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 chronic kidney disease (CKD) 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, 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.  

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^®. 

Specifically, as of January 1,2006, average sales price (ASP) plus 6 percent is now the payment methodology for all separately payable drugs administered in the dialysis center, physician office, and hospital outpatient settings under Medicare.  As always, Medicare will pay 80 percent of this amount, and the patient or the secondary insurer is responsible for the remaining 20 percent.  A more detailed summary of coverage, coding, and reimbursement in each setting can be found below.

Dialysis Center
Physician Office
Hospital Outpatient Department


DIALYSIS CENTER

Coverage
In the dialysis center, Medicare covers Venofer ^® and related supplies (needles and syringes) when provided to hemodialysis-dependent or peritoneal dialysis-dependent CKD patients receiving an erythropoietin.  Medicare reimburses for Venofer® in additional to, and separate from, the composite rate in ESRD.  Beneficiaries' expenses are subject to premium, deductible, and coinsurance requirements. 

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 the specific dosing regimens of Venofer ^®.  Including copies of other payers' coverage policies with claims is often an effective way to educate payers and ensure proper coverage. 

Coding
Proper coding of services provided is critical to ensuring appropriate reimbursement.  When billing Medicare for dialysis services, dialysis centers use an electronic version of the Uniform Bill 04 (UB-04) form.  Effective May 25, 2007, Medicare contractors no longer accept the UB-92 form.  Providers must bill all claims using the new UB-04 form.  (The Administrative Simplification Compliance ACT (ASCA) mandated that all providers, practitioners, and suppliers submit claims electronically to Medicare).

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) effective for dialysis services rendered on or after January 1, 2003.

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

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.  It is not permissible to bill Medicare twice for the same vial.

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

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

HCPCS code:
      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 non-dialysis dependent - chronic kidney disease (CKD) patients receiving or not receiving an erythropoietin and in hemodialysis and peritoneal dialysis dependent - chronic kidney disease patients receiving an erythropoietin.

Examples of diagnosis codes that may support the use of Venofer ^® in an appropriate case 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 are for reference only; coding as submitted is the sole responsibility of the prescribing physician.

Reimbursement
In 2006, CMS revised the payment mechanism for separately billable drugs in the dialysis setting. For dates of service on or after January 1, 2006, payment for all separately billable drugs, including Venofer^®, is ASP plus 6 percent. The new payment mechanism applies to both free-standing and hospital-based facilities¹. To calculate ASP, manufacturers submit sales data, including price increases, discounts, rebates, and segment mix, to CMS 30 days after each calendar quarter. CMS publishes ASPs quarterly with a two-quarter lag. For example, Q2 2006 ASP rates are based on sales data collected during Q4 2005. ASP rates can be found on the CMS website atwww.cms.hhs.gov/McrPartBDrugAvgSalesPrice/.

In addition, Medicare pays centers separately for the supplies (ie, needles and syringes) used to administer Venofer ^®. HCPCS code A4657 is reimbursed at $0.50 per use.

^¹Federal Register Volume 70 Number 223 November 21, 2005

 

PHYSICIAN OFFICE

Coverage
Medicare is likely to cover Venofer ^® and supplies related to 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 the physician office, 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.

Coding
Billing for Venofer ^®:  Report Venofer ^®  with HCPCS code J1756, Iron sucrose injection, per 1 mg.
For additional information on coding for Venofer^®, refer to the  Dialysis Center setting section above. 

Billing for drug administration:
Depending on the method of administration of Venofer ^®, report the most appropriate Current Procedural Terminology (CPT) code²:

90774  Therapeutic, prophylactic or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug

90765  Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

90766   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)

90767    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)

90768   Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); concurrent infusion (List separately in addition to code for primary procedure)

²CPT ^© 2005 American Medical Association.  All rights reserved.

