Note: Please see RAD Intraocular Epiretinal Brachytherapy for additional information.

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1 Subject: for Oncologic Indications Document #: Current Effective Date: 07/09/2008 Status: Revised (Coding updated 10/01/2008) Last Review Date: 05/15/2008 Description/Scope 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. This 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 RAD Intraocular Epiretinal for additional information. Position Statement Breast Cancer: Medically Necessary: Breast brachytherapy is considered medically necessary as an adjunctive boost to the tumor bed in patients who have received whole breast radiation therapy after prior breast conserving surgery (i.e., lumpectomy). Breast brachytherapy is considered medically necessary as a technique of partial breast irradiation as an alternative to whole breast irradiation in patients who meet ALL of the following criteria: Tumor removed with breast conserving surgery (i.e., lumpectomy) with resected margins free of tumor; and Histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast; and Stage 0, I or II disease (Stage II tumors must be less than or equal to 3 cm in diameter); and No more than three positive axillary nodes Investigational and Not Medically Necessary: Breast brachytherapy is considered investigational and not medically necessary in patients not meeting the above criteria. Choroidal Melanoma: Medically Necessary: Ocular brachytherapy for choroidal melanoma is considered medically necessary in patients who meet ALL of the following criteria: Unilateral choroidal melanoma has been confirmed; and Apical height of the tumor is 2.5 to 10.0 mm; and No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. Page 1 of 17

2 Maximum basal tumor diameter of 18.0 mm or less Investigational and Not Medically Necessary: Ocular brachytherapy is considered investigational and not medically necessary in patients not meeting the above criteria. Endobronchial tumors: Medically Necessary: Endobronchial brachytherapy is considered medically necessary for primary tumors that cannot be excised surgically or cannot be treated by EBRT or as palliative treatment for obstructing primary or metastatic endobronchial tumors. Investigational and Not Medically Necessary: Endobronchial brachytherapy is considered investigational and not medically necessary as a 'boost' for EBRT. Prostate