Oncology & Hematology Coding Alert

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, about half of the uses of anticancer chemotherapy drugs are for indications other than those referenced on the FDA-approved label.

Document Justification for Off-label Drug Use

Payment-denial reasons are two-fold, according to the Health Care Financing Administration (HCFA) guidelines: use of chemotherapeutic agent in an off-label use that has not been validated in a clinical trial, or unreasonable and unnecessary use of the chemotherapy drug.

In addition, HCFA or the FDA must not list the intended use of the chemotherapeutic agent as not indicated, and justification for coverage of off-label use should be based on data from clinical trials.

To document that off-label use of a chemotherapy drug is justified, physicians should provide evidence from one of the following sources:

The Compendia. (HCFA refers to two publications as the Compendia: USP DI, published by the United States Pharmacopial Convention Inc., and AHFS Drug Information, published by the American Society of Hospital Pharmacies.) The Compendia must not list the drug as not indicated for the diagnosis that will be placed on the claim. If the unlabeled use does not appear or is listed as insufficient data or investigational, determine whether a report is forthcoming. An expected report can be used to determine whether the off-label use is justified.

Phase III clinical trials. (Phase III is the final stage, essentially the efficacy stage, of a clinical trial.) In order for Medicare to consider the clinical trial data, the trial must have a defined combination and dosage schedule, an appropriate study design, an adequate number of study subjects, and evidence of significant decrease in tumor size or reduction in tumor-related symptoms. Stabilization is not considered a response to therapy.

Peer-reviewed medical literature. Payers will consider only scientific, medical and pharmaceutical
publications in which original manuscripts are published following a critical, unbiased review for scientific accuracy, validity and reliability. In-house
publications or abstracts of pharmaceutical companies
are not acceptable. Here are a few examples of
acceptable publications: American Journal of Medicine, Journal of Clinical Oncology, Blood, Cancer; Drugs, and British Journal of Cancer.

Also, the medical record must document the medical need for using these chemotherapy drugs, and clearly indicate the condition for which these drugs are being used. This documentation should be found in the history and physical, or in the physicians progress notes.

Despite the number of denials for off-label use of chemotherapy drugs, Cothern estimates that virtually every denial will be paid eventually if physicians provide the proper support documentation. But because of the effort involved in appealing these denials, many practices are willing to write off the denied payment, which could average about $2,000 per claim.

Up-front Preparation for An Appeal

To speed up the appeals process, oncology practices should keep updated files of supportive documents for chemotherapy drugs commonly used off label, says Cothern. This allows the practice to quickly retrieve the proper information when needed, rather than having to do time-consuming research each time a drug is denied, says Cothern.

Our billing department here at Baptist has an ongoing file of information and articles from published trials and documented results of drugs with off-label usage, along with letters of medical necessity from the physician, Cothern adds.

She also says practices should not be afraid to seek assistance from drug companies when documentation is needed. Dont be afraid to use them to your advantage, she says. After all, they want your business. This helps make the process more efficient and keeps researching time and effort to a minimum.

Response to a Denial

Cotherns practice recently received one of those denial form letters from a Medicare payer, which denied their use of Gemzar (gemcitabine HCL, J9201), a chemotherapy agent that is indicated for use in non-small-cell lung cancer and pancreatic cancer (157.0-157.9). The physician had used Gemzar to treat a patient with small-cell lung cancer.

The denied claim amounted to $50,000. The physician response was to write a letter of medical necessity and provide copies of journal articles and clinical trial information that justified its use for the situation.

Cothern says it could take months before they are paid, but if necessary, they will ask for an administrative hearing.