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replace into fedregorigdata (url, contents, filedate) values ('http://edocket.access.gpo.gov/2008/08-1305.htm', '[Federal Register: June 5, 2008 (Volume 73, Number 109)] [Rules and Regulations] [Page 32087-32220] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr05jn08-6] [[Page 32087]] ----------------------------------------------------------------------- Part II Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services ----------------------------------------------------------------------- 42 CFR Part 418 Medicare and Medicaid Programs: Hospice Conditions of Participation; Final Rule [[Page 32088]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 418 [CMS-3844-F] RIN 0938-AH27 Medicare and Medicaid Programs: Hospice Conditions of Participation AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule revises the existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The final conditions address the comments that we received on the proposed rule published on May 27, 2005. This final rule focuses on the care delivered to patients and their families by hospices and the outcome of that care. The final requirements continue to reflect the unique interdisciplinary view of patient care and allow hospices flexibility in meeting quality standards. These changes are an integral part of the Administration\'s efforts to achieve broad based improvements in the quality of health care and our efforts to improve the quality of care furnished through the Medicare and Medicaid programs. EFFECTIVE DATE: These regulations are effective on December 2, 2008. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of December 2, 2008. FOR FURTHER INFORMATION CONTACT: Steve Miller, (410) 786-6656; Mary Rossi-Coajou, (410) 786-6051; Danielle Shearer, (410) 786-6617; or Jeannie Miller, (410) 786-3164. SUPPLEMENTARY INFORMATION: I. Background Hospice care is an approach to caring for the terminally ill individual that provides palliative care rather than traditional medical care and curative treatment. Palliative care is an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illness through the prevention and relief of suffering by means of early identification, assessment and treatment of pain and other issues. Hospice care allows the patient to remain at home as long as possible by providing support to the patient and family, and by keeping the patient as comfortable as possible while maintaining his or her dignity and quality of life. A hospice uses an interdisciplinary approach to deliver medical, social, physical, emotional, and spiritual services through the use of a broad spectrum of caregivers. Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Public Law 97-248, added section 1861(dd) to the Social Security Act (the Act) to provide coverage for hospice care to terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice. Under the authority of section 1861(dd) of the Act, the Secretary has established the Conditions of Participation (CoPs) that a hospice must meet to participate in Medicare and/or Medicaid, and these conditions are set forth at 42 CFR part 418. The CoPs apply to a hospice as an entity as well as to the services furnished to each individual under hospice care. Under section 1861(dd) of the Act, the Secretary is responsible for ensuring that the CoPs, and their enforcement, are adequate to protect the health and safety of individuals under hospice care. To implement this requirement, State survey agencies conduct surveys of hospices to assess their compliance with the CoPs. The hospice CoPs were originally published on December 16, 1983 (48 FR 56008) and were amended on December 11, 1990 (55 FR 50831) largely to implement provisions of section 6005(b) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239). However, many of the current CoPs have remained unchanged since their inception. As the single largest payer for health care services in the United States, the Federal Government assumes a critical responsibility for the delivery and quality of care furnished under its programs. Historically, we have adopted a quality assurance approach that has been directed toward identifying health care providers that furnish poor quality care or fail to meet minimum Federal standards. These problems would either be corrected or would lead to the exclusion of the provider from participation in the Medicare or Medicaid programs. However, we have found that this problem-focused approach has inherent limits. Ensuring quality through the enforcement of prescriptive health and safety standards, rather than improving the quality of care for all patients, has resulted in our expending much of our resources on dealing with marginal providers, rather than on stimulating broad-based improvements in quality of care. In order to take advantage of continuing advances in the health care delivery field, incorporate changes made to the Act, and incorporate recommendations made by various government agencies we are revising the Medicare hospice CoPs, which are also used by Medicaid. The revised CoPs focus on a patient-centered, outcome-oriented, and transparent process that promotes quality patient care for every patient every time. We have developed a set of core requirements for hospice services that encompass the following: Patient rights, comprehensive assessment, patient care planning and coordination by a hospice interdisciplinary group (IDG). Overarching these requirements is a quality assessment and performance improvement program that builds on the philosophy that a provider\'s own quality management system is key to improved patient care performance. The objective is to achieve a balanced regulatory approach by ensuring that a hospice furnishes health care that meets essential health and quality standards, while ensuring that it monitors and improves its own performance. We are revising the CoPs based on four main considerations. First, we considered the recommendations from the Secretary\'s Advisory Committee on Regulatory Reform. In an effort to make regulations more predictable and responsive to relevant stakeholders, the Committee heard public testimony on a variety of hospice-related topics and developed recommendations to address key issues that were highlighted. The Committee recommended that we clarify the relationship between nursing facilities and hospices (found in our final rule at Sec. 418.112); change the requirements for 24-hour nursing services for hospices providing respite care (Sec. 418.108 of the final rule); and clarify that all qualified individuals, including nurses, are permitted to furnish dietary counseling (Sec. 418.64(d)(2) of the final rule). Second, we considered the Balanced Budget Act of 1997 (Pub. L. 105- 33) because it made changes to the hospice statute that must now be incorporated into the CoPs. Specifically, the Balanced Budget Act of 1997 (BBA) permitted hospices to provide physician services, including those of a medical director, under contract (Sec. 418.64 and Sec. 418.102 of the final rule). It also allowed hospices located in non- urbanized areas to receive a waiver of the requirement that physical therapy, occupational therapy, speech-language pathology, and dietary counseling be available on a 24-hour as needed basis (Sec. 418.74 of the final rule). Additionally, the [[Page 32089]] legislation allowed hospices located in non-urbanized areas to receive a waiver of the requirement that dietary therapy be provided by hospice employees (Sec. 418.74 of the final rule). Third, we considered section 946 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Section 946 of the MMA amended section 1861(dd) of the Act, to permit a hospice to enter into an arrangement with another hospice to provide core hospice services or to provide the highly specialized services of a registered professional nurse, in certain circumstances (Sec. 418.64 of the final rule). Finally, this revision is part of a larger effort to bring about improvements in the quality of care furnished to hospice patients and their families through an outcome-oriented approach to patient care. The revised CoPs focus on the core elements of hospice care that are necessary to achieve positive patient outcomes to meet the growing challenges associated with the changing hospice care environment such as increasingly diverse patient populations and care settings. Before developing the proposed CoPs for hospices, published in the Federal Register on May 27, 2005, we analyzed our hospice survey data, and received advice and suggestions from the hospice industry, professional associations, practitioner communities, consumer advocates, and State and other governmental agencies with an interest in, or responsibility for, hospice regulation and oversight. Based on the data and suggestions, we developed the following principles: Focus on the continuous, integrated health care process that a patient/family experiences across all aspects of hospice care, and on activities that center around patient assessment, care planning, service delivery, and quality assessment and performance improvement; Use a patient-centered, interdisciplinary approach that recognizes the contributions of various skilled professionals and other support personnel and their interaction with each other to meet the patient\'s needs; Incorporate an outcome-oriented quality assessment and performance improvement program; Facilitate flexibility in how a hospice meets performance expectations; Require that patient rights are ensured; and Use performance measurement systems to evaluate and improve care. Based on these principles and the public comments that were submitted regarding the May 2005 proposed rule, we are setting forth this final rule. II. Provisions of the Proposed Regulations and the Analysis and Responses to Public Comments On May 27, 2005, we set forth proposed rules for hospices that choose to participate in Medicare and Medicaid. We proposed to revise all of the existing conditions of participation (CoPs), and to add several new CoPs to address aspects of hospice care that we believe need attention. This section will briefly describe the content of each CoP in the proposed rule. We proposed no changes to Subparts B (Eligibility, Election and Duration of Benefits), G (Payment for Hospice Care), or H (Coinsurance) of 42 CFR part 418. We received 205 timely items of correspondence that raised numerous issues. These comments, detailed below, came from accrediting bodies, consumer advocacy organizations, hospices, individuals, national health care provider organizations, State agencies, and State health care provider organizations. 