Venofer^®(iron sucrose injection, USP) 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 make it difficult for providers to stay informed. Caring for end-stage renal disease (ESRD) patients 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., (AR) is committed to helping providers better understand reimbursement issues and has prepared these answers to common billing questions about Venofer^® (iron sucrose injection, USP).

This Web page provides general coverage, coding, and reimbursement information that will help you understand the policies of the Medicare ESRD program and other payers of Venofer^®. In addition, AR's Venofer^® Reimbursement Hotline is available to provide expert assistance with all types of insurance claims, including Medicare. This service can be reached at 800-282-7712, Monday through Friday, between 9:00 AM and 5:00 PM, eastern time.

Coverage for Venofer^®
In the dialysis setting, Medicare covers Venofer^® and related supplies (needles and syringes) when provided to Medicare beneficiaries with ESRD, in accordance with the National Coverage Decision (NCD) regarding Venofer^®.  Medicare ESRD beneficiaries’ 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 secondary 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^®.  Including copies of other payers' coverage policies with claims often is an effective way to educate payers and ensure proper coverage.

Coding for Venofer^®
Proper coding of services provided is critical to ensuring appropriate reimbursement. When billing Medicare, dialysis centers use the Uniform Bill 92 (UB-92) form. Claims may be submitted on paper or electronically—either way, the same coding rules apply.

To bill Medicare and most payers for Venofer^®, use the following Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) code:

J1756 Injection, Iron Sucrose, 1 mg

Each 1 mg of Venofer^® equals one (1) service unit. When billing for quantities greater than 1 mg, indicate the total amount used as a multiple of service units on the claim form.

For example:

• One (1) vial or 100 mg (5 mL) equals 100 service units
• Ten (10) vials or 1000 mg (50 mL) equals 1000 service units, and so forth

Please Note: Field 46 of the UB-92 claim form has been expanded to allow the reporting of seven digits. This will accommodate the total number of service units needed for Venofer^®.

Since Venofer^® is a single-dose vial containing 100 mg, if less than 5 mL of a vial is administered, the remainder should be discarded. Current CMS policy permits billing for the entire vial, even if the entire vial is not used, if the remainder is discarded and there is documentation that the remainder was discarded.

To identify the revenue center associated with providing Venofer^® (iron sucrose injection, USP), use the following revenue code:

636 Drugs/Detail Code

To bill Medicare for related supplies (ie, needles and syringes), use the following HCPCS and revenue codes:

HCPCS code:

A4656 Needle (any size, for dialysis, each)

A4657 Syringe (with or without needle, for dialysis, each)

Revenue code:

270 Medical/Surgical Supplies

International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) diagnosis codes identify the patient's diagnosis and tell the claims processor why a service was provided. Medicare claims for separately billable drugs, including Venofer^®, must include an appropriate diagnosis to explain the need for the drugs billed. Thus, accurate coding is critical to obtaining appropriate reimbursement for Venofer^® provided in the dialysis center setting.

Venofer^® is indicated for the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Examples of diagnosis codes that may support the use of Venofer^® in an appropriate case include the following:

280 Iron deficiency anemias

280.9 Iron deficiency anemia, unspecified

Please note that only a physician is qualified to make a diagnosis and the diagnosis must be documented in the patient's medical record.

American Regent, Inc., does not recommend the use of any particular diagnosis code in any particular situation.

Some Medicaid agencies require dialysis centers to bill using the National Drug Code (NDC) for Venofer^®, while others establish state-specific local codes. The NDC number for Venofer^® is: 0517-2340-10.

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^®.

Venofer^® Reimbursement Hotline
AR has created a toll-free hotline to help physicians and other providers understand payers' coverage and reimbursement policies for Venofer^® and, when necessary, address reimbursement issues. Specifically, hotline reimbursement specialists assist with the following:

• Insurance verifications. Help callers verify payer coverage and reimbursement policies for Venofer^® (iron sucrose injection, USP) for specific patients with patient consent. Reimbursement specialists will determine patients' benefits level and discuss potential billing options
• Billing assistance. Assist callers with filing claims and understanding the reimbursement policies for Venofer^®, including researching state-specific local codes
• Claims appeals. Support callers in appealing denied claims or inadequate reimbursement for Venofer^®
• Patient assistance. Screen individuals with no health insurance who are ineligible for public assistance for enrollment in a free product replacement program

