MULTI-DISCIPLINARY NEPHROLOGY DISEASE MANAGEMENT TEAM

BUSINESS PLAN

ONE TEAM - ONE MODEL

TO PREVENT PROGRESSIVE RENAL DISEASE WHERE

POSSIBLE, MANAGE IT WHERE NECESSARY,

AND PROVIDE TIMELY DIALYSIS AND TRANSPLANTATION

COST-EFFECTIVELY USING LITERATURE AND INDUSTRY-SUPPORTED BEST PRACTICES

PREPARED AND PRESENTED BY:

DR. TJ O’NEIL DR. SCOTT MOORE DR. DAVID JOSEPH

ONE TEAM - ONE MODEL TO PREVENT PROGRESSIVE RENAL DISEASE WHERE POSSIBLE,

MANAGE IT WHERE NECESSARY AND PROVIDE TIMELY DIALYSIS AND TRANSPLANTATION COST-EFFECTIVELY

USING LITERATURE AND INDUSTRY-SUPPORTED BEST PRACTICES

EXECUTIVE SUMMARY

An unparalleled opportunity currently exists at James H. Quillen VAMC to significantly reduce costs-of-care, improve patient outcomes, improve patient quality of life and become a national model of Nephrology disease-management. This opportunity exists because of an expansion of the Nephrology Physician workforce; (from one to three providers) occurring simultaneously with the vacating of an ideal floor space for a comprehensive renal disease-management. This presentation will give the justification in detail for a major change in the model of care-delivery for the Nephrology Section:

Adopting a version of the “specialty PACT” structure using literature-proven methods to delay progression to dialysis, manage high-risk/high-cost renal patients more efficiently.

Having dedicated administrative/clerical support to identify Veterans most at-risk, identify them for specialized care and manage transition to dialysis and transplantation.

Placing all elements of care, from identification of patients at-risk, fusion of primary and specialty renal care, education of patients and family in disease self-management, and dialysis in one physical location to optimize Veteran access to multiple disciplines of care

Fusing multiple clinics held in different locations at different times into one locus of care.

The strategy presented fulfills the criteria recently set forth by Undersecretary Shulkin in his New England Journal of Medicine editorial in which he stated the VA’s enterprise goal is to execute a “whole health” model of care as a key component of the VA’s proposed future delivery system, incorporating physical care with psychosocial care focused on the veteran’s personal health and life goals, aiming to provide personalized, proactive, patient-driven care through multidisciplinary teams. Dialysis money is Operational and Maintenance (O&M) funded. We are currently hamstrung in promoting these goals here because our clinical model is outdated and delivered in multiple different clinics in different locations and it lacks a multi-disciplinary approach integrating primary and specialty care. To assure that this proposed plan met the required content elements, it was reviewed by Dr. Susan Crowley, the VHA Nephrology Consultant, who responded: “Great work - would love to see this implemented and measured- could then use as national template.”

This presentation will request that:

The Nephrology Service’s New Patient Consult, Follow-up, Patient Education, CVAT-Tele-Medicine Dialysis Follow-up and Erythropoietin clinics be co-located in one space adjacent to the Dialysis function, with dedicated clerical, transplant-management and data-management support, and work-space for the current part-time Pharmacy and Nutritional Medicine disciplines to perform their functions immediately adjacent.

A fifth hemodialysis machine and two additional Dialysis Nurses added to expand ability to deal with mechanical outages and the increasing number of inpatients requiring acute dialysis and PICC lines.

The modality of peritoneal dialysis(PD) be provided here using a contracted-in approach to provide our Veterans on that dialysis modality inpatient support at this Facility, versus being fee-based out to Johnson City Medical Center (JCMC) when they require inpatient care for any reason.

The modality of ambulatory blood pressure monitoring (for which we already have the hardware) be staffed and included in the same floor space so it can be added to the diagnostic armamentarium of this Facility.

For every year we delay a Veteran going on hemodialysis, we save $50,000 - $80,000.

For every Veteran on PD vice hemodialysis, we save $20,000 each year.

For every Veteran transplanted versus remaining on dialysis we save between $30,000 and $50,000 each year.

For every patient we must fee-basis out to JCMC due to lack of an inpatient Peritoneal Dialysis (PD) capability we are charged in higher teens up to $30,000 in O&M dollars for the cost of that patient’s entire episode of care.

**Note: We have sent out over a dozen such patients in the past two years. Contracting of experienced PD Nursing support to provide that modality in house, would cost about the same annually as sending one patient. Finally, for every patient we misdiagnose as having fixed hypertension versus masked hypertension or white-coat hypertension due to lack of Ambulatory Blood Pressure Measurement (ABPM) outpatient clinic capability, we reduce our Primary Care metrics for hypertension control, we risk over- or under-medicating Veterans with multiple co-morbidities, putting them at-risk for unwarranted complications, and we increase the cost of care for medications dispensed but not taken. We already have the hardware to run such a clinic, but not the Nursing support or the location of care to set it up. Even if we weren’t improving the quality of Veterans’ lives through this initiative, these would still be worthy objectives.

It is a fact that in population health care the goal is to maximize “Value” as defined by the equation:

Value = Quality (outcomes) / Cost

It is judged to be beneficial to maintain quality while lowering cost. If we apply a multi-disciplinary approach as outlined above we have the opportunity to improve outcomes very significantly and also lower costs vary significantly, thereby achieving a tremendous increase in value. This can be realized, however, only if we change the model of care as emphasized by Dr. Shulkin. We will discuss each of these points in more detail, showing projected cost savings from preliminary data from DSS and the Office of the VA Nephrology Consultant

CLINICAL / BUSINESS PLAN FOR CREATION OF A MULTI-DISCIPLINARY RENAL DISEASE MANAGEMENT TEAM

1. BACKGROUND The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), unlike most other healthcare systems in the country, at this time, has long-term “ownership” of costs and outcomes of its patients. It has a robust Electronic Medical Record (EMR) designed for integrated patient care delivery and allowing for the further build-out of the Patient Aligned Care Team (PACT) model, realizing true population health care precepts. It therefore is the best-positioned healthcare system in the country to benefit from comprehensive disease management strategies. It is uniquely positioned among US healthcare systems to promote cost effective healthcare. Redesign of the Nephrology Clinic along the lines of a multi-disciplinary super Nephrology PACT will allow for improved care coordination for the Veteran resulting in better outcomes and a better quality of life. The enclosed referenced Taiwan experience, documents from their study, the benefits to be realized from this type of Nephrology Service structure. To quote Undersecretary Dr. David J. Shulkin in the March 2016 New England Journal of Medicine:

“Few other systems enroll patients in areas where they have no facilities for delivering care. Fewer still provide comprehensive medical, behavioral, and social services to a defined population of patients, establishing lifelong relationships with them. These realities, combined with the wait-time crisis, have led the VA to reexamine its approach to care delivery.”

