Based on these principles and the public comments that were submitted regarding the May 2005 proposed rule, we are setting forth this final rule.
II. Provisions of the Proposed Regulations and the Analysis and Responses to Public Comments

On May 27, 2005, we set forth proposed rules for hospices that choose to participate in Medicare and Medicaid. We proposed to revise all of the existing conditions of participation (CoPs), and to add several new CoPs to address aspects of hospice care that we believe need attention. This section will briefly describe the content of each CoP in the proposed rule.

We proposed no changes to Subparts B (Eligibility, Election and Duration of Benefits), G (Payment for Hospice Care), or H (Coinsurance) of 42 CFR part 418.

We received 205 timely items of correspondence that raised numerous issues. These comments, detailed below, came from accrediting bodies, consumer advocacy organizations, hospices, individuals, national health care provider organizations, State agencies, and State health care provider organizations.

1. Scope of the Part (Sec. 418.2)

We proposed to revise Sec. 418.2 to reflect the reorganization of the part and to include an introductory statement describing the purpose of the part. We did not receive any comments on this section. Therefore, we are adopting the provisions as proposed.

2. Definitions (Sec. 418.3)

We proposed to remove, revise, and add numerous definitions to this section in order to clarify the meaning of the proposed rule. We proposed to move the definitions of ``physician'' and ``social worker'' from the definitions section to the personnel requirements section at Sec. 418.114 because the definitions set forth the standards that these individuals must meet in order to function in a hospice. In addition, as it is not a condition of participation, and is only used for hospice payment purposes, we proposed to maintain the existing definition of the term ``cap period.''

We proposed to revise the definitions of the terms ``attending physician'', ``bereavement counseling'', ``employee'', ``hospice'', ``representative'', and ``terminally ill''. Finally, we proposed to add definitions for the following terms: ``clinical note'', ``drug restraint'', ``hospice care'', ``licensed professional'', ``palliative care'', ``physical restraint'', ``progress note'', ``restraint'', ``satellite location'', and ``seclusion''.

We proposed to add nurse practitioners to the definition of ``attending physician'' because section 408 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) changed the statutory definition of ``attending physician'' to include nurse practitioners with respect to some (but not all) aspects of hospice services.

The terms ``drug restraint'', ``physical restraint'', and ``seclusion'' were presented for the first time in the proposed rule. Seclusion and restraint requirements were proposed because anecdotal evidence suggested that there are occasions when hospice inpatient facilities must use seclusion and/or restraints for patient and/or staff safety. Moreover, Section 591 of the Public Health Service (PHS) Act, as added by the Children's Health Act (Pub. L. 106310), prohibits the use of restraint and seclusion, except under specific
circumstances, in any health care facility, that receives support in any form from any program supported in whole or in part with funds appropriated to any Federal department or agency.

We proposed to define the term ``satellite location'' to codify longstanding Medicare survey and certification policies that permit hospices to operate multiple locations under a single provider number. Multiple locations were not an issue when the hospice CoPs were originally implemented, and, as such, were not addressed. We believed that the proposed definition would help hospices determine when they do or do not need to obtain Medicare approval for a new location and what criteria would be used by Medicare in approving or denying a multiple location application.

Comment: Many commenters requested that changes be made to the proposed definition of ``attending physician.'' Some of these commenters requested that, in addition to ``nurse practitioner,'' we also add ``advanced practice nurse,'' ``clinical nurse specialist,'' and ``physician's assistant'' to the definition of ``attending physician'' in order to broaden the category of individuals who could receive payment in that capacity. A single commenter suggested that we defer to the States to determine training, education and experience requirements for nurse practitioners. Another commenter suggested that the definition of ``attending physician'' should be divided into two definitions, one for physicians and one for nurse practitioners. Still another commenter requested that we delete the
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requirement that an attending physician must be legally authorized to practice surgery by the State in which he or she performs that function because surgery is not a specialty necessary to be considered qualified as an attending physician. Several other commenters requested that we specify in the definition of ``attending physician'' that a patient's attending physician may be a hospice employee. Another commenter suggested that we add a statement that a nurse practitioner may cover for an attending physician in the attending physician's absence.

Response: Section 408(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108173) (MMA) amended the term ``attending physician'' at section 1861(dd)(3)(B) of the Act specifically for hospices to allow nurse practitioners to function as a patient's attending physician if the patient identifies the nurse practitioner as such. Following publication of the proposed rule, CMS published two final rules (70 FR 45144 and 72 FR 50214) on other matters that, among other things, modified the definition of the term ``attending physician'' to incorporate changes made by the MMA. We are deferring to these final rules. Furthermore, Section 1861(r)(1) of the Act specifically defines a physician as ``a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he performs such function or action.'' We believe that this statutory definition is appropriate for hospice providers, as well as for the many other health care providers for which it is used. We do not have the authority to delete the term ``and surgery'' from this definition.

