Accelerated Breast Irradiation and Brachytherapy Boost After Breast-Conserving Surgery for Early-Stage Breast Cancer

POLICY NUMBER

A.8.01.13

DESCRIPTION

Radiotherapy is the standard of care for patients with breast cancer undergoing breast-conserving surgery because it reduces recurrences and lengthens survival. A conventional radiotherapy regimen consists of approximately 25 treatments of 2 Gray (a measure of absorbed radiation dose) delivered over 5 to 6 weeks. Nonetheless, not all patients undergo radiotherapy following breast-conserving surgery; the duration and logistics of treatment may be barriers for some women. Accelerated radiotherapy approaches have been proposed to make the regimen less burdensome for patients with early-stage breast cancer at a low-risk of recurrence. Accelerated (also called hypofractionated) whole-breast irradiation (AWBI) reduces the number of fractions and the duration of treatment to about 3 weeks. Accelerated partial-breast irradiation (APBI) targets a limited part of the breast in and close to the tumor cavity. By reducing the area irradiated, fewer treatments are needed, and the total treatment takes about one week.

Breast Cancer

Current estimates suggest that 310,720 new cases of breast cancer of any stage will occur in the United States in 2024. Based on adjusted data from 2017 to 2021, among women, the number of new cases is 129.4 per 100,000 women per year and the number of deaths is 19.3 per 100,000 women per year.

Breast Conservation TherapyFor patients diagnosed with stage I or II breast tumors, survival after breast conservation therapy (BCT) is equivalent to survival after mastectomy. BCT is a multi-modality treatment that initially comprises breast-conserving surgery 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 whole-breast irradiation (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 randomized controlled trials have demonstrated that the addition of radiotherapy after breast-conserving surgery reduces recurrences and mortality. In an expanded update of an individual patient data meta-analysis, the Early Breast Cancer Trialists’ Collaborative Group reported that radiotherapy halved the annual recurrence rate after 10 years for women with node-negative disease (n=7,287), from 31.0% for those not receiving radiotherapy to 15.6% for those receiving radiotherapy. 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=1,050), 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 breast-conserving surgery. A potential exception is for older women at low-risk of recurrence. For example, current National Comprehensive Cancer Network guidelines state that women ages 70 years or older may omit radiotherapy if they are hormone receptor-positive, HER2-negative, have T1 tumors, have clinically negative lymph nodes, and plan to take adjuvant endocrine therapy, or if they are 65 years or older with hormone receptor positive and HER2-negative tumors (≤3 cm) and have no lymph node metastases. However, the agreement is not universal.

Controversy continues on the length of follow-up needed to determine whether accelerated partial-breast irradiation (APBI) is equivalent to WBI. 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 non-breast cancers tend to occur 10 or more years after treatment. For accelerated whole-breast irradiation (AWBI), some 10-year data are available. However, for newer approaches, the issue may be resolved by statistical issues rather than biologic ones.

Currently, most patients diagnosed with stage I or II breast cancer are offered a choice between BCT and 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 breast-conserving surgery, and have recommended the use of multidisciplinary management strategies to eliminate known disparities in rural, minority, and uninsured populations.

Approaches to Radiotherapy Following Breast-Conservation Treatment

The goals of cancer radiotherapy are to deliver a high dose of homogeneous radiation (ie, all parts of the tumor cavity receive close to the targeted dose) to the tumor or tumor bed. Areas adjacent to the tumor may be given 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.

The major types of radiotherapy used after breast-conserving surgery are outlined in the table below. They differ by technique, instrumentation, dose delivery, and possible outcomes.

Major Types of Radiotherapy Following Breast-Conserving Surgery^a

APBI: accelerated partial-breast irradiation; EBRT: external-beam radiotherapy; 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.^b Interstitial brachytherapy entails placement of multiple hollow needles and catheters to guide placement of the radioactive material by a remote afterloading device. It is more difficult to perform than other types of brachytherapy and has a steep learning curve.^c Balloon brachytherapy (eg, MammoSite) entails inserting a balloon into the tumor bed, inflating the balloon, confirming its position radiographically, and then using a remote afterloader to irradiate the targeted area. Some brachytherapy systems combine aspects of interstitial and balloon brachytherapy.^d External-beam APBI is delivered in the same way as conventional or accelerated whole-breast radiotherapy but to a smaller area. All 3 external-beam regimens can use 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy.^e Intraoperative APBI is performed during breast-conserving surgery with a single dose of radiation delivered to the exposed tumor bed.

In 2002, the MammoSite® Radiation Therapy System (Proxima Therapeutics), the first device specifically designed for breast brachytherapy, was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. 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 cleared for marketing by the FDA through the 510(k) process. The FDA determined that several devices (eg, Axxent® Electronic Brachytherapy System [Xoft, Strut-Adjusted Volume Implant [SAVI™] Applicator Kit [Biolucent (now Cianna Medical)], Contura® Multi-Lumen Balloon Source Applicator for Brachytherapy [SenoRx], ClearPath™ Adjustable Multi-Catheter Source Applicator [North American Scientific], Intrabeam® System [Carl Zeiss Surgical]) were substantially equivalent to predicate devices. 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 is subject to FDA regulation, it does not fall under the regulatory purview of the U.S. Nuclear Regulatory Commission. In some states, the participation of radiation oncologists in delivering radiation is not required.

POLICY

For 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 individuals who meet the following conditions:

• invasive carcinoma of the breast,

• tumors ≤5 cm in diameter,

• negative lymph nodes,

• technically clear surgical margins, ie, no ink on tumor or invasive carcinoma or ductal carcinoma in situ, and

• age at least 50 years old.

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 individuals undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in those who are also treated with breast-conserving surgery and whole-breast external-beam radiotherapy.

