INTRODUCTION

The FLUDARA® (fludarabine phosphate) FOR INJECTION Coverage and Reimbursement Guidebook is provided by Bayer HealthCare Pharmaceuticals as a service to health care providers. This edition reflects the most current information affecting coverage and payment for FLUDARA®.

The FLUDARA® Guidebook contains sections on coding, coverage and reimbursement by type of payer, as well as a sample claim form and a description of special programs offered by Bayer HealthCare Pharmaceuticals. A Quick Reference Chart to coding is included at the end of this guidebook for your convenience. We hope this Guidebook increases your understanding of the reimbursement environment facing FLUDARA®.

OVERVIEW

COVERAGE
Most third-party payers cover and reimburse for FLUDARA® (fludarabine phosphate) FOR INJECTION and the associated physician services when used for refractory B-cell chronic lymphocytic leukemia.

Medicare Part B: All carriers cover FLUDARA® and associated services
Medicaid: Most agencies cover FLUDARA® and associated services
Private Payers/
Fee-for-Service:		 Most cover FLUDARA® and associated services
Private Payers/
Managed Care Plans:		 Many cover FLUDARA® as a physician service without requiring it to be on formulary

If you have general, patient-specific or payer-specific reimbursement questions, call the FLUDARA® Reimbursement Hotline at 1-800-473-5832 for assistance.

REIMBURSEMENT
Payment differs among payers, but is usually based on the published average wholesale price (AWP) or contracted rates.

ADMINISTRATION FEES
Most payers reimburse for the administration of FLUDARA®.

PROFESSIONAL SERVICES
Most payers cover the cost of office visits to administer FLUDARA®. Some payers, however, do not reimburse for both an office visit and the administration fee on the same date of service.

SPECIAL PROGRAMS

THE FLUDARA® REIMBURSEMENT HOTLINE
1-800-473-5832, Monday through Friday
8:30 AM - 5:30 PM (ET)

The FLUDARA® Reimbursement Hotline was established to answer general or specific questions about third-party coverage and reimbursement for FLUDARA®. The Hotline provides information about:

  • Verification of benefits
  • Third-party payer coverage for FLUDARA®
  • ICD-9, CPT-4, and other billing codes
  • Denied and/or under-reimbursed claims
  • OBRA '93
  • Professional services and treatment associated with the use of FLUDARA®

The FLUDARA® Reimbursement Hotline can be particularly helpful in providing patient-specific information. If you are calling to verify benefits, please have the following information available:

  • Name of patient
  • Name of insured
  • Name of insurer
  • Phone number of insurer (if possible)
  • Insured's policy ID number and group number
  • Physician's provider number
  • Site where FLUDARA® will be administered
  • Diagnosis

Hotline analysts will provide a response to your inquiry within 24-48 hours.

 

THE FLUDARA® REIMBURSEMENT PACT PROGRAM
1-800-473-5832, Monday through Friday
8:30 AM - 5:30 PM (ET)

The FLUDARA® Patient Assistance for Cancer Treatment (PACT) Program is designed to provide access to FLUDARA® (fludarabine phosphate) FOR INJECTION for uninsured cancer patients with low incomes. The program's patient eligibility criteria are:

  • Uninsured: patients covered by private insurance, Medicare, or Medicaid, or any governmental (federal/state/local) healthcare program are not eligible
  • Annual income of less than $25,000 with no dependents, or less than $45,000 with dependents
  • The patient must be a legal US resident
  • The treating physician provides professional services relating to FLUDARA® free of charge

Please call the PACT Program at 1-800-473-5832 if your patient meets these criteria. Analysts will need the following information about your patient to begin processing the application for the FLUDARA® PACT Program:

  • Name, date of birth, and state of residence
  • Insurance coverage status
  • Income

An application will be mailed to you requiring your signature verifying the above, as well as your agreement to provide your professional services free of charge. If your patient is eligible, FLUDARA® will be shipped to your office once a month at no cost for the first six months of therapy. Your patient will need to be requalified if additional treatment is required after the initial six-month qualification period.

CODING

All insurers require diagnosis codes (ICD-9-CM) on claims forms to determine if the billed treatment is appropriate and medically necessary. Other coding mechanisms include the American Medical Association's Current Procedural Terminology (CPT) codes, which indicated outpatient physician services performed. Many insurers also recognize the alphanumeric codes established by the Health Care Financing Administration (HCFA) which form one level of the HCFA Common Procedure Coding System (HCPCS). The alphanumeric HCPCS codes represent drugs, supplies, and procedures not found in the CPT coding manual.

