The Role of the Nephrologist in Care of CKD patients James Brandes, M.D. Chair, Medical Review Committee Network 11 Medical Director, Midwest Dialysis Milwaukee

Chronic Kidney Disease NKF/DOQI has produced treatment guidelines for patients with CKD to optimize outcomes Based on creatinine clearance (derived from the MDRD formula), CKD divided into 5 stages

Prevalence of CKD Stages GFR (ml/min/1.73 m2 Prevalence (millions) I > 90 16,400,000 II 60-89 12,400,000 III 30-59 7,600,000 IV 15-29 400,000 V <15 350,000

Rate of Growth of CKD Population From USRDS, projection of number of patients at Stage V is 661,330 by 2010. By 2030, 2.24 million prevalent CKD, Stage V Rate of growth for Stages I-IV largely unknown, but is increasing More referrals to nephrologists are occurring at Stages III-IV. This greatly increases the number of patients needed to be seen by a nephrologist

Growth of Practicing Nephrologists AMA shows about 4,900 nephrologists of 6,800 listed are full time Currently, about 340 fellows in nephrology complete their training per year. About 240 nephrologists retire per year. Net gain of nephrologists is about 2 % per year Of this 2 % net gain, about 33 % are females many of whom will work limited hours. About 10 % of this net gain have visa restrictions requiring primary care time

Shortage of Nephrologists Rate of growth of Stage V CKD patient population is 9-10 % per annum Rate of growth of nephrologists is less than 2 % per annum U.S. would need to train a 3-fold increase of new nephrologists per year compared to current numbers to match the increase in demand This analysis does not even account for the increasing burden of patients referred at stages III-IV

A Solution: Physician Extenders Need for NP’s and PA’s who can bill for services “CKD program” developed by the nephrologist with respect to NKF/DOQI practice guidelines “CKD program” protocol developed by the nephrologist allowing them to keep control establishing their particular practice habits within the protocol and maintaining their standard of care (e.g. referral to surgeon for vascular access) Ideal extender would be an NP/PA with dialysis experience

Financial Costs of Extenders to the Nephrology Practice Extenders may command a median pay of $66,000 per year Need to tie in anemia management reimbursement to offset costs of extenders in the nephrology practice

Components of CKD Program CKD Clinic -manage the manifestations of CKD -Anemia Clinic QA/QI -Are we doing what we say we’re doing? Educational Resource Liaison with Dialysis Facility -Coordinate transfer from CKD to Dialysis Clinic

CKD Clinic: Patient Visits Determine Stage of CKD using MDRD GFR estimation Treat complications of CKD (bone disease, disorders of Ca and P, hypertension) Anemia management Risk reduction for cardiovascular disease Vascular access placement by Stage IV Provide immunizations (Hep B, influenza, pneumovax, tetanus) Nutritional counseling Education on dialysis modalities and transplantation Avoidance of nephrotoxic agents

CKD Clinic: Serum Phosphate Levels Phosphate excess has been linked to calcification of the coronary arteries and aorta Phosphate excess independently linked to cardiovascular and all-cause mortality in the setting of ESRD

CKD Clinic: Control of Serum Phosphate Levels The following conclusions are based on a study at the University of Washington, VA system, in 6730 CKD patients (JASN ’05) Serum phosphate levels >3.5 mg/dl in CKD patients are associated with a significantly increased risk for death Mortality risk increased linearly with each subsequent 0.5 mg/dl increase in phosphate levels Elevated phosphate levels were independently associated with increased mortality risk in CKD

CKD Clinic: Guidelines for Bone Metabolism and Disease Based on KDOQI, October 2003 Calcium, phosphate, intact PTH measured in all CKD patients by Stage III (every 12 months for Stage III; every 3 months for Stage IV) Goal intact PTH levels -Stage III: 35-70 pmol/L -Stage IV: 70-110 pmol/L -Stage V: 150-300 pmol/L

