“What You Need to Know About The ‘New’ CoPs and Interpretive Guidelines”

1. “What You Need to Know About The ‘New’ CoPs andInterpretive Guidelines” Jennifer Kennedy, MA, BSN National Hospice and Palliative Care Organization

2. Objectives • Review highlights of the new hospice CoPs and accompanying interpretive guidelines. • Discuss “survey ready” action tips. • Identify resources on the NHPCO website that your hospice can access as a provider member.

3. Interim Final Interpretive Guidelines Version 1.1 posted by the Center for Medicare and Medicare Services’ Survey and Certification Group as “interim” final guidelines on January 2, 2009. NHPCO posted a scanned copy of the draft interim interpretive guidelines, Version 1.0 on their website on November 21, 2008. There may be changes in the interim final interpretive guidelines before they publically post to the State Operations Manual.

4. Survey focus • The primary focus of the survey is on patient outcomes, the hospice’s practices in implementing the requirements, and provision of hospice services. • The process: • Surveyor focus on the services provided • Surveyor examines structures and processes that contribute to the quality of the services. • The intent of the survey is to evaluate each of the CoPs in the most efficient manner possible.

5. 418.52 Patient’s rights A violation of any patient right would be subject to a condition level deficiency. L502 - Policy and procedures reflects: During the initial assessment visit. Provide rights verbally and in writing. Verify representative authority. Evidence translation services provided or all attempts were made to provide translation in a language the patient understands. Family per patient request/ last resort L504 - Signature of patient/ representative that notice of rights and responsibilities was received.

6. L500 - 418.52 Patient’s rights • L503 - Advance directives. • Hospice must provide advance directive information as needed/ per patient request. • Cannot refuse service based on advance directive content. • Hospice must provide a statement of limitation if advance directive cannot be honored on the basis of conscience. • L505 - Exercise of rights and respect for property and person. • 5 working days from becoming aware of complaint to investigate; If verified, report to state/local bodies within those 5 days.

7. 418.52 Patient’s rights L512 - Pain management & symptom control • Hospice response to patient’s request for pain management 24/7 L513 - (2) Be involved in developing his or her hospice plan of care • Surveyor will: • Ask staff how they facilitate patient/family participation in planning care. • Ask the patient/family how they are involved in planning care. • L514 - Refuse care or treatment • Has the hospice tracked and trended service refusal?

8. Survey readiness tips! • Ensure staff members understand this regulation • Observe hospice admission staff’s performance • Review grievance reporting procedure and organizational chain to report a patient grievance • Ensure that you have reliable translation services in place • Keep a clean, updated copy of a patient rights signature form and admission packet ready for time of survey • Provide the patient with a copy of the signed notice of rights • Designate a common location in a patient’s home where the admission information will be kept • Periodically re-review patient rights information with patient/family

9. 418.54 Initial & comprehensive assessment Interpretives guidelines – L520 – L535 L522 - Initial assessment. • Not a “meet and greet” visit. • Completed by RN. • 48 hours from the effective date of the notice of election. • Must be completed in the location where the hospice services are being delivered. • RN begins to develop the plan of care. • Focus is on meeting immediate needs of patient/ family.

10. 418.54 Initial & comprehensive assessment L523, L524 - Comprehensive assessment • 5 calendar days from the effective date of the notice of election. • Plan of care is not formed by RN in a vacuum. • IDG participation • Attending physician • Guidelines: • Heavy focus on pain assessment. • Initial bereavement assessment. • Medication review. • Are current medications achieving the outcome wanted by the patient?

11. 418.54 Initial & comprehensive assessment L533 - Update of the comprehensive assessment. • Assessment updates should be easily identified in the clinical record. • Required to document if there were no changes in the condition of the patient/family needs. • Evidence that IDG is actively involved in evaluating patient care. L534 - Patient outcome measures. • Must be include data elements in assessment that would allow for the measurement of outcomes.

12. Survey readiness tips! • Adhere to the specified timeframes in 418.54 • Initial assessment = 48 hrs • Comprehensive assessment = 5 calendar days • Use your assessment tools as tools; these forms are not just pieces of paper! • Educate hospice staff about importance of comprehensive assessment and its impact on the plan of care and patient outcomes • Ensure that you can evidence there is patient/family participation • Be able to describe your process for patient element data identification and collection

13. § 418.56 Interdisciplinary group, care planning, and coordination of services Plan of Care • Individualized plan of care. • Development is collaborative. • Signatures on plan of care not necessary, but documentation of collaboration must be evident. • Include complimentary/ alternative therapies if provided to patient/ family. • Medications • Proactive anticipation of side effects. • Preventative measures implemented. • Hospice response to patient needs for pain/ symptom management.

