CoPs/IGs: The Rules We Live By

CoPs/IGs: The Rules We Live By
Anne Koepsell, RN, BSN, MHA, CLNC Executive Director WA State Hospice & Palliative Care Org.

Course Objectives Learner will be able to:
Identify the components of certification/recertification. Identify the elements of the Comprehensive Assessment. Describe how the IDT care planning process improves patient care. Describe the cycle of care process. Restate the role of the Medical Director.

Focus of CoPs Patient centered Emphasizes quality improvement
Emphasizes patient outcomes Non-prescriptive, organization policy determines process Patient Centered The patient and family are members of the interdisciplinary team. A framework is set up that allows patient outcomes of care to drive improvements in care. Process requirements are updated where necessary to protect patient safety. Set clear expectations for accountability Stimulate improvements in processes, outcomes of care, and beneficiary satisfaction

Components of Rule List of Subjects/Authority
Subpart A. General Provision and Definitions Subpart B. Eligibility, Election and Duration of Benefits Applies to Medicare patients only Subpart C. Patient Care Applies to all patients served Subpart D. Organizational Environment Subpart B – applies to Medicare patients only Subpart C & D – apply to all patients served

State Operations Manual
Part I – Investigative Procedures Read thoroughly Review regularly Will guide you through survey experience Defines what surveyors will be looking for Part II – Interpretive Guidelines Subpart C. Patient Care Subpart D. Organizational Environment Subpart B – applies to Medicare patients only Subpart C & D – apply to all patients served

SUBPART A: General Provisions
Section Definitions Always review definitions and refer back to them when reading a condition or standard 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. Preamble information: CMS response to comments: 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 § 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.

Section 418.3 Definitions – cont
Clinical note: 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. Preamble information: Numerous commenters indicated that the proposed definitions for the terms ‘‘clinical note’’ and ‘‘progress note’’ were either unnecessary or redundant. 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 § 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.

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

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

Licensed professional: Licensed professional means a person licensed to provide patient care services by the State in which services are delivered. No list of examples because CMS felt it was unnecessary and may be confusing. States vary in titles and licensure requirements Must be familiar with state requirements Preamble highlights: (CMS) 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 § (a) and finalized at § (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.

Multiple location means a Medicare-approved location from which the hospice provides the same full range of hospice care and services that is required of the hospice issued the certification number. A multiple location must meet all of the conditions of participation applicable to hospices. Preamble highlights: 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 § 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 § to the paragraph addressing multiple locations at § (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.

Restraint (1) 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); or (2) A drug or medication when it is used as a restriction 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. Preamble highlights: At § 418.3, we (CMS) 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.

Seclusion: Seclusion means the involuntary confinement of a patient alone in a room or an area from which the patient is physically prevented from leaving. Preamble highlights: Comment: Several commenters noted that the proposed definition of the term ‘‘seclusion’’ implies that any placement of patients in private rooms would constitute seclusion. CMS Response: While it was not our intent, we agree that the proposed definition of ‘‘seclusion’’ could embrace private rooms. Therefore, at § 418.3, we have revised the definition of ‘‘seclusion’’ by adding the term ‘‘involuntary.’’ 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).

Section 418.3 Definitions Comprehensive assessment:
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. Preamble – “Basis for completing the Plan of Care”

Section 418.3 Definitions Dietary counseling:
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.

Section 418.3 Definitions 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. Preamble – “gathering critical information necessary to meet immediate needs.”

Section 418.3 Definitions 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.

SUBPART B: Eligibility, election and duration of benefits
Eligibility requirements Duration of hospice care coverage – Election periods Certification of terminal illness Election of hospice care

Section 418.20 & 418.21 418.20 – Eligibility requirements
Entitled to Medicare Part A Certified as Terminally Ill in accordance with – Election periods Initial 90-day period Subsequent 90-day period Unlimited number of subsequent 60-day periods

Section 418.22 Certification of Terminal Illness
(a) Timing Written certification for each of the periods in Must be obtained before submitting claim Exceptions: If not obtained within 2 calendar days after period begins, must obtain oral certification within 2 days and written prior to submitting claim Certs/Recerts may be completed no more than 15 days prior to effective date of election or start of subsequent period

Section 418.22 Certification of Terminal Illness – cont.
(a) Timing – cont. Face-to-Face encounter Hospice Physician or NP must have F2F with each hospice patient whose total stay across all hospice is anticipated to reach the 3rd benefit period. No more than 30 calendar days prior to recertification thereafter To gather clinical findings to determine continued eligibility for hospice care (my emphasis) Can occur on the first day of the 3rd benefit period (clarified in 2012)

(b) Content Based on the physician/medical director’s clinical judgment regarding the normal course of illness. Cert must conform to the following: Specify that the individual’s prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course Clinical information that supports the medical prognosis must accompany certification Initial certification requires two signatures – hospice medical director/physician AND attending. Recertifications only require one signature

(b) Content – cont. Brief Narrative explanation of clinical findings that supports a life expectancy of 6 months or less Can be on form or as an addendum If part of form, narrative must be immediately prior to the physician’s signature If addendum, physician must also sign immediately following the narrative. Addendum creates need for two signatures – one with certification statement and one with brief narrative addendum

(b) Content – cont. Brief Narrative explanation of clinical findings that supports a life expectancy of 6 months or less Narrative shall have statement directly above the signature attesting that physician composed narrative based upon his/her review of medical record or examination of patient. Narrative must reflect the patient’s individual clinical circumstances and cannot contain check boxes or standard language used for all patients

(b) Content – cont. Face-to-Face Encounter if entering third benefit period More than one physician can be involved. MD or NP must attest in writing that he/she had a face to face encounter with the patient, including the date of that visit. If different NP or MD performs F2F, they shall state the clinical findings were provided to MD for use in determining prognosis. Attestation, signature, and date must be a separate and distinct section of addendum or form and must be clearly titled. CMS change in position memo dated 25 Mar 2011

SUBPART C: PATIENT CARE
Conditions: Patient Rights Initial and Comprehensive Assessment Interdisciplinary Group, Care Planning, and Coordination of Services Quality Assessment and Performance Infection Control Licensed Professional Services Core Services Nursing Services Waiver

SUBPART C: PATIENT CARE – Cont.
Conditions, cont. Furnishing of non-core services PT, OT, Speech Waiver of requirement – PT, OT, Speech, Dietary Hospice Aide and Homemaker services Volunteers

Subpart C – Patient Rights
SEC : PATIENT RIGHTS While not a new rule, it is new to Hospice rules Determine how you will demonstrate compliance during a survey Train staff on reviewing as part of assessment Obtain a signature that acknowledged receipt of Notice Look at P&P on communication barriers with persons of limited English proficiency Family members should not be first choice

Patient’s rights (a) Standard: Notice of rights and responsibilities. Verbally and in writing; 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. In a language and manner that the patient understands; and make all reasonable efforts to secure a professional, objective translator for hospice-patient communications, including those involving the notice of patient rights. During the initial assessment visit in advance of furnishing care. Preamble highlights: CMS rationale for final rule: 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. 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. Written and verbal translation exceptions: 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.

418.52 Patient’s rights Interpretive Guidelines (IG)
Pt refers to patient or patient representative Family members can serve as interpreters only when an objective translator cannot be obtained or the patient requests it. Procedures and Probes (PP) Ask for copies of material Ask patients if, who and when informed

Patient’s rights (a) Standard: Notice of rights and responsibilities. Advance directives ‘‘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.’’ Interpretive Guidelines (IG) Admission does not require an advance directive Policies and Procedures Procedures and Probes (PP) Review clinical record for evidence

Patient’s rights (b) Standard: Exercise of rights and respect for property and person. Patients have the right to: exercise their rights, be treated with respect, voice grievances, and be protected from discrimination or reprisal for exercising their rights Process for dealing with alleged violations: Report violations to hospice administrator Investigate violations & complaints Take corrective action if violation is verified Report verified significant violations within 5 working days of becoming aware of incident

418.52 Patient’s rights Interpretive Guidelines (IG)
Definitions of various types of abuse Procedures and Probes (PP) Review admission information for instructions on making a compliant Review prior 12 months documentation of complaints – how received, investigated, resolved Ask patient if they know how to make a complaint and treatment Determine if staff can ID various forms of abuse and if they know how to report Preamble highlights: 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 applies to incidences of alleged violations. ________________________________________________________________________ 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. 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. 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. 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.

418.52 Patient’s rights (c) Standard: Rights of the patient
Pain management and symptom control. Interpretive Guidelines Patients should not have to experience long waits for pain and symptom management, medication, interventions Hospice should have methods to assure 24 hours/7 days response in all settings and where ever pt resides Procedures and Probes Ask to describe policies Determine how hospice assures timely response Ask patients how quickly hospice responds Preamble highlights: All hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We have revised this standard and clarified this point at § (c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR and 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 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. 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 (c)(7), which requires hospices to provide this general benefit information. 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 § (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.

Be involved in developing plan of care. Probes Ask staff how they facilitate pt/family involvement Ask patient/family if they are involved. Refuse care or treatment. Interpretive Guidelines Probes further if particular trend is identified, i.e. a majority of patients is refusing a particular service, to assure that hospice is fully prepared to provide the service with qualified personnel. Preamble highlights: All hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We have revised this standard and clarified this point at § (c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR and 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 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. 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 (c)(7), which requires hospices to provide this general benefit information. 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 § (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.

Choose attending physician. Interpretive Guidelines Pts have right to choose physician and have this person involved in their medical care in all settings Probes Is there evidence that the hospice does not allow the patient to choose their physician? Preamble highlights: All hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We have revised this standard and clarified this point at § (c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR and 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 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. 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 (c)(7), which requires hospices to provide this general benefit information. 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 § (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.

Confidential clinical record/ HIPAA. Interpretive Guidelines Safeguarding content, paper and electronic, from unauthorized disclosure without consent Observe whether staff shows evidence of protecting confidentiality Is patient information posted in public places Are clinical records accessible for reading or removing? Preamble highlights: All hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We have revised this standard and clarified this point at § (c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR and 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 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. 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 (c)(7), which requires hospices to provide this general benefit information. 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 § (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.

Be free of abuse, neglect, mistreatment Interpretive Guidelines If issue identified during survey, investigate and report Ensure that the hospice addresses the incident immediately Preamble highlights: All hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We have revised this standard and clarified this point at § (c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR and 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 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. 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 (c)(7), which requires hospices to provide this general benefit information. 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 § (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.

Receive information about hospice benefit. Interpretive Guidelines Fully inform on covered services (Medicare and non-Medicare) Procedures and Probes Is pt/family aware of all covered services? Has hospice described any services for which pt might have to pay? Consider pts ability to understand and retain information Preamble highlights: All hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We have revised this standard and clarified this point at § (c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR and 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 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. 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 (c)(7), which requires hospices to provide this general benefit information. 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 § (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.

Receive information about scope and limitations of hospice services. Procedures and Probes Ask pt/family what services they are receiving Are they aware of any limitations to those services Hospices are required to provide all services necessary for palliation and management of terminal illness and should not accept a patient if they cannot provide all services. Preamble highlights: All hospice employees and contractors should be patient rights advocates with the best interest of the patients in mind at all times. We have revised this standard and clarified this point at § (c)(1). The continuous home care level of care described in the payment and coverage sections at 42 CFR and 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 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. 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 (c)(7), which requires hospices to provide this general benefit information. 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 § (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.

418.54 Initial/Comprehensive assessment
Conduct and document in writing patient-specific comprehensive assessment and pts need for physical, psychosocial, emotional and spiritual care The comprehensive assessment is not a single static document, a symptom and severity checklist, or a set of generic questions that all patients are asked. It is a dynamic process that needs to be documented in an accurate and consistent manner for all patients. Hospice P&Ps will serve to guide decisions about who assesses patient/family needs and how Preamble highlights: A nurse is not qualified to provide detailed assessments in all of these areas; therefore we cannot place the burden of completing the comprehensive assessment on the nurse alone. The broad nature of the comprehensive assessment requires the active involvement of all of the members of the IDG in order to ensure that a complete and accurate picture of the patient and family is obtained. The active involvement can occur in any number of ways depending on the patient’s needs and preferences. Some families may need a face-to-face visit from a social worker to help them sort through myriad insurance papers or simply provide a supportive presence, while other families may find it easier to discuss difficult issues by phone. If families need or prefer in person visits, then those needs should be met. If they prefer the limited anonymity afforded by the telephone, then their preference should be accommodated.

(a) Standard: Initial assessment. Completed by RN Election can be another IDG member Must occur within 48 hours after election of hospice care Need staffing to address needs that require a shorter than 48 hours assessment and weekends/holidays This is an initial overall assessment of the patient/family needs If there are significant issues in one area, then it is recommended that the specialty IDG member complete the comprehensive assessment Preamble highlights: Best case scenario example: significant psychosocial issues assessed during initial assessment; SW makes a visit to complete the comprehensive assessment. 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 § (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. 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. 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. 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; The requirement has been clarified to read, ‘‘The hospice registered nurse must complete an initial assessment within 48 hours.

(a) Standard: Initial assessment – cont. Initial contact cannot be substituted for initial assessment Cannot wait until comprehensive assessment is complete to formulate Plan of Care and provide services Initial assessment guides decisions about who comprehensively assesses patient/family needs Document the IDG formulation of the POC based upon initial assessment 48 hours unless patient or physician requests an expedited initial assessment (less than 48 hours) If patient requests longer than 48 hours, delay election to timeframe patient requests This is not the ‘meet and greet’ visit – they can happen sequentially, but are separate events

(a) Standard: Initial assessment – cont. Interpretive Guidelines Purpose is to gather critical information necessary to treat immediate care needs In the location where the hospice services are being delivered Not a ‘meet and greet’ visit RN must conduct, other IDTS can be involved Procedures and Probes Determine through interview, observation and record review if immediate care needs met Did RN complete initial assessment?

(b) Standard: Time frame for completion of the comprehensive assessment. Completed by the hospice IDG in consultation with the attending physician. Attending not required to sign, but they do need to be involved – how to document Completed within 5 calendar days after the patient elects hospice care, based upon patient needs. – IN TOP 10 DEFIENCIES FOR THE LAST 3 YEARS Ensure imminently dying patients receive appropriate and timely assessments despite their short length of stay Highlights from preamble: the requirement that hospices consult with the patient’s attending physician when completing the comprehensive assessment is maintained. 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. 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. We (CMS) 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. May die in less than 5 days, it does not absolve hospices of the responsibility to comprehensively assess these patients. Still responsible for taking all appropriate steps to complete the CA as that assessment is tailored to the patient’s needs. We do not expect or require designated disciplines to complete assessments if those assessments are not indicated.

b) Standard: Time frame for completion of the comprehensive assessment. All members of the IDG do not necessarily need to visit the patient/family to complete the comprehensive assessment. Comprehensive assessment is about assessing WHAT the patient needs, not all about WHO completes the assessment. CMS does not dictate how the comprehensive assessment is completed Preamble – The CA is not a single static document, a symptom or severity checklist, or a set of generic questions that all patients are asked. It is a dynamic process that needs to be documented in an accurate and consistent manner for all patients. While the CA often begins with a nursing assessment that is focused on the physical status, ..the broad nature of the comprehensive assessment requires the active involvement of all of the members of the IDG in order to ensure that a complete and accurate picture of the patient and family is obtained.

b) Standard: Time frame for completion of the comprehensive assessment. Interpretive Guidelines If no attending, hospice physician must assume role If attending, must be consulted Consultation occurs through phone calls, fax, s, text messages, etc.) Attending often has history and family dynamics Election may be signed with a later date, but not earlier May be completed earlier than 5 days Preamble – The CA is not a single static document, a symptom or severity checklist, or a set of generic questions that all patients are asked. It is a dynamic process that needs to be documented in an accurate and consistent manner for all patients. While the CA often begins with a nursing assessment that is focused on the physical status, ..the broad nature of the comprehensive assessment requires the active involvement of all of the members of the IDG in order to ensure that a complete and accurate picture of the patient and family is obtained.