DIAGNOSIS AND PROCEDURE CODES

In the treatment of refractory B-cell chronic lymphocytic leukemia:
Diagnosis Code: 204.10
Chronic lymphocytic leukemia, without mention of remission
Drug Code: J9185
Fludarabine phosphate, 50 mg

On claim forms, be sure to indicate the actual dosage administered along with the "J" code
Procedure Code: 96410
Chemotherapy administration, intravenous infusion technique, up to one hour

 

OFFICE VISIT CODES

Codes for office visits depend on the level of service provided. Most third-party payers reimburse for physician office visit services based on CPT codes, called Evaluation and Management (E/M) codes.

The following E/M codes are used when services are provided to established patients who are present for follow-up and/or periodic re-evaluation. The codes can also be used to report E/M services provided for a new problem(s) in established patients.

Select From These E/M Codes When Treating Established Patients
 Use Code #
  • may not require the physician's presence
  • presenting problems are minimal, usually requiring 5 minutes of supervision
99211
  • a problem-focused history
  • a problem-focused examination
  • straightforward medical decision-making
99212
  • an expanded problem-focused history
  • an expanded problem-focused examination
  • medical decision-making of low complexity
99213
  • a detailed history
  • a detailed examination
  • medical decision-making of moderate complexity
99214
  • a comprehensive history
  • a comprehensive examination
  • medical decision-making of high complexity
99215

Medicare Part B carriers allow you to submit office visit codes for services provided on the same day as FLUDARA® (fludarabine phosphate) FOR INJECTION. To determine whether other insurers will reimburse for an office visit the same day FLUDARA® is administered, call the FLUDARA® Reimbursement Hotline at 1-800-473-5832.

PAYER POLICIES: MEDICARE PART B

DRUG COVERAGE
FLUDARA® is currently covered by all Medicare Part B carriers when used for the treatment of refractory B-cell chronic lymphocytic leukemia as specified in the labeling. Contact the FLUDARA® Reimbursement Hotline at 1-800-473-5832 for more information.

To be covered under Medicare Part B, FLUDARA® must:

  • Be purchased by the physician and represent an expense to the practice
  • Be administered by the physician or by auxiliary personnel employed by the physician and under his or her personal supervision
  • Be reasonable and necessary for the diagnosis of treatment of the illness or injury for which it was administrated according to accepted standards of medical practice

OFFICE VISITS
HCFA has instructed carriers to pay for the office visits in addition to the fee for FLUDARA®. Reimbursement for an office visit is based on the appropriate level E/M code indicated and will vary by locality.

ADMINISTRATION
Medicare Part B carriers reimburse physicians for their services, including the administration of injectable drugs, based on the Resource-Based Relative Value Scale (RBRVS) fee schedule. In general:

  • Reimbursement for the administration of FLUDARA® (fludarabine phosphate) FOR INJECTION varies according to the carrier, location of the facility, and the procedure code indicated
  • If other chemotherapy drugs are required for a patient on the same day that FLUDARA® is administered, Medicare Part B reimburses for chemotherapy administration by both push and infusion techniques
  • Medicare Part B reimburses for two infusion techniques on the same day, but pays for only one push technique per day, regardless of the number of drugs administered via push
  • Physicians should use CPT code 96410 (Chemotherapy administration, infusion technique, up to one hour) to bill for the administration

REIMBURSEMENT
Effective January 1, 1998, reimbursement for drugs and biologicals is based on the AWP minus 5%. Medicare Part B pays physicians 80% of the allowance and the patient is responsible for the 20% coinsurance

BILLING FOR FLUDARA®

  • “J” codes are used to bill for injectable drugs
  • FLUDARA® is billed with HCPCS code J9185
  • To ensure appropriate reimbursement for your FLUDARA® claims, include the dosage amount along with the “J” code
  • Providers may bill electronically using the assigned code for FLUDARA®

(See example of HCFA-1500 claim form)

Some carriers require a letter of medical necessity (see sample letter) before ruling on payment. A letter of medical necessity should include information about the following:

  • Diagnosis
  • Specific alkylating agents used prior to treatment with FLUDARA®
  • Copies of the published reports in pharmaceutical compendia or medical journals that support the efficacy and safety of FLUDARA®

The Professional Services Department at Bayer HealthCare Pharmaceuticals can provide copies of articles published in medical literature. Call 1-888-84-BAYER (1-888-842-2937) for more information.

