Brachytherapy is a form of radiation treatment used to stop the growth of cancer cells and involves placing radioactive material directly into or near a tumor, which allows the tumor to receive a dose of radiation while reducing the exposure to surrounding tissue. Treatment time varies, depending upon the method of treatment, the type of radioactive material, and the cancer site.

Note: Please see the following documents for additional information: 

• RAD.00015 Proton Beam Radiation Therapy
• RAD.00017 Intraoperative Radiation Therapy
• RAD.00041 Intensity Modulated Radiation Therapy (IMRT)
• RAD.00056 Intraocular Epiretinal Brachytherapy

Medically Necessary:

Brachytherapy is considered medically necessary for any of the following (1-10) indications:

1. Breast cancer
   1. As an adjunctive "boost" to the tumor bed in individuals who have received whole breast radiation therapy after prior breast conserving surgery (i.e., lumpectomy); or
   2. As a technique of partial breast irradiation (e.g., multicatheter interstitial or balloon) as an alternative to whole breast irradiation in individuals who meet ALL of the following criteria:
      1. Tumor removed with breast conserving surgery (i.e., lumpectomy) with resected margins free of tumor; and
      2. Stage 0, I or II disease (Stage II tumors must be less than or equal to 3 cm in diameter); and
      3. Node negative; and
      4. Individual's age is greater than or equal to 50 years.
2. Cholangiocarcinoma – as secondary or adjuvant treatment for individuals who meet any of the following criteria:
   1. Resected with positive margin (R1); or
   2. Resected gross residual disease (R2); or
   3. Carcinoma in situ at margin; or
   4. Positive regional nodes.
3. Esophageal cancer, to treat unresectable tumors and as palliative treatment for obstructing tumors.
4. Head and neck cancers- including lip, tongue, floor of mouth, tonsil, pharynx, nasopharynx, sinuses and neck cancers.
5. Lung cancer:
   1. Endobronchial treatment of primary bronchial tumors that cannot be excised surgically or cannot be treated by external beam radiation therapy (EBRT); or
   2. Palliative treatment for obstructing primary or metastatic endobronchial tumors.
6. Ocular brachytherapy for choroidal melanoma and retinoblastoma when ALL of the following criteria are met:
   1. Apical height of the tumor is 2.5 to 10.0 mm; and
   2. Maximum basal tumor diameter of 18.0 mm or less; and
   3. For choroidal melanoma, unilateral disease has been confirmed.
7. Penile cancer when the following criteria are met:
   1. Squamous cell carcinoma confined to the glans or prepuce; and
   2. Tumor size is less than or equal to 4 cm; and
   3. Inguinal lymph nodes are negative (N0) or are unable to be assessed (NX).
8. Prostate cancer that is clinically localized when one of the following criteria are met:
   1. Individual with low-risk of recurrence which is defined as tumor stage T1-T2a, low Gleason score ([GS] less than or equal to 6), serum PSA level below 10 ng/mL, and greater than or equal to 10 year expected survival and treatment involves:
      1. Permanent low dose rate [LDR] brachytherapy as monotherapy.
   2. Individual with intermediate-risk of recurrence which is defined as tumor stage any T2b to T2c, or GS of 7, or PSA value of 10-20 ng/mL, and greater than or equal to 10 year expected survival and treatment involves one of the following:
      1. LDR brachytherapy in combination with EBRT; or
      2. HDR brachytherapy in combination with EBRT.
   3. Individual with high-risk of recurrence which is defined as stage T3a or Gleason score 8-10, or PSA level greater than 20 ng/mL after definitive therapy and treatment involves one of the following:
      1. LDR brachytherapy in combination with EBRT; or
      2. HDR brachytherapy in combination with EBRT.
9. Soft tissue sarcoma with positive margins or margins less than 5mm.
10. Uterine, cervical, endometrial or vulvar/vaginal cancer.

Investigational and Not Medically Necessary:

Brachytherapy is considered investigational and not medically necessary in individuals not meeting the above criteria.

Endobronchial brachytherapy is considered investigational and not medically necessary as a 'boost' for EBRT. 

The use of high dose rate electronic brachytherapy is considered investigational and not medically necessary for all indications, including but not limited to the treatment of breast cancer.

Breast Cancer
Breast brachytherapy as a "boost" to whole breast irradiation is an accepted technique for women who have undergone breast conserving surgery. Partial breast irradiation using breast brachytherapy after breast conserving surgery is now emerging as an alternative to whole breast irradiation. This option is based on the observation that for appropriately selected individuals, irradiation of the whole breast is not necessary. For example, randomized trials comparing lumpectomy alone versus lumpectomy followed by whole breast irradiation do not show a significant difference in the rate of tumor recurrence outside of the tumor bed. These findings suggest that the benefit of irradiation in general is related to the decreased risk of tumor recurrence in the tumor bed alone, the tissue at highest risk of a local recurrence. A number of clinical studies of partial breast irradiation in conjunction with lumpectomy demonstrate five year local recurrence rates of 0.0%-4.7%, which is comparable to external beam radiation (Benitez, 2004; Keisch, 2003; King, 2000; Polgar, 2002; Polgar, 2007; Vicini, 2003). Partial breast irradiation using brachytherapy is also associated with good to excellent cosmetic outcomes with minimal treatment times, compared to the 6-7 week course of whole breast irradiation. 

Methods of providing partial breast irradiation include multiple interstitial catheters, or devices placed directly into the lumpectomy cavity and afterloaded with radioactive material. Examples of devices include Mammosite^® RTS (Hologic Inc., Marlborough, MA), SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy (SenoRx, Irvine, CA) and Savi™ (Cianna, Aliso Viejo, CA).

Currently, there are ongoing randomized phase III studies of accelerated partial breast irradiation (APBI) with brachytherapy to confirm the results of initial phase II studies suggesting that the local control rates of partial and whole breast irradiation (WBI) are equivalent (University of Wisconsin, 2005). However, at the same time, the American Brachytherapy Society and the American Society of Breast Surgeons have published recommendations regarding selection criteria for breast brachytherapy, indicating the general acceptance of brachytherapy as an alternative to whole breast irradiation (American Society of Breast Surgeons, 2008; Arthur, 2003). This position indicates that partial breast irradiation with breast brachytherapy is considered medical necessary in certain individuals and reflects the general acceptance of these techniques among the medical community. The selection criteria in this document are similar to the selection criteria included in the large randomized study of breast brachytherapy sponsored by the National Cancer Institute (University of Wisconsin, 2005) and recommended inclusion criteria from the American Brachytherapy Society Breast Brachytherapy Task Group (2007).

In 2010, recommendations for selection criteria for accelerated partial breast irradiation were provided by the Groupe Europeen de Curietherapie-European Society for Therapeutic Radiology and Oncology ([GEC-ESTRO], Polgar, 2010). The reviewers noted conflicting results for partial breast irradiation for women between ages 41 and 50 years, and further prospective trials are needed to determine the safety and efficacy for these women. Therefore, the authors recommend women below the age of 40 years should not be treated with accelerated partial breast irradiation. In addition, based on published data and the high risk of fat necrosis with large tumors (greater than 3 cm) and the large volume of implants required to adequately treat large tumors, the authors do not recommend APBI therapy for large tumors (T3 or T4). Polgar and colleagues acknowledged long-term data from prospective studies are needed to support the use of APBI for low-risk ductal carcinoma insitu (DCIS) as many of the published trials had excluded individuals with DCIS. Positive lymph node status portends a higher risk of local recurrence and development of distant metastases. Thus, the authors noted, "it seems to be safe not to treat patients with involved axillary lymph nodes with APBI outside the context of prospective clinical trials."