Election of hospice Patient/ representative signs form Initial assessment RN completes Within 48 hours of election of hospice Comprehensive assessment All needs of patient/ family Completed within 5 days of election of hospice Update comprehensive assessment Updates identified needs of patient/family Every 15 days of as necessary Preamble highlights: First, hospices will obtain a signed election statement in accordance with § Next, the hospice registered nurse must complete an initial assessment of the patient’s physical, psychosocial and emotional status related to the terminal illness and related conditions in order to evaluate the patient’s immediate care and support needs within 48 hours of completing the election form. This assessment need not go into great detail in each of these areas. Rather, it needs to gather key information, as identified in the hospices policies and procedures, about the patient that will enable the hospice IDG accurately to determine

c) Standard: Content of the comprehensive assessment. Physical, Psychosocial, Emotional, Spiritual needs related to the terminal illness and related conditions Ensure that assessment and POC address actual as well as potential problems Interpretive Guidelines Identifies minimum symptoms to be assessed Pain, dyspnea, N&V, constipation, restlessness, anxiety, sleep disorders, skin integrity, confusion, emotional distress, spiritual needs, support systems, need for counseling/education Identifies components of comprehensive pain assessment History, characteristics, physical exam, current meds, goals Information gathered in CA is the basis for completing the plan of care.

c) Standard: Content of the comprehensive assessment Must take into consideration the following 8 factors: 1) Nature and condition causing admission 2) Complications and risk factors that affect care planning 3) Functional Status including the patient’s ability to understand and participate in his/her own care (structure, function, activity) 4) Imminence of death as evidenced by…. Preamble highlights: Complications and risk factors – caregiver and family willingness and ability to care for patient Functional status: We (CMS) have added a new element at § (c)(3) that requires hospices to assess the patient’s ‘‘ functional status, including the patient’s ability to understand and participate n his or her own care.’’ We agree that the functional status of the patient, both physically and mentally, impacts the patient’s ability to participate in his or her own care and the hospice’s ability to furnish that care. Furthermore, we agree that this information should be collected as part of the comprehensive assessment. Imminence of death: The imminence of a patient’s death will often drive the type and frequency of services provided to a patient. Identifying the imminence of death as part of the comprehensive assessment will allow hospices to more accurately tailor the plan of care to the patient’s status. We are adding this element as new § (c)(4).

c) Standard: Content of the comprehensive assessment 5) Severity of symptoms Use rating scales for consistency Document pt’s self-identified threshold (SIT score) All IDG members need to ask and report symptoms at every visit Procedures and Probes Ask staff how they complete comprehensive assessment Evidence in clinical record? Symptom severity: The severity of a patient’s symptoms is an important aspect of the comprehensive assessment that should be assessed for all patients, and we have added this requirement as new § (c)(5). Gathering accurate information about symptom severity will allow hospices to make more accurate care planning decisions. We (CMS) are not prescribing how hospices must assess symptom severity. Drug profile: The purpose of the drug profile assessment is to gather the information necessary to enable the hospice to make appropriate care decisions, and it is the role of the individual completing this portion of the assessment to collect this information. Several of the commenters suggestions (1, 3 and 4) require the individual completing the drug profile portion of the assessment to draw conclusions. This thorough review must document all substances which the patient is using. While we understand that patients and families may be unwilling to disclose the use of certain substances, we expect hospices to use all available and appropriate methods to develop a complete list. These efforts may include asking the patient, family, attending physician, and any other health care providers. Efforts may also include asking to look at all medications in the home, being attentive to tell-tale odors, and looking for medication-specific equipment in the home. Hospices may choose how to document the drug profile review and the efforts made to complete it in the manner that best suits their individual needs. The phrase ‘‘effectiveness of drug therapy’’ is more inclusive and will help to capture the range of effectiveness of different drugs and therapies. The additional level of detail required by this new provision will help hospices develop a more complete overall assessment from which to make more accurate care planning decisions.

c) Standard: Content of the comprehensive assessment 6) Drug profile – includes effectiveness, side effects, interactions, duplicate drug therapy, therapy associated with clinical monitoring Interpretive Guidelines Include non pharmacological interventions Includes definitions Procedures and Probes Ask staff to describe process/policy of medication review Complete medication reconciliation on home visit and compare IN TOP 10 DEFIENCIES FOR THE LAST 3 YEARS Symptom severity: The severity of a patient’s symptoms is an important aspect of the comprehensive assessment that should be assessed for all patients, and we have added this requirement as new § (c)(5). Gathering accurate information about symptom severity will allow hospices to make more accurate care planning decisions. We (CMS) are not prescribing how hospices must assess symptom severity. Drug profile: The purpose of the drug profile assessment is to gather the information necessary to enable the hospice to make appropriate care decisions, and it is the role of the individual completing this portion of the assessment to collect this information. Several of the commenters suggestions (1, 3 and 4) require the individual completing the drug profile portion of the assessment to draw conclusions. This thorough review must document all substances which the patient is using. While we understand that patients and families may be unwilling to disclose the use of certain substances, we expect hospices to use all available and appropriate methods to develop a complete list. These efforts may include asking the patient, family, attending physician, and any other health care providers. Efforts may also include asking to look at all medications in the home, being attentive to tell-tale odors, and looking for medication-specific equipment in the home. Hospices may choose how to document the drug profile review and the efforts made to complete it in the manner that best suits their individual needs. The phrase ‘‘effectiveness of drug therapy’’ is more inclusive and will help to capture the range of effectiveness of different drugs and therapies. The additional level of detail required by this new provision will help hospices develop a more complete overall assessment from which to make more accurate care planning decisions.

c) Standard: Content of the comprehensive assessment 7) Bereavement incorporated into POC and considered in the bereavement POC Interpretive Guidelines Assess grief/loss issues through-out care Scope of assessment – history of previous losses, family problems, legal/financial concerns, communication issues, drug/alcohol abuse, health concerns, support system, mental health issues Procedures and Probes What evidence is present in assessment and POC? Bereavement: We are requiring that the information from the initial bereavement assessment be considered in the bereavement plan of care. This change still requires hospices to begin the bereavement assessment process early in the patient’s stay. Issues identified in the initial bereavement assessment such as anticipatory grief and previous experiences with loss should inform care planning decisions long before the patient dies. By requiring hospices to incorporate bereavement assessment information into the plan of care, hospices will be able to develop a more complete picture of the patient and family.

c) Standard: Content of the comprehensive assessment 8) Need for referrals For further evaluation by appropriate health professionals Related/Unrelated Procedures and Probes Ask staff how they determine need for referral Bereavement: We are requiring that the information from the initial bereavement assessment be considered in the bereavement plan of care. This change still requires hospices to begin the bereavement assessment process early in the patient’s stay. Issues identified in the initial bereavement assessment such as anticipatory grief and previous experiences with loss should inform care planning decisions long before the patient dies. By requiring hospices to incorporate bereavement assessment information into the plan of care, hospices will be able to develop a more complete picture of the patient and family.

(d) Standard: Update of the comprehensive assessment. Updated by the IDG As frequently as the patient’s condition requires At a minimum every 15 days Update those sections of the comprehensive assessment that require updating. Patient condition change - comprehensive assessment must be updated to reflect changes. Preamble highlights: We believe that establishing a standard comprehensive assessment timeframe in this rule will help those hospices ensure that their update timeframe is consistent with patient needs and standards of practice. Updating the comprehensive assessment at reasonable regular intervals ensures that hospices have the most recent information about the patient from which to make accurate care planning decisions. Updating the comprehensive assessment at least every 15 days was the proper match, as the 15-day timeframe would correspond with the 60- and 90-day Medicare Hospice Benefit election periods described in § We also note that hospices are permitted to update the assessment more frequently than every 15 days if the 15th day falls on a holiday or if day-to-day hospice operations are scheduled to be suspended for any reason on the 15th day.

(d) Standard: Update of the comprehensive assessment. Interpretive Guidelines Hospices are free to choose the method that best suits their needs when documenting the comprehensive assessment and the updates to that assessment. Assessment updates should be easily identified Only update those areas of change Identify if there are no changes Procedures and Probes Determine through interview, observation and record review evidence of IDG active involvement Preamble highlights: We believe that establishing a standard comprehensive assessment timeframe in this rule will help those hospices ensure that their update timeframe is consistent with patient needs and standards of practice. Updating the comprehensive assessment at reasonable regular intervals ensures that hospices have the most recent information about the patient from which to make accurate care planning decisions. Updating the comprehensive assessment at least every 15 days was the proper match, as the 15-day timeframe would correspond with the 60- and 90-day Medicare Hospice Benefit election periods described in § We also note that hospices are permitted to update the assessment more frequently than every 15 days if the 15th day falls on a holiday or if day-to-day hospice operations are scheduled to be suspended for any reason on the 15th day.

418.54 Initial/comprehensive assessment cycle
Change in patient status Update the comprehensive assessment Update of patient plan of care

(e) Standard: Patient outcome measures. Patient level data elements must be included in each patient assessment Data elements must be used in patient care planning and evaluation AND in the hospice’s QAPI program Data elements must be integral part of comprehensive assessment Data elements must be collected and documented in a consistent, systematic, and retrievable way. Interpretive Guidelines Data elements for patient reported outcomes on symptoms Procedures Interview key staff and have them explain Preamble highlights: These measures should help the hospice identify areas of strength and weakness in patient and family care delivery. Once the measures are identified, hospices must choose which data elements they will collect in order to measure their performance. Example: A hospice may choose to focus on pain control as one of its QAPI domains. Within the pain control domain, that hospice may choose an outcome measure that identifies the percentage of patients whose pain was controlled within 48 hours of admission to hospice. In order to measure this outcome, that hospice may choose to incorporate a data element in its initial assessment that identifies those patients who are experiencing uncontrolled pain upon admission as well as a data element in its comprehensive assessment to identify patients who experienced uncontrolled pain upon admission and had that pain controlled within 48 hours of admission. The information gathered by these data elements during the comprehensive assessment can then be collected, aggregated, and used to identify areas of strength and weakness within the hospice’s care delivery system. 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. Therefore, QAPI-related data elements must be included in the patient assessments completed by the hospice.

Documentation – SOAPIER clinical notes Subjective Objective Assessment Plan Intervention Evaluate Reassess *Weatherbee Resources, Inc.

Techniques for compliance WHAT HAS WORKED FOR YOUR HOSPICE PROGRAM?

418.56 IDG, care planning, and coordination of services
Interpretive Guidelines Physician member may be hospice medical director Nurse, social worker and counselor members must be hospice employees If hospice is sub-division of organization, must be appropriately trained and assigned to hospice Probes Ask how POC is developed by full IDG with attending Request documentation that verifies 4 L-tags in this condition were in the TOP 10 DEFICIENCES IN 2011

(a) Standard: Approach to service delivery Hospice designates an IDG who work together to meet the needs of the patient and family. IDG in entirety must supervise care and services Interpretive Guidelines Supervision may be accomplished by face-to-face, telephone, conferences, evaluations, discussions, general oversight, direct observations Procedures Ask RN Coordinator to describe developing goals, facilitating exchange of information with pt and IDG PREAMBLE HIGHLIGHTS: This section is tied to the patient rights section. The IDG is paramount in directing and monitoring the patient care and is one of the factors that make the hospice benefit unique. Final rule requires the case coordinator to be a registered nurse. A registered nurse has the necessary medical and interpersonal background to meet the demands of the coordinator position in a way that no other discipline does. The unique skills of registered nurses, who are educated to assess and manage the overall aspects of a patient’s physical and psychosocial care, can be used to oversee the coordination and implementation of the care identified by the IDG. No timeline specified – it is based upon patient needs

(a) Standard: Approach to service delivery The hospice designates a registered nurse who is member of the IDG to provide program coordination, ensure continuous assessment of each patient’s and family’s needs, and ensure the implementation and revision of the plan of care. Procedures and Probes Ask administrator to identify RN coordinators How does this person assure coordination of care with IDG? PREAMBLE HIGHLIGHTS: This section is tied to the patient rights section. The IDG is paramount in directing and monitoring the patient care and is one of the factors that make the hospice benefit unique. Final rule requires the case coordinator to be a registered nurse. A registered nurse has the necessary medical and interpersonal background to meet the demands of the coordinator position in a way that no other discipline does. The unique skills of registered nurses, who are educated to assess and manage the overall aspects of a patient’s physical and psychosocial care, can be used to oversee the coordination and implementation of the care identified by the IDG. No timeline specified – it is based upon patient needs

(a) Standard: Approach to service delivery Required members of the IDG: Doctor of medicine or osteopathy (employee/contract) Registered nurse; Social worker; and Pastoral or other counselor Interpretive Guidelines Number of individuals is not important, it is qualifications – i.e., dually licensed individuals Procedures Determine that all disciplines contribute to assessments and POC

If there is more than one IDG, the hospice must identify a specifically designated IDG to establish day-to-day policies and procedures. Interpretive Guidelines Does not need to be the same group that works together to care for patients.

(b) Plan of Care When establishing the written plan of care, IDG consults with the following: Attending physician (if any); Patient or representative; and Primary caregiver All hospice services furnished to patients and their families must follow an individualized written plan of care. Patient and primary caregiver(s) receive education and training related to their care responsibilities identified in the plan of care. MOST FREQUENT DEFICIENCY FOR LAST 3 YEARS Preamble highlights: First stage of the plan of care to be completed after the initial patient assessment has been completed. This preliminary plan of care must address the immediate care needs identified during the initial assessment. Once the comprehensive assessment is complete, the hospice must then update the plan of care to address the other care needs identified through the comprehensive assessment. We (CMS) believe that beginning and completing the first iteration of the plan of care should be based on the needs of the patient and family rather than specific timeframes. Plan of Care – Information turns into action that will result in patient comfort and dignity, self-determined life closure and any other goals that the hospice, patient and family establish.

(c) Standard: Content of the plan of care Reflects patient and family goals Includes interventions for problems identified throughout the assessment process Includes all services necessary for palliation and management of terminal illness and related conditions Individualized written POC for each patient TOP 10 DEFICIENCES FOR THE PAST 3 YEARS Preamble highlights: Hospice goals should correlate with patient goals and should use the data in the patient outcomes. Does this leave room for a non-compliant patient?? Document input from attending, pt, family, primary caregiver Document caregiver training/ responsibilities. We (CMS) expect the hospice plan of care to address all patient goals in some way. If a patient has a goal that is not related to the terminal illness and related conditions, and if the hospice does not intend to address this goal, then the hospice plan of care should identify the party that is responsible for meeting the unrelated goal. Furthermore, final § (e) requires the hospice to actively communicate with the outside party to ensure that the goal is addressed.

(c) Standard: Content of the plan of care Procedures and Probes Determine through interview, observation and record review if POC identifies all services needed Is there evidence of pt receiving medications ordered? Are POCs patient-specific? Does the POC integrate changes based upon the assessment? Is there evidence the POC was a collaborative effort? Preamble highlights: 1-5 visit ranges=not acceptable; needs to be specific & individualized The level of detail established by the hospice in the plan of care should be clear enough to provide a complete picture of which disciplines will be furnishing which services, how frequently that care will be furnished, and what needs are being addressed by such care. The plan of care serves as a primary means of communication between all hospice disciplines, the patient, the primary care giver, and the family. It must contain enough information so that all of these individuals know exactly what is supposed to be done, by whom, at what time, and for what purpose.

(c) Standard: Content of the plan of care 1. Interventions to manage pain and symptoms Interpretive Guidelines Goal is quality of life Ongoing assessment of all needs Evidence of interventions, including alternative therapies Procedures and Probes Ask staff for specific patient information Is there evidence of proactively anticipating side effects Ask pt if satisfied with level of comfort? What was response when pain escalated? Investigate when not managed Preamble highlights: 1-5 visit ranges=not acceptable; needs to be specific & individualized The level of detail established by the hospice in the plan of care should be clear enough to provide a complete picture of which disciplines will be furnishing which services, how frequently that care will be furnished, and what needs are being addressed by such care. The plan of care serves as a primary means of communication between all hospice disciplines, the patient, the primary care giver, and the family. It must contain enough information so that all of these individuals know exactly what is supposed to be done, by whom, at what time, and for what purpose.

(c) Standard: Content of the plan of care 2. Detailed statement of the scope and frequency of services to meet the patient’s and family’s needs Interpretive Guidelines May include range of visits and PRN Range must be small intervals, but 0 is not allowed IDG may exceed number in range, but documentation should support need for extra visits If requires frequent use of PRN, POC should update frequency to meet current need Standing orders must be individualized Preamble highlights: 1-5 visit ranges=not acceptable; needs to be specific & individualized The level of detail established by the hospice in the plan of care should be clear enough to provide a complete picture of which disciplines will be furnishing which services, how frequently that care will be furnished, and what needs are being addressed by such care. The plan of care serves as a primary means of communication between all hospice disciplines, the patient, the primary care giver, and the family. It must contain enough information so that all of these individuals know exactly what is supposed to be done, by whom, at what time, and for what purpose.

(c) Standard: Content of the plan of care 2. Detailed statement of the scope and frequency of services to meet the patient’s and family’s needs Procedures and Probes Ask IDG members what criteria is used to assess need, who is involved, how does IDG decide what services, how does IDG evaluate effectiveness, how monitor contracted services Ask pt/family if aware of all services included in benefit, who comes to see them, how often, what services provided, are they satisfied? Determine if any indication that pt needs services not receiving Preamble highlights: 1-5 visit ranges=not acceptable; needs to be specific & individualized The level of detail established by the hospice in the plan of care should be clear enough to provide a complete picture of which disciplines will be furnishing which services, how frequently that care will be furnished, and what needs are being addressed by such care. The plan of care serves as a primary means of communication between all hospice disciplines, the patient, the primary care giver, and the family. It must contain enough information so that all of these individuals know exactly what is supposed to be done, by whom, at what time, and for what purpose.