14. § 418.56 Interdisciplinary group, care planning, and coordination of services L547 - Content of the plan of care • Scope and frequency of services • Visit ranges acceptable • Small intervals (1-3/week) • PRN visits acceptable as an accompaniment to an established visit frequency. • PRN may not be a standalone visit frequency • Standing orders must be individualized and signed by patient’s physician. • Measurable outcomes • Outcomes should be a measureable result of the implementation of the plan of care.

15. § 418.56 Interdisciplinary group, care planning, and coordination of services L522 - Review of the plan of care • As frequently as the patient’s condition requires, but no less frequently than every 15 calendar days. • Communication with attending may be through phone calls, electronic methods, orders received, or other means. • Define in policy

16. § 418.56 Interdisciplinary group, care planning, and coordination of services L554 - Coordination of services • What systems are in place to facilitate exchange of information and coordination of services between: • Hospice staff • Non-hospice staff • Is there documentation in the clinical record of information sharing between: • Hospice staff • Non-hospice staff

17. Survey readiness tips! • Continuously review your IDG meeting process • Does your current process focus on patient care planning or is it just a “report” format? • Consider a performance improvement project focusing on improvement of your IDG meeting process as needed • Ensure that the patient plan of care should be individualized • If your hospice organization uses HER, ensure that you can customize and free text • Use every opportunity to reinvent and reenergize your patient care planning process • Be able to evidence collaboration with the patient’s attending physician regarding the update of the patient plan of care

18. L559 - § 418.58 Quality assessment and performance improvement (QAPI) • Organization self assessment • QAPI plan – written • Program scope • Adverse patient events • Program data • Program activities • Performance improvement projects • Governing body involvement

19. Survey readiness tips! • Ensure that all staff is engaged in the QAPI program at some level. • Stress how every department in the organization has a stake in QAPI. • Present QAPI updates at staff meetings. • Involve staff in selected Quality Partner Self-Assessments as applicable. • Display progress charts on the bulletin board in the office. • Develop a reward program for staff participation in improving performance. • Include quality improvement roles and responsibilities in all job descriptions. • Develop a short information sheet about your QAPI program for staff with bullet points about your program, current projects, and your progress!

20. § 418.64 Core services • Hospice must routinely provide substantially all core services directly by hospice employees. • Nursing • Medical Social Services • Counseling • May use contracted staff, if necessary, to supplement hospice employees in order to meet the needs of patients under extraordinary or other non-routine circumstances.

21. § 418.64 Core services • Nursing services • Highly specialized may be contracted • Complex wound care • Infusion specialties • Pediatrics • Continuous home care is not highly specialized. • Counseling: • Dietary • If patient needs exceed expertise of RN, then the hospice must have a trained & qualified RD or nutritionist. (W-2 employee) • Spiritual • Evidence in clinical record that hospice offered or provided spiritual counseling or facilitated visits by local clergy, pastoral counselors, or others.

22. Survey readiness tips! • Ensure documentation supports circumstances for core staff contracting for a short-term temporary event that was unanticipated • Ensure proper notification of state agency is documented if contracting for nursing services due to a chronic nursing shortage • Be able to demonstrate that all licensed professionals whether employed or provided under arrangement participate in the QAPI program and in-service training programs. • Be able to evidence an organized system for tracking staff competency evaluation.

23. § 418.76 Hospice Aide Supervision L629 A registered nurse must make an on-site visit to the patient’s home: No less frequently than every 14 days to assess the quality of care and services provided by the hospice aide and to ensure that services ordered by the hospice interdisciplinary group meet the patient’s needs. The hospice aide does not have to be present during this visit. Follow most stringent regulation for this requirement (state may be stricter)

24. § 418.76 Hospice Aide In-service Training L620 • A hospice aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient Procedures and Probes §418.76(d) • Ask how the hospice schedules training to assure that every aide receives at least 12 hours of in-service training within each 12 month period

25. Survey readiness tips! • Ensure your tracking system for aide supervision visits every 14 days is implemented and working. • Consider a performance improvement project for this requirement. • Problem on 2009 surveys • Assess if your program has provided 12 in-service hours for your aides annually. • Develop a schedule for aide personal file review. • Develop a schedule for annual competency review for aides • Facilitate an aide skills fair for competency assessment. • Hospices may accept external education hours if they were supervised by an RN.

26. § 418.78 Volunteers Role and activities: • Used in day to day administrative and/ or direct patient care roles. • Office activities • Direct patient care services • Non-administrative patient care activities (cannot use these hours for 5% cost savings) • Direct patient care services must be evident in patient plan of care. • There should be documentation of time spent and the services provided by volunteers.