We do not believe that it is necessary to state in the definition that an attending physician may be an employee of the hospice. The decision as to who is or is not the attending physician belongs to the patient regardless of that individual's employment relationship (or lack thereof) with the hospice. We do not prohibit attending physicians from being hospice employees as long as it is the patient's choice to decide whether or not to have an attending physician and who that attending physician will be during the patient's hospice care. In addition to consulting with the hospice interdisciplinary group (IDG) regarding the patient's hospice care, the attending physician retains responsibility for meeting the patient's needs that are not related to the terminal illness and that terminal illness's related conditions. The attending physician is typically someone with whom the patient had a relationship before electing to receive hospice care. The role of the attending physician is to provide a long term perspective on the patient and family that takes into account their medical and personal history. The attending physician is not typically an individual provided by the hospice to fill this role because a patient does not have an attending physician, although we recognize that this does occur at times.

We also do not believe that it is necessary to state that a nurse practitioner may act on behalf of the attending physician in the attending physician's absence. If the attending physician is unable to fulfill his or her duties, then the hospice physicians are responsible for fulfilling the attending physician's duties in his or her absence in accordance with Sec. 418.64(a)(3) of the final rule. Therefore, there is no need for the attending physician to designate another individual to cover his or her hospice patients. The role and function of the nurse practitioner is also addressed in CMS hospice payment policies (see, for example, 42 CFR 418.304(e)).

Comment: A commenter requested that we revise the definition of ``bereavement counseling'' to reflect the fact that bereavement counseling begins before the patient dies. The commenter noted that the proposed rule even required the initial step of bereavement counseling to begin before the patient's death by requiring that the initial bereavement assessment be completed at the time of the comprehensive assessment. Another commenter questioned the qualifications of persons providing bereavement counseling and indicated that we should consider adding language to address this question within the definition of ``bereavement counseling.'' Another commenter requested that we specify, in the definition of bereavement counseling, that the counseling only applies to the patient's immediate family members as set out in the Act.

Response: We agree that effective bereavement counseling must begin before the patient's death and that the proposed rule and this final rule reflect this practice by requiring a bereavement assessment early in the patient's hospice stay. To clarify our intent, at section Sec. 418.3 of this final rule, we are revising the definition of ``bereavement counseling'' to specify that it occurs both before and after the patient's death.

With respect to counseling immediate family members, current practice in many hospices is expanding this activity. Many hospice programs have extensive bereavement programs that extend beyond immediate family members to embrace other caregivers, friends, and the larger community. As the commenter pointed out, the statute at section 1861(dd)(2)(A)(i) of the Act mandates bereavement counseling for the immediate family of the terminally ill individuals, but does not explicitly limit counseling to only such family members. We believe that limiting counseling to immediate family members would disregard the work that many hospices do for other persons whose relationship with the patient is important. To restrict bereavement counseling to a select few would discourage hospices from providing this service, thus harming the bereaved and the larger community. Therefore, we did not insert language limiting the definition of ``bereavement counseling'' to immediate family members. Bereavement counseling is part of the hospice's bundled daily payment rate.

In order to facilitate bereavement counseling services beginning at an early time and being furnished to whomever the hospice assesses as needing services, we believe that it is necessary to allow hospices flexibility in deciding who is qualified to provide bereavement services in accordance with their own policies, current standards of practice, and other applicable Federal, State, and local laws and regulations. In the proposed and final rule at Sec. 418.64(d), we require that counseling services, including bereavement counseling, are provided by or under the supervision of a qualified individual with experience in grief or loss counseling. Some hospices may use a social worker while other hospices may choose to use chaplains or volunteers to provide this service. This flexibility allows hospices to meet the needs of their patients and families in a manner that works best for their needs and resources. Therefore, we are not prescribing who may or may not furnish bereavement counseling services.

Thus, the revised definition for ``bereavement counseling'' is as follows: ``Bereavement counseling means emotional, psychosocial, and spiritual support and services provided before and after the death of the patient to assist with issues related to grief, loss, and adjustment.''

Comment: Numerous commenters indicated that the proposed definitions for the terms ``clinical note'' and ``progress note'' were either unnecessary or redundant. The commenters suggested that these definitions either be deleted or further clarified to distinguish their purpose. In addition, many commenters suggested that the terms ``psychosocial'' and ``spiritual note'' be added to the definition of [[Page 32091]]
``clinical note'' to reflect the fact that individuals who furnish psychosocial and spiritual care such as social workers, counselors and chaplains also write notations in the patient's clinical record.

Response: Notations in a patient's clinical record by individuals furnishing services on behalf of a hospice are standard practice. They are a primary and crucial means of communication between various care providers who are in the patient's home at different times while furnishing different services. Therefore, we believe that it is important to acknowledge their use in the hospice environment by requiring their presence in the patient's clinical record. At the same time, we agree that having two separate definitions for notations is not necessary and may even be confusing. Therefore, at Sec. 418.3, we are using a single definition, ``clinical note,'' that addresses notations regarding both the patient and the family. We also added the terms ``psychosocial'' and ``spiritual'' to the definition to reflect the need for this important information in the patient's clinical record. The condensed and revised definition is as follows: ``Clinical note means a notation of a contact with the patient and/ or the family that is written and dated by any person providing services and that describes signs and symptoms, treatments and medications administered, including the patient's reaction and/or response, and any changes in physical, emotional, psychosocial or spiritual condition during a given period of time.''