(c) Standard: Content of the plan of care 3. Measurable outcomes Interpretive Guidelines Outcomes should be measurable result of implementation of POC Using data elements to see if they are meeting goals Probes Are outcomes measurable and documented? Look for movement towards expected outcomes and revisions to POC Preamble highlights: 1-5 visit ranges=not acceptable; needs to be specific & individualized The level of detail established by the hospice in the plan of care should be clear enough to provide a complete picture of which disciplines will be furnishing which services, how frequently that care will be furnished, and what needs are being addressed by such care. The plan of care serves as a primary means of communication between all hospice disciplines, the patient, the primary care giver, and the family. It must contain enough information so that all of these individuals know exactly what is supposed to be done, by whom, at what time, and for what purpose.

(c) Standard: Content of the plan of care 4. Drugs and treatments Interpretive Guidelines References (c) (1) – Rights of pt to effective pain & symptom management 5. Medical supplies and appliances 6. Documentation (in the clinical record) of the patient’s or representative’s level of understanding, involvement and agreement with the plan of care IG - do not need to be present at IDG meetings Preamble highlights: 1-5 visit ranges=not acceptable; needs to be specific & individualized The level of detail established by the hospice in the plan of care should be clear enough to provide a complete picture of which disciplines will be furnishing which services, how frequently that care will be furnished, and what needs are being addressed by such care. The plan of care serves as a primary means of communication between all hospice disciplines, the patient, the primary care giver, and the family. It must contain enough information so that all of these individuals know exactly what is supposed to be done, by whom, at what time, and for what purpose.

(d) Standard: Review of the plan of care Plan of care must be reviewed as frequently as the patient’s condition requires, but no less frequently than every 15 calendar days Revised plan of care includes: Information from the updated comprehensive assessment Information regarding the progress toward achieving specified outcomes and goals Completed by the IDG in collaboration with the attending physician (if any) TOP 10 DEFICIENCES FOR THE PAST 3 YEARS Preamble highlights: The plan of care is the map that the hospice will follow when delivering care to a patient and family. It is essential that the plan of care accurately reflect the services that must be delivered in order to meet the needs of the patient and family. As the patient’s condition changes, the plan of care changes as well.

(d) Standard: Review of the plan of care Interpretive Guidelines Communication with attending may be through various means according to policy and patient needs Procedures and Probes Ask the hospice to describe the POC review process How does the hospice ensure the review process occurs by the IDT no later than 15 days from the prior review? Preamble highlights: The plan of care is the map that the hospice will follow when delivering care to a patient and family. It is essential that the plan of care accurately reflect the services that must be delivered in order to meet the needs of the patient and family. As the patient’s condition changes, the plan of care changes as well.

(e) Standard: Coordination of services Develop and maintain a system of communication and integration Ensure the IDG maintains responsibility for directing, coordinating, and supervising the care and services provided Care and services are provided in accordance with the plan of care TOP 10 DEFICIENCES IN 2011 Care and services are based on assessments of the patient and family needs Preamble highlights: As an interdisciplinary care model, hospice relies on communication between and integration of providers to effectively plan and furnish care to patients and families. This isn’t a once a week meeting – it is an ongoing process – need system of communication for updating. This standard requires hospices to communicate, not only with their employees, but also with their contractors. It also requires hospices to integrate those same contractors into the hospice team. Communication and integration with service providers outside of the hospice’s direct purview will help hospices ensure that each patient receives appropriate, high quality care in accordance with his or her plan of care, regardless of whether that care is furnished by hospice employees or contractors. As always, the hospice is ultimately responsible for the care furnished on its behalf and must actively ensure that contractors are fulfilling their patient care and communication contractual obligations.

(e) Standard: Coordination of services – cont. Sharing information between all disciplines providing care and services, in all settings, whether provided directly or under arrangement Sharing information with other non-hospice healthcare providers furnishing services unrelated to the terminal illness and related conditions.

(e) Standard: Coordination of services – cont. Probes What systems are in place to facilitate exchange of information among staff and with non-hospice providers? How does the hospice ensure that coordination of care occurs between services provided directly and those under arrangement? Is there documentation of the sharing of information between all disciplines and other providers?

Techniques for compliance Establish methods of communication to ensure that modalities are adequate, efficient and reliable. Define term ‘change in condition’ IDG meetings IDG – “planning” - this is the time to anticipate what you expect and plan for that. It is not reviewing past care, reporting current condition. DARE format – Deaths, Admits, Recertifications (group by LCD category), Existing patients (group by diagnosis/LCD category)

Techniques for compliance WHAT HAS WORKED FOR YOUR HOSPICE PROGRAM?

418.58 Quality assessment and performance improvement
Develop, implement and maintain an effective, ongoing, hospice-wide data-driven QAPI program. Reflect complexity of organization Involves all services Focuses in indicators to improved palliative outcomes Takes action to demonstrate improvement The hospice must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS CMS Staff – “You have done fabulous work in these 3 years” 360 degree view of hospice

418.58 QAPI Interpretive Guidelines
Each hospice develops its own QAPI program Methods used are flexible – documentation, direct observation, incident reports, complaints, surveys, interviews Information gathered should be based on measures generated by medical/professional staff Reflect best practices, staff performance and patient outcomes Ongoing means continuous and periodic collection and assessment of data CMS Staff – “You have done fabulous work in these 3 years” 360 degree view of hospice

QAPI program should have following elements Program objectives All patient care disciplines Description of how administered and coordinated Method for monitoring and evaluating quality of care Priorities for resolution of problems Monitoring to determine effectiveness of action Oversight responsibility reports to governing body Documentation of review of QAPI program CMS Staff – “You have done fabulous work in these 3 years” 360 degree view of hospice

Fundamental purpose is to set a clear expectation of proactive approach to improve performance and focus on improved care Stresses improvement in systems in order to improve processes and patient outcomes All components of QAPI in place hospice wide Must be ongoing and have written plan of implementation Performance Improvement fosters a ‘blame free’ environment CMS Staff – “You have done fabulous work in these 3 years” 360 degree view of hospice

418.58 QAPI Procedures and Probes Request the following:
Aggregated data and its analysis of data QAPI plan Individuals responsible for QAPI program Evidence the QAPI has been implemented and is functioning effectively Regular meetings, investigation of sentinel and adverse events Recommendations for systemic change Identified performance measures that are tracked and analyzed Regular review and use of QAPI analysis by management and governing body CMS Staff – “You have done fabulous work in these 3 years” 360 degree view of hospice

418.58 QAPI Procedures and Probes
Match data provided with actual experiences of hospice staff and patients Focus on how and why quality measures chosen, how it ensures consistent data collection, how it uses data in patient care planning and how it aggregates and analyzes data Documentation of analysis can be meeting minutes, reports, recommendations for change CMS Preamble – “Tools must allow hospices to document information in a systematic and retrievable way for each patient.” CMS Staff – “You have done fabulous work in these 3 years” 360 degree view of hospice

418.58 QAPI Operates on 2 levels Focuses on
Patient Hospice Focuses on Collecting data to assess quality Using data to identify opportunities for improvement Patient focused – outcome oriented Two related process Quality Assessment Performance Improvement

418.58 QAPI (a) Standard: Program scope
Show measurable improvement in indicators related to improved palliative outcomes and hospice services Must measure, analyze, and track quality indicators, including adverse pt events CMS Preamble- Failure to meet the quality assurance condition is consistently one of the top 10 deficiencies cited by Medicare surveyors nationwide. Preamble highlights: QAPI is a core program in many other Medicare funded programs. The intent of the program is a spring board to validate measures; good data Data collection is not going away – but will be expanding (PEACE project). Outcomes and the QAPI program will help to continue the hospice benefit. Collecting data and outcomes of care validates your care for the patient. With an effective quality assessment and performance improvement program in place and operating properly, a hospice can better identify and reinforce the activities it is doing well, identify its activities that are leading to poor patient outcomes, and take actions to improve performance.

418.58 QAPI (a) Standard: Program scope Interpretive Guidelines
Assess quality in all areas of operations Specific requirement to track adverse events and reduce occurrence Show, using quantitative data, that quality is improved as measured by own indicators or measures Procedures and Probes Does hospice adhere to its own definition of adverse event Preamble highlights: QAPI is a core program in many other Medicare funded programs. The intent of the program is a spring board to validate measures; good data Data collection is not going away – but will be expanding (PEACE project). Outcomes and the QAPI program will help to continue the hospice benefit. Collecting data and outcomes of care validates your care for the patient. With an effective quality assessment and performance improvement program in place and operating properly, a hospice can better identify and reinforce the activities it is doing well, identify its activities that are leading to poor patient outcomes, and take actions to improve performance.

418.58 QAPI (b) Standard: Program data Interpretive Guidelines
The program must utilize quality indicator data, including patient care, and other relevant data, in the design of its program Interpretive Guidelines Not limit data collection to patient assessments Examine all facets of hospice operations Procedures and Probes Is the hospice’s QAPI program data driven? Is there evidence it uses data to identify opportunities for improvement? Notes: Patient level data that needs collection – comprehensive assessment will yield this data. Hospice level data needs collection degree view of the hospice-all services (relationships to each) Ask the questions: What do you do? What do you do well? What could you do better? What was important? Why? What did you do about it? Look at things in a systematic way, areas for improvement can appear Preamble: Analysis of patient outcome measures, as well as administrative data, will allow hospices to determine objectively what care results in the best outcomes for a particular patient or subset of patients. This will help hospices identify best practices and avoid ineffective practices, which may reduce hospice expenditures in the future. We believe these benefits will outweigh any costs associated with the process. Did not propose any particular process or outcome measures. However, a hospice that would choose to use the available quality measures would be able to expect an enhanced degree of insight into the quality of its services and patient satisfactions compared to developing a process anew because [these tools] have been tested to some degree for validity and reliability.

418.58 QAPI (b) Standard: Program data Interpretive Guidelines
Hospice must use data collected to monitor effectiveness and safety of services and quality of care and identify opportunities and priorities for improvement Frequency and detail of the data collection must be specified by the hospice’s governing body Interpretive Guidelines Governing Body may assume hands-on control or delegate Notes: Patient level data that needs collection – comprehensive assessment will yield this data. Hospice level data needs collection degree view of the hospice-all services (relationships to each) Ask the questions: What do you do? What do you do well? What could you do better? What was important? Why? What did you do about it? Look at things in a systematic way, areas for improvement can appear Preamble: Analysis of patient outcome measures, as well as administrative data, will allow hospices to determine objectively what care results in the best outcomes for a particular patient or subset of patients. This will help hospices identify best practices and avoid ineffective practices, which may reduce hospice expenditures in the future. We believe these benefits will outweigh any costs associated with the process. Did not propose any particular process or outcome measures. However, a hospice that would choose to use the available quality measures would be able to expect an enhanced degree of insight into the quality of its services and patient satisfactions compared to developing a process anew because [these tools] have been tested to some degree for validity and reliability.

418.58 QAPI (c) Standard: Program activities
The hospice’s performance improvement activities must: Focus on high risk, high volume, problem prone areas Consider evidence, prevalence, and severity of problems in those areas Affect palliative outcomes, patient safety and quality of care Performance activities must track adverse patient events, analyze their causes and implement preventive actions and mechanisms that include feedback and learning throughout the hospice Interpretive Guidelines – hospice may choose to develop own definition for adverse event or use one developed by national accrediting organization Preamble highlights: PRIORITIZE – link needs to be tied back to improving patient care Aggregation of data must be done in accordance with the policies and procedures established by the hospice. If a hospice has an extremely small average monthly census, then it may make sense for that hospice to aggregate several months of data. Likewise, if a hospice has an extremely large average monthly census, then it may make sense for them to aggregate the data more frequently to ensure that the amount of data does not become overwhelming to those analyzing it. The flexible nature of the patient outcome measure standard and the quality assessment and performance improvement CoP allow hospices to adapt data collection and analysis to their needs and goals. More work is needed to establish a wide variety of valid patient outcome measures that hospices may choose from. We (CMS) commissioned a special study, the PEACE project, conducted by the North and South Carolina QIO. This study created a quality-focused self-audit tool for hospices to use, and identified quality measures that focus on the quality of clinical care furnished to hospice patients. Results of the study are available at ContentServer?pagename=Medqic/ MQPage/Homepage. In addition, the National Hospice and Palliative Care Organization launched a National Quality Initiative and Quality Collaborative to improve hospice and palliative care outcomes. This initiative is helping hospices develop functional QAPI programs, including patient outcome measures. Adverse Events – ‘In general, any action or inaction by a hospice that causes harm to a hospice patient.’ Each program needs to have its own definition in policy and then adhere to it. Provides a list of possible adverse events on p

418.58 QAPI (c) Standard: Program activities (cont’d)
Take action aimed at performance improvement Measure success of action Track performance of action to ensure that improvements are sustained Interpretive Guidelines Consider how often certain quality issues arise and severity of potential harm Procedures and Probes Determine if hospice has taken appropriate action to correct identified problems Evidence performance continually monitored?

418.58 QAPI (d) Standard: Performance improvement projects (PIP)
The number and scope of projects conducted annually must reflect the scope, complexity and past performance of the hospice’s services and operations Document what quality improvement projects are being conducted, reasons for conducting the projects and measurable progress achieved on these projects Interpretive Guidelines No requirement for specific number of PIPs Procedures and Probes Do the number and scope of PIPs reflect scope, complexity and past performance of hospice? Preamble: In accordance with this rule, hospices are required to identify opportunities and priorities for improvement based on the data that they have collected. We agree that it would be appropriate to delay implementation of the performance improvement projects requirement to allow hospices time to develop and implement a data collection program, and actually amass several months of data. For this reason, we have added a 240 day phase-in period. This phase-in period will allow hospices to gather several months of data before being required to develop and implement their data-driven performance improvement projects. Once the 240 day phase-in period is complete, we expect hospices to begin developing and implementing their data-driven performance improvement projects, with evaluation of those performance improvement projects to follow thereafter.

418.58 QAPI (e) Standard: Executive responsibilities
Governing body ensures: That an ongoing program for QI and patient safety is defined, implemented and maintained. (Board needs to approve details.) The QAPI efforts address quality of care and patient safety, and all improvement actions are evaluated for effectiveness. That an individual(s) is designated to lead QAPI efforts. Preamble: Section (b) of this rule requires the hospice’s governing body to assume full legal authority and responsibility for the management of the hospice, including its QAPI program. Section (e) of the proposed rule specified the QAPI responsibilities of the governing body. It would require the hospice’s governing body to ensure that a QAPI program is defined, implemented, and maintained. In addition, the rule proposed that the governing body must ensure that the QAPI program addresses the hospice’s quality priorities and that its effectiveness is evaluated. As the entity that is legally responsible for the hospice, we believe that it is essential that the hospice governing body ensures that the hospice’s QAPI program is meeting the requirements of this rule. We (CMS) believe that our governing body requirements meet the intent of the Joint Commission leadership standards. Therefore we are setting forth this requirement as final. The governing body may assume hands-on control of the QAPI program to ensure that the program is in compliance with this rule, or it may choose to appoint one or more individuals to handle the structure and administration of the QAPI program while the governing body retains ultimate responsibility for the actions of the designated individual(s). A new provision has been added at § (e)(3) explicitly requiring the governing body to appoint QAPI leaders.

418.58 QAPI (e) Standard: Executive responsibilities Probes
Do hospice records indicate that the hospice’s governing body is involved in oversight of the QAPI program? Is there an individual appointed by the governing body who is responsible for operating the QAPI program Preamble: Section (b) of this rule requires the hospice’s governing body to assume full legal authority and responsibility for the management of the hospice, including its QAPI program. Section (e) of the proposed rule specified the QAPI responsibilities of the governing body. It would require the hospice’s governing body to ensure that a QAPI program is defined, implemented, and maintained. In addition, the rule proposed that the governing body must ensure that the QAPI program addresses the hospice’s quality priorities and that its effectiveness is evaluated. As the entity that is legally responsible for the hospice, we believe that it is essential that the hospice governing body ensures that the hospice’s QAPI program is meeting the requirements of this rule. We (CMS) believe that our governing body requirements meet the intent of the Joint Commission leadership standards. Therefore we are setting forth this requirement as final. The governing body may assume hands-on control of the QAPI program to ensure that the program is in compliance with this rule, or it may choose to appoint one or more individuals to handle the structure and administration of the QAPI program while the governing body retains ultimate responsibility for the actions of the designated individual(s). A new provision has been added at § (e)(3) explicitly requiring the governing body to appoint QAPI leaders.

