coding & reimbursement
Avastin: What About Reimbursement?
Navigating through coding expectations and criteria for off-label usage.

This drug has become the subject of controversy in the retinal specialist community, but can physicians who use bevacizumab (Avastin, Genentech), for wet AMD treatment expect to get reimbursed?

Avastin is FDA-approved for treatment of metastatic cancer of the colon. Now, some ophthalmologists are using it off-label to treat patients with wet AMD for whom all other therapies have failed.

No clinical trials have been conducted for this indication of Avastin. While physicians are permitted to use drugs in ways not approved by the FDA, sometimes reimbursement becomes a problem.

Q. Will Medicare cover medications used off-label? Sometimes. Medicare coverage for medications is based on specific criteria. Consider carefully how you would answer each question for Avastin.

Drug Coverage Criteria:

►Were standard, accepted treatments, including approved drugs, tried or contraindicated before considering a drug for an off-label use?

►Do any of the major drug compendia (U.S. Pharmacopaeia Drug Information; American Hospital Formulary Service Drug Information; American Medical Association Drug Evaluations) and related peer reviewed scientific articles support the off-label use (MCM 2049.1)?

►Do any specialty society publications recommend this off-label use?

►Is this off-label use an accepted standard of medical practice?

►Is authoritative medical literature available to support this use? Is the level of evidence, endpoint measured and number of patients adequate (MCM 2049.C.3)?

Q. If the drug is not covered, how about the intravitreal injection? Medicare does cover intravitreal injections, described by CPT code 67028. However, when the sole purpose of the intravitreal injection is to administer a non-covered medication, the injection itself is also non-covered. The patient is responsible for this charge (MCM 2049.4).

Doctors are advised to get a signed Advance Beneficiary Notice (ABN) whenever they believe that Medicare is likely to deny a claim for an item or service they are planning to provide. Always get it signed in advance, before providing the service. By signing an ABN, the Medicare beneficiary acknowledges that he or she has been advised that Medicare will probably not pay for the service and agrees to be responsible for payment either personally or through other insurance.

The claim is submitted with modifier GA appended to the appropriate CPT or HCPCS code. Medicare rules require that a claim be filed for any services identified on an ABN.

When providing non-covered services, physicians are permitted to collect payment from the patient at the time of service. The amount of the charge is a matter between the physician and the patient; Medicare does not limit charges for non-covered services.

Q. How is the supply of Avastin identified on the claim? Avastin has an HCPCS code, J9035 (Injection, bevacizumab, 10 mg). However, its use in this context is not appropriate. Use HCPCS code J3490 (Unclassified drug) rather than J9035.

There are two reasons for this selection. First, instructions in HCPCS indicate that codes listed in the Chemotherapy Drug section are administered subcutaneously, intramuscularly or intravenously. Ophthalmic use of Avastin does

not meet this definition; it is administered via intravitreal injection. Secondarily, while some codes are defined as "up to" a certain quantity, J9035 specifically indicates "10 mg" of Avastin. Ophthalmologists use far less when treating AMD. Lastly, some Medicare carriers have issued instructions requiring use of HCPCS code J3490 instead. Check your local carrier policy for instructions.

Q. What about the informed consent, are there special requirements? Yes. In addition to the conventional language in an informed consent addressing risks, benefits and alternatives to the procedure, the consent form for intraocular Avastin injections should clearly state that Avastin is off-label and that there is little evidence available describing the efficacy of the treatment or possible side effects. The informed consent also should explain in easy to understand terms the meaning of an off-label use. Care must be taken to address the lack of data in a balanced manner so as not to lead the patient to believe that there are no side effects. The informed consent might also mention that collection of this type of data is underway.

Q. There is a lot of discussion about coverage. Are any Medicare carriers going to start reimbursing for Avastin? Probably, but no one knows at this time when or how. Only a few carriers have even published policies on Avastin. First Coast (Florida) published a policy clearly stating that the use of Avastin in the eye is not covered. Cigna (Tennessee, Idaho) recently stated that the drug and injection would be covered under limited circumstances. NHIC (California, several New England states) has said that they will not issue a policy at this time, but will be auditing claims for off-label use of drugs and may ask for recoupment at some future time.

What the Future May Bring

Many retinal specialists have found promising results following use of this drug for wet AMD. Avastin clinical studies have been initiated, and over the next 6 to 12 months, we will likely see more policies published and changes in reimbursement made.

Suzanne Corcoran is vice president of Corcoran Consulting Group. You can reach her at (800) 399-6565 or at scorcoran@corcoranccg.com.