Physician's Office

Medicare is likely to cover and reimburse for Aranesp® when its use is reasonable and necessary and it is administered "incident to a physician's service". This means that the product must be

• Furnished by and represent a cost to the physician
• Administered in the office by a physician or auxiliary personnel under the physician's supervision

As of January 1, 2005, Medicare reimbursement for Aranesp® is based on the average sales price (ASP). Medicare sets an allowable charge, based on ASP plus 6%. Medicare reimbursement is based on the lesser of this allowable amount or actual charges, as follows:

• Physician offices are reimbursed for 80% of the allowable amount
• The patient or patient's secondary insurer is responsible for the remaining 20% coinsurance

For dates of service on or after January 1, 2006, Aranesp® for non-ESRD use should be billed with J0881 per 1 mcg. J0881 continues to be in effect in 2007.

Hospital Outpatient

Medicare's hospital outpatient prospective payment system (OPPS), frequently referred to as the Ambulatory Payment Classification (APC) system, went into effect August 1, 2000.

Services paid under the Medicare hospital OPPS are assigned to APCs, and each APC is linked to a payment amount that represents the total payment to the hospital.

In addition, there are separate payments for some drugs, biologicals, and devices.

The Medicare hospital OPPS is used to reimburse for outpatient services provided in practically all types of hospitals, including:

• Acute care hospitals
• Cancer hospitals
• Eye and ear hospitals
• Rural hospitals
• Rehabilitation and psychiatric hospitals & units
• Children's hospitals
• Long-term care hospitals
• Trauma centers

The only hospitals not affected by Centers for Medicare and Medicaid Services' (CMS) OPPS are:

• Critical access hospitals
• Maryland hospital services included under state waiver and subject to Maryland's Health Services Cost Review Commission (HSCRC) oversight
• Indian Health Service hospitals

There are also 11 diagnosis-related group (DRG)-exempt cancer hospitals and several children's hospitals that qualify for additional protections. These hospitals are therefore able to recoup the difference between OPPS payments and reasonable cost payments under OPPS indefinitely.

If you have questions about Amgen products or whether your facility is affected by these or any other guidelines, contact the toll-free reimbursement information service provided by Amgen: the Reimbursement Connection® at 1-800-272-9376.

Aranesp® (darbepoetin alfa) is reimbursed by Medicare under the APC system.

For dates of service on or after January 1, 2006, CMS has assigned HCPCS code J0881 for Aranesp® used in the hospital outpatient setting for non-ESRD patients.

Reimbursement for Aranesp® use for non-ESRD patients in 2006 is based on average sales price (ASP) plus 6 percent.

Hospital Inpatient

Medicare inpatient benefits are covered under Medicare Part A.

Inpatient services are paid using a prospective payment system (PPS).

• Payment amounts are based on the DRG to which the case is assigned
• DRG assignment depends on the patients' diagnosis and the services provided
• All drugs provided on an inpatient basis are included in the DRG-based payment
• Medicare does not pay separately for drugs, including Aranesp®, administered in an inpatient setting

Pharmacy

The Medicare Part D Prescription Drug Benefit went into effect January 1, 2006. CMS does not plan to move Part B drugs, such as Aranesp®, to part D. In general, Aranesp® will continue to be accessed through the Part B benefit.

Medigap and Supplemental Plans

Some Medicare beneficiaries have Medigap plans that cover prescription drugs (policies H, I and J). If those individuals enroll in a Part D plan, then Medigap drug coverage will no longer be valid. However, their Medigap plan will continue to cover Part B related services, including covered Part B drugs administered in the physician's office or hospital outpatient settings.

The Reimbursement Connection® (1-800-272-9376) can conduct insurance verifications to confirm whether a patient's Medigap or supplemental plan covers Aranesp®.

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.

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