“I believe that addressing Veterans’ needs requires a new model of care.”

“Our “whole health” model of care is a key component of the VA’s proposed future delivery system. This model incorporates physical care with psychosocial care focused on the Veteran’s personal health and life goals, aiming to provide personalized, proactive, patient-driven care through multidisciplinary teams of health professionals. The VA will also maintain care registries, crisis lines, and centers-of-excellence programs in services for Veterans that are not available in many communities.”

The Nephrology multi-disciplinary disease management system proposal detailed in this presentation follows literature-proven models which have shown the ability to delay onset of dialysis, thereby averting costs of $89,000 per patient year of dialysis avoided and promote use of more cost effective, life-quality promoting techniques of End Stage Renal Disease (ESRD) treatments such as renal transplantation and peritoneal dialysis. It will reduce reliance of catheter dialysis while smoothing the transition to whatever treatment modality is most suitable for the Veteran`s circumstances, thereby reducing mortality and morbidity.

An additional goal of our multi-disciplinary clinic is to better build out and define peritoneal dialysis in the VA. It is a very cost-effective and under-utilized both inside and outside the VA. One of our Nephrologists found that by using strong educational programs and a sound home training program, he was able to put 33% of his ESRD patients on peritoneal dialysis over a 2 - 3 year period. This was accompanied by a marked improvement in patient quality of life and reduced re-hospitalization rates. Here at Mountain Home VA Medical Center (MHVAMC), we are far less successful than we could be at promoting these goals because:

Our clinical model is outdated; we treat incident illness without preventing/slowing it

Nephrology care is being delivered in multiple different clinics throughout the facility

We lack a multi-disciplinary approach integrating primary and specialty care In short, our proposal will, by leveraging the assets the VA already possesses, provide our Veterans with improved quality of life measured by reduced hospitalizations, more cost effective treatments and thereby realize here at the VA what is for the most part only being envisioned at present on the outside under the rubric of “population health care”. 2. Renal Disease Is A Continuum: Largely Asymptomatic, Progressive, & Serious

Chronic Kidney Disease (CKD) is a continuum from normal kidney function-for-age to severely compromised function progressed to the point of requiring substitution of dialysis or transplant for the missing kidney function called ESRD. We are almost all born with two fist sized kidneys containing 1 million tiny kidney filters in each kidney. These filters “burn out” with normal wear and tear over years of life. This results in: Stage 1: Normal Kidney Function: Taking into account age, since virtually everyone’s renal filtration estimated glomerular filtration rate (e-GFR) falls by about 1mL/min/year. (Diabetes, hypertension, overweight, systemic inflammatory disease, and exposure to environmental and medical toxins to include over the counter (OTS) products increase the slope of that decline.) Stage 2: Elevated Risk: With identified diagnoses and risk factors attached to the patient which may accelerate the normal decline, but with normal-for-age renal function and importantly, no symptoms deriving from the renal disease for virtually all patients. Stage 3: CKD: Exists when the renal function has decreased to less than 60mL/min but is still above 30mL/min. During this period, in the evolution of the disease, decline is relatively slow for most patients because there are still enough kidney filters functioning to buffer the dropout of the diseased ones. However, the remaining filters are hyper filtering, (working so hard under such pressure that they spill protein into the urine and burn out early.) Stage 4: Exists when the e-GFR has dropped to between 30mL/min and 15mL/min: At this stage, there are so few kidney filters remaining that the survivors cannot effectively buffer small additional insults to the kidney function.

It is during Stage 4, that the first subjective symptoms of progressive kidney diseasebegin to bother the Veterans; ankle swelling, frequent nocturnal urination, loss ofappetite, anemia, and often bone pain.

During this Stage, frequent follow-up, careful monitoring and management of bloodpressure, blood sugar, fluid status and judicious use of certain blood pressure controlagents can save the Veteran from a devastating crash into dialysis; it is a critical timeperiod for aggressive state-of-the-art management.

Good management during at this Stage can and does change the slope ofthe functional decay curve. It is, in this Stage, when we can make a majordifference in delaying the onset of dialysis and reserving residual renalfunction.

During this Stage, when the e-GFR declines to below 20mL/min the patient canbegin to undergo evaluation for potential renal transplantation and be listed at atransplant center for pre-emptive transplantation, thereby improving the quality of lifeand saving enterprise money for avoidable years of dialysis.

This is also the Stage when detailed planning for ESRD must be done, with thepatient selecting the best form of dialysis for them and their overall medical situation.If hemodialysis is the only option, planning is critical for a permanent vascular accesswhich will take 60-120 days to mature for use. Failure to see and manage thisaspect of the patient’s future care during this phase means that they may “crash”onto hemodialysis with a temporary cuffed venous catheter, with all its attendantcomplications. In the first 180 days of dialysis, having a catheter for dialysis asopposed to a permanent vascular access increases a Veteran’s mortality by 60%. Ithas been said that the 20% difference in first year hemodialysis mortality betweenthis Country and Europe is accounted for largely by the increased catheter use in theUS and poor transition onto dialysis.

Stage 5: ESRD: Is when the patient must be readied for and placed on dialysis. Social, financial (including fee-basis contracting), emotional counseling, dietary, and other arrangements must be made during this time.

“Annual U.S. expenditures on the treatment of chronic kidney disease exceed $48 billion, with yearly per-patient costs of approximately $89,000 for hemodialysis and $25,000 after the first post-transplantation year. Furthermore, kidney transplantation significantly improves quality of life and decreases mortality as shown by Wolfe, et al, in 1999. [Wolfe RE, et al; “Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation and recipients of a first cadaveric transplant”, N Engl J Med 1999; 341:1725-30] http://www.nejm.org/doi/full/10.1056/NEJM199912023412303 edited from Rostaing LPE and Malvezzi P in N Engl J Med; 374:982-984 http://www.nejm.org/doi/full/10.1056/NEJMe1601379

3. Renal Disease is Extremely Common in the Population Served by the VHA

Fully 25% of the population over 60 years of age has Stage 3 or worse CKD, per the CDC and the NIDDK:

Conversely, the fraction of patients with Stage 3 or worse kidney function in the 20 - 39 year age group is almost invisible on the chart above. In the past several years, the fraction of Veterans in the highest-risk (~25% prevalence) population has been steadily maintaining at about 9.5 million, Nationwide:

