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L.6.01.424
Radioactive seed localization is used to detect nonpalpable breast lesions, which have become more common with the increasing use of breast cancer screening in asymptomatic women. This technique is used before breast-conserving surgery or excisional biopsies to identify the location of an original tumor after neoadjuvant chemotherapy. A radiologist places a titanium “seed” containing radioactive iodine 125 with an 18-gauge needle using ultrasound, mammography, or stereotactic guidance. Then, using a gamma probe, the surgeon locates the seed and the breast tissue that needs to be removed. Alternative methods to localize nonpalpable breast lesions include wire localization (the traditional approach) or radio-guided occult lesion localization.
Nonpalpable Lesions
More nonpalpable lesions are currently detected (about 25% to 35% of breast cancers at diagnosis) due to the increased use of breast screening in asymptomatic women. These nonpalpable lesions require a localization technique to perform excisional biopsies or breast-conserving surgery (i.e., lumpectomy).
Localization Methods
The traditional localization method for nonpalpable breast lesions is image-guided wire localization. This approach has limitations, including the following: the wire can bend or be displaced (because the wire protrudes from the breast); there may be scheduling issues given the wire should be placed on the same day as the surgery; and the radiologist may follow a different route to place the wire than the surgeon does to excise the lesion, which may complicate locating all of the lesion (in addition to potentially causing cosmetic concerns). The percentage of cases with positive margins after wire localization is 14% to 47%.
Radioactive seed localization of nonpalpable breast lesions uses radio-opaque titanium seed(s) containing radioactive iodine 125 (I-125). These seeds are inserted by a radiologist using ultrasound or stereotactic guidance to identify the location of a nonpalpable breast lesion. They may be placed several days or weeks before surgery. The surgeon then uses a gamma probe to locate the radioactive seed and remove it with surrounding tissue. Therange of radioactive doses in one group of studies was 3.7 to 10.7 MBq (one megabecquerel [MBq] equals 0.027 millicuries). Seeds were 4.5 x 0.8 mm, which has been described as similar to a grain of rice. The half-life of I-125 is 60 days, and I-125 is a 27-keV source of gamma radiation. I-125 can be detected on a different signal than the 140-keV technetium 99 (Tc-99) that may be used for sentinel lymph node biopsy. Once the radioactive seed is removed, its presence in the tumor specimen is confirmed using the gamma probe. Lack of radioactivity in the tumor cavity is also assessed to ensure that the radioactive seed has not been left in the breast. A disadvantage of radioactive seed localization is that special procedures must be followed to safely handle and track the radioactive seed before placement and after excision.
Radioactive seed localization may also be used to guide excision after neoadjuvant chemotherapy, which is performed primarily in women with locally advanced cancer in an effort to shrink the tumor. A proportion of these women (25% to 32%) are then able to have breast-conserving surgery rather than a mastectomy. The challenge is that if there is a complete clinical and radiologic response, it may be difficult to localize the original tumor bed. Pathologic confirmation of response is needed because there is residual microscopic cancer in about half of these patients. Radioactive seed localization can mark the tumor location before beginning neoadjuvant chemotherapy.
An alternative to wire localization or radioactive seed localization, developed in the late 1990s, is radio-guided occult lesion localization. First, a twist marker is placed in the breast to identify the tumor. Before surgery, a liquid radioactive radiotracer (Tc-99) is injected next to the twist marker using image guidance. The surgeon uses a gamma probe to locate the radiotracer and guide the incision. The main disadvantage of this approach is that the radiotracer has a short half-life of about 6 hours. It also does not provide a point source of radiation. An advantage is that Tc-99 may be used for sentinel lymph node biopsy, so the same radiotracer is used for both purposes. Alternatively, a radioactive seed and Tc-99 for sentinel lymph node biopsy can be used concurrently. Another alternative is intraoperative ultrasound-guided resection, although the procedure is discussed less frequently in this literature. It can only be done when the lesion is detectable by ultrasound.
In 2011, the BrachySciences Radioactive Seed Localization Needle with AnchorSeed™ (Biocompatibles) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K111979). This device is indicated for the localization of suspicious tissues (non-palpable lesions) for excision with the use of radioactive seeds.
In 2012, the Best® Localization Needle with I-125 Seed (Best Medical International) was cleared for marketing by the FDA through the 510(k) process (K122704). This device is indicated for breast localization under the direct supervision of a qualified physician. It consists of an iodine-125 seed and an 18-gauge 5-cm to 20-cm needle.
These devices are not always used for radioactive seed localization. Radioactive seeds approved for another indication (i.e., off-label) may also be implanted with an 18-gauge needle. These seeds were initially approved for permanent implantation (i.e., brachytherapy) in select localized tumors such as prostate cancer. These seeds use I-125 beads (activity from 0.1 to 1.0 mCi) encapsulated in a titanium tube. An example is the International Isotopes I3RAD I-125 Seed, which, in 1999, was cleared for marketing by the FDA through the 510(k) process (K992963).
Radioactive seed localization of nonpalpable breast lesions may be considered medically necessary for the purposes of locating lesions to guide excisional biopsy or breast-conserving surgery because the clinical outcomes are likely to be equivalent to wire localization (See Policy Guidelines).
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Radioactive seed localization of nonpalpable breast lesions is likely to produce equivalent outcomes compared to wire localization. Therefore, the “least costly alternative” provision of the medically necessary definition may apply.
When it is determined that a strategy using radioactive seed localization is more costly than one using wire localization (as determined by product pricing, provider charges, and/or other mechanisms), then radioactive seed localization may be considered not medically necessaryfor localization of nonpalpable breast lesions.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
04/01/2014: Approved by Medical Policy Advisory Committee.
10/17/2014: Policy reviewed; no changes.
07/27/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number A.6.01.57 added. Policy Guidelines updated to add medically necessary and investigative definitions.
11/29/2016: Policy description updated. Policy statement revised to state that radioactive seed localization of nonpalpable breast lesions may be considered medically necessary for the purposes of locating lesions to guide excisional biopsy or breast-conserving surgery, because the clinical outcomes are likely to be equivalent to wire localization. Information on least costly alternative moved from policy statement to Policy Guidelines.
10/18/2017: Policy description updated. Policy statement unchanged.
10/09/2018: Policy description updated. Policy statement unchanged.
11/01/2019: Policy reviewed; no changes.
10/15/2020: Policy description updated. Policy statement unchanged.
01/10/2022: Policy reviewed. Policy statement unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."
12/02/2022: Policy reviewed; no changes.
10/12/2023: Policy reviewed; no changes.
01/22/2025: Policy updated to change the medical policy number from "A.6.01.57" to "L.6.01.424." Policy reviewed. Policy statement unchanged.
Blue Cross and Blue Shield Association Policy # 6.01.57
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Code Number | Description |
CPT-4 | |
19499 | Unlisted procedure, breast |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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