ESRD Special Study

• 1. Delivery of Dialysis TreatmentWithin theLong Term Care Facility ESRD Special Study Delivery of Dialysis Treatment Within the Long-Term Care FacilityProject ReportJuly 1, 2005 June 30, 2006Contract # 500-03-NW09June 30, 2006Submitted to:Glenda PayneMarion Broderick Project Officer Project Officer CMS, Region VICMS, Region VII Division of Clinical Standards & QualityDivision of Clinical Standards & Quality 1301 Young Street New Federal Office Buildingth Dallas, TX 75202601 E 12 Street, Room 242 Kansas City, MO 64106 Submitted by:The Renal Network, Inc. ESRD Network 9/10th 911 E. 86 Street, Suite 202 Indianapolis, IN 46240 317-257-8265 Janeen Len, Project Manager Mary Ann Webb, MSN, RN, CNN Susan Stark, Executive Director Jenny Kitsen, Executive Director ESRD Network of New England The Renal Network, Inc. 911 E. 86th Street, Suite 202 Indianapolis, IN 46240 317-257-8265 ESRD Network of New England 30 Hazel Terrace Woodbridge, CT 06525 203=387-9332

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The Renal Network, Inc.Special Project on the Delivery of Dialysis TreatmentWithin the Long-Term Care Facility Table of Contents 1.0 Executive Summary12.0 Literature Review....12.1 Methods... 12.2 Project Background.22.3 The Need for Dialysis for LTC Facility Residents.22.4 The Need for Staff-Assisted Dialysis Within a LTC Facility Setting. 22.5 Current ESRD Program...32.5.1 Approved Facility Types.. 32.5.2 Billing Considerations.. 32.5.3 Back-up Facility Considerations..4 2.5.4 Staffing Considerations42.5.5 Facility Oversight Considerations52.5.6 Dialysis and Hospice52.6 Proposed Conditions for Coverage.52.7 LTC Facility ESRD Patient Outcomes72.8 Other Considerations... 82.9 National Renal Administrators Association Recommendations.92.10 TRN Dialysis in Nursing Homes Conference...93.0 Technical Expert Panel (TEP).104.0 Recommendations for Staff-Assisted dialysis in the LTC Facility Setting 114.1Rationale.. 114.2 Recommended Program Structure..114.3 Minimum Staffing, Staff Qualifications and Training Requirements. 124.3.1 Nursing. 124.3.1a Nurse Responsible for Dialysis Subunit Program.. 124.3.1b On-Site Nurse. 134.3.2 Patient Care Technicians..134.3.3 Other Staff 144.4 Patient ESRD Care Assessment..144.5 Patient ESRD Care Plan of Care. 154.6 Access to Nephrologist154.7 Vascular Access Care..154.8 Infection Control.154.9 Medications.164.10 End of Life Issues..16 i 3. 4.11 Physical Environment... 164.12 Water Quality 164.13 Coordination of Care.164.13.1 LTC Facility Expectations.164.13.2 ESRD Provider Expectations.174.13.3 Emergencies During Dialysis Treatment...174.13.4 Back-up Treatment Facility.... 174.13.5 Utilities... 174.13.6 Communication.. 174.14 Internal Oversight..184.15 External Oversight. 184.16 System for Data Collection... 184.17 Certification Process. 184.18 Financial Model Development..195.0 Conclusions.196.0 Technical Expert Panel, Consultants, Staff & Observers 207.0 References... 21iiDialysis in the LTC Facility Project Report 4. 1.0Executive Summaryhome, skilled nursing facility, long term care facility, and hospice. The table below The Centers for Medicare & Medicaid Serviceslists total number of citations for each (CMS) contracted with The Renal Network, Inc. combination, number of unique citations, (End Stage Renal Disease (ESRD) Network 9/10) and number of possibly relevant citations in collaboration with The ESRD Network of New based on abstract review. There was England, Inc (Network 1) for a special project to substantial overlap between search results. convene a Technical Expert Panel (TEP) to develop recommendations for providing dialysis in the long- SearchTotal Cited Possibly term care facility. The need for more information TermsCitations in Relevant focusing on quality of care, financial Other responsibilities and structural issues was identifiedSearch following a meeting of renal stakeholders in JuneNursing 54 0 39 2004. Convening a nationally focused Technical home Expert Panel to develop recommendations forand providing dialysis in a nursing home that ensuresdialysis quality of care for these patients represents an Extended13 111 important first step in benefiting ESRD patients care residing in LTC facilities. The model defined in facility this project will begin to provide the benchmark for and quality dialysis services within the LTC facility. dialysisSkilled 11 110 The contract period was from July1, 2005 to June nursing 30, 2006. The contract specified nine key tasks to facility be completed within the 12-month timeframe.anddialysisLong1244 Task Task Requirementterm care 1Submit a detailed work plan to CMSfacility 2Conduct a focused literature review and 3Identify a Technical Expert Panel dialysis 4Arrange TEP meeting Hospice 2419and 5Facilitate and Document TEPdialysisdiscussions 6Document proposed recommendations Each possibly relevant article was retrieved 7Obtain input from renal community and references were reviewed to yield 8Prepare Final Report additional relevant articles. All relevant 9Obtain TEP evaluations articles were abstracted and categorized into a customized database. Current ESRD program requirements were obtained from documents available on the CMS website and from the Code of Federal Regulations 2.0Literature Review (CFR). 2.1Methods A MEDLINE search was conducted to Note: For convenience, the term long-term review the literature to gain ancare (LTC) facility will be used throughout understanding of the current knowledge of this document to represent the terms skilled the care and dialysis of ESRD patients in nursing facility, long-term care facility, the nursing home. The MESH term extended care facility, and nursing home. dialysis was combined with nursing 1 Dialysis in the LTC Facility Project Report 5. residents is likely to grow as both the 2.2Project Background general and ESRD populations continue to There are increasing numbers of dialysis age.6-10 patients throughout the United States being dialyzed within LTC facilities, however2.4The Need for Staff-Assisted there are no officially recognized models ofDialysis Within a LTC Facility treatment. A conference hosted by Setting Network 9/10 in June 2004 resulted in theLTC facility patients may be transported to successful collaboration of dialysis hospital-based or freestanding dialysis providers, state agencies, Networks andfacilities for treatment or obtain self- CMS and identified the need for a structuredialysis treatment through a home program. of quality management for patients Transporting LTC facility patients to off- receiving dialysis in a LTC facility. This site dialysis facilities is burdensome to both conference only touched on describing thepatients and LTC facilities. LTC patients parameters for a model delivery system for are often frail, sensitive to temperature dialysis in residential settings.1 variations, and uncomfortable while beingtransported to dialysis facilities.1, 11 Knowledge of dialysis in the LTC facilityPatients routinely miss meals, medications, would benefit the ESRD program and its rehabilitation services, resident activities, patients. The goal of this project was toand other services provided by the LTC develop recommendations for providingfacility due to the length of dialysis dialysis in a LTC facility environment thattreatment, time associated with preparing ensures quality of care for these patients.for transfer to and from the dialysis facility,and actual transportation time.1 Some 2.3The Need for Dialysis for LTCpatients are unable to be transported due to Facility Residents their complex medical needs such as There were approximately 1.6 million ventilator dependency. individuals residing in nursing homes in 1999.2 The 2004 USRDS Annual dataTransporting LTC facility patients to off- report estimated that in 1999, 16,408 pointsite dialysis facilities is costly. CMS prevalent ESRD patients resided in LTC recognizes the difficulty in transporting facilities. This represents 4.8% of ESRD LTC facility patients and therefore allows a patients.3 This appears to be a growingLTC facility to be considered a patients trend. Data from a study of ESRD patientshome for the purpose of payment of self- dialyzed in Network 5 between April 1990 dialysis.11, 15 However, given that 57.5% of and December 1991 suggested that a the incident nursing home ESRD patients in minimum of 1000 to 1500 ESRD patients1999-2000 had moderately to severely reside in nursing homes at any given time. impaired decision-making ability, more The authors estimated that 2000 to 3000than 44 percent were unable to walk ESRD patients enter a nursing home in theindependently and 25% were unable to United States each year.4 Elderlytransfer from bed to chair3, it seems likely individuals without ESRD recruited fromthat the majority of LTC facility patients hospital geriatric wards and nursing homes are unable to perform self-dialysis. were surveyed to determine their desire for dialysis treatment should they need it. Eighty-three percent of nursing home residents indicated they would want dialysis if it became necessary and 75% said they would prefer home dialysis.5 The need for dialysis services to LTC facility 2 Dialysis in the LTC Facility Project Report 6. 