Nelson and colleagues (2009) reported 4-year data from an ongoing registry trial collecting data on 1,440 individuals with 1,449 breasts treated with the Mammosite device. Invasive cancers with a median tumor size of 10 mm were treated in 1255 breasts, and 194 breasts had ductal carcinoma with a median size of 8 mm. The median follow-up for the entire cohort was 36.1 months, while the median follow-up was 44.3 months for the first 400 treated breasts. Ipsilateral breast tumor recurrence (IBTR) developed in 28 individuals (1.9%) with a 3-year actuarial rate of 2.15%. Recurrence occurred in 10 individuals. The 3-year actuarial rate for true recurrence/marginal miss was 0.72%, elsewhere recurrence was 1.44% and axillary recurrence was 0.36%. The overall survival rate for the entire group was 95.6%. In the cohort of the initial 400 individuals with longer median follow-up, the 4-year actuarial rate of IBTR was 2.65%. The 4-year actuarial rate for true recurrence/marginal miss was 0.33%, elsewhere recurrence was 2.32% and axillary recurrence was 0.6%. The 4-year actuarial overall survival rate was 94%. Description of appearances reported as good or excellent were 95% at 12 months and 91% at 48 months. Adverse events included seromas 26.8%, with most seromas occurring during the first 12 months and more frequently with the open implant placement. Infectious complications occurred in 11.5% of participants. Fat necrosis was reported in 2% of individuals. The authors noted the IBTR rates were comparable to 4% in-breast failure rate reported in a group of individuals treated with multicatheter brachytherapy.

A consensus statement about accelerated partial breast irradiation (APBI) outside of the clinical trial context, was developed by a Task Force for the American Society for Radiation Oncology ([ASTRO]; Smith, 2009). The published literature was reviewed and 4 randomized trials and 38 prospective single-arm studies were analyzed. The data was insufficient to identify a subset of individuals at very low-risk of occult disease. Therefore, the Task Force used the available evidence, inclusion criteria and the specific clinical characteristics of participants in the prospective trials to determine the selection criteria used in the "suitable" group. The "cautionary" group included study participants when the Task Force had uncertainty about the appropriateness of APBI. The "unsuitable" group was based on the paucity of clinical trial evidence to support the use of APBI. Factors included in the "suitable" group are T1 tumors (less than or equal to 2 cm); negative tumor margins; and node status of pN0 (i^-, i⁺). The "cautionary" group included T0 or T2 tumors (2.1 to 3.0 cm) and close (less than 2 mm) tumor margins. The factors included in the "unsuitable" group were T3 or T4 tumors (greater than 3 cm); positive tumor margins and node status of pN1 – pN3. The Task Group was not able to determine the optimal technique for APBI delivery as there is insufficient clinical and dosimeteric data. Additionally, the long-term effectiveness data was available for interstitial brachytherapy (average 5.4 years), but the average follow-up for balloon brachytherapy was 2.3 years and intraoperative brachytherapy was 2.1 years. There are ongoing clinical trials comparing the safety and effectiveness of APBI and whole breast irradiation.

The National Comprehensive Cancer Network^® (NCCN, 2011) guideline lists brachytherapy treatment for breast cancer as a "boost" with whole breast radiation therapy and as a method to provide APBI. The NCCN recommends treatment with APBI to be provided in a prospective clinical trial when possible. If APBI is provided off trial, then brachytherapy is recommended for those with a low risk of recurrence.

Cholangiocarcinoma
Cholangiocarcinoma (intrahepatic and extraphepatic) is a rare malignancy that develops from the epithelial cells lining the bile ducts and accounts for approximately 3% of all gastrointestinal cancers (Shinohara, 2009). In a retrospective review of the data of individuals with cholangiocarcinoma in the Surveillance, Epidemiology and End Results (SEER) database, Shinohara and colleagues (2009) reviewed a total of 9,704 individuals with extrahepatic (EHC) or intrahepatic (IHC) carcinomas. Forty-three of theses individuals received brachytherapy alone while 150 individuals received a combination treatment of external-beam radiation therapy (EBRT) and brachytherapy. A comparison group of 6859 individuals were not treated with any radiation therapy. Median survival was significantly longer at 11 months for those treated with brachytherapy (95% confidence interval [CI], 9-13 months) versus 4 months (P< 0.0001) for those who did not receive any radiation therapy. According to the National Cancer Institute (2010), extrahepatic bile duct cancer is curable by surgery in less than 10% of all cases. Palliative measures with brachytherapy or stents allow biliary drainage and improved survival. In addition, specialty consensus opinion recommends the use of brachytherapy as a treatment of cholangiocarcinoma.

Esophageal cancer
Frobe and colleagues (2009) reported on a series of 30 individuals treated with intraluminal high-dose rate brachtherapy (ILHDR BT) as palliative therapy for squamous cell carcinoma of the esophagus. Twenty-nine participants received two sessions of ILHDR BT within a week, and one person received one treatment. Eight individuals received additional EBRT. Two individuals required dilations and one had a stent placement for worsening dysphagia. Overall quality of life (QOL) was assessed, and a statistically significant improvement was noted for dysphagia (P less than 0.006). Other improvements were also noted in ability to eat (P = 0.02), sleeping (P = 0.032) and social life (P = 0.002). One person died from distant metastasis and a 165 day median overall survival (95% CI 128-195 days) from death of any cause was noted. The authors noted the subset of eight individuals who received combined ILHDRBT and EBRT was too small to show a statistical difference between the treatments.

In a prospective randomized trial Guo (2008) compared intraluminal brachytherapy stents with iodine 125 (I125) versus conventional self- expandable covered stents in individuals with advanced esophageal cancer. Although all 53 participants had significant improvement of dysphagia at one month, the 27 individuals in the treatment group had improved significantly better than the control group at two months (P < 0.05). Adverse events included hemorrhage in both groups with a combined occurrence rate of 30% (16 individuals). There was a significant difference (P < 0.001) in the median and mean survival times in the irradiation stent cohort compared to the control group. The irradiation stent group had a median survival of 7 months (95% CI) with a mean of 8.3 months, versus a median survival of 4 months (CI 95% CI) in the control group, with a mean of 3.5 months.

Head and Neck Carcinoma
Brachytherapy is usually provided in conjunction with moderate doses of external beam radiation therapy (EBRT). A literature review and expert panel consensus resulted in the American Brachytherapy Society (Nag, 2001) recommendation to include high dose rate (HDR) brachytherapy as a treatment option for head and neck carcinomas based on the extrapolation of low-dose rate (LDR) brachytherapy. The authors recognized the paucity of literature for HDR brachytherapy use in head and neck cancers as well as the concerns of radiation safety. LDR brachytherapy has been used for head and neck cancers, including lip, tongue, floor of mouth, tonsil, pharynx, nasopharynx, sinuses and neck. The panel was unable to come to unanimous consensus on the sequencing of EBRT and brachytherapy.

Combined practice guidelines (Erickson, 2011) by the American Society for Radiation Oncology (ASTRO) and American College of Radiology (ACR) in cooperation with the American Brachytherapy Society (ABS) include recommendations for high-dose-rate brachytherapy treatment for head and neck cancers. The guidelines note the same "operative techniques may be used for HDR brachytherapy" as LDR brachytherapy.

Lung Tumors
There are two categories of individuals who may be considered candidates for endobronchial brachytherapy.

Primary endobronchial treatment
Candidates for primary treatment have principally included individuals with early-stage endobronchial tumors who are not otherwise considered candidates for surgical resection or external beam radiation due to co-morbidities or location of the tumor. Results have predominantly been reported in case series where complete response rates in the range of 60%–80% have been noted (Perol, 1997; Raben, 1997). The indications and outcomes of brachytherapy as primary therapy are comparable to those reported for photodynamic therapy.

