Oncology & Hematology Coding Alert

In the past six months, three drugs graduated from the often-denied "off-label" drug status. Expect to start seeing payment for these drugs, recently approved by the U.S. Food and Drug and Administration (FDA). Provided are links to important documentation information for these new drugs, with documentation you could include in your claims or appeals. GLIADEL Wafer (Prolifeprosan 20 Carmustine Implant). The FDA approved GLIADEL on Feb. 25, 2003, as an adjunct to surgery and radiation for the treatment of newly diagnosed, high-grade malignant glioma. The procedure involves the implantation of the wafer directly into the tumor site after the tumor is removed by surgery. Note that GLIADEL is also an approved drug as an adjunct to surgery for recurrent glioblastoma multiforme (GBM) brain tumors. For full information for your documentation, go to www.fda.gov/cder/foi/label/2003/020637s016lbl.pdf. Gleevec (Mesylate). The FDA approved Gleevec in May 2001 for second-line treatment of chronic myeloid leukemia (CML) (205.1x) after interferon-alpha therapy failed, but on Dec. 20, 2002, the FDAapproved Gleevec for first-line treatment. You may have seen denials for Gleevec even after its first approval because further studies needed to affirm the  drug's actual clinical benefit, as stated in the FDA News Press Release. Officials at the Centers for Medicare & Medicaid Services at that time relegated cost responsibilities to beneficiaries. The first-line approval, however, will hopefully persuade payers to start reimbursing this drug based on your documentation.

Note that the FDA has approved Gleevec for the treatment of all three stages of CML (myeloid blast crisis, accelerated phase, and chronic phase), either before or after use of other therapy. Gleevec is also an approved treatment for gastrointestinal stromal cancer. Unfortunately, Medicare does not cover Gleevec because it is an oral agent, even though it has FDA approval. For full information on this drug for your documentation, go to www.fda.gov/cder/foi/label/2002/021335s004lbl.pdf. Taxotere (Docetaxel). On Nov. 27, 2002, the FDA approved the use of this drug in combination with cisplatin for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) not removable by surgery. Patients receiving this drug must not have previously received chemotherapy for this condition. For full information on this drug for your documentation, go to www.fda.gov/cder/foi/label/2002/20449s018lbl.pdf. Your medical records will likely show 75 mg/m2 of Taxotere administered intravenously over one hour, followed by 75 mg/m2 of cisplatin over 30-60 minutes every three weeks.