Aetna considers any of the following minimally invasive image-guided breast biopsy procedures medically necessary as alternatives to needle localization core surgical biopsy (NLBx) in members with abnormalities identified by mammography that are non-palpable or difficult to palpate (i.e., because they are deep, mobile, small (less than 2 cm), or are composed of clustered microcalcifications):

1. Advanced Breast Biopsy Instrument (ABBI); or
2. Stereotactically guided core-needle biopsy; or
3. Ultrasound-guided core-needle biopsy; or

4. Vacuum assisted core-needle biopsy (Mammotome™ device).

Aetna considers other minimally invasive image-guided breast biopsy procedures (i.e., those not mentioned above) experimental and investigational (e.g., PET-guided breast biopsy (Naviscan)).

See also CPB 071 - Positron Emission Tomography (PET), and CPB 517 - Breast Ductal Lavage and Fiberoptic Ductoscopy.

Recent comparative studies have demonstrated several advantages of minimally invasive breast biopsy procedures over needle localization core surgical biopsy (NLBx). Minimally invasive breast biopsy procedures take less time to perform than NLBx, cause less patient discomfort and cosmetic deformity, result in less artifact on subsequent mammography, and are more cost effective. If a benign lesion is found, the patient can be followed with clinical examinations and mammography and an open surgical procedure is avoided.

Biopsies can be obtained either with a fine-needle (20-gauge) or large bore (11- and 14-gauge) needle. However, the large-core biopsy is favored over fine-needle biopsy for several reasons: large core biopsy samples can be interpreted by pathologists who do not have special training in cytopathology; specimens obtained by large core biopsy are more likely to be sufficient than those obtained by fine-needle biopsy; large core biopsy samples allow the pathologist to differentiate in-situ from invasive carcinoma; and pathologists can characterize lesions more completely with large-core biopsy samples.

For larger, fixed, palpable lesions, image guidance is considered not medically necessary for performing an adequate biopsy. In these cases, palpation-guided biopsy is sufficient for locating the lesion and obtaining an adequate tissue sample. However, image-guidance has been shown to be useful for directing the biopsy of non-palpable or vaguely palpable lesions. The Center for Medicare and Medicaid Services (2002) concluded that imagine-guided biopsy may be indicated for lesions that are non-palpable or vaguely palpable, and that “clinical studies suggest that such lesions may include those that are vaguely palpable, mobile, deep, or small, particularly less than 2 cm. Palpable lesions that demonstrate a small area of clustered microcalcifications on a mammogram may be difficult to biopsy using palpation alone and thus may warrant image-guided biopsy. Lesions that are difficult to biopsy using palpation are generally those that border on being non-palpable; non-palpable lesions are not amenable to palpation-guided biopsy.”

Hanna et al (2005) stated that stereotactic breast biopsy techniques minimize the surgical trauma associated with conventional wire-guided open breast biopsy for non-palpable breast lesions (NPBLs). Advanced breast biopsy instrumentation (ABBI) allows for a 2-cm core of breast tissue to be excised under stereotactic guidance in an outpatient setting. These investigators reported their initial experience with ABBI. Hospital charts from 89 ABBI procedures between October 1996 and July 2002 were retrospectively reviewed for patient characteristics, ABBI parameters, radiographic appearance, pathology, complications, and clinical follow-up. Data were presented as percentage/median (range). Median age was 59 years (range of 39 to 80 years), mammographic lesions were classified as calcifications 49 % (44/89), soft tissue 39 % (35/89), or mixed 11 % (10/89). Median radiographic size was 7 mm (1 to 60 mm). Final pathology revealed ductal carcinoma in situ (DCIS) in 7 % (6/89) and invasive cancer in 22 % (20/89). Microscopically clear margins were obtained in 55 % (11/20) of patients with invasive cancer. Of these, 82 % (9/11) chose not to undergo further local surgical therapy. Eight patients remain disease free at 56 months (range of 41 to 95 months) follow-up. The 9th patient was deceased at 6 months from an unrelated cause. The overall complication rate was 3 % (3/89). A definitive diagnosis was obtained in 100 % of malignant and 87 % of benign cases. Median waiting time was 19 days (range of 0 to 90 days). The authors' experience demonstrated that ABBI is an effective diagnostic tool for NPBLs. It is associated with minimal complications, and provides negative margins in over 50 % of malignant cases. In selected patients with invasive cancer and negative margins, ABBI may obviate the need for further local surgical treatment. Furthermore, ABBI merits additional investigation as a therapeutic modality for early breast cancer.