1. Scope of the Part (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. 106-310), prohibits the use of restraint and seclusion, except under specific circumstances, in any health care facility, that receives support in any form from any program supported in whole or in part with funds appropriated to any Federal department or agency. We proposed to define the term ``satellite location\'\' to codify long-standing 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 [[Page 32090]] requirement that an attending physician must be legally authorized to practice surgery by the State in which he or she performs that function because surgery is not a specialty necessary to be considered qualified as an attending physician. Several other commenters requested that we specify in the definition of ``attending physician\'\' that a patient\'s attending physician may be a hospice employee. Another commenter suggested that we add a statement that a nurse practitioner may cover for an attending physician in the attending physician\'s absence. Response: Section 408(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (MMA) amended the term ``attending physician\'\' at section 1861(dd)(3)(B) of the Act specifically for hospices to allow nurse practitioners to function as a patient\'s attending physician if the patient identifies the nurse practitioner as such. Following publication of the proposed rule, CMS published two final rules (70 FR 45144 and 72 FR 50214) on other matters that, among other things, modified the definition of the term ``attending physician\'\' to incorporate changes made by the MMA. We are deferring to these final rules. Furthermore, Section 1861(r)(1) of the Act specifically defines a physician as ``a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he performs such function or action.\'\' We believe that this statutory definition is appropriate for hospice providers, as well as for the many other health care providers for which it is used. We do not have the authority to delete the term ``and surgery\'\' from this definition. We do not believe that it is necessary to state in the definition that an attending physician may be an employee of the hospice. The decision as to who is or is not the attending physician belongs to the patient regardless of that individual\'s employment relationship (or lack thereof) with the hospice. We do not prohibit attending physicians from being hospice employees as long as it is the patient\'s choice to decide whether or not to have an attending physician and who that attending physician will be during the patient\'s hospice care. In addition to consulting with the hospice interdisciplinary group (IDG) regarding the patient\'s hospice care, the attending physician retains responsibility for meeting the patient\'s needs that are not related to the terminal illness and that terminal illness\'s related conditions. The attending physician is typically someone with whom the patient had a relationship before electing to receive hospice care. The role of the attending physician is to provide a long term perspective on the patient and family that takes into account their medical and personal history. The attending physician is not typically an individual provided by the hospice to fill this role because a patient does not have an attending physician, although we recognize that this does occur at times. We also do not believe that it is necessary to state that a nurse practitioner may act on behalf of the attending physician in the attending physician\'s absence. If the attending physician is unable to fulfill his or her duties, then the hospice physicians are responsible for fulfilling the attending physician\'s duties in his or her absence in accordance with 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. [[Page 32092]] 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 sub-regulatory guidance such as the State Operations Manual. Comment: A commenter requested clarification about the definition of ``palliative care\'\' and its relationship to the requirement that, in order for a Medicare beneficiary to qualify for the Medicare hospice benefit, the beneficiary must be certified as being terminally ill. Specifically, the commenter asked if palliative care could be provided by a hospice to individuals who are not terminally ill or who have not elected the Medicare hospice benefit. Response: Hospice care is a very specific type of care provided within a defined timeframe at the end of life. Palliative care, on the other hand, can be provided at any time of life when there is a need to anticipate, prevent and treat suffering to optimize a patient\'s quality of life. Hospices have a long history of providing palliative care and are often in a position to provide [[Page 32093]] 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 [[Page 32094]] 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 [[Page 32095]] 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, patient-directed 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 over-the-counter drugs in use at the time of the assessment, including, but not limited to, an identification of the effectiveness of the drug therapy regimen, any potential or existing drug side effects, any potential or existing drug interactions, any duplicate drug therapies, and any drug therapy requiring laboratory monitoring. Excessive dosages or durations, or inadequate monitoring would likely lead to effectiveness and side effect issues that will be assessed during the comprehensive assessment and subsequent updates. The IDG, in conference with an individual who has specialized education and training in drug management, such as a pharmacist, will be required to address these issues in the patient\'s individualized hospice plan of care. Comment: A commenter suggested that we should define the term ``adverse event\'\' using the Joint Commission patient safety event taxonomy. Another commenter suggested that we should define the term as an, ``unanticipated, non-therapeutic response or injury\'\'. Response: While we agree that using the Joint Commission patient safety taxonomy or suggested definition may be helpful for some hospices, we do not believe that a single definition of ``adverse event\'\' would meet the needs of all hospices at this time. In general, an adverse event would be any action or inaction by a hospice that causes harm to a hospice patient. We believe that hospices are capable of determining what is or is not an adverse event based on the characteristics and needs of their patient populations and staff. We recognize that hospices are seeking further guidance on this issue, and we plan to provide such guidance in future sub-regulatory guidance, such as the State Operations Manual and Interpretive Guidelines. Comment: A few commenters requested that we define the term ``homemaker services\'\' with specific references to the Medicaid personal care benefit that many states offer to Medicaid beneficiaries. Commenters asked for clarification about the role of homemakers in hospice care, their relationship to Medicaid personal care aides, and the qualifications for individuals who furnish homemaker services. Response: Section 418.202(g) in subpart F of the current hospice regulations states, ``[h]omemaker services may include assistance in maintenance of a safe and healthy environment and services to enable the individual to carry out the treatment plan.\'\' We believe that this language adequately describes the role that homemakers play in hospice care, and we are making no changes to it in this final rule. Each State establishes its own Medicaid personal care aide benefit, pursuant to our regulations at 42 CFR 440.167, including its own eligibility criteria, scope of services to be provided, and personnel qualifications. Medicaid regulations impose only minimal restrictions on the state\'s discretion regarding these services. Hospice care is meant to supplement the care provided by the patient\'s caregiver. If the individual(s) furnishing Medicaid personal care services is functioning as the patient\'s caregiver, then the hospice would not be expected to replace the Medicaid personal care providers with its own homemaker services on a round-the-clock basis. The Medicare hospice benefit is not meant to be a caregiver benefit and should not be expected to function as such. Hospices should work with their respective State Medicaid agencies if they have questions about who pays for services provided to patients eligible for both Medicare and Medicaid. With regard to who is qualified to furnish homemaker services on behalf of a hospice, we proposed in 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 [[Page 32096]] 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, patient-centered hospice care that we require hospices to furnish. We do not intend for this regulation to suggest that any spiritual counseling