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DESCRIPTIONBreast conservation therapy (BCT) is a multi-modality alternative to mastectomy to treat early (stage I or II) breast cancer. In current practice, most conventional BCT includes breast-conserving surgical excision of the tumor (lumpectomy, segmentectomy, or quadrantectomy) and whole breast radiotherapy (WBRT), delivered 5 days/week over 5-7 weeks using external beam radiation (EBR). For those at higher risk of recurrence (based on age younger than 50 years, tumor size >2–3 cm, nodal involvement, inadequate tumor-free margins etc.), "boost" radiotherapy narrowly directed to the tumor bed is included in WBRT. In randomized trials, WBRT reduced local (i.e., in-breast) recurrence, and meta-analysis showed it also improved survival compared with breast-conserving surgery alone. Other trials and meta-analysis showed that efficacy of BCT with WBRT is equivalent to mastectomy. The radiation is hypothesized to eliminate residual cancer near the surgical site and treat any undetected multicentric disease. Radiation alone (i.e., without resection) is not recommended in current guidelines to manage early breast cancer.
Breast brachytherapy uses radiation sources placed inside the breast. Interstitial brachytherapy uses multiple sources spaced in 2 or more planes through the breast, with computerized treatment planning to optimize dose homogeneity in the target. The number, spacing, and radiation strength of sources vary with the breast volume to be treated. Balloon brachytherapy uses a single source placed in an inflatable catheter inside the surgical cavity. It treats the cavity plus a surrounding margin of 1–2 cm, with radiation dose declining as a function of distance from the source.
Differences between interstitial and balloon brachytherapy in geometry and target dose homogeneity are of less concern for boost therapy, since the target volume is limited to the tumor bed close to the radiation source. External beam radiation separate from the boost adequately treats breast tissue outside the tumor bed.
However, when brachytherapy is used alone without EBR to the remaining breast, i.e., for partial breast irradiation (PBI), target volume extends beyond the tumor bed, and these differences may have greater impact on outcomes. For PBI, it is thus uncertain whether outcomes of interstitial brachytherapy could be used to reliably predict outcomes of balloon brachytherapy.
Methods other than brachytherapy are also used for APBI, such as several types of external beam therapy. They are not discussed in this policy. This policy separately addresses use of interstitial or balloon brachytherapy as alternatives to external beam radiation therapy in two settings:
This second, more recent application of brachytherapy is based in part on the observation that the majority of ipsilateral breast recurrences after breast-conserving surgery and radiation therapy occur at or near the tumor bed, with only a minority of recurrences located elsewhere in the breast. In addition, in trials of breast-conserving surgery with versus without radiation therapy, most recurrences also occurred near the tumor bed, suggesting that multicentric disease may not be common. Together these findings suggest that tumor bed irratiation may provide the major benefit from whole breast external beam radiation therapy. Also, the extended treatment course for WBRT may be difficult for some patients, for example those living in remote locations, or the elderly or disabled.
Both methods of brachytherapy usually are delivered over a week. This shortened, more convenient treatment course, which has been termed accelerated partial-breast irradiation (APBI), may increase the proportion of patients choosing breast-conserving surgery. On the other hand, APBI may sacrifice some or all of the radiobiological advantage associated with fractionated doses and the slower repair of sublethal radiation damage in tumor versus normal cells.
Various interstitial brachytherapy techniques have been investigated. They differ in the timing of implantation relative to other components of breast-conserving therapy, the radiation dose rate, the loading technique, the number and volumetric distribution of radioactive sources, and the radioisotopes used. Most of the older studies of local boost brachytherapy temporarily implanted needles, wires, or seeds after patients recovered from surgery and completed whole breast radiation therapy. Since the 1990s, investigators have perioperatively implanted hollow needles and catheters that guide placement of the radioactive material. This can be done during the initial lumpectomy if brachytherapy has been selected, or at re-excision if the lumpectomy specimen has positive surgical margins. Intraoperative implantation avoids the need for a separate surgical procedure with anesthesia for brachytherapy.
Both low-dose rate and high-dose rate techniques have been used, with high-dose rate techniques increasing in popularity. In the low-dose rate technique, radioactive seeds are temporarily implanted in hospitalized patients. They deliver radiation therapy continuously over 4 days and then are removed. In the high-dose rate technique, a computer controlled device pushes a highly radioactive isotope into catheters that have been placed into the tumor bed. The patient is exposed to the radiation therapy for a brief period - 5 to 15 minutes - and then the radioactive source is withdrawn. High-dose rate brachytherapy is typically administered to outpatients as 8 fractions given twice daily over 4 days.
