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

Chronic Kidney Disease: A Global Public Health Problem

Clinical Definition

Staging

Burden & Consequences

Barriers to Care


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.


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


CKD is Common

Levey et al. Kidney International (2011) 80, 17–28; doi:10.1038/ki.2010.483

8.5%

4.9%


CKD is harmful

Levey et al. Kidney International (2011) 80, 17–28; doi:10.1038/ki.2010.483


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


Barriers to CKD Care I


Barriers to CKD Care II


Barriers to CKD Care III


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


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


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)


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



•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


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


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!)


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



•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


Patient Population

•Clinic focuses on late stage 4/5 patients (mostly older > 70y males)

with high comorbidities


Practice Procedures and Referrals

•Provide ONLY tertiary/quaternary consults to referring physicians (co-management 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



•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


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



•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


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




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


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


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


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


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


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


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


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


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.


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.


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.


Organizational Recommendations


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.


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