We would like to point out that the term ``clinical note'' does not limit the notations only to those individuals who are clinicians. Clinical notes may be written by any individual furnishing care and services to a patient, including volunteers, homemakers, vendors, etc. Indeed, we would expect that clinical notes from all individuals would be included in the clinical record because the goal of the clinical note is to include as much information as possible to ensure that all hospice care providers have complete and correct information to use in making care decisions and furnishing care.

Comment: Many commenters were confused by the terms ``initial assessment'' and ``comprehensive assessment'' as they are used in Sec. 418.54, ``Initial and Comprehensive assessment of the patient.'' The commenters requested definitions for these terms in order to help clarify the difference between the two assessment requirements to ensure that the proper information was being gathered within the stated timeframes.

Response: We agree that adding definitions of these two terms will help ensure that patients are being assessed in a timely fashion. We are clarifying that the initial assessment is to determine the patient's immediate care needs. Hospices must complete this abbreviated assessment in 48 hours. The comprehensive assessment must assess in depth all of the patient's areas of need and will ensure that hospices are fully aware of the patient's current status. Hospices will be able to use these assessments to establish an individualized hospice plan of care that meets the patient's needs. We did not, as some commenters suggested, specify which disciplines must complete the comprehensive assessment. Hospices provide many different services and not every patient will require an assessment by a provider of each of those services. If, upon completion of the initial assessment, it is determined that a patient may benefit from physical therapy services, then we would expect a physical therapist to complete a physical therapy assessment as part of the comprehensive assessment. However, if there is no indication that the therapy services may benefit the patient, then a therapy assessment by a therapist would be unnecessary. The new definitions for ``initial assessment'' and ``comprehensive assessment'' are added at Sec. 418.3 as follows:
``Initial assessment means an evaluation of the patient's physical, psychosocial and emotional status related to the terminal illness and related conditions to determine the patient's immediate care and support needs.''
``Comprehensive assessment means a thorough evaluation of the patient's physical, psychosocial, emotional and spiritual status related to the terminal illness and related conditions. This includes a thorough evaluation of the caregiver's and family's willingness and capability to care for the patient.''

Comment: A number of commenters asked us to define the terms ``dietary counseling'' and/or ``dietitian'' to help clarify what type of counseling hospices are required to provide to their patients, and who may furnish this service. A few commenters further suggested that we should differentiate between dietary counseling furnished by a dietitian and dietary counseling furnished by a qualified individual such as a nurse or nutritionist.

Response: Section 1861(dd)(1)(H) of the Social Security Act (the Act) requires hospice facilities to provide ``counseling (including dietary counseling) with respect to care of the terminally ill individual and adjustment to his death.'' However, the term ``dietary counseling'' has never been defined for hospices, and there is a great deal of confusion in the hospice industry regarding exactly what constitutes ``dietary counseling.'' Therefore, we agree that a definition of ``dietary counseling'' is necessary. The definition at Sec. 418.3 reads as follows:
``Dietary counseling means education and interventions provided to the patient and family regarding appropriate nutritional intake as the patient's condition progresses. Dietary counseling is provided by qualified individuals, which may include a registered nurse, dietitian or nutritionist, when identified in the patient's plan of care.''

We do not agree that we should prescribe what type of counseling must be provided by a dietitian. We would expect that, based on an assessment of the patient's dietary needs, a hospice would furnish dietary counseling services through an individual whose skills best meet the patient's identified needs. We believe that the needs of the individual patient, rather than preset rules, should be the determining factor relative to services and staff. We do not believe it is appropriate to define the term ``dietitian'' or establish personnel requirements for dietitians because we believe that hospices should have the flexibility to employ an individual that would meet the needs of their patients in accordance with all other applicable Federal, State, and local laws and regulations.

Comment: A few commenters submitted suggestions for the proposed definition of the term ``employee.'' A single commenter asked that we replace the definition of the term ``employee'' with a definition of the term ``staff.'' Another commenter suggested that, through the definition of the term, hospice employees should be required to be appropriately trained in death and dying.

Response: The term ``employee'' is singular and is used throughout the regulation to refer to the direct relationship between the hospice and the individual in terms of furnishing services (that is, a direct employee), supervision, and lines of authority and responsibility. The term ``staff,'' on the other hand, is plural and may include individuals who are contracted through an outside entity, supervised by that outside entity, and primarily responsible to that outside entity. ``Staff,'' as a broader term, is not an appropriate substitution for the term ``employee'' in these definitions.

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Additionally, it is not appropriate to require in the definition of the term ``employee'' that an employee must be trained in issues related to death and dying. We agree that thorough training in issues related to death and dying is necessary for all individuals furnishing patient care services, including clinicians and patient care volunteers. In final Sec. 418.100(g)(1) we now require hospices to educate all hospice employees who have patient contact in the hospice philosophy. Education in the hospice philosophy would, we believe, encompass issues related to death and dying, as the commenter suggested. It is not necessary for office employees with no patient contact to be trained in issues relating to death and dying. To require the training for all employees, regardless of their role within the hospice organization, would unnecessarily burden hospices and divert resources from more critical patient care activities. Therefore, we are not requiring all hospice employees to receive such training.

