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Medicare coding for macular degeneration pharmacotherapies requires caution
Combination therapies and off-label uses such as intravitreal injection of bevacizumab present coding challenges.
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Riva Lee Asbell |
It seems that a day does not go by that some new drug is developed, presented and used for treating wet macular degeneration, or that a new use is found for an old standby, or that drugs developed for other uses are usurped for ophthalmic use.
Combination therapies are being tried more often. Combining photodynamic therapy and intravitreal injection of a steroid or anti-VEGF, for example, does not present any coding problems, but there may be future reimbursement complications when expensive supplies are used frequently and in tandem.
Retina physicians are excited about these endless possibilities and potential vision-saving technology advances; however, their billing departments have begun threatening to switch to other fields of medicine.
Let us review some of the problems.
CPT coding
There is not much difficulty in selecting the proper CPT code. The method of delivery dictates the code, and most of the technologies use existing codes. The most common codes are:
67028 Intravitreal injection of pharmacologic agent (separate procedure)
67221 Destruction of localized lesion of choroid (eg, choroidal neovascularization); photodynamic therapy (includes intravenous infusion)
67255 Photodynamic therapy, second eye, at single session (list separately in addition to code for primary eye treatment) (use 67255 in conjunction with code 67221)
0124T Conjunctival incision with posterior juxtascleral placement of pharmacological agent (does not include supply of medication)
Code 0124T has not received approval from the Food and Drug Administration. The intended drug and its delivery system, Retaane (anecortave acetate) manufactured by Alcon, does not have FDA approval as of this date, and it would be best to check with the company for further details.
Supply
When a drug has its own HCPCS (Health Care Procedure Coding System) Level II code, there usually is no problem getting reimbursed for the supply. However, when a drug differs from the HCPCS listing or has been approved for a certain use but does not have an established code yet, an unlisted supply code often has to be used. This is usually coded as J3490.
When a new drug comes out or when a drug is used for an off-label treatment, such as has occurred with Avastin, if the drug is deemed investigational the patient usually is financially responsible for the supply. The final determination is made at the Medicare local carrier level.
Informed consent
One should ascertain that your informed consent covers the off-label use of drugs, particularly when they are not yet the standard of care, do not have FDA approval for the specific use, and there are no clinical trials on its use.
For Medicare, there is the issue of medical necessity. If the off-label use of a drug is considered investigational, both the drug and its delivery usually are not covered under the Medicare program. As more papers are published and more clinical studies are performed, a given drug may assume a “standard of care” role. Even so, it is wise to include this information in your informed consent. Physicians are often reluctant to do this – why, I am not sure. Your malpractice carrier wants it. Attorneys will insist upon it. In case of malpractice litigation, if a lawyer detects that a drug was used in an off-label use without proper informed consent, surely your defense is going to be weaker.
The use of a proper informed consent is mandatory, and Ophthalmic Mutual Insurance Co. has one posted on its Web site for Avastin and other procedures (www.omic.com).
Local carrier determinations
Some Medicare carriers have specific policies for off-label use of non-oncological drugs or off-label use of FDA approved drugs. It behooves you to read one of these; they are all similar. The policy for the Kansas carrier can be found at www.kansasmedicare.com Another similar policy, entitled Off-label Coverage for FDA-approved Drugs, can be found at www.empiremedicare.com.
For carriers with such a policy, there is an obligation to consider the use of drugs that do not meet the criteria listed in the policy as investigational and, thus, non-covered. As such, the vehicle for delivering that drug will be considered non-covered as well.
If, after due consideration, you believe the use of the drug is investigational, you can still use the drug, but the patient needs to be financially responsible for the service and the supply, not Medicare.
But once again, your carrier rules.
Case studies
Avastin. Probably the hottest item in fall 2005 was the use of Avastin (bevacizumab, Genentech) for treatment of wet macular degeneration. There were no clinical trials with verifiable results for the intravitreal injection of Avastin (compounded by local pharmacies for use as an intravitreal injection), but almost everyone jumped on the bandwagon. (Lucentis [ranibizumab, Genentech], a related drug formulated for intravitreal injection, has been in ophthalmic clinical trials).
There is no question that the use of Avastin for intravitreal injection is an off-label use of a drug that has FDA approval for only one condition in its original formulation – infusion for treatment of gastrointestinal cancer. For ophthalmic use, the code is easy to select (67028) and, if billed to Medicare, probably will get paid because there is no reason for the carrier to deny the claim.
However, when it came to the attention of the Medicare carriers that the drug itself did not meet the criteria for local carrier determination on “Off-Label Use of Non Oncological Drugs,” many carriers started to deny the service as investigational. Some practices had the claims paid even though the claim was processed with GA modifier (indicating an Advance Beneficiary Notice was signed by the patient) appended. Other carriers decided to pay the injection and not the supply, whereas some carriers paid both.
It appears that this currently is an off-label and investigational use of Avastin, and as such neither the delivery of the drug (intravitreal injection) nor the supply should be covered service. Nevertheless, your Medicare carrier policy and instructions may differ.
Visudyne. A different problem arose when Visudyne (verteporfin for injection, Novartis/QLT) first came on the market. The drug was not on the Medicare list, and many practices were left fronting the money for the expensive drug and unable to collect from the patient because proper protocols were not followed.
Macugen. When Macugen (pegaptanib, Pfizer/Eyetech) came on the market, the drug had FDA approval for its intended use, and providers had the experience of Visudyne behind them. The manufacturer received praise for its adept handling of the supply reimbursement issues.
Conclusion
Whereas the use of pharmacological therapies in treating wet macular degeneration may present challenges in reimbursement for supply, the CPT coding is relatively straightforward and easily accomplished. Be sure the patient is informed in writing of the financial debt that is being incurred, of the risks and benefits, and of potential problems as well as alternative therapies.
For Your Information:
- Riva Lee Asbell can be reached at www.rivaleeasbell.com.
- CPT codes, copyright 2005, American Medical Association.