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 in this guide and has no obligation to update this guide 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^® Reimbursement Hotline: 800-282-7712

Reimbursement Hotline Service Features

• Assistance with coverage and reimbursement inquiries via a toll-free hotline
• Direct contact with third-party payers to resolve coverage and reimbursement questions:
—Medicare
—Medicaid
—Managed Care Organizations
• Private Commercial Insurers

Assistance in Resolving Reimbursement Issues
Provide comprehensive reimbursement case management including:

• Patient-specific insurance policy verification with third-party payers
• Research prior authorization criteria
• Review of coverage, coding, and claims processing guidelines
• Identify explanation for claims rejection
• Guidance for claims appeals

Instructions on Using the Reimbursement Hotline

• Hours of operation are Monday through Friday from 9:00 AM to 5:00 PM, eastern time. Call toll-free 800-282-7712
• A Reimbursement Specialist answers most calls. There may be times when you need to leave a message that includes your name, telephone number, and a brief summary of your question or request. Calls are returned on the same day, or within one business day whenever possible
• During your call, you will be asked to provide the following information:
—Name and telephone number(s) of the patient's primary and secondary third-party payer(s)
—The patient's name, date of birth, policy holder's name, and policy number(s)
—Your reimbursement questions

Patient information will be kept strictly confidential at all times.

The Reimbursement Specialist will either provide you with the information you request or will contact the insurer for clarification. The Reimbursement Specialist will call you back with the information you requested.

There is no limit to the number of times you call or the number of cases you may discuss with the Reimbursement Specialist.

There is no charge for this service.

Every attempt is made to provide accurate, up-to-date information. The Venofer^® Reimbursement Hotline cannot guarantee successful reimbursement.

For more details about coverage and reimbursement, call the Venofer^® Reimbursement Hotline at 800-282-7712, Monday through Friday, 9:00 AM to 5:00 PM, eastern time.

For Customer Service or Professional Services Departments, call 800-645-1706.

Venofer^® Patient Assistance Program

A program for patients who lack insurance coverage

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

If a patient is eligible, AR will replace the Venofer^® provided free of charge while the patient is enrolled in the program.

AR 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, patients must completely lack health insurance and be ineligible for public insurance or financing. The patient must also be a US citizen, legal entrant in the United States, or permanent resident. Proof of citizenship may also be required. Patients must also meet income and other criteria established by AR.

How to Apply
Providers may apply to the Program on behalf of their patients by following these steps.

Step 1: Provider submits patient application.
A hospital, physician, or dialysis center may apply to the Program on behalf of its patients. The provider submits a patient application for each patient, which is used to determine patient eligibility. A link to a copy of this form is provided below:

Patient Assistance Program Application (requires Adobe^® Reader^®)

The provider may also contact the Program at 800-282-7712 to apply by telephone. Program staff will ask the healthcare provider for the patient's insurance and financial information to determine whether the patient is likely to qualify.

(Note: All release of information is subject to patient authorization and consent.)

Step 2: Provider and patient are notified of enrollment status.
The provider and patient will receive notification by mail of the patient's enrollment or denial. If approved, the patient is eligible for replacement product during the enrollment period.

Step 3: Provider requests replacement Venofer^®.
If the patient is approved, the provider submits a product replacement request for each patient at the end of each month. This form documents the amount of Venofer^® (iron sucrose injection, USP) provided to the patient free of charge and must be signed by a physician. The provider will receive free replacement vials approximately 30 days after the product replacement request is received by the Program. A link to a copy of this form is provided below:

Patient Assistance Program Product Request (requires Adobe^® Reader^®)

Step 4: Provider reapplies if continued assistance is required.
Providers may reapply on behalf of their patients by completing a new patient application or by calling the Program at the end of the patient's enrollment period. All Program forms should be sent to:

Venofer^® Patient Assistance Program
c/o InTeleCenter^™
PO Box 4280
Gaithersburg, MD 20885-4133
Fax: 240-632-3001

How to Contact the Program
Healthcare providers who would like to apply on behalf of their patients should call the Venofer^® Patient Assistance Program at 800-282-7712.

Program staff are available Monday through Friday between 9:00 AM and 5:00 PM, eastern time. If you call at another time, please leave your name and telephone number, and program staff will return your call within one business day.

Or write to this address:

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