Comment: A commenter suggested that, in the definition of ``hospice care,'' we should specify that hospice care may be provided in the home, the community, or a facility.

Response: Hospice care is currently being furnished in a variety of settings, and we do not believe that it is necessary or appropriate to specify in this rule where hospice care may be provided. To do so may unintentionally preclude hospices from providing services in settings that are appropriate but that are outside of an established definition.

Comment: Numerous commenters requested changes to the definition of ``licensed professional.'' Many of those commenters suggested that dietary therapy should be added to the list of examples of services that should be furnished by a licensed professional. Another commenter suggested deleting the list of examples because the examples may inadvertently limit the types of services that should be provided by licensed professionals. Yet another commenter suggested that medical social services should be deleted from the list of examples because not all States license social workers. Therefore, in those States where no State licensure for social workers exists, medical social services, CMS presumes, that the commenter is advocating that such services be furnished by a professional without a license.

Response: We agree that the proposed definition needs to be clarified. While the commenters are correct in suggesting that dietary therapy should be provided by a licensed professional, whether a nurse, dietitian or nutritionist, we agree with the commenter who suggested that the mere presence of the list of services is limiting. Therefore, while we agree that dietary therapy should be provided by a licensed professional, we are not adding dietary therapy to the list of examples. Rather, at Sec. 418.3, we are deleting the entire list of examples because they are unnecessary and may be confusing. Deleting the list of examples also addresses the commenter's concern regarding the licensure status of social workers. We recognize that some States may not license social workers or other health care disciplines, and we do not intend to imply that States must provide licensure for all health care disciplines furnishing hospice services. Rather, our intent, as proposed at Sec. 418.116(a) and finalized at Sec. 418.114(a) is that if a State licenses a particular health care discipline, then any individual working within that discipline in the hospice environment must obtain and maintain that State license. If no State license exists for a particular discipline, and if that individual meets all other personnel and training requirements as required by this rule and any other applicable Federal, State, or local laws, regulations, policies, and requirements, then it is acceptable for that individual to furnish services to hospice patients absent a State license.

Comment: Numerous commenters requested clarification on the definition of the term ``satellite location.'' Specifically, hospices requested that the definition include: Concrete criteria that hospices must meet in order to be considered satellite locations, information about the approval and survey process, and information about the type of services furnished by satellite locations.

Response: The term ``satellite location'' is now referred to as ``multiple locations,'' and Sec. 418.3 has been modified to reflect this change. We believe that this new terminology more accurately describes those entities that furnish a full array of services from two or more locations. We have also clarified our intent by stating that multiple locations are those locations ``from which the hospice provides the same full range of hospice care and services that is required of the hospice issued the certification number.'' We note that the term ``certification number'' is now used in place of the term ``provider number.'' This change reflects a change in the terminology used by CMS to describe the number issued to a hospice to identify it in certain Medicare systems.

We believe that clarifying that a multiple location provides the same full array of services as the hospice location originally issued the certification number will alleviate commenter concerns that convenience sites where staff stop in to complete paperwork or check messages, or warehouse sites where equipment is stored would need to be approved by Medicare as multiple locations. We note that although we do not require hospices to obtain approval for warehouse and other single function sites, States may still require hospices to receive approval from State or local authorities. The requirement that multiple locations must share administration, supervision, and services with the hospice that was issued the certification number is relocated from the definition of the term at Sec. 418.3 to the paragraph addressing multiple locations at Sec. 418.100(f)(1)(ii). We continue to believe that it is the level of control and supervision exercised by the hospice that was issued the certification number over the multiple location, rather than mileage limitations or staffing levels, which determines whether or not a site is a multiple location of an existing hospice or a completely separate hospice.

We do not believe that it is appropriate to add specific criteria or procedures for the approval of multiple locations in the regulatory definition because this level of specificity may reduce our ability to adapt to rapid changes in the hospice industry related to the use of multiple locations. Rather, we will continue to address specific criteria and procedures for multiple locations in subregulatory guidance such as the State Operations Manual.

Comment: A commenter requested clarification about the definition of ``palliative care'' and its relationship to the requirement that, in order for a Medicare beneficiary to qualify for the Medicare hospice benefit, the beneficiary must be certified as being terminally ill. Specifically, the commenter asked if palliative care could be provided by a hospice to individuals who are not terminally ill or who have not elected the Medicare hospice benefit.

Response: Hospice care is a very specific type of care provided within a defined timeframe at the end of life. Palliative care, on the other hand, can be provided at any time of life when there is a need to anticipate, prevent and treat suffering to optimize a patient's quality of life. Hospices have a long history of providing palliative care and are often in a position to provide
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the care either on a direct or contract basis to patients who either do not qualify for the Medicare hospice benefit (or another health care insurer's hospice benefit) or who do not choose to forgo curative treatment in order to elect the Medicare hospice benefit. We do not prohibit hospices from providing these palliative care services to patients that do not elect or qualify for hospice care, as long as the hospices are primarily engaged in furnishing hospice care as required by section 1861(dd) of the Act.