0

5

10

15

20

25

30

1988-1994 1999-2002 2003-2006 2001-2008

20-39

60+

NHANES SAMPLING PERIOD

Patient Age

20-39 Years 60+ Years

1988 - 1994 0.1% 18.8%

1999 - 2002 0.3 24.2

2003 - 2006 0.1 24.5

2001 - 2008 0.2 26

FIGURE 2: Number of Living Veterans by Age Group

FIGURE 1: National Distribution of CKD 3 or Worse by Age

Because James H. Quillen VA Medical Center (JHQVAMC) is located in a region of high obesity, hypertension, and diabetes mellitus, all of which are diseases that greatly increase hyper filtration injury to the residual kidney filters and cause accelerated loss of kidney function as noted earlier. The above VA-wide data has been locally reduplicated, resulting in the number of patients in NIDDK Stage 3 or higher and therefore at-risk for progression to ESRD being a large part of our local patient-base. The following DSS Data was obtained by Ms. Belinda Mink for fiscal year (FY) FY13 thru FY15: Although better blood pressure and diabetes care may be responsible for the very slight decrease in the overall number of patients with Stage 3 and worse renal function, that group is declining toward ESRD at a rate of 2-5mL/min/year, creating a future potential tsunami of ESRD patients. Furthermore, as seen in data above, the age of our nation’s Veterans is increasing at the same rate as the general population and concurrently, thus resulting in an increase in the expected prevalence of obesity, hypertension and diabetes mellitus. Using the rich DSS database, we have obtained local data on the prevalence of Stage 2, Stage 3 and Stage 4 CKD for the JHQVAMC enrolled population for FY13, FY14 and FY15. For these three years, the prevalence has been fairly constant at 4,700 total patients in Stage 3 and Stage 4 combined out of a total population of ~55,000 enrollees. As the importance of good prospective management has been impressed on the Primary Care Providers (PCPs) and the Stage 4 population has progressed toward ESRD. However, the number of Nephrology consults has risen dramatically. This has led to a corresponding rapid rise in both inpatient dialysis workload and consults for outpatient maintenance dialysis.

FIGURE 3: Mountain Home Veterans with Stage 3 or Worse CKD

4. Nephrology Workload The above conditions have resulted in sharply rising inpatient consults and workloads for Nephrology, which until recently was supported thinly by a contract workforce consisting of five community Nephrologists who spent three hours at JHQVAMC on-site here five days a week and occasionally provided care on-site when paged for inpatient/acute emergencies:

These patients are currently being managed separately by Primary Care, Nephrology, Vascular Surgery and others without a single systems-based management system. The default to comprehensive, prospective outpatient management is inpatient admission with much more expensive crisis-management when the patient reaches the point of renal failure without having had prospective outpatient advance-management. As suggested by data collected from DSS that is currently occurring at a rising rate. For inpatient acute/urgent dialysis alone, the number of procedures has gone from ~500 three years ago to the current number of 700 per year.

0

10

20

30

40

50

60

70

80

90

Oct Dec Feb Apr Jun Aug

FY13

FY14

FY15

FY16

Linear(FY13)

Linear(FY14)

FY13 FY14 FY15

Workload 562 608 818

0

200

400

600

800

1000

Wo

rklo

ad

Month FY13 FY14 FY15 Oct 24 20 48

Nov 29 27 47

Dec 25 45 51

Jan 44 41 82

Feb 35 30 61

Mar 57 50 53

Apr 32 56 29

May 60 48 44

Jun 31 25 53

Jul 55 44 78

Aug 25 68 54

Sep 60 43 82

Total 477 497 682

FY13 FY14 FY15 FY16

Hemodialysis Workload Alone 562 608 818 306

Figure 4: Total Inpatient Consults per FY

Note: Huge jump in trend line

Figure 5: Inpatient Workload CPT 90937 by FY

Hemodialysis treatment lasts from 3 – 4 hours, and requires an hour of machine setup and calibration before each treatment, and another 45 minutes to an hour of take-down and cleaning after each treatment, resulting in a “shift” for our three-machine dialysis unit being able to handle three Veterans every 5 - 6 hours. If there are more than six inpatient Veterans at a time, this results in dialysis Nurses working 15 -18hour days. That is not safe, due to “crew fatigue” 5. Renal Disease Is Expensive If Un-Managed or Poorly-Managed:

Patients who progress to ESRD requiring (renal replacement therapy (RRT), hemodialysis, PD, or transplant) cost the VA an enormous amount of money.

- Every year of hemodialysis avoided saves $80,000-89,000. - Every year of peritoneal dialysis avoided saves $60,000.

Prompt renal transplantation also saves money: After the first year, renal transplant management costs $29 - $30,000, as opposed to the dialysis costs which continue to be incurred every year the patient remains on dialysis pending transplantation. Nationally, only 10 - 15% of patients maintained on hemodialysis can continue to work, whereas ~40% can continue to work at least half-time if they are on peritoneal dialysis. The societal costs of dialysis are also huge; many spouses who would otherwise be able to work cannot do so in order to remain home and care for their chronically-ailing spouses on hemodialysis who must be brought to and from dialysis three times a week. There is no benefit to early start of dialysis and most Veterans are in no hurry to start dialysis, unless it will improve their well-being and or give them a safety advantage. Along with Ms. Mink’s help, we have only begun to dig into the tremendous DSS resources available. However, at present we have been able to derive an estimate of the growth in the prevalence of dialysis-requiring Veterans. If we take the literature-supported estimate of the ability of multi-disciplinary disease management to delay the incidence of new ESRD cases by 20% for at least a year and use the VA’s cost-estimates for dialysis, significant savings can be achieved (See TABLE 7). If we are able to encourage 15% of those Veterans appropriate for it to go on PD instead of hemodialysis, the additional cost savings to the system, including those from decreased predicted hospitalization, are even more significant (See TABLE 8). These figures do not capture the very hard-to-quantify but real issues such as improved quality of life on peritoneal dialysis versus in-center hemodialysis and just as importantly, the reduced rate of hospitalization for the PD population. Once the baseline has been established we will be able to track all this data and report on the effectiveness of our approach using DSS for this crucial outcomes data. 6. Management Meeting Dr. Shulkin’s Goals Must Be Systems-Based:

Care in isolated specialist clinics has never been shown to be cost-effective; it is “illness management” and not disease-management. On the other hand in the past five years two

published studies have convincingly shown that multidisciplinary, systems- and outcomes-based care delays progression to ESRD, saves money, and results in better care.