418.58 QAPI Patient – level QAPI
Collect data on what happened to an individual patient Assessment/reassessment (418.54) Care Plan (418.56) Visit Notes Use the data to improve quality of care and outcomes for that patient (418.56)

418.58 QAPI Hospice – level QAPI Clinically focused
Aggregate patient level data Collect satisfaction data Non Clinically focused Administrative data Marketing – referral source contact Outreach to community Profitability Fund raising

418.58 QAPI Quality Assessment requires quantitative information
Numbers OR Uniform variables (yes/no, increased/decreased) Performance Improvement requires qualitative information Narrative data Detail behind quantitative

418.58 QAPI Visualize – QAPI Hospice SEE – quality data is posted
FEEL – culture of quality Quality of assessment is a core activity across the organization Positive questioning, not finger pointing or blaming Reliance on data for decision making PI, not criticism or punishment, is the organizational response to errors and problems. READ – QAPI plan, PIP report, Board meeting minutes WATCH - Everybody participates

418.58 QAPI Initial Steps to QAPI
Appoint individual/team responsible for QAPI program Generate buzz about QAPI Educate everyone about QAPI and their role Develop a QAPI Plan – to be reviewed/evaluated yearly Implement Plan Develop Performance Improvement Project teams to address identified areas for improvement (this can take 4 – 6 months) – all professionals and volunteers are to be involved in QAPI

QAPI Act Plan Study Do Redesign

Reassess (data)/ Change POC
Patient Level – The Cycle of Care Assess (data) Reassess (data)/ Change POC ID Problems Intervention (POC) QAPI

QAPI Hospice Level – The QAPI Process Gather data
Institutionalize improvements ID areas for improvement Performance Improvement Projects (PIP) QAPI

418.58 QAPI QAPI Leaders - Governing body retains responsibility
Appoint one or more to manage day to day - At least part-time defined hours/days Chairs committee (CQO) Monitor compliance with the QAPI plan Manages collection of indicator data Oversee analysis and reporting Supports PI teams QAPI Committee Clinical and non-clinical (include medical records) Managers and staff Generate Buzz and Celebration

418.58 QAPI Use available quality measurement tools
Agency satisfaction survey tools NHPCO – National Data Set, FEHC, STAR, QP Agency for Healthcare Research and Quality – EOL outcomes National Quality Forum – Standards for symptom management and EOL care excelleRx – pharmaceutical tools Multiview – financial OCS – QAPI snapshot Deyta – FEHC and other satisfaction surveys CMS Pilot to determine outcomes currently underway in New York

Infection control Must maintain and document effective infection control program that protects patients, families, visitors and hospice personnel by preventing and controlling infections and communicable diseases Interpretive Guidelines IC program must identify risks in all settings where pts reside System to communicate with all staff, pts/families, visitors about infection prevention and control Used to be a standard – now is a condition and is consistent with other provider types Hand washing, sanitary environment

418.60 Infection control Interpretive Guidelines
IC program may include, but not limited to: Educating staff Protocols related to infusion therapy, urinary tract care, respiratory tract care and wound care Guidelines on caring for pts with multi-drug resistant organisms Policies on protection from blood borne or airborne pathogens Monitoring for compliance Protocols for educating in standard precaution and prevention/control Used to be a standard – now is a condition and is consistent with other provider types Hand washing, sanitary environment

418.60 Infection control Procedures and Probes
Ask what steps it takes to assure staff take appropriate prevention and control precautions How does the hospice ensure timely instructions regarding standard precautions If providing inpatient care directly, observe for appropriate infection prevention and control precautions including signage or other posted information or materials in pt rooms or staff area. Used to be a standard – now is a condition and is consistent with other provider types Hand washing, sanitary environment

418.60 Infection control (a) Standard: Prevention
Follow accepted standards of practice to prevent transmission, including standard precautions Interpretive Guidelines Accepted standards of practice are typically developed by government agencies, professional organizations and associations Standard Precautions are based on principle that all body fluids may contain transmissible infectious agents These include hand hygiene, gloves, mask, gown, eye protection, face shield and safe injection practices Procedures During home visit, observe practices Used to be a standard – now is a condition and is consistent with other provider types Hand washing, sanitary environment

418.60 Infection control (b) Standard: Control
Maintain a coordinated, agency-wide program for surveillance, identification, prevention, control, and investigation of infectious and communicable diseases That is an integral part of QAPI program Includes method of identify infectious and communicable disease problems and A plan for implementing appropriate actions that are expected to result in improvement and disease prevention Used to be a standard – now is a condition and is consistent with other provider types Hand washing, sanitary environment

418.60 Infection control (b) Standard: Control Interpretive Guidelines
Examples of infection control practices are monitoring work related employee illness and infections Analyzing them in relation to patient infections Taking appropriate actions when an infection or communicable disease is present to prevent spread Procedures and Probes Ask hospice to explain methods it uses to ID problems Does the hospice redesign its strategies to improve when it identifies problems? Used to be a standard – now is a condition and is consistent with other provider types Hand washing, sanitary environment

418.60 Infection control (c) Standard: Education Probes
Infection control education provided to staff, patients, families, and other caregivers Probes Is hospice staff aware of infection control principles and procedures? Do they demonstrate this knowledge during home visits? During home visit ask pt/family to describe infection control education they have received. Used to be a standard – now is a condition and is consistent with other provider types Hand washing, sanitary environment

418.62 Licensed professional services
(a) Standard: Services, whether provided directly or under arrangement, must be authorized, delivered, and supervised by qualified personnel (b) Standard: Professionals must actively participate in coordinating patient care (includes: patient assessment; care planning and evaluation; and patient and family counseling and education) (c) Standard: Professionals must participate in the hospice’s QAPI and in-service training programs Preamble highlights: Licensed professional services, for purposes of this section, would include, but not be limited to, skilled nursing care, physical therapy, speech language pathology, occupational therapy, and medical social services. We proposed that licensed professionals who provide services to hospice patients either directly or under arrangement would participate in coordinating all aspects of care, including updating the interdisciplinary comprehensive assessments, developing and evaluating plans of care, participating in patient and family counseling, participating in the quality assessment and performance improvement plan, and participating in in-service training.

418.62 Licensed professional services
Interpretive Guidelines Would include, but not be limited to: skilled nursing care, physical therapy, speech language pathology, occupational therapy and medical social services Procedures and Probes Interview key staff to determine how hospice ensures the licensed professionals participate in QAPI and in-service training What evidence is there that all employees have been properly oriented to tasks, participate in in-service training programs and demonstrate appropriate skills Preamble highlights: Licensed professional services, for purposes of this section, would include, but not be limited to, skilled nursing care, physical therapy, speech language pathology, occupational therapy, and medical social services. We proposed that licensed professionals who provide services to hospice patients either directly or under arrangement would participate in coordinating all aspects of care, including updating the interdisciplinary comprehensive assessments, developing and evaluating plans of care, participating in patient and family counseling, participating in the quality assessment and performance improvement plan, and participating in in-service training.

Core services Routinely provide substantially all core services directly by hospice employees. These services include nursing, medical social services and counseling. May use contracted staff, if necessary, to supplement hospice employees in order to meet needs of pts under extraordinary or other non-routine circumstances. May also enter into an agreement with another Medicare certified hospice Reasons: unanticipated periods of high patient loads

418.64 Core services Reasons to contract Interpretive Guidelines
Unanticipated periods of high patient loads or CC level Staffing shortages due to illness or other short-term temporary situations Pts evacuated due to disaster Temporary travel of a patient outside the service area Interpretive Guidelines Employee definition – works for hospice/organization and receives a W-2 or is a volunteer Probes How does hospice assure that all contract providers receive training in hospice philosophy and care before providing services

418.64 Core services (a) Standard: Physician services Probe
Employee or contracted Responsible for the palliation and management of the terminal illness and related conditions Supervised by the hospice medical director Meets the medical needs of the patient when the attending physician is not available Probe Is there evidence that the medical needs of pts are being met by hospice physician when no attending or attending unavailable? Preamble: The existing and proposed requirement states that hospice physicians, in conjunction with the patient’s attending physician, are responsible for the palliation and management of the terminal illness, conditions related to the terminal illness, and the general medical needs of the patient. As a result of changes made to the Act by the BBA, we also proposed to add a provision to the CoPs permitting hospices to contract for physician services. This proposed provision would align the CoPs with current CMS policy permitting hospices to contract for physician services. If contracting, need to identify who will cover in absence of contracted physician. Includes volunteer physicians

418.64 Core services (b) Standard: Nursing services
Care provided by or under the supervision of a registered nurse If state law permits ARNPs to treat and write orders, then ARNPs may provide services Highly specialized nursing services maybe provided under contract – i.e., complex wound, infusion, peds Interpretive Guidelines Services provided by ARNP who is not the pt’s attending are included under nursing care (i.e., cannot be billed) TOP 10 DEFICIENCES IN Preamble: Nursing: The services provided by nurse practitioners continue to be guided by Medicare statutory requirements. Within these statutory requirements, we propose to allow nurse practitioners to perform hospice functions that are within the scope of their practice and license, as well as within the laws of the State in which they practice. We also proposed in § (b) to allow hospices to provide certain types of nursing services under contract. This proposed change also resulted from section 946 of the MMA, which amended the Act by adding section 1861(dd)(5)(E). As amended, the Act provides that these nursing services must be highly specialized and provided non-routinely and so infrequently that their provision by hospice employees would be impracticable and prohibitively expensive. Medical social services: This standard would continue to require that medical social services be provided by a qualified social worker under the direction of a physician. This standard would also require that medical social services, when accepted by a patient and family, be based on an assessment of that patient’s psychosocial needs.

418.64 Core services (c) Standard: Medical social services
Provided by a qualified social worker under the direction of a physician Services to patient and family based on psychosocial assessment and pt/family needs and acceptance of services Interpretive Guidelines Assessment should include adjustment to terminal illness, social/emotional factors, coping mechanisms, family dynamics, communication patterns, financial resources, caregiver’s ability, risk factors, support systems

418.64 Core services (c) Standard: Medical social services Probes
How does the hospice introduce and offer medical social services? Ask the SW or CM to describe factors included in psychosocial assessment, how is info used in care planning Is there evidence that each patient receives SW services, unless refused?

418.64 Core services (d) Standard: Counseling services
Counseling services must be available to pt/family to assist in minimizing the stress and problems that arise from terminal illness, related conditions and dying process Include, but are not limited to: Bereavement Dietary Spiritual Broad language includes CAM therapy providers

418.64 Core services TOP 10 DEFICIENCES IN 2011
(d) Standard: Counseling services - Bereavement Bereavement counseling: under the supervision of a qualified professional with experience or education in grief or loss counseling Available to family and other individuals, including residents of a SNF/NF or ICF/MR, when appropriate and identified in the bereavement plan of care Development of the bereavement plan of care starts before the patient’s death. TOP 10 DEFICIENCES IN 2011

418.64 Core services (d) Standard: Counseling services – Bereavement
Interpretive Guidelines Supervisor may be IDG social worker or other professional with documented evidence of experience or education in grief or loss counseling Procedures and Probes Ask the hospice to explain how and when they incorporate bereavement assessment into comprehensive assessment What services are provided to reflect needs of pt/family? How does hospice evaluate outcomes and effectiveness of bereavement services? Select and sample 2 – 3 bereavement POC from pts who have died in past 12 months. Determine if bereavement follow-up was appropriate. Removed from the final rule: Requirement that bereavement counseling must be provided to facility staff.

418.64 Core services d) Standard: Counseling services - Dietary
Dietary counseling: preformed by a qualified individual such as dieticians and nurses Interpretive Guidelines RN can provide dietary counseling within scope of practice If needs exceed RN expertise, then must have an appropriately trained and qualified registered dietician or nutritionist Includes CAM therapies – core services are to be employees.

418.64 Core services d) Standard: Counseling services - Dietary
Procedures and Probes Ask the clinical manager how hospice meets the needs of pts/family who experience challenges and conflict with EOL dietary issues. Ask clinical manager how hospice meets the needs of pts who experience dysphasia, problematic enteral feedings, unresolved nutritional issues secondary to N&V or the dying process. Includes CAM therapies – core services are to be employees.

Core services d) Standard: Counseling services - Spiritual counseling Spiritual counseling: Make all reasonable efforts to facilitate visits from local clergy, pastoral counselors, or other individuals who support the patient’s spiritual needs. Interpretive Guidelines Evidence in record that spiritual counseling was offered and/or provided in accordance with pt/family desires. Includes CAM therapies – core services are to be employees.

Core services d) Standard: Counseling services - Spiritual counseling Procedures and Probes Determine through record review, interview and home visits how the hospice addresses the spiritual needs of pt/family How does the hospice introduce the availability of spiritual counseling? What mechanisms are in place to meet the spiritual needs? Includes CAM therapies – core services are to be employees.

418.66 Nursing services – Waiver
Applies only to hospices in existence on or before Jan. 1, 1983 in non-urbanized areas Preamble: The requirements for obtaining a nursing services waiver as provided by section 1861(dd)(5) of the Act is currently set forth in § , and remained virtually unchanged in the proposed rule. This condition provides hospices the opportunity to obtain a waiver from the requirement that substantially all nursing services be routinely provided directly by the hospice. The Act specifies that to obtain a waiver a hospice must be located in an area that is not an urbanized area, must have been in operation on or before January 1, 1983, and must demonstrate a good faith effort to hire a sufficient number of nurse employees. Section 1861(dd)(5)(B) of the Act also specifies that if a waiver is requested by an organization that meets the statutory requirements and other provisions required by the Secretary, then the waiver will be deemed granted unless the request is denied within 60 days after the request is received by the Secretary. We proposed to maintain the existing requirement, as well as the regulatory timeframe that provides that waivers are effective for 1 year at a time, and that CMS may approve a maximum of two 1-year extensions for each initial waiver. We (CMS) understand that there may be some confusion about this nursing waiver at § , which is currently in regulations at § , and the nursing shortage exemption that has been in effect the past several years. The nursing waiver at § is statutory and allows rural hospices in operation before 1983 the opportunity to obtain a waiver from the statutory requirement that substantially all nursing services be routinely provided directly by the hospice, thereby permitting such hospices to contract for nursing services if they meet the statutory requirements. The nursing shortage exemption implemented in 2004, and renewed in 2006, permits all hospices that are having difficulty hiring nurses to apply for an exemption that allows the hospice to contract for nursing services. These two waivers are completely separate from one another. As noted, the nursing waiver is statutory and applicable only to hospices located in a nonurbanized area and in operation since By contrast, the nursing shortage exemption provides short-term relief to all hospices who qualify during this nursing shortage.

Non-core services Services in thru are provided directly or under arrangements. Services must be consistent with current standards of practice Interpretive Guidelines Must ensure all staff are aware of and follow professional standards, laws, policies, procedures. If question arises during home visit, ask staff what the policies are regarding the issue Procedure Ask how hospice monitors professional skills to determine if appropriate and adequate for its patients. Preamble: This CoP would establish authority to waive the requirement that eligible hospices must provide physical therapy (PT), occupational therapy (OT), and/or speech-language pathology (SLP) services as needed on a 24-hour basis as otherwise required by section 1861(dd)(2)(A)(i). This CoP would also establish authority to waive the requirement that eligible hospices must provide dietary counseling services on a 24-hour basis and/or that eligible hospices must routinely provide dietary counseling services directly through hospice employees.

PT, OT, and SLP PT, OT, SLP services must be available and provided in a manner consistent with accepted standards of practice. Interpretive Guidelines: Rehab services, i.e., use of adaptive equipment, home safety assessment, caregiver instructions in good body mechanics, may be appropriate/beneficial for the pt. Preamble: This CoP would establish authority to waive the requirement that eligible hospices must provide physical therapy (PT), occupational therapy (OT), and/or speech-language pathology (SLP) services as needed on a 24-hour basis as otherwise required by section 1861(dd)(2)(A)(i). This CoP would also establish authority to waive the requirement that eligible hospices must provide dietary counseling services on a 24-hour basis and/or that eligible hospices must routinely provide dietary counseling services directly through hospice employees.

418.74 Waiver of requirement- PT, OT, SLP, and dietary counseling
Waives 24 hour requirement for non-urbanized programs Unlimited 1 year extensions Preamble: This CoP would establish authority to waive the requirement that eligible hospices must provide physical therapy (PT), occupational therapy (OT), and/or speech-language pathology (SLP) services as needed on a 24-hour basis as otherwise required by section 1861(dd)(2)(A)(i). This CoP would also establish authority to waive the requirement that eligible hospices must provide dietary counseling services on a 24-hour basis and/or that eligible hospices must routinely provide dietary counseling services directly through hospice employees.

