Chronic kidney disease: a quiet revolution in nephrology

Chronic Kidney Disease: A Quiet Revolution in Nephrology 6 Case Studies
Christos Argyropoulos MD,PhD

Chronic Kidney Disease Case Studies
2
Background
•Kidney disease has been defined primarily in terms of end-stage renal disease (ESRD)
•However ESRD is the final end point of a chronic progressive condition (CKD)
•Moderatively effective treatments do exist for the prevention of progression of CKD and for the therapy of its complications
•In the near future medications that more effectively stabilize or even reverse CKD may become available
•The possibility of preventing early-stage CKD from developing into kidney failure has presented an opportunity to improve patient outcomes (“quiet revolution in nephrology”)
•Need to understand challenges and barriers for the success of this revolutions

3

Chronic Kidney Disease: A Global Public Health Problem
Clinical Definition Staging Burden & Consequences Barriers to Care

5
Defining “CKD”
Kidney damage for ≥ 3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either
Pathologic abnormalities, or
Markers of kidney damage, such as abnormalities of the blood or urine, or in imaging tests
GFR < 60 mL/min/1.73 m2 for ≥ 3 months with or without kidney damage.

6
Classification
Stages of chronic kidney disease (NICE-UK, KDOQI-US)
Stagea
GFR (ml/min/1.73m2)
Description
1
 90
Normal or increased glomerular filtration rate (GFR), with other evidence of kidney damage
2
60–89
Slight decrease in GFR, with other evidence of kidney damage
3A
45–59
Moderate decrease in GFR with or without other evidence of kidney damage
3B
30–44
4
15–29
Severe decrease in GFR, with or without other evidence of kidney damage
5
< 15
Established renal failure
a Use suffix (p) to denote presence of proteinuria when staging CKD

Chronic Kidney Disease Case Studies 7
CKD is Common
Levey et al. Kidney International (2011) 80, 17–28; doi:10.1038/ki.2010.483
8.5%
4.9%

Chronic Kidney Disease Case Studies 8
CKD is harmful
Levey et al. Kidney International (2011) 80, 17–28; doi:10.1038/ki.2010.483

9
Kidney Failure Compared to Cancer Deaths in the U.S. in 2000 (in Thousands)
Seer, 2004 Lung Cancer
Kidney
Failure
Colorectal
Cancer
Breast
Cancer
Prostate Cancer
57
100
41
30
160
CKD 5 (ESRD) is lethal

10
Barriers to CKD Care I

11
Barriers to CKD Care II

12
Barriers to CKD Care III

13
The Health Policy Outcomes Core CKD Study
•A study conducted during the mid 2000s to understand operations and challenges of leading CKD clinics and practices in the US
•Tel. Interview conducted through the comprehensive Center for Health Disparities – Chronic Kidney Disease (CCHD-CKD):
–Charles Drew University
–David Geffen School of Medicine – UCLA
–RAND corporation
•Study highlights:
–Benefits of CKD clinics
–Challenges of nephrologist practitioners
–Need for better coordination between PCPs and kidney specialists

14
Study Sites
Diverse group of nephrology clinics in private and academic practices:
• CKD Clinic at Northwestern University, Chicago,
Illinois
• Associates in Nephrology (AIN) Chronic Kidney Disease
Clinic, Chicago, Illinois
• Mayo Clinic Nephrology, Jacksonville, Florida
• Indiana Medical Associates, Fort Wayne, Indiana
• St. Clair Specialty Physicians, P.C., Detroit, Michigan
• Winthrop University Hospital, Division of Nephology
and Hypertension, Long Island, New York.