or services be provided to a hospice patient or family against their wishes. Comment: Many commenters asked us to define the phrase ``patient\'s home\'\' or ``patient\'s residence\'\' as a house, apartment, SNF/NF, ICF/ MR, assisted living facility, adult home, shelter, foster home or any other place where a patient lives. Response: We are unable to develop a single definition of the terms ``home\'\' or ``residence\'\' at this time. We will consider these suggestions for future rulemaking. Comment: Many commenters requested a definition of the term ``facility\'\' as it is used in proposed and final Sec. 418.112. Response: The general term ``facility\'\' has been removed from this condition of participation (CoP) in favor of a more specific list of the facility types to which Sec. 418.112 applies. As the general term no longer appears in the rule in the context of Sec. 418.112, it is no longer necessary to define it. Comment: A commenter suggested that we define the term ``hospice patient\'\' as a patient who has been certified as being terminally ill and who has accepted the care of a hospice agency. Response: There is no single definition of ``hospice patient\'\' that can encompass all types of patients treated by a hospice and all eligibility criteria for all payment sources. Certifying a patient\'s terminally ill status is a Medicare and Medicaid payment requirement that does not necessarily apply to other health insurance or private pay patients. To say that un-certified patients are not ``hospice patients\'\' by excluding them from the definition would be inappropriate. However, ``hospice patients\'\' for Medicare payment purposes are those Medicare beneficiaries certified under Sec. 418.22 and electing hospice services under Sec. 418.24. Furthermore, we note that the term ``hospice patient\'\' does not appear in statute or regulation, and, as such, we do not believe that it requires a definition in this rule. 3. Condition of Participation: Patient\'s Rights (Proposed Sec. 418.52) We proposed to replace the existing CoP, Informed consent, at Sec. 418.62, with a new patient rights CoP. The proposed patient rights CoP was divided into five standards. The first standard, ``(a) Notice of rights,\'\' would have required hospices to develop a notice of rights, including information about advance directives and the hospice\'s controlled [[Page 32097]] drug policies. Under the proposed requirement, hospices would have been required to present the notice of rights verbally (meaning spoken) and in writing to patients and families in a language and manner that they are able to understand. This would have occurred before the hospice furnished care to a patient and family. Hospices would also have been required to document the patient\'s or representative\'s understanding of the notice of rights. In standard (b), ``Exercise of rights and respect for property and person,\'\' we proposed that the patient would be able to exercise his or her rights, be respected, voice grievances, and not be subjected to discrimination or reprisal. We also proposed that hospices would investigate and report all alleged violations of patient rights, and take appropriate corrective action where necessary. The third standard, ``(c) Pain management and symptom control,\'\' proposed that patients would have the right to receive effective pain management and symptom control from the hospice. Standard (d), ``Confidentiality of clinical records,\'\' proposed that hospices would be required to maintain the confidentiality of clinical records in accordance with the Privacy Rule published in the Federal Register on December 28, 2000 (65 FR 82461) as amended on August 14, 2002 (67 FR 53182) and set out at 45 CFR parts 160 and 164. Finally, the fifth standard, ``(e) Patient liability,\'\' proposed that patients would be informed about the extent to which payment may be expected from the patient, Medicare or Medicaid, third-party payers, or other sources, verbally and in writing in a language that the patient was able to understand. This standard proposed that this information would be provided to patients before care was furnished. The intent of this standard was to ensure that patients were aware of their potential out-of-pocket costs for hospice care, such as co- payments, so that they would not be surprised by financial concerns at this stressful time. Comment: A majority of commenters on this issue expressed concern about the proposed requirement that hospices provide a notice of the patient\'s rights and responsibilities verbally, as well as in writing, in a language and manner that the patient would understand. Many of these commenters requested that hospices not be required to furnish written notices in obscure or otherwise uncommon languages. Other commenters requested that the choice of language(s) used to communicate be left to the discretion of each hospice or that the communication be done in accordance with guidance issued by the Department of Health and Human Services (HHS) related to Title VI of the Civil Rights Act of 1964, Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons. Still other commenters requested that we specifically recognize in the regulation that interpreters, family or otherwise, be permitted to facilitate communication of the notice of rights to patients and families. Response: We recognize that this is an area of concern for hospices, as it may be challenging for hospices to communicate with patients who speak languages other than English. However, ensuring that patients are aware of their rights and how to exercise them are vital components of improving overall hospice quality and patient satisfaction. If patients are unaware of their rights or the methods and protections available for exercising those rights, then hospices cannot expect to receive valid feedback from patients on ways to improve their services. Without the valid feedback, true quality measurement and improvement cannot exist. Therefore, we believe it is in the interest of patients and hospices to ensure that all patients, regardless of their communication needs, are informed of their patient rights. Even so, we are sensitive to the concerns of hospice providers. The HHS guidance on Title VI (August 8, 2003, 68 FR 47311) applies to those entities that receive federal financial assistance from HHS, including hospices. This guidance presents four areas for hospices to consider when developing and implementing strategies to meet the needs of limited English proficient persons. The guidance recognizes the role of professional translation services, as well as family and friends of the patient, in communicating important information to patients, including the notice of rights. Hospices are already expected to comply with the HHS guidance, and doing so will enable them to comply with the requirements of the proposed rule. Using family and friends as translators should not be the communication plan of choice for the hospice for its patients who do not speak English, unless the patient specifically requests this approach. Hospices should make all reasonable efforts to secure a professional, objective translator for hospice-patient communications, including those involving the notice of patient rights. Furthermore, hospices should make all reasonable efforts to have written copies of the notice of rights available in the language(s) that are commonly spoken in the hospice\'s service area. For those patients who speak uncommon languages in areas where professional translators for those languages are not readily available, using family and friends of the patient is an acceptable option. Comment: A commenter asked that we explicitly specify in Sec. 418.52(a)(2) that patients have the right to refuse to formulate advance directives. Response: Under this final rule, hospices are required to comply with 42 CFR part 489 Subpart I, ``Advance directives.\'\' Patients may choose to develop advance directives in accordance with applicable State requirements. Likewise, they may choose to not formulate advance directives. We believe that 42 CFR part 489 adequately addresses all aspects of advance directives, including patient choice. Therefore, we are not adding the commenter\'s suggestion. Comment: Some commenters asked that we clarify what type of documentation would be necessary to demonstrate that the hospice provided patients with a notice of rights and that the patient or representative demonstrated an understanding of the rights. A majority of commenters noted that language in the proposed rule, ``demonstrated an understanding of,\'\' was imprecise and difficult to measure. Additional commenters suggested that language from the home health agency CoPs at 42 CFR 484.10 should be used in the hospice CoPs. Section 484.10 states that ``the HHA must maintain documentation that it has complied with the requirements of this section.\'\' This language, commenters noted, would allow hospices to determine in their own policies how the documentation would be handled. Several other commenters suggested that hospices be required to obtain the patient\'s or family\'s signature, confirming that they received the notice of rights. Response: We agree that a more precise requirement will help hospices ensure that patients and families are fully informed about the notice of rights. Furthermore, we agree that more precise language will help hospices ensure that they are in compliance with our documentation requirements. Therefore, this final rule at Sec. 418.52(a)(3) states, ``The hospice must obtain the patient\'s or representative\'s signature confirming that he or she has received a copy of the notice of rights and responsibilities.