Multidisciplinary Team Care May Slow the Rate of Decline in Renal Function, BaylissEA, et al; Clin J Am Soc Nephrol. 2011 Apr; 6(4): 704–710.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3069359/

Multidisciplinary Care Program for Advanced Chronic Kidney Disease: ReducesRenal Replacement and Medical Costs, Chen PM et al; The American Journal ofMedicine (2015) 128, 68-76. http://ac.els-cdn.com/S0002934314006871/1-s2.0-S0002934314006871-main.pdf?_tid=f7d30c1e-ce9a-11e5-a2cc-00000aacb35e&acdnat=1454960248_8ce94368851923372234eed68fac5f47

The elements of systems-based renal disease care across the continuum from elevated risk to ESRD include:

Selection of patients at risk from the PCC milieu

We have unrivalled tools in VistA/CPRS and DSS data that no other healthcaresystem has! A data manager can use that database to identify patients down to the PACT of assignment, and determine their rate of loss of renal function.

Management must be according to uniform, literature-and-outcomes-basedalgorithms

Management of CKD-associated anemia is an excellent example of the need for andeffectiveness of multidisciplinary care. Prior to FY 2010 renal anemia was being managed at this VAMC with an expensive biologic (recombinant human erythropoietin) at the Primary Care Clinic level without Pharmacy involvement or established, consistent management. A study requested by Dr. O’Neil in 2011 found that 2/3 of those patients were not having best-practices followed, including verifying that the problem was one treatable with EPO, and that optimization of iron and erythropoietic co-factors, dosing to keep HGB between 11 and 13Gm%, and monitoring for symptomatic changes such as hypertension exacerbations and thrombotic problems were being done. The EPO Clinic now with established criteria for patient enrollment and uniform consensus management, has decreased the number of Veterans being needlessly or inadequately treated with EPO, and the resulting costs, have fallen dramatically.

Whereas 90 Veterans were being treated with EPO in 2010 at one dose/week,most inappropriately, on the wrong dose, or inadequate iron stores, there arecurrently 22 properly-managed Veterans on the drug. A properly-managed EPOclinic has also been found to be effective at maintaining a sense of well-being inour Veterans. The fact that EPO unfortunately does not delay progression toESRD was demonstrated by the TREAT study(http://www.ncbi.nlm.nih.gov/pubmed/19880844 ). However, others have foundthat initiation of dialysis is delayed by proper use of EPO can delay dialysisinitiation (http://annals.org/article.aspx?articleid=477522 ) as well.

Identification of the multi-disciplinary mix needed for good care and bringing them to

the patient as part of an integrated team, as with the PACT model, are critical. Comprehensive Nephrology disease management using best-practices requires

special management expertise outside the routine PCC purview including:

Nephrology Dietician/Nutritional Medicine Clinical Social Work Pharmacy Vascular and General Surgery Nurse Educator Dialysis Nurse

Management of transition from CKD 5 to dialysis and transplantation must take place

in a compact, efficient process. Identification of Veterans rapidly declining to ESRD requires regular systematic

reviews of existing DSS data by someone knowledgeable. Decision points for abandoning attempts to delay progression and switching to

making concrete dialysis & transplant plans must be identified. Vascular/venous mapping for permanent hemodialysis access must be done timely;

this requires close cooperation between Vascular Surgery, Vascular Lab, and Nephrology

Patients must be identified whose medical condition and overall cognitive and compliance ability is such that they are peritoneal dialysis candidates; and those patients must be consulted to a General Surgeon who is following best-practice guidelines for timely peritoneal dialysis catheter insertion.

Those patients likely to be good transplant candidates must be identified and the 35-test-and-consult criterion process of preparing them for VHA approval for transplantation must be implemented in a timely fashion. We need to use this process pre-emptively, if possible, and if not to utilize the concept of “dialysis as a short-as-possible bridge” to transplant.

Patients on contract dialysis in the community must have timely review of their status and medications and when necessary re-evaluation of their vascular accesses or peritoneal catheters by the VAMC through an orderly process. Also, at those reviews

TABLE 5: EPO Cost by FY

Epotein Alpha Patients

Cost/Year at $100/Week

FY10 92 $478,400

FY11 61 $317,200

FY12 57 $296,400

FY13 36 $187,200

FY14 32 $166,400

FY15 39 $202,800

FY16 22 $114,400

0 100

FY10

FY12

FY14

FY16 EpoteinAlpha

Linear(EpoteinAlpha)

Figure 6: Epotein Alpha Patients

the VA Nephrologist needs to be able to determine whether changing to alternative dialysis modalities such as peritoneal dialysis should be suggested to the Veterans.

The powerful tools of tele-medicine must be brought to bear for remote assessment and medication reconciliation to preserve patient safety and minimize fragmentation of care between Nephrology, the PACT’s-of-assignment, and community Providers caring for day-to-day dialysis management under the contracts.

The number of such patients being cared for by dialysis vendors in this VAMC’s community catchment area under the VHA contract is rising very rapidly:

TABLE 6: Non-VA HD Consults by FY

# NON VA Dialysis Consults

FY10 12

FY11 28

FY12 17

FY13 33

FY14 66

FY15* 124

FY16 28

*Outlier year due to re-certification of contracts

This data comes straight from DSS, from the question of “How many new fee-basis dialysis consults were filed in each fiscal year, 2010 – 2015, to include the number thus far for 2016?” Some of this startling rise, and the accompanying cost, can be delayed or avoided by systems-based prospective management to delay onset of dialysis. Since the data from FY2015 was distorted by a mandated renewal of all the VA contracts and distinguishing those truly new from those simply renewed is not possible from DSS data without a time-intensive contract-by-contract search, 2015 will be treated as an anomalous outlier year for purposes of trending. A new trend line can be established by doing a least-squares-fit through the existing prior year’s data and extrapolating the ½ year of data for FY2016 which are all new consults:

0

20

40

60

80

100

120

140

FIGURE 7B: New Non-VA Consults From FIGURE 7A Data

Incident New Non-VACONSULTS (Actual Data)

0 50 100 150

FY10

FY12

FY14

FY16

FIGURE 7A: # NON VA DialysisConsults

   # NON VADialysisConsults

Linear (   # NON VADialysisConsults)

1/2 year of data

*

At the local contract-specific $308/HD treatment-only rate of $48,048 per patient-year, the following interpretation can be made, based on the following conservative assumptions:

The prevalence of dialysis patients is equal to the incidence plus prevalence adjusted formortality and leaving dialysis due to transplantation. Nationally, mortality on dialysis is22.5 - 25% per year due to cardiac sudden death

As a result, ~25% of the patients on dialysis currently will die or be transplanted annually

Rigorous population health management can put off by at least one year the entry ontodialysis of 20% the population currently reaching or predicted to reach dialysis per thedata-based trend line without population management.