Palliative endobronchial treatment
Many individuals with non-small cell carcinoma are initially treated with external beam radiation therapy but ultimately experience local recurrence. Unfortunately, many individuals are not candidates for further external beam radiation therapy due to the limited tolerance of normal tissue. Therefore, endobronchial brachytherapy has been explored as an alternative. Resolution of symptoms short-term, such as hemoptysis, cough, dyspnea and resolution of obstructive atelectasis or pneumonitis are appropriate for palliative therapy. In a summary of studies of palliative endobronchial brachytherapy between 1985 and 1994, Villanueva and colleagues reported effective palliation in 60%–100% of individuals (Villanueva, 1995). The median survival of these individuals is typically less than 9 months. No randomized controlled study has shown that endobronchial brachytherapy improves survival rate.

There have been no comparative trials of palliative or primary treatment comparing different methods of local control (i.e., endobronchial brachytherapy, photodynamic therapy, laser therapy, microwave or cryotherapy) to determine if any one method is superior to another in different subsets of individuals or if combinations of therapy provide improved results. The choice of modality may depend on local availability and expertise.

Brachytherapy has also been investigated as a technique to deliver a "boost" to individuals undergoing primary EBRT. External beam radiation therapy is typically the primary treatment for the majority of individuals with non-small cell lung carcinoma (NSCLC) who usually present with surgically unresectable disease and NSCLC is unresponsive to chemotherapy. Huber and colleagues (1997) reported on the results of a trial that randomized 98 individuals with inoperable lung cancer to receive either external beam radiotherapy or endobronchial brachytherapy. While the brachytherapy group experienced a longer period of local control, there was no significant difference in survival between the two groups.

Ocular Cancers
Choroidal Melanoma
Choroidal melanoma is the most common type of primary intraocular melanoma. Information to determine treatment plans includes the stage of the disease, tumor size and proximity to other eye structures. Enucleation is performed for small and large tumors, primarily when vision loss is anticipated as a result of other treatment modalities (American Cancer Society, 2009).

The Collaborative Ocular Melanoma Study Group (COMS, 2006) studied enucleation versus brachytherapy in a multicenter randomized trial enrolling 1,317 individuals. Within the first 5 years, 252 participants died with 19% (127) in the enucleation group versus 19% (125) in the brachytherapy group. At 5 years, there was no significant difference in the mortality rate from all causes with 19% in the enucleation cohort compared to 18% in the brachytherapy group. Data on 1,263 of the participants was assessable for the first 5 years and 799 participants at 10 years. During the 12 years after enrollment, the cumulative rates of death by histopathologically confirmed metastasis and other causes were similar. Pooled data on all-cause mortality at 5 years was 19% and 35% at 10 years. Histopathologically confirmed melanoma metastasis did not differ in cumulative rates of death by treatment assignment. Pooled data on histopathologically confirmed mortality was 10% and 17% at 5- and 10-years, respectively. Forty-five percent of all individuals treated by either brachytherapy or enucleation were alive and disease free at the 12 year follow-up.

Melia and Colleagues (2006) reported results of a 5-year quality of life study on 209 participants randomized to either enucleation or brachytherapy treatment. Visual function (i.e., driving, peripheral vision) was reported to be significantly better in the brachytherapy cohort compared to the enucleation group for up to 2 years following treatment. In both groups, anxiety levels were decreased significantly after treatment, but later resolution of anxiety was reported less in the brachytherapy group. The authors suggested the ongoing anxiety in the brachytherapy group might have been a result of uncertainty with unknown survival benefits between the treatment modalities.

Retinoblastoma
According to the NCI, retinoblastoma is a relatively uncommon cancer affecting the eye in 3% of cancers occurring in children less than 15 years old, and 95% of the cases occur before the age of 5 years. A heritable form of retinoblastoma may present as unilateral or bilateral disease. Retinoblastoma is frequently confined to the eye in 90% of the cases, and can be successfully treated with local therapies. The goals for treatment include preservation of the eye, prevention of blindness and improved overall survival and quality of life. Treatment options include enucleation, external beam radiation, photocoagulation, chemotherapy and brachytherapy. A nonrandomized, assignment trial is currently recruiting participants. 

In a retrospective analysis, Shields and colleagues (2006) reviewed the records of children treated with plaque radiotherapy (I¹²⁵) for retinoblastoma recurring after prior therapy with chemoreduction (CRD) or CRD with external beam radiation therapy (EBRT). The cohort consisted of 64 children with 84 retinoblastomas in 71 eyes. Mean tumor size was 9 mm in basal dimension (range 3 -18 mm) and 4 mm in thickness (range 1 – 8 mm). At a median follow-up of 4 years, plaque brachytherapy provided complete tumor control for 81 (95%) tumors. Recurrence occurred at a mean of 6 months in 3 eyes. Complications at 5-years by Kaplan-Meier analysis included transient mild vitreous hemorrhage (54%), cataract (43%), nonproliferative maculopathy (24%), proliferative retinopathy (19%), papillopathy (16%), iris neovascularization (8%) and glaucoma (4%).

Penile Cancer
According to the National Cancer Institute (NCI) penile cancer is rare in developed countries. Treatment includes surgical excision of the lesion which may include a partial or total penectomy. De Crevoisier (2009) and colleagues treated 144 inguinal node-negative men with squamous cell carcinoma (SCC) of the penile glans or prepuce with brachytherapy. The median tumor diameter was 20 mm (range 2-50). Needles loaded with Iridium-192 lines were inserted into the penis at equal distances with a medium number of six lines placed. Participants were assessed every 4 months for 2 years and then every 6 months thereafter. The median follow-up was 5.7 years. Local recurrence occurred in 21(17%) of the participants with a median of 1.8 years to penile recurrence. Salvage treatment included partial penectomy (n=12), total penectomy (n=6), repeat brachytherapy for 2 individuals, and 1 participant had local excision. Complications included a 10-year stenosis rate of 29% and a 10-year painful ulceration rate of 26%. The 10-year cancer-specific and overall survival rates were 92% (CI 95% 87-97) and 65%, (CI 95%, 56-74) respectively. The 10-year recurrence-free rate was 78% (CI 95%, 70-86) and the 10-year probability for avoidance of penile surgery related to complications or recurrence was 72% (CI 95%, 62-82). After multivariate analysis, the authors noted the tumor diameter greater than 4 cm had a significantly increased risk of recurrence (p= 0.02).

Prostate Cancer
Treatment options for clinically localized prostate cancer include surgery, brachytherapy and watchful waiting. Randomized studies of these options have been very difficult to conduct due to prolonged natural history of prostate cancer and the many variables of individual prostate cancer, such as levels of prostate specific antigen (PSA), tumor size and tumor grade (i.e., Gleason score). However, LDR brachytherapy using permanently implanted seeds is a well accepted treatment option for clinically localized prostate cancer. The American College of Radiology (ACR) and the American Society for Therapeutic Radiation and Oncology (ASTRO) practice guideline (2010) for transperineal LDR brachytherapy notes individuals "with a significant risk of disease outside of the implant volume may benefit from the addition of external beam irradiation and/or total hormonal ablation."

Long-term outcomes on 1,656 consecutive participants treated with permanent interstitial brachytherapy at a single institution had a median follow-up of 7 years. At 12 years, results for the entire cohort were 95.6% biochemical PFS (bPFS), 98.2% cause-specific survival (CSS), and OS was 72.6%. Stratification of cohorts by low-risk cohort included 575 individuals, the intermediate-risk group included 608 men and 473 individuals were high-risk. Analysis based on low-, intermediate- and high-risk disease, respectively at 12 years were bPFS 98.6%, 96.5% and 90.5%. CSS was 99.8%, 99.3%, and 95.2% and OS was 77.5%, 71.1%, and 69.2% for men with low-, intermediate- and high-risk disease, respectively. The authors concluded permanent interstitial brachytherapy had excellent long-term outcomes in all risk categories (Taira, 2010).

