1. 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

2. 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

3. 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

4. Rate of Growth of CKD Population
From USRDS, projection of number of patients at Stage V is 661,330 by 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

5. 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 % 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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: pmol/L
-Stage IV: pmol/L
-Stage V: pmol/L

14. CKD Clinic: Guidelines for Bone Metabolism and Disease
Stages III-IV: Serum phosphate levels maintained between mg/dl
Restrict dietary phosphate to 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

15. 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

16. 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

17. 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

18. 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

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

20. 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

21. 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

22. 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

23. 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

24. 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!

25. Fistula Prevalence Rates in ESRD: Network 11 Data
USA

26. Fistula Prevalence by State: Network 11 Data March 2007
Minnesota: %
Wisconsin: %
North Dakota: %
South Dakota: %
Michigan: %

27. 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

28. 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

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

30. 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 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

31. 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

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

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

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

35. 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

36. 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

37. 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

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

39. 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

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

41. 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