418.76 Hospice aide & homemaker services
All hospice aide services must be provided by individuals who meet requirements in paragraph (a) Homemaker services must be provided by individuals who meet requirements in paragraph (j) Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(a) Standard: Hospice aide qualifications Qualified aide has successfully completed one of the following: Hospice aide training and competency evaluation as specified in (b) and (c) Competency evaluation as specified in (c) Nurse aide training and competency evaluation approved by state and is in good standing State licensure program that meets requirements of (b) and (c) If there has been a 24 month lapse in furnishing services, individual must complete another program Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(b) Standard: Content and duration of hospice aide training Classroom and supervised practical training Minimum of 16 classroom hours Minimum of 16 supervised practical trainings with person, not mannequin Total of at least 75 hours 13 training subject areas identified Maintain documentation that demonstrates requirements are met Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(b) Standard: Content and duration of hospice aide training Interpretive Guidelines May receive training from different organizations if amount of training totals 75 hours, content addresses all subject areas and all requirements of regulation are met. Document that requirements of standard are met Documentation should include: descriptions of program, qualification of instructors, record that distinguishes between classroom and practical training, how additional skills are taught is hospice requires more complex procedures Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(c) Standard: Competency evaluation Individual may furnish services only after successfully completed a competency evaluation program. Competency evaluation must address all 13 subjects of (b). Specific subjects are to be with a patient, remaining subjects can be written, oral or observation May be provided by any organization, except those identified in (f) TOP 10 DEFICIENCES IN 2011 Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(c) Standard: Competency evaluation Interpretive Guidelines: Must ensure that skills learned elsewhere can be successfully transferred in all settings Review of skills can be done when nurse installs new aide in patient care situation or during supervisory visit Mannequin may not be used for this evaluation Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(c) Standard: Competency evaluation Must be performed by RN in consultation with other professionals, as appropriate Hospice aide not considered competent in any task evaluated as unsatisfactory and must not perform task without direct supervision until retrained If rated unsatisfactory in more than one area, not considered to have successfully completed competency evaluation. IG – precluded from functioning as aide Interpretive Guidelines: No restrictions on number of times or timeframe for testing in deficient area. Documentation must demonstrate that requirements of standard are met Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(d) Standard: In-service training (same) 12 hours of in-service training during each 12 month period. May occur while furnishing care. Interpretive Guidelines: May be calendar year, employment anniversary or rolling 12 month basis Training that occurs with pt in place of residence, supervised by RN, may occur as part of supervisory visit Should not be repetition of basic skill Procedures and Probes: Ask how the hospice schedules training to assure the 12 hours within 12 months Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(d) Standard: In-service training (same) Training may be offered by any organization and must be supervised by a registered nurse. Interpretive Guidelines: May be calendar year, employment anniversary or rolling 12 month basis Training that occurs with pt in place of residence, supervised by RN, may occur as part of supervisory visit Should not be repetition of basic skill Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(d) Standard: In-service training (same) Procedures and Probes: Ask how the hospice schedules training to assure the 12 hours within 12 months Training may be offered by any organization and must be supervised by a RN Hospice must maintain documentation demonstrating requirements of standard are met Review a sample of 3 – 4 hospice aides training files to validate aides are receiving required number of hours. If concerns arise, interview aides regarding in-service training Home Health Aide language replaced with Hospice Aide. Language wholly cut and pasted from the home health rule. If an aide met competency through a nursing home competency evaluation, it is acceptable for the hospice. In-service = 12 hrs annually Aide must be oriented by the hospice.

(e) Standards: Qualifications for instructors conducting classroom and supervised practical training Training performed by RN, at least 2 years experience, with at least 1 year in homecare (home health or hospice) Interpretive Guidelines: 2 years experience should be “hands-on” clinical experience such as providing care or supervising nursing services or teaching nursing skills in an organized curriculum or in-service program Other individuals may help with training

(f) Eligible competency evaluation organizations May be offered by any organization except one that has one of the identified deficiencies in the prior 2 years (g) Hospice Aide assignments and duties Assigned specific pt by IDT RN, written patient care instructions must be prepared by RN who is responsible for supervision of aide Interpretive Guidelines: Written instructions must be patient specific and not generic

(g) Hospice Aide assignments and duties Procedures and Probes: Interview key staff to determine: if aides are employees or under arrangement, if under arrangement how ensure competency How hospice ensures aides are proficient to carry out assignments in safe, efficient, effective manner How hospice monitors the assignments of aides to match skills needed for individual pts If questions arise as a result of home visits or interviews, ask clinical managers to respond to specific issues

(g) Hospice Aide assignments and duties Hospice Aide provides services that are ordered by IDG, included plan of care, permitted by State and consistent with hospice training Duties of hospice aid include: provision of hands-on personal care, performance of simple procedures as extension of therapy or nursing services, assistance in ambulation or exercises, assistance in administering medications that ordinarily self-administered.

(g) Hospice Aide assignments and duties Interpretive Guidelines: Administering medication is based upon needs of pt/family, training/competency of aide, policies, state law and rules. If allowed, hospice is required to provide training in medication administration and assure that aide is competent before assigned to patient

(g) Hospice Aide assignments and duties Hospice Aides must report changes in pt’s medical, nursing, rehab or social needs to RN, as changes related to POC and QAPI Must complete documentation in compliance with P&P Procedures: During home visit, be observant for changes in pts needs that aide should be reporting to RN Through record review, look for documentation by aide describing changes and to whom reported Clinical notes should be dated and signed

(h) Standard: Supervision of hospice aides RN onsite visit to pt’s home to assess the quality of care and services provided by the hospice aide Every 14 days Ideally is same RN that oversee care, if substitute used should be noted in documentation (see (g)) Hospice aide does not have to be present during this visit If concerns related to care and services provided by the hospice aide are noted by the supervising RN, the hospice must make an on-site visit while the patient receives care (observation of aide) If concerns are verified, the aide must complete a competency evaluation Preamble: Clarifying the intent of the every-14-day supervisory visit will be helpful to hospices. We have added language at § (h)(1)(i) to reflect the intent of the suggestion. In addition, we have added a statement that the every-14-day supervisory visit is also meant to ensure that the services ordered by the hospice are sufficient to meet the patient’s needs.

(h) Standard: Supervision of hospice aides The RN must make an annual onsite visit to observe and assess each aide while performing care Interpretive Guidelines: Aide must be directly supervised one time annually on one patient (no requirement to assess each patient annually) Procedures and Probes: Interview key staff to determine how hospice assures all aides are supervised on-site annually

(h) Standard: Supervision of hospice aides Assess and document satisfactory performance in meeting outcomes that include, but not limited to: Following plan of care Creating successful interpersonal relationship with pt Demonstrating competency with assigned tasks Complying with infection control P&P Reporting changes in pt’s condition Interpretive Guidelines: Supervisory visits may be made in conjunction with professional visit

(h) Standard: Supervision of hospice aides TOP 10 DEFICIENCES SINCE???

(i) Standard: Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit (COPES) May be provided on behalf of the hospice agency – must demonstrate competency in services provided Medicaid personal care benefit services are used to the extent that the hospice would use the patient’s family in delivering care Coordinate hospice aide services with Medicaid personal care benefit Preamble: The Medicaid personal care benefit is designed to assist eligible Medicaid beneficiaries with daily personal care tasks such as household chores and personal hygiene. The hospice aide and homemaker services covered under the Medicare hospice benefit cover many of the same tasks. However, hospice aide and homemaker services are not necessarily meant to be daily services, and are certainly not meant to be 24-hour daily services. Hospices are neither expected to nor prohibited from fulfilling the caregiver role for a patient. Rather, hospice aide and homemaker services are provided to supplement the primary caregiver(s). Since there may be occasions where a patient receives services through a personal care aide benefit while receiving hospice services, we agree with the commenters that this rule should address the responsibilities of the hospice for coordinating the care provided by hospice personnel and the Medicaid personal care aide. We have added new elements to address this, § (i)(2) and § (i)(3). Section (i)(2) provides that services furnished by the Medicaid personal care benefit may be used to the extent that the hospice would routinely use the services of a hospice patient’s family in implementing a patient’s plan of care. Section (i)(3) requires that a hospice coordinate hospice aide and homemaker services with the services furnished by the Medicaid personal care aide benefit to ensure that patients receive all the services that they require.

(i) Standard: Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit (COPES) Interpretive Guidelines: State defines optional Medicaid personal services benefit and determines if benefit is more extensive that H/HA benefit provided under Medicare hospice benefit State pays for covered Medicaid personal care services that exceed scope of Medicare hospice benefit Preamble: The Medicaid personal care benefit is designed to assist eligible Medicaid beneficiaries with daily personal care tasks such as household chores and personal hygiene. The hospice aide and homemaker services covered under the Medicare hospice benefit cover many of the same tasks. However, hospice aide and homemaker services are not necessarily meant to be daily services, and are certainly not meant to be 24-hour daily services. Hospices are neither expected to nor prohibited from fulfilling the caregiver role for a patient. Rather, hospice aide and homemaker services are provided to supplement the primary caregiver(s). Since there may be occasions where a patient receives services through a personal care aide benefit while receiving hospice services, we agree with the commenters that this rule should address the responsibilities of the hospice for coordinating the care provided by hospice personnel and the Medicaid personal care aide. We have added new elements to address this, § (i)(2) and § (i)(3). Section (i)(2) provides that services furnished by the Medicaid personal care benefit may be used to the extent that the hospice would routinely use the services of a hospice patient’s family in implementing a patient’s plan of care. Section (i)(3) requires that a hospice coordinate hospice aide and homemaker services with the services furnished by the Medicaid personal care aide benefit to ensure that patients receive all the services that they require.

(j) Standard: Homemaker qualifications A qualified homemaker is an: Individual who meets the standards in (g) and has successfully completed hospice orientation OR A hospice aide as described in Interpretive Guidelines: Homemaker services may include assistance in maintaining a safe and healthy environment and services to help the pt/family carry out the treatment plan Preamble: Homemaker be either an individual who has completed aide training or an individual who has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness. Hospices may contract for homemaker services. Volunteers are permitted to fulfill many roles in hospice care, including providing homemaker services, provided that the volunteers meet all qualifications and personnel requirements established by this rule.

(j) Standard: Homemaker qualifications (g) Home health aide services furnished by qualified aides as designated in Sec. § and homemaker services. Home health aides (also known as hospice aides) may provide personal care services as defined in §409.45(b) of this chapter. Aides may perform household services to maintain a safe and sanitary environment in areas of the home used by the patient, such as changing bed linens or light cleaning and laundering essential to the comfort and cleanliness of the patient. Aide services may include assistance in the maintenance of a safe and healthy environment and services to enable the individual to carry out the treatment plan. Preamble: Homemaker be either an individual who has completed aide training or an individual who has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness. Hospices may contract for homemaker services. Volunteers are permitted to fulfill many roles in hospice care, including providing homemaker services, provided that the volunteers meet all qualifications and personnel requirements established by this rule.

(k) Standard: Homemaker supervision and duties Homemaker services must be coordinated and supervised by a member of the IDG Instructions for homemaker duties must be prepared by a member of the IDG Homemakers must report all concerns to member of IDG who is coordinating homemaker services Preamble: Homemaker be either an individual who has completed aide training or an individual who has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness. Hospices may contract for homemaker services. Volunteers are permitted to fulfill many roles in hospice care, including providing homemaker services, provided that the volunteers meet all qualifications and personnel requirements established by this rule.

(k) Standard: Homemaker supervision and duties Procedures and Probes: Interview key adm staff regarding which member of the IDG is responsible for coordination and supervision of homemaker services Through interview, home visits and record reviews assure that there are written instructions and that concerns are being reported Duties and services must be documented Preamble: Homemaker be either an individual who has completed aide training or an individual who has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness. Hospices may contract for homemaker services. Volunteers are permitted to fulfill many roles in hospice care, including providing homemaker services, provided that the volunteers meet all qualifications and personnel requirements established by this rule.

Volunteers Must use volunteers to the extent specified in section (e). Must be used for defined roles and under supervision of designated hospice employee Interpretive Guidelines Volunteers are considered hospice employees to facilitate compliance with the core services requirement (418.64) Procedures and Probes Conduct an interview with the individual designated to supervise the volunteers regarding use, training and supervision of volunteers. Preamble: if a hospice does pay an employee for time spent traveling for direct patient care and administrative purposes, and does not compensate a volunteer for the time, then it may include the volunteer’s travel time, direct patient care and administrative services in its documentation of the cost savings it achieves. Likewise, hospices may document the time that volunteers actually spend providing direct patient care and administrative services, because hospices would compensate paid employees for the time spent performing these duties. We note that travel time is not the same as direct patient care.

418.78 Volunteers (a) Standard: Training
The hospice must maintain, document and provide volunteer orientation and training that is consistent with industry standards. Interpretive Guidelines All required volunteer training should be consistent with specific tasks that volunteers perform Preamble: if a hospice does pay an employee for time spent traveling for direct patient care and administrative purposes, and does not compensate a volunteer for the time, then it may include the volunteer’s travel time, direct patient care and administrative services in its documentation of the cost savings it achieves. Likewise, hospices may document the time that volunteers actually spend providing direct patient care and administrative services, because hospices would compensate paid employees for the time spent performing these duties. We note that travel time is not the same as direct patient care.

418.78 Volunteers (a) Standard: Training Probes
How does the hospice supervise volunteers? Is there documentation supporting that all volunteers have received training and orientation before being assigned to a patient/family? What evidence is there that the volunteers are aware of: Duties/responsibilities; person to whom they report or contact for concerns; hospice goals/philosophy; confidentiality; HIPAA, family dynamics, coping mechanisms and psychological issues surrounding terminal illness, death and bereavement; procedures to follow in emergency or after death of pt; guidance related to individual responsibilities Preamble: if a hospice does pay an employee for time spent traveling for direct patient care and administrative purposes, and does not compensate a volunteer for the time, then it may include the volunteer’s travel time, direct patient care and administrative services in its documentation of the cost savings it achieves. Likewise, hospices may document the time that volunteers actually spend providing direct patient care and administrative services, because hospices would compensate paid employees for the time spent performing these duties. We note that travel time is not the same as direct patient care.

418.78 Volunteers (b) Standard: Role
Volunteers must be used in day-to-day administrative and/or direct patient care roles Interpretive Guidelines: Qualified volunteers who provide professional services must meet all requirements associated with their specialty area Duties of volunteers in direct patient care services must be evident in plan of care There should be documentation of time spent and services provided Probes: What evidence exists that the IDG conducts an assessment of the pt/family’s need for a volunteer? Preamble: if a hospice does pay an employee for time spent traveling for direct patient care and administrative purposes, and does not compensate a volunteer for the time, then it may include the volunteer’s travel time, direct patient care and administrative services in its documentation of the cost savings it achieves. Likewise, hospices may document the time that volunteers actually spend providing direct patient care and administrative services, because hospices would compensate paid employees for the time spent performing these duties. We note that travel time is not the same as direct patient care.

418.78 Volunteers (c) Standard: Recruiting and retaining
Must document and demonstrate viable and ongoing efforts to recruit and retain volunteers (d) Standard: Cost savings Must document the cost savings achieved through the use of volunteers. Must include: ID of each position that is occupied by volunteer Work time spent in occupying these positions Estimates of the dollar costs that the hospice would have incurred if filled by paid employees Interpretive Guidelines: There is no requirements for what the costs savings must be, only on how it is computed Preamble: if a hospice does pay an employee for time spent traveling for direct patient care and administrative purposes, and does not compensate a volunteer for the time, then it may include the volunteer’s travel time, direct patient care and administrative services in its documentation of the cost savings it achieves. Likewise, hospices may document the time that volunteers actually spend providing direct patient care and administrative services, because hospices would compensate paid employees for the time spent performing these duties. We note that travel time is not the same as direct patient care.

418.78 Volunteers (e) Standard: Level of activity
Volunteers must provide a minimum hours worked that of equals 5% of total patient care hours of all paid and contract staff Hospice must maintain records on use of volunteers including type of service and time worked Hospices may count volunteer driving hours in the 5% calculation as long as they count staff driving hours. Board and fund raising hours do not count. Total paid hours (minus fund raising) x 1.05 = number of hours needed to meet 5% calculation. Preamble: if a hospice does pay an employee for time spent traveling for direct patient care and administrative purposes, and does not compensate a volunteer for the time, then it may include the volunteer’s travel time, direct patient care and administrative services in its documentation of the cost savings it achieves. Likewise, hospices may document the time that volunteers actually spend providing direct patient care and administrative services, because hospices would compensate paid employees for the time spent performing these duties. We note that travel time is not the same as direct patient care.