CKD Clinic: Guidelines for Bone Metabolism and Disease Stages III-IV: Serum phosphate levels maintained between 2.7-4.6 mg/dl Restrict dietary phosphate to 800-1000 mg/day if above target If diet cannot control phosphate levels, calcium containing phosphate binders are effective in lowering phosphate levels as initial binder therapy. Non-calcium, non-aluminum phosphate binders can be used

CKD Clinic: Guidelines for Bone Metabolism and Disease In CKD stages III and IV, therapy with an active oral Vitamin D sterol (calcitriol, alfacalcidol or doxercalciferol) is indicated when serum levels of 25(OH)-vitamin D are >30 ng/ml, and plasma levels of intact PTH are above target levels Follow intact PTH every 3 months when on Vitamin D sterol. Back off dosage if PTH below target to avoid adynamic bone disease

CKD Clinic: Guidelines for Bone Metabolism and Disease Measure serum total CO2 every 12 months in CKD, Stage III and every 3 months in CKD, Stage IV In CKD patients, maintain total CO2 > 21 mEq/L with supplemental alkali salts, if necessary

CKD Clinic: Control of HTN Strict BP control slows the progression of chronic kidney disease BP control reduces cardiovascular morbidity and mortality BP control is a major component of the CKD Clinic

CKD Clinic: Control of HTN Population BP Goal Pharmacological Therapy General <140/90 Beta blockers, diuretics CKD Stages I-IV with proteinuria/DM <125/75 ACE, ARB, diuretics CKD Stages I-IV without proteinuria <135/85

CKD Clinic: Anemia Management Based on KDOQI, 2006 Maintain Hgb values between 11-13 g/dl using ESA agents Begin testing at all stages of CKD

CKD Clinic: Anemia Management Monthly monitoring of Hgb in ESA treated patients ESA doses should be decreased, not necessarily held when a downward trend in Hgb is needed Details in the next presentation

CKD Clinic: Anemia Management Iron testing every month at initiation of ESA treatment Iron testing every 3 months during stable ESA treatment Sufficient iron should be administered to maintain the following indices of Fe status -Serum ferritin > 100 ng/ml -TSAT > 20 % -Discontinue IV Fe is ferritin > 500 ng/ml

CKD Clinic: Risk Reduction for Cardiovascular Disease Blood pressure control Smoking cessation Encourage physical activity (> 30 minutes of moderate-intensity physical activity on most days of the week) Anemia management Phosphate, calcium, intact PTH management Dyslipidemia management

CKD Clinic: Dyslipidemia Management Measure LDL, HDL, triglycerides (fasting) Correct with diet, physical activity, and smoking/EtOH reduction Use pharmacological agents if above measures fail to achieve target levels -Triglycerides > 500 mg/dl, triglyceride lowering agent -LDL > 70 mg/dl, ? Use of low dose statin -LDL > 100 mg/dl, low dose statin -LDL > 130 mg/dl, high dose statin -LDL< 100 mg/dl, fasting triglycerides > 200 mg/dl, non-HDL cholesterol > 130 mg/dl, consider statin therapy

CKD Clinic: Vascular Access By Stage IV, patients are educated on dialysis modalities and should be able to make a decision concerning dialysis type For those who choose hemodialysis, vascular access is placed by Stage IV. Fistulas are the access of choice!