2.5 Current ESRD Program residing there, or locations in needof ESRD facilities under 2.5.1 Approved Facility Typesemergency conditions.16 The current ESRD program is defined in the Code of Federal Regulations, Title 42, Inpatient dialysis is defined as Part 405, Subpart U Conditions for dialysis furnished to an ESRD Coverage of Suppliers of End-Stage Renal patient on a temporary basis in a Disease (ESRD) Services. The ESRDhospital due to medical necessity. program is comprised of five CMS Outpatient dialysis is defined as approved facility types according to dialysis provided on an outpatient 405.2102 of the Conditions for Coverage basis at either a renal dialysis including the renal transplantation center,center or facility and includes staff- renal dialysis center, renal dialysis facility,assisted dialysis or self-dialysis. self-dialysis unit, and special purpose renalSelf-dialysis and home dialysis dialysis facility.16 training is defined as a programthat trains patients and/or their A renal dialysis center is defined asfamily member or caregiver to a hospital-based unit that furnishes perform self-dialysis or home the full spectrum of diagnostic, dialysis with little or no therapeutic, and rehabilitativeprofessional assistance. Services to services including inpatient dialysishome dialysis patients are expected to ESRD patients. A renal dialysis to be at least equivalent to those center may provide inpatient orprovided to in-center patients.16 A outpatient dialysis either directlyskilled nursing facility may be using its own staff and employeesconsidered a patients home for or under arrangement. A renalself-dialysis.15 dialysis facility is approved to furnish dialysis services directly to 2.5.2 Billing Considerations ESRD patients using its own staff The composite rate payment system is used and employees, or through to pay for outpatient maintenance dialysis individuals under direct contract toservices in hospital-based centers and furnish such services for the facilityfreestanding facilities. The composite rate (not through agreements orsystem is also used for Method I payment arrangements). A self-dialysisfor home dialysis services. Under the unit is part of an approved renal composite rate system, the dialysis facility dialysis program that furnishes self- must furnish all necessary dialysis services, dialysis services. Self-dialysis is equipment, and supplies for one set defined as dialysis provided by anpayment. Physician patient care services, ESRD patient who has completedcertain laboratory services, and drugs are an appropriate course of self-billed separately.15 dialysis training. Lastly, a special purpose renal dialysis facility Home patients must complete form CMS furnishes dialysis at special 382 upon initiating home dialysis. The locations on a short-term basis to aform requires patients to indicate the group of patients who are unable to location where home dialysis will be obtain treatment in the provided (private residence, skilled nursing geographical area. The locationsfacility, or nursing home) and to choose a must be special rehabilitativebilling method (Method I or II). Method I (including vacation) locationspayment utilizes the composite rate system serving ESRD patients temporarily discussed above. Method II payment pays suppliers directly for supplies and 3 Dialysis in the LTC Facility Project Report 7. equipment. A patient may use only one payment provision to reimburse a paid Method II supplier for all equipment andassistant.11, 13 Also, reimbursement for supplies. The supplier must have a writtenhome dialysis is based on one machine agreement with a Medicare approvedbeing used for only one patient.18 dialysis facility to serve as a provider for backup, support, and emergency dialysis 2.5.3 Back-up Facility services. The dialysis facility billsConsiderations separately for any backup, support, orAs stated above, a Method II supplier must emergency dialysis services provided. have a written agreement with a back-up There are payment limits for supportdialysis facility to provide backup, support, services. Support services include, but are and emergency dialysis services (see not limited to: monitoring of the patients section 2.5.2 for details regarding required home adaptation, including home visits; dialysis support services). The back-up consultation for the patient by qualified provider is required to be within reasonable social worker and dietitian; maintaining adriving distance from the patients home. If medical record-keeping system;the Method II supplier is unable to enter maintaining and submitting all required into an agreement with a backup provider documentation to the ESRD network;located within a reasonable distance from assuring appropriate water quality; assuringthe patients home, then the supplier may supplies are ordered on an on-going basis;use a provider outside the geographical area arranging for all ESRD laboratory testing;if the backup provider enters into a written testing and appropriate water treatment for agreement with a local dialysis facility to dialysis; monitoring the functioning of provide in-facility dialysis should it become dialysis equipment; documentation ofnecessary. In this case, the out-of-area Method II supplier provided items and back-up provider will provide dialysis services in the medical record; written plans support services, coordinate care, and of care; and all other dialysis servicesconduct frequent home visits. The signed required under the ESRD Conditions foragreement must detail how these support Coverage. If the patient receives homeservices will be provided.15 CAPD, the facility must also provide observation of the patient performing 2.5.4 Staffing Considerations CAPD and ongoing training necessary toConditions for Coverage specify that one assure proper administration of treatment;currently licensed health professional documenting presence or absence of(physician, RN, or LPN) experienced in peritonitis and related treatment;providing ESRD care is on duty (present monitoring of catheter exit site; changingand available) during dialysis. Qualified the connection tubing. When a patient home training nurses are required to have receives dialysis in a LTC facility, the12 months of clinical nursing experience dialysis services are excluded from the LTC and 6 months of ESRD experience. Three facilitys consolidated billing and homemonths of that experience must be in ESRD dialysis services are billed by either theself-care training. 16 ESRD provider facility or supplier, depending on the payment method Conditions for Coverage specify selected.15 requirements for qualified social workers and dietitians.16 The LTC facilitys social Home dialysis is based on the assumptionworker and dietitian may not meet the that the patient and/or a family member ordefinition of qualified. caregiver has received thorough training by a qualified home training nurse and the patient, family member or caregiver will administer the treatment. 16, 17 There is no 4 Dialysis in the LTC Facility Project Report 8. 2.5.5 acility Oversight F home training can only be provided by a Considerationsdialysis facility certified to provide home Home patients are considered as receiving dialysis services. Therefore durable medical care through an approved dialysis facility; equipment (DME) companies will continue therefore ESRD Networks are required to to be prohibited from providing home monitor the patients through data collectiondialysis training. The training program and quality improvement activities and to content is more fully defined in the process grievances. LTC surveyors do notProposed Conditions compared to the survey dialysis services provided on site atcurrent Conditions.11 LTC facilities; this currently falls under the purview of ESRD surveyors, who may notA summary of additional proposed changes know that dialysis is occurring within arelated to home treatment follows. LTC facility. LTC surveyors may generate494.100(b)(2) requires collection and a complaint for the ESRD surveyors to review of patient data at least every two investigate if potential problems are noted months. In 494.100(c)(1)(iii) CMS would during their LTC survey process.18require the use of the same clinical performance measures for home dialysis 2.5.6 Dialysis and Hospicepatients as used for in-center patients. Hospice care is underutilized by ESRD 494.100(c)(1)(v) requires onsite patients.19, 20 If ESRD is the reason for the evaluation of the water system for home terminal illness, the hospice provider must hemodialysis patient. 