The Chronic Kidney Disease Clinic at Northwestern University, Chicago, Illinois
Outpatient Clinic in an Academic University Center

16
Origins and Development
•Started off in 2000 as a late stage CKD program to prepare patients for dialysis:
–Treatment of complications (Anemia/BMD)
–Prepare patients for renal replacement therapy
–Manage cardiovascular disease
•In 2002 expanded its focus to comprehensive care of early CKD:
–Adoption of KDOQI guidelines
–Multi-factor interventions to slow CKD progression (ACEIs/ARBs), aggressive treatment of hyperlipidemia and proteinuria, management of cardiovascular risk factors
•Clinic practice described as paradigm shift, one not reflected in traditional nephrology training
•Patients with CKD 4/5 have much lower mortality than untreated patients of the same stage (published 4 year f/u data)

17
Clinic Procedures
•Stages patients using MDRD eq. (reported by the hospital lab)
•Frequency of evaluation depends on CKD stage:
1.Stage II/IIIa: 1/yr once proteinuria and BP are under control
2.Stage IIIb: 2/yr once proteinuria and BP are under control
3.Stage IV: Q 3 months, unless being treated with ESAs (biweekly – monthly)
•Limited community outreach: mostly interact with internists and physicians in the same hospital (do participate in local non – nephrology conferences)
•Other specialties from the same hospital less likely to think they steal patients or that there are hidden ($$$) agendas behind early referrals
•Relies heavily on EMR to track patients, treatment outcomes and adapt local versions of the KDOQI guidelines
•Implements nutritional counseling, at 30-50 ml/min GFR and at 20-25 ml/min (follow up)

Associates in Nephrology, Chicago, Illinois
Single-Specialty Community Practice

19
Origins and Development
•Started off in the 70s as a group of nephrologists working in a small dialysis chain in Chicago (27 nephros at the time of the study staffing 34 HD units and 1 ½ clinic)
•“CKD” program set up in 1998 (no one was talking about prevention then!) in a hostile environment
•Referrals were made by PCPs when Scr ~ 4mg/dl
•Initially the clinic focused on slowing the progression of CKD, or smoothing the transition to ESRD
•Emphasis later shifted to preventing premature death from cardiovascular disease in patients with CKD as well as stabilizing and reversing progression.
•Clinic started off as ½ day per week -> 4 ½ days per week

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Outreach, Education and Referrals
•Strong educational and community outreach programs to educate patients and other providers (mobile screening with urine tests and sphygmomanometers through patient groups, local government and health organization chapters)
•Had to deal ignorance and nihilism by other nephros when “MDRD” consult # started going up
•Reciprocal consults (especially to cardiologists, less so with endos) are used to keep the consults coming
•Emphasize very early (>60 ml/min) referrals in order to stabilize renal fx
Business model of a community CKD clinic: Steady Inflow of Patients

21
Clinic Procedures and Outcomes
•Staging of CKD based on MDRD eGFR (done and billed by the nephrologists as many labs in Illinois did not report it)
•Do comprehensive evaluations of patients (long visits) and provide written feedback to both patients and referring physicians
•Hold educational classes for their patients on various issues (nutrition, complications of dz, renal replacement therapies)
•Utilize KDOQI guidelines and RPA physician toolkits to standardize care
•Tracked outcomes in 431 patients from one site:
–53% stabilized
–30% worsened
–17% improved (one upstaging!)

22
External Relations and Challenges
•Use an ecosystem of the dialysis units corporate structure to help finance the clinics to avoid losing money:
–Dialysis chain obtains first picker’s status as far as ESRD patients is concerned (downstream revenues)
–CKD clinic both stabilizes CKD and if/when it fails acts as a feeder stream to the dialysis chain
•Comprehensive communication to keep patients and referring physicians satisfied
•Focuses their own treatment plans only on aspects of CKD care (leaving everything else to the PCP) but provide written advice on all aspects of care that are modified/impacted by CKD
•Reciprocal referrals to specialties most likely to see other patients with CKD (cardio/endo)
•Extensive community outreach and educational activities to raise awareness about CKD (and thus generate referrals)

Mayo Clinic Nephrology, Jacksonville, Florida
Nephrology Division of a large multispecialty practice, affiliated with the Mayo Clinic

