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 considered a response
to therapy.

3. Peer-reviewed Medical Literature. To better document the efficacy of a drug, practices should send copies of the most recent literature to carriers. 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. The following peer-reviewed material is considered acceptable by payers:

American Journal of Medicine;
Annals of Internal Medicine;
The Journal of the American Medical Association;
Journal of Clinical Oncology;
Blood;
Journal of the National Cancer Institute;
The New England Journal of Medicine;
British Journal of Cancer;
British Journal of Hematology;
British Medical Journal;
Cancer;
Drugs;
European Journal of Cancer;
Lancet;
Leukemia.

The medical record also must document the medical need for the use of these chemotherapy drugs, clearly indicating the condition for which they are being used. This documentation should be found in the history and physical or in the physicians progress notes.

Keeping a current file of the latest literature for commonly used chemotherapy drugs is a good way speed up documentation, says Margaret Hickey, MS, MSN, RN OCN, CORLN, an independent coding consultant and former clinical director of the Tulane Cancer Center in New Orleans. By keeping a file of articles on gemcitabine and other drugs used outside current FDA labeled use, oncology practices can quickly refer to needed documentation. Usually you just pull some journal articles to show the payer that the drug has been effective in patients with the same diagnosis, says Hickey. This prevents having to do time-consuming research each time a drug is denied.

Ultimately, the best way to gain coverage for gemcitabine is for national oncology or medical organizations to lobby the Health Care Financing Administration (HCFA) for changes in national policy, says Johnson.

Outside of that, however, physicians are at the mercy of their local carriers. For that reason, Johnson recommends that oncology practices lobby local carriers by writing letters to their medical directors to garner reimbursement before a payment denial is received. Once youve been denied, its difficult to get reimbursed, Johnson says.

Physicians can try getting a HCPCS Level III local code that would clear the way for reimbursement. Johnson says physicians should provide the same evidence listed above to their carriers local advisory committee to get such a code established. The key is FDA approval, Johnson says. Medicare has wider coverage options for pain and cancer drugs.

Finally, the patients represent a source of payment. Although published articles regarding gemcitabine are helpful, cost and efficacy may still be an issue with payers. Johnson says physicians should require their patients to sign a waiver that requires payment if the carrier denies coverage.

In addition, if billers have a rudimentary knowledge of the drug and can explain to a payer why the drug should be covered, this could help ensure reimbursement. For example, gemcitabine used with radiation is shown to be effective because of its radiosensitive properties. In addition, gemcitabine in combination with other chemotherapy drugs has shown clinical applications for lung cancer, ovarian cancer, and non-Hodgkins lymphoma.