential facility staff.

In proposed § 418.112(d), Medical director, a hospice medical director would be expected to play an integral role in providing medical supervision to the hospice interdisciplinary group and in providing overall coordination of the patient's plan of care. The medical director's expertise in managing pain and symptoms associated with the patient's terminal disease is necessary, regardless of the setting in which the patient is receiving hospice services to ensure that the hospice patient has access to quality hospice care. Therefore, the medical director must communicate with all facility physicians and the attending physician and other professionals involved in developing and/or implementing the patient's plan of care.

Under proposed § 418.112(e), Written agreement, we are proposing that a comprehensive and legally binding written agreement be developed between the hospice and facility and that it be in effect before any hospice care is provided to a facility resident. The purpose of the written agreement would be to ensure that the duties and responsibilities of the hospice and facility are clearly articulated and executed in a manner that ensures that the resident will receive quality hospice care. The written agreement would be required to include the following:

(1) Written consent and documentation of the patient or the patient's representative that hospice services were desired;

(2) Identification of the services that the hospice and the facility would provide;

(3) The manner in which the facility and the hospice would communicate to ensure that the needs of the patient were addressed and met 24 hours a day; and

(4) A requirement that the facility immediately notify the hospice when—

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

(ii) Clinical complications appeared that suggested a need to alter the plan of care;

(iii) A life threatening condition(s) appeared;

(iv) A need to transfer the patient from the facility arose; and

(v) The patient died.

As the primary entity responsible for the patient's care, the hospice should assume responsibility for determining the appropriate course of care and the decision to change the level of services provided. The hospice would make arrangements for, and remain

responsible for, any necessary continuous care or necessary inpatient care related to the terminal illness.

We would require that the agreement delineate the facility's responsibilities, including room and board and other services and treatment, support or otherwise. We would also require a delineation of the hospice's responsibilities including medical direction and management of the patient, as well as nursing, counseling (including spiritual and dietary counseling), social work, bereavement counseling for family members, the provision of medical supplies and durable medical equipment, and the provision of drugs necessary for the palliation of pain and symptoms associated with the terminal illness. The hospice would be required to provide directly substantially all of the services necessary for the care of the patient's terminal illness.

The hospice would be able to utilize the facility's nursing personnel (where permitted by the facility and by law), for the administration of prescribed therapies included in the plan of care, but only to the extent that the hospice would routinely use the services of a hospice patient's family in implementing the plan of care.

These would be mandatory agreement provisions, but would not limit the scope of the relationship between the hospice and the facility. Additional provisions could be added subject to mutual agreement.

Under proposed § 418.112(f), Hospice plan of care, just as required for hospice services furnished to patients not residing in an inpatient facility, we are proposing that a written plan of care would be required to be established and maintained for each facility patient. The plan of care would be required to be coordinated with and developed by the hospice interdisciplinary group and SNF/NF, ICF/MR, or other facility in collaboration with the attending physician. The care provided would have to be in accordance with the plan. The plan would have to reflect the hospice philosophy in all aspects and be based on an assessment of the patient's needs and unique living situation in the facility. The plan would have to address the patient's current medical, physical, social, emotional, and spiritual needs based on the problems identified in the initial comprehensive and updated comprehensive assessments, and other assessments. Directives for the management of pain would have to be addressed and updated as necessary to reflect the patient's status.

We are proposing that the plan of care identify the care and services that would be needed and specifically identify which provider would be responsible for performing the respective functions that were agreed upon and included in the plan of care. The performance of the functions should reflect the participation of the hospice, SNF/NF, ICF/MR, or other facility, and the patient and family to the extent possible. The plan of care would need to be reviewed at least every 14 days and as needed to reflect changes in the patient's condition. In conjunction with members of the facility's team, the hospice and the attending physician would have to discuss any changes in the plan of care, and these changes would have to be approved by the hospice before implementation.

At proposed § 418.112(g), Coordination of services, we are proposing that the hospice designate a member of the interdisciplinary group to coordinate the implementation of the plan. The hospice would provide the facility with the plan of care, hospice consent form, contact information for hospice personnel involved in the care of the resident, instructions on accessing the hospice 24-hour on-call system, medication information specific to the patient, physician orders, and any advance directives. We believe that these requirements would ensure effective communication between the hospice and the facility.