SUBPART D: ORGANIZATIONAL ENVIRONMENT
Conditions: Organization and administration of services Medical Director Clinical Records Drugs, Biologicals, Medical Supplies, DME Short Term Inpatient Care Hospices that provide inpatient care directly Hospice that provide care to residents in SNF/NF Personnel qualifications Compliance

418.100 Organization & administration of services
Hospice must organize, manage, and administer its resources to provide hospice care and services for palliation and management of terminal illness and related conditions (a) Standard: Serving the patient and family Optimizes comfort and dignity Consistent with patient and family goals Patient’s needs and goals are hospices primary consideration

(b) Standard: Governing body and administrator Governing body (or designated person) assumes full legal authority and responsibility Qualified Administrator is appointed by and reports to the governing body Must be employee and possess education and experience required by governing body

(b) Standard: Governing body and administrator Interpretive Guidelines: If hospice part of larger organization and the governing body is the same, there must be documented evidence that the governing body is assuming full authority and responsibility for operations, services and QAPI program If Administrator not available, must identify another individual to assume assigned duties Procedures and Probes How is governing body informed of ongoing operations, service delivery issues and QAPI activities? Ask administrator/clinical supervisor to describe relationship between governing body, management and staff

(c) Standard: Services Hospice must be primarily engaged in providing: Nursing, medical social, and physician Counseling (spiritual, dietary and bereavement) Hospice aide, volunteer, homemaker PT, OT, SLP Short-term inpatient care Medical supplies (including drugs) and medical appliances Nursing, physician and drugs must be provided 24/7 Other services on 24 hour basis when reasonable and necessary

(d) Standard: Continuation of care Hospice may not discontinue or reduce care provided to a Medicare or Medicaid beneficiary because of beneficiary’s inability to pay for that care Interpretive Guidelines: Applies to Medicare and Medicaid beneficiaries only

(e) Standard: Professional management responsibility Must retain oversight of staff and services for all arranged services Arranged services must be supported by written agreements that require all services be: Authorized by hospice Furnished in safe and effective manned by qualified personnel Delivered in accordance with pt’s POC Preamble: In § (e), ‘‘Professional management responsibility,’’ we proposed to revise some of the current requirements found at § (b) and § (c). This proposed standard would require written agreements for services furnished under arrangement, and would require that the hospice retain professional management, supervisory, and financial responsibility for all services that are provided to the patient and family. The hospice would be required to ensure that it authorizes all services that it provides, that they are furnished in a safe and effective manner by qualified personnel, and that items and/or services specified in the plan of care are provided. New standard to address the issue of multiple service locations. This provision was intended to codify long-standing Medicare survey and certification policy, which allows for the operation of multiple locations by a single hospice provider with a single Medicare agreement. We expect that any hospice that requests to establish a satellite location (now referred to as a multiple location) will be able to demonstrate how it is able to manage and monitor all of the services provided in its entire service area, including services from a multiple location. 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. Before operating a multiple location, also known as a practice location on CMS form 855, a hospice must enroll with the fiscal intermediary and notify the State agency and CMS of all currently approved multiple locations at the time it requests approval for any additional multiple locations.

(e) Standard: Professional management responsibility Interpretive Guidelines: Hospice must retain administrative, financial management and oversight of staff and services provided under arrangement. For Medicare services, hospice is responsible for payment For non-Medicare services, hospice is responsible for establishing how payment for those services will occur Preamble: In § (e), ‘‘Professional management responsibility,’’ we proposed to revise some of the current requirements found at § (b) and § (c). This proposed standard would require written agreements for services furnished under arrangement, and would require that the hospice retain professional management, supervisory, and financial responsibility for all services that are provided to the patient and family. The hospice would be required to ensure that it authorizes all services that it provides, that they are furnished in a safe and effective manner by qualified personnel, and that items and/or services specified in the plan of care are provided. New standard to address the issue of multiple service locations. This provision was intended to codify long-standing Medicare survey and certification policy, which allows for the operation of multiple locations by a single hospice provider with a single Medicare agreement. We expect that any hospice that requests to establish a satellite location (now referred to as a multiple location) will be able to demonstrate how it is able to manage and monitor all of the services provided in its entire service area, including services from a multiple location. 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. Before operating a multiple location, also known as a practice location on CMS form 855, a hospice must enroll with the fiscal intermediary and notify the State agency and CMS of all currently approved multiple locations at the time it requests approval for any additional multiple locations.

(e) Standard: Professional management responsibility Procedures and Probes: Ask how the hospice: Assures that all contracted personnel provide care that is in accordance with POC? Assures that all services are authorized? Monitors and exercises control over services? Assure professional management of pts receiving inpatient care under arrangement? Communicates with contracted individuals, agencies, organizations? Assure that services are furnished by qualified staff? Preamble: In § (e), ‘‘Professional management responsibility,’’ we proposed to revise some of the current requirements found at § (b) and § (c). This proposed standard would require written agreements for services furnished under arrangement, and would require that the hospice retain professional management, supervisory, and financial responsibility for all services that are provided to the patient and family. The hospice would be required to ensure that it authorizes all services that it provides, that they are furnished in a safe and effective manner by qualified personnel, and that items and/or services specified in the plan of care are provided. New standard to address the issue of multiple service locations. This provision was intended to codify long-standing Medicare survey and certification policy, which allows for the operation of multiple locations by a single hospice provider with a single Medicare agreement. We expect that any hospice that requests to establish a satellite location (now referred to as a multiple location) will be able to demonstrate how it is able to manage and monitor all of the services provided in its entire service area, including services from a multiple location. 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. Before operating a multiple location, also known as a practice location on CMS form 855, a hospice must enroll with the fiscal intermediary and notify the State agency and CMS of all currently approved multiple locations at the time it requests approval for any additional multiple locations.

(f) Standard: Multiple locations Medicare approval before providing services to Medicare patients The multiple location must share administration, supervision, and services with the hospice issued the certification (provider) number Lines of authority and control must be clearly delineated All locations must comply with CoPs Interpretive Guidelines: Several pages of these to review prior to doing this Preamble: In § (e), ‘‘Professional management responsibility,’’ we proposed to revise some of the current requirements found at § (b) and § (c). This proposed standard would require written agreements for services furnished under arrangement, and would require that the hospice retain professional management, supervisory, and financial responsibility for all services that are provided to the patient and family. The hospice would be required to ensure that it authorizes all services that it provides, that they are furnished in a safe and effective manner by qualified personnel, and that items and/or services specified in the plan of care are provided. New standard to address the issue of multiple service locations. This provision was intended to codify long-standing Medicare survey and certification policy, which allows for the operation of multiple locations by a single hospice provider with a single Medicare agreement. We expect that any hospice that requests to establish a satellite location (now referred to as a multiple location) will be able to demonstrate how it is able to manage and monitor all of the services provided in its entire service area, including services from a multiple location. 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. Before operating a multiple location, also known as a practice location on CMS form 855, a hospice must enroll with the fiscal intermediary and notify the State agency and CMS of all currently approved multiple locations at the time it requests approval for any additional multiple locations.

(g) Standard: Training Must provide orientation to all employees (includes volunteers) and contracted staff who have patient and family contact, addressing specific job duties Must assess skills and competencies of employees Must have written P&P describing methods of assessment of competency Maintain written description of in-service training and education provided during the previous 12 months Rolling 12 month period

(g) Standard: Training Procedures and Probes: Review sample of personnel records to verify initial orientation, assessment of skills/competency, and in-service training was provided to all employees, contracted staff and volunteers furnishing care/services to pts Review written agreements and training programs provided for contracted personnel If concerns are identified, interview the administrator/staff regarding the specific issue. Rolling 12 month period

Medical Director Must designate a physician to serve as medical director. Must be an MD or DO who is employee or under contract When medical director not available, physician designated by the hospice assumes the same responsibilities Interpretive Guidelines: There is only one medical director, including multiple locations. May be FT/PT, may be volunteer All other hospice physicians functions under the supervision of the medical director Preamble: Our intent in this proposed standard was to ensure that medical directors are actively involved in patient care. The hospice is better suited than the medical director exclusively to choose the physician designee, and we have incorporated this suggestion in § We are requiring hospices to employ or contract with physician designees because, in many hospices, the medical director may be the only physician employee or contractor in the entire hospice. It is essential that another physician be available to assume the medical director’s role when the medical director is absent to ensure continuous quality care for the hospice’s patients. Likewise, it is essential that there be a specific individual identified to be the physician designee. Allowing numerous physicians to fulfill the medical director role would likely result in inconsistent care and decreased accountability. ‘‘Medical director contract,’’ which permits hospices to contract with a self employed physician or a physician employed by a professional entity or physicians’’ group. The new standard at § (a) establishes that, when contracting for medical director services, the contract must specify the name of the physician who assumes the responsibilities and obligations of the medical director.

418.102 Medical Director (a) Standard: Medical director contract
May contract for medical director with self-employed physician OR a physician employed by a professional entity or physicians group. When contracting with group, must specify the physician who assumes the medical director responsibilities Interpretive Guidelines: May be volunteer, a long as person meets all Federal and State requirements Preamble: Our intent in this proposed standard was to ensure that medical directors are actively involved in patient care. The hospice is better suited than the medical director exclusively to choose the physician designee, and we have incorporated this suggestion in § We are requiring hospices to employ or contract with physician designees because, in many hospices, the medical director may be the only physician employee or contractor in the entire hospice. It is essential that another physician be available to assume the medical director’s role when the medical director is absent to ensure continuous quality care for the hospice’s patients. Likewise, it is essential that there be a specific individual identified to be the physician designee. Allowing numerous physicians to fulfill the medical director role would likely result in inconsistent care and decreased accountability. ‘‘Medical director contract,’’ which permits hospices to contract with a self employed physician or a physician employed by a professional entity or physicians’’ group. The new standard at § (a) establishes that, when contracting for medical director services, the contract must specify the name of the physician who assumes the responsibilities and obligations of the medical director.

Medical Director (b) Standard: Initial certification of terminal illness Reviews clinical information for each patient and provides written certification of terminal illness Factors to examine when making terminal illness determination Primary terminal condition Related diagnoses Current subjective/objective medical findings Current medications and treatment orders Information about medical management of unrelated conditions Preamble: Our intent in this proposed standard was to ensure that medical directors are actively involved in patient care. The hospice is better suited than the medical director exclusively to choose the physician designee, and we have incorporated this suggestion in § We are requiring hospices to employ or contract with physician designees because, in many hospices, the medical director may be the only physician employee or contractor in the entire hospice. It is essential that another physician be available to assume the medical director’s role when the medical director is absent to ensure continuous quality care for the hospice’s patients. Likewise, it is essential that there be a specific individual identified to be the physician designee. Allowing numerous physicians to fulfill the medical director role would likely result in inconsistent care and decreased accountability. ‘‘Medical director contract,’’ which permits hospices to contract with a self employed physician or a physician employed by a professional entity or physicians’’ group. The new standard at § (a) establishes that, when contracting for medical director services, the contract must specify the name of the physician who assumes the responsibilities and obligations of the medical director.

Medical Director (c) Standard: Recertification of the terminal illness Review clinical information before recertifying (d) Standard: Medical director responsibility Responsible for medical component of the hospice’s patient care program Interpretive Guidelines: Single individual assumes overall responsibility for medical component of pt’s care. Extends to all multiple locations Includes overseeing implement of care for entire IDG Preamble: Our intent in this proposed standard was to ensure that medical directors are actively involved in patient care. The hospice is better suited than the medical director exclusively to choose the physician designee, and we have incorporated this suggestion in § We are requiring hospices to employ or contract with physician designees because, in many hospices, the medical director may be the only physician employee or contractor in the entire hospice. It is essential that another physician be available to assume the medical director’s role when the medical director is absent to ensure continuous quality care for the hospice’s patients. Likewise, it is essential that there be a specific individual identified to be the physician designee. Allowing numerous physicians to fulfill the medical director role would likely result in inconsistent care and decreased accountability. ‘‘Medical director contract,’’ which permits hospices to contract with a self employed physician or a physician employed by a professional entity or physicians’’ group. The new standard at § (a) establishes that, when contracting for medical director services, the contract must specify the name of the physician who assumes the responsibilities and obligations of the medical director.

Clinical records Correct past and current clinical information available to attending physician and hospice staff May be maintained electronically

418.104 Clinical records (a) Standard: Content
Initial plan of care, updated plans of care, initial/comprehensive/updated assessments, clinical notes Signed notice of patient rights and election statement Responses to medications, symptom management, treatments and services Outcome measure data elements (from assessments) Physician certification and recertification Advance directives Physician orders

418.104 Clinical records (b) Standard: Authentication
Entries must be clear, complete, legible, authenticated and dated in accordance with hospice policy and current standards of practice. Interpretive Guidelines: May create its own policy on authentication Must be handwritten or electronic (not stamped) Surveyors must have access to the clinical record. If maintained electronically, hospice must provide all equipment necessary to read record in its entirety Must also produce a paper copy, if requested Preamble: Authentication would include verification of handwritten and/or electronic signatures by signature logs or a computer secure entry of a unique identifier for a primary author who has reviewed and approved the entry. This new standard would address technological changes in information management, such as the computerization of records and electronic signatures. Under § (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.

418.104 Clinical records (b) Standard: Authentication
Procedures and Probes: Ask hospice to explain system of authentication Verify that it includes the following safeguards Method of identify author of each entry, includes verification of author of faxed/electronic entries Electronic authentication must have user ID and password protections in place Every entry must be signed and dated Preamble: Authentication would include verification of handwritten and/or electronic signatures by signature logs or a computer secure entry of a unique identifier for a primary author who has reviewed and approved the entry. This new standard would address technological changes in information management, such as the computerization of records and electronic signatures. Under § (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.

418.104 Clinical records (c) Standard: Protection of information
Must be safeguarded against loss or unauthorized use Must be in compliance with HIPAA regulations Interpretive Guidelines: Must ensure that unauthorized individuals cannot gain access to patient records, and that individuals cannot alter patient records Preamble: Authentication would include verification of handwritten and/or electronic signatures by signature logs or a computer secure entry of a unique identifier for a primary author who has reviewed and approved the entry. This new standard would address technological changes in information management, such as the computerization of records and electronic signatures. Under § (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.

418.104 Clinical records (c) Standard: Protection of information
Procedures and Probes: How does the hospice protect confidentiality of clinical records? What is the policy on leaving and protecting clinical record info in the patient’s home? For EMR, what security safeguards are in place to protect the EMR against loss, theft, damage, disruption of operations or unauthorized use? Is access controlled? Are there measures in place to protect the patient from identify theft? Observe the security practices for patient records – are they left unsecured or unattended (hard copy or electronic?) Verify that adequate precautions are taken to prevent physical or electronic altering. Preamble: Authentication would include verification of handwritten and/or electronic signatures by signature logs or a computer secure entry of a unique identifier for a primary author who has reviewed and approved the entry. This new standard would address technological changes in information management, such as the computerization of records and electronic signatures. Under § (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.

418.104 Clinical records (d) Standard: Retention of records
6 years after death or discharge unless State law says longer If the hospice discontinues operation, it must still comply and notify State agency and CMS Regional Office (RO) of where records will be stored Preamble: Authentication would include verification of handwritten and/or electronic signatures by signature logs or a computer secure entry of a unique identifier for a primary author who has reviewed and approved the entry. This new standard would address technological changes in information management, such as the computerization of records and electronic signatures. Under § (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.

418.104 Clinical records (e) Standard: Discharge or transfer of care
Another Medicare/Medicaid facility- Forward the discharge summary (always) and record (if requested) Revoke election or discharge- Copy of discharge summary to attending physician (always) and record (if requested) Discharge summary includes summary of treatments, symptoms, and pain management; current plan of care; recent physician orders; other documentation Electronic Health Record (EHR) is not mandatory. HHS has a goal that the most individuals will have an EHR by 2014.

418.104 Clinical records (f) Standard: Retrieval of clinical record
Whether hard copy or electronic, the clinical record must be readily available on request by appropriate authority Interpretive Guidelines: Appropriate authority includes representatives from the Surveying Authority or other authorized entity who visit the hospice for the purpose of determining whether the hospice is meeting all CoPs. If EMR, the hospice must provide all equipment necessary to read the record in its entirety. Must also produce a paper copy of the entire record, if requested by the surveyor. Ascertain how the hospice ensures that the record is up-to-date including documentation of recent services/visits or handwritten notes held by staff that were not included in the record when the paper copy was produced. Electronic Health Record (EHR) is not mandatory. HHS has a goal that the most individuals will have an EHR by 2014.

418.106 Drugs/biologicals, medical supplies, and DME
Medical Supplies, Appliances, DME, drugs and biologicals related to the palliation and management of the terminal illness and related conditions, as identified in the hospice POC, must be provided by the hospice while the patient is under hospice care. Preamble: Research shows a 70% reduction in med errors and # of meds prescribed In new standard (a), ‘‘Managing drugs and biologicals,’’ we combined some of the requirements of proposed § (m) and § (n), such as the proposed requirement that a qualified licensed pharmacist direct the inpatient hospice’s pharmaceutical services, including evaluation of a patient’s response to drug therapy, and identification of adverse drug reactions. New standard (a) requires the hospice to ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient’s needs. Hospices may choose to use a licensed pharmacist, an individual who has an extensive and up-to-date knowledge of drugs, to fulfill this role. Standard (a)(2) also incorporates the proposed requirements of § (m) and § (n) that a pharmacist must oversee an inpatient hospice’s pharmacy program. The provided pharmacist services must include evaluation of a patient’s response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action.