A balloon catheter system (the MammositeTM RTS device; Cytyc Corp; Alpharetta, GA ) is also available for brachytherapy. The device is implanted in the lumpectomy cavity during or shortly after breast-conserving surgery. The balloon is inflated with sterile solution of contrast media in saline, and its position is confirmed radiographically using computed tomography. A high-dose rate source of iridium-192 is then centrally positioned within the applicator by a remote afterloader. This system is used to deliver 34 Gy in 10 fractions over 5 days. Thus, balloon brachytherapy uses a single radioactive source that delivers radiation to a spherical or elliptical target volume. Like interstitial brachytherapy, it can be used to deliver local boost or accelerated partial-breast radiation therapy.
In December 2005, the U.S. Food and Drug Administration (FDA) approved the Axxent Electronic Radiotherapy device (Xoft, Inc., Fremont, CA) via 510(k) as substantially equivalent to the MammositeTM and other brachytherapy systems. The Axxent device is a ballon brachytherapy system that uses a disposable, microminiature radiation source to deliver the radiation rather than radioisotopes. Additional brachytherapy devices have received FDA 510(k) marketing clearance, e.g., the SenoRad multi-lumen balloon source applicator for brachytherapy (SenoRX, Inc., Aliso Viejo, CA, May 18, 2007).
POLICYFor Coding Guidelines see the Anesthesia Coding Policy.
Interstitial or balloon brachytherapy may be considered medically necessary for patients undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in patients who are also treated with breast-conserving surgery and whole breast external beam radiotherapy.
Following breast-conserving surgery for early stage breast cancer, accelerated whole breast irradiation may be considered medically necessary for patients who meet the following conditions:
Accelerated whole breast irradiation is considered investigational in all other situations.
Accelerated partial breast irradiation (APBI), using interstitial APBI, balloon APBI, external beam APBI, and intra-operative APBI, is considered investigational.
Accelerated partial breast irradiation using an electronic radiotherapy device is considered investigational.
POLICY EXCEPTIONSFederal 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.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/1997: Approved by the Medical Policy Advisory Committee (MPAC)
2/14/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
11/27/2002: Sources updated
4/15/2004: Policy reviewed, Description revised to be consistent with BCBSA policy # 8.01.13, Sources updated
3/23/2005: Code Reference section updated, CPT 19296 19297, 19298, 77299, 77781, 77782, 77783, 77784 added, CPT 79900 deletion date of 12/31/2004 and Note: "See HCPCS Level II A and Q codes to report provision of therapeutic radiopharmaceuticals" added, CPT code 79999 deleted, ICD-9 diagnosis code 173.9 deleted, ICD-9 diagnosis code 175.8 typo corrected to be 175.9, Note "See HCPCS Level II A and Q codes to report provision of therapeutic radiopharmaceuticals" added to HCPCS section
2/23/06: Policy reviewed, no changes.
8/29/2006: Policy updated.Approved per Medical Policy Advisory Committee (MPAC) 5/18/2006
4/25/2007: Axxiom device information and policy notes addition
5/17/2007: Policy reviewed, description and policy statements updated to include accelerated partial breast irradiation. Policy title changed to "Breast Brachytherapy after Breast-Conserving Surgery, as Boost with Whole Breast Irradiation, or Alone as Accelerated Partial Breast Irradiation (APBI)," previously titled "Breast Brachytherapy"
6/26/2007: Code Reference section updated per quarterly HCPCS and Category III revisions
5/9/2008: Policy reviewed, no changes
7/18/2008: Anesthesia Coding Policy hyperlink added
12/29/2008: Code Reference section updated per the 2009 CPT/HCPCS revisions
08/03/2011: Policy title changed from "Breast Brachytherapy after Breast-Conserving Surgery, as Boost with Whole Breast Irradiation, or Alone as Accelerated Partial Breast Irradiation (APBI)" to "Accelerated Breast Irradiation after Breast-Conserving Surgery for Early Stage Breast Cancer and Breast Brachytherapy as Boost with Whole-Breast Irradiation." Added policy statement to indicate that accelerated whole breast irradiation may be considered medically necessary in specific situations; accelerated partial breast irradiation (APBI), including intraoperative APBI, remains investigational. Clarified policy statement regarding accelerated partial breast irradiation (APBI). FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Removed the following deleted codes from the Code Reference section: 77781,77782,77783, and 77784.
04/02/2013: Verbiage in the medical necessity criteria for accelerated whole breast irradiation was changed from "negative surgical margins" to "technically clear surgical margins." Intent of policy statement unchanged.
09/18/2014: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.13
CODE REFERENCEThis 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.
For Coding Guidelines see the Anesthesia Coding Policy.