Under proposed § 418.112(h), Transfer, revocation, or discharge from hospice care, we would specify that the proposed requirement for discharge or revocation found at § 418.104(e) applies. In addition, we would specify that discharge or revocation of the hospice care would not impact the eligibility to continue to reside in a SNF/NF, ICF/MR, or other facility.

At proposed § 418.112(i), Orientation and training of staff, we would specify that the hospice staff would be required to train facility staff who provide care to hospice patients on aspects of the hospice philosophy and unique program features, including policies and procedures, methods of comfort, pain control and symptom management, general principles about death and dying and individual responses, patient rights, appropriate forms, and record keeping requirements.

We are specifically soliciting public comment on this proposed condition of participation.

Condition of Participation: Personnel Qualifications for Licensed Professionals (Proposed § 418.114)

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

We are proposing significant revisions to the personnel qualifications for hospice employees. Specifically, we would provide that in cases where personnel requirements are not statutory, or do not relate to a specific payment provision, we would require personnel to meet State certification or licensure requirements. Under our proposal, the personnel qualifications would fall into three basic categories that include: (1) General qualifications, (2) personnel qualifications for physicians, speech-language pathologists, and home health aides, and (3) personnel qualifications when no State licensing laws or State certification or registration requirements exist. Under our proposed reorganization of part 418, the personnel qualifications would be located at § 418.114. We discuss the personnel qualifications in detail below.

(1) General qualifications (proposed § 418.114(a)).

This category would encompass licensed professionals who provide hospice services directly, either as employees or under individual contract, or under arrangement with a hospice. These professionals must be licensed, or certified or registered to practice by the State in which they perform the functions, as applicable. All personnel who fall into this category must act exclusively within the scope of the State license, certification or registration. Examples of personnel who fall into this category are registered nurses, licensed practical nurses, physical therapists, and physical therapist assistants; all States currently have licensing or certification requirements for these caregivers.

(2) Personnel qualifications for physicians, speech-language pathologists, and home health aides (proposed § 418.114(b)).

Section 1861(r) of the Act defines a physician as a doctor of medicine, osteopathy, or podiatry legally authorized to practice medicine and/or surgery by the State in which that function or action is performed. We would refer to this definition at § 418.114(b)(1). Sections 1861(ll)(1) and (3)(A) of the Act define a qualified speech-language pathologist as an individual with a master's or doctoral degree in speech-language pathology who is licensed as a speech-language pathologist by the State in which the individual furnishes those services. In the case of an individual who furnishes services in a State that does not license speech-language pathologists, the

individual must have successfully completed 350 clock hours of supervised clinical practicum (or is in the process of accumulating the supervised clinical experience), performed not less than 9 months of supervised full-time speech-language pathology services after obtaining a master's or doctoral degree in speech-language pathology or a related field, and successfully completed a national examination in speech-language pathology approved by the Secretary.

Section 1891(a) of the Act also defines the qualifications for home health aides. However, we believe that the description of qualifications for home health aides would be more appropriately located under the home health aide services CoP. Thus, the requirement would be cross-referenced at proposed § 418.76(a).

(3) Personnel qualifications when no State licensing laws or State certification or registration requirements exist.

When a State does not have a licensure, certification, or registration requirement, the hospice would apply the qualifications in § 418.114(c). This category would consist of all current personnel qualifications specified in proposed § 418.3, Definitions. We understand that portion of these qualifications may seem outdated. However, we believe that there may still be individuals who met the requirements of the 1960s and 1970s and who are still practicing in their chosen field today. Therefore, we propose to include these personnel qualifications. We welcome comments on these revisions.

[If you choose to comment on issues related to the qualification standards for social workers, please include the caption “SOCIAL WORK” at the beginning of your comments.]

We are specifically requesting comment on the qualifications for a social worker. Hospice care marks the passage from life to death. The services furnished by a hospice takes on a higher level of importance that greatly affects a patient's physical and emotional comfort, and which will be remembered by family members forever. The social worker plays an important role in providing these services to patients and their families. Patients often enter hospice care in a time of crisis and they along with their families sometimes require intense interventions that are handled by a social worker. Patients and their families rely on social workers for emotional support and guidance during the patient's care.