24 Origins and Development
•Originally set up as a nephrology contractor service to provide ESRD care to local dialysis units
•In 2002, upon publishment of KDOQI started pre ESRD / CKD care
•KDOQI guidelines were used to develop templates of care, addressing the multiple and complex issues of CKD patients in a standardized fashion and a time/cost effective manner

25
Patient Population
•Clinic focuses on late stage 4/5 patients (mostly older > 70y males) with high comorbidities

26
Practice Procedures and Referrals
•Provide ONLY tertiary/quaternary consults to referring physicians (comanagement model): cause of CKD, screening of complications and CV factors, treatment recommendations and dosing of meds/drug interactions in CKD (drug renal safety consultation)
•40% of pts are seen only once
•Patients stage 1-3 are not seen in this clinic
•Nephros verify MDRD eGFR with 24hr clearance and then stages patient and decides on treatment frequency (usually q3-6 mo for late stage 3->4)
•Uses EMR to implement a renal visit note template
•“Mine” the EMR to create registry for QA/QI issues (tracking achievement of treatment guidelines as far as anemia/lipids/proteinuria/BMD/BP : KPIs for renal care
•Treatment protocols developed after the KDOQI and the RPA toolkits
•Use diary tool to communicate to pts their renal fx, treatment goals and how well they do in terms of achieving them
•Engage in community outreach and educational activities to generate consults

Indiana Medical Associates, Fort Wayne, Indiana
Multispecialty private practice group

28 Origins and Development
•Multispecialty practice group of endocrinologists, pulmonologists, GI and internal medicine formed in 1977
•Large players in ESRD care (560+ patients, owing dialysis units, involved in joint ventures with LDOs and outpatient access centers)
•CKD program developed in the late 1990s when incidence of ESRD dropped from 7%/yr to 1% so that physician revenue was at stake
•CKD program started as pilot project funded by AMGEN in order to develop a practice as well as business model for a CKD practice

29
Practice Organization
•Organized a practice rather than a clinic (patients are referred to specific nephrologists in the group, rather than a faceless/impersonal entity)
•Ecosystem comprised mainly of cardiologists and surgeons (60% of pts) and medical subspecialties
•60% of patients are stage 3-5 CKD (microalbuminuria w/o GFR declines are not actively sought after)
•Triggers for consultations and evaluations include: SCr>2 mg/dl or eGFR<30ml/min, need for anemia management
•Referrals are obtained through personal contacts established during community outreach and educational activities

30
Practice Organization
•Practice has established clinical pathways for: anemia, BMD, diabetes, dialysis orientation, lipid management vaccination
•These pathways preceded KDOQI but have been modified to be consistent with them
•Patients are seen every 2-3 months
•EMRs are used to track patients, implement the pathways and establish registries for QA/QI purposes
•Dialysis operations subsidize CKD care
•Pharma grants subdisized CKD operations as well

St. Clair Specialty Physicians, P.C., Detroit, Michigan
Nephrology integrated practice incorporating “support” specialties: GP, surgeons, IM, transplant physicians

32 Origin and Development
•Established in 1988 to deal with the increasing volume of patients with “early kidney insufficiency” referred by other physicians
•Cross-subsidized by revenue from ESRD care’ once established, the CKD program generated revenues for the ESRD business
•One of the first community based preventive programs focusing on CKD (Robert Provenzano the group leader is now a major figure in this area within the American Nephrology community)
•Integrated practice featuring:
Primary Care Unit
Vascular Access Center
Long Term Transplant Care
Vascular Access Centers
ESRD care: HD/CAPD/CCPD/nocturnal program

•Integrated CKD practice outreach, education, patient referral system allowed rapid growth in patient volume:
•Extensive and numerous outreach activities: nursing homes, churches, barber shops, news articles in local newspapers, radio and TV stations
•Extensive educational activities targeting other physicians (Stage 1 and 2 CKD, at-risk groups: HTN, DM, first degree relatives of pts with CKD)
•Intense education of cardiologists (40% of pts have CKD) who receive a lot of feedback about preventing AKI in their cath pts
•Endos are allowed to “offload” difficult pts with CKD to the practice which then assumes the care
33 Practice Organization