Comment: A few commenters requested that we define the term ``physician designee'' as it was proposed in Sec. 418.102, ``Medical director.'' The commenters believed that a definition would help to clarify this individual's role.

Response: We agree that defining this term will help clarify what responsibilities this individual has as well as when those responsibilities are assumed. The purpose of the physician designee role is to ensure that, if the medical director is unavailable, there is a predetermined, qualified individual who can assume all of the medical director's responsibilities. Having a predetermined individual who is ready and able to assume the medical director responsibilities will help to ensure that patients receive high quality hospice care even when the usual medical director is not available to perform his or her duties. With this in mind, we are adding a definition for ``physician designee'' at Sec. 418.3 to read as follows:
``Physician designee means a doctor of medicine or osteopathy designated by the hospice who assumes the same responsibilities and obligations as the medical director when the medical director is not available.''

Comment: Several commenters asked us to clarify the definition of the term ``representative'' by recognizing case law, common law, and health care powers of attorney in determining whether or not an individual is a patient's representative.

Response: The proposed definition of ``representative'' states that a representative is an individual who has the authority under State law to authorize or terminate care on the patient's behalf. In the context of this definition, we are deferring to State law in its entirety, including statutes, agency regulations, and binding court rulings. Since designations of health care powers of attorney are deemed to appoint legal representatives by most, if not all states, our proposed definition would include individuals granted health care powers of attorney. Thus, case law, common law, and health care powers of attorney are subsumed within the definition of the term

``representative'', and there is no need to amend it.

Comment: A majority of commenters requested that we revise the proposed definition of ``drug restraint'' to remove the stigma associated with the term ``drug.'' A minority of commenters requested that we delete the definition of ``drug restraint'' completely, and suggested that the hospice industry at large or hospices individually should be allowed to determine a definition.

Response: Drugs have long played a prevalent role in hospice care. They are used to relieve pain, calm anxiety, improve breathing and support the patient. However, the idea of drugs used as restraints is relatively new in hospice care and has provoked much anxiety in the hospice industry. We understand that hospices are concerned about an overly restrictive definition of the term ``drug restraint.'' We also understand that hospices are concerned about State surveyors applying the drug restraint regulations applicable to other health care providers to hospices. We believe that these regulations clearly apply only to hospice inpatient facilities (hospice programs do not have outpatient facilities). Deleting the definition of ``drug restraint'' will not resolve providers' uncertainty, and will only leave hospices and patients in the untenable position of not knowing what is and is not a drug restraint; and simply renaming the definition as ``chemical restraint'' will not resolve the ambiguity either. While we acknowledge that the term ``drug'' may have a negative connotation among patients, we are not requiring hospices to use this term when discussing medications or chemicals with patients. Hospices are free to refer to drugs used for any purpose within the hospice in a manner that suits their patients and their representatives, families, other caregivers, and the hospice. Moreover, section 591(d)(1)(B) of the PHS Act prohibits the use of drugs ``used as a restraint to control behavior or restrict the resident's freedom of movement that is not a standard treatment for the resident's medical or psychiatric condition.'' This provision of the Act applies to any health care facility that receives any financial support from any program receiving Federal dollars.

Comment: Many commenters suggested that we narrow the definition of ``drug restraint'' to tailor it to the hospice environment. Specifically, commenters requested that we indicate, in the definition, that a drug is only considered a restraint if it is not an accepted treatment within a hospice program. The commenters expressed concern that drugs that may be considered restraints in other health care settings (for example, long term care facilities) are not restraints in hospice care because those drugs are used to treat distressing symptoms (for example, terminal restlessness). A single commenter requested that we not consider a drug to be a restraint if that drug is requested by the patient or the patient's representative while another commenter suggested that drugs should only be considered restraints if they are used inappropriately.

Response: Narrowing the definition of ``drug restraint'' by specifying that a drug is not a restraint if it is a ``standard treatment within a hospice program'' may hinder hospices from adopting new symptom management drugs in the future because they may have not yet met the ``standard treatment within a hospice program'' criteria. Our final language states that drugs used as a restraint are drugs that are not standard treatment or dosage for the patient's condition, and we believe that this will afford adequate protection to the hospice patient population. Therefore, we are not adding this additional limitation to the definition.

Similarly, narrowing the definition by adding a provision that a drug is not a restraint if it is requested is not appropriate. Requesting a drug does not alter its status as a restraint. In fact, there are times when a patient, representative or family member may request that a drug be administered to protect a patient from his or her own behavior. The requestor would, in essence, be asking for a restraint. Once the drug is administered, the patient would require the increased level of supervision required by this rule in order to ensure the patient's safety and well being at all times. Therefore, we are not adding a provision to exclude drugs from the definition of ``drug restraint'' if those drugs are requested by the patient or family.

Furthermore, narrowing the definition of ``drug restraint'' to those drugs that are used inappropriately is not suitable. There are drugs commonly used in the hospice environment for symptom management that can also be used appropriately as drug restraints under limited circumstances when warranted by the patient's condition and needs as documented in the patient's clinical record.