494.100(c)(1)(vii) absorb the cost of dialysis treatments within requires facilities to plan and arrange for their per diem payment.19, 21 Because the backup dialysis services. hospice per diem rate is insufficient to414.330(a)(2)(ii)(C) requires DME cover the cost of dialysis treatments, most companies to report all services and items hospice programs will not accept actively supplied to the patient to the dialysis dialyzing patients if their terminal illness is facility every 30 days.1, 11 due to ESRD.20 If a patient withdraws from dialysis, he/she is a candidate for hospice CMS requested input on whether current because death is imminent. Hospice is alsohome dialysis regulations should be an option for ESRD patients receiving modified to protect hemodialysis patients dialysis if they have a terminal illness otherreceiving dialysis within a LTC facility, than ESRD and a life expectancy less than and ways to do so. Additionally, CMS 6 months. If the terminal illness is notclarified the requirement that dialysis related to ESRD, a patient may receivefacilities are to be responsible for covered services from both the ESRD and coordinating and providing patient care, hospice Medicare benefits.19, 21rather than DME companies. CMS proposed requiring a written agreement between the LTC facility, the dialysis 2.6 roposed Conditions for P facility, and DME company (if applicable). CoverageCMS also requested input to determine if On February 4, 2005, CMS published thehome dialysis services provided in a LTC proposed rule to update the Conditions forfacility must meet all of the proposed Coverage for End-Stage Renal DiseaseConditions for Coverage. CMS solicited Facilities in the Federal Register. input regarding the requirement that a Comments regarding the proposed registered nurse (RN) is on the premises conditions were accepted until May 5, and available whenever in-center patients 2005. The proposed Conditions for receive treatment, and if the RN can be a Coverage contain a few changes related to LTC facility RN trained by the ESRD home dialysis and dialysis provided in thefacility or a RN provided by the dialysis LTC facility. 494.100(a) specifies thatfacility. If a LTC facility RN is allowed, 5 Dialysis in the LTC Facility Project Report 9. then limits on his/her other duties whileresponsibilities in the event of emergency patients are being dialyzed may be evacuation were specific examples cited.25 necessary. The competency and training The Advocate of Not-For-Profit Services requirements for the LTC facility RN mustfor Older Ohioans (AOPHA) requested also be determined. CMS also requested clarification regarding who should be comments on whether they should requireresponsible for arranging and paying for the specific patient to staff ratios for dialysis of dialysis caregiver services for patients in patients in this setting.11LTC facilities since friends or relatives maynot be available to provide services. Public comments to the proposedAOPHA reported that ESRD or DME Conditions for Coverage are posted on theproviders claim to be prohibited from CMS website. Many comments stated that providing the caregiver service for free due home dialysis is inappropriate for mostto fraud and abuse laws. As a result, LTC residents in the LTC setting and urged facilities may arrange for the services. CMS to consider the development of a AOPHA expressed concern that LTC separate definition for the provision of facilities may be subject to the federal anti- dialysis within LTC facilities.22-29 kickback statute (42 USC 1320a-7a(a)(5); Commenters reported that staff-assisted42 CFR 1003.102(1)(13) if they provide the dialysis in the LTC facility is needed, but it services for free. However, Medicaid must be economically feasible and providepatients would be unable to personally pay reimbursement for all staff who provide thefor the cost of caregiver services.30 The treatment.25-29 American Association ofCalifornia Dialysis Council stated that the Kidney Patients (AAKP) stated that staff-current recommendation for a written assisted dialysis services in the LTC settingdocument describing the relationship may be more costly due to the need for between the LTC facility and ESRD more intense services,22 but other provider is sufficient to define the commenters suggested that transportation coordination of care arrangements between savings would be realized.26, 27, 29 parties.31 One commenter recommendedmonthly joint provider meetings to review Both AAKP and the National Kidneypatients.32 Foundation (NKF) acknowledged barriers to access to LTC facility care.22, 23 NKFSeveral commenters from hospitals and commented that the increased requirementshospital associations asserted that CMS is for LTC facilities will cause LTC facilities authorized under Sections 1881(b)(1) and to either refuse admission of dialysis 1888(e)(2)(A)(i)(II) to pay LTC facilities patients or fall short in meeting their the composite rate for dialysis services responsibilities.23 AAKP stated thatunder Part B.26-29 These organizations increased payment for LTC facility-based propose three payment options: 1) ESRD dialysis may reduce barriers to access toprovider provides dialysis services at LTC care.22facility and is directly paid the compositerate; 2) LTC facility provides dialysis The need for coordination of care wasservices and receives separate payment for discussed by the commenters. The services outside PPS for Part A; and 3) American Health Care Association LTC facility provides dialysis services, (AHCA) stated that CMS must delineatewithout separate ESRD licensure, for the responsibilities between the ESRDbeneficiaries who have exhausted Part A provider and the LTC facility and clarifybenefits.28, 29 The California Hospital how the regulations for each party willAssociation requested clarification to the interface. The areas of infection control, questions of can a LTC facility prevent a staff responsibility, physicianpatient from choosing Method II and can communication, coordination of care and6 Dialysis in the LTC Facility Project Report 10. they limit patients to specific dialysis advised that patients dialyzing in the LTC providers or DME providers?28facility be capable of being transported toand safely dialyzed in an outpatient dialysis Concerns regarding the clinical and legalfacility in the event back-up dialysis liability to LTC facilities for providingservices are required.32 home dialysis in the LTC facility were discussed by AHCA and AOPHA.25, 30 Commenters generally agreed that it is 2.7LTC Facility ESRD appropriate to require a RN be on the premises when dialysis is performed25, 28, 29,Patient Outcomes although AOPHA stated that administrationAs noted in section 2.3, 4.8% of ESRD of hemodialysis, not peritoneal dialysis,patients resided in nursing homes in 1999.3 requires direct supervision by a RN.30 A No information was provided to describe current LTC facility dialysis provider statedwhere their dialysis was provided (off that an experienced licensed practical nurse premise dialysis in approved dialysis (LPN) is acceptable, and that a designated facility vs. home dialysis with treatment RN be on call at all times when dialysis isprovided in the LTC facility directly). being provided.32 AHCA recommended thatNetworks (and therefore USRDS) cannot the RN present and providing supervision currently distinguish patients dialyzing in during the dialysis treatments not beLTC facilities from home patients.33 responsible for other LTC residents during Therefore, quality oversight by Networks dialysis treatments. AHCA noted that nurse for these patients cannot occur. In a letter to recruitment is problematic for both LTCThe Renal Network, Inc. from CMS, it was and ESRD providers due to the nursingnoted that dialysis organizations are shortage, so adequate reimbursement will requesting data be suppressed on the be required.25 Dialysis Facility Compare website forpatients receiving dialysis in the LTC Additional staff-related comments included facility setting, billed through the home the need to specify training requirements, program methods. The Renal Network, Inc. use of a dedicated dialysis facility nurse,responded, infection control nurse, and LTC facility- based Advanced Practice Nurse (APN).25 ItESRD providers must was recommended that LTC facility staff betake responsibility for the required to be trained in the care of ESRDoutcomes of all of their patients and that dialysis facility staff patients. If an ESRD should monitor its own staff and not be provider enters into an responsible for monitoring LTC facility agreement with a DME or staff. It was suggested that a minimum of nursing home to provide one year of hemodialysis experience bedialysis treatment on-site at required for the licensed nurse.32the nursing home and Commenters stated that CMS should not allows the provider number mandate specific patient-to-caregiver to be used for billing for ratios.28, 29 these patients, the provider needs to realize that Lastly, commenters requested CMS provideoversight of care for those guidance regarding what patients arepatients remains with the appropriate for a LTC facility dialysis ESRD provider. Patients program.25, 32 It was suggested that thereceiving treatment within program be reserved for LTC residents who the nursing home setting