The U.S. government has announced that Medicare will begin covering image-guided breast biopsies for breast abnormalities that can be felt by hand (i.e., palpable breast lesions). Medicare currently covers surgical breast biopsy procedures and imaged-guided biopsies for abnormalities that are detected with diagnostic tests (such as mammography) but cannot be physically felt. The new coverage will provide many women with a less invasive breast biopsy option.

A breast biopsy involves removing a sample of breast tissue to determine whether it is cancerous or benign. Over one million breast biopsies are now performed annually in the United States: approximately 800,000 are surgical biopsies and 200,000 are minimally invasive percutaneous ("through the skin") biopsies.

Medicare decided to add coverage of image-guided biopsies for palpable breast abnormalities at the suggestion of Ethicon Endo-Surgery, Inc., a Johnson & Johnson companies that manufactures the Mammotome breast biopsy system. Mammotome is a type of minimally invasive, vacuum-assisted breast biopsy that relies on image guidance to remove multiple tissue samples.

According to Dr. Sean Tunis, Director of the Centers for Medicare and Medicaid Services Coverage and Analysis Group, the new coverage will improve the quality of care for many Americans. Approximately half of all suspicious breast abnormalities are palpable, or able to be physically felt.

Biopsy methods that may require image guidance include:

• fine needle aspiration biopsy (FNA)
• core needle biopsy
• vacuum-assisted biopsy (Mammotome or MIBB)
• large core biopsy (ABBI)
• open surgical biopsy (excisional or incisional)

Typically, either stereotactic mammography or ultrasound is used during an image-guided breast biopsy. Stereotactic mammography involves using computers to pinpoint the exact location of a breast mass based on mammograms (x-rays) taken from two different angles. The computer coordinates help the physician to guide the needle to the correct area in the breast. With ultrasound, the radiologist or surgeon watches the needle on the ultrasound monitor to help guide it to the breast abnormality.

While the majority of breast biopsies are still being performed as surgical procedures, imaged guidance provides the opportunity for many women to undergo less invasive biopsies. A fine needle aspiration, core needle biopsy, or vacuum assisted biopsy can typically be performed in a physician’s office without the need for stitches. While minimally invasive biopsy methods are not appropriate for all cases, they are often an option and should be discussed with radiologist or surgeon.

The biopsy method most suitable for a particular patient depends on a number of factors, including:

• whether or not an abnormality can be felt or only seen with imaging
• how suspicious the abnormality appears on x-ray (or feels on palpation)
• the size, shape, and other distinct characteristics of the abnormality
• the location of the abnormality in the breast and in relation to other anatomic structures
• the number of abnormalities detected during physical examination or with x-ray imaging
• the patient’s medical history and current medications
• the preference of the patient, as long as an option is medically safe and appropriate

The Medicare coverage for image-guided biopsy on palpable breast abnormalities is expected to begin within the next six months.

• The Medicare website is available at www.medicare.gov/
• To learn more about breast biopsy, please visit http://www.imaginis.com/breasthealth/biopsy/