Coding and Claims Processing
Required Documentation

Payors often require additional documentation to describe the drug used. In addition, they often require patient-specific information for anemia treatment. The type of information required varies by payor and varies based on whether the provider is submitting an initial claim for the patient or a subsequent claim.
  • Some payors will recognize and use this supplemental information immediately if it is sent with the initial claim.
  • Other payors will not recognize the information immediately. For example, some Fiscal Intermediaries (FIs) will not accept this additional information until they have returned the claim to the provider for an additional development request (ADR).

Initial Aranesp® (darbepoetin alfa) Claims

To ensure that the payor understands what drug was used and that use is appropriate, providers should submit an Aranesp® package insert with initial claims if requested by the payor.

The provider should also submit patient information to justify medical necessity. Some of the information requested may include:

  • The most recent Hct or Hb level prior to the initiation of erythropoietic agent therapy
  • The date and the level of the most recent SCr, within the last month, prior to the initiation of Aranesp® therapy
  • The patient's weight in kilograms,
  • The patient's starting dose per kilogram, and
  • The expected treatment regimen on Aranesp®

Subsequent Aranesp® Claims

Subsequent claims for Aranesp® may include the following information (based on payor requirements):

  • package insert, and
  • documentation of the patient's Hct/Hb

Letters of Medical Necessity

With either initial or subsequent claims for a patient, payors may require additional information to verify the patient is an appropriate candidate for treatment. Letters of medical necessity are the most appropriate way to submit this information. When drafting a letter of medical necessity, physicians should be as specific as possible. Some of the information providers may wish to highlight include:

  • Date of Aranesp® (darbepoetin alfa) FDA approval,
  • A description of the drug,
  • The amount of the drug administered,
  • The indication for treatment,
  • The expected treatment regimen on Aranesp®
  • A description of the patient's condition, previous treatment, and other relevant patient information

The Reimbursement Connection® is available to help you identify the types of information that your payor requires. Please call 1-800-272-9376.


The information provided in this section is of a general nature and for informational purposes only. Coding and coverage policies change periodically and often without warning. The responsibility to determine coverage and reimbursement parameters and appropriate coding for a particular patient and/or procedure is always the responsibility of the provider or physician. The information provided in this section should in no way be considered a guarantee of coverage or reimbursement for any product or service.

Aranesp® (darbepoetin alfa) Indications and Important Safety Information including Boxed WARNINGS

Indications

Aranesp® is indicated for the treatment of anemia:

  • associated with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis.
  • in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. Aranesp® use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being. Aranesp® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.

Important Safety Information including Boxed WARNINGS

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

  • ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL.
  • The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
  • To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
  • Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • Discontinue following the completion of a chemotherapy course.

Aranesp® is contraindicated in patients with uncontrolled hypertension. Patients with chronic renal failure (CRF) experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels in two clinical studies. 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. Aranesp® and other ESAs increased the risks for death and serious cardiovascular events in controlled clinical trials of patients with cancer. 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. Seizures have occurred in patients with CRF participating in Aranesp® clinical trials.

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 Aranesp®. This has been reported predominantly in patients with CRF receiving Aranesp® by subcutaneous administration. A sudden loss of response to Aranesp®, accompanied by severe anemia and low reticulocyte count, should be evaluated. If anti-erythropoietin antibody-associated anemia is suspected, withhold Aranesp® and other erythropoietic proteins. Aranesp® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other erythropoietic proteins as antibodies may cross-react.

The most commonly reported side effects in clinical trials in patients with CRF were infection, hypertension, hypotension, myalgia, headache, and diarrhea. The most commonly reported side effects in clinical trials in patients with anemia due to concomitant chemotherapy were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.

Please click here for accompanying Aranesp® package insert for full prescribing information, including Boxed WARNINGS.

© 2008 Amgen All Rights Reserved.