(a) Standard: Managing drugs and biologicals Ensure that IDG confers with individual with education and training in drug management to ensure that drugs and biologicals meet each patient’s needs. Employee or under contract Interpretive Guidelines: Pharmacist, Physicians or Nurses certified in palliative care Or others who complete a specific palliative care drug management. Must demonstrate the individual has the training. May take place in person or through other means Preamble: Research shows a 70% reduction in med errors and # of meds prescribed In new standard (a), ‘‘Managing drugs and biologicals,’’ we combined some of the requirements of proposed § (m) and § (n), such as the proposed requirement that a qualified licensed pharmacist direct the inpatient hospice’s pharmaceutical services, including evaluation of a patient’s response to drug therapy, and identification of adverse drug reactions. New standard (a) requires the hospice to ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient’s needs. Hospices may choose to use a licensed pharmacist, an individual who has an extensive and up-to-date knowledge of drugs, to fulfill this role. Standard (a)(2) also incorporates the proposed requirements of § (m) and § (n) that a pharmacist must oversee an inpatient hospice’s pharmacy program. The provided pharmacist services must include evaluation of a patient’s response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action.

(a) Standard: Managing drugs and biologicals Inpatient care directly: Pharmacy services under direction of licensed pharmacist, including evaluation of patient’s response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective actions. (Ensure that no drugs are obtained through Medicare Part D.) Preamble: Research shows a 70% reduction in med errors and # of meds prescribed In new standard (a), ‘‘Managing drugs and biologicals,’’ we combined some of the requirements of proposed § (m) and § (n), such as the proposed requirement that a qualified licensed pharmacist direct the inpatient hospice’s pharmaceutical services, including evaluation of a patient’s response to drug therapy, and identification of adverse drug reactions. New standard (a) requires the hospice to ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient’s needs. Hospices may choose to use a licensed pharmacist, an individual who has an extensive and up-to-date knowledge of drugs, to fulfill this role. Standard (a)(2) also incorporates the proposed requirements of § (m) and § (n) that a pharmacist must oversee an inpatient hospice’s pharmacy program. The provided pharmacist services must include evaluation of a patient’s response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action.

(b) Standard: Ordering of drugs Ordered by physician or NP Verbal or electronic orders given only to licensed nurse, pharmacist, or physician and must be recorded and signed in accordance with all regulations Preamble: New standard (b), ‘‘Ordering of drugs,’’ relocates the requirements of proposed § (n)(1). This new standard indicates who may order drugs for a hospice patient and how verbal or electronic drug orders should be documented. New standard (c), ‘‘Dispensing of drugs and biologicals,’’ combines some of the requirements of proposed § (m), with proposed § (n)(4)(ii). This new standard requires a hospice to have a written policy that promotes dispensing accuracy, to maintain current and accurate records of the receipt and disposition of all controlled drugs, and to obtain drugs and biologicals from community or institutional pharmacists or from its own stock.

(c) Standard: Dispensing of drugs and biologicals Obtain drugs from community or institutional pharmacists or stock itself (no Canadian pharmacies) Inpatient care directly: Written policy to promote dispensing accuracy; accurate records (Ensure no conflict of interest – Access/performance rebates should not drive patient care decisions) Interpretive Guidelines: Biological is any medicinal preparation made from living organisms and their products including, but not limited to serums, vaccines, antigens and antitoxins Preamble: New standard (b), ‘‘Ordering of drugs,’’ relocates the requirements of proposed § (n)(1). This new standard indicates who may order drugs for a hospice patient and how verbal or electronic drug orders should be documented. New standard (c), ‘‘Dispensing of drugs and biologicals,’’ combines some of the requirements of proposed § (m), with proposed § (n)(4)(ii). This new standard requires a hospice to have a written policy that promotes dispensing accuracy, to maintain current and accurate records of the receipt and disposition of all controlled drugs, and to obtain drugs and biologicals from community or institutional pharmacists or from its own stock.

(d) Standard: Administration of drugs and biologicals IDG must determine, as part of POC, patient/family ability to safely administer drugs Inpatient care directly-Administered by licensed nurse, physician, other health care professionals in accordance with State requirements(family intentionally left out) Patient may self administer upon approval by IDG Interpretive Guidelines: Individualized written POC should identify if pt and/or family are self-administering. If not capable, IDG must address this in POC Preamble: New standard (d), ‘‘Administration of drugs and biologicals,’’ combines the requirements of proposed § (a)(2) and § (n)(2). The new standard addresses drug administration in both the home and hospice inpatient facility environments to ensure that drugs and biologicals are administered to a patient by an individual who is competent to do so, regardless of the patient’s current environment. New standard (e), ‘‘Labeling, disposing, and storing of drugs and biologicals,’’ combines and revises the requirements of proposed § (b) and § (n)(3), (n)(4)(i), (n)(4)(iii), and (n)(5). This new standard ensures that drugs are safely labeled, stored, and disposed of in accordance with accepted standards of practice and applicable Federal and State laws and regulations. It also ensures that patients and families are properly educated about drug disposal.

(e) Standard: Labeling, disposing, and storing of drugs and biologicals Labeled in accordance with accepted standards, including appropriate instructions and expiration date Interpretive Guidelines: Must have system to ensure that outdated, mislabeled, or otherwise unusable drugs are not provided Preamble: New standard (d), ‘‘Administration of drugs and biologicals,’’ combines the requirements of proposed § (a)(2) and § (n)(2). The new standard addresses drug administration in both the home and hospice inpatient facility environments to ensure that drugs and biologicals are administered to a patient by an individual who is competent to do so, regardless of the patient’s current environment. New standard (e), ‘‘Labeling, disposing, and storing of drugs and biologicals,’’ combines and revises the requirements of proposed § (b) and § (n)(3), (n)(4)(i), (n)(4)(iii), and (n)(5). This new standard ensures that drugs are safely labeled, stored, and disposed of in accordance with accepted standards of practice and applicable Federal and State laws and regulations. It also ensures that patients and families are properly educated about drug disposal.

(e) Standard: Labeling, disposing, and storing of drugs and biologicals (cont’d) Written policies and procedures for managing and disposing of drugs in patient’s home At the time when controlled drugs are first ordered, must provide these P&P to family in a language and manner the patient and family can understand, document discussion in clinical record Interpretive Guidelines: Must also address safe use and disposal of controlled drugs at other times, such as when discontinued, new drug ordered, or patient dies

(e) Standard: Labeling, disposing, and storing of drugs and biologicals (cont’d) Inpatient care directly- Dispose in compliance with hospice policy and Federal and State requirements, maintain current and accurate records Inpatient care directly- Stored in secured areas in locked compartments, only authorized personnel may have access (double locked) Inpatient care directly: Investigate discrepancies and report to appropriate State authority, document investigation and make available to appropriate authorities as required

(f) Standard: Use and maintenance of equipment and supplies Follow manufacturer recommendations for DME maintenance Ensure policies developed in absence of manufacturer recommendations DME must be safe and must work as intended Instruct patient and family in proper use of DME and supplies, must be able to demonstrate May contract for all DME services; must only contract with supplier meeting Medicare DMEPOS Standards DME: If no recommendations written for equipment; then recommendations need to be developed Can continue to contract out service Pt/family-be able to demo back to hospice use of equipment Needs to be with a DMEPOS accredited company-if they provide service to Medicare beneficiaries, must be accredited. Preamble: As part of the effort to ensure quality DME services for Medicare beneficiaries, the Medicare Supplier Quality and Accreditation Standards require DME suppliers to be accredited by national accrediting organizations. (See 42 CFR ) Accreditation requires regular surveys by CMS-approved accrediting bodies.

(f) Standard: Use and maintenance of equipment and supplies Interpretive Guidelines: Instruction on use of DME and supplies must be documented in the clinical record as well as the pt/family’s understanding of the safe use of Procedures and Probes: During home visit ask the pt/family to describe any instructions received regarding use of DME/supplies. Has the pt/family had any problems? Does the DME function as required and intended Clinical record should support their responses DME: If no recommendations written for equipment; then recommendations need to be developed Can continue to contract out service Pt/family-be able to demo back to hospice use of equipment Needs to be with a DMEPOS accredited company-if they provide service to Medicare beneficiaries, must be accredited. Preamble: As part of the effort to ensure quality DME services for Medicare beneficiaries, the Medicare Supplier Quality and Accreditation Standards require DME suppliers to be accredited by national accrediting organizations. (See 42 CFR ) Accreditation requires regular surveys by CMS-approved accrediting bodies.

418.108 Short Term In-Patient Care
Inpatient care must be available for pain control, symptom management and respite purposes (a) Standard: Inpatient care for symptom management and pain control Provided in a Medicare-certified facility Hospice that meets CoPs of Hospital that meets CoPs of 418. (b) and (e) LTC with 24 hour nursing (RN) services Removed 24 hr RN requirement for respite care (effective December 2, 2008) Facility staff must be trained (evidence of training) Identify go to person for facility and hospice in contract Absence of ‘caregiver breakdown’ as reason for GIP

(b) Standard: Inpatient care for respite purposes Same 3 locations as (a) Nursing services must meet patient needs (does not require 24 hour RN) Typo in CoPs- Reference SHOULD be to (e) NOT (f) Interpretive Guidelines: Must assure that the facility has enough nursing personnel present on all shifts to guarantee adequate safety measures and routine, special and emergency needs of all patient are met at all times. Removed 24 hr RN requirement for respite care (effective December 2, 2008) Facility staff must be trained (evidence of training) Identify go to person for facility and hospice in contract Absence of ‘caregiver breakdown’ as reason for GIP

(c) Standard: Inpatient care provided under arrangements with written agreement Hospice must: provide copy of the plan of care, specify services, retain responsibility for ensuring training of facility personnel, and have a method for verifying that the requirements of this section are met. Facility must: have copy of plan of care, have patient care policies consistent with the hospice, and have an identified individual responsible for implementation of the written agreement. Inpatient clinical record must document all inpatient services and events; a copy of the inpatient clinical record must be available to the hospice at discharge; and a copy of the discharge summary is provided to the hospice at discharge Preamble: § (c)(5) and § (c)(6) to require the agreement between the hospice and the inpatient facility to state: ‘‘that the hospice retains responsibility for ensuring that the training of personnel who will be providing the patient’s care in the inpatient facility has been provided and that a description of the training and the names of those giving the training is documented; and (6) A method for verifying that the requirements in paragraphs (c)(1) through (c)(5) of this section are met.’’

(c) Standard: Inpatient care provided under arrangements with written agreement Interpretive Guidelines: May have arrangements with more than one facility Procedures and Probes Ask the clinical manager what facility they use and how they monitor care. If concerns, ask to review the written agreement. Ask how the hospice assures that all staff caring for hospice patients have been trained in hospice philosophy and are able to provide care according to POC. If necessary, contact or visit the facilities to verify compliance. Preamble: § (c)(5) and § (c)(6) to require the agreement between the hospice and the inpatient facility to state: ‘‘that the hospice retains responsibility for ensuring that the training of personnel who will be providing the patient’s care in the inpatient facility has been provided and that a description of the training and the names of those giving the training is documented; and (6) A method for verifying that the requirements in paragraphs (c)(1) through (c)(5) of this section are met.’’

(d) Standard: Inpatient care limitation Total number of inpt days used by Medicare beneficiaries over 12 month period may not exceed 20% of total number of hospice days in the aggregate. Interpretive Guidelines: Applies to Medicare beneficiaries only (e) Standard: Exemption from limitation Exemption applied between 1975 and 1986 Preamble: If the patient is admitted for a reason other than the need for short-term respite care, or for symptom management or pain ---control, then the patient is not receiving an inpatient level of care that counts toward the 20 percent inpatient cap. Patients admitted for reasons other than short-term respite care, symptom management, or pain control receive the routine home care level of payment.

418.110 Hospices that provide in-pt care directly
(a) Standard: Staffing Reflects volume, acuity, and intensity of services needed by patients to achieve patient care outcomes and avoid negative outcomes Interpretive Guidelines Adequate staffing means that the numbers and types of qualified, trained and experienced staff on the inpt unit meet the care needs of every patient. Waiver – for 2 patient per room requirement Preamble: allow existing hospice facilities with more than two patients in each room to receive a waiver of this requirement. This waiver would be based on whether the hospice was already providing direct inpatient care in a non-compliant facility when this regulation became effective. That is, if a hospice was providing direct inpatient care in a non-compliant building on the day before the effective date of the final rule and could demonstrate that the imposition of a two-patient-per-room requirement would result in unreasonable hardship or jeopardize its ability to continue to participate in Medicare or Medicaid, then the hospice operating in the non-compliant building could qualify for a waiver of the proposed requirement. A hospice would have to demonstrate to CMS that the waiver served the needs of its patients and did not adversely affect their health and safety. If that same hospice moved into a non-compliant building after the effective date of this final rule, then the hospice would be deemed out of compliance with our rules. If a hospice chose to begin operating its own inpatient unit after the effective date of this final rule, then it would not qualify for the proposed waiver, and would be required to have no more than two patients per room. The remaining paragraphs in this standard would be virtually the same as in the current requirement, with only minor revisions to the language that would not change the substantive requirements of the Regulation.

(a) Standard: Staffing Procedures and Probes: How does the hospice assure there is adequate staff, especially during evenings, nights, weekends and holidays? Interview pt/family to determine if they were satisfied with the care and services Observe if staff is responsive to needs and if call bells are answered promptly Do pts frequently call for assistance? Are pts checked frequently? Waiver – for 2 patient per room requirement Preamble: allow existing hospice facilities with more than two patients in each room to receive a waiver of this requirement. This waiver would be based on whether the hospice was already providing direct inpatient care in a non-compliant facility when this regulation became effective. That is, if a hospice was providing direct inpatient care in a non-compliant building on the day before the effective date of the final rule and could demonstrate that the imposition of a two-patient-per-room requirement would result in unreasonable hardship or jeopardize its ability to continue to participate in Medicare or Medicaid, then the hospice operating in the non-compliant building could qualify for a waiver of the proposed requirement. A hospice would have to demonstrate to CMS that the waiver served the needs of its patients and did not adversely affect their health and safety. If that same hospice moved into a non-compliant building after the effective date of this final rule, then the hospice would be deemed out of compliance with our rules. If a hospice chose to begin operating its own inpatient unit after the effective date of this final rule, then it would not qualify for the proposed waiver, and would be required to have no more than two patients per room. The remaining paragraphs in this standard would be virtually the same as in the current requirement, with only minor revisions to the language that would not change the substantive requirements of the Regulation.

(a) Standard: Staffing Procedures and Probes: Ask hospice management for inpt staffing schedules and pt census for the past month to determine if staffing was adequate to meet needs How does the hospice determine the staff-to-patient ratios on each shift? Review at least one clinical record to evaluate if staff provided treatments, medications, personal care and diet in compliance with POC If questions arise concerning staffing patterns (illness, tardiness), review staffing schedule and/or timecards Waiver – for 2 patient per room requirement Preamble: allow existing hospice facilities with more than two patients in each room to receive a waiver of this requirement. This waiver would be based on whether the hospice was already providing direct inpatient care in a non-compliant facility when this regulation became effective. That is, if a hospice was providing direct inpatient care in a non-compliant building on the day before the effective date of the final rule and could demonstrate that the imposition of a two-patient-per-room requirement would result in unreasonable hardship or jeopardize its ability to continue to participate in Medicare or Medicaid, then the hospice operating in the non-compliant building could qualify for a waiver of the proposed requirement. A hospice would have to demonstrate to CMS that the waiver served the needs of its patients and did not adversely affect their health and safety. If that same hospice moved into a non-compliant building after the effective date of this final rule, then the hospice would be deemed out of compliance with our rules. If a hospice chose to begin operating its own inpatient unit after the effective date of this final rule, then it would not qualify for the proposed waiver, and would be required to have no more than two patients per room. The remaining paragraphs in this standard would be virtually the same as in the current requirement, with only minor revisions to the language that would not change the substantive requirements of the Regulation.

(b) Twenty-four hour nursing services 24 hour nursing services to meet patient needs Each pt must received nursing services prescribed and must be kept comfortable, clean, well-groomed and protected from accident, injury and infection If at least one patient is receiving GIP, then each shift must include a RN who provides direct patient care Interpretive Guidelines: General Inpatient Care for pain control, symptom management, which cannot be managed in other settings, is a different level of care than respite care. Procedures and Probes: Ask for schedule of RN personnel for past month, inquire about mechanism to ensure RN provides direct pt care. Waiver – for 2 patient per room requirement Preamble: allow existing hospice facilities with more than two patients in each room to receive a waiver of this requirement. This waiver would be based on whether the hospice was already providing direct inpatient care in a non-compliant facility when this regulation became effective. That is, if a hospice was providing direct inpatient care in a non-compliant building on the day before the effective date of the final rule and could demonstrate that the imposition of a two-patient-per-room requirement would result in unreasonable hardship or jeopardize its ability to continue to participate in Medicare or Medicaid, then the hospice operating in the non-compliant building could qualify for a waiver of the proposed requirement. A hospice would have to demonstrate to CMS that the waiver served the needs of its patients and did not adversely affect their health and safety. If that same hospice moved into a non-compliant building after the effective date of this final rule, then the hospice would be deemed out of compliance with our rules. If a hospice chose to begin operating its own inpatient unit after the effective date of this final rule, then it would not qualify for the proposed waiver, and would be required to have no more than two patients per room. The remaining paragraphs in this standard would be virtually the same as in the current requirement, with only minor revisions to the language that would not change the substantive requirements of the Regulation.