\'\' Comment: Some commenters noted that State practices and laws may [[Page 32098]] govern a legal representative\'s exercise of a patient\'s rights as described in Sec. 418.52(b)(3). The commenters requested that we add the phrase ``and practice\'\' at the end of this requirement so it would read: ``If a State court has not adjudged a patient incompetent, any legal representative designated by the patient in accordance with State law may exercise the patient\'s rights to the extent allowed by State law and practice.\'\' Response: Without more specific information from the commenters regarding what practices states may unofficially have in place, we do not believe that it is appropriate for us to add the phrase ``and practice\'\' to the requirement at this time. If more specific information is made available at a future time, we will reconsider this suggestion. Comment: Many commenters had concerns about the scope of the responsibilities of hospices when investigating and reporting violations of patient rights by hospice staff. In addition, the commenters had concerns about the proposed timeframes for investigating and reporting alleged violations to local authorities and State survey agencies. Specifically, the commenters noted that it would not be necessary to notify State and local bodies having jurisdiction about unverified violations. The commenters also noted that alleged violations may occur several days before the hospice becomes aware of them, and indicated that the reporting timeframe should not begin before a hospice even becomes aware of the alleged violation. Numerous commenters suggested that the patient rights requirement in the home health agency regulations at Sec. 484.10 might be more appropriate, while others suggested that the investigation and reporting requirements be deleted in their entirety. Response: Requiring hospices to investigate potential violations of patient rights by hospice staff (including contracted or arranged services) will protect patients and their families. Reporting violations (when verified in accordance with hospice policies and procedures and any applicable State and local laws and regulation) is an integral part of improving the quality of hospice care provided to Medicare beneficiaries. At the same time, adopting regulations more in line with those currently in the home health agency rules would not, we believe, be appropriate for the hospice industry because hospices typically care for more fragile patients and families in a wider variety of patient care settings, such as private homes, long term care facilities, and hospice inpatient units. The home health agency requirements are narrower than what we are requiring. We believe that a broader framework in these hospice regulations, coupled with a hospice\'s own policies and procedures, will allow hospices to adapt the requirements to the particular needs and concerns of their patient populations now and in the future. However, we agree that further clarifications are warranted to ensure that a hospice assumes full responsibility for its staff, while not overwhelming the hospice with responsibilities beyond its control. To that end, we are requiring hospice staff that discover alleged violations to immediately report such allegations involving anyone furnishing services on behalf of the hospice, including contracted and arranged services, to the hospice\'s administrator. The hospice administrator must investigate violations involving anyone furnishing services on behalf of the hospice and, if verified, the hospice must report the violation to State and local bodies having jurisdiction within 5 working days of any member of the hospice staff (including those furnishing contracted or arranged services) becoming aware of the violation in accordance with the hospice\'s own policies and procedures. We would expect that significant violations, such as illegal actions by hospice staff, would be reported to State and local bodies. We believe that these modifications will ensure that violations are fully addressed while not overburdening hospices. Comment: A single commenter requested that we defer to State requirements for violation reporting. Response: If State requirements for reporting violations are stricter than our Federal requirements, then those stricter State requirements would take precedence. Stricter State requirements may be those that require violations to be reported regardless of whether they are verified or not, or requirements that verified violations be reported in less than 5 days. However, if State requirements are less stringent than Federal requirements, then the Federal requirements will take precedence. We believe that the scope and timeframes contained in this final rule are the minimum health and safety requirements with which facilities could reasonably be expected to comply. Comment: Several commenters specifically focused their concerns on the implementation of proposed Sec. 418.52(b)(4) in the context of the dual and possibly overlapping responsibilities of hospices that provide services to residents of long term care facilities. In particular, commenters suggested that hospices should only be held responsible for those individuals functioning on behalf of the hospice and that concerns pertaining to individuals functioning on behalf of the long term care facility should be the responsibility of that facility. Response: We agree that hospices should only be held responsible for investigating and reporting violations pertaining to their own employees and contractors. To address this comment, at Sec. 418.112(c)(8), we are setting forth a requirement that the written agreement between the hospice and the SNF/NF or ICF/MR must contain a provision whereby the hospice must report all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by anyone unrelated to the hospice to the facility administrator within 24 hours of the hospice becoming aware of the alleged violation. This requirement will assure that the SNF/NF or ICF/MR is made aware of the alleged violation in a timely manner so that it can begin its own investigation and implement its own intervention(s). A hospice may also want to consider incorporating a provision in the contract to require a SNF/NF or ICF/MR to notify the hospice if any of its staff become aware of a potential patient rights violation involving hospice staff. Such a provision may enhance hospice-facility communication and cooperation. In addition, we will consider this issue when developing complementary regulations for long term care facilities. Comment: A few commenters asked that we define the term ``immediately\'\' as it applies to the timeframe for reporting alleged violations to the hospice\'s administrator. The commenter recommended that the timeframe for reporting alleged violations be based on an assessment of the patient\'s needs. Response: It is in the patient\'s best interest to involve the hospice administrator at the time that the potential violation is noted to assure that the situation is adequately and expeditiously dealt with. Once notified, it is up to the hospice\'s policies and procedures and the hospice administrator\'s judgment, in accordance with this rule, to handle the allegation. The hospice administrator is the designated leader of the hospice and assumes responsibility for the care and services furnished by the hospice, whether directly or under contract. This is a 24-hour a day responsibility, and it [[Page 32099]] applies to incidences of alleged violations. Comment: Some of commenters expressed concern regarding the manner in which the terms ``mistreatment\'\' and ``injury\'\' are used in the proposed patient\'s rights CoP. They believe the terms to be vague and too difficult to judge objectively. Response: The terms ``mistreatment\'\' and ``injury\'\' encompass two important areas that affect patient safety and satisfaction. While other terms such as ``abuse\'\' and ``neglect\'\' imply actual harm to a patient, ``mistreatment\'\' is a broader term that encompasses quality of life issues that are crucial as patients and families cope with death and dying. We understand that the broad nature of the term makes it difficult to judge. This judgment difficulty is exactly why we are requiring hospices to conduct their own internal investigation into the potential patient rights violation. We are leaving these terms mostly undefined so that hospices may determine whether ``mistreatment\'\' or ``injury\'\' have occurred on a case-by-case basis. State tort liability laws may serve as a guide for hospices in determining whether ``mistreatment\'\' or ``injury\'\' have occurred. Through a thorough investigation, hospices can determine, in accordance with their own policies and procedures, whether mistreatment occurred and what steps need to be taken to resolve the mistreatment and prevent future occurrences. The presence of the term ``injury\'\' is also important in this standard because it addresses other issues that may not constitute ``abuse\'\' or ``neglect\'\' but that nonetheless impact a patient\'s well- being. We understand that some relatively minor injuries such as skin tears may be perceived as injuries. By maintaining the term ``injury\'\' in this standard, hospices are required to fully investigate incidents of minor injuries (like skin tears) to determine if they constitute a violation of a patient\'s rights. If the internal investigation reveals that all appropriate steps were taken to prevent the minor injury, then the hospice may determine that the injury is not a violation of a patient\'s rights. However, if the investigation reveals that reasonable precautions were not taken, then the hospice may determine that the injury is a violation of patient rights. In setting forth a standard in the final rule that requires hospices to report patient injuries to the hospice administrator, hospices have the opportunity to conduct a self assessment to determine if care processes need to be changed to improve the consistent delivery of quality care. Comment: Some commenters asked for clarification regarding proposed Sec. 418.52(c), which reads, ``The patient has a right to receive effective pain management and symptom control from the hospice.