TABLE 7: Projected Number and Cost of Maintenance Hemodialysis by FY

Incident New Non-VA CONSULTS If FY15 is Accepted as an Artificial Outlier (Projected from 2016)

Incident New Non-VA CONSULTS if 20% Could be Prevented by Disease Management

Prevalent Consults If There is No Disease-Management Benefit

Prevalent Consults If 20% of Incident New Consults Could be Prevented Through Disease Management

Cost of Prevalent Consults at $48048/Pt/Year (After Adjustment for Anomalous 2015) With No Disease Management Benefit

Cost of Prevalent Consults if Incidence Could be Decreased by 20% by Disease Management

Cost Savings if Incidence Could be Decreased by 20% by Disease Management

FY2010

FY2011

FY2012

FY2013

FY2014

FY2015

FY2016

FY2017

FY2018

FY2019

FY2020

FY2021

These cost-saving projections are startling, and they may be over-estimates of savings if:

The actual cost-of-total-care is less than the VA contract place-holder cost of $48,000 inVSSC, or

The trend line for the rising number of incident non-VA hemodialysis consults is too high.

However, the costs savings may be even higher if:

More than 25 % of the prevalent dialysis patients do not die or get transplanted eachyear and the number of prevalent dialysis patients.

If the extended cost-of-care for the contract dialysis patients (contract cost plus duplicatecare at the VAMC by PCP’s) is actually closer to $80,000 per year than $48000.The VA’s published rate of $48048/patient-year is dramatically lower than the validatedcommunity cost of $87,945 per USRDS data published athttp://www.usrds.org/2013/pdf/v2_ch11_13.pdf ).

Currently, virtually all of our dialysis patients are placed on community in-center hemodialysis, whether that is the best medical strategy for them or not. In part, this is due to our past contract Nephrologists preferring hemodialysis, since they were the Medical Directors of the community dialysis units. It is also in part because we do not currently have the capability to care for our Veterans on PD in this Facility and must fee-basis them out to other community medical centers for all care if they require inpatient care. That lack results in a considerable additional cost, not just for the fee-basis send-out inpatient care, but also for the contracted cost of care. If we encouraged PD as an option, it appears we could

achieve significant cost-savings. Many parts of the country have 30% of their ESRD patients on PD. With a $20,000 lower annual cost for PD than HD, just a few patients placed on PD would make a significant cost-saving opportunity. All the consults were reviewed and renewed in 2015, so that renewal shows up as an outlier for which new and renewed contracts could not be separated easily in DSS. The following estimates are based on placing only 15% of our dialysis patients on PD each year: TABLE 8: Projected Costs and Cost-Savings by Placing 15% of the Incident ESRD Patients Annually on Peritoneal Dialysis (PD) Versus Hemodialysis (HD). (All Dollar Values Are in Millions):

FY

Incident New Non-VA ESRD CONSULTS (Actual and Projected Data)

Incident New Non-VA CONSULTS If FY15 is Accepted as an Artificial Outlier

Incident New PD Patients 15% Could be Put on PD Instead of Hemodialysis

Prevalent PD Patients if 85% Survive Each Year

Incident New Non-VA HD CONSULTS if 15% Could be Put on PD

Prevalent HD Patients If 15% of Incident New Consults go on PD versus HD

Prevalent HD Consults (Predicted from 2016 Forward) If Everyone Goes on HD

Cost of Prevalent HD Consults at $48048/Patient/Year (After Adjustment for Anomalous 2015) If Everyone Goes on HD

Cost of Prevalent PD at $60,000/pt-yr

Cost of Prevalent HD if Incidence Could be Decreased by 20% by Disease Management at $80,000/pt-yr

Total Dialysis Costs if 85% Go on HD and 15% go on PD Without a 20% Delay in ESRD from Disease Management Effect

Total Dialysis Costs if 85% Go on HD and 15% Go on PD With a 20% Delay in Going on Dialysis from Disease Management Effect

Cost Savings from 100% HD Model If 15% To on PD Without a 20% Delay in HD from Disease Management Effect

Cost Savings from 100% HD Model If 15% Go on PD With Add 20% Delay in HD from Disease Management Effect

FY10 12 12 FY11 28 28 F012 17 17 FY13 33 33 FY14 66 66

115 $9.2 FY15 124 44 4

117 148 $11.84

$9.36

FY16 56 56 8 12 48 135 190 $15.2 $0.708 $10.828 $11.536 $9.37 $4.372 $5.83

FY17 62 62 9 16 53 154 237 $18.92 $0.986 $12.337 $13.323 $10.856 $6.583 $8.064

FY18 68 68 10 18 58 173 288 $23.00 $1.086 $13.877 $14.963 $12.188 $9.123 $10.812

FY19 74 74 11 20 63 193 343 $27.44 $1.186 $15.44 $16.626 $13.538 $12.00 $13.902

FY20 80 80 12 21 68 213 403 $32.24 $1.286 $17.020 $18.305 $14.902 $15.220 $17.338

FY21 86 86 13 23 73 233 468 $37.40 $1.386 $18.613 $19.999 $16.276 $18.787 $21.124

FY22 94 94 14 25 80 254 538 $43.04 $1.504 $20.352 $21.855 $17.785 $22.688 $25.255

7. Residence Locations of Our Current Population-At-Risk: These patients are scattered over a wide area of three states (Virginia, Tennessee, and Kentucky), but the majority are concentrated in the Johnson City/Knoxville area. However, as best we are able to determine, about 2/3 reside within a 40-mile radius of the main campus of the Mountain Home VAMC. 8. Current Model of Nephrology Care at This JHQVAMC:

The Nephrology Service is currently organized as a standard multiple-clinic/multiple-location isolated model of care. There are Nephrology Consultation and Follow-up clinics that depend on Primary Care to refer patients most at-risk for evaluation and treatment, then discharge patients back to primary care providers who see them irregularly mixed in with their other primary care patients at individually-variable time intervals. EPO Clinic is only loosely joined to the Nephrology Clinic. Timely EPO use delays ESRD. Ambulatory Blood pressure measurement devices are available on-station, but support for an Ambulatory Blood Pressure Clinic has never evolved despite proven efficacy of this tool. Patient education is not managed prospectively for maximal benefit. Education and prevention counseling depends on Primary Care PACT clinics identifying patients whose renal function is within their ability to manage, but yet who can benefit from in-depth patient education regarding the nature and effects of renal disease. This means educating Veterans on ways they can retard the progression of chronic renal disease, as well as the options that might be required (such as dialysis) if they do not do so or if attempted

management fails. Although a two-hour patient education class with tele-medicine outreach exists currently, referral is spotty because disease data-management is not developed. Patients approaching ESRD may or may not be recognized timely for placement of vascular accesses. Most patients are not told of the possibility of PD until late in the course of their disease. Opportunities for patients to see dialysis and understand viscerally the effect it will have on their lifestyles if they do not take disease-management ownership are few and far between, and sometimes do not occur at all until the patient is at the point of requiring RRT. Each Provider/clinic draws blood studies independently of the others, without coordination of timing, resulting in additional unnecessary blood loss for patients already anemic and possibly on expensive erythropoietic stimulating agents. Dietary and pharmacology counseling is dependent on a standard delayed-consultation model. The predictive population management potential of DSS to identify patients whose rate of renal function loss is excessive is currently not being utilized. This situation often results in a “crash” onto dialysis, necessitating initiation of dialysis with a hospital admission rather than a more appropriate outpatient transition to dialysis. Renal transplant candidacy evaluation, a 35-step testing process, must be managed by the Nephrologists essentially without support, because the one Transplant Coordinator working with Gastroenterology (GI) is effectively fully-utilized by GI. This results in transplant evaluation frequently not occurring until after the patient is on dialysis. A recent change in VHA policy allows evaluation and listing of appropriate renal transplant candidates for transplant upon reaching e-GFR of 20mL/min, can meaningfully shorten the waiting time on dialysis for a transplant by 1 - 2 years. Vascular Surgery Clinics which service the needs of patients approaching HD or already on dialysis with a temporary catheter are held without active participation by Nephrology. PD, a renal replacement technique associated with increased quality of life for many patients, better survival, and improved outcomes, is not currently offered here, resulting in any Veterans using that technique who require inpatient admission being fee-based out for all care, regardless of the need for admission. 9. Current Nephrology Workflow:

The patient flow plan for Nephrology begins with an inpatient or outpatient consult. The Nephrologists determine which procedures are indicated (dialysis, transplant candidacy evaluation, vascular or PD catheter access referral). Consultations, either e-Consults or face-to-face consultation requests are individually reviewed by a Nephrologist within three days of their release (typically same-day or one day later). That evaluation includes a brief records review and selection of the tests needed for a one-visit diagnosis and treatment and ordering with performance dates corresponding to available in-person consultation appointments, so results are timely and relevant. The consultation is then arranged and the patient is notified by a Patient Services Assistant (PSA) working with Nephrology Service. This practice, introduced in 2015, has reduced the number of return visits required by inadequate data to an average of two per patient, and has resulted in significant reduction in waiting time for Nephrology consults.

If a Veteran is admitted in need of inpatient dialysis, we can care for up to six such patients at a time without putting the Nursing staff on overtime. Unfortunately Dialysis Unit overload and Nursing overtime has occurred over 40 times this past year, due to workload increase. If a Veteran on PD is consulted for inpatient admission either through the Emergency Department (ED) or one of the outpatient clinics, they must be fee-based to Johnson City Medical Center (JCMC) for the entirety of their inpatient care. Since we cannot provide PD support for inpatients. This has occurred twelve times in the past two years. There is no dedicated Nursing support for prevention education. There is a once-monthly two-hour group clinic held in Building 160 either in-person or by tele-medicine taught by one of the Nephrologists which teaches patients voluntarily referred by the PCP’s what kidney disease is, how it affects their bodies, and how they can take ownership of the disease and reduce its progression. The education also includes, in detail, the Veteran’s options if it progresses to ESRD. We currently offer six new-outpatient Nephrology consultations a week and thirty-six outpatient Nephrology follow-up appointments by placing two Nephrologists in the outpatient clinic. If an East Tennessee State University (ETSU) Medicine Resident is rotating on nephrology that Resident is also in the morning outpatient clinic under close supervision seeing 1-2 consults or follow-ups. One Nephrologist performs as many inpatient consultations and follow-ups as needed, plus provides night and weekend call, supervising inpatient acute HD and CVVHDF. In that way, a break from outpatient clinic is not required to attend to an unstable dialysis patient or critical new consultation. The in-patient Nephrologist also provides inpatient Resident teaching. The roles (in-patient and outpatient) rotate every week. We currently have 35 Veterans at various stages of transplantation evaluation:

18 Veterans active in workup

7 Veterans listed and awaiting transplant

10 Veterans pending resolution of a question delaying active listing Each of these Veterans require individual attention to the details of their transplant evaluation status and monitoring of which tests have been accomplished and which need expediting. There is currently insufficient time for Nephrologists to do this, and the Transplant Coordinator working for GI has her own long and growing list of patients. Due to delays and the fact that the mortality from cardiac disease on dialysis is 22.5% annually, five patients have died on dialysis awaiting transplantation in the past three years. There is also a separate joint Pharmacy/Nephrology Erythropoietic Stimulating Agent (ESA) clinic held for three hours every other Tuesday afternoon. This clinic seeks to reduce the cost and improve the quality of management of those patients placed on erythropoietin for literature-supported indications. As of early May the next available new Nephrology Consultation is mid-June (5-6 weeks) Dialysis and CVVHDF are available immediately to inpatients, although the small number of RN’s requires overtime or extra shifts if there are more than six in-patients requiring dialysis at any given time.

The limited number of dialysis machines with occasional mechanical or bacteriological off-line periods may mean that on any given day we are attempting to provide care for six patients with two working machines, which also requires additional overtime for Nursing Staff. This problem is too important to continue with the same operating plan, as it jeopardizes Veteran safety and leads to Nurse burn-out and has resulted in emergency presentations to the ED being fee-based to JCMC. We can do better! 10. Current Nephrology Staffing: Nephrologists under Medicine Service

3 full time attending Nephrologists

Transplant Coordinator (10% Nephrology/90% GI) The Dialysis Unit Staffing under Nursing Service

3 RN’s Renal Replacement Treatment Devices

3 Gambro Phoenix® Hemodialysis machines with paired MARCOR 300H® reverse-osmosis machines

2 Gambro Prismaflex® machines 11. Proposed Nephrology Workflow:

The sort of multidisciplinary Renal Care Center proposed would incorporate the current pre-reviewed Outpatient Consults and immediate Inpatient Consults currently used, but would place the Veteran in the center of a comprehensive care matrix.

The Nephrologists would provide specialized renal care using best-practices.

The expertise of Nutritional Medicine would be employed from the beginning.

An Administrative Assistant (AA) with data-management expertise who would act as transplant coordinator, and data-miner to identify patients most at-risk for out-reach.