should not be transported to an outside are entitled to the same ESRD facility25, yet another commentertreatment as those being 7 Dialysis in the LTC Facility Project Report 11. treated within the dialysis2.8Other Considerationsfacilities The rate of LTC facility placement is lower for ESRD patients than the general One published article contained datapopulation, suggesting barriers to LTC regarding outcomes of patients residing infacility placement such as transportation, LTC facilities who received hemodialysisfinancial difficulties, and a general treatments (86%) at in-center dialysisreluctance of LTC facilities to admit ESRD facilities (not in the LTC facility setting) or patients.4 The inability to provide LTC peritoneal dialysis (13%). Three, six, andfacility-based dialysis treatment may delay twelve-month survival rates from date ofhospital discharge and reduce effectiveness LTC facility admission were 74%, 56%, of rehabilitation programs.39 and 42% respectively. Increasing age, poorer activity of daily living score, andThere are practical advantages to allowing peritoneal dialysis were independentLTC facility dialysis areas to be treated as survival risks.4 Yearly survival rates from an extension of an existing dialysis facility. date of first dialysis between years one andIf a dialysis facility is built within a LTC five were 83%, 63%, 45%, 35%, and 24% facility, it must conform to all LTC facility per year. These percentages are similar toregulations. Additionally, adding a dialysis that of the general dialysis population4 Thefacility to an older LTC facility may require appropriate benchmark for dialysis patientit to upgrade its systems throughout the survival rates from date of LTC facilityfacility to meet current code, making it cost admission is unknown. prohibitive. It may be possible to build a freestanding facility adjacent to the LTC It may be useful to differentiate patients as facility for less money,40 but a sufficient being admitted for short- term rehabilitation number of patients would be needed to vs. permanent placement in the LTCmake building a full unit cost effective. facility. Length of stay may be an appropriate measure for patients admitted The Renal Network, Inc. received for short term rehabilitation.34comments from the California Dialysis Council (CDC) in preparation for the TEP There have been seven published articlesmeeting. The CDC recommended that the regarding outcomes of patients receivingTEP discuss coverage for dialysis in a wide peritoneal dialysis (PD) in LTC facilitiesrange of institutional settings including (see Appendix A).6, 7, 10, 35-38 Two of the SNFs, intermediate care facilities, LTC articles referred to the same dataset.10, 38facilities, long term acute care centers, The PD home programs analyzed variedcomprehensive outpatient rehabilitation with one dialysis facility referring patients facilities, and hospices. They also to either one LTC facility or to many.recommended inclusion of non-ESRD Peritonitis rates published in 5 papers patients who require dialysis on a varied from 0.61 to 2.43 episodes/patienttemporary basis (such as in acute renal year.6, 7, 10, 35, 37, 38 Exit site infection rate, failure). CDC stated that patients requiring published in only two studies, ranged fromsuch care in a lower-cost setting such as a 0.2 episodes/patient-year to 0.5SNF are unable to obtain this care, and thus episodes/patient-year.6, 35Hospitalizationthe healthcare system pays excessively for rates reported in 3 studies ranged from 18.5their care within the acute hospital setting. to 44.6 days/patient-year.6, 7, 35 In one study,CDC advised creating a program separate patients who switched modality to from the home dialysis program. The hemodialysis had better survival rates.6organization suggested that most patients receiving dialysis in institutional settings will have already been dialysis patients, and therefore already have long-term programs, 8 Dialysis in the LTC Facility Project Report 12. patient care plans, etc. They requested on-site at least once each month. The RN avoiding duplicative requirements for should also participate in care planning patients who are in the alternate dialysismeetings as specified in the Conditions for setting on a temporary basis. The CDC Coverage.1 advised that special coding be created to allow identification of the method of The NRAA recommended social workers dialysis being performed in the alternate and dietitians with ESRD patient site facility, and to use coding to distinguish experience provide services to the dialysis between ESRD and non-ESRD patients. patients. These clinicians could work They also advised creating a coding directly for the nursing home (if they had solution to reflect patient acuity (such as a adequate ESRD experience) or be affiliated code for dialyzing ventilator-dependent with the backup dialysis facility.1 patients).41 The LTC facility should have an 2.9 National Renal Administrators arrangement with a medical director of an Association Recommendations approved dialysis facility or home program. In February 2003, the National RenalThe medical director would be responsible Administrators Association (NRAA) for ensuring appropriate care to patients and published a position paper on home dialysis other requirements according to the for nursing home residents. The NRAAConditions for Coverage. The position supported the use of home hemodialysis forpaper recommended that each LTC facility LTC facility patients on LTC facility have a backup agreement with a nearby premises and encouraged CMS to ensure Medicare-approved in-center dialysis that the services not become cost facility in case the approved home dialysis prohibitive, and therefore limit availability.provider is unable to provide treatments. The position paper provided specificThey also recommended each LTC facility staffing, support service, facility, andhave an agreement with a nearby hospital to hospital coverage recommendations.allow admission of hemodialysis patients Benefits to patients for LTC facility-based when needed.1 hemodialysis included avoidance of the physical and emotional strain ofThe NRAA opposed any requirement that transportation to a dialysis facility, missed the area within the LTC facility set up to meals, and missed resident activities.provide dialysis be certified as a dialysis Medicaid savings were estimated at $156 facility. Each individual LTC facility is million per year in saved transportationlikely to dialyze only a few patients, costs.1 making certification cost prohibitive. Instead, they advocated the LTC facility- The NRAA explicitly opposed defined based dialysis services be established as an staffing ratios due to the potential economic extension of a Medicare-certified ESRD burden. They recommended all staff have a home program. The NRAA supported the minimum of two years prior dialysis use of a central area within the LTC facility experience. NRAA suggested a registered to provide dialysis services to multiple nurse (RN) with at least two years dialysis patients, but did not go so far as to experience supervise all on-site staffrecommend multiple patients share dialysis (licensed practical nurses or dialysismachines.1 technicians) and that the RN be accessible at all times while dialysis treatments are2.10 TRN Dialysis in Nursing Homes being administered. The RN would be Conference responsible for all initial patient In June 2004, The Renal Network, Inc. assessments, staff training, and be present (TRN) convened a meeting of 279 Dialysis in the LTC Facility Project Report 13. representatives from CMS, The Renal dialyzing in LTC facilities from home Network Inc., the Illinois Department ofpatients. It was recommended that LTC Public Health, Fresenius Medical Care,facility patient data be identified to allow Gambro Healthcare, and Circle Medical separate data analysis for quality oversight Management to discuss dialysis in the LTC purposes. Conference attendees noted that facility setting. Discussion focused on the state surveyors would need to be trained to provision of hemodialysis. Attendeessurvey both LTC facilities and ESRD expressed that there is a need forfacilities.33 hemodialysis within LTC facilities and that the number of patients requiring this service Billing and reimbursement issues were is likely to expand. Attendeesdiscussed. Various medication recommended that a new model for service, administration scenarios were suggested dubbed Method 3, be developed with itssuch as LTC facility staff give oral own set of regulations. Discussion at the medications instead of IV medications meeting explored staffing, equipment, when possible and LTC facility staff water treatment, quality oversight, infection administer Erythopoeitin when the patient control, medication administration, and is not on dialysis. Regulations regarding billing issues related to hemodialysis on reimbursement for medication and supplies LTC facility premises.33would need to be adjusted to accommodate Method 3. It was suggested that