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Breast Conservation Therapy
For patients diagnosed with stage 1 or 2 breast tumors, survival after breast-conservation therapy (BCT) is equivalent to survival after mastectomy. BCT is a multi-modality treatment that initially comprised BCS to excise the tumor with adequate margins, followed by whole-breast external-beam radiotherapy (EBRT) administered as 5 daily fractions per week over 5 to 6 weeks. Local boost irradiation to the tumor bed often is added to WBI to provide a higher dose of radiation at the site where recurrence most frequently occurs. For some patients, BCT also includes axillary lymph node dissection, sentinel lymph node biopsy, or irradiation of the axilla. A number of RCTs have demonstrated that the addition of radiotherapy after BCS reduces recurrences and mortality. In an expanded update of an individual-level meta-analysis, the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) reported that radiotherapy halved the annual recurrence rate after 10 years for women with node-negative disease (N=7287), from 31.0% for those not receiving radiotherapy to 15.6% for those receiving it. It also reduced the 15-year risk of breast cancer death from 20.5% to 17.2% (p=0.005). For women with node-positive disease (n=1050), radiotherapy reduced the 1-year recurrence risk from 26.0% to 5.1%. Radiotherapy also reduced the 15- year risk of breast cancer death from 51.3% to 42.8% (p=0.01).
Consequently, radiotherapy is generally recommended following BCS. A potential exception is for older women at low risk of recurrence. For example, current National Comprehensive Cancer Network guidelines state that women aged 70 or older may omit radiotherapy if they have estrogen-receptor positive, T1 tumors, clinically negative lymph nodes, and plans to take adjuvant endocrine therapy. However, a 2012 study has raised questions about this recommendation.
Controversy continues on the length of follow-up needed to determine whether APBI is equivalent to WBI (for more information, see the 2013 TEC Assessment on Accelerated Radiotherapy After Breast- Conserving Surgery for Early Stage Breast Cancer). Because recurrences are relatively rare among low risk early breast cancer patients, it may take considerable time for enough recurrences to occur to provide sufficient power for comparing recurrence rates across radiotherapy approaches. Additionally, radiation-induced adverse cardiovascular effects and radiation-induced nonbreast cancers tend to occur 10 or more years after treatment. For AWBI, some 10-year data are available. However, for newer approaches, the issue may be resolved by statistical issues rather than biological ones. For example, in the large NSABP-39/RTOG 0413 trial comparing WBI and APBI, enrollment has reached the revised target of 4216. Trial duration (barring early termination) is determined by the occurrence of a prespecified number (175) of in-breast recurrences. The researchers expect that reaching that number of recurrences will take approximately 10 years.
Currently, most patients diagnosed with stage 1 or 2 breast cancer are offered a choice of BCT or modified radical mastectomy, but BCT is selected less often than expected. Studies have shown that those living farthest from treatment facilities are least likely to select BCT instead of mastectomy and most likely to forgo radiotherapy after BCS. A study using data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results tumor registries from 1992 to 2002 examined how many women with early stage (1 or 2) breast cancer received radiotherapy within 4 months following BCS. After adjusting for age, they found that, in 2002, 30.8% of Caucasian women and 44.7% of African-American women had not received radiotherapy. Furthermore, these rates had increased from 24.7% for Caucasian and 34.0% for African-American women in 1992.
Given that duration and logistics appear to be barriers to completion of treatment, there has been interest in developing shorter radiotherapy regimens. Two approaches have been explored.
The first method is to provide the same dose to the whole breast in a shorter time by increasing the dose provided per treatment (hypofractionation). This approach was initially avoided out of concern that increasing doses might induce more severe adverse events from radiation exposure, thus tipping the balance between benefits and harms. More recent research, some of which is highlighted below, has allayed most of these concerns. AWBI has been adopted widely in Canada and Europe.
The second approach to reducing radiotherapy treatment time is APBI. It differs from conventional WBI in several ways. First, the radiation only targets the segment of the breast surrounding the area where the tumor was removed, rather than the entire breast. This approach was based in part on the finding that recurrences are more likely to occur close to the tumor site rather than elsewhere in the breast. Second, the duration of treatment is 4 to 5 days (or 1 day with intraoperative radiotherapy) rather than 5 to 6 weeks, because radiation is delivered to the tumor bed in fewer fractions at larger doses per fraction.
The major types of radiotherapy used after BCS are outlined in the table below. They differ in their techniques, instrumentation, dose delivery, and possibly in their outcomes.
Major Types of Radiotherapy Following Breast-Conserving Surgery (a)
APBI: accelerated partial-breast irradiation; EBRT: external-beam radiotherapy; RCT: randomized controlled trial; WBI: whole-breast irradiation.
(a) Noninvasive breast brachytherapy using Accuboost® has been described by the manufacturer as capable of delivering APBI, but no studies on this indication were found.