\'\' While the commenters supported the intent of this standard, they questioned its scope. One commenter wanted to know whether this standard would require hospices to furnish continuous home care, while another questioned if hospices were supposed to be responsible for pain and symptom management unrelated to the terminal and related conditions. Still another commenter suggested that hospices should be allowed to refer patients to other providers for pain and symptom management. Response: Effective pain and symptom management have long been the hallmark of hospice care, and we appreciate that the commenters recognized the importance of this patient right. We agree that hospices are required to furnish pain and symptom management for the terminal illness for which the patient is receiving hospice care and conditions related to the terminal illness. We have revised this standard and clarified this point at Sec. 418.52(c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR 418.204 and 418.302 may or may not be the most effective way to provide effective pain management and symptom control while maintaining a patient at home. It is acceptable for hospices to refer pain and symptom control issues unrelated to the terminal illness and related conditions to other providers. If a hospice were to make a referral, we would expect the hospice to coordinate its efforts with the other provider to avoid duplicative or contradictory therapies in accordance with final Sec. 418.56(e)(5). The goal of this coordination is to ensure that the patient\'s hospice plan of care is implemented, and that the hospice care is furnished in concert with other care sources to ensure that all patient needs are met. In accordance with Sec. 418.100(c) hospices are responsible for pain and symptom management related to the terminal illness and related conditions and should not refer patients to other providers for these issues. If a hospice does not have the expertise to handle pain and symptom management issues related to the terminal and related conditions, it is responsible for procuring the expertise for the patient as part of its regular hospice services. Comment: Many commenters suggested that we should add provisions stating that patients have the right to refuse treatment and the right to be involved in developing their plans of care. Response: We agree that these are important patient rights that should be included in this final rule. We believe that including these rights, at new Sec. 418.52(c)(2) and Sec. 418.52(c)(3) respectively, will help to ensure that the patient\'s goals and needs are consistently reflected in the hospice\'s plan of care and actions. Comment: A few commenters requested that we add a provision requiring hospices to provide patients with a written statement of the scope of care and services that will and will not be provided. One commenter requested that we add a provision stating that patients have the right to receive information about the services covered under the hospice benefit. Response: We agree that providing a patient with general information about his or her hospice benefit is an important step in ensuring that hospice patients are educated about their rights. Therefore, we are establishing section 418.52(c)(7), which requires hospices to provide this general benefit information. We also agree that providing a patient with general information about the scope of services that the hospice provides, as well as any limitations on those services, will further empower hospice patients and their caregivers to take an active role in hospice care planning. Providing the patient and family a list of services that the hospice may provide gives the patient and family an opportunity to request specific services that the IDG had not considered. Simply knowing that help is available may lead patients and families to reach out for it. For this reason, we are establishing section Sec. 418.52(c)(8), which requires hospices to provide information about the scope of services that the hospice will provide to its patients, and specific limitations on those services. Comment: A single commenter requested that we add a specific provision stating that patients have the right to continue to maintain a relationship with their attending physician once they elect the hospice benefit. Response: It is understood and widely accepted throughout the health care community, including in the hospice industry, that patients should be allowed, even encouraged, to continue to work with their attending physicians as they transition from one health care provider or setting to another. The goal of this practice is to enhance continuity and quality of care by actively including the attending physician, who knows [[Page 32100]] that patient\'s medical and family history, in planning and delivering the patient\'s hospice care. We believe that this is in the best interest of patients and providers. Explicitly identifying a patient\'s right to choose his or her attending physician without undue influence from a hospice will help ensure that hospices and patients continue to benefit from the knowledge of attending physicians. Therefore, we have added this patient right at Sec. 418.52(c)(4). Comment: A commenter requested that we add a provision stating that patients have the right to access, request amendments to, and receive an accounting of disclosures regarding their health information. Response: Patient rights regarding their health information are explicitly addressed in the HIPAA regulations at 45 CFR 164.502(a)(2)(i) and 164.524. Hospices are already required to comply with these extensive regulations, and we see no need to duplicate the HIPAA patient rights requirements in this rule. Therefore, we are not adding this suggested provision. Comment: Many commenters expressed confusion and concern about our proposed requirement that hospices notify patients of the extent to which payment may be expected from the patient before care is initiated. Commenters sought clarification on how this requirement would dovetail with the Advanced Beneficiary Notice (ABN), long term care facility payments, and private health insurance payment rules. In addition, commenters wanted to know if, before care is initiated, hospices would be required to advise patients of those services that would not be covered by the hospice because those items would not be in the plan of care, even though the plan of care had not yet been formulated. Some commenters suggested that, rather than providing exact dollar amounts for patient liability, we should require a more general description about co-pays, Medicaid spend down requirements, etc. Other commenters requested that this notice not be in writing or that it be provided at the time of the initial assessment rather than before any care is provided. A single commenter requested that the requirement be phased in over a period of time. Response: The original intent of this proposed standard was to educate patients and families about their potential liability in consideration of all available payment sources. Patients and families often come to hospice after long illnesses with pressing financial concerns. In requiring hospices to provide information when services are first provided (particularly on Medicare\'s comprehensive benefit with minimal co-pays) we sought to alleviate some of those financial worries. However, as many commenters noted, hospices regularly provide this payment overview as part of their patient intake process when patients are choosing whether or not to elect the hospice benefit. We encourage hospices to continue this practice. Furthermore, commenters noted that financial liability for long term care facility residents becomes very complicated and uncertain because of the patient\'s residential status. Information provided before the start of care is likely to be inaccurate because hospices do not control the resident\'s long term care facility liability. The proposed timing of the notification and its all-encompassing nature make it impractical for hospices to implement and would likely not increase the benefit of hospice services to patients and families. Therefore, we are deleting this requirement. We believe that the existing ABN requirements at 42 CFR 411.404, which require hospices to notify patients should a particular service or item potentially not be covered by Medicare, provide the most timely and accurate information to patients and families. The ABN should be delivered far enough in advance that the patient or representative has time to consider the options and make an informed choice. The ABN should be verbally reviewed with the patient or representative and any questions raised during that review should be answered before it is signed. Comment: A commenter requested that we add a provision to the patient\'s rights CoP stating that patients have the right to refuse to participate in experimental research. Response: Ethical research practices dictate that patients must choose to participate in experimental research and that their participation or lack thereof may not negatively impact their well- being. In addition, although we acknowledge that it may occur at times, experimental research in palliative care is not, to our knowledge, a common occurrence. We believe that the existing patient opt-in research standard, combined with the rarity of the situation, does not warrant us issuing a new standard within this