Most corporations provide their own reimbursement policies also consider longer dialysis staff instead of using LTC facilityor more frequent dialysis sessions and staff. However, coordination of careincreased staff-to-patient ratios to care for between dialysis staff and LTC facility staff high acuity patients. Financial incentives to is essential. An experienced RN typically promote expertise and excellence were oversees the program, training of staff and recommended. Lastly, cost savings could patients, and provides staff supervision. be realized by eliminating the need to Current ESRD dietary and social servicestransport patients to dialysis facilities.33 regulations are appropriate for the LTC facility setting. It was recommended that 3.0Technical Expert Panel (TEP) nephrologists and geriatricians shouldA Technical Expert Panel was convened in round on the patients at least once a month Baltimore on January 20 and 21, 2006 to and multidisciplinary care plan meetingsassist the contractor (ESRD Network 9/10) should be held.33 in developing recommendations for providing staff-assisted dialysis in the LTC Dialysis of stable patients in a common facility. TEP members, including patients room would allow a technician to dialyzeand professionals, were sought to represent more than one patient at a time. Attendeesvarious ESRD stakeholders involved in or unanimously agreed that the one patientimpacted by dialysis in the LTC facility. one machine rule be abolished. One Members were chosen by the contractor attendee mentioned that a facility couldand CMS based on their area of expertise more easily maintain fewer machines. It and knowledge of the subject area. was felt that water treatment should follow Individual TEP members were approved by AAMI standards applicable to in-centerCMS. The final TEP membership included dialysis facilities. The providers attendinga patient and spouse, physicians, and the conference did not perform dialyzer representatives from state departments of reuse.33health; CMS; quality improvement organization; nursing home administration; Quality oversight would begin at theLarge Dialysis Organizations (LDOs); facility level. It was noted that NetworksDME representative, and members of cannot currently distinguish patients10 Dialysis in the LTC Facility Project Report 14. American Nephrology Nurses Associationadmission was of a rehabilitative nature. (ANNA) and NRAA. Observers includedDialysis care at the nursing home would additional CMS staffers and representativesoffer convenience to patients because they from nursing home programs.would be less likely to miss meals andmedication doses. TEP members believed The TEP was tasked with making patients may experience increased quality recommendations on the following:of life by avoiding the discomforts and recommended program structure; minimum inconvenience associated with long waits staffing, staff qualifications and trainingfor transportation to and from an outside requirements; patient assessment; patientdialysis facility. Coordination and plan of care; access to nephrologist;continuity of care between dialysis facilities vascular access care; infection control; and LTC facilities would likely increase medications; end of life issues; back-up and overall access to nursing home care treatment facility; physical environment;may improve for dialysis patients. water quality; coordination of care; internalAdditionally, hospitalized patients may be and external oversight; system for datadischarged earlier if dialysis is available in collection; certification process; and the LTC facility setting. financial model development.4.2Recommended Program 4.0 Recommendations for Staff-Structure Assisted Dialysis in the Long-Term The TEP discussed how to structure the Care Facility Settingstaff-assisted dialysis program within LTCfacilities. The decision was made to use the The following recommendations propose a newterm long-term care (LTC) facility model of dialysis care: Staff-Assisted Dialysis(hereafter referred to as LTC facility), (hemodialysis and peritoneal) in the Long-Termconsistent with guidance in the CMS Care Facility. These recommendations do notSurvey and Certification Group Addendum eliminate current models of providing dialysis suchI to S&C Letter 04-24 on the Care for as home dialysis or Medicare-certified in-centerResidents of Long-Term Care (LTC) dialysis facilities adjacent to LTC facilities.Facilities Who Receive End Stage Renal Additionally, all recommendations were madeDisease (ESRD) Services, dated July 8, considering the adult population, however the2004.18 The term LTC facility refers to recommendations do not preclude provision of carenursing homes including skilled nursing to pediatric patients under this proposed model.facilities and nursing facilities. Institutionsfor persons with mental retardation or 4.1 Rationale rehabilitation facilities are not included. There are increasing numbers of dialysis patients throughout the United States beingThe TEP recognized that a large spectrum dialyzed within long-term care (LTC) of ESRD patients require dialysis care facilities, but there are currently no within the LTC facility: 1) stable dialysis officially recognized models of staff- patients who require LTC facility care; 2) assisted treatment in the LTC setting. individuals with progressive renal failure Providing dialysis care on the premises of that develop an acute illness, start dialysis LTC facilities would provide cost savingsin the hospital, and are discharged to a LTC by avoiding the need to transport patients tofacility; 3) individuals who develop new freestanding dialysis facilities. Theacute renal failure and are discharged to a frequency and duration of dialysis LTC facility; and 4) patients with multiple treatments could be more flexible andorgan failure who are discharged to a LTC patients would be available for services facility. The decision was made to define a such as rehabilitation, possibly decreasingprogram inclusive of all ESRD patients. the length of stay if nursing home 11 Dialysis in the LTC Facility Project Report 15. Dialysis providers may ultimately decide the level of medical acuity they are willingThe TEP felt strongly that in the case of to accept into their program. hemodialysis, the entire treatment must be visibly monitored by a qualified caregiver. The TEP recommended that the staff- It was recommended that properly trained assisted dialysis LTC facility program be personnel be present and available in organized as a subunit of a Medicare- adequate numbers to meet the needs of the certified ESRD provider (hereafter referred patients, including those arising from to as Dialysis Subunit). The Dialysis medical and non-medical emergencies, Subunit may only provide hemodialysis consistent with language in the Proposed treatments if the Dialysis Provider mainConditions for Coverage of Suppliers of facility offers hemodialysis. Likewise, anEnd-Stage Renal Disease (ESRD) Services ESRD provider that only offers peritoneal 494.180(b), with the exception that dialysis may only provide peritoneal494.180(b)(2) incorporate the term LTC dialysis in the LTC facility. A program facility. The revised Proposed language is organized or affiliated with an ESRDas follows: The governing body or provider that is certified for home dialysisdesignated person responsible must ensure training only should not be permitted tothat -- (1) An adequate number of qualified open a subunit. personnel are present whenever patients are undergoing dialysis so that the It was recommended that the Dialysispatient/staff ratio is appropriate to the level Subunit only dialyze residents of the LTC of dialysis care given and meets the needs facility. It is expected that several patientsof the patients. (2) A licensed nurse, may be dialyzed together in a common area educated in ESRD is present onsite at the or dialysis room or patients may be LTC facility at all times that patients are dialyzed in their rooms (e.g. ventilator or being treated.(3) All employees have traction dependent patients). appropriate orientation to the facility and their work responsibilities upon Additionally, it was recommended that employment; (4) All employees have an proposed Conditions for Coverage be opportunity for continuing education and scrutinized to ensure dialysis patients related development activities; and (5) residing in nursing facilities are provided There is an approved written training the same level of protection and ancillaryprogram specific to dialysis technicians services as are provided to patientsthat includes; (6) When State receiving care under the staff-assisted in- requirements meet or exceed center model. 