HDR or temporary brachytherapy is a treatment option, which has been primarily investigated as an adjunct to external beam radiation therapy (i.e., three dimensional conformal radiation therapy [3D-CRT], intensity modulated radiation therapy [IMRT], and image guided radiation therapy [IGRT]) in individuals with poor prognostic factors. Several large case series have been reported. Martinez and colleagues (2003) reported on the outcomes of a series of 207 individuals treated between 1991 and 2000. All participants had poor prognostic factors, which included tumor stage T2B, a Gleason score of 7 or a PSA greater than 10 nl/mL. External beam radiation therapy was alternated with HDR radiation therapy as a boost. At a mean follow-up of 4.7 years, overall biochemical control rate (as indicated by PSA monitoring) was 74%, but was 85% if one poor prognostic factor was present, 75% if 2 factors were present, and 50% if all 3 factors were present. Late toxicity was minimal. The authors suggest that these results are similar to or better than other treatment alternatives for prostate cancer with poor prognostic features. In another analysis, the authors performed a matched-pair analysis of HDR brachytherapy boost versus EBRT alone (Kestin, 2000). A total of 161 participants received an HDR boost; they were randomly matched with a unique individual who received EBRT alone. Participants were matched according to PSA level, Gleason score, T stage, and duration of follow-up. Those who received the HDR boost reported a 5-year biochemical control rate of 67% compared to 44% in those receiving EBRT alone. In a review article, Vicini and colleagues (2003) summarized the experience reported in 8 other case series of locally advanced prostate cancer totaling just over 1,000 participants. The biochemical control rate ranged from 74% to 97% with median follow-ups ranging from 11 to 74 months. An international group of investigators reported on the use of HDR as an adjunct to EBRT with or without androgen-deprivation therapy in a case series of 611 participants (Galale, 2004). A total of 209 individuals were treated at William Beaumont Hospital, and thus it is likely that there are overlapping participants with the studies reviewed above. The authors reported that adjunctive HDR was associated with excellent long-term outcomes in terms of biochemical control, disease-free survival and cause-specific survival.

Hoskins and colleagues (2007) reported results from a phase III randomized trial that compared EBRT monotherapy with a dose escalated schedule using high-dose rate brachytherapy. Participants were assigned to receive either standard radiotherapy 55 Gy in 20 fractions five days per week over 4 weeks, or a combined treatment schedule of EBRT followed by HDR brachytherapy. Two hundred twenty participants were randomized with stratification according to T-stage, PSA and Gleason score. Biochemical relapse-free survival was the primary end point and secondary endpoints included overall and relapse-free survival. Participants were treated by two specialists at a single institution. The characteristics of participants were well balanced between the cohorts. A significant improvement (P=0.03) in actuarial biochemical relapse-free survival was reported in the combined HDR treatment group at a median follow-up of 30 months (range 3-91). Mean PSA relapse-free survival in the treatment arm was 5.1 years (95% confidence interval [CI] 4.6 – 5.5 years) compared to the control arm of 4.3 years (95% CI 3.8 – 4.8 years). Acute toxicity scores for urinary and bowel functions were comparable. Acute rectal discharge by score, was more significant in the treatment cohort compared with the control group (P=0.025). The authors concluded, "this suggest the therapeutic ratio is in favor of using HDR brachytherapy as a boost with external beam radiotherapy in intermediate and high risk localized carcinoma of the prostate."

A nonrandomized comparison of biochemical outcomes using an ultra-high dose of conventionally fractionated intensity-modulated radiation therapy (IMRT) versus a lower dose of IMRT combined with high-dose-rate (HDR) brachytherapy was performed retrospectively by Deutsch (2010). Six hundred thirty individuals were treated at a single institution with 160 participants receiving combination HDR iridium-192 brachytherapy boost followed by IMRT. Ultra-high-dose IMRT of 86.4 Gy was used to treat 470 individuals. Participants were stratified into risk groups based on NCCN's clinical and pathological parameters. In general, HDR boost was not offered to individuals with low-risk prostate cancers, except in cases with multiple positive cores or those with other high-risk factors. Those with intermediate- and high-risk classifications were given both options. Androgen deprivation therapy was utilized for those in the high-risk group and those in the intermediate-risk group with particularly poor pathologic features. A statistically significant improvement in PSA relapse-free survival (PRFS) for those treated with HDR boost with IMRT at 5-year was 97.7% compared to 82% for those treated with ultra-high-dose IMRT (p<0.0001). Response analysis based on risk groups for the intermediate-risk cohort remained significant, but PRFS was not statistically significant for those in the low- or high-risk cohort. Stratified 5-year actuarial PRFS for HDR boost with IMRT compared to ultrahigh-dose IMRT were 100% vs. 98% (p=0.71) for low-risk, 98% vs. 84% (P<0.001) for intermediate-risk and high-risk 93% vs. 71% (p=0.23), respectively. The authors commented the nonsignificant results for the high-risk group was "likely related to the confounding implications of androgen deprivation therapy, smaller patient numbers and events, a higher probability of micrometastatic disease at the time of treatment, and the modest followup." The authors further stated none of the failures in the high-risk HDR group was local, which suggested possible metastatic spread prior to radiation treatment. "Should the benefit seen in our high-risk cohort persist and become statistically significant, it would likely suggest a benefit of local control of disease on subsequent development of distant metastases (Deutsch, 2010)."

The ACR-ASTRO guideline (2010) notes HDR brachytherapy may be combined with EBRT for the treatment of prostate cancer in any risk group. Guidelines for treatment of prostate cancer from the American Urological Association (AUA, 2007) note high recurrence rates for individuals with high-risk localized prostate cancer. Treatment options for the management include active surveillance, interstitial prostate brachytherapy, external beam radiotherapy, and radical prostatectomy. Despite the lack of high-quality evidence of treatment benefit among this cohort, a high risk of disease progression and death from disease, the AUA notes active treatment may be a preferred option.

The National Comprehensive Cancer Network^® (NCCN, 2011) Clinical Practice Guideline notes monotherapy with permanent low-dose rate (LDR) brachytherapy for men with low-risk of recurrence, clinically confined prostate cancers (T1c-T2a, Gleason 2-6, PSA less than 10 ng/ml;) and expected survival of 10 or more years is a popular regimen (NCCN, 2011). Combination LDR brachytherapy with EBRT and androgen deprivation therapy may be efficacious in some intermediate and high-risk individuals. Men with intermediate-risk or recurrent cancers as defined by NCCN include individuals with T2b to T2c tumors or Gleason score of 7, or a PSA value of 10 to 20 ng/mL. Men with high risk of recurrence after therapy include those with T3a clinically localized tumor, or Gleason score of 8 to 10 or PSA level greater than 20 ng/mL. High-dose rate (HDR) brachytherapy can be used in combination with EBRT instead of LDR brachytherapy. Escalation of radiation doses may be achieved safely by combining EBRT with HDR brachytherapy in treatment of individuals with intermediate or high risk prostate cancer (NCCN, 2011).

Soft Tissue Sarcoma
The use of brachytherapy as part of a multidisciplinary and combined treatment approach in the management of soft tissue sarcoma has become standard of care. Brachytherapy is commonly utilized in conjunction with surgical resection with positive or close margins to improve therapeutic results (NCCN, 2011). The NCCN panel "recommends brachytherapy as a radiation boost for positive or close margins." It was noted the use of brachytherapy as a boost afer preoperative radiation for individuals with widely negative margins are no longer used by many institutions because of 95% local control, rates with preoperative radiation at 50 Gy and negative margins (NCCN, 2011). In addition, specialty consensus opinions support the use of brachytherapy to treat soft tissue sarcomas with close or positive margins. The American Brachytherapy Society identifies soft tissue sarcoma as an indication for brachytherapy applications.

