Dont Be Denied Reimbursement for Appropriate Off-label Chemotherapy Use
Published on Mon May 01, 2000
You may have put several patients through a chemotherapy regimen using a drug (Taxol, for example) outside the Food and Drug Administrations (FDA) labeled indication, and had no difficulty getting reimbursement. Nevertheless, most oncology practices eventually receive a form letter saying that payment is denied because the billed-for drug is not indicated for the reported diagnosis. Unfortunately, there may be little up-front remedy for this scenario, but you should not dismiss these denials as reimbursement casualties. Instead, prepare for the eventuality of denial by gathering, in advance, documentation showing the chemotherapeutic agent has also been effective in off-label use.
The FDA originally approved Taxol (paclitaxel, J9265), for example, for second-line therapy for ovarian cancer (183.0-183.9). Its off-label uses include first-line treatment for ovarian cancer, second-line treatment for breast cancer (174.0-174.9), treatment for non-small- cell lung carcinoma (162.2-162.9) and bladder cancer (188.0-188.9). In addition, many off-label uses involve multi-drug combinations, for example, the combination of a new drug such as Herceptin (trastuzumab, J9355) for metastatic breast cancer with Taxol.
Usually you just pull some journal articles to show the payer that the drug has been effective in patients with the same diagnosis, says Margaret Hickey, MS, MSN, RN OCN, CORLN, clinical director for the Tulane Cancer Center, an oncology practice in New Orleans.
For commercial payers, oncology practices should consider reporting the chemotherapy regimen during the precertification process, rather than reporting the intended course of treatment simply as chemotherapy, Hickey says. If the oncology practice receives prior coverage approval for a specific off-label use of chemotherapy, the insurer will have difficulty justifying a denial when the claim is processed.
Hickey recognizes the difficulty in this, however, because most often office staff obtains certification for coverage from the insurance company, and they may not be aware of the exact chemotherapy regimen.
FDA Encourages Responsible Off-label Drug Use
Commercial insurers are more likely to deny payment than Medicare carriers, says Hickey, but both routinely deny reimbursement for anticancer drugs prescribed for indications not on the FDA-approved label. Payers often regard such use as experimental or investigational.
In recent years, the FDA, the National Cancer Institute, the Institute of Medicine and others have criticized this trend for depriving patients of effective therapies as well as discouraging drug development. The FDA has made it clear that the drugs label is in no way intended to regulate or restrict the ability of practicing physicians to use the drug for other purposes consistent with their professional judgment.
Almost any chemotherapy drug is used outside its FDA-approved label, says Nancy Cothern, business manager at Baptist Regional Cancer Institute, an oncology practice in Jacksonville, Fla. And, according to the American Society of Clinical Oncology, [...]