494.180(b)(5) the State requirements must be met. 4.3 Minimum Staffing, Staff Qualifications and Training 4.3.1N ursing RequirementsThere was lengthy discussion regarding It was acknowledged that no data addressesnurse staffing and coordination of care with specific staff ratios for staff-assistedthe LTC facility. TEP members discussed dialysis in nursing facilities and that staff whether the licensed nurse must be a quality is more important than staff quantity Registered Nurse (RN) and if the nurse if a minimum is met. It was recognized that must be in the building during dialysis centers providing more treatments will have treatment. The recommendations that a higher level of staff experience and skill. follow assume that LTC facility staff will As a result, it may be possible to eventually take care of all patient needs outside the establish Centers of Excellence based ondialysis needs of the patient. treatment volume and staff skill level. 12 Dialysis in the LTC Facility Project Report 16. 4.3.1a Nurse Responsible for Dialysis administration of manual and automated Subunit Program peritoneal dialysis; access care including The TEP agreed with the proposedsigns, symptoms, and treatment of catheter Conditions for Coverage requirements forexit site infections; signs, symptoms, and the responsible nurse and recommended treatment of peritonitis; measurement of these apply to the nurse assigned adequacy of dialysis; and infection control. responsibility for the subunit(s) as well. It was recommended that a qualified RN be4.3.2 Patient Care Technicians responsible for the hemodialysis and/or The TEP recommended adoption of the peritoneal Dialysis Subunit program. It was language proposed in 494.140(e) and recommended that the Responsible Nurse494.180(b)(5)(i)-(viii), with an increased must (i) Be a fulltime employee of thehemodialysis experience requirement of dialysis facility; (ii) Be a registered nurse two years and a training curriculum specific who meets the practice requirements of theto either hemodialysis or peritoneal dialysis State in which he or she is employed; (iii) modalities, as applicable. Have at least 12 months of experience in clinical nursing, and an additional 6 months Current proposed language is as of experience in providing nursing care to follows 494.140(e): Patient care patients on maintenance dialysis.dialysis technicians must - (1) Meetall applicable State requirements 4.3.1b On-Site Nurse for education, training, In the case of hemodialysis, a licensedcredentialing, competency, nurse educated in ESRD must be present standards of practice, certification, on-site and readily available during the and licensure in the State in which dialysis treatment to assist in the event of he or she is employed as a dialysis an emergency. In the case of peritonealtechnician; and (2) Have a high dialysis, a licensed nurse educated in ESRDschool diploma or equivalency. must be available to support staff-assisted peritoneal dialysis. The on-site nurse mayThe TEP recommended increasing the or may not be the same person as the nurseexperience requirement of patient care responsible for the Dialysis Subunittechnicians administering staff-assisted program. The on-site nurse must meet thehemodialysis in a Dialysis Subunit to two practice requirements of the State in which years because the patient care technician she is employed, and for hemodialysis would need to function more independently programs, complete a training curriculumand with less back-up personnel on the that includes: principles of dialysis; care ofpremises in the Dialysis Subunit setting patient with kidney failure; an compared to patient care technicians understanding of dialysis procedures andworking at in-center dialysis facilities. The documentation, including the initiation,TEP recommended the following language: monitoring, and termination of dialysis;(3)(i) Have completed at least two years possible complications of dialysis; water hemodialysis patient care experience, treatment; infection control; safety; accessfollowing a training program that is care; medications; and emergency take-off approved by the medical director and procedures. governing body. This training experienceCompletion of a training program inmust be under the direct supervision of a manual and automated peritoneal dialysis is registered nurse, and be focused on the required if peritoneal dialysis is provided operation of kidney dialysis equipment and by the Dialysis Subunit. The training machines, providing direct patient care, program should be focused on the types of and communication and interpersonal skills peritoneal dialysis; understanding theincluding patient sensitivity training and care of difficult patients.13 Dialysis in the LTC Facility Project Report 17. TEP recommended that the ESRD provider The TEP recommended adding an be required to periodically monitor experience and training requirement for performance including at least an annual patient care technicians administeringevaluation of patient care technician skills peritoneal dialysis in LTC facilities. Theand knowledge, including observation of TEP recommended the following language: competency. (ii) If administration of peritoneal dialysis (manual or automated) is applicable, then 4.3.3Other Staff the patient care technician must have three The TEP recommended that the Medicare- months peritoneal dialysis patient care certified ESRD provider assign a Medical experience, following a training programDirector that meets the proposed conditions that is approved by the medical directorlanguage in 494.140(a). The Medical and governing body. This training Director may serve as the Medical Director experience must be under the direct for other Dialysis Subunits or ESRD supervision of a registered nurse trained infacilities. 494.140(a): (1) The medical administration of peritoneal dialysis, anddirector must be a physician who has be focused on the administration of manualcompleted a board approved training and automated peritoneal dialysis, access program in nephrology and has at least 12 care, signs and symptoms of peritonitis and months of experience providing care to catheter exit site infections, measurement of patients receiving dialysis. (2) If a adequacy of dialysis, infection control,physician, as specified in paragraph (a)(1) providing direct patient care, andof this section is not available to direct a communication and interpersonal skillscertified dialysis facility, another physician including patient sensitivity training andmay direct the facility, subject to the care of difficult patients. approval of the Secretary.The TEP recommended modifying The TEP recommended adopting language language in the proposed condition that from the proposed Conditions for both specifies training program requirements Dietitians (494.140(c)) and Social 494.180(b)(5)(i)-(viii) as follows: (4)Workers (494.140(d)). 494.140(c) successful completion of a training specifies: The facility must have a dietitian program that includes: (i) Principles ofwho must (1) Be a registered dietitian dialysis; (ii) Care of patients with kidney with the Commission on Dietetic failure, including interpersonal skills; (iii)Registration; (2) Meet the practice Dialysis procedures and documentation,requirements in the State in which he or she including the initiation, monitoring, and is employed; and (3) Have a minimum of termination of dialysis; (iv) Possibleone years professional work experience in complications of dialysis; (v) Waterclinical nutrition as a registered dietitian. treatment; (vi) Infection control; (vii)494.140(d) specifies: The facility must Safety; (viii) Access care; (ix) Applicable have a social worker who (1) Holds a medications; (x) Emergency take-off masters degree in social work from a procedures; (xi) Dialyzer reprocessing, ifschool of social work accredited by the applicable; and (5) have completed aCouncil on Social Work Education; and (2) training program in manual and automatedMeets the practice requirements for social peritoneal dialysis, if applicable. (6) Whenwork practice in the State in which he or state requirements meet or exceed (3) she is employed. above, then the State requirements must be met.The TEP recommended adoption of proposed Conditions language for Ongoing high quality performance of Biomedical Technicians. Proposed patient care technicians is essential. TheCondition 494.140(f) Water treatment14 Dialysis in the LTC Facility Project Report 18. system technicians states: Technicians who Dialysis Subunit and the LTC facility and perform monitoring and testing of the waterintegrate the LTC facility plan of care. treatment system must complete a training program that has been approved by theThe TEP recommended modification of medical director and the governing body. Proposed Condition 494.90(b)(4) asfollows: The dialysis facility must ensurethat all dialysis patients are seen by a 4.4 Patient ESRD Care Assessment physician providing the ESRD care at least The TEP recommended patient ESRD caremonthly, and at least every other month assessment (which includes assessment of during the patients treatment in the appropriateness of modality selection) beDialysis Subunit, as evidenced by a consistent with proposed Condition monthly progress note placed in the 494.80, with modifications of patients medical record. interdisciplinary team members and