Uterine, Cervical, Endometrial, and Vulvar/Vaginal Tumors
Brachytherapy is considered the standard of care in individuals with gynecologic malignancies, including uterine, cervical, endometrial, and vulvar/vaginal tumors. In a Cochrane Review (Wang, 2010) a meta-analysis of published trial data compared high-dose rate (HDR) and low-dose rate (LDR) brachytherapy treatment for uterine and cervical cancer. The authors determined there were no significant differences in the outcomes between LDR and HDR brachytherapy for overall survival, relapse-free survival, local control rate, recurrence and rates of metastases.

Other energy source for brachytherapy: Electronic Brachytherapy
In December 2005, Xoft, Inc. (Fremont, CA) received U.S. Food and Drug Administration (FDA) 510K clearance for the Axxent™ Electronic Brachytherapy System. The FDA approved the Xoft Axxent electronic system as similar to predicate device that utilizes 192IR seeds as the source of radiation. The Axxent system is a proprietary form of providing electronic brachytherapy for accelerated partial breast irradiation for early stage breast cancer. Electronic brachytherapy is a non-radioactive, isotope-free treatment requiring minimal shielding, provided via a miniaturized X-ray tube. Therefore, this device is not subject to regulatory requirements by the U.S. Nuclear Regulatory Commission (NRC) or public health departments at this time. The system utilizes disposable micro-miniature X-ray radiation sources. This will allow radiation services to be provided in a variety of settings and not limited to heavily shielded settings. Axxent electronic brachytherapy is approved to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer. Axxent is not approved to provide whole breast irradiation. Although the device received FDA approval, due to the paucity of comparative clinical trials of high dose rate electronic brachytherapy and standard brachytherapy methods, the long term safety and efficacy of the high dose rate electronic brachytherapy procedure for the treatment of breast cancer or other carcinomas have not been determined.

An updated literature search revealed some industry-sponsored case reports and case series reporting on the feasibility of delivering the planned doses of electronic brachytherapy for treatment of breast cancer and endometrial cancer and short term adverse events (Dickler, 2010; Dooley, 2010; Mehta, 2010). However, the published literature did not compare the long-term effectiveness and safety data between the electronic brachytherapy devices versus outcomes from conventional brachytherapy utilizing radioactive sources. After review of the published data, specialty consensus opinion does not recommend the use of electronic brachytherapy due to the lack of published literature investigating the comparative effectiveness and long-term clinical outcomes to standard sources of radiation.

Breast Brachytherapy as a Boost to Whole Breast Irradiation
Breast conservation surgery (BCS) and radiotherapy (RT) of the conserved breast became widely accepted in the last decade as an alternative to mastectomy for the treatment of early invasive breast cancer. The external beam radiation treatment may be preceded, or followed by, a supplemental or "boost" dose administered to the primary tumor site. When brachytherapy is used as a boost, the radiation is delivered either as a low dose or high dose rate and the radioactive material is left in place until the dose is delivered. For low-dose-rate this usually is 2 to 3 days and for high dose it is a matter of minutes (but may be repeated 1 or 2 times a day for 1 or 2 days).

Breast Brachytherapy as an Alternative to Whole Breast Irradiation
In contrast to whole breast irradiation, brachytherapy can be completed in a much shortened treatment course.  Because of this shortened time frame, there has been interest in breast brachytherapy as a sole modality after lumpectomy. The recent application of brachytherapy is based partly on the observation that most 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 at or near the tumor bed suggesting that undetected multicentric disease may not be common. Together, these findings suggested that tumor bed irradiation may provide the major benefit from external beam radiation therapy. Also, external beam radiation therapy typically is delivered in fractionated doses over a course of 5 to 7 weeks. This extended treatment course may be difficult for some individuals for example, those living in remote locations, or the elderly or disabled. Brachytherapy usually is delivered over a week. This shortened treatment course, which has been termed accelerated partial-breast irradiation, may increase the proportion of individuals choosing breast-conserving surgery.

There are various brachytherapy techniques that 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. Older studies of local boost brachytherapy included temporarily implanted needles, wires, or seeds after participants recovered from surgery and completed whole-breast radiation therapy. More recently, investigators have perioperatively implanted hollow needles or catheters that guide placement of the radioactive material. This can be done during the initial lumpectomy if the decision to use brachytherapy has already been made or at the time of a re-excision if the lumpectomy specimen has positive surgical margins. Intraoperative implantation avoids the need for a separate surgical procedure with anesthesia for brachytherapy. Whether intra- or post-operative, these methods are collectively termed interstitial brachytherapy and use multiple radioactive sources placed to deliver a prescribed radiation dose to a defined target volume.

Phase II studies have suggested that in individuals with small, well defined tumors, partial breast irradiation using brachytherapy may provide the same levels of local tumor control compared to whole breast irradiation. The vast majority of individuals who receive partial breast irradiation are treated with either interstitial irradiation or more recently, balloon brachytherapy via a balloon catheter system called the Mammosite^® RTS device. 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.

Both LDR and HDR interstitial techniques have been used, with HDR techniques increasing in popularity. In the LDR technique, temporarily implanted radioactive seeds deliver radiation therapy continuously over a course of 4 days and then are removed. This treatment is generally an inpatient procedure. In the HDR technique, a computer-controlled device pushes a highly radioactive isotope into a catheter that has been placed into the tumor bed. The individual is exposed to the radiation therapy for a brief period (i.e., up to 15 minutes) and then the radioactive source is withdrawn. High-dose rate brachytherapy is typically administered on an outpatient basis in 8 fractions given twice daily over 4 days.

Cholangiocarcinoma
Cholangiocarcinoma is rare type of cancer that develops in cells that line the bile ducts and the diagnosis includes the anatomic site, either intrahepatic or extrahepatic. Surgical resection is the only potentially curative therapy for cholangiocarcinomas, with liver transplantation the only "other potentially curative option for patients with extrahepatic cholangiocarcionma (NCCN, 2011)." Brachytherapy is used to treat the cholangiocarcinoma as well as maintain the patency of the stent due to tumor obstruction.

Lung Brachytherapy
Endobronchial brachytherapy describes the delivery of radiation therapy directly to endobronchial lesions, using either permanent interstitial implantation of radioactive seeds or a temporary afterloading implant. The technique permits targeted radiation while minimizing exposure to surrounding radiosensitive structures, such as normal lung, heart, and spinal cord.

Endobronchial brachytherapy has been most thoroughly investigated as a treatment of non-small cell lung cancer, specifically for early-stage nonresectable tumors without extraluminal extension, or as a palliative treatment of obstructing primary or metastatic tumors. The technique can be performed in the inpatient setting (30 to 72 hours) using low-dose rate radiotherapy, or more commonly as an outpatient procedure using multiple sessions of high-dose rate radiotherapy. Iridium-192 has become the radioisotope of choice for high-dose therapy. Two to 5 fractions delivered weekly is a typical schedule, although some individuals may receive hyperfractionated radiotherapy, i.e., twice daily treatments for 2 consecutive days. However, doses vary among institutions, and there is no clear consensus as to the optimal dose and frequency of fractionation for brachytherapy.

In the outpatient setting, the individual receives local anesthesia and monitored sedation. A flexible bronchoscope is passed transnasally; a separate port on the bronchoscope allows passage of the afterloading catheter to the target lesion. Once the catheter is placed, the radioisotope can be administered by the high-dose radiotherapy afterloading machine. Individuals with potential airway compromise due to bleeding may require treatment with a rigid bronchoscope, which requires general anesthesia and frequently an overnight hospitalization.

Endobronchial brachytherapy represents one approach to the local treatment of endobronchial lesions. Other technologies include electrocoagulation, cryosurgery, laser resection, and endobronchial stent placement. In some instances, the therapies may be used together, such as using laser therapy for initial debulking followed by brachytherapy. In addition, brachytherapy has been investigated as a "boost" to curative external beam radiation therapy.