CoP. Comment: A few commenters suggested that we should add a provision, either in the ``Patient\'s rights\'\' requirement or other requirements, that ensures that long term care facility residents are provided a choice of which hospice furnishes their care. Response: We are aware of concern within the hospice industry about long term care facilities that choose to not contract with hospice providers, or to only contract with a single hospice provider to furnish hospice services to residents. However, authority to govern long term care facilities\' actions is not contained in the hospice regulations found in 42 CFR part 418. Therefore, we are not adding the suggested requirement. We will however, take these comments into consideration as we review the long term care CoPs for possible future revisions that would address this aspect of long term care facility responsibility relative to the care of residents. Comment: Some commenters requested that we require hospices to recognize board-certified chaplains as advocates for patient rights in hospices. Response: We expect that all hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We are not requiring that hospices use patient advocates. However, if hospices choose to designate specific patient rights advocates, they are free to do so, and are free to select those individuals who are best suited for the task. Board- certified chaplains may serve well in the patient rights advocate capacity, and hospices are free to explore this option. Comment: Another commenter requested that we add a provision stating that patients should not be denied hospice care based on the cost of their reasonable and necessary palliative care. Response: Decisions about admission to hospice fall outside of the purview of this rule, which focuses on ensuring the safe and effective provision of quality care to patients and their families once the patient is admitted to a hospice. Although we take this issue very seriously, we are not incorporating the suggested provision in this rule. We note that providers, in general, cannot be required to provide services to Medicare patients (see Section 1802(a) of the Social Security Act). Comment: A single commenter suggested that patients should be required to demonstrate their willingness to comply with the plan of care. Response: We understand that patient noncompliance is occasionally an obstacle for hospices in providing safe and effective hospice care. However, we have no authority to mandate patient compliance. It is the hospice\'s responsibility to fully educate the patient and family regarding hospice care, as well as hospice policies and [[Page 32101]] procedures for handling plan of care disagreements, emergencies and other situations that may prompt patient noncompliance. For these reasons we are not adding a patient compliance provision. Comment: A single commenter suggested that hospices be required to comply with any additional State reporting requirements for elder abuse. Response: We agree that hospices should be required to comply with all health and safety related Federal, State and local laws and regulations, which would include reporting requirements for elder abuse. This rule finalizes Sec. 418.116, ``Compliance with Federal, State and local laws and regulations related to the health and safety of patients,\'\' which requires hospices to comply with State elder abuse reporting requirements. 4. Condition of Participation: Initial and Comprehensive Assessment of the Patient (Proposed Sec. 418.54) The proposed assessment requirement identified the general areas that would be included in a patient assessment and the timeframes for completing the assessments to help hospices ensure that they were identifying needs in all areas in a timely fashion. The proposed comprehensive assessment requirement was divided into five standards. The first standard, (a), ``Initial assessment,\'\' would require a registered nurse to make an initial assessment visit within 24 hours of receiving a physician\'s admission order for care, unless ordered otherwise by the physician. The purpose of this initial assessment was to determine the patient\'s immediate care and support needs. In the proposed rule we differentiated this initial assessment from the hospice\'s evaluation of a patient\'s appropriateness for hospice care. We stated that visiting a patient to determine his or her appropriateness for hospice care does not constitute an initial assessment. The second standard, (b), ``Timeframe for the completion of the comprehensive assessment,\'\' proposed that the hospice IDG and the patient\'s attending physician complete the comprehensive assessment no later than four calendar days after the patient elected the hospice benefit. The four day timeframe was proposed because many hospice patients are admitted to hospice late in their terminal illness and often require intensive hospice services at the beginning of their hospice stay. A hospice must assess a patient to identify his or her needs before it can develop and implement a plan of care to meet those needs. Therefore, a timely assessment is necessary to properly care for a patient. In the third standard, (c), ``Content of the comprehensive assessment,\'\' we proposed that hospices identify the physical, psychosocial, emotional, and spiritual needs of the patient related to the terminal illness and related conditions. As proposed, the comprehensive assessment would include information about the terminal condition, complications and risk factors, an initial bereavement assessment, a drug profile review, and any further referrals or evaluations, as appropriate. We did not propose that hospices use a specific assessment form or tool. Under proposed standard (d), ``Update of the comprehensive assessment,\'\' the hospice IDG would be required to update each patient\'s comprehensive assessment no less frequently than every 14 days and at the time of each recertification. The proposed comprehensive assessment update would document changes that had occurred since the last assessment, including the patient\'s progress toward desired outcomes and the patient\'s response to the care furnished by the hospice. We proposed these update timeframes because the condition of a hospice patient is expected to change over the course of hospice care, and often does so quite rapidly, considering that the median length of a hospice stay is about 26 days. The final standard in this proposed CoP, (e), ``Patient outcome measures,\'\' would require hospices to include, as part of the information gathered by the comprehensive assessment, data elements to allow hospices to measure patient outcomes. This standard proposed that the data elements would be collected and documented in the same manner for all patients in order to ensure the accuracy and consistency of the data. Hospices would be required to use the data in individual care planning and the quality assessment and performance improvement program described in proposed Sec. 418.58. We did not propose to require hospices to use any specific patient outcome measures or data elements. Comment: Many commenters requested that we clarify in the opening paragraph of the CoP that hospices are not required to assess a patient\'s condition beyond the patient\'s need for hospice care and services related to the terminal illness and related conditions. Commenters suggested that we delete the phrase ``but is not limited to\'\' because it implies that hospices are required to assess and address areas beyond the boundaries of the terminal illness and related conditions. Response: The Medicare hospice benefit covers all care provided by hospices for the palliation and management of an individual\'s terminal illness and related conditions. Hospices are required to furnish these services; however, they are not required to furnish services for needs unrelated to the terminal illness and related conditions. Our intent in specifying that hospices are not limited to assessing the patient\'s status and needs associated with the terminal and related conditions was to explicitly permit hospices to look beyond the terminal and related conditions to gain a complete picture of the patient. We did not intend to imply that hospices would be required to provide care for those issues that are outside of the scope of hospice care under the hospice benefit. In order to clarify our intent in the second sentence of the CoP, we have removed the phrase ``but is not limited to\'\' and we have replaced the word ``care\'\' with ``assessment\'\'. The final sentence of the introductory paragraph at 418.54 now reads, ``This assessment includes all areas of hospice care related to the palliation and management of the terminal illness and related conditions.