Diagnosis: 
Venofer^® is indicated for the treatment of iron deficiency anemia in non-dialysis dependent-chronic kidney disease (CKD) patients receiving or not receiving an erythropoietin, and in hemodialysis and peritoneal dialysis dependent-chronic kidney disease patients receiving an erythropoietin.

Examples of primary or secondary diagnosis codes that may support the use of Venofer in an appropriate case include the following:

280.0    Iron deficiency anemia secondary to blood loss (chronic)
280.1    Iron deficiency anemia secondary to inadequate dietary iron intake
280.8     Other specified iron deficiency anemias
280.9    Unspecified iron deficiency anemia
585.1    Chronic kidney disease, Stage I
585.2    Chronic kidney disease, State II (mild)
585.3     Chronic kidney disease, Stage III (moderate)
585.4    Chronic kidney disease, Stage IV (severe)
585.5     Chronic kidney disease, State V
585.6    End stage renal disease
585.9      Chronic kidney disease, 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.  The above is for reference only; coding as submitted is the sole responsibility of the prescribing physician.

Reimbursement
Medicare:   In 2005, CMS implemented an MMA provision requiring that average wholesale price (AWP) no longer serve as the basis of reimbursement for drugs administered in physicians' offices.  Beginning January 1, 2005, payment for Part B drugs administered in the physician office is ASP plus 6 percent.  This mechanism continues in 2007.

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.


 

HOSPITAL OUTPATIENT DEPARTMENT

Coverage

Venofer ^® and its administration are likely to be covered when used for its approved indications.  Please refer to the Venofer®  Full Prescribing Information.    

Coding
Billing for Venofer ^®:  The HCPCS code for Venofer^® administered in the outpatient setting is J1756, iron sucrose injection, per 1 mg.  Also report revenue code 636,Drugs that require detailed coding.

Some non-Medicare payers may require revenue code 250,General pharmacy, with J1756,iron sucrose injection, per 1 mg.  Drug charges must also be listed.

Billing for drug administration:
For Medicare:  Depending on the method of administration of Venofer®, report a revenue code, for example 510, Clinic visit, along with the CPT code for injection:

C8950³     IV infusion for therapy/diagnosis; up to 1 hour
C8951      IV infusion for therapy/diagnosis; each additional hour (List separately in addition to C8950)
C8952       Therapeutic, prophylactic or diagnostic injection; IV push

Non-Medicare:  Refer to the CPT codes for drug administration listed in the section for the physician office setting.

³C codes are for use under the Medicare Outpatient Prospective Payment System (OPPS) system only.  For other payers and other settings, use CPT codes.

Diagnosis:
Venofer ^® is indicated for the treatment of iron deficiency anemia in non-dialysis dependent - chronic kidney disease (CKD) patients receiving or not receiving an erythropoietin, and in hemodialysis and peritoneal dialysis dependent - chronic kidney disease patients receiving an erythropoietin.

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

280.0     Iron deficiency anemia secondary to blood loss (chronic)
280.1     Iron deficiency anemia secondary to inadequate dietary iron intake
280.8     Other specified iron deficiency anemias
280.9     Unspecified iron deficiency anemia
585.1     Chronic kidney disease, Stage I
585.2     Chronic kidney disease, Stage II (mild)
585.3      Chronic kidney disease, Stage III (moderate)
585.4     Chronic kidney disease, Stage IV (severe)
585.5     Chronic kidney disease, Stage V
585.6     End stage renal disease
585.9      Chronic kidney disease, 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.  The above is for reference only; coding a submitted is the sole responsibility of the prescribing physician.

Reimbursement
Medicare:  Effective January 1, 2006, separately payable drugs administered in the hospital outpatient setting are reimbursed at ASP plus 6 percent.  ASP is updated quarterly.  Venofer ^® is paid separately under its own APC, 9046.

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.  The NDC number for Venofer ^® is 0517-2340-10.

Venofer ^® Reimbursement Hotline

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.

Disclaimer:  This Web page is not intended to provide legal, medical, or other professional advice.  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.


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:

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

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