Esophageal cancer
Options to treat esophageal cancer include chemotherapy, surgery, radiation therapy and photodynamic therapy. Brachytherapy for esophageal cancer involves implantation of radioactive seeds or devices and is often times used in combination with other treatment modalities. Brachytherapy is typically utilized to palliate symptoms of the cancer, which may include pain, and difficulty swallowing.

Head and Neck Carcinoma
Radiation therapy is a common treatment modality for head and neck carcinomas, and may be combined with other methods such as chemotherapy, external beam radiotherapy or surgery. Brachytherapy may involve temporary or permanent placement of radioactive sources at the site of the tumor(s). 

Ocular cancers:
Choroidal Melanoma
According to the American Cancer Society (ACS), cancers originating in the eyeball, also known as intraocular cancer, are rare. Melanoma is the most common primary cancer originating in the eyeball (ACS, 2010). Uveal melanomas are the most common subset of intraocular cancer, with 90% of the cases occurring in the choroid. The choroid cells in the uvea are comprised of pigment similar to the melanocytes in skin. Surgical options include resection of small tumors or enucleation or removal of the entire eyeball. Brachytherapy, external radiation therapy, laser surgery and chemotherapy are therapeutic options. Treatment decisions are determined by the location and size of the tumors.

Prostate Brachytherapy
Brachytherapy is a common treatment option for clinically localized prostate cancer. The most common application involves the permanent implantation of low-dose-rate radioactive isotopes, in the form of seeds, into the prostate gland. This is done under general anesthesia as an outpatient surgery procedure. The seeds are inserted into the prostate using preloaded needles and ultrasonic guidance to assist with correct placement. The number of seeds depends on the size of the prostate, but typically requires between 60 to 120 seeds. A computerized tomography scan is usually performed at some time after the procedure to determine the quality of seed placement. More may be added if placement is inadequate. The choice of radioactive source, iodine or palladium is usually based on physician preference. Iodine has a half-life of 60 days while palladium has a shorter half-life of 17 days with a slightly higher dose rate. Locally advanced cancers may be undertreated by permanent brachytherapy alone and these individuals are usually treated by brachytherapy in combination with external beam radiation therapy.

Another form of brachytherapy that has been used to treat prostate cancer is high-dose-rate (HDR) brachytherapy. This technique uses a high activity radioisotope, such as iridium-192, which delivers radiation at a high dose rate through needle catheters inserted into the prostate. The isotope is left in place for a predetermined time, known as the 'dwell' time, which typically falls in the range of 8 to 10 minutes. The dwell time can be altered to control dose distribution to the tumor and surrounding tissue. This type of treatment is commonly referred to as 'temporary brachytherapy' since the radioactive source is removed from the individual at the end of each HDR treatment session. The radiation may be delivered in one or two sessions each day over the course of one to two days. Theoretically, HDR brachytherapy achieves greater dose accuracy and control as it permits more precise delivery of radiation compared to permanent seed implantation in which the dose cannot be altered after seed implantation. In addition, when using permanent seed implantation, swelling (edema) of the prostate and other factors may cause the permanent seed to "migrate" and thus become less effective in delivering the dose to the precise target. HDR brachytherapy is proposed as an adjunct to EBRT to provide local boost radiation in individuals with locally advanced prostate cancer. There exists some risk of urethral strictures with HDR treatment (4% – 8%) and a slightly increased incidence of rectal fistula. Otherwise the treatment is generally well tolerated. Overall, late toxicity is comparable to local dose-escalated external radiation treatment.

Soft Tissue Sarcoma Brachytherapy
Soft tissue sarcomas are a heterogenous group of tumors that may originate in the mesodermal tissues of the extremities, trunk, retroperitoneum or head and neck in adults and from mesenchymal tissues in children. Tumors arising from the gastrointestinal stroma are called gastrointestinal stromal tumors (GIST) with occur most frequently in the stomach and the small intestine (National Cancer Institute, 2008). Preoperative, intraoperative or postoperative radiation therapies are commonly used as part of a combined modality approach in managing the disease.                                                                     

Uterine, Cervical, Endometrial, and Vulvar/Vaginal Tumors
Brachytherapy can be used to prevent local cancer recurrences after surgery (adjuvant therapy) or for the treatment of recurrent uterine, cervical and endometrial and vulvar/vaginal cancer. Radiation is directly placed in the area of the cancer or in the area where unseen cancer is suspected. For uterine cancer, this is the "vaginal cuff" region where the incision was made when the uterus was removed. Brachytherapy does not penetrate very deep and external beam radiation therapy is often combined with brachytherapy for treatment of uterine cancer. In the case of endometrial cancer, the radioactive pellets are placed in the vagina, after hysterectomy, to prevent cancer recurrence in the vaginal cuff.

Radioactive material is placed directly into the cervix for cervical cancer. Placing the radiation in this manner allows a high radiation dose to be delivered directly to the cancer, while reducing radiation to surrounding normal organs, such as the rectum and bladder. During a procedure in the operating room, a small device is placed into the cervix and vagina. This device is later "loaded" with the radiation capsules while the individual is in a lead-shielded hospital room. The radioactive material is left in place for 1-3 days. This procedure may be performed once or twice during the course of treatment. The individual is discharged from the hospital once the device is removed from the cervix. Primary vaginal cancer is rare and occurs in approximately 1% of cancers of the female reproductive system (ACS, 2011). Intracavitary vaginal brachytherapy alone may be used for selected individuals with superficial disease. Tumors that are more extensive may require interstitial brachytherapy to achieve adequate tissue doses (Bradley, 2006).

Electronic Brachytherapy
Historically, brachytherapy utilized radioactive sources to produce the therapeutic radiation doses. Newer technology utilizes non-radioactive, isotope-free electronic brachytherapy. The use of electronic brachytherapy allows treatment to be provided in environments that are not heavily shielded. However, the long term efficacy and safety of utilizing electronic brachytherapy versus conventional radioactive sources to provide brachytherapy have not been published.

Boost: An additional dose of radiation to a reduced size radiation field.

Breast-conserving surgery: A treatment alternative to mastectomy for early stage breast cancer that consists of tumor removal (lumpectomy) followed by external radiation to the whole breast.

Brachytherapy (also known as internal radiation): A type of radiation treatment used to stop the growth of cancer cells by implanting radioactive material directly into the tumor or into the surrounding tissues.

External beam radiation therapy (EBRT): A form of radiation therapy (i.e., three dimensional conformal radiation therapy [3D-CRT], intensity modulated radiation therapy [IMRT], and image guided radiation therapy [IGRT]) used to stop the growth of cancer cells. A linear accelerator directs a photon or electron beam from outside the body through normal or healthy body tissue to reach the cancer. The radiation is typically given 5 days a week for a period of three to eight weeks.

Extrahepatic bile duct cancers: A type of cancer that originates outside of the bile duct. Perihilar and distal tumors comprise the extrahepatic category.

Gleason Grading System: A prostate cancer grading system based on a number range from one to five; the lower the number, the lower the grade, and the slower the cancer growth.

Gleason score: Represents the sum of the two most common Gleason grades observed by the pathologist on a specimen, the first number is the most frequent grade seen.

Head and neck cancers: Cancers arising from the oral cavity and lips, larynx, hypopharynx, oropharynx, nasopharynx, paranasal sinuses and nasal cavity, salivary glands, mucosal melanoma and occult primaries in the head and neck region are considered "head and neck cancers." Cancer of the cervical esophagus, trachea, lymphoma, and thyroid cancer are not "head and neck cancers" even when they arise in that body area.

High dose rate (HDR) brachytherapy (temporary): Involves implantation of high intensity radiation for a short time period of 3 to 10 minutes and then removing the radiation source. The most commonly used source is Iridium.