Comment: A few commenters suggested that we should use the same definition of ``chemical restraint'' for hospices as we do for other provider types.

Response: We agree that using the same definition will help to ensure that
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hospice patients receive the same level of care and protection regardless of where they receive health care services. In addition, we agree that using the same definition will help to ensure that employees moving from another provider type to the hospice setting will more likely be familiar with the regulatory requirements. Therefore, at Sec. 418.3, we are adopting the same definition and definitional format for drug restraints as is used in the Hospital Conditions of Participation. We are deleting the definitions of ``drug restraint'' and ``physical restraint'' in favor of a more expansive definition of ``restraint'' that encompasses both drug and physical restraints. We believe that having a single definition, rather than three separate definitions, will simplify the regulation and increase the public's understanding of the requirements. The specific section of the new ``restraint'' definition that applies to drug restraints is as follows: ``A drug or medication when it is used as a restraint to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.''

Comment: Many commenters suggested changes for the definition of ``physical restraint'' ranging from a suggestion to delete the definition to a suggestion that devices adjacent to the patient's body also be considered physical restraints.

Response: As with ``drug restraints,'' we understand that there is a great deal of apprehension and uncertainty regarding physical restraints. In the preamble to the proposed rule we asked for public comments regarding instances when physical restraints may or may not be appropriate and necessary. We heard from a few commenters that bedrails and positional devices are used for patient safety, and for assisting patients in functioning independently. No commenters described a single instance where physical restraints have been, or to their knowledge, are now used, whether appropriately or inappropriately, for patient safety, behavior management or any other purpose. The lack of specific comments leads us to conclude that this is an issue that most hospices choose not to discuss. Without this input, we are unable to gauge the level of physical restraint utilization in the hospice industry or the purposes of that utilization.

The Children's Health Act (CHA) requires us to promulgate regulations concerning the use of restraints in hospices. Deleting the definition of ``physical restraint'' would be in conflict with the requirements of the CHA and will not alleviate the concern about the safe and proper use of physical restraints. Indeed, deleting the definition will only leave hospices wondering whether their practices constitute physical restraint and what precautions should be taken to ensure patient safety and well being. We do not believe that this is in the best interest of patients or hospices; therefore we are including a definition to address physical restraints. Moreover, section 591 of the PHS Act sets forth a statutory definition, which is the basis for enforcing regulations on the use of restraints.

At the same time, however, we are sensitive to commenters' concerns that the definition of ``physical restraint,'' as was proposed, could include bedrails and positional devices. Bedrails and positional devices may have the effect of restraining one patient but not another, depending on the individual patient's condition and circumstances. For example, a partial bedrail may assist one patient to enter and exit the bed independently while acting as a restraint for another patient. Patients who attempt to exit a bed through, between, over, or around bedrails are at risk of injury or death. The potential for serious injury is more likely from a fall from a bed with raised bedrails than from a fall from a bed where bedrails are not used. Bedrails also potentially increase the likelihood that the patient will spend more time in bed and fall when attempting to transfer from the bed. To address these potential hazards, many long term care facilities have replaced the use of bedrails with lower beds, perimeter mattresses, alarms, and sitters for restless individuals. We encourage hospices to have a dialogue with their long term care facility colleagues about the safe and appropriate use of bedrails for hospice patients, as we believe that both parties can learn from their successes. To reflect the fact that it is the function and effect of a device, rather than a device itself, that determines whether or not the device is a physical restraint, we have revised the definition at Sec. 418.3 as follows: ``Restraint means: (a) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely, not including devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort).''

This language almost precisely tracks 591(d)(1)(A) of the PHS Act, and matches the definition in the Hospital Conditions of Participation. As a commenter suggested, physical restraint applies to any device that has a restrictive effect, regardless of whether the device is attached to or adjacent to a patient's body. It is the effect of the device, rather than its location, that makes it a restraint. Using the same definition for hospices as is used for other provider types will help ensure that patients are consistently provided the same quality of care and supervision when restraints are used, regardless of whether those patients are in a hospital or a hospice inpatient facility. At the same time, using the same definition will make staff transitions between different provider types easier because the same set of restraint rules will apply to some other provider types. This may be particularly helpful to hospices that have occasion to furnish services under contract where a nurse or other practitioner may be more familiar with the rules governing restraints in hospitals. Having the same definition will help to ensure that there is no conflict between the
practitioner's previous background and training and the applicable hospice rules.

Comment: Several commenters noted that the proposed definition of the term ``seclusion'' implies that any placement of patients in private rooms would constitute seclusion. One commenter suggested that the term should be completely removed.

Response: While it was not our intent, we agree that the proposed definition of ``seclusion'' could embrace private rooms. Therefore, at Sec. 418.3, we have revised the definition of ``seclusion'' by adding the term ``involuntary.'' Patients who request private rooms do so voluntarily, and therefore would not be in seclusion. However, if a patient is placed alone in a private room against his or her will and is not permitted visitors or egress from that room, then the patient would be considered to be in seclusion. We also believe that it is essential for the term ``seclusion'' to remain in this rule. Seclusion, as defined in section 591(d)(2) of the PHS Act, may only be used under circumstances described at 591(b). Deleting the term ``seclusion'' will not assist hospices in complying with the statutory requirement, and will only leave hospice facilities and patients in the untenable position of not knowing
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what situations do and do not qualify as ``seclusion'' and whether they may be in violation of the Children's Health Act. We do not believe that this is in the best interest of hospices or their patients.