Later, the social worker's goal is to help family members during the bereavement process through in-depth counseling. Bereavement counseling can take many forms, depending on the individuals who will be receiving it. For example, one patient's family may require intimate counseling sessions for the patient's children while a large group session may be more appropriate for nursing facility staff and residents. Determining the exact needs of these individuals and meeting those needs through counseling sessions and other support mechanisms requires the expertise of a qualified social worker.

At present, a social worker is required to possess a bachelor's degree in social work from an accredited school. There is no consensus regarding the optimum qualifications that a social worker must possess when furnishing services to a hospice patient. However, there is strong anecdotal evidence that a social worker who possess a Master's of Social Work (MSW) degree from an accredited institution and who has at least one year of health care experience would provide a higher level patient care. Anecdotal evidence also exists that suggests that patients and families that receive services from a Master's of social work are more satisfied with the care they receive.

In addition to the patient care advantages that MSWs offer, a hospice may anticipate a reduction in overall and per patient costs when utilizing MSWs who have at least one year of experience. A study conducted by the National Hospice and Palliative Care Organization (NHPCO) found that an increase in social work experience after academic training resulted in decreased overall care costs, including nights of continuous care. The study concludes that, “[h]ospice programs will benefit by hiring the best qualified and most experienced social workers available.” (Reese, Dana J.; Raymer, Mary; and Richardson, Joan, National Hospice Social Work Survey, 2000 March).

Two issues may contribute to limiting any change in the social work qualification requirement— the availability of personnel to work full time, and the availability of personnel to serve rural areas. Some hospices may not be able to employ an MSW on a full-time basis. Even if CMS were to increase the education requirement to an MSW level, hospices would still be allowed to employ individuals with a bachelor's degree in some circumstances. These individuals would be able to work under the supervision of an MSW and would be identified as social work assistants. A social work assistant would be defined as an individual who has a bachelor's degree from a school accredited by the Council on Social Work Education, or a bachelor's degree in psychology, sociology or another field related to social work.

In 2001, 4,087 MSWs were employed by the nation's 2,316 hospices (National Association for Homecare, 2002 Hospice Industry Report,

http://www.nahc.org/Consumer/hpcstats.html).

We recognize that MSWs may not be available in all areas. If a hospice chooses to also utilize the services of a social work assistant, then the MSW would only have to be employed part-time to supervise the services. According to the NHPCO study, “[a]ppropriate clinical supervision is essential for social workers. Like any other profession, social workers require supervision by seasoned social work practitioners to continue to grow into high quality skilled professionals.”

We are specifically soliciting comments about whether the care furnished by an MSW should be considered the standard of care for hospice patients. Would an MSW provide a higher level of care than a social worker with a bachelor's degree? Should CMS require that any social worker, regardless of the degree, have at least one year of experience in a health care setting? Should CMS allow social work assistants with bachelor's degrees to function under the supervision of an MSW? Would increasing the qualifications for social workers to an MSW while retaining social work assistants with bachelor's degrees impact patient access to social work services? Would employing both social workers and social work assistants ensure that hospices have the flexibility to meet the needs of patients and their families?

Please note that the policy regarding credentialing would not apply under Medicare Part B, when a specific level or education or training is specified as a precondition for reimbursement. For example, Part B payment may be made for the services of clinical social workers, and the law specifically defines a clinical social worker in section 1861(hh) of the Act. Thus, the definitions contained in this section generally would apply for hospice certification purposes only in States where there were no State licensure requirements.

In § 418.114(d), we are proposing a new requirement that a hospice be required to obtain a criminal background check for all hospice and contract employees before employment at the hospice. We believe that this is an important safety measure to protect both patients and the hospice. We are soliciting public comment on this proposed standard.

