A study released in December 2001 suggests that a new class of breast cancer drug works better than tamoxifen. Called aromatase inhibitors, these drugs are more successful in shrinking tumors and show fewer side effects than tamoxifen. Like tamoxifen, these drugs are not reimbursed by Medicare because they are self-administered and taken in pill form.
They are marketed under the names femara, arimidex and aromasin. Femara is approved as a first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown, advanced or metastatic breast cancer. Arimidex and aromasin are approved for first-line treatment of postmenopausal women with hormone receptor positive or unknown locally advanced or metastatic breast cancer. They are also for treatment of advanced breast cancer in postmenopausal women whose disease has progressed despite a regimen of tamoxifen.
While some oral anticancer drugs are reimbursed by Medicare, these three drugs do not meet regulations. Drugs are covered if all of six criteria are met:
It is a drug or biological approved by the Food and Drug Administration (FDA)
It has the same ingredients as a non-self-administered anticancer chemotherapeutic drug or biological that is covered when furnished "incident to" a physician's service
The oral anticancer drug and the non-self-administered drug must have the same chemical/generic name as indicated by the FDA's approved drug products (Orange Book), Physician's Desk Reference (PDR), or an authoritative drug compendium
It is used for the same indications, including unlabeled use, as the non-self-administered form of
the drug
It is prescribed by a physician or other practitioner licensed under state law to prescribe such drugs as anticancer chemotherapeutic agents
It is prescribed for the treatment of cancer (ICD-9 codes 140.0-208.9, 236.1, 273.3)
It is reasonable and necessary for the patient.
Also, a class of oral anticancer drugs known as prodrugs is approved for reimbursement. They include busulfan, capecitabine, cyclophosphamide, etoposide, melphalan, methotrexate and temozolomide.
To bill for oral anticancer drugs and prodrugs, practices must submit claims to a durable medical equipment regional carrier (DMERC) on the HCFA 1500 form or its electronic equivalent, says Elaine Towle, CMPE, practice administrator for New Hampshire Oncology and Hematology. Unlike other billable drugs to a DMERC, these oral anticancer drugs are not submitted with HCPCS codes. They are billed using the National Drug Code (NDC) number. NDC numbers can be found at:
http://www.fda.gov/cder/ndc/index.htm.
Before this can be done, physicians must obtain a DMERC supplier number. Unless an oncology practice already bills DMERC for durable medical equipment such as pumps, it's likely the practice doesn't have a supplier number. Numbers may be obtained from The National Supplier Clearinghouse, P.O. Box 180142, Columbia, S.C., 29202-3142; phone: 1-866-238-9652.
Aromatase inhibitors are not the only promising drugs to gain attention recently, but fall outside [...]