Comment: A few commenters requested that we delete the definition of the term ``terminally ill'' because it is a term that may discourage patients from accepting hospice care.

Response: Section 1861(dd) of the Act establishes the Medicare hospice benefit for beneficiaries who are terminally ill with a prognosis of 6 months or less if the illness runs its normal course. The definition that we proposed is the same definition that is used in the Act. We believe that this is necessary to maintain the definition in this rule because this term is used in the hospice payment rules.

Comment: A number of commenters requested that we define the term ``family'' using a very broad, patientdirected approach that allows the patient to identify those who are considered to be his or her ``family.''

Response: We do not believe that a single definition of the term ``family'' would benefit beneficiaries or hospices. The meaning of ``family'' can change depending on circumstances and availability of persons close to the patient. While allowing the patient to identify his or her ``family'' would be ideal, this may not be possible for patients who cannot communicate and who do not have written information available for the hospice. We have decided that it would be most appropriate to allow each hospice to establish its own policy on what ``family'' means in its community and with its own patients.

Comment: A single commenter requested that we add a definition for the term ``unnecessary drugs'' to include drugs used in excessive dosages, for excessive durations, without adequate monitoring, without adequate indications for use, or in the presence of adverse events.

Response: The term ``unnecessary drugs'' did not appear within the proposed rule. The concept is very interesting and may be useful to hospices when assessing a patient's drug therapy regimen as required by Sec. 418.54(c), Content of the comprehensive assessment. We have incorporated some of the commenter's concerns in our final rule at section 418.54(c)(6). This section requires hospices to review a patient's prescription and overthecounter drugs in use at the time of the assessment, including, but not limited to, an identification of the effectiveness of the drug therapy regimen, any potential or existing drug side effects, any potential or existing drug interactions, any duplicate drug therapies, and any drug therapy requiring laboratory monitoring. Excessive dosages or durations, or inadequate monitoring would likely lead to effectiveness and side effect issues that will be assessed during the comprehensive assessment and subsequent updates. The IDG, in conference with an individual who has specialized education and training in drug management, such as a pharmacist, will be required to address these issues in the patient's individualized hospice plan of care.

Comment: A commenter suggested that we should define the term ``adverse event'' using the Joint Commission patient safety event taxonomy. Another commenter suggested that we should define the term as an, ``unanticipated, nontherapeutic response or injury''.

Response: While we agree that using the Joint Commission patient safety taxonomy or suggested definition may be helpful for some hospices, we do not believe that a single definition of ``adverse event'' would meet the needs of all hospices at this time. In general, an adverse event would be any action or inaction by a hospice that causes harm to a hospice patient. We believe that hospices are capable of determining what is or is not an adverse event based on the characteristics and needs of their patient populations and staff. We recognize that hospices are seeking further guidance on this issue, and we plan to provide such guidance in future subregulatory guidance, such as the State Operations Manual and Interpretive Guidelines.

Comment: A few commenters requested that we define the term ``homemaker services'' with specific references to the Medicaid personal care benefit that many states offer to Medicaid beneficiaries. Commenters asked for clarification about the role of homemakers in hospice care, their relationship to Medicaid personal care aides, and the qualifications for individuals who furnish homemaker services.

Response: Section 418.202(g) in subpart F of the current hospice regulations states, ``[h]omemaker services may include assistance in maintenance of a safe and healthy environment and services to enable the individual to carry out the treatment plan.'' We believe that this language adequately describes the role that homemakers play in hospice care, and we are making no changes to it in this final rule.

Each State establishes its own Medicaid personal care aide benefit, pursuant to our regulations at 42 CFR 440.167, including its own eligibility criteria, scope of services to be provided, and personnel qualifications. Medicaid regulations impose only minimal restrictions on the state's discretion regarding these services. Hospice care is meant to supplement the care provided by the patient's caregiver. If the individual(s) furnishing Medicaid personal care services is functioning as the patient's caregiver, then the hospice would not be expected to replace the Medicaid personal care providers with its own homemaker services on a roundtheclock basis. The Medicare hospice benefit is not meant to be a caregiver benefit and should not be expected to function as such. Hospices should work with their respective State Medicaid agencies if they have questions about who pays for services provided to patients eligible for both Medicare and Medicaid.

With regard to who is qualified to furnish homemaker services on behalf of a hospice, we proposed in Sec. 418.76(j) that a homemaker must have either completed home health aide training requirements or must have successfully completed a hospice's orientation addressing the needs and concerns of patients and families coping with a terminal illness. We continue to believe that either home health aide (now referred to as a hospice aide) training or hospice orientation provides sufficient knowledge for an individual to function as a homemaker under the supervision of the IDG, and our final requirements at Sec. 418.76(j) and Sec. 418.76(k) reflect this.

