Description:
Techniques to biopsy the breast include fine-needle aspiration, needle core biopsy, vacuum-assisted core biopsy (i.e., Mammotome device), and techniques using a rotating biopsy device (i.e., ABBI system). Fine-needle aspiration and needle core biopsy are well-established techniques and are not considered further in this policy. Vacuum-assisted core biopsy and a rotating biopsy device are identified by a distinct CPT code, 19103, introduced in 2001 (See Policy Guidelines, below). This policy focuses on the use of vacuum-assisted core biopsy only, primarily because rotating biopsy devices (i.e., the ABBI biopsy device) has not won widespread physician acceptance and its use appears to be waning.

Vacuum-assisted core biopsy is a relatively new biopsy technique in which a cannula equipped with a suction device is inserted into the breast via a small skin incision. When positioned at the target site, the suction is activated and tissue is collected. With a single incision, up to 8 core biopsies can be taken from 1 site. In contrast, if a conventional needle core biopsy technique is used, the device would require multiple insertions into the breast. A metallic clip may also be placed at the site of vacuum-assisted biopsy to facilitate its identification if further surgical excision or further radiologic follow-up is considered necessary. While the vacuum-assisted technique was initially used for biopsying clusters of microcalcifications, more recently its use has expanded to include biopsy of a wider range of breast lesions, both palpable and nonpalpable.

Breast biopsy techniques are frequently accompanied by image guidance, using a variety of imaging techniques. Stereotactic localization requires that the breast be compressed between a compression paddle and a plate, called the image receptor, which can detect the x-ray beam and produce either a film image (mammogram) or a digital computer-generated image of the breast indicating the exact coordinates of the biopsy target. Stereotactic guidance is particularly useful for guiding biopsy of microcalcifications. For masses that can be seen with ultrasound, ultrasound guidance may be preferable because of the absence of radiation and the lower cost. Other forms of image guidance include computed tomography (CT) or magnetic resonance imaging (MRI).

When the results of a fine-needle aspiration or conventional needle core biopsy are either suspicious or positive for malignancy, an additional open excisional biopsy or lumpectomy is typically performed to both confirm the findings and ensure that the entire lesion has been removed. Since additional breast tissue is removed with the Mammotome system, there has been interest in exploring whether this procedure could be considered a definitive biopsy procedure, rendering a subsequent open excisional biopsy unnecessary. For example, some authors have proposed that if vacuum-assisted biopsy reveals ductal carcinoma in situ, a patient may be further assessed with a sentinel node biopsy of the axillary nodes. If these biopsy results are negative, the patient may need no further surgical management.

Policy:
Image-guided breast biopsy of nonpalpable breast lesions using a vacuum-assisted biopsy technique may be considered MEDICALLY NECESSARY as an alternative to standard needle-core biopsy or fine-needle aspiration.

Breast biopsy of palpable breast lesions using a vacuum-assisted biopsy technique may be considered NOT MEDICALLY NECESSARY as an alternative to standard needle core biopsy or fine needle aspiration.

Breast biopsy of breast lesions using a vacuum-assisted biopsy technique may be investigational/unproven therefore considered NOT MEDICALLY NECESSARY as an alternative to open excisional biopsy or lumpectomy.

Policy Guidelines
In 2001, the following CPT code was introduced that explicitly defines vacuum-assisted biopsy:

19103: Biopsy of breast; percutaneous, automated vacuum assisted or rotating biopsy device, using imaging guidance.

Rationale
Since this policy was originally issued in 1998, vacuum-assisted core biopsies have won acceptance by physicians. In particular, the Mammotome device has been extensively used in patients with multiple microcalcifications, a type of lesion that may be difficult to completely biopsy using needle core biopsies, and where the ability to collect a larger sample size is thought to reduce the rate of false negative results.Ideally, evidence supporting an improvement in diagnostic performance of a vacuum-assisted biopsy technique would consist of a controlled trial in which patients, stratified according to the pretest probability of malignancy based on the mammographic abnormality, would be randomly assigned to undergo either a fine-needle aspiration, a conventional core biopsy, or a vacuum-assisted biopsy. All biopsies would then be followed by an open excision biopsy to confirm findings and assess the false negative rate. Alternatively, patients with benign biopsy results could be followed up for several years to determine the incidence of subsequent cancer. Any improvement in diagnostic performance would then need to be balanced against any increased risk of a vacuum-assisted biopsy procedure. Possible risks include an increased periprocedure incidence of bleeding or infection. Long-term risks might include an increased incidence of scarring, limiting interpretation of future mammograms.

