We estimate that for all 2,872 hospices, 1 hour per hospice will be required to comply with the documentation of the domains and measures, 91 hours per hospice for data entry and 48 hours to aggregate the data. The commenters suggested that hospices be required to assure that the staff of the SNF/NF or ICF/MR has received the required training, rather than requiring each hospice to provide the training. Under 418.104(d), Retention of records, we proposed to ensure protection of patient information by adding a new requirement that patient records be retained for five years after the death or discharge of the patient, unless State law stipulated a longer period of time. We expect that a hospice administrator will investigate alleged patient rights violations. This section describes the general content areas of each patient's plan of care. Comment: One commenter requested that we add language that states that general inpatient care and respite care are coordinated by the hospice in a Medicare or Medicaid facility. This standard would also require hospices to ensure that patients and families received appropriate education and training that would enhance the implementation of the plan of care. Response: The home health regulations at 42 CFR part 484 do not define the term licensed professionals; therefore we cannot incorporate this suggestion into the final rule. We will work with the hospice and long term care industries to address any situations that may occur during the intervening time period. A hospice may not discontinue or reduce care provided to a Medicare or Medicaid beneficiary because of the beneficiary's inability to pay for that care. Hospices are seeking to use drugs more effectively and efficiently to improve patient outcomes and reduce costs. A person who is licensed, registered or certified as a physical therapist assistant, if applicable, by the State in which practicing, unless licensure does not apply and meets one of the following requirements: (i) Graduated from a physical therapist assistant curriculum approved by the Commission on Accreditation in Physical Therapy Education of the American Physical Therapy Association; or if educated outside the United States or trained in the United States military, graduated from an education program determined to be substantially equivalent to physical therapist assistant entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified at 8 CFR 212.15(e); and. Response: We agree that further clarification is warranted in this standard. This proposed provision would apply to the hospice as an entity, as well as to any personnel furnishing services to hospice patients. The data elements for each patient must be used in individual patient care planning and in the coordination of services, and must be used in the aggregate for the hospice's quality assessment and performance improvement program. Commenters stated that medical directors may not be the individuals who are most qualified to direct QAPI programs. As defined in 5 CFR 1320.3(b)(2), documenting an investigation and reporting the investigation to the appropriate State authority is a usual and customary business practice. This section also provides for coverage of homemaker services. The average hospice in this group received $571,945 from Medicare for routine home care days under the 2005 rates. Additionally, we believe that the new standards (for example, development of hospice-wide policies and procedures, patient and family education) will help hospices create partnerships with patients and families to ensure that controlled drugs are used and disposed of in a safe manner. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. Establishing a contract with another provider to coordinate patient care is standard practice and does not pose a burden to a hospice that chooses to care for patients in these settings. (a) Standard: Notice of Rights. 48 FR 56026, Dec. 16, 1983, unless otherwise noted. Response: We agree that the phrase end of life support systems is vague, and we have removed it in the opening paragraph and standard (a) because it is duplicative of the requirement that a hospice's QAPI program must involve all hospice services, including those services furnished under contract or arrangement. We also appreciate the suggestions to help clarify the role of the bereavement assessment within the comprehensive assessment. If more specific information is made available at a future time, we will reconsider this suggestion. (iv) Any other documentation that will assist in post-discharge continuity of care or that is requested by the attending physician or receiving facility. Revised 418.58(e) by adding a requirement that the governing body annually evaluates the hospice's QAPI program. Hospices need to choose a form or tool that gathers thorough information about the patient's physical, psychosocial, emotional and spiritual status related to the terminal illness and related conditions. Response: As noted above, this waiver language, like the nursing waiver option at proposed 418.66, is statutory. 