Using Physician Extenders to Create a CKD Clinic

Theresa Becker, MSN, APNPMidwest Nephrology Assoc.Chronic Kidney Disease Clinic

CKD Clinic

The ideas of:

Linking CKD Clinics & Anemia Management Programs

Using physician extenders in a multidisciplinary approach

Are not new!

CKD Clinic

ADEPT Clinic Arizonia Disease Education Prevention &

Treatment Started as an anemia management clinic but soon

developed into a CKD Clinic Patients are referred to the Vascular Access

Program when GFRs are 25-30 mL/min.

Curtis C, Yee B. The process of implementing a CKDClinic Nephrology News & Issues. 2005;19:53-54.

CKD Clinic

SHAPE UP Program Staging & Smoking Cessation Hypertension, Hyperglycemia, Hyperlipidemia, Hyperphosphatemia,

Hyperparathyroidism, Hyperkalemia, & Hypervolemia Anemia Proteinuria Evaluation for KRT Undo nephrotoxins Preservation of veins & Patient education

Gnanasekaran I, Kim S, Dimitrov V, Soni A. SHAPE UP-A management program for chronic kidney disease Dialysis & Transplantation. 2006;35: 294-302.

CKD Clinic

One step further : A study by Curtis et al. suggested that even after

appropriate & timely referral to a nephrologist, there is additional value of a multidisciplinary team approach in optimizing both short and long term patient outcomes.

Curtis BM, Ravani P, Malberti F, et al. The short and long term impact of multi-disciplinary clinics in addition to standard nephrology care on patient outcomes. Nephrol Dial Transplant. 2005;20:147-154.

CKD Clinic

CKD Care PlanCKD StagingKDOQI Guideline Follow up

CKD

EducationPatient Community Professional

Vaccination ComponentFluPneumovaxHepatitis B

Anemia Management ProgramAranesp Iron Therapy

Midwest Nephrology Associates CKD Clinic Model

CKD Clinic

Components of the CKD Care PlanGFR < 60 ml/min. HTN Anemia Nutritional Status/DM Bone/Mineral Metabolism Neuropathy Functioning & Well-being Delaying Progression of CKD

CKD Clinic

Components of the CKD Care PlanGFR < 30 ml/min. Review Modality Options Preparation for chosen option Transplant referralGFR < 15 ml/min. Tour Clinic Monitor for ESRD signs & symptoms

CKD Clinic

CKD Patient Education Topics CKD and consequences; anemia and bone

disease Common medications used in CKD Avoidance of nephrotoxic agents KRT Modalities Arm Preservation for HD access, Access

placement & care of site Healthy living

CKD Clinic

Access Teaching Pre AV access: Evaluation for appropriate

arm such as vein mapping and instruction on saving that arm.

Post AV access: Care of the site, exercising the access, and monitoring its development as well as instruction on its future use.

CKD Clinic

Documentation

Medication List Clinical Action Plan Health Maintenance Clinic Note Surgical Referral Form Vascular Access Record Chart Label

CKD Clinic

Surgical Referral Form

Date: __________________Surgeon: __________________________ Phone: ______________ Fax: ________________Patient: _________________________________________________ DOB: _______________Nephrologist: ________________________ Phone: ______________ Fax: _______________PCP: ______________________________ Phone: _______________This patient is being referred to you for access placement. The desired access is an AV Fistula. In the event you are not planning to place an AV Fistula in this patient, please call the nephrologist prior to placing any other access.Patient’s non-dominant are is: Right LeftPatient has been saving the following arm: Right LeftComments (ie: arm injury/mastectomy/pacemaker/previous access):Vein Mapping done pre-referral: No Yes – Date/Location: ______________________Patient is currently on dialysis:Days: ____________________________________________________________________Location/Phone: ____________________________________________________________Patient is not on dialysis at this time:Anticipated hemodialysis start date: _______________________ monthsMost recent serum creatinine: ________ mg/dL & Creatinine Clearance/GFR: ________ ml/minPatient is on Anti-Coagulant Therapy: No Yes ___________________________________Allergies: NKDA Yes _______________________________________________________The following patient information is also enclosed: Face Sheet Vein Mapping Report H & P Recent Labwork Medication List

CKD Clinic

Vascular Access Record

Stage 4 (GFR < 30 ml/min): Surgical consult should be for ‘AVF Only’.

