Coding for EPOGEN® (Epoetin alfa) Administered in the Dialysis Setting

Item

Coding Guidance
(HCPCS1/CPT®2/ICD-9-CM3)

Notes

EPOGEN® (Epoetin alfa)

Injection, Epoetin alfa, 100 units (for ESRD on dialysis)

Report each administration of EPOGEN® on its own line item

Revenue Code

0634 - Drugs requiring specific identification-EPO under 10,000 units

0635 - Drugs requiring specific identification-EPO 10,000 units or more

Non-Medicare payors may require 0250, general pharmacy

Modifiers

Enter appropriate modifiers, such as -GS, -ED, or -EE

Visit the CMS Website or the MLN Matters article referenced below for more information on the modifiers

Route of Administration*

Providers are encouraged to include the modifier JA on the claim to indicate an intravenous administration or modifier JB to indicate a subcutaneous administration

Although reporting the route of administration is optional at this time, CMS has indicated that guidance is forthcoming that will require such information

Hemoglobin (Hb)/ Hematocrit (Hct) Level

Report Hb and/or Hct test results on the UB-04 using value code 48 for Hb or value code 49 for Hct

Hb/Hct levels should indicate the patient’s most recent reading taken before the start of the billing period

HCPCS Code for Supplies

Report code A4657 with revenue code 0270 to capture the charges for syringes used in the administration of EPOGEN®

Reimbursement for A4657 is $0.50 per use. Only when a new syringe is used in the administration of the drug should HCPCS code A4657 be used; it is not appropriate to bill for supplies when a pre-filled syringe is used.

Diagnosis/Condition

Appropriate ICD-9-CM code(s) for patient condition

Example: 285.21, Anemia in chronic kidney disease; 585.6, end stage renal disease

* In patients on hemodialysis, the IV route is recommended. Please refer to the EPOGEN® Prescribing Information.

1 HealthCare Common Procedure Coding System

2 Current Procedure Terminology (CPT). CPT codes® 2008 American Medical Association (AMA). All rights reserved. CPT is a trademark of the AMA. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

3 International Classification of Disease, Ninth Revision, Clinical Modification.

Product Information

Indications

EPOGEN® (Epoetin alfa) is indicated for the treatment of anemia in patients with chronic renal failure (CRF) on dialysis. EPOGEN® is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.

Important Safety Information, including Boxed WARNINGS

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Chronic Renal Failure:

  • In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense EPOGEN® (Epoetin alfa) to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
  • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Perisurgery: EPOGEN® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

  • EPOGEN® (Epoetin alfa) is contraindicated in patients with uncontrolled hypertension.
  • Patients with chronic renal failure (CRF) participating in clinical studies experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients.
  • These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis.
  • A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN®.
    • This has been reported predominantly in patients with CRF receiving ESAs by subcutaneous administration.
    • PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin.
    • A sudden loss of response to EPOGEN®, accompanied by severe anemia and low reticulocyte count, should be evaluated.
    • If anti-erythropoietin antibody-associated anemia is suspected, withhold EPOGEN® and other ESAs. EPOGEN® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other ESAs as antibodies may cross-react.
  • Seizures have occurred in patients with CRF participating in EPOGEN® clinical trials.
  • The most commonly reported side effects in clinical trials were hypertension, headache, arthralgias, and nausea.