34
Philosophy of Care and Delivery
•Staged approach to CKD care and delivery:
Identify pts at risk
If kidney dz present, determine whether it is reversible
If irreversible try to forestall progression
If unable to stabilize renal fx educate patient about dialysis options and make the appropriate preparations
•Comanagement of stage 3-4 patients with other specialties (outreach focuses on explaining the nephrology specific aspects of care delivered by the practice)
•For Stage 5 patients, the practice becomes the Principle Physicians

35
Practice Procedures
•Staging of CKD based on MDRD eGFR
•Open clinic (walk-ins welcomed) with a waiting time of 24hrs to see a physician
•Once a patient is established with the clinic, care is guideline (RPA) guided, enabled by a custom made HIT system
•Laboratory, diagnostic and ancillary services integrated in the clinic (one stop shop)
•Utilizes a hub and spoke configuration with satellite clinics to increase geographic coverage
•Partnership with “doc-in-the-box” providers to recruit pts with episodic acute encounters with the health care system
•Nephrologists in the practice receive written about their performance on CPMs as a QI tool

Chronic Kidney Disease Case Studies 36 Challenges and Directions
•Changing physicians mentality who make more money dialyzing patients than providing preventive CKD care
•Financial aspects of running the CKD clinic: currently subsidized by ESRD (dialysis) revenue and ancillary services (labs services)
•Education of referring physicians that the practice provides expert care, focused to the patient’s problems, utilizing predictable interventions with measurable outcomes
•Securing funding for public educational activities
•Encouraging laboratory networks and health insurances to mine their databases for patients with CKD so that interventions are applied at an earlier stage

Winthrop University Hospital, Division of Nephrology and Hypertension, Mineola, Long Island, New York
University Based Practice in an Academic Center with extensive research activities

38
Origin and Development
•Wake up call came in 1995-96 when he was involved to do a second consult on a patient who needed dialysis after 20 years of being seen by an internal medicine physician
•Fishbane started researching early CKD and wrote a calculator that tracked pts’ BP, creatinine, medications and constructed an inverse creatinine, time plot to predict the day a patient would need to start dialysis
•One of the first university programs to come up with internal treatment guidelines before the KDOQI ones
•Their guidelines/care pathways co-evolved with the IT system used to enter patients into a database registry and track patients over time

39
Outreach, Education, and Referrals
•Extensive community outreach activities with PCPs
•Team of two nephros and a cardiologist that engage in face to face meetings, local presentations, dinner talks and lectures to educate about CKD and the cardio-renal syndrome
•These activities take place in the background of extensive medicalization (pts in Long Island see multiple specialists, not uncommonly up to 8!) and competition for providers
•Have established processes for effective, timely and formal communication with referring physicians in the community
•Practice works closely with cardiologists who generate a large % of the referral volume

Chronic Kidney Disease Case Studies 40 Organization
•Patients are staged according to the MDRD formula based on serum creatinine.
•eGFR calculations are also verified by the nephrologists
•Uncertainty about the 60-90 ml/min eGFR patient, which generates a large number of false alarms
•Developed EMR out of the original database to monitor patients, track medications and track clinical research projects (PMOS, randomized trials and registries)
•Utilizes trained nurses to make up the most of the limited resources they have (nephrologists, office space, time)
•Have adopted a personalized approach to health care, tailoring KDOQI guidelines to patient needs

41
Challenges
•Financial: the practice loses money by seeing CKD patients (money maker for nephrologists still lies with dialysis/ESRD and acute hospital visits
•Increasing number of early stage CKD patients
•Long waiting times and unavailability sends mixed signals to referring physicians about the importance of CKD (if this is such a big deal, why aren’t you available around the clock)