Instruct Patient to Preserve Veins of Non-Dominant or Appropriate Arm

Obtain Vein Mapping KDOQI Benchmark: AVF placement of > 65%

for prevalent patients.

CKD Clinic

Surgeon ___________________ Date _______________

Right Arm _____ Left Arm _____

Direct AV Fistula: Transposition AV Fistula:

PTFE Graft:

Radial/Cephalic ____

Radial/Basilic _____ Straight _____

Brachial/Cephalic ___ Brachial/Basilic _____ Loop _____

Upper____Lower____

CKD Clinic

Access Complication History

Date Intervention Outcome

CKD Clinic

Save ____________________ Arm

Access Placed ___________________________________

Flu Vaccine __________________________

Pneumovax __________________________

Tetanus __________________________

Hepatitis B Vaccine #1 _______________________

Recombivax-HB X 3 #2 _______________________

Engerix-B X 4 #3 _______________________

#4 _______________________

Transplant Clinic _________________________________

Chart Label

CKD Clinic

N=106

Non-CKD Clinic Patients N= 57

CKD Clinic Patients N= 49

AVF Used

at Start of HD

12 % 35 %

AVF Placed

at Start of HD

30 % 63 %

AVF StatisticsPatients Initiating HD

1/1/06 to 10/31/06

CKD Clinic

N=347 N %

Flu Vaccine 231 67

Pneumovax 289 83

Hepatitis B Vaccine 109 31

Vaccination Statistics

7/1/06 to 12/31/06

CKD Insurance Issues

CPT Office Visit Billing Codes

Low complexity visit (~ 15 min.) – 99213 Moderate complexity visit (~ 25 min.)

– 99214 High complexity visit (~ 40 min.) – 99215

CKD Insurance Issues

ICD 9 Office Visit Billing Codes

CKD Stage 1 (GFR > 90) – 585.1 CKD Stage 2 (GFR 60-89) – 585.2 CKD Stage 3 (GFR 30-59) – 585.3 CKD Stage 4 (GFR 15-29) – 585.4 CKD Stage 5 (GFR<15) – 585.5

CKD Insurance Issues

Office Visit Reimbursement

Commercial Insurances reimburse NPs at 100% of MD charges

Medicare only reimburses NPs at 80% of MD charges

Medicare and a secondary insurance reimburses NPs at 100% of MD charges

Anemia Management Program

Agent Similarity to Endogenous

Erythropoietin

Estimated

T 1/2

Initial Dosing Maintenance Dosing

Epoetin alfa (Procrit)

Ortho Biotech

Identical Immunologically

~ 16 to 19 hours

50-150 units/kg TIW

Typical Dosing is 150-300 u/kg weekly

Generally weekly or QOW dosing

Darbepoetin alfa

(Aranesp)

Amgen

20% more carbohydrate content

~ 33 to 48 hours

0.45 mcg/kg/wk

Typical Dosing is 0.9 mcg/kg QOW

Generally every 2 to 4 week dosing

Erythropoietin Stimulating Agents (ESA)

Available for Stage 1 – 5 CKD Patients

McClellan, Schoolwerth A., Gehr, T. Clinical Management of Chronic Kidney Disease. Cadido, OK: Professional Communications, Inc.; 2006:185-208.