27. § 418.100 Organization and Administration of Services – Professional management responsibility • Written agreement with another agency, individual, or organization to furnish any services under arrangement must retain: • administrative and • financial management, and • oversight of staff and services for all arranged services • Arranged services must be supported by written agreements that require that all services be– • Authorized by the hospice; • Furnished in a safe and effective manner by qualified personnel; • Delivered in accordance with the patient's plan of care.

28. Survey readiness tips! • Ensure your organizational structure chart is current. • Be able to evidence communication with the governing board. • Ensure that all contracts are revised with new CoP requirements. • I.e.: criminal background checks • Be able to present evidence of training, competency, criminal background check, and supervision on contracted staff. • Ensure all multiple locations have been approved by Medicare. • Audit direct employee personnel files for evidence of training and competency.

29. § 418.102 Medical Director • Each hospice provider certification number will have ONE medical director • The “physician designee” is a pre-selected physician that assumes the Medical Director’s duties in his/her absence • All additional physicians report to the Medical Director • Title for these additional physicians is at the hospice’s discretion • Additional physicians perform IDG duties (d) Standard: Medical director responsibility- Responsible for medical component of the hospice’s patient care program

30. Survey readiness tips! • Ensure job descriptions, job titles and /or contractual relationships with the Medical Director and other hospice physicians include new regulatory language. • Ensure organizational structure chart clearly indicates that there is one medical director. • Show reporting relationship of other hospice physicians to the one medical director • Ensure that there is evidence of a physician designee. • Be able to demonstrate physician involvement in your QAPI program.

31. § 418.104 Clinical records (b) Standard: Authentication • Must have a policy for authentication • Must be able to explain system and method to identify the author of each entry • Electronic authentication = user ID and password • Acceptable identifiers: • Handwritten • Electronic • Faxed handwritten • NO stamped signatures allowed • Hospice must provide equipment to surveyors to view electronic records and provide a paper copy upon request

32. § 418.106 Drugs and biologicals, medical supplies, and durable medical equipment • (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. • Individuals may include: • Licensed pharmacist • Board certified physicians in palliative medicine • RN’s certified in palliative care • Physicians, RN’s, NP’s who complete a specific hospice or palliative care drug management course

33. § 418.106 Drugs and biologicals, medical supplies, and durable medical equipment (d) Standard: Administration of drugs and biologicals • IDG must determine patient/family ability to safely administer drugs • Must be identified in patient plan of care. (e) Standard: Labeling, disposing, and storing of drugs and biologicals • Provide a copy of written policies and procedures for managing and disposing of drugs in patient’s home, ad discuss with patient and family at the time when controlled drugs are first ordered, document discussion in clinical record. • When drug discontinued • A new drug is ordered • Patient dies

34. § 418.106 Drugs and biologicals, medical supplies, and durable medical equipment (f) Standard: DME • Contract with an accredited DME provider • Current contract – no DME accreditation • the hospice should have a letter in their file from the DME stating the DME has applied for and is waiting for accreditation by the September 2009 deadline date. • Contract with a DME that only serves hospice providers – no DME contract • the hospice will need to make sure the same type of letter from the DME is in place in their files. The accrediting bodies are aware that these DME’s serving hospice only will be calling for accreditation • If the hospice owns its own DME, then no accreditation is needed.

35. Survey readiness tips! • Ensure that you can evidence individual who IDG confers meets qualification criteria in 418.106(a). • Ensure that provide a copy of your drug disposal policy to all patients/ family. • Ensure that you are knowledgeable and compliant with all specific state drug disposal regulations. • Be able to evidence documentation of DME education and patient/family understanding in the clinical record. • Be able to demonstrate that you are contracted with an accredited DME provider • Or DME accreditation in process letter is in files

36. § 418.108 Short-term inpatient care • Inpatient care (GIP) for pain control and symptom management must be provided in one of the following: • A Medicare-certified hospice that meets the conditions of participation for providing inpatient care directly as specified in §418.110 • An RN must be staffed on every shift providing hand on care

37. § 418.108 Short-term inpatient care • Inpatient care for respite purposes must be provided by one of the following: • A Medicare or Medicaid-certified nursing facility that also meets the standards specified in §418.110 (f) • Elimination of the 24 hour RN requirement • Staffing for a facility solely providing the respite level of care to hospice patients should be based on each patient’s care needs • Hospice may not contract with Assisted Living Facilities for respite care.

38. § 418.110 Hospices that provide inpatient care directly – Restraints and seclusion A violation of seclusion and restraint requirements at 418.110 (m) would be subject to a condition level deficiency. Restraints for fall prevention must not be considered routine. Side rail guidance – LTC current interpretive guidelines. Hospices must be able to evidence staff specialty training in restraints and seclusion. Hospices may develop their own training programs or use an outside source. Training curricula will be reviewed by surveyor. All inpatient staff must be CPR certified.