Clinical Pharmacy would perform medication reconciliation and medication counseling for pre- and dialysis-dependent patients and EPO followup.

Clinical Social Work would assist with transitions to dialysis and to help with arrangements for dialysis-associated re-admissions and procedural arrangements.

A Nurse Educator who could be called upon to educate patients on kidney disease, its effects on their bodies, how they could take ownership of preventing its progression, as well as the options available if ESRD supervened would be vital.

Dialysis Nursing would perform PICC line insertions, provide dialysis treatments and educate patients placed on dialysis.

A Renal PCP (NP) would provide general non-Nephrology medical care for the most- at-risk (Stage 4/5) enrolled Veterans residing in a reasonable radius of the Facility.

Together this mix of personnel would create a treatment and learning environment for those Veterans not yet on dialysis in effect giving them the tools to slow progression of their renal disease. Those Veterans already on dialysis would have either tele-medicine or face-to-face availability of care to minimize fragmentation of care that can exist between the VAMC and their community dialysis clinic, as well as to expedite their transition to renal transplant if their overall condition made them a viable candidate.

12. Analysis of Staffing Needed to Support Multi-Disciplinary Nephrology Care With Workload Increases: Nephrologists under Medicine Service

3 full time Attending Nephrologists

Transplant Coordinator (at least 1/2-time)

The Dialysis Unit staffing under Nursing Service

4-5 Dialysis RN’s Renal Replacement Treatment Devices

For Hemodialysis: 5 Gambro Phoenix® Hemodialysis machines with associated supplies and expendables and 5 paired MARCOR 300H® reverse-osmosis units

For Continuous Veno-Venous Hemofiltration/Dialfiltration: 3 Gambro Prismaflex® machines with associated supplies and expendables.

For Peritoneal Dialysis: A contract to bring qualified, proficient peritoneal dialysis

nursing personnel to this facility as-needed when patients on peritoneal dialysis are admitted, for any reason. Explanation and cost listed below.

For Ambulatory Blood Pressure Monitoring (ABPM): Two Nurses available 4 half-

days a week to instruct patients referred for ABPM testing, to place the devices on them, to remove them at the end of the testing, and to download and prepare the data for analysis by the Nephrologists.

13. Analysis of Infrastructure Required to Support Multi-Disciplinary Nephrology Management Clinic Matrix: Currently, when a Veteran with renal disease is seen by a Nephrologist, it is in a clinic isolated from other related specialties, remote from Dialysis and the Intensive Care Unit (ICU) where medical emergencies during dialysis may result in the need for immediate care to prevent serious complication or death. This arrangement not only frustrates delivery of the multi-disciplinary care that Dr. Shulkin is advocating, it may also endanger the individual Veteran on inpatient urgent dialysis. Placing the entire multidisciplinary matrix of Nephrology care, from outpatient management and patient education to ESRD/renal replacement in one physical location would increase immediacy and quality of care and permit achievement of the results positively extolled by Bayliss, et al, and Chen, et al, as referenced above. Such a locus of care exists, and exploratory talks with Engineering have indicated the costs of creating that environment from its current configuration would be minimal. The ICU complex of rooms, located immediately adjacent to the Hemodialysis Unit in B030, contains exactly the right number of rooms and working space to create the Renal Care Center envisioned in Dr. Shulkins’ and our proposal. It is extremely fortunate that this ideal setting for comprehensive, systems-based nephrology care is available here at our facility exactly where it is. Engineering advises that it would only be necessary to put a door on one current copier workspace, close over one door leading from the nephrologist’s current office opposite the Dialysis Unit, and open the non-weight-bearing wall from that office to the ICU area. Also, drilling five drain holes from rooms B020 to B028 for an already-existing Dialysis Unit drain would complete the renovation. Everything else except for minor movement of some data drops is already in place. This makes for a uniquely cost-effective remodeling, allowing for the inaction of a game-changing new care paradigm.

Dialysis / PICC

#1

Dialysis / PICC

#2

Dialysis / PICC

#3

Dialysis / PICC

#4

Dialysis / PICC

#5

HD

Nurse Med Room

MD Office

Supply Rm Patient & Staff Classroom and Education Rm

Staff Break

Rm

Patient Care / Clinic Office #1

Patient Care / Clinic Office

#2

Patient Care / Clinic Office

#3

Patient Care / Clinic Office

#4

Patient Wait Area for Appts

Clinic Check In

HD Nursing Station

Clean Utility

Dirty Utility

Pt BR

AA, CSW, Pharmacy Nutr

ition

E&

M

Staff Locker

Staff Locker

Emergency Access/Exit

14. Analysis of Staffing and Infrastructure to Support Peritoneal Dialysis: We currently lack the ability to provide PD treatment to either inpatients or outpatients. As part of an exploration of institutional options for providing inpatient-acute PD services, vendors were sought who provide those services to other federal facilities. It was found that Fresenius Medical Care Holdings, Inc. currently provides such services under contract to the Dwight D. Eisenhower Army Medical Center (DDAMC). After confirming by telephone that such a contract was in-place at DDAMC, I requested information on what such a service based on that provided to the Army would involve for our facility. BACKGROUND: We currently provide only inpatient/acute hemodialysis, and we send all inpatients on peritoneal dialysis whether admitted as a result of complications of PD or with unrelated medical conditions to Johnson City Medical Center for their inpatient care. On average to-date we have transferred 4-6 such patients annually, at a fee-basis cost of >$250,000 annually. A cost-effectiveness study resulted in determination that leasing PD hardware and training the number of Nursing and Pharmacy personnel necessary to perform PD services safely for that low number of cases might be cost-effective. However, the low number of procedures annually is not expected to provide current-competency for the Nursing staff. Due to a national-level VHA emphasis on all home- and ambulatory-based RRT modalities, it is anticipated that an increase in the number of annual PD-requiring admissions/transfers to JCMC will occur; 8-12 in FY2016 and probably more in the out-years. Institutional policy considerations will require that even if patients are placed on and taken off PD by a non-VA Nurse to minimize technique-associated peritonitis at its most crucial points, a core of Nurses on affected units would need to be trained in basic safety and contingency procedures in case of catheter obstruction, machine malfunction, and other foreseeable PD-related events. Those basic competencies and the training that led to establishing them would need to be auditable and documented. Fresenius Medical holdings, Inc., a subsidiary of Fresenius U.S.A., has a contract with the Dwight D. Eisenhower U.S. Army Medical Center at Fort Gordon, Georgia, for providing PD hardware and expendables on an as-needed/per-patient basis. Fresenius Medical provided on a no-obligation basis a boilerplate contract proposal with rates for services based on those charged to the U.S. Army at Fort Gordon. Under this contract, a qualified Nurse with current competency comes to the Medical Center and puts patients on/takes patients off PD using a cycler machine provided by Fresenius, checks on their status daily, and provides 24-hour “help” services if the Ward Nurses have questions or problems:

SPECIFIC COST DATA:

CAPD (We would use this for ED patients with PD $100.00/Exchange

Problems that did not need to be admitted as inpatients

CCPD (Treatment includes initiation and termination – Inpatient daily monitoring to be provided by HOSPITAL)

$360.00/Treatment

Daily Supervision Visit $65.00/Visit

Nurse Call Back $65.00/Hour*

Nurse Training $65.00/Hour*

Additional Dialysis Charges:

Incomplete procedure [100]% of rate

Canceled procedure after setup [75]% of rate

Canceled procedure after nurse arrival before setup [30]% of rate

Canceled procedure before 2 hours of scheduled start time [No charge]

Education (Education other than CRRT Nurse Training) $65.00/Hour*

Delay initiation due to HOSPITAL issue [10]% /Hour*

After hours or between 5:01PM and 7:59AM…(Weekend/Holiday procedure (New Year’s Day, Memorial Day, 4th of July, Labor Day, Thanksgiving Day, Christmas Day)

[125]% of rate

Other Dialysis Service Charge (Charge to include other services requested by Nephrologist or HOSPITAL that require a Call Back visit or dialysis-related patient intervention, eg catheter care, antibiotic instillations)

$65.00/Hour*

*Hourly services will be billed at a [1 hour] minimum, with any time exceeding [1 hour] billed in quarter-hour increments.

For 4-10 patients/year, staying 4 days ALOS each:

Minimum Maximum

Costs for Fresenius Nurse to put 4-10 patients/year on and take those patients off PD:

Anticipated training costs for Nurses at a minimum of twelve hours of training for providing inpatient PD supervision between Fresenius Nurse putting patients on and taking patients off cycled PD:

$1,360 $3,600

Anticipated one-hour daily supervision visits with ALOS 4 days and 4-10 patients: $65/visit for 4-day ALOS for 4-10 patients/year:

$780 $800

Anticipated call-backs to Fresenius Nurse during treatments for troubleshooting and problem resolution; 4 hours/patient with 4-10 patients @ $65.00/hour (all hourly services are billed at a 1-hour minimum regardless of the length of the call);

$1,040 $2,600

Total projected annual cost for contracted services: $4,300 $9,600

In comparison, here are the rates and expendables costs for leasing the PD cycler; Liberty Cycler Rental: 150/month ($1800/year; we would need to lease two to be assured of having one operational at all times: $3600/year).

All inpatient Nursing management would need to be provided by VAMC Nurses, in this scenario, which would incur FTE costs for competency training of a significant number of the VAMC Inpatient Nursing Staff if PD care was to be provided outside the ICU setting. Fluids and Expendables: 5L Delflex® (solution) 8.85 each on average, patients require 30L/day of fluid exchanges, or $53/day/patient with an ALOS of 4 days and an anticipated range of 4-10 patients/year: $850-2120/year . Expendable tubing and supplies needed on-hand: $80/4-day ALOS for 4-10 patients/year: $240-800/year Total costs for hardware and expendables to lease PD equipment: $4700-$6500/year ASSESSMENT: Based on the attached proposed contract from Fresenius and after computing anticipated costs based on generous projections, it appears reasonable to have a qualified VA Contracting Officer and a representative of James Quillen VAMC Nursing initiate further detailed discussions with Fresenius Medical holdings, Inc., regarding contractual provision of inpatient PD support services for about 8-12 admissions, annually. Critical but difficult-to-project “sunk costs” involved in the two options would be those associated with the storage of the leased equipment and supplies and those associated with the selection and training of sufficient Nurses in the SCU’s and on the Wards to provide competent care for routine checks and basic procedural safety and contingency issues during PD treatments between initial and terminal treatment care. Legal issues not considered are whether and how contracted Nurses could be administratively cleared and liability-covered to operate within the VAMC and the response time for those personnel to report to this VAMC upon notification of an admission, and whether competencies meeting VA standards could be developed, whether a 24-hour help-info system for VAMC Nurses to safely deal with situations falling outside those defined competencies.

15. Analysis of Staffing and Infrastructure Needed to Support Ambulatory Blood Pressure Measurement (ABPM) Clinic: Nephrologists under Medicine Service: No change Clinic Nursing Staffing under Nursing Service: 1.0 FTEE (.5 FTEE for two LPNs) (to instruct patients, put on and take off BP cuffs, and post results to Nephrologists for interpretation) Equipment: We already have five SPACELABS® ABPM units on-hand that have not been usable due to lack of dedicated personnel to run a clinic.

16. OVERALL SUMMARY PRO-CON ASPECTS OF BUSINESS PLAN: Adoption of this Nephrology Business Plan and the concept of care underlying it is recommended.

Pro-Factors for This Concept and Its Proposed Siting:

Its adoption would result in creation of an integrated model of renal care with proven value in the literature and very high promise for long-term savings to the VAMC and the VHA in the multi-million-dollar range, while executing a model of care publicly declared by senior VHA figures as being consistent with the desired enterprise model for future care.

Execution of the above model could proceed with minimal additional FTE; in most cases existing personnel from multiple specialties would perform what they are currently doing in a more efficient and compact manner.

Minimal cost would be incurred to modify/renovate existing space adjacent to Dialysis which is being vacated soon, creating an extremely efficient space utilization.

There would be increased continuity of care with less outsourcing to JCMC for procedures which can be done here but which would exceed staff and equipment constraints. Specifically, expensive outsourcing of patients to JCMC for peritoneal dialysis, which currently cannot be done here, would cease.

Veteran quality of life would be improved by delaying onset of ESRD and the need for dialysis.

Con-Factors:

Need for one-two more Hemodialysis Nurses over the next 2 years for maximum efficiency and minimizing the risk of personnel burn-out or fatigue-caused errors in care and one more GAMBRO PRISMAFLEX machine to provide safety backup.

Need for a peritoneal dialysis contract to avoid the expense of training and leasing equipment, FTE costs of training and routine re-training time.

_________________________________ ____________________ Chief, Medicine Service Date _________________________________ _____________________ Chief Nurse, Medical Outpatient Services Date

___________________________________ _____________________ Chief, Engineering Date ___________________________________ ______________________ Medical Director, Dialysis Unit Date ____________________________________ _______________________ Medical Center Director for Date Patient Care/Nursing Service ____________________________________ _______________________ Chief of Staff Date