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

Introduction
Understanding today's complex world of healthcare reimbursement requires a good sense of direction.  Daily changes in payment policies, the ever changing role of government programs, multiple insurers and multiple treatment options make it difficult for providers to stay informed.

Caring for patients with chronic kidney disease (CKD) requires that 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 this guide to assist with 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 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, Coding, and Reimbursement for Venofer ^®
Generally, Venofer^® is covered by Medicare, Medicaid, and private payers when used according to its approved indications.  The sections below provide specific coding and reimbursement information in the various settings in which Venofer^® may be given.

Coverage
Medicare is likely to cover Venofer^® and its administration when used for its approved indications.  In the physician office, Venofer^® is approved for non-dialysis dependent-CKD patients receiving or not receiving an erythropoietin.  In physician offices, Venofer^® is covered only when administered incident to a provider's service (under his or her direct supervision).  Please refer to the Venofer^®  Full Prescribing Information.
 
Insurers of CKD patients not on dialysis, including Medicaid and leading private insurers, may also cover Venofer^®.  Medicaid coverage policies may vary from state to state. 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 Venofer^®.  

As of January 1, 2009, average sales price (ASP) plus 6 percent is the payment methodology for all separately payable drugs administered in physician offices under Medicare.

Coding
Proper coding of services provided is critical to ensuring appropriate reimbursement.  The National Healthcare Common Procedure Coding System (HCPCS) Panel has granted a specific HCPCS code (also known as J code) for Venofer^® (iron sucrose injection, USP) 

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 (5 mL) or 100 mg equals 100 service units
• Two (2) vials (10 mL) or 200 mg equals 200 service units

Since Venofer^® is a single-dose vial containing either 100 mg or 200 mg, if less than the entire 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.  It is not permissible to bill Medicare twice for the same vial. 

Billing for drug administration
Depending on the method of administration of Venofer^®, report the most appropriate Current Procedural Terminology (CPT) code¹:

96374  Therapeutic, prophylactic or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug

96365  Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

96366   Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour, up to 8 hours (List separately in addition to code for primary procedure)

96367    Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion, up to 1 hour (List separately in addition to code for primary procedure)

96368   Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); concurrent infusion (List separately in addition to code for primary procedure)

¹CPT ^© 2008 American Medical Association.  All rights reserved.

Outpatient Departments

Reimbursement
Under the Outpatient Prospective Payment System (OPPS) drugs and biologicals, which include Venofer^®, receive either packaged payment or separate payment. Payment for drugs and biologicals with estimated per day costs equal to or below the applicable drug packaging threshold (in 2009 the threshold is $60) is packaged into the payment for the associated procedure, commonly a drug administration procedure. Drugs and biologicals with per day costs above the applicable drug packaging threshold ($60) are paid separately through their own Ambulatory Payment Classification (APC).  Venofer’s^® APC is number 9046; the reimbursement from Medicare for this APC includes the cost of Venofer. 


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

Examples of diagnosis codes, regardless of the setting, that may support the use of Venofer ^® include the following:
 

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. The above codes are for reference only; coding as submitted is the sole responsibility of the prescribing physician.


Physicians' Offices
Coverage and coding in physicians' offices is the same as in the outpatient department section above.  Please note that in the physicians' offices Venofer^® is only covered when administered incident to a provider's service (under his or her direct supervision).

Reimbursement
Medicare:  As of January 1, 2009, payment for Part B drugs administered in the physicians' offices remains at Average Sales Price (ASP) plus 6 percent.  
Other payers:  Reimbursement for Venofer^® varies by payer.  For private payers, reimbursement typically may be based on ASP or subject to negotiated rates.  Medicaid reimbursement varies by state and typically is based on cost.

Dialysis Centers
Dialysis Centers are paid based on composite rate from Medicare; most other payers follow the Medicare payment guidelines.  Venofer^® is separately billable in addition to the composite rate and can be billed using its J code, J1756.  The coding and administration codes are the same for dialysis as they are for hospital outpatient departments and physician offices.  

Other Payers
Reimbursement for Venofer^®  varies by payer.  For private payers, reimbursement typically is cost-based or subject to negotiated rates as part of the facility-payer contract.  Medicaid reimbursement varies by state but typically is based on cost.

Some insurers and third party payers may require providers to bill using the National Drug Code (NDC) for Venofer^®, while others establish state-specific local codes. 

Venofer^® is available as 100 mg/5 mL single dose, preservative-free vials and 200 mg/10 mL single dose, preservative-free vials.  The NDC numbers are:


NDC# 0517-2340-10...........................................5 mL Single Dose Vial (100 mg) (10 pack)
NDC# 0517-2340-25...........................................5 mL Single Dose Vial (100 mg) (25 pack)
NDC# 0517-2310-05..........................................10 mL Single Dose Vial (200 mg) (5 pack)


Venofer ^® Reimbursement Hotline:  800-282-7712 - FOR NON DIALYSIS FACILITIES AND PROVIDERS ONLY

AR has created a toll-free hotline to help physicians and other providers understand payer's 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.

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, and 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 - FOR NON DIALYSIS FACILITIES AND PATIENTS ONLY

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 infusion 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:

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


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Disclaimer:  This Web page is not intended to provide legal, medical, or other professional advise.  This information is provided for reference only.  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.