Forms and Documents
| The information below includes a directory of downloadable sample forms and documents to support successful claims submissions — including examples of claim forms and potential codes that may be appropriate when billing for Aranesp® (darbepoetin alfa) and related services. Properly coding your claim forms will help facilitate timely claims processing and reduce the risk of having claims denied. |
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| Physicians or providers are responsible for selecting the appropriate codes used in filing a claim. Codes should be based on the patient's diagnosis and the items and services furnished by the physician or the provider. |
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Billing Instruction Sheet, Physician Office
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Billing Instruction Sheet, Physician Office
Sample Form CMS 1500
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- Most physician offices use the CMS-1500 form (or the electronic equivalent) to submit claims to local Part B Medicare carriers, state Medicaid programs, and many commercial insurers.
- Infrequently, commercial insurers require specific, customized claim forms.
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Hospital Outpatient Sample Form CMS-1450 (UB-04)
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Sample Letter of Medical Necessity
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- Some insurers will require additional information justifying the medical necessity of Aranesp® (darbepoetin alfa) therapy.
- Letters of Medical Necessity provide a detailed explanation of why Aranesp® (darbepoetin alfa) therapy is appropriate for the medical condition described.
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© 2007 Amgen All Rights Reserved.
Prescribing Information for Aranesp® |
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Sample Letter of Appeal
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- If an insurer denies a claim as "not medically necessary," it is up to the physician/provider to demonstrate the medical necessity of the treatment.
- In the case of Medicare, it may be appropriate/necessary to submit a written appeal to the denied claim, providing written justification on why Aranesp® (darbepoetin alfa) was used.
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© 2007 Amgen All Rights Reserved.
Prescribing Information for Aranesp® |
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FDA Approval Letter
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Authorization to Disclose Health Information
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Aranesp® CKD/ESRD Insurance Verification Form
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Aranesp® 2008 ESA coding requirements- CMS MLN Matters
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Click on the link below to leave the Amgen site and access the CMS MLN Matters Number MM5699, titled:
Reporting of Hematocrit or Hemoglobin Levels on All Claims for the Administration of Erythropoiesis Stimulating Agents (ESAs), Implementation of New Modifiers for Non-ESRD ESA Indications, and Reporting of Hematocrit or Hemoglobin Levels on all Non-ESRD, Non-ESA Claims Requesting Payment for Anti-Anemia Drugs |
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CMS MLN Matters Number MM5699 | |
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| *CPT® five-digit codes, nomenclature, and other data are ©2008 American Medical Association. All rights reserved. No fee schedules, basic unit, relative values, or related listings are included in CPT®. The AMA assumes no liability for the data contained herein. |
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.
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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
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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.
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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.
© 2008 Amgen All Rights Reserved.