Interstitial implant: A procedure in which radioactive material is placed directly into a tumor site.

Intrahepatic bile duct cancers: Cancers that develop in the smaller bile duct branches inside the liver. These can sometimes be confused with cancers called hepatocellular carcinomas that start in the liver cells.

Low dose rate (LDR) brachytherapy (temporary): A low dose of radiation is delivered over the course of several days, after which the radiation source is removed. This requires an inpatient hospital stay; the most commonly used sources are Cesium and Radium.

Low dose rate (LDR) brachytherapy (permanent): Permanently implanted radioactive material (most commonly iodine-125 and palladium-103 radioisotopes).

Partial breast irradiation: Radiation focused at the tumor bed of the breast, after prior breast conserving surgery. An alternative to whole breast irradiation, breast brachytherapy is one technique of delivering partial breast irradiation.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Breast cancer, specific procedures
When Services may be Medically Necessary when criteria are met: 

When Services are Investigational and Not Medically Necessary for the treatment of breast cancer:
For the procedure codes listed above, when criteria are not met, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Cholangiocarcinoma, specific procedure
When Services may be are Medically Necessary when criteria are met: 

When Services are Investigational and Not Medically Necessary:
For placement of radioelement for cholangiocarcinoma when criteria are not met and for all other diagnoses

Ocular brachytherapy, specific procedures
When Services may be Medically Necessary when criteria are met: 

When Services are Investigational and Not Medically Necessary for ocular brachytherapy:
For the procedure and diagnoses codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Endobronchial tumors, specific procedure
When Services may be Medically Necessary when criteria are met: 

When Services are Investigational and Not Medically Necessary:
For the procedure code listed above when criteria are not met, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Esophageal cancer, specific procedure
When Services are Medically Necessary: 

When Services are Investigational and Not Medically Necessary:
For esophageal placement of radioelement, for all other diagnoses

Head and neck cancer, specific procedure
When Services are Medically Necessary: 

When Services are Investigational and Not Medically Necessary:
For the procedure code listed above, for all other diagnoses

Penile cancer, specific procedure
When Services are Medically Necessary: 

When Services are Investigational and Not Medically Necessary:
For penile placement of radioelement, for all other diagnoses

Prostate cancer, specific procedures
When Services may be Medically Necessary when criteria are met: 

When Services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Soft tissue sarcoma, specific procedures
When Services may be Medically Necessary when criteria are met: 

When Services are Investigational and Not Medically Necessary:
For the procedure and diagnoses codes listed above when criteria are not met, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Uterine, cervical, endometrial, and vulvar/vaginal tumors, specific procedures
When Services are Medically Necessary:

When Services are Investigational and Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Radiation Oncology brachytherapy procedures, not specific
When services are Medically Necessary: 

When services may be Medically Necessary when criteria are met:
For the procedure codes listed above, for the following diagnosis codes 

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for all other tumor diagnoses not listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary: 

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Literature:

