Ob-Gyn Coding Alert

The FDA has recently approved the use of a menopause home test. It is the first in-minutes test kit for menopause, manufactured by Toronto-based Genua 1944 Inc.

The urine test is a rapid in-vitro diagnostic immunoassay designed for the qualitative determination of human follicle stimulating hormone (FSH) in urine for the confirmation of hormone changes related to the symptoms associated with the stages of menopause.

The test sold in packages of two for consumers and packages of 10 and 25 for physicians indicates whether FSH levels are above or below 25 IU/L.

Some physicians question the need for a home test, however. "They are of very little practical value," says gynecologist Wulf Utian, executive director of the North American Menopause Society. "FSH levels vary too much to yield useful information. Also, any woman missing periods should see her doctor: older women for a consult on the effects of menopause, and younger women to determine if there is an underlying health problem."

Aaron T. Tabor, CEO of Physicians Pharmaceuticals, which markets the test, defends it as an early screening tool. "It's meant to drive women to their doctors sooner rather than later," he says. "And doctors who use the test can get qualitative results in the office in 10 to 15 minutes and can bill for the test."

The appropriate code is 83001 (Gonadotropin; follicle stimulating hormone [FSH]) appended with modifier -QW (CLIA waived test). Medicare reimburses $25.69 for the test.

Note: The reimbursement will vary by region, insurance carrier, contracting HMO, specialty profile and type of testing performed.