\'\' Modifying the requirement does not mean that hospices are prohibited from identifying and/or addressing issues and areas of patient need outside of the hospice benefit, even though hospices are not responsible for providing services for these issues. Indeed, not gathering the information may make it more difficult for hospices to effectively plan to care for a patient because important information would not be available when making care planning decisions. Comment: The majority of commenters who submitted comments in this section expressed concern about the timing of the initial assessment. Commenters seemed unclear about the proposed requirement that hospices would have 24 hours from the time that a physician order is received to make the assessment. Additionally, commenters were concerned that the proposed rule, as written, would not allow hospices to adjust the initial assessment timeframe based upon patient and family wishes. Many commenters specifically requested that we replace the term ``physician\'s order for care\'\' with ``physician\'s certification\'\', which would require the assessment to be completed after the physician has certified that the patient is terminally ill and thus an appropriate candidate for hospice care. A few commenters explicitly disagreed with [[Page 32102]] this suggestion. Several other commenters questioned the role that the patient\'s election to receive hospice care played in determining when to begin the timeframe for completing the assessment. Response: We agree that a more definitive time point needs to be established and that patient and family wishes should be taken into account when establishing this timeframe. We recognize that some patients are self-referred and therefore may not have a physician\'s order for hospice care. These patients could create uncertainty in hospices because hospices would not know when to begin the 24 hour period for completion of the initial assessment. This uncertainty could lead to situations of non-compliance that are out of the hospice\'s control. We do not believe that this would be in the best interest of patients or hospices; therefore, we are revising the timeframe language as requested by many commenters. In order to clarify the length of time that hospices have to complete the initial assessment, we have referenced language used in Subpart B, Eligibility, election and duration of benefits, of the existing hospice regulations, into the initial assessment requirement at Sec. 418.54(a). Once a hospice has obtained an election statement for a particular Medicare or Medicaid patient in accordance with the requirements of Subpart B, the hospice has 48 hours to complete the initial assessment, unless the patient, his/her representative, and/or physician request an expedited timeframe. Since election requirement is particular to the Medicare and Medicaid hospice benefits, hospices are free to establish a similar starting point for non-Medicare and Medicaid patients in their own policies, based on the needs of the hospice, its community, and any applicable State and local laws and regulations. We also agree that the needs of patients or their representatives should be taken into consideration when completing the initial assessment. There are times when patients or representatives may want to expedite the initial assessment, and their wishes, along with the health status of the patient, should be taken into account when scheduling and completing the initial assessment. For example, a patient\'s representative may request that the hospice complete the initial assessment in a shortened timeframe because the patient is in acute distress and requires immediate hospice assistance. We would expect the hospice to consider the patient\'s or representative\'s request for a change in the initial assessment timeframe when scheduling the necessary visit(s) to complete the initial assessment. Therefore, we have modified the language to state that the patient or representative may request that the initial assessment be completed in less than 48 hours. If a patient or representative wishes to delay the completion of the initial assessment, it would not be appropriate to have that patient or representative elect the hospice benefit. When a patient elects the hospice benefit she waives the right to receive all other Medicare covered services for the terminal illness and related conditions. If the patient may not receive all other Medicare covered services for the terminal illness and related conditions, and that patient cannot receive hospice services because she has not received an initial assessment to determine her immediate care needs, then the terminally ill patient is effectively without health care for the intervening time period. We do not believe that this is an acceptable situation. Standard (a), ``Initial assessment,\'\' now states, ``The hospice registered nurse must complete an initial assessment within 48 hours after the election of hospice care in accordance with Sec. 418.24 is complete (unless the physician, patient, or representative requests that the initial assessment be completed in less than 48 hours).\'\' Comment: A few commenters expressed support for separating the initial assessment from the comprehensive assessment. Response: We agree that separating the assessment requirements will enable hospices to quickly assess the most critical areas of need and begin furnishing appropriate care while ensuring that all areas of need are assessed by the appropriate disciplines in a timely manner. Comment: Some commenters requested that we replace the requirement that hospices complete initial assessments within 24 hours with a requirement that hospices make or make available an initial patient contact within 24 hours of receiving a referral. In addition, commenters requested that any hospice employee, or at least an RN or social worker, be permitted to make this initial contact. Response: We understand there may be some confusion in the hospice community about the purpose of the initial assessment. The purpose of the initial assessment is to gather the critical information necessary to treat the patient\'s immediate care needs. The initial assessment is not a ``meet and greet\'\' visit whereby the hospice introduces itself to the patient and begins to evaluate the patient\'s interest in and appropriateness for hospice care. As the commenters stated, the initial patient contact takes place before the hospice assumes responsibility for the patient\'s care. Hospices may choose the timeframe and appropriate individual for completing this initial contact. It is not appropriate to substitute an initial contact for an initial assessment. Merely requiring an initial contact within 24 hours would not be sufficient to meet the needs of critical patients. Patients often come to hospice in moments of crisis. An initial contact when a patient is in need of timely assistance would be a disservice to the patient and family and would not lead to effective, high quality care. Hospices may choose to send a social worker or other discipline to complete the initial assessment along with the RN, and this may lead to better patient outcomes and satisfaction. Because other disciplines do not have the skills necessary to independently complete the initial assessment, we are not incorporating the commenters\' suggestions. Comment: Several commenters suggested that we change the phrase ``RN must make an initial assessment visit\'\' to ``RN must complete an initial assessment.\'\' Similarly, another commenter suggested that we require that ``the hospice registered nurse must perform and document an initial assessment visit.\'\' The commenters stated that their proposed revised language would clarify our intent that, rather than simply making a visit to begin the initial assessment, the initial assessment must be fully complete within the specified timeframe. Response: The commenters are correct in their assertion that the initial assessment must be completed, not just started, within the timeframe. Completing the initial assessment, which means that it is both performed and documented, enables the hospice to determine the patient\'s immediate care and support needs in a timely manner. An accurate determination of care and support needs cannot be made until the initial assessment is complete; therefore, we agree that it is necessary that it be completed within 48 hours. We have clarified the requirement to read, ``The hospice registered nurse must complete an initial assessment within 48 hours * * * .\'\' Comment: A few commenters questioned the role of the hospice physician in completing the initial assessment. Response: The initial assessment completed by hospice staff must address the patient\'s critical physical, psychosocial and emotional status [[Page 32103]] related to the terminal and related conditions. It is likely not the most efficient use of a physician\'s time to complete a task (the initial assessment) that can be fully handled by a registered nurse. Therefore, we continue to require that a registered nurse complete the initial assessment. This requirement in no way prevents a hospice from using the knowledge and skills of both a registered nurse and a physician to complete the initial assessment. A physician who is employed by or under contract with a Medicare hospice cannot bill separately for the initial and comprehensive assessments. Comment: Several commenters requested that we revise the timeframe for completing the initial assessment. Suggestions included 48 hours, 72 hours, the close of the day following the day the patient is referred, and 24 hours ``when reasonably possible.