Conclusions and Recommendations

43
Conclusions
•Reimbursement: Many health plans in the US do not reimburse for CKD care (nor they offer contracts to nephrologists for seeing patients with CKD
•Lack of awareness that CKD is common, harmful and preventable
•Therapeutic nihilism exists about the ability of the medical system (including many nephrologists) to intervene at an early stage of the dz to slow, stop or even reverse progression
•Lack of awareness exists about the interplay of CKD with CV disease and the extremely high burden of other bad things (all cause and cardiac mortality and hospitalizations) that can happen to patient with CKD

Chronic Kidney Disease Case Studies 44 Economic/Reimbursement Considerations 1. Provide adequate reimbursement for CKD care in a nephrologist’s office, including adequate payment for nonphysician services (i.e., physician assistants, nurses, dietitians). 2. Eliminate financial disincentives for screening of CKD patients. 3. Adequately reimburse facility costs for CKD clinics. 4. Develop evaluation and management (E and M) reimbursement with appropriate severity-of-illness adjusters. 5. Direct government funding of CKD care in high-risk populations. 6. Create “empowerment zones” to facilitate access to CKD care for underserved patients wherever these zones already exist for other purposes. 7. Consider a prospective payment system to cover care for CKD stage 4 and 5 patients.

45
Referral and Screening Considerations
Patient Referral
1. Facilitate transparent interaction between nephrologists and non-nephrologists.
2. Modify the standard of care for non-nephrologists to include appropriate, early referral to a nephrologist.
3. Require the Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO) to include appropriate referral to a nephrologist for any hospitalized
patient with a discharge diagnosis of CKD as a requirement for hospital certification.
Screening
1. Require all government-sponsored health care entities to report eGFR on any patient who has a serum creatinine ordered.
2. Encourage all health insurers and health plans to reimburse for eGFR.
3. Have eGFR added as a Healthcare Effectiveness Data and Information Set (HEDIS) measure for health plans for relevant at-risk groups.

46
Education Recommendations
1. Utilize all appropriate sites for education, including dialysis facilities, especially for approved education of stage 4 CKD patients.
2. Extend patient education to stage 3 CKD patients.
3. Reimburse the costs of patient education, even at early stages.
4. Emphasize in teaching materials for patients and physicians that the progression of CKD can be slowed even in advanced stages.
5. Develop culturally sensitive patient educational materials.
6. Encourage partnerships with community organizations and institutions serving vulnerable populations.
7. Develop end-of-life education for patients with CKD and reimburse the costs of development and implementation.

47 Organizational Recommendations Practice Organization 1. Integrate care across venues and domains of care. 2. Where feasible and reimbursed, provide CKD care in a CKD clinic with a multidisciplinary team. 3. Organize CKD clinics to provide holistic care for patients with CKD. 4. Target care-coordination programs to high-risk and vulnerable populations. 5. Provide culturally competent care and language-concordant providers and staff. Use of Clinical Practice Guidelines 1. Integrate available evidence-based CPGs into clinical practice, including NKF KDOQI and RPA CPGs. 2. Use and track performance measures based on CPGs to monitor and guide quality of care for CKD patients. Health Information Technology 1. Use electronic health records (EHRs) for ongoing care of CKD patients. 2. Use EHRs to drive clinical practice, including the collection and analysis of data.

Chronic Kidney Disease Case Studies 48 Other Recommendations
Nephrologist Accountability
1. Ensure that the discipline of nephrology emphasizes the commitment to improve
and participate in CKD care prior to initiation of dialysis.
2. Ensure that nephrologists are accessible and available to nonphysician colleagues to ensure coordinated, transparent care of CKD patients.
3. Ensure that nephrologists are accountable for clinical outcomes in CKD patients
and embrace a culture of accountability.
Research
1. Increase basic research on the causes and prevention of CKD.
2. Focus clinical research on the most effective means of slowing the progression ofCKD.
3. Enhance health services research to better understand the most effective and efficient
approaches to caring for patients with CKD.
4. Include minorities (e.g., women and disadvantaged groups) as appropriate in all research

Chronic kidney disease: a quiet revolution in nephrology

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