Venofer^® (iron sucrose injection, USP) Patient Reimbursement Guide

Introduction
Understanding today’s complex world of reimbursement in medicine takes a good sense of direction. Daily changes in payment policy, the expanding role of government, and multiple treatment options might sometimes make it difficult for your doctor and healthcare team to stay informed.

Caring for people with end-stage renal disease (ESRD) requires that nephrologists and dialysis providers work closely with third-party payers to ensure that appropriate reimbursement is provided for medically necessary healthcare services. American Regent, Inc., is committed to helping doctors and providers better understand reimbursement issues.

This Web page provides general coverage and reimbursement information to help you understand the policies of the Medicare ESRD program as well as those of other insurers who might pay for your Venofer^® (iron sucrose injection, USP) treatment. In addition, the American Regent Venofer^® Reimbursement Hotline is available to provide expert assistance to your doctor and healthcare team with all types of insurance claims, including Medicare. Your doctor can reach this service by calling 800-282-7712 between 9:00 AM and 5:00 PM, Monday through Friday, eastern time.

Coverage for Venofer^®
Medicare covers Venofer^® and related supplies (ie, needles and syringes) if you are a Medicare-eligible beneficiary with ESRD. Remember, Medicare ESRD expenses are subject to Medicare premium, deductible, and coinsurance requirements. Medicare pays for Venofer^® in addition to, and separate from, the dialysis composite rate.

Most managed care insurers of ESRD patients, including Medicaid and leading private insurers, also cover Venofer^®. Private payer coverage policies can vary considerably from one insurer to another and from patient to patient based on specific policy benefits. Some insurers may not have a formal coverage policy for the dialysis-specific dosing regimen of Venofer^®.

Reimbursement for Venofer^®
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) was signed into law on December 8, 2003.  This law is the largest overhaul to the Medicare program since its creation in 1965, and it includes significant payment changes for drugs reimbursed by Medicare, such as Venofer^®.  

Medicare will no longer reimburse based on 95 percent of the average wholesale price (AWP), as in previous years.  Beginning January 1, 2005, Medicare’s allowable charge for all separately billable ESRD drugs, including Venofer^®, in free-standing and hospital-based dialysis centers, is the lesser of the billed charge or the average acquisition cost (AAC).   As always, Medicare will pay 80 percent of this amount, and the patient or their third-party insurer is responsible for the remaining 20 percent.

Medicare pays centers separately for the supplies (ie, needles and syringes) used to administer Venofer^®.

Disclaimer: This Web page is not intended to provide legal, medical, or other professional advice. American Regent, Inc., makes no representations or guarantees regarding the completeness or accuracy of the information presented here and has no obligation to update the information to reflect changes in laws that may affect reimbursement for Venofer^®. For assistance with legal or medical issues, you are urged to consult a qualified professional.

Venofer^® Patient Assistance Program

A program for patients who lack insurance coverage

Program Overview
American Regent, Inc., created the Venofer^® (iron sucrose injection, USP) Patient Assistance Program to help improve access to Venofer^® for patients who lack health insurance and cannot afford therapy.

If you are eligible, American Regent will replace the Venofer^® provided free of charge to your healthcare provider while you are enrolled in the program.

American Regent reserves the right to modify or cancel the program with respect to any patient, or in its entirety, at any time.

Program Eligibility
To be eligible for the program, you must completely lack health insurance and be ineligible for public insurance or financing. You also must be a US citizen, legal entrant in the United States, or permanent resident. Proof of citizenship also may be required. You also must meet income and other criteria established by American Regent.

How to Apply
Your doctor or dialysis provider may apply to the program on your behalf by following these steps.

Step 1: Doctor/Provider submits patient application.
A hospital, physician, or dialysis center may apply to the program on your behalf by submitting a patient application, which is used to determine your eligibility. A link to a copy of this form is provided below. You may print out the form and give it to your doctor/provider; you may not submit it yourself.

The doctor or dialysis provider may also contact the program at 800-282-7712 to apply by telephone. Note: All release of information is subject to your authorization and consent.

Step 2: You and the doctor/provider are notified of enrollment status.
You and your doctor/provider will receive notification by mail of your enrollment or denial. If approved, you are eligible for replacement product during the enrollment period.

Step 3: Doctor/Provider requests replacement Venofer^®.
If you are approved, a product replacement request is submitted at the end of each month. This form documents the amount of Venofer^® (iron sucrose injection, USP) provided to you free of charge and must be signed by a doctor. A link to a copy of this form is provided below for you to give your doctor/provider.

Step 4: Doctor/Provider reapplies if continued assistance is required.
Your doctor/provider may reapply on your behalf by completing a new patient application or by calling the program at the end of your enrollment period.

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