Fistula Prevalence Rates in ESRD: Network 11 Data USA

Fistula Prevalence by State: Network 11 Data March 2007 Minnesota: 45.0 % Wisconsin: 46.3 % North Dakota: 51.4 % South Dakota: 51.4 % Michigan: 40.3 %

Fistula First Project Goals for ESRD K/DOQI: AVF placement rates of > 65 % for prevalent patients CMS: 66 % AVF prevalent use nationally by June 2009

CKD Clinic: Vascular Access Placement Establish good working relationship with access surgeon who is skilled in placing fistulas Surgeon should be equipped to do all types of fistula placements including basilic fistulae with transposition Coordinate pre-op eval with surgeon in terms of vein mapping, appointments, etc. Begin vascular access flow sheet in CKD clinic concerning evaluation of vasculature, placement of fistulae, maturation, and complications. This flow sheet will be transitioned to the ESRD chart once dialysis begins

CKD Program: QA/QI Are we doing what we say we’re doing? Major component of CKD program

CKD Program: Elements of QA/QI Anemia Management: % patients with Hgb>11 g/dl Bone Disease and Rx: % patients with P< 4.6 mg/dl, intact PTH between 70-110 pmol/L, total CO2 >22 mEq/L Vascular Access: Incidence rates of fistulae in patients beginning dialysis Immunizations: % patients completing Hep B, influenza, pneumovax, tetanus Hypertension: % patients with BP in goal range Risk Reduction: % patients with LDL < 100 mg/dl

CKD Clinic Approach vs. Standard Nephrologist Care Study by Curtis, et.al. (Nephrol Dial Transplant, 2005), compared patients with CKD with longer than 3 months exposure to nephrology care who were part of a CKD Clinic approach vs. standard nephrology care The CKD Clinic patients had significantly higher Hgb and Alb levels at the commencement of dialysis compared to standard nephrology care patients. Survival was significantly better in the CKD Clinic patients than the standard nephrology care patients

QA/QI: Midwest Nephrology Experience Anemia Clinic Average Hgb: 11.5 g/dl % patients with Hgb >11 g/dl: 83 % (n = 208)

QA/QI: Midwest Nephrology Experience Vascular Access Placement CKD Clinic: 58.6 % had AVF placed by start of dialysis Standard Neph Care: 13.3 % had AVF placed by start of dialysis

CKD Program: Educational Resource Provide education on CKD to: Primary Care physicians Insurance Companies, HMO’s, PPO’s etc. Healthcare systems, laboratories Patients, families

CKD Program: Educational Resource for PCP’s Study by Lea, et.al. (AJKD, 2006), found that up to 34.4 % of PCP respondents did not recognize all risk factors for CKD (race, diabetes, hypertension, family history, etc.) Use of grand rounds, noon-time talks at PCP clinics, night-time dinner talks to present CKD management Provide “CKD packet” to PCP’s reviewing early referral, management, and creatinine clearance calculators

CKD Program: Educational Resource to Healthcare Systems, Laboratories Report creatinine clearance and Stage of CKD with all serum creatinine levels Bring attention to early CKD and referral

CKD Program: Liaison with Dialysis Facilities Provide smooth transition for patient from CKD Clinic to the Dialysis Facility Transition important patient information including vascular access flow sheet, medication list, immunization record, and kidney transplant work-up

CKD Program: Financial Issues Medicare reimburses NP at 80 % of MD charges Commercial insurance reimburses NP at 100 % of MD charges To optimize reimbursement, Midwest Nephrology incorporated the anemia clinic into the CKD clinic under the direction of the NP

CKD Program: Midwest Nephrology, Milwaukee One full time NP (7/1/05-6/30/06). We hired a second NP The anemia clinic (aranesp) had about 164 patients between 7/1/05-12/31/05 and about 208 patients from 1/1/06-6/30/06

CKD Program: Midwest Nephrology, Milwaukee Expenses: NP salary and benefits, aranesp purchase, overhead Revenue: Pharmaceutical, administration fee, Hemacue fee, CKD Clinic appointment fee

CKD Program: Midwest Nephrology, Milwaukee CKD portion of the Clinic revenue was 82 % of the NP’s salary and about 66 % of NP’s salary and benefits With the addition of the aranesp clinic to the CKD program, the net profit after all expenses was $271,328 for the 6 months 1/1/06-6/30/06 Linking anemia clinic to the CKD program is key to ongoing solvency of the complete program