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. Deleted the term other facilities throughout this section. However, the requirements contained in many provisions are already standard medical or business practices. We also revised 418.64(d)(1)(iv) by changing provided to offered.. Requiring such certification for all hospice aides nationwide would likely result in a shortage of qualified aides, which would negatively impact patient care and outcomes. We believe this requirement and the associated burden is exempt from the PRA under 5 CFR 1320.3(c)(4). This standard proposed that this information would be provided to patients before care was furnished. Comment: A commenter suggested that, when hospices are caring for residents of long term care facilities, the long term care facility medical director should be the individual responsible for designating the members of the IDG to care for the patient. Providing a copy of physician orders to the SNF/NF or ICF/MR allows the staff of the facility to implement any portions of the order for which they may be responsible. Deleted 418.110(d)(4) and 418.110(d)(5), the phase-in provisions requiring hospices to comply with certain emergency lighting and door latching requirements as of March 13, 2006. A hospice is required to investigate and document all allegations of abuse, unexplained injuries, and misappropriations of patient property involving hospice employees and contractors. The requirements for obtaining a nursing services waiver as provided by section 1861(dd)(5) of the Act is currently set forth in 418.83, and remained virtually unchanged in the proposed rule. We recognize that it may be cost-prohibitive for a hospice to employ a nurse that possesses very highly specialized skills when he or she may only care for a few patients a year. Comment: One commenter asked for clarification of whether or not a freestanding hospice inpatient facility operated by a Medicare-certified hospice would qualify as a participating Medicare or Medicaid facility. To restrict bereavement counseling to a select few would discourage hospices from providing this service, thus harming the bereaved and the larger community. Corresponding the update timeframe length to the benefit period length would help hospices avoid completing separate assessments for the routine comprehensive assessment update and the update to re-certify that the patient is terminally ill. Two separate assessments within a few days of each other would be overwhelming for the patient and burdensome for the hospice. 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. However, we do not believe that the supervision requirements for nurse aides in long term care facilities meet the needs of hospices, whose hospice aides furnish care in the community rather than in a self-contained facility. For purposes of this section, we have assessed the impact of all provisions that may present a burden to a hospice. A qualified homemaker is, (1) An individual who meets the standards in 418.202(g) and has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness; or. (6) The interdisciplinary group's documentation of the patient's or representative's level of understanding, involvement, and agreement with the plan of care, in accordance with the hospice's own policies, in the clinical record. Furthermore, CMS plans to sponsor work that will develop a method for QIOs to actively assist interested hospices in developing and implementing QAPI programs. Revised 418.106(d) is divided into two elements, one for patients receiving care in their home and another for patients receiving care in a hospice inpatient facility. In addition, some hospices may choose to conduct more extensive background checks that may cost more. In this way, the patient's assessment and plan of care are both updated to provide accurate and timely information to all disciplines providing services to the patient, and the hospice complies with our requirements to update both the comprehensive assessment and the plan of care. This section permits the use of another type of counselor instead of, or in addition to, the pastoral counselor. If a patient has an attending physician who is actively involved in his or her care, then the hospice is required to consult the attending physician in developing and updating the patient's hospice plan of care. Replaced the term nurse practitioner with registered nurse in 418.64(b)(2). Since the assessment and recertification timeframes are now coordinated, we agree that it is appropriate to delete the recertification assessment requirement. (c) Standard: Protection of information. Other commenters stated that it would be difficult for a hospice physician to get to the inpatient facility in time to complete the one-hour visit and evaluation of a patient in seclusion or restraint. Response: We agree that these are important patient rights that should be included in this final rule. Comment: A few commenters expressed support for separating the initial assessment from the comprehensive assessment. Before sharing sensitive information, make sure youre on a federal government site. (2) The hospice must maintain documentation that demonstrates the requirements of this standard are met. If the attending physician is unable to fulfill his or her duties, then the hospice physicians are responsible for fulfilling the attending physician's duties in his or her absence in accordance with 418.64(a)(3) of the final rule. In addition to meeting the conditions of participation at 418.10 through 418.116, a hospice that provides hospice care to residents of a SNF/NF, ICF/MR, or other residential facility must abide by the following additional standards, Resident eligibility election, and duration of benefits. Furthermore, we agree that the two-patient-per-room waiver for existing facilities should remain. The homemaker would be required to report all concerns about the patient or family to the member of the IDG who was coordinating the homemaker services. (a) Standard: Managing drugs and biologicals. The burden associated with this requirement is the time and effort associated with