ESA Agents

Epoetin alfa Dose

(Units/week)

Darbepoetin alfa Dose

(mcg/week)

< 2,500 6.25

2,500 to 4,999 12.5

5,000 to 10,999 25

11,000 to 17,999 40

18,000 to 33,999 60

34,000 to 89,999 100

> 90,000 200

Aranesp Package Insert Amgen®

ESA Agents

Side Effect Profile HTN and Headaches Myalgias DiarrheaContraindications Uncontrolled HTN Known hypersensitivity to the active substance

or any of the excipients

ESA Agents

FDA Black Box WarningIssued 3/9/07

Use the lowest dose of ESA that will gradually increase the Hgb concentration to the lowest level sufficient to avoid the need for RBC transfusion.

ESAs increase the risk for death and serious CV events when administered to target a Hgb > 12 gm/dL.

ESA Agents

RPARenal Physicians

Association Risks and benefits must

be on individual patient basis

Evidence based Hgb targets are helpful and should be reintroduced

May lead to unacceptably low Hgb levels

AAKPAmerican Association of

Kidney Patients Warning may be

confusing to patients & providers

Supports targeting Hgbs between 11 and 12

Lower Hgb lead to concerns regarding QOL

ESA Agents

Epoetin alfa (Procrit)Single-Dose Preservative Free Vials 2,000 units, 3,000 units, 4,000 units,

10,000 units, 40,000 units/1 mLMulti-Dose Preserved Vials 20,000 units/1 mL 20,000 units/2 mL

ESA Agents

Darbepoetin alfa (Aranesp)

Single-Dose Preservative Free Vials 25 mcg, 40 mcg, 60 mcg, 100 mcg, 200

mcg, 300 mcg, 500 mcg/1 mL 150 mcg/0.75 mL

ESA Agents

Darbepoetin alfa (Aranesp)Single-Dose Prefilled Syringes 25 mcg/0.42 mL 40 mcg/0.4 mL 60 mcg/0.3 mL 100 mcg/0.5 mL 150 mcg/0.3 mL 200 mcg/0.4 mL

SingleJect Syringe

SureClick Syringe

ESA Utilization Guidelines

Hgb Level of < 11.0 gm/dL within 30 days T. Sat. and/or Ferritin within 30 to 90 days Serum creatinine within 30 days Patient’s weight in kilograms ESA Dose per kilogram Erythropoietin level is NOT recommended

ESA Utilization Guidelines

Target Hgb at or above 11.0 gm/dL Caution when intentionally maintaining

Hgb > 13.0 gm/dL Monitor Hgb minimum of every 30 days Target Ferritin > 100 ng/mL and T.

Saturation > 20% Monitor Iron Indices Quarterly

ESA Utilization Guidelines

Dose Adjustments

If Hgb increases by > 2 gm/dL per 4 weeks and/or Hgb level > 12 gm/dL, decrease dose by 20 to 25%

If Hgb level is increasing < 1 gm/dL per 4 weeks, increase dose by 20 to 25%

ESA Utilization Guidelines

Dose Adjustments

20 to 25% dose adjustments may be achieved by:

Altering the ESA dose Altering the time interval between

injections

ESA Utilization Guidelines

Dose Adjustments Increases in dose should not be made

more frequently than once a month. Avoid holding doses to avoid marked drop

in ESA sensitive RBC precursors and the ‘seesaw’ effect of Hgb poor response pattern.

ESA Utilization Guidelines

Dose Adjustments

More frequent Hgb &/or iron indices monitoring may be necessary when:

Recent bleeding or surgery Post hospitalization Post IV iron course Periods of ESA hypo-response

ESA Utilization Guidelines

ESA Resistance Infection/Inflammation Blood Loss, Guiac Positive Stools Hyperparathyroidism B12, Folate Deficiencies Sickle cell, Thalacemias Multiple Myeloma/Malignancy ACE Inhibitor Use

ESA Utilization Guidelines

Dose Adjustments

Recent data indicates Hgb levels can be maintained with every two week epoetin alfa dosing and monthly darbepoetin alfa dosing.