frequency of assessment.4.6Access to Nephrologist The Condition defines the facility LTC facility patients receive 24-hour care interdisciplinary team as including at a and are more closely monitored than other minimum, the patient or the patientsdialysis patients. The TEP felt it would be designee, a registered nurse, a nephrologist overly burdensome to expect a nephrologist or the physician treating the patient forto travel to Dialysis Subunits to see patients ESRD, a social worker, and a dietitian. Theon a weekly basis, particularly because TEP recommended the interdisciplinarypatients may be located within several team also include member(s) of the LTC Dialysis Subunits across a wide facility staff.geographical area. As a result, the TEPrecommended that patients be assessed by The TEP recommended the initialthe nephrologist in the Dialysis Subunit comprehensive assessment be completedwithin the first two weeks of admission or within two weeks of admission to the readmission to a Dialysis Subunit. The Dialysis subunit and reassessment everyTEP advised that stable patients be seen by month thereafter due to the short length ofthe nephrologist monthly thereafter, with stay of many patients and their high level ofthese visits being in the dialysis subunit at acuity.least every other month. Unstable patientsshould be seen more frequently. The TEP 4.5 Patient ESRD Plan of Carefelt it would be acceptable for Nephrology The TEP recommended the patient ESRD Nurse Practitioners or Physicians Assistants plan of care be consistent with proposed to see the patients in addition to the Condition 494.90, with modifications of monthly visit by the nephrologist. It was interdisciplinary team members,suggested that CMS consider reimbursing communication and frequency of nephrologists at the home dialysis rate, assessment.since the frequency of nephrologist visits islikely to be similar to the frequency of The TEP recommended thevisits of home dialysis patients. interdisciplinary team developing the plan of care also include member(s) of the LTC4.7Vascular Access Care facility staff. In addition to the proposedThe assessment and care of patient vascular Condition, it was recommended that the access is covered by the Patient ESRD Care ESRD plan of care demonstrateAssessment and Patient ESRD Plan of Care communication between the staff of the (see sections 4.4 and 4.5 above). It will beimportant for communication to occur15 Dialysis in the LTC Facility Project Report 19. between the Dialysis Subunit and the LTCfamilies. The TEP recommended that facility regarding the care and monitoringpatient advance directives be of vascular access. The TEP advised thatcommunicated from the LTC facility staff LTC residents who receive long-term to the Dialysis Subunit staff. Decisions to dialysis services should have the goal of a terminate dialysis treatments should be functioning fistula as their dialysis access, discussed with the nephrologist. however the TEP recognized this may often not be possible. It was recommended thatThe TEP discussed barriers to providing all ESRD data related to patients receiving hospice care for dialysis patients. If ESRD care in LTC facilities, including vascularis the cause of the terminal illness, then access data, be reported and reviewed dialysis services cannot be billed under the separately from in-center data. Medicare Part B payment system, but would need to be covered under the hospice 4.8Infection Controlbenefit. Dialysis patients with terminal The TEP recommended adoption of illnesses unrelated to their kidney failure language consistent with proposed may continue dialysis under Part B and Condition 494.30 Infection Control.receive the hospice benefits. Communication and coordination of care between the LTC facility and Dialysis 4.11 Physical Environment Subunit will be critical. It wasThe TEP recommended that the Dialysis recommended that dialysis providers beSubunit comply with all applicable federal, required to educate LTC facility staff aboutstate, and local regulations related to Center for Disease Control and Prevention physical environment for LTC facilities requirements specific to dialysis.(including the requirement for a functional emergency call system in the room(s) used 4.9 Medications for dialysis) and for dialysis facilities (see Administration of medications may beproposed Condition 494.60). handled in various ways. For example, Erythropoietin could be administered4.12 Water Quality subcutaneously or intravenously duringThe TEP recommended that facilities meet dialysis or subcutaneously by the LTC standards for water and the practice facility when the patient is off dialysis.guidelines for dialysate as published by the Coordination of care will require thatAssociation for the Advancement of medication administration be well defined Medical Instrumentation (AAMI). in terms of who administers the medications, what form of medication is to4.13 Coordination of Care be given (e.g. IV or oral), and when theThe TEP believes that coordination of care medication will be administered.is critical to the success of staff-assisted Medications given by the dialysis providerdialysis within the Dialysis Subunit setting. must be reported to the LTC facility so thatResponsibilities must be clearly delineated the pharmacy can monitor care as is and useful or necessary information in the required by LTC facility regulations. The care of the patient must flow bidirectionally quality of care should equal that providedbetween the LTC facility staff and Dialysis to in-center dialysis patients. Subunit staff on a routine basis.4.10End of Life IssuesThe TEP recommended that the Conditions The LTC facility and Dialysis Subunit carerequire a Letter of Agreement between the providers should work together to facilitateESRD provider and the LTC facility advance care planning discussions and specific to this service. This letter of decision-making by patients and their agreement should clearly define areas of 16 Dialysis in the LTC Facility Project Report 20. responsibility and how care will be maintenance of patient dialysis records at coordinated between parties to safeguardboth the LTC facility and ESRD provider the health and safety of ESRD patients. offices. The Letter of Agreement should be reviewed and signed by both parties 4.13.3 Emergencies During Dialysis annually. The TEP recommended specificTreatment items be required within the Letter ofThe parties should define their Agreement as follows. responsibilities for emergencies during dialysis. Both the ESRD provider and LTC 4.13.1 LTC Facility Expectationsfacility must have specific policies and The LTC facility will be responsible for theprocedures in place to handle medical and overall care delivered to the patient,non-medical emergencies that may be monitoring of the patient prior to and afteranticipated during dialysis. The ESRD the completion of each dialysis treatment,provider must have a protocol that and providing for all non-dialysis needs of identifies the arrangements for physician the patient including during the time periodand hospital services in the event of an when the patient is receiving dialysis. emergency during dialysis.The LTC facility Medical Director should be responsible for each patients 4.13.4 Back-up Treatment Facility comprehensive plan of care, which shouldESRD providers should be required to have address dialysis. The LTC facility Medicala written plan for back-up dialysis Director is expected to be involved in thetreatment. If a Dialysis Subunit cannot coordination of ESRD patient care.provide treatment on site, there must be capacity to provide dialysis elsewhere The Letter of Agreement should specifyeither directly by the ESRD provider or that ESRD staff be educated on applicable under arrangement. These back-up LTC facility protocols and that LTC facilityfacilities must be within a reasonable staff be educated regarding ESRD. LTC geographic distance of the LTC facility. facility staff should be prepared to assist in the event of an emergency during dialysis. The LTC Facility record of care should 4.13.5 Utilities The Letter of Agreement should specify include dialysis treatment records. who is responsible for the provision of utilities. 