(c) Standard: Physical environment Maintain a safe environment free of hazards Procedures and Probes: Ask what security mechanism are in place and being followed Review and analyze incident and accident reports, expand review if suspect a problem. If hospice has identified problems, did it evaluate and take steps to ensure a safe patient environment? How does hospice assure staff follows current standards of practice for environmental safety, infection control and security?

(c) Standard: Physical environment Written disaster preparedness plan for emergencies that affect ability to provide care. Plan must be periodically reviewed and rehearsed with staff Interpretive Guidelines: There should be documentation of LSC fire drills at varied times on all shifts

(c) Standard: Physical environment Procedures and Probes: Request a copy of the disaster plan and determine if content addresses power failures, natural disasters and other potential emergencies Request a copy of staff orientation/training on components of the disaster plan What is the procedure for notification of staff, pts, physicians and others in the case of an emergency? Interview random staff to assess their knowledge of specific responsibilities during a disaster or drill Are evacuation diagrams posted and visible? Review evidence of planning

(c) Standard: Physical environment Procedures to control trash, light, temperature, ventilation, gas, water, and equipment Interpretive Guidelines: Trash refers to garbage and biohazardous waste Disposal should be in accordance with laws and regs Must have system to provide emergency gas and water as needed Procedures and Probes: Ask for explanation of system for providing emergency water and gas and routine maintenance. Determine that maintenance inspections are performed How does hospice assure reliability and quality of light, temperature, ventilation/air?

(d) Standard: Fire protection- compliance with 2000 edition of the Life Safety Code Procedures and Probes: Is there documentation of compliance with LSC or state requirements? Request to see evidence that drills have been held on all shifts at varied times Where does the hospice document and store its dated, written report and evaluation of each drill? Request evidence of latest checks of fire extinguishers, sprinkler systems, smoke alarms and observe location of each Are there functional smoke alarms in each patient room? Does a preventive maintenance program exist?

(e) Standard: Patient areas Home-like, family accommodations, visitors at any hour Privacy during stay and after death Interpretive Guidelines: Homelike de-emphasizes the institutional character of the setting to the extent possible. Procedures: Interview pt/family to validate visiting hours not restricted and accommodations during the night are provided Observe pt areas for above requirements Are window treatments and floor coverings homelike?

(f) Standard: Patient rooms Rooms designed for nursing care, dignity, comfort and privacy Accommodate request for private room whenever possible Details rooms specifics in standard and IG No more than 2 patients per room with a waiver available if there is an unreasonable hardship for facilities in existence prior to Dec. 2, 2008. Procedures: Does each bed have flame retardant cubicle curtains, movable screen or other means of providing full visual privacy?

(g) Standard: Toilet / bathing facilities- In the patient room or nearby. (h) Standard: Plumbing facilities- Adequate hot water supply with temperature control valves (i) Standard: Infection control- Program that meets § 418.60 (j) Standard: Sanitary environment– Current standards of practice Interpretive Guidelines/Procedures and Probes: Review full IG/PP for above standards

(k) Standard: Linen- Adequate supply of clean linens available; handled in a manner to prevent spread of infection (l) Standard: Meal service and menu planning Consistent with patient plan of care Palatable and attractive Prepared under sanitary conditions Interpretive Guidelines/Procedures and Probes: Review full IG and PPs for above standards

(m) Standard: Restraint or seclusion All patients have the right to be free from restraint or seclusion imposed as a means of coercion, discipline, convenience, or retaliation Only imposed to ensure safety of patient, staff, or others when less restrictive interventions have not succeeded Discontinued at the earliest possible time In accordance with a modification to the patient’s plan of care AND a physician’s order Interpretive Guidelines: No standing orders or PRN Restraints (new section) not many comments returned statute followed-hospital must have restraint regs Last resort-document lead up to the use of the restraints Only applies to inpatient – not home care

(m) Standard: Restraint or seclusion Medical Director notified ASAP if attending did not order Implemented with safe techniques No more than 24 hours total; orders renewed every 4 hours for adults (shorter time for pediatrics) Face to face assessment after 24 hours before writing a new order Monitored by trained staff Face-to-face evaluation every hour for violent or self-destructive behavior

(n) Standard: Restraint or seclusion staff training requirements Staff trained before implementing seclusion or restraint techniques, at orientation, and on a periodic basis thereafter Training addresses all relevant areas Training documentation in personnel records Interpretive Guidelines: Review IGs and Standards for details on training and documentation

(o) Standard: Death reporting requirements Report deaths associated with use of or within 24 hours after removed from seclusion or restraint Report deaths within 1 week of seclusion or restraint use when reasonable to assume a relationship. Report by phone to CMS no later than the close of the next business day after death; document reporting in patient’s clinical record Interpretive Guidelines: Review IGs for details regarding this standard

418.112 Hospices that provide care in SNF/NF
There will eventually be companion regulations in the SNF/NF rules. These rules apply to SNF residents on Routine Home Care (a) Standard: Resident eligibility, election, and duration of benefits Same as for other hospice patients Revised from proposed version. LTC proposed regs placed on hold until hospice published; in CMS clearance now – on hold until 2009 LTC regs are the companion to the hospice regulations

(b) Standard: Professional management Hospice assumes responsibility for professional management of resident’s hospice care Hospice arranges for hospice-related inpatient care Interpretive Guidelines: Professional management for a pt who resides in a SNF has the same meaning as the pt living in his/her own home – all services are provided Involves assessing, planning, monitoring, directing, and evaluating hospice care across all settings Core services cannot be delegated to the facility Facility staff should immediately notify hospice of unplanned interventions Revised from proposed version. LTC regs published in 2010 LTC regs are the companion to the hospice regulations

(c) Standard: Written agreement Signed written agreement specifying the provision of hospice services in the facility before services begin Agreement includes: Communication and documentation strategy to meet patient needs 24 hours/day Interpretive Guidelines: Should be evidence of agreement on how to communicate concerns and responses 24 hours/day to meet needs of pt identified in POC

(c) Standard: Written agreement Procedures and Probes: What system is in place to assure that the facility knows how to notify the hospice 24/7? Is there evidence that communication is not occurring during various times of week or specific shifts How does hospice ensure that facility staff are able to recognize the individual who are receiving hospice services and know that services should be in accordance with coordinated POC? What evidence is there of communication during and between visits? Does the hospice staff have access to and ability to communicate with facility staff as often as needed?

(c) Standard: Written agreement Agreement includes: Provision for notifying hospice if: Significant change in patient condition, Clinical complications, Need to transfer and hospice makes arrangements and remains responsible for, Patient dies Procedures and Probes: Have there been instances when facility transferred pt to hospital without notifying the hospice? Have there been instances when the hospice was unaware of significant change in pt status or pt death? How does the hospice ensure that facility staff will contact the hospice immediately with any change in pt condition?

(c) Standard: Written agreement Agreement includes: Hospice responsibility for determining hospice level of care Facility responsibility for 24 hour room and board, meeting patient needs as the primary caregiver (same level of services) Interpretive Guidelines: Both providers must comply with their application CoPs Facility must offer same services to residents who have elected MHB as those who have not elected MHB If facility failed to address concerns as advised by hospice, surveyor is to report concerns to state agency responsible for oversight of facility.

(c) Standard: Written agreement (cont’d) Agreement includes: Hospice responsibility to provide services to same extent as serving a patient in a private home (IG - may not delegate services to facility staff) Delineation of hospice responsibilities (same as in home care) Probe: Is there evidence that the hospice provides the services as needed, as well as medications, equipment and supplies 24/7?

(c) Standard: Written agreement (cont’d) Agreement includes: Provision to use facility personnel to assist in implementing the plan of care only to the extent that a hospice would routinely use a patient’s family, (include how specific crisis situations will be handled in the plan of care.) Hospice reports to facility administrator all patient rights violations by anyone unrelated to the hospice Bereavement services to SNF/NF staff Interpretive Guidelines: Hospice may offer bereavement services to facility staff or residents that fulfill the role of a pt’s family as identified in the POC

(d) Standard: Hospice plan of care Established and maintained for each patient in accordance with Established and maintained in consultation with facility representatives and patients/families Interpretive Guidelines: POC must identify which provider is responsible for performing a specific service Procedures and Probes: Interview pt/family to determine their involvement in development of POC Determine whether all interventions have been provided by hospice and have there been any delays?

(d) Standard: Hospice plan of care Changes discussed with patient/ representative and facility representative, and approved by hospice before implementation Interpretive Guidelines: Must have a process by which information will be exchanged when updating the POC. Hospice must authorize all changes to hospice portion Procedures and Probes: Based on observations, if concerns are identified or pt/family indicates that interventions are not meeting needs, interview hospice and facility staff

(e) Standard: Coordination of services Hospice designates IDG member to coordinate implementation of plan of care with facility representatives Designated individual provides overall coordination of care with facility, communicates with facility to implement hospice plan of care Interpretive Guidelines: May or may not be RN, can be any other member of IDG Coordinate how hospice staff access/communicate with facility staff over elements of providing services CMS Staff “Current practice is a ‘disaster’ – POC aren’t coordinated, Hospice/SNF staff don’t know what the other is doing SNF surveys will always include a hospice record. If issues are found, then hospice surveyors are notified Aide functions as a caregiver; hospice provides the additional care needed Bereavement for facility staff-removed; facility responsible

(e) Standard: Coordination of services Procedures and Probes: Does the hospice’s system for ordering, renewal, delivery and administration of medications work effectively in the facility? What procedures are in place to ensure that the pt receives timely medication and treatments? Is the evidence that the hospice provides education to the facility on hospice resident’s pain and symptom management plan? Does the hospice work with the facility to monitor effectiveness of treatments related to pain and symptom control? CMS Staff “Current practice is a ‘disaster’ – POC aren’t coordinated, Hospice/SNF staff don’t know what the other is doing SNF surveys will always include a hospice record. If issues are found, then hospice surveyors are notified Aide functions as a caregiver; hospice provides the additional care needed Bereavement for facility staff-removed; facility responsible

(e) Standard: Coordination of services Hospice ensures IDG communication with outside physicians, beyond terminal illness Procedures and Probes: If problems identified regarding failure to communicate, interview hospice designated IDG member and facility care plan coordinator in order to determine system of communication If concerns related to coordination and implementation of POC, interview facility nurse aides who provide direct care to patient Review POC to determine if plan was coordinated Interview facility staff person who is knowledgeable about needs and care of pt to determine if needs met CMS Staff “Current practice is a ‘disaster’ – POC aren’t coordinated, Hospice/SNF staff don’t know what the other is doing SNF surveys will always include a hospice record. If issues are found, then hospice surveyors are notified Aide functions as a caregiver; hospice provides the additional care needed Bereavement for facility staff-removed; facility responsible

(e) Standard: Coordination of services Hospice provides facility with: Plan of care Hospice election form and advance directives Certification and re-certification forms Contact information for hospice personnel Instructions for accessing hospice’s 24-hour on-call system Patient-specific medication information Physician orders – hospice and attending Interpretive Guidelines: Must have process by which information will be exchanged Probes: Interview facility staff involved in care of pt on their knowledge of how to contact hospice 24/7

(f) Standard: Orientation and training of staff Hospice assures orientation of facility staff in hospice philosophy, policies and procedures, pain control and symptom management methods, patient rights, forms, and record keeping. Include rules and processes for hospice/SNF care coordination Interpretive Guidelines: Hospice’s responsibility to assess need and frequency for training Procedures and Probes: During observations, if concerns noted, interview hospice staff on how they provide education to facility staff Must document facility staff training to hospice. If another hospice has already trained facility staff, your hospice may use documentation of that training to meet requirement.

418.114 Personnel Qualifications
(a) Standard: General qualification requirements All professionals (direct employees, individual contractors, and those under arrangements) must be legally authorized to practice in the State in which they work All professionals must only act within their scope All professionals must keep their qualifications current at all times

(b) Standard: Personnel qualifications for certain disciplines Physicians- 1861(r) of the Act and §410.20 Hospice aide- Meet requirements of §418.76 Social worker- MSW with 1 year experience; or Bachelors in social work, psychology, sociology, or other related field AND 1 year experience AND supervised by MSW; or Bachelor’s in social work AND employed by hospice before the effective date of the final rule (December 2, 2008) Interpretive Guidelines: Must employ or contract with at least one MSW to serve in supervisor role, may occur in person, over phone or electronic Preamble: The large number of public comments submitted in reference to the personnel requirements for social workers, coupled with the divergent views expressed in the comments, leads us to believe that there is no standard or consensus in the hospice industry on this issue. Our goal is to balance the needs of patients and families at a very stressful time and the needs of hospices that may have difficulty employing personnel who meet appropriate personnel standards. We believe that all hospices should strive to employ the most qualified individuals possible to provide social work services to patients and families. If a hospice chooses to employ a social worker with a baccalaureate degree in social work, psychology, sociology, or other field related to social work, the services of that baccalaureate social worker must be provided under the supervision of a social worker with an MSW from a school of social work accredited by the Council on Social Work Education and one year of experience in a health care setting. We believe that requiring MSW supervision of BSW services will help ensure that patient and family needs are met in a complete and timely manner. The MSW supervisor role is that of an active advisor, consulting with the BSW on assessing the needs of patients and families, developing and updating the social work portion of the plan of care, and delivering care to patients and families. This supervision may occur in person, over the telephone, through electronic communication, or any combination thereof. Social workers with a baccalaureate degree from a school of social work accredited by the Council on Social Work Education and who are employed by the hospice before the effective date of this final rule are exempted from the MSW supervision requirement. Therefore, if a hospice currently employs a BSW, unsupervised by an MSW, it is not required to hire an MSW to supervise the BSW. If a hospice hires a new social worker with a baccalaureate degree and one year of experience in a health care setting, then the new baccalaureate social worker must be supervised by an MSW who has one year of experience in a health care setting. Supervision can be done remotely. Internship could qualify for experience.

(b) Standard: Personnel qualifications for certain disciplines Speech-language pathologists Occupational therapist Occupational therapy assistant Physical therapist Physical therapist assistant (c) Personnel qualifications when no State licensing, certification or registration requirements exist Registered nurse Licensed practical nurse Preamble: In this final rule we are incorporating changes made by a separate final rule (72 FR 66222, 66406, November 27, 2007) to the personnel qualifications for physical therapists, physical therapist assistants, occupational therapists, occupational therapist assistants, and speech-language pathologists. That final rule amended § of the existing hospice regulations to cross reference the revised personnel requirements contained in 42 CFR 484.4, thereby requiring physical therapists, physical therapist assistants, occupational therapists, occupational therapist assistants, and speech-language pathologists subject to the requirements of the hospice conditions of participation to meet the same personnel requirements as therapists subject to the requirements of the home health agency conditions of participation. In this final rule, we continue to require therapists who are subject to the requirements of the hospice conditions of participation to meet the same personnel requirements as therapists subject to the requirements of the home health agency conditions of participation, as was required by the November 27, 2007 final rule.

(d) Standard: Criminal background checks All employees with direct patient contact or access to patient records (hospice staff & contracted staff) Hospice contracts must require contracted entities to obtain employee background checks Obtained in accordance with State requirements If no State requirements, must be obtained within 3 months of date of employment for all states where the individual has lived or worked in the past 3 years WA has less restrictive requirements that meet this standard Preamble: We believe that any individual who has direct patient contact or has access to a patient’s records, clinical, financial or otherwise, should have a criminal background check because these individuals are in a position that enables them to violate patient rights to both safety and privacy. This includes all current paid hospice employees, volunteers, and contracted employees, as well as any new employees. If an office employee, such as a receptionist, does not have access to patient records, and does not make patient visits, then that employee is not required to have a criminal background check. If a volunteer is a homemaker, and thus has direct patient contact, he or she is required to have a background check. We understand that hospices would likely not actually conduct background checks on contracted employees. We have added a statement to § (d)(1) that hospices must require, as part of their written agreement with a contractor, that the contractor provides the hospice a background check for each contracted employee who has direct hospice patient contact or access to hospice patient records. We believe that requiring all individuals who have direct patient contact or access to patient records to have background checks will help hospices assure that patient rights are protected at all times.

Compliance with Federal, State, and local laws and regulations related to health and safety of patients In compliance with all laws and regulations. (Catch all condition) Hospice licensed if required by State (a) Standard: Multiple locations Disclosure of ownership Approved by Medicare and licensed by the State (b) Standard: Laboratory services Lab testing (self or contracted) in accordance with CLIA requirements Interpretive Guidelines: Review in detail as they apply to this standard

Any Final Questions? Anne Koepsell WSHPCO

Resources CMS – NHPCO - Weatherbee Resources, Inc. Deyta OCS Systems

Resources Agency for Healthcare Research and Quality
National Quality Forum excelleRx – (Hospice Pharmacia) MultiView

CoPs/IGs: The Rules We Live By

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