educating and training the patient and patient caregiver(s). This section also requires a hospice that provides inpatient care directly in its own facility to provide pharmacy services under the direction of a qualified licensed pharmacist who is an employee of, or under contract with, the hospice. We proposed to add a new standard to address the issue of multiple service locations. Should a seclusion or restraint-related death occur, our intent is to ensure that hospices fully investigate the death and notify CMS of the death and the investigation findings. Other commenters asked for a delay in the proposed requirement that hospices must collect and analyze adverse event data. Comment: Numerous commenters expressed concern regarding the proposed requirement at 418.102(c) that the medical director or physician designee and the other members of the IDG have joint responsibility for coordinating the patient's medical care in its entirety. Patients who receive care and services from a hospice multiple location must receive the full range of services that are documented in the plan of care. (2) Is consistent with patient and family needs and goals, with patient needs and goals as priority. We do not believe that it is necessary to include the suggested language because the options mentioned above are already available to hospices. In proposed standard (c), Content of the plan of care, we would require hospices to develop a plan of care based on the problems identified in the patient's assessments. Some commenters wanted to know if this requirement was the same as proposed 418.64, Core Services. If so, the commenters suggested that it should be deleted because it is duplicative and unnecessary. (vii) Recognizing emergencies and the knowledge of emergency procedures and their application. (d) Standard: Retention of records. We believe that these requirements would ensure effective communication between the hospice and the facility. This rule finalizes 418.116, Compliance with Federal, State and local laws and regulations related to the health and safety of patients, which requires hospices to comply with State elder abuse reporting requirements. A significant change in the patient's condition must be documented and the assessment must then be updated to reflect the patient's revised status. Other commenters believed that, in extraordinary circumstances, hospices should be allowed to contract with non-hospice agencies in addition to contracting with other Medicare-certified hospice agencies, as we proposed. If a patient is receiving care in an inpatient facility operated by the hospice, then drugs may only be administered to the patient by a designated list of individuals working in the inpatient facility. (f) Standard: Retrieval of clinical records. In addition, the largest hospice industry group, the National Hospice and Palliative Care Organization, has launched a major quality initiative to provide hospices with the tools they need to begin collecting and analyzing QAPI data and to develop, implement, and analyze performance improvement projects. Revised 418.112(g) (redesignated as 418.112(e)) to clarify the hospice's patient care coordination responsibility. Other commenters urged CMS to streamline and simplify the process. This does not mean that the hospice does not assess the patient's pain between the initial pain assessment and the 48 hour pain assessment. Windows in atrium walls are considered outside windows for the purposes of this requirement. (k) Standard: Sanitary environment. Physician certification of terminal illness as required in 418.22(c) and described in proposed 418.102(a) and (b) (now (b) and (c) in the final rule). Section 418.76(k)(3) states that homemakers must report all concerns about the patient or family to the member of the IDG who is coordinating the homemaker's services. In addition, commenters expressed uncertainty about how national benchmarks may be used to measure patient outcomes. Response: Section 1861(dd)(2)(A)(ii)(I) of the Act requires hospices to routinely provide substantially all core services, including counseling services to care for the terminally ill patient and to assist the patient in adjusting to his or her condition. Use the navigation links in the gray bar above to view the table of contents that this content belongs to. An improperly or inadequately maintained piece of DME is neither safe nor effective. Based on discussions with the leading hospice pharmacy benefit management company, for approximately this same price ($12-18 per patient day), a hospice may contract with a pharmacy benefit management company to provide all drugs and biologicals for its patients. 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. 73 FR 32204, June 5, 2008, unless otherwise noted. 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. (15) When restraint or seclusion is used, there must be documentation in the patient's clinical record of the following: (i) The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior; (ii) A description of the patient's behavior and the intervention used; (iii) Alternatives or other less restrictive interventions attempted (as applicable); (iv) The patient's condition or symptom(s) that warranted the use of the restraint or seclusion; and the patient's response to the intervention(s) used, including the rationale for continued use of the intervention. 