Comment: Several commenters requested that we define the term ``nursing services.'' Most of these commenters defined the term to include those services furnished by a registered nurse, licensed practical nurse (LPN), licensed vocational nurse (LVN), nurse practitioner or other advanced practice nurse. However, the commenters were divided on whether or not services should be allowed to be delegated by a nurse to a hospice aide and whether these delegated services should be considered nursing services.

Response: The intent of section 1861(dd) of the Act has always been to require hospices to furnish nursing services to their patients as part of the Medicare hospice benefit. Hospices have complied with this requirement for the past two decades using the services of a variety of different categories of nurses ranging from nurse practitioners to licensed vocational nurses to registered nurses. Hospices have not, to our knowledge, had any difficulty in determining what constitutes nursing services and we see no reason to
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establish a definition for the term at this time.

It is important to point out that if we had included delegated services in the definition of the term ``nursing services,'' then the inclusion would effectively prohibit hospices from contracting for hospice aide services. We believe that this de facto prohibition would occur because those contracted hospice aides would routinely be furnishing delegated nursing services, and section 1861(dd) of the Act requires that substantially all nursing services should be furnished by direct hospice employees. We do not think that the commenters intended to establish this de facto prohibition on contracting for hospice aide services.

Comment: A commenter asked us to define the term ``covering physician'' as a physician acting on behalf of the attending physician.

Response: The term ``covering physician'' did not appear in the proposed rule. If the patient's attending physician is not available to care for his or her patients, then a hospice physician would assume care responsibilities. In accordance with the proposed and final rule at Sec. 418.64(a)(3), a hospice is responsible for providing an alternate physician to meet the medical needs of the patient in the attending physician's absence.

Comment: A few commenters asked us to add a definition for the term ``social worker.'' Some commenters proposed maintaining the current definition as an individual with a Bachelors degree in Social Work from an accredited university. Others suggested raising the requirement to a Masters degree in Social Work from an accredited university.

Response: We believe that the commenters raise important issues, which are discussed in a subsequent portion of the preamble. We are relocating the credential requirements for social workers from the definitions section to the new personnel requirements section (Sec. 418.114). We believe that this new, central location for all credentialing requirements is the appropriate location for the social work credentialing requirements as well. Therefore, we are addressing these suggestions in the personnel qualifications section of this rule.

Comment: Several commenters asked us to add definitions for the four levels of care provided in hospice (routine home care, continuous home care, respite care, and general inpatient care). A few commenters even provided their own definitions for these levels of care.

Response: These ``levels of care'' are payment rather than health and safety issues, and therefore we are not addressing them in this rule. These terms are used specifically in reference to our hospice payment rules found at 42 CFR 418 Subpart F ``Covered Services'' and Subpart G ``Payment for Hospice Care.'' In these two subparts, specific criteria for these payment levels are detailed, and these criteria constitute the definitions for these payment terms.

Comment: Some commenters asked us to define the term ``plan of care,'' and suggested the plan of care should be defined as a written document that addresses the patient and family needs identified in the comprehensive assessment and is updated as needed.

Response: We agree with the commenters that the plan of care must be a written document and that it must address the status of the patient and family as identified in the comprehensive and updated assessments. We also agree that the plan of care should be updated as frequently as necessary based on changing status and needs. We do not believe that it is necessary to define ``plan of care'' because pertinent issues are being specified in this final rule at Sec. 418.56, ``Interdisciplinary group, care planning, and coordination of services.'' Section 418.56 requires that a hospice IDG ``prepare a written plan of care for each patient. The plan of care must specify the hospice care and services necessary to meet the patient and family specific needs identified in the comprehensive assessment as such needs relate to the terminal illness and related conditions.'' In addition, Sec. 418.56(d) will require that the plan of care be updated by the IDG ``as frequently as the patient's condition requires, but no less frequently than every 15 calendar days.'' We believe that these requirements adequately address the commenters' concerns.

Comment: A commenter requested that we define the term ``spiritual assessment'' to ensure that these assessments address more than a person's religious affiliation.

Response: Our inclusion of ``spiritual assessments'' in hospices should not be solely related to religious affiliation (or lack thereof). These assessments might focus on a patient's sense of peace, purpose, beliefs, etc., but may not be warranted for all patients, particularly if they already have an available spiritual/emotional support system. Therefore, we do not believe that it is in the best interest of hospice patients and hospice providers to prescribe exactly what constitutes a spiritual assessment. A definition may
unintentionally interfere with the individualized, patientcentered hospice care that we require hospices to furnish. We do not intend for this regulation to suggest that any spiritual counseling or services be provided to a hospice patient or family against their wishes.

Comment: Many commenters asked us to define the phrase ``patient's home'' or ``patient's residence'' as a house, apartment, SNF/NF, ICF/ MR, assisted living facility, adult home, shelter, foster home or any other place where a patient lives.

Response: We are unable to develop a single definition of the terms ``home'' or ``residence'' at this time. We will consider these

FOR FURTHER INFORMATION CONTACT Steve Miller, (410) 786-6656; Mary RossiCoajou, (410) 7866051; Danielle Shearer, (410) 7866617; or Jeannie Miller, (410) 7863164.