This type of study has not been done. However, the available data do suggest that vacuum-assisted biopsy is an effective technique for sampling microcalcifications. For example, Meyer and colleagues compared the success rate of sampling microcalcifications between the traditional core biopsy and vacuum-assisted biopsy.¹ Of 130 focal calcifications sampled with the conventional technique, 12 clusters had no particles depicted on specimen radiography. In contrast, all of the 106 microcalcifications sampled with the vacuum-assisted technique were confirmed on a specimen radiograph. In a series of 42 sequential patients reported by Nisbet and colleagues, vacuum-assisted biopsy was also associated with improved sampling of microcalcifications, from 62% in patients undergoing conventional core biopsy to 86% in those undergoing vacuum-assisted biopsy.² Regarding diagnostic accuracy, Jackman and colleagues compared the histologic finding of atypical ductal hyperplasia, identified at either vacuum-assisted biopsy or conventional core biopsy of nonpalpable breast lesions, with the results of a subsequent surgical excisional biopsy.³ In 26 of the 54 (48%) lesions biopsied with conventional core biopsy, the diagnosis of atypical ductal hyperplasia was incorrect, based on the finding of cancer at excisional biopsy. In contrast, the diagnosis was only incorrect in 13 of the 74 lesions (18%) sampled with vacuum-assisted biopsy. The authors attributed the improved diagnostic accuracy to the increased amount of tissue sampled with vacuum-assisted biopsy. However, the authors also pointed out that carcinoma was significantly underestimated in both techniques such that surgical biopsy was still required. Other authors have also recommended subsequent surgical excision in patients diagnosed with atypical ductal hyperplasia or ductal carcinoma based on results of vacuum-assisted biopsy. In their study of 428 biopsies yielding atypical ductal hyperplasia or ductal carcinoma in situ, Darling and colleagues found that, based on results of subsequent surgical excision, underestimation of an invasive ductal carcinoma was less in those undergoing biopsy with an 11-gauge vacuum-assisted technique (10%) compared to a 14-gauge vacuum-assisted technique (17%) or a 14-gauge conventional needle core biopsy (21%).⁴ Nevertheless, the 10% to 17% rate of underestimation in the 2 vacuum-assisted biopsy techniques casts doubt on the practice of foregoing surgical excision when atypical ductal hyperplasia or ductal carcinoma in situ are present.⁵

The available data also suggest that vacuum-assisted biopsy is a safe technique. Simon and colleagues studied the complications of vacuum-assisted biopsy in 71 lesions in 67 consecutive women.⁶ Five of the 71 biopsies (7%) resulted in bleeding beyond 10 minutes. One patient experienced a vasovagal response. In a case series of 340 vacuum-assisted biopsies, Burbank reported a 1% complication rate.⁷ In addition, vacuum-assisted biopsy does not appear to result in scarring that would preclude interpretation of mammograms. Liberman and colleagues reported that procedure-related mammographic changes were seen 88% of the time immediately after vacuum-assisted biopsy, but that these changes resolved within 2 weeks of biopsy.⁸ Lamm and Jackman reported on the mammographic abnormalities associated with both vacuum-assisted biopsy and conventional core biopsy.⁹ A mammographic abnormality thought to be related to the biopsy procedure was noted in 5 of the 322 (1.5%) patients undergoing vacuum-assisted biopsy compared to none of the 422 patients undergoing conventional core biopsy.

Therefore, while there are no studies directly comparing the diagnostic performance of vacuum-assisted biopsy and conventional core biopsy, the available data suggest that the vacuum-assisted biopsy does result in an increased amount of tissue removed with a minimal complication rate. The technique has been most thoroughly investigated in patients with nonpalpable lesions, particularly those with microcalcifications, where adequate tissue sampling may be a concern with conventional core biopsy techniques. These are the patients most likely to benefit from a vacuum-assisted biopsy. In contrast, there were no published studies identified that focused on the use of vacuum-assisted biopsy of palpable lesions. In these lesions, adequate tissue sampling is not as great a concern, and thus the use of a vacuum-assisted technique is less likely to be associated with an improved diagnostic performance. Therefore, this application of vacuum-assisted biopsy is considered not medically necessary. Also, the data do not suggest that a vacuum-assisted biopsy is an alternative to an excisional biopsy if atypical ductal hyperplasia, ductal carcinoma in situ, or a malignancy is identified. Therefore, this application is considered investigational.

References:

1. Meyer JE, Smith DN, DiPiro PJ et al. Stereotactic breast biopsy of clustered microcalcifications with a directional, vacuum-assisted device. Radiology 1997;204(2):575-6.
2. Nisbet AP, Borthwick-Clark A, Scott N. 11-gauge vacuum-assisted directional biopsy of breast calcifications, using upright stereotactic guidance. Eur J Radiol 2000;36(3):144-6.
3. Jackman RJ, Burbank F, Parker SH et al. Atypical ductal hyperplasia diagnosed at stereotactic breast biopsy: improved reliability with 14-gauge, directional, vacuum-assisted biopsy. Radiology 1997;204(2):485-8.
4. Darling ML, Smith DN, Lester SC et al. Atypical ductal hyperplasia and ductal carcinoma in situ as revealed by large-core needle breast biopsy: results of surgical excision. AJR Am J Roentgenol 2000;175(5):1341-6.
5. Adrales G, Turk P, Wallace T et al. Is surgical excision necessary for atypical ductal hyperplasia of the breast diagnosed by Mammotome? Am J Surg 2000;180(4):313-5.
6. Simon JR, Kalbhen CL, Cooper RA et al. Accuracy and complication rates of US-guided vacuum-assisted core breast biopsy: initial results. Radiology 2000;215(3):694-7.
7. Burbank F. Stereotactic breast biopsy: comparison of 14- and 11-gauge Mammotome probe performance and complication rates. Am Surg 1997;63(11):988-95.
8. Liberman L, Hann LE, Dershaw DD et al. Mammographic findings after stereotactic 14-gauge vacuum biopsy. Radiology 1997;203(2):343-7.
9. Lamm RL, Jackman RJ. Mammographic abnormalities caused by percutaneous stereotactic biopsy of histologically benign lesions evident on follow-up mammograms. AJR Am J Roentgenol 2000;174(3):753-6.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

Index
Breast biopsy, Mammotome
Breast biopsy, vacuum-assisted
Mammotome
Vacuum-assisted breast biopsy

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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