 

PAYER POLICIES: MEDICAID

COVERAGE
Medicaid programs cover FLUDARA® (fludarabine phosphate) FOR INJECTION in one of two ways: (1) through the physician services program or (2) through the outpatient drug program when dispensed by a pharmacy.

FLUDARA® is covered in almost all states for claims submitted by pharmacies, physician's offices, or both.

  • Most state programs elect to cover physician-administered drugs through the physician services program. FLUDARA® and its administration are covered whether provided in the office, the patient's home, a hospital, a skilled nursing facility, or elsewhere.
  • A small number of states require the patient to obtain FLUDARA® at a pharmacy and return to the physician's office for administration.

For state-specific information, call the FLUDARA® Reimbursement Hotline at 1-800-473-5832.

REIMBURSEMENT
Reimbursement varies by state, but will most likely be based on the AWP or estimated acquisition cost.

 

PAYER POLICIES: PRIVATE PAYERS/FEE-FOR-SERVICE:

COVERAGE
Most Blue Cross Blue Shield plans and other private payers cover FLUDARA® when it is used for its labeled indication.

Office visits for the administration of FLUDARA® are covered under most policies. One of several types of office visits can be billed depending upon the level of service provided. Use the E/M codes provided in the coding section of this guidebook.

IMPORTANT STEPS TO ENSURE COVERAGE

  • Determine that the patient has a benefit plan that covers drugs administered in a physician's office and that coverage will apply to FLUDARA®
  • Determine the appropriate visit and procedure codes your patient’s insurer recognizes for reimbursement
  • File a properly completed claim form with the patient’s insurer

The majority of private payers accept the HCFA-1500 claim form; however, some require a special claim form which they will provide.

Before submitting the claim:

  • Verify that the claim is properly coded
  • Double-check for proper spelling and correct information
  • Be sure to include all information that is requested

REIMBURSEMENT
Payment amounts very by plan, but most insurers reimburse based on the AWP, submitted charges, or reasonable and customary charges.

 

PAYER POLICIES: PRIVATE PAYERS/MANAGED CARE PLANS

Prepaid managed care is a system that integrates the delivery and financing of health care services to covered individuals. MCO benefits are plan-specific and may contain formulary restrictions. The major types of MCOs include:

  • Health maintenance organizations (HMOs);
  • Preferred provider organizations (PPOs);
  • Exclusive provider organizations (EPOs); and
  • Point-of-service (POS) plans.

Payment for oncology products and services is not generally based on the traditional fee-for-service system but is based on a capitated rate or a discounted charge. Depending on the contract between the provider and the MCO, oncology products may be separately reimbursable.

Please call the FLUDARA® Reimbursement Hotline to verify coverage for specific patients.

THE HCFA-1500 CLAIM FORM

Physicians should use this form to request reimbursement from Medicare Part B and many private payers. It is the responsibility of the physician or supplier to obtain the enrollee's signature on the form if no yearly assignment has been obtained.

BLOCK 1A: Enter patient's ID number.

BLOCK 2: Enter patient's name exactly as it appears on his or her card.

BLOCK 5: Enter patient's current mailing address, including ZIP code.

BLOCK 13: Have the insured sign the block. This authorizes the insurer to pay you directly. (NOTE: Before paying you directly, Medicare requires that you accept assignment; many Blue Cross Blue Shield plans require you to be a participating provider.

BLOCK 21: Enter diagnosis code and description.

BLOCK 24A: Enter month, day and year of each service being claimed.

BLOCK 24B: Enter the code indicating the place service was administered.

BLOCK 24C: Enter the code indicating the type of service.

BLOCK 24D: List all appropriate procedure, service, and supply codes and applicable modifiers for each service rendered.

BLOCK 24E: Enter the number of the ICD-9 code relating to the primary diagnosis for which the patient is receiving FLUDARA®. 


Please see full Prescribing Information for FLUDARA®.

Distributed by Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470
Manufactured by Ben Venue Laboratories, Bedford, OH 44146