39. § 418.110 - Deaths while in restraints or seclusion If a patient has an unexpected death that occurs while in restraint or seclusion, or an unexpected death occurs within 24 hours after restraint or seclusion has been discontinued, the death must be reported to CMS RO. Additionally, if a death occurs within one week after the use of restraint or seclusion and it is reasonable to assume the death was associated with restraint and/or seclusion, the death should be reported to CMS RO.

40. Survey readiness tips! • Ensure policy/ procedure for restraints and seclusion includes regulatory language from the 418.110 (m), (n), and (o). • Ensure that all staff have had restraints and seclusion training. • Document training and competency in staff personnel files. Make a list of trained personnel available at the inpatient IDG station at all times. • Develop a documentation flow sheet for restraints and seclusion. Educate appropriate staff regarding it use. • Ensure that all staff are CPR certified if they have direct patient contact.

41. § 418.112 Hospices that provide hospice care to residents of a SNF/NF or ICF/MR Professional management • Professional management involves assessing, planning, monitoring, directing, and evaluating. • Hospice duties: • Ongoing assessment • Care planning • Monitoring • Coordination and provision of hospice care by IDG • Coordination of care with facility

42. § 418.112 Hospices that provide hospice care to residents of a SNF/NF or ICF/MR Agreement includes: • Hospice responsibility to provide services to same extent as serving a patient in a private home • Delineation of hospice responsibilities • 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 • Hospice reports to facility all patient rights violations unrelated to the hospice • Bereavement services

43. § 418.112 Hospices that provide hospice care to residents of a SNF/NF or ICF/MR The facility must offer the same services to its residents who have elected the hospice benefit as it furnishes to its residents who have not elected the hospice benefit. • Room and board services. • Care for conditions unrelated to hospice terminal illness. • Core hospice services may not be delegated to facility staff. • Hospice may offer bereavement services to facility staff or residents that fulfill the role of a hospice patient’s family as identified in the plan of care.

44. § 418.112 Hospices that provide hospice care to residents - Hospice Responsibilities L769 A delineation of the hospice’s responsibilities, which include, but are not limited to the following: • Providing medical direction and management of the patient • Nursing • Counseling, including spiritual, dietary and bereavement • Social work • Provision of medical supplies, durable medical equipment and drugs necessary for the palliation of pain and symptoms • All other hospice services that are necessary for the care of the resident’s terminal illness and related conditions.

45. § 418.112 Hospices that provide hospice care to residents of a SNF/NF or ICF/MR Hospice plan of care • Coordinated and guides both providers. • May be divided into two portions; one maintained by facility, one maintained by hospice. • Hospice plan of care must identify the provider responsible for each function/ intervention in plan of care. • Both providers portion of plan of care should reflect identification of: • Common problem list • Palliative interventions and outcomes • Responsible discipline/ provider • Patient goals

46. § 418.112 Hospices that provide hospice care to residents of a SNF/NF or ICF/MR Coordination of services • Hospice designates IDG member to coordinate implementation of plan of care with facility representatives. • May or may not be the hospice RN. • Designated individual provides overall coordination of care with facility, communicates with facility to implement hospice plan of care. • Surveyors will look for evidence of communication, system coordination, outcomes meeting patient goals.

47. § 418.112 Hospices that provide hospice care to residents of a SNF/NF or ICF/MR Orientation and training of staff • Hospice assures orientation facility staff in hospice philosophy, policies and procedures, pain control and symptom management methods, patient rights, forms, and record keeping. • Hospices can collaborate for general hospice philosophy and pain management training. • Specific training regarding coordination between each hospice and the facility needs to be completed individually.

48. Survey readiness tips! • Ensure that contracts are updated with new regulatory language and requirements. • Ensure communication process between the hospice and the SNF/NF or ICF/MR is clear and working. • Be able to evidence completed education with contracted facilities about new hospice regulations. • Be able to evidence criminal background checks of staff who have direct patient contact or contact with clinical records. • Be able to clearly communicate which IDG members is serving as the liaison between the facility and the hospice for each patient.

49. § 418.114 Personnel Qualifications - Criminal Background Checks • The hospice must obtain a criminal background check on all hospice employees who have direct patient contact or access to patient records. • Hospice contracts must require that all contracted entities obtain criminal background checks on contracted employees who have direct patient contact or access to patient records.

50. Regulatory Assistance • Three ways to contact NHPCO’s Regulatory Department: • 703-647-8516 – Regulatory Assistance line • Email us at regulatory@nhpco.org • Log on to the NHPCO Regulatory & Compliance Center and click the BLUE BOX • The NHPCO Regulatory team: • Judi Lund Person, VP Regulatory and State Leadership • Jennifer Kennedy, Regulatory & Compliance Specialist