1. Arthur DW, Vicini FA, Kuske RR, et al. Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Brachytherapy 2003; 2(2):124-130.
2. Aumont-le Guilcher MA, Prevost B, Sunyach MP, et al. High-Dose-Rate Brachytherapy for Non-Small-Cell Lung Carcinoma: A Retrospective Study of 226 Patients. Int J Radiat Oncol Biol Phys. 2010; 79(4):1112-1116.
3. Bellon JR, Katz A, Taghian A. Hematology/Oncology of North America. Radiation therapy for breast cancer. Hematol Oncol Clin North Am. 2006; 20(2):239-257.
4. Benitez PR, Chen PY, Vicini FA, et al. Partial breast irradiation in breast conserving therapy by way of interstitial brachytherapy. Am J Surg. 2004; 188(4):355-364.
5. Benitez PR, Keisch ME, Vicini F, et al. Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg. 2007; 194(4):456-462.
6. Bradley KA, Petereit DG. Radiation therapy for gynecologic malignancies. Hematol Oncol Clin N Am. 2006; 20(2):347-361.
7. Cuttino LW, Keisch M, Jenrette, JM, et al. Multi-institutional experience using the MammoSite radiation therapy system in the treatment of early-stage breast cancer: 2-year results. Int J Radiat Oncol Biol Phys. 2008; 71(1):107-114.
8. Dagnault A, Ebacher A, Vigneault E, Boucher S. Retrospective study of 81 patients treated with brachytherapy for endobronchial primary tumor or metastasis. Brachytherapy. 2010; 9(3)243-247.
9. D'Amico AV, Moran BJ, Braccioforte MH, et al. Risk of death from prostate cancer after brachytherapy alone or with radiation, androgen suppression therapy, or both in men with high-risk disease. J Clin Oncol. 2009; 27(24):3923-3928.
10. Demanes DJ, Brandt D, Schour L, Hill DR. Excellent results from high dose rate brachytherapy and external beam for prostate cancer are not improved by androgen deprivation. Am J Clin Oncol. 2009; 32(4):342-347.
11. Dickler A, Puthawala MY, Thropay JP, et al. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010; 5:67.
12. Dooley WC, Thropay JP, Schreiber, GJ, et al. Use of electronic brachytherapy to deliver postsurgical adjuvant radiation therapy for endometrial cancer: a retrospective multicenter study. Onco Targets Ther. 2010; 3:197-203.
13. Dziewirski W, Rutkowski P, Nowecki ZI, et al. Surgery combined with intraoperative brachytherapy in the treatment of retroperitoneal sarcomas. Ann Surg Oncol. 2006; 13(2):245-252.
14. Finger PT, Chin KJ, Duvall G; Palladium-103 for Choroidal Melanoma Study Group. Palladium-103 ophthalmic plaque radiation therapy for choroidal melanoma: 400 treated patients. Ophthalmology. 2009; 116(4):790-796.
15. Frobe A, Jones G, Jasik B, et al. Intraluminal brachytherapy in the management of squamous carcinoma of the esophagus. Dis Esophagus. 2009; 22(6):513-518.
16. Galale RM, Martinez A, Mate T, et al. Long-term outcome by risk factors using conformal high-dose-rate brachytherapy (HDR-BT) boost with or without neoadjuvant androgen suppression for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004; 58(4):1048-1055.
17. Hoskin PJ, Motohashi K, Bownes P, et al. High dose rate brachytherapy in combination with external beam radiotherapy in the radical treatment of prostate cancer: initial results of a randomised phase three trial. Radiother Oncol. 2007; 84(2):114-120.
18. Keisch M, Vicini F, Kuske R et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early stage breast cancer treated with breast conserving therapy. Int J Radiat Oncol Biol Phys. 2003; 55(2):289-293.
19. Kestin LL, Martinez AA, Stromberg JS et al. Matched-pair analysis of conformal high-dose-rate brachytherapy boost versus external-beam radiation therapy alone for locally advanced prostate cancer. J Clin Oncol. 2000; 18(15):2869-2880.
20. King TA, Bolton JS, Kuske RR, et al. Long term results of wide field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T(is, 1,2) breast cancer. Am J Surg. 2000; 180(4):299-304.
21. Koukourakis G, Kelekis N, Armonis V, Kouloulias V. Brachytherapy for prostate cancer: a systematic review. Adv Urol. 2009:327945.
22. Martinez A, Gonzalez J, Spencer W, et al. Conformal high dose rate brachytherapy improves biochemical control and causes specific survival in patients with prostate cancer and poor prognostic factors. J Urol. 2003; 169(3):974-980.
23. Mehta VK, Algan O, Griem KL, et al. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010; 33(4):327-335.
24. Melia M, Moy CS, Reynolds SM, et al.; Collaborative Ocular Melanoma Study-Quality of Life Study Group. Quality of life after iodine 125 brachytherapy vs. enucleation for choroidal melanoma: 5-year results from the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3.Arch Ophthalmol. 2006; 124(2):226-238.
25. Nelson JC, Beitsch PD, Vicini FA, et al. Four-year clinical update from the American Society of Breast Surgeons Mammosite brachytherapy trial. Am J Surg. 2009; 198(1):83-91.
26. Patel RR, Arthur DW. Hematology/Oncology of North America. The emergence of advanced brachytherapy techniques for common malignancies. Hematol Oncol Clin North Am. 2006; 20(1):97-118.
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28. Polgar C, Major T, Fodor J, et al. Accelerated partial-breast irradiation using high-dose-rate interstitial brachytherapy: 12-year update of a prospective clinical study. Radiother Oncol. 2010; 94(3):274-279.
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30. Polgar C, Van Limbergen E, Potter R, et al.; GEC-ESTRO breast cancer working group. Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: recommendations of the Groupe Europeen de Curietherapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009). Radiother Oncol. 2010; 94(3):264-273.
31. Rivard MJ, Davis SD, DeWerd LA, et al. Calculated and measured brachytherapy dosimetry parameters in water for the Xoft Axxent X-Ray Source: an electronic brachytherapy source. Med Phys. 2006 (11):4020-4032.
32. Shinohara ET, Guo M, Mitra N, Metz JM. Brachytherapy in the treatment of cholangiocarcinoma. Int J Rad Oncol Biol Phys. 2010; 78(3):722-728.
33. Taira AV, Merrick GS, Galbreath RW, et al. Natural history of clinically staged low- and intermediate-risk prostate cancer treated with monotherapeutic permanent interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2010; 76(2):349-354.
34. Truong MT. Hematology/Oncology Clinics of North America. Current role of radiation therapy in the management of malignant brain tumors. Hematol Oncol Clin North Am. 2006; 20(2):431-453.
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37. Vicini FA, Kestin L, Chen P, et al. Limited field radiation therapy in the management of early stage breast cancer. J Natl Cancer Inst. 2003; 95(16):1205-1211.
38. Vicini FA, Vargas C, Edmundson G, et al. The role of high dose rate brachytherapy in locally advanced prostate cancer. Semin Radiat Oncol. 2003; 13(2):98-108.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Brachytherapy Society. Breast Cancer. Available at: http://www.americanbrachytherapy.org/resources/brachyapps.cfm. Accessed on September 9, 2011.
2. American College of Radiology (ACR) and the American Society for Therapeutic Radiation and Oncology (ASTRO) Practice Guidelines & Technical Standards. Available at: http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/ro.aspx.  Accessed on September 15, 2011.
   • ACR–ASTRO Practice guideline for the performance of high-dose-rate brachytherapy (2010)
   • ACR–ASTRO Practice guideline for the performance of low-dose-rate brachytherapy (2010)
   • ACR–ASTRO Practice guideline for transperineal permanent brachytherapy of prostate cancer (2010)
3. American Society of Breast Surgeons. Consensus statement for accelerated partial breast irradiation. Revised October 7, 2008. Available at: http://www.breastsurgeons.org/statements/APBI_statement_revised_100708.pdf.  Accessed on September 9, 2011.
4. American Urological Association. Prostate Cancer. Reviewed and validated 2009. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=pc. Accessed on September 15, 2011.
5. Blue Cross Blue Shield Association. Comparative evaluation of radiation treatments for clinically localized prostate cancer: an update. Health Technology Assessment. 2010; 24(9).
6. Blue Cross Blue Shield Association. Brachytherapy for accelerated partial breast irradiation after breast-conserving surgery for early stage breast cancer. TEC Assessment. 2002; 17(18).
7. Collaborative Ocular Melanoma Study (COMS) Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: Twelve-year mortality rate and prognostic factors: COMS report No.28. Arch Ophthalmol. 2006; 124(12):1684-1693.
8. Collaborative Ocular Melanoma Study Group.Incidence of cataract and outcomes after cataract surgery in the first 5 years after iodine 125 brachytherapy in the Collaborative Ocular Melanoma Study: COMS Report No. 27. Ophthalmology. 2007; 114(7):1363-1371.
9. Erickson BA, Demanes DJ, Ibbott GS, et al. American Society for Radiation Oncology (ASTRO) and American College of Radiology (ACR) practice guideline for the performance of high-dose-rate brachytherapy. Int J Radiat Oncol Biol Phys. 2011; 79(3):641-6490
10. Nag S, Cano ER, Demanes DJ, et al.; American Brachythreapy Society. The American Brachytherapy Society recommendations for high-dose-rate brachytherapy for head-and-neck carcinoma. Int J Radiat Oncol Biol Phys. 2001; 50(5):1190-1198.
11. Nag S, Quivey JM, Earle JD, et al.; American Brachytherapy Society. The American Brachytherapy Society recommendations for brachytherapy of uveal melanomas. Int J Radiation Oncol Biol Phys. 2003; 56(2):544-555.
12. National Comprehensive Cancer Network^® (NCCN). Clinical Practice Guidelines in Oncology™. © 2011 National Comprehensive Cancer Network, Inc. For additional information: http://www.nccn.org. Accessed on September 9, 2011.
    • Breast Cancer. V.2.2011. Revised March 25, 2011.
    • Head and Neck Cancers V.2.2011. Revised March 30, 2011.
    • Hepatobiliary Cancer V.2.2011. Revised June 29, 2011
    • Non-Small Cell Lung Cancer V.3.2011. Revised January 7, 2011.
    • Prostate Cancer V.4.2011. Revised June 21 2011.
    • Soft Tissue Sarcoma. V.2.2011. Revised August 4, 2011.
    • Uterine Neoplasms. V.1.2012. Revised August 11, 2011.
13. Park CC, Yom SS, Podgorsak MB, et al; Electronic Brachytherapy Working Group. American Society for Therapeutic Radiology and Oncology (ASTRO) Emerging Technology Committee report on electronic brachytherapy. Int J Radiat Oncol Biol Phys. 2010; 76(4):963-972.
14. Shaitelman SF, Vicini FA, Beitsch P, et al. Five-year outcome of patients classified using the American Society for Radiation Oncology consensus statement guidelines for the application of accelerated partial breast irradiation: an analysis of patients treated on the American Society of Breast Surgeons MammoSite Registry Trial. Cancer. 2010; 116(20):4677-4685.
15. Smith BJ, Arthur DW, Buchholz, et al. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg. 2009; 209(2):269-277.
16. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Axxent Electronic Brachytherapy System. No. K050843. Rockville, MD: FDA. Available at: http://www.fda.gov/cdrh. Accessed on September 9, 2011.
17. Wang X, Liu R, Ma B, et al. High dose rate versus low dose rate intracavity brachytherapy for locally advanced uterine cervix cancer. Cochrane Database Syst Rev. 2010; Issue 7. Art. No.:CD007563.

1. American Cancer Society. Available at:  http://www.orgsites.com/ga/acs/.  Accessed on September 9, 2011.
2. National Cancer Institute (NCI). Available at http://www.cancer.gov/ Accessed on September 9, 2011.
   • Breast cancer physician data query (PDQ^®): Treatment. Last modified July 14, 2011.
   • Intraocular (Eye) Melanoma Treatment (PDQ). Last modified June 15, 2010.
   • Penile Cancer Treatment (PDQ). Last modified August 29, 2011.
   • Prostate Cancer Treatment (PDQ). Last modified December 9, 2010.
   • Radiation therapy for cancer: Fact Sheet. Reviewed June 30, 2010.

Axxent Electronic Brachytherapy System
Breast Brachytherapy
Contura
Electronic Brachytherapy
High Dose Rate Temporary Brachytherapy
Implant Radiation
Internal Radiation
Interstitial Seed Brachytherapy
MammoSite Radiation Therapy Systems
ProstRcision
Savi

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.