4.13.2 ESRD Provider Expectations The Letter of Agreement should specify that the ESRD provider will be responsible 4.13.6 Communication The Letter of Agreement should specify for providing dialysis staff; dialysis that the LTC facility and the ESRD subunit treatments; monitoring the patient during share state survey statements of treatment; oversight of dialysis care and deficiencies. Other areas of coordination dialysis staff; dialysis staff training; LTC that should be carefully defined in the letter facility staff training regarding ESRD; of agreement include interdisciplinary patient and family ESRD education and patient assessment and plan of care modality selection; dialysis orders; patient (sections 4.4 and 4.5), vascular access care ESRD assessment and plan of care; (section 4.7), infection control (section 4.8), provision of qualified social worker and provision of medications (section 4.9), and registered dietitian services; installation, end of life issues (section 4.10). testing, and maintenance of the water and dialysate systems and all dialysis There was significant TEP discussion equipment; appropriate reporting; and regarding the coordination of care between17 Dialysis in the LTC Facility Project Report 21. parties to meet the nutritional needs of the reported to ESRD Networks on a unit by patient. In theory, the provision of dialysisunit basis, but not be posted on the Dialysis at the LTC facility should automatically Facility Compare (DFC) website, because improve communication and planning patient numbers could be very small. DFC between the LTC facility dietitian and renal reports could aggregate provider Dialysis dietitian. However, given scheduling Subunit data as a report separate from the restraints and the fact that many LTCprovider in-center data, if applicable. facility dietitians are consultants who are at Additionally, DFC should report that staff- the LTC facility on a limited basis, and thatassisted dialysis in LTC facilities is a the ESRD RD may seldom visit the LTC service offered by the ESRD provider. The facility, particular effort should be made toTEP recommended that Dialysis Subunit- ensure real dialogue and joint care-planning specific quality standards should be occur. Dialysis patients are at high risk of defined, however it was recognized that malnutrition. LTC facility dietary servicesdata identifiable as Dialysis Subunit data should be expected to provide a variety of must first be collected and analyzed to palatable meals that provide sufficientdevelop specific standards. protein and calories, are nutritionally complete, and renal-compatible while taking into account patient preferences. 4.16 System for Data Collection Creative menu writing has the potential to The TEP recommended that current data overcome the common problem of lack of collection methods be changed so that variety and insufficient food choice.analysis can distinguish treatment type,treatment setting, patient residency, 4.14 Internal Oversightfrequency of treatment, and modality type. The TEP recommended that Dialysis Subunits meet proposed Condition 4.17 Certification Process 494.110 Quality assessment andThe TEP recommended the following performance improvement. 494.110(a)(2)process to certify ESRD providers for the specifies the program must include, but notprovision of staff-assisted dialysis within be limited to, the following: (i) Adequacy oflong-term care facilities. Providers would dialysis; (ii) Nutritional status; (iii) Anemiasubmit an application to the state agency management; (iv) Vascular access; (v)for service. The application should require Medical injuries and medical errorsan estimate of patient capacity. The new identification; (vi) Hemodialyzer reusecertification of a provider or the addition of program, if the facility reusesa Dialysis Subunit to existing providers hemodialyzers; (viii) Patient satisfaction would require an onsite survey prior to and grievances. The TEP recommendedinitiating Dialysis Subunit dialysis that data from Dialysis Subunits be reported treatments. After the initial Dialysis and reviewed separately from in-center Subunit is approved, if an ESRD provider data. Dialysis Subunits should report theirchooses to open additional Dialysis quality assurance results to both the LTCSubunits, they would need to notify the facility and the ESRD facility.state agency of this intent. After the stateagency acknowledges the intent to open, 4.15 External Oversightthe certified ESRD facility could open the The TEP recommended that Dialysisadditional Dialysis Subunits, understanding Subunit data be included in qualitythat a survey would occur as soon as reporting by the provider, but a Dialysispossible. Waiting for a survey would not Subunit identifier should be added to thehold up opening of additional Dialysis dataset to facilitate separate data analysis.Subunits. It is expected that a transition The Dialysis Subunit data should beperiod will be required to certify existing18 Dialysis in the LTC Facility Project Report 22. LTC facility Dialysis subunits under the provide staff-assisted dialysis within the new regulations. A request for expansion LTC facility setting. A WebEx call was by an existing Dialysis Subunit to add held on January 9, 2006 to familiarize all dialysis stations when dialysis is providedparticipants to the issues and tasks for the in a common area would need to be sent toproject. Strategies to structure the dialysis the state agency.program, staffing issues, patientcoordination of care issues, physical If a Dialysis Subunit is out of compliance atenvironment and technical considerations, a Condition level, the Dialysis Facility and oversight, facility certification process, and all Subunits under that dialysis providera financial model were further discussed would be considered out of compliance. Ifduring a two day face- to- face meeting on the facility failed to correct the deficient January 20 and 21, 2006 in Baltimore. A practice(s), the provider would lose draft report containing TEP certification for their entire ESRD program. recommendations was then prepared and The CMS Regional Office must be notified made available for public comment through when a provider with a Dialysis Subunit is May 15, 2006. The recommendations were determined to have Conditional level nonsent to representatives of major renal compliance. It was recommended that theorganizations as well as state departments ESRD Network be informed if an ESRDof health, quality improvement provider with a Dialysis Subunit is out of organizations, and leadership of the large compliance.dialysis organizations. Public feedback wascollated and sent to the TEP members to 4.18 Financial Model Development review. The TEP reconvened by WebEx in The TEP recommended that a separateJune to discuss the public comments and to section be created on the Medicare Costdecide how to revise the final report. Reports to identify LTC facility dialysisThe TEP urged CMS to consider creation services. The TEP suggested that CMS of this new model because the need for simultaneously develop a case-mixstaff-assisted dialysis in the LTC setting is adjustment methodology and conduct a anticipated to grow as the population pilot project. The composite rate for thesecontinues to age and the current use of the higher acuity patients is expected tohome dialysis method in the LTC setting incorporate the cost of labor. does not appropriately meet this need.5.0 Conclusions In summary, a TEP was convened to formulate recommendations for the development of a definition and method to 19 Dialysis in the LTC Facility Project Report 23. 6.0Technical Expert Panel, Consultants, Observers & StaffTechnical Expert Panel Susan Cronin, Dialysis Consultant, representing American Nephrology Nurse Association, Elkhorn, WI Marlene Demers, CMS Region 1, Nurse Consultant, ESRD Lead, Boston, MA Marilyn Duncan, Fresenius Medical Care North America, Westchester, IL Kathy Hybarger, Health Care Excel, Terre Haute, IN Stephen M. Korbet, MD, Circle Medical Management, Chicago, IL Veronica Marotta, Illinois Department of Public Health, Bellwood, IL Cecilia Meehan, DaVita, Rocky Hill, CT Maureen Michael, National Renal Administrator Association, Orlando, FL Gail Palmeri, MA Department of Public Health, Boston, MA Lana Price, Chronic Care Policy Group, CMS, Baltimore, MD Joan Rogers, Independent Dialysis Foundation, Baltimore, MD Anita Rowan, Hemodialysis Patient, Nurse, Zion, ILCMS Representatives Condict Martak Glenda PayneObservers: Curt Anliker, Executive Director, Renal Therapies, IL Steve Bucher, Chief Executive Officer, Renal Therapies, IL Sheri Floramo, Circle Medical Management, Chicago, IL Judi Kari , CMSStaff: Susan A. Stark, Executive Director, Network 9/10 Jenny Kitsen, Executive Director, Network 1 Jay W. Wish, MD, President, Network 9/10 George Aronoff, MD, MRB Chair, Network 9/10 Bridget Carson, Assistant Director, Network 9/10 Mary Ann Webb, MSN, CNN, Quality Improvement Coordinator, Network 9/10 Raynel Kinney, RN, CNN, CPHQ, Quality Improvement Director, Network 9/10 Janeen Len, MS, RD, LD, Project Assistant, MetroHealth Medical Center Alan Kliger, MD, Nephrologist, Forum Representative, New Haven, CT 21 Dialysis in the LTC Facility Project Report 24. 7.0 References 1.National Renal Administrators Association. Position Paper on Home Hemodialysis forNursing Home Residents. February 2003. 2.Jones A. The National Nursing Home Survey: 1999 summary. National Center for HealthStatistics. Vital Health Stat 13(152). 2002. 3.U.S. Renal Data System, USRDS 2004 Annual Data Report: Atlas of End-Stage RenalDisease in the United States, National Institutes of Health, National Institute of Diabetesand Digestive and Kidney Diseases, Bethesda, MD, 2004. 4.Anderson JE, Kraus J, Sturgeon D. 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