Oncology & Hematology Coding Alert

There is increasing evidence that the chemotherapy drug gemcitabine (J9201) approved for use in breast (174.0-175.9), ovarian (183.0-183.9) and non-small cell lung cancers (162.0-162.9) is effective in treating advanced pancreatic (157.0-157.9) and gallbladder cancer (156.0-156.9) when used in combination with other chemotherapeutic drugs. Although this offers additional options for oncology physicians, their billing staff could be faced with payment denials as a result of using the drug outside its labeled use.

But denials dont have to result in practices absorbing the cost of this expensive drug. With greater attention to documentation, oncology practices can be reimbursed for gemcitabine used for pancreatic cancer and gallbladder cancer.

To use gemcitabine outside of the approved diagnoses, oncologists have to navigate the uncertain realm of unlabeled use of chemotherapy drugs. But oncology practices have greater leeway when it comes to chemotherapy and pain-management drugs, says Daniel Johnson, healthcare consultant and director with HealthCare Consultants of America, a coding consulting firm based in Augusta, Ga.

Over the years, the federal Food and Drug Administration (FDA) has recognized the growing importance of off-label use of chemotherapy drugs to advance effective treatment of cancer. The FDA has clearly stated 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.

Since 1994, the agency has allowed unlabeled use of FDA-approved drugs used in an anti-cancer chemotherapeutic regimen for a medically accepted indication, including using combinations of chemotherapeutic drugs. But Medicare requires specific conditions
for reimbursement.

Medicare Requirements

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

1. The Compendia. This is a number of drug information publications distributed by the U.S. Pharmacopeia and the American Society of Hospital Pharmacia, among others. If the Compendia lists the drug as not indicated for the diagnosis that will be placed on the claim, oncologists should not include the Compendia in their documentation. If the unlabeled use does not appear or is listed as insufficient data or investigational in the Compendia, the oncologist should determine whether a report is forthcoming, and if so, indicate it in the documentation. The expected report can be used to determine whether the off-label use is justified.

2. Phase III Clinical Trials. For Medicare to consider the clinical trial data of the drug, 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. The documentation provided should show that the studies take all these things into account.

Tip: Stabilization is not [...]