\'\' Other commenters requested that the timeframe be deleted completely. Response: Establishing a clear and consistent timeframe for completing the initial assessment is essential to ensuring that patients benefit from hospice care early in their stay. Completing the initial assessment within 48 hours will help hospices gather the essential information to begin a plan of care that addresses the patient\'s needs before those needs escalate and become extremely difficult to address. Overall, many commenters stated that the 24 hour timeframe for the initial assessment, as we proposed, was too restrictive. In this final rule we have effectively increased the length of the timeframe by changing its starting point from the time the physician\'s order is received to the time that the election statement is complete in accordance with the applicable requirement of Subpart B. Under the proposed rule, hospices would have been required to complete the initial assessment within 24 hours of the physician\'s order to begin hospice care, even if the hospice was unable to schedule a visit with the patient and family within that timeframe. Under the revised final rule language, hospices have 48 hours after the patient elects the hospice benefit to complete the initial assessment. At times, a patient, representative, or physician may request that the comprehensive assessment be completed in a timeframe less than 48 hours, and we expect hospices to accommodate such requests when they are made. Comment: Many commenters questioned the role of the patient\'s attending physician in completing the comprehensive assessment. Some commenters explicitly requested that hospices should not be required to involve attending physicians. Other commenters requested that a provision be added permitting attending physicians to ``opt out\'\' of participating in the assessment. Still others indicated that we should require attending physicians to approve, in writing, the content of the comprehensive assessment. Response: The scope of public comments submitted regarding the role of the attending physician in hospice care suggested that there is no single model that applies. Some commenters indicated that community- based attending physicians provide a leading role in hospice care, actively participating in the IDG, writing orders, and even making visits. Some commenters, however, indicated that community-based attending physicians preferred to step back once a patient has elected hospice, typically transferring their patients to the hospice physician\'s care. While we are pleased to know that there are many attending physicians who wish to stay involved in caring for their patients, these physicians should not assume that their attending physician service role is part of the hospice benefit. Likewise, while we are pleased to know that hospices are fully prepared to care for all of their patients needs, including those needs unrelated to the terminal illness and related conditions that the attending physician would be responsible for, it would be inappropriate for a hospice to influence a patient to relinquish his or her attending physician. At the same time, we are sensitive to the concerns expressed by the hospices. Some patients do not have attending physicians. Some patients do not want to continue seeing their attending physicians. Some attending physicians may be unresponsive to, or uncooperative with, the hospice. We do not want to place patients in a position where they must choose between receiving services from their attending physician and their hospice, nor do we want to place hospices in a position where they are forced to handle difficult attending physicians who disrupt their operations. In light of these considerations, we are maintaining the requirement that hospices consult with the patient\'s attending physician when completing the comprehensive assessment. Involving the attending physician to the extent possible will allow hospices to gain additional information about the patient. Attending physicians can often provide a lengthy history of the patient\'s disease process and family dynamics can help the hospice make better care planning decisions that result in improved patient outcomes. In recognition of the fact that not all patients have willing attending physicians, we have added a caveat that this consultation need only occur if there is an attending physician to consult with. In this way, attending physicians may, with the patient\'s agreement, opt out of following the patient\'s care through the patient\'s hospice stay. We are not, as some commenters suggested, requiring that the attending physician sign a document approving the content of the comprehensive assessment. Rather, we leave it to hospices to define in their own policies and procedures how they will document that they have conferred with the attending physician. We believe that this will give hospices the ability to structure their communication and coordination system in a way that meets their needs for timely information sharing and documentation. Comment: Several commenters wanted to know if the consultation with the attending physician to complete the comprehensive assessment could be accomplished over the telephone or through electronic communication methods. Response: A hospice would need to consult with willing attending physicians in accordance with its own policies and procedures. If a hospice\'s policies and procedures permitted it to consult with attending physicians on the telephone or through electronic communications, then that would be an acceptable practice. Rather than dictate what is or is not an acceptable communication method, this rule seeks to ensure that these communications occur. Effective communication between the hospice and attending physician in completing the comprehensive assessment will enable a hospice to develop a more complete understanding of the patient and family in order to develop a plan of care that addresses all areas of need related to the terminal illness and related conditions. Comment: A majority of commenters addressed the issue of the length of time necessary to complete the comprehensive assessment. As with the initial assessment, some commenters questioned the exact time that the timeframe began. Some commenters expressed strong support for the proposed four-day timeframe, with a few commenters even suggesting that, in the future, we should move to a two- or three-day timeframe. Other commenters suggested that the timeframe should be lengthened to five, seven, eight, or even 14 days. Some suggested that no [[Page 32104]] timeframe be established at all. Still other commenters suggested that we should add a caveat that completion of the comprehensive assessment should be dependent upon the patient\'s condition. Response: Completing the comprehensive assessment is an integral step in hospice care. The information gathered in the comprehensive assessment is the basis for completing the plan of care. If the information is not gathered in a timely manner, then completing the plan of care is delayed. This results in patients and families not receiving all of the services they need in order to maximize comfort and dignity and achieve the patient\'s and family\'s hospice care goals. Comprehensive assessment plays an important role in hospice care and a reasonable time is needed for its completion. The timeframes suggested by the commenters varied greatly, with some being so short as to potentially preclude hospices from conducting a truly thorough assessment and some being so long as to virtually ensure that hospices would never be required to complete comprehensive assessments for more than 30 percent of their patients. Neither extreme would successfully meet the needs of patients and hospices. In the middle are the commenters who suggested maintaining the four-day requirement, lengthening it to five days, or lengthening it to seven days. While we appreciate the support from commenters who agreed with the proposed four-day timeframe, we agree with those commenters who suggested that a longer timeframe would be more appropriate due to the scheduling demands of hospice providers. We have lengthened the timeframe from four days to five days. Allowing hospices another day to complete the comprehensive assessment will allow more time to schedule the necessary contacts. While we have lengthened the timeframe, we note that it is a maximum, a length of time that should not be exceeded. The timeframe should not be misinterpreted to prevent hospices from completing the comprehensive assessment earlier than five days after the patient or representative elects the hospice benefit. Indeed, we encourage hospices to complete comprehensive assessments in less than five days if at all possible. This is particularly true for patients who enter hospice in crisis. While the initial assessment will provide the necessary information to begin the plan of care for these critical patients, it is the comprehensive assessment that will fill in important pieces of information to be used to maximize the patient and family\'s physical, emotional and spiritual comfort. While we recognize that a portion of patients enter hospice at the end stage of the disease process and may die in less than five days after electing the hospice benefit, their physical condition does not necessarily absolve hospices of the responsibility to comprehensively assess these patients. The hospice is still responsible for taking all appropriate steps to complete the comprehensive assessment as that assessment is tailored to the patient\'s areas of need. The ability of hospices to tailor the exact content of the comprehensive assessment, and the individuals who complete it, to the needs of patient and families addresses concerns about extremely short stay patients who may not be contacted by all disciplines before death. We do not expect or require designated disciplines to complete assessments if those assessments are not indicated as being necessary during the initial assessment and any subsequent contacts. Comment: A few commenters suggested that we eliminate certain areas from the comprehensive assessment. In particular, commenters suggested that we eliminate the requirement that hospices assess spiritual or potential bereavement issues as part of the comprehensive assessment. Commenters noted that eliminating either of these areas from the comprehensive assessment would make it easier to complete the comprehensive assessment within the required timeframe. The commenters acknowledged that these areas would still need to be assessed, and stated that completing the assessments by the time of the first IDG meeting would be sufficient. Response: As discussed above, we agree that fully assessing all areas may require more than the four days we initially proposed for this process. For this reason, we have extended the timeframe from four days to five days. We believe that this appr