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. In another effort, the Health Information Technology Standards Panel (HITSP) has identified widely accepted, consensus-based HIT standards to enable and support the development and use of interoperable HIT products in several healthcare domains. We believe active participation would lead to better quality care and patient outcomes. When the medical director is not available, a physician designated by the medical director assumes the same responsibilities and obligations as the medical director. Commenters asked us to clarify the relationship between the requirements for equipment failures and the requirements of the Safe Medical Devices Act of 1990 (Pub. (b) Standard: Laboratory services. To clarify, we are requiring hospices to update those sections of the comprehensive assessment that require updating. Without these individual pieces of information gathered during the assessments, the hospice does not have the information it needs to make effective judgments of its quality and to make appropriate performance improvement project decisions. In addition, we replaced the phrase for which there is evidence that improvement in those indicators will improve palliative outcomes with the phrase related to improved palliative outcomes.. Response: Drugs have long played a prevalent role in hospice care. (1) The hospice must designate an interdisciplinary group or groups composed of individuals who work together to meet the physical, medical, social, emotional, and spiritual needs of the hospice patients and families facing terminal illness and bereavement. Comment: A few commenters asked us to specify which disciplines and providers within those disciplines must complete the comprehensive assessment. Response: We agree that this clarification would be helpful, and we have made the suggested change. Bereavement counseling, Clinical note, Employee, Hospice care, Licensed professional, Restraint, Seclusion, Attending physician, Cap period, Drug restraint, Physical restraint, Progress note, Terminally ill, The hospice must provide the patient or representative with verbal and written notice of the patient's rights and responsibilities in a language and manner that the patient understands during the initial evaluation visit in advance of furnishing care, The hospice must inform the patient and family of the hospice's drug policies and procedures, including the policies and procedures regarding the tracking and disposing of controlled substances, The hospice must maintain documentation showing that it has complied with the requirements of this section and that the patient or representative has demonstrated an understanding of these rights, The hospice mustEnsure that all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property are reported to State and local bodies having jurisdiction (including to the State survey and certification agency) within at least 5 working days of the incident, and immediately to the hospice administrator. We estimate there are approximately 2,872 hospices with average admissions of approximately 303 patients per hospice (based on the number of patients in 2005 divided by the number of hospices in 2005). and. (3) If a state court has not adjudged a patient incompetent, any legal representative designated by the patient in accordance with state law may exercise the patient's rights to the extent allowed by state law. However, it is not appropriate to allow the family or primary care giver of a patient to administer medications in an inpatient facility. Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. On the other end of the spectrum some providers do not have any quality program. These patients, the commenters contended, should not be compelled to accept the involvement, even if that involvement is only through the spiritual counselor's participation in the IDG meetings. The use of the written agreements between facilities is a usual and customary business practice. Clear communication between the hospice and the SNF/NF or ICF/MR will help hospices ensure that they are meeting their responsibility to furnish the care necessary to meet the needs of its patients. (2) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc., (NBCOT). We believe that this impact will be offset by a decreased level of hospice liability. Secs. (a) Standard: Managing drugs and biologicals. We believe that this requirement is sufficient to ensure that QAPI programs benefit from the expertise of medical directors. The hospice would be required to promptly investigate, correct, and report to appropriate State and local bodies with jurisdiction all breaches of safety. The individual only needs to demonstrate competency in the services the individual is required to furnish, Homemaker qualifications. Redesignated 418.112(e) as 418.112(c), deleted some provisions, clarified other provisions, and incorporated new provisions regarding the written agreement between a hospice and a SNF/NF or ICF/MR. We believe this is a usual and customary business practice and is thereby exempt from the PRA under 5 CFR 1320.3(b)(2). 