To appreciate the differences among radiotherapy techniques, it is useful to understand attributes of radiation delivery. The goals of cancer radiotherapy are to provide the tumor or tumor bed with a high dose of homogeneous radiation (ie, all parts of the tumor cavity receive close to the targeted dose). Areas adjacent to the tumor may be treated with a lower dose of radiation (eg, with WBI) to treat any unobserved cancerous lesions. Radiation outside the treatment area should be minimal or nonexistent. The goal is to target the tumor or adjacent areas at risk of harboring unseen cancer with an optimum dose, while avoiding healthy tissues.
Brachytherapy Boost with WBI
Brachytherapy also can be used as an alternative to EBRT to deliver boost radiotherapy combined with whole-breast EBRT. Most studies of local boost brachytherapy use temporarily implanted needles, wires, or seeds after patients have recovered from surgery and completed whole-breast radiotherapy.
The MammoSite® Radiation Therapy System (Proxima Therapeutics; Alpharetta, GA), the first device specifically designed for breast brachytherapy, was FDA-cleared under a 510(k) premarket notification in 2002. Its intended use is ‘‘to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.’’
Since 2002, several other devices for breast brachytherapy have been FDA-cleared for marketing through the 510(k) process as substantially equivalent to predicate devices (eg, Axxent® Electronic Brachytherapy System [Xoft; San Jose, CA], Strut-Adjusted Volume Implant [SAVI™] Applicator Kit [Biolucent (now Cianna Medical); Aliso Viejo, CA], Contura® Multi-Lumen Balloon Source Applicator for Brachytherapy [SenoRx; Aliso Viejo, CA], ClearPath™ Adjustable Multi-Catheter Source Applicator [North American Scientific; Chatsworth, CA], Intrabeam® System [Carl Zeiss Surgical, GmbH; Oberkochen, Germany]). Each includes an FDA-required warning that the safety and effectiveness of the device “as a replacement for whole-breast irradiation in the treatment of breast cancer has not been established.”
Although the Intrabeam® System (discussed further below; see Intraoperative Brachytherapy subsection) is subject to FDA regulation, it does not fall under the regulatory purview of the U.S. Nuclear Regulatory Commission. In some states, participation of radiation oncologists in delivering radiation is not required.
POLICYFor Coding Guidelines see the Anesthesia Coding Policy.
When using radiotherapy after breast-conserving surgery (BCS) for early stage breast cancer:
Accelerated whole-breast irradiation (AWBI) may be considered medically necessary for patients who meet the following conditions:
Accelerated whole breast irradiation is considered investigational in all other situations involving treatment of early stage breast cancer after BCS.
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.
Accelerated partial-breast irradiation (APBI), using interstitial APBI, balloon APBI, external-beam APBI, noninvasive brachytherapy using Accuboost®, and intra-operative APBI, is considered investigational.
Noninvasive brachytherapy using Accuboost® for patients undergoing initial treatment for stage 1 or 2 breast cancer when used as local boost irradiation in patients who are also treated with BCS and whole-breast external-beam radiotherapy is considered investigational.
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.
State Health Plan (State and School Employees):
High Dose Rate Electronic Brachytherapy
High dose rate electronic brachytherapy is considered investigational for breast cancer indications.
Electronic brachytherapy is considered a type of balloon brachytherapy that can be used to deliver APBI.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
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.
06/01/2015: Policy description revised. For clarification, first policy statement revised to change "Following breast-conserving surgery" to "When using radiotherapy after breast-conserving surgery (BCS)." Medically necessary patient criteria for accelerated whole breast irradiation updated to change "Exclude invasive disease or ductal carcinoma in situ involving the margins of excision;" to "Exclude disease involving the margins of excision." Revised first investigational statement to state that AWBI is considered investigational in all other situations involving treatment of early stage breast cancer after BCS. Added noninvasive brachytherapy using Accuboost® as investigational for APBI. Removed the following statement: Accelerated partial breast irradiation using an electronic radiotherapy device is considered investigational. Added statement that noninvasive brachytherapy using Accuboost® for patients undergoing initial treatment for stage 1 or 2 breast cancer when used as local boost irradiation in patients who are also treated with BCS and whole-breast external-beam radiotherapy is considered investigational. Policy guidelines updated regarding electronic brachytherapy.
08/21/2015: Code Reference section updated to add ICD-10 codes and CPT codes 77316,77317, and 77318. Removed ICD-9 procedure code 85.0.
10/21/2015: Policy Exceptions section updated to add brachytherapy criteria for State Health Plan members.
12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to remove deleted CPT codes 77326, 77327, and 77328. Added new 2016 CPT codes 0395T, 77770, 77771, 77772, and 77799. Revised code description for CPT code 77778 with an effective date of 01/01/2016.
05/25/2016: Policy number A.8.01.13 added.
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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.