Accelerated partial breast irradiation (APBI), including 3D conformal radiation therapy, intensity modulated radiation therapy, or multicatheter brachytherapy, may be considered medically necessary for individuals who meet the following conditions:

• Age at least 40 years old,

• ER-positive histology,

• grade 1-2 disease,

• tumor ≤2 cm in diameter,

• negative lymph nodes,

• negative surgical margins,

• no known germline pathogenic or likely pathogenic BRCA 1 or BRCA 2 variant.

Noninvasive brachytherapy using AccuBoost for individuals undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in those who are also treated with BCS and whole-breast external-beam radiotherapy is considered investigational.

POLICY EXCEPTIONS

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):

Effective 10/15/2015:Brachytherapy is considered medically necessary for breast cancer if the following criteria are met:

• Initial treatment for stage I or II breast cancer when used as local boost irradiation in individuals treated with breast conserving surgery and whole breast external beam radiation therapy OR

• Accelerated partial breast irradiation (APBI) as an alternative to whole breast irradiation when ALL of the following criteria are met:

  • Age 45 years old or greater; AND

  • Invasive ductal carcinoma or ductal carcinoma in situ; AND

  • Total tumor size (invasive and ductal carcinoma in situ (DCIS)) less than or equal to 3cm in size; AND

  • Negative microscopic surgical margins or excision; AND

  • Sentinel lymph node negative

High Dose Rate Electronic Brachytherapy

High dose rate electronic brachytherapy is considered investigational for breast cancer indications.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Electronic brachytherapy is considered a type of balloon brachytherapy that can be used to deliver accelerated partial-breast irradiation (APBI).

As recommended by the Society of Surgical Oncology and the American Society for Radiation Oncology (ASTRO), technically clear surgical margins can be defined as no ink on tumor of invasive carcinoma or ductal carcinoma in situ.

As part of the clinical input process, ASTRO recommended additional criteria that should be satisfied for individuals undergoing AWBI:

1. Pathologic stage is T1–2N0 and the individual has been treated with breast-conserving surgery.

2. Individual has not been treated with systemic chemotherapy.

3. Within the breast along the central axis, the minimum dose is no less than 93% and maximum dose is no greater than 107% of the prescription dose (±7%) (as calculated with 2-dimensional treatment planning without heterogeneity corrections).

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.

POLICY HISTORY

11/1997: 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.

02/16/2017: Policy title changed from "Accelerated Breast Irradiation after Breast-Conserving Surgery for Early Stage Breast Cancer and Breast Brachytherapy as Boost with Whole-Breast Irradiation" to "Accelerated Breast Irradiation and Brachytherapy Boost After Breast-Conserving Surgery for Early-Stage Breast Cancer." Policy description updated regarding radiotherapy. Medically necessary policy statement criteria for AWBI updated with the following: 1) added "tumors greater than 5 cm in diameter" and "age at least 50 years old" as indications; 2) removed "Exclude disease involving the margins of excision; tumors >5 cm in diameter; breast width >25 cm at posterior border of medial and lateral tangential beams;" 3) clarified meaning of "technically clear surgical margins." Policy guidelines updated regarding additional criteria recommended by ASTRO for patients undergoing AWBI. Code Reference section updated to remove the following deleted CPT codes: 0182T, 77776, 77777, 77785, 77786, and 77787.

12/20/2017: Code Reference section updated to add new 2018 CPT code 19294.

05/23/2018: Coding policy links updated in the Policy and Code Reference sections.

07/26/2018: Medically necessary criteria regarding accelerated whole-breast irradiation updated to make the following correction: "tumors greater than 5 cm" changed to "tumors ≤5 cm." Policy Guidelines updated to change "accelerated whole-breast irradiation" to "accelerated partial-breast irradiation" in the statement regarding electronic brachytherapy.

09/05/2018: Policy description updated regarding new breast cancer data. Policy statements unchanged.

09/16/2019: Policy description updated regarding noninvasive breast brachytherapy. Policy statements unchanged.

09/30/2019: Code Reference section updated to add new ICD-10 procedure codes DM10BB1 and DM11BB1, effective 10/01/2019.

09/21/2020: Policy description updated regarding breast cancer data and to remove information regarding AWBI, APBI, brachytherapy boost with WBI, and noninvasive breast brachytherapy. Policy statements unchanged. Code Reference section updated to add new ICD-10 procedure codes DM10B6Z and DM11B6Z, effective 10/01/2020.

12/02/2021: Policy description updated regarding 2021 data for breast cancer cases and major types of radiotherapy following breast-conserving surgery. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Removed deleted ICD-10 procedure codes 0HHTX1Z, 0HHUX1Z, and 0HHVX1Z.

08/11/2022: Policy description updated regarding new data for breast cancer. Policy statements updated with minor changes.

08/10/2023: Policy description updated regarding new data for breast cancer. Policy statements and Policy Guidelines updated to change "patients" to "individuals."

08/14/2024: Policy description updated regarding breast cancer and breast conservation therapy. Policy statements unchanged.

08/25/2025: Policy reviewed. Policy statement regarding accelerated partial breast irradiation changed from investigational to medically necessary stating that accelerated partial breast irradiation (APBI), including 3D conformal radiation therapy, intensity modulated radiation therapy, or multicatheter brachytherapy, may be considered medically necessary for individuals who meet the listed conditions. It previously stated: Accelerated partial-breast irradiation (APBI), using interstitial APBI, balloon APBI, intraoperative APBI, external-beam APBI, and noninvasive brachytherapy using AccuBoost, is considered investigational.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes C50.A0, C50.A1, and C50.A2.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.13

CODE REFERENCE

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.

For Coding Guidelines see the Anesthesia Coding Policy .

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.