Condition of Participation: Compliance With Federal State and Local Laws and Regulations Related to Health and Safety of Patients (Proposed § 418.116)

The provisions concerning licensure requirements for hospices are currently located at § 418.72, Condition of participation: Licensure. We are proposing to expand this condition in the following manner:

We would make a minor revision to the language at existing § 418.72(a), which would require the hospice and its staff to operate and furnish services in compliance with all Federal, State, and local laws and regulations applicable to hospices related to health and safety of patients. The State agency and CMS would exercise discretion in determining whether a violation of an applicable Federal, State, or local law or regulation related to health and safety would be cited as a violation under the Medicare CoPs. We would not cite a hospice whose problem was remedied. We will cite hospices when violations of Federal, State, and local laws and regulations affect the health and safety of patients; the ability of hospices to deliver quality services; the rights and well-being of patients; and/or the management of the hospice and its ability to recruit qualified staff.

Under § 418.116(b), Multiple locations, we would continue to require that the hospice comply with the requirements of § 420.206 regarding disclosure of ownership and control information. We would also provide that the hospice and any other satellite locations operated under the same provider number be licensed in accordance with applicable State licensure laws before the hospice could be reimbursed for Medicare services. This provision seeks to ensure that hospice patients receive the same level of quality care from the appropriate personnel at all sites of service. The requirement that hospices comply with State licensure laws before providing services to Medicare beneficiaries would apply to the hospice as an entity as well as to any personnel furnishing services to hospice patients.

We are proposing to recodify the current requirements at § 418.92(b), regarding laboratory services, at § 418.116(c).

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

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

Derivation Table

Current conditions

(Part 418, subpart C, D, E)

Citation

existing

section

Proposed condition

Citation

Scope of Subpart

Definitions

418.3

Definitions

418.3

General provisions

418.50

(a) Compliance

Organization and Administration of Services

418.100(c)(2)

(b) Required services

Organization and Administration of Services

418.100(c)(2)

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

Organization and Administration of Services

418.100(c)(1)

(2) Other 24 hour services.

(3) Utilize accepted standards of practice

Core Services and Furnishing of Non-core Services

418.64 and 418.72

(d) Disclosure of information

Deleted

Medical director

: The medical director is: A hospice employee, a doctor of medicine or osteopathy, responsible for the medical component of the hospice's patient care program

418.54

Medical Director

418.102

Professional management

418.56

(a) Continuity of care

Deleted.

(b) Written agreement:

(1) Identification of services to be provided

Interdisciplinary Group Care Planning and Coordination of services

418.56(c)

(2) Express authorization of the hospice required for all services

Organization and Administration of Services

418.100(e)(1)

(3) Coordination, supervision, and evaluation of contracted services

Organization and Administration of Services

418.100(e)

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

Deleted

(5) Documentation of services furnished by contractor

Organization and administration of services

418.100(e)

(6) Personnel qualifications

Organization and administration of services

418.100(e)(2)

(c) Professional management

Organization and administration of services

418.100(e)

(d) Financial responsibility.

(e) Inpatient care:

(1) Copy of the patient plan of care specifying the services to be provided is given to inpatient provider

Short term inpatient care

418.108(c)(1)

(2) Inpatient provider abides by hospice patient care protocols and maintains compatible policies

Short term inpatient care

418.108(c)(2)

(3) Medical record provided to hospice upon request. Must include all inpatient services and events and a copy of the discharge summary

Short term inpatient care

418.108(c)(3)

(4) Responsibility for implementing agreement provisions

Short term inpatient care

418.108(c)(4)

(5) Hospice responsible for training all care providers

Short term inpatient care

418.108(c)(5)

NEW

Comprehensive Assessment of the Patient Initial assessment

418.54

(a) Time frame for the completion of the comprehensive assessment

(b) Content of the comprehensive assessment

(c) Update of the comprehensive assessment

(d) Outcome measures on the patient

Plan of Care

418.58

A written plan of care must be established and maintained for each individual admitted to a hospice program and the care provided to an individual must be in accordance with the plan

Interdisciplinary Group Care Planning and Coordination of Services

418.56

(a) Plan established by attending physician, medical director or physician designee and interdisciplinary group prior to providing care

Interdisciplinary Group Care planning and Coordination of Service

418.56(b)

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

Interdisciplinary Group Care Planning and Coordination of Services

418.56(d)

(c) Plan includes assessment of needs and identification of services. It state in the scope and frequency of services needed

Interdisciplinary Group Care Planning and Coordination of Services

418.56(c)

Continuation of care:

No discontinuation or diminishment of care due to the Medicare beneficiary's inability to pay for that care

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