Benefits include increased staff productivity and patient satisfaction/compliance.

Moore T., Chookie S. Extended dosing od darbepoetin alfa in patients with chronic kidney disease not on dialysis: A review of recent data. Journal of ANNA 2005;32:399-407.

ESA Utilization Guidelines

Medicare considers doses exceeding 90,000 units per week for epoetin alfa or 200 mcg per week for darbepoetin alfa to be rarely reasonable and necessary. Medical justification for doses exceeding these amounts should be documented in the patient’s record.

ESA Utilization GuidelinesName ________________________________ DOB __________

Access____________________________ Weight ________

Date ESADose

Lot # Site Hgb BP HR Comments

Signature _________ Iron Studies

Iron Ferritin TIBC T. Sat.

Date

DateESA Flowsheet

Hemoglobin Monitoring

HemoCue vs. Lab Draw

HemoCue Analyzer utilizes an optical measuring microcuvette. It provides nearly instantaneous Hgb results with very good accuracy.

Traditional Lab Draw may be used. However, it will require another appointment or extended patient visit while awaiting lab results.

Hemoglobin Monitoring

HemoCue AnalyzerHemoCue Inc.40 Empire DriveLake Forest, CA 92630Phone: 1800.881.1611 Fax: 1800.333.7043www.hemocue.com

HemoCue machines require a CLIA (Clinical Laboratory Improvement Amendment) Certificate of Waiverwww.cms.hhs.gov/clia/

ESA Insurance Issues

CPT ESA Billing Codes

Epoetin alfa – J0885 (Standard unit 1,000 units) Darbepoetin alfa - J0881 (Standard unit 1 mcg) Injection – 90772 HemoCue Lab – 85018QW

ESA Insurance Issues

ICD 9 ESA Billing Codes

Anemia – 285.9 CKD Stage 1 (GFR > 90) – 585.1 CKD Stage 2 (GFR 60-89) – 585.2 CKD Stage 3 (GFR 30-59) – 585.3 CKD Stage 4 (GFR 15-29) – 585.4 CKD Stage 5 (GFR<15) – 585.5

ESA Insurance Issues

Benefit Determination

Billing Office Review of Patient’s Insurance Procit – PROCRITline

1800.553.3851 or www.procritline.com

Aranesp – Amgen Reimbursement Connection1800.272.9376 or www.reimbursementconnection.com

ESA Insurance Issues

Benefit Assistance

HealthWell FoundationP.O. Box 4133

Gaithersburg, MD 20885-4133

Phone: 1800.675.8416

Fax: 1800.282.7692

www.healthwellfoundation.org

ESA Insurance Issues

Drug Assistance

Drug company vouchers which generally allow one month supply of ESA

ESA samples may be available

ESA Self Administration

Initial Teaching

ESA script must include Anemia & CKD Stage ICD 9 codes

Instruct patient on storage, handling, and observe administration of ESA

Office visit charge

ESA Self Administration

Monitoring

Monthly HemoCue lab charge vs. traditional lab draw

Office visit charge

New Agents

Mircera Developed by Roche First and only Continuous Erythropoietin

Receptor Activator (C.E.R.A.) Twice monthly dosing schedule, however

generally will be able to administer monthly yet maintain stable Hgb levels

IV/SC administration May be used in CKD & dialysis patients

IV Iron

Iron Sucrose (Venofer) 100 mg/1 mL vial Administer 200 mg slow IV infusion over 2 to 5

minutes on 5 different occasions within a 14 day period. Typically dosed weekly for 5 weeks.

Generally administered when Ferritin < 100 ng/mL and/or T. Saturation < 20%

IV Iron Insurance Issues

CPT Iron Billing Code Iron Sucrose – J1786 (Standard unit 1 mg) IV Infusion – 90765 Office charge, high complexity visit - 99215

ICD 9 Iron Billing Code Iron Deficiency Anemia – 280.9

Questions