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.. (2) A hospice aide provides services that are: (i) Ordered by the interdisciplinary group. The goal of the program is to protect patients, families, visitors, and hospice staff by preventing and controlling infectious and communicable diseases. (b) Personnel qualifications for certain disciplines. As defined in 5 CFR 1320.3(b)(2), providing proper instruction on the use of durable medical equipment to patient, family members, and caregivers is a usual and customary business practice. Nothing in this requirement prohibits hospices from using certified chaplains as the IDG member to fulfill this role. (c) Standard: Content of the comprehensive assessment. We expect hospices that use the services of a nurse staffing agency to ensure that the nurses provided by such agency are qualified to furnish nursing care to hospice patients. In addition to using quality measure data on a patient level, a hospice must gather the patient-level data and other data. It is not appropriate to substitute an initial contact for an initial assessment. Response: A hospice would need to consult with willing attending physicians in accordance with its own policies and procedures. The provisions of standard (f) come directly from Section 1891(a)(3) of the Act. If a hospice wishes to receive a 1 year extension, it must submit a request to CMS prior to the expiration of the waiver period and certify that conditions under which it originally requested the waiver have not changed since the initial waiver was granted, Home health aide and homemaker services: All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. Transitions from one care setting/provider to a hospice, or from a hospice to another care setting/provider, are an opportunity for hospices to improve their relationships with their referral sources while improving patient care and safety. In place of these prescriptive requirements, we proposed that a hospice should focus on meeting the individual patient's nutritional and plan of care needs. (iii) The patient's latest physician orders. 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. However, 100 percent success is not always guaranteed. Section 418.54(c) sets out the content of the assessment. Comment: A single commenter suggested that patients should be required to demonstrate their willingness to comply with the plan of care. Comment: A few commenters suggested that we should require a bereavement counselor as a member of the IDG. With respect to counseling immediate family members, current practice in many hospices is expanding this activity. The hospice would be required to take steps to prevent equipment failures, and correct and report any equipment failures promptly. Therefore, we are not incorporating this suggestion. Once those two extensions expired, the hospice would have been required to submit another original waiver request. We believe that prescribing specific data measures and improvement projects is not appropriate at this time because there is no currently available, valid, reliable, widely applied set of clinical and/or administrative quality measures. (5) Occupational therapist. (4) A hospice aide is not considered competent in any task for which he or she is evaluated as unsatisfactory. Comment: One commenter requested that we amend the language at 418.104(e) so that it does not apply to patients discharged as a result of their death. Comment: Several commenters supported the proposed requirement that, if a State offers licensure for any discipline, including social workers, the individuals practicing within that discipline must obtain State licensure. Therefore, we are adopting the provisions as proposed. 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 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. for better understanding how a document is structured but Response: We strongly agree. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. (iii) Make all reasonable efforts to facilitate visits by local clergy, pastoral counselors, or other individuals who can support the patient's spiritual needs to the best of its ability. We do not believe that the coordinator needs to be given a specific title in this rule. Thus, we have not included physicians in the burden associated with these requirements. Table 5.Drugs, Medical Supplies and Durable Medical Equipment Burden Assessment. Therefore, no cost savings is achieved. All services furnished by the hospice must be in accordance with the individualized plans of care. We believe it is appropriate for a hospice to consider the bereavement needs of these individuals. This situation is already addressed through separate waiver authority in section 1135 of the Act. According to the CMS 2005 national expenditure data, Medicare paid $8.2 billion to providers for hospice care in FY 2005. Staff must be in immediate response proximity to the patient, The condition of the patient who is in a restraint or in seclusion must continually be assessed, monitored, and reevaluated by an assigned staff member, All staff who have direct patient contact must have ongoing education and training in the proper and safe use of seclusion and restraint application and techniques and alternative methods for handling behavior, symptoms, and situations that traditionally have been treated through the use of restraints or seclusion, The hospice must report to the CMS regional office any death that occurs while the patient is restrained or in seclusion, within 24 hours after a patient has been removed from restraint or seclusion, Hospices that provide hospice care to residents of a SNF/NF, ICF/MR, or other facilities. As such, it is standard practice and does not pose a burden. The requirements for nursing services for respite care are now at 418.108(b)(2). Except as specified in paragraph (c) of this section, all professionals who furnish services directly, under an individual contract, or under arrangements with a hospice, must be legally authorized (licensed, certified or registered) to practice by the State in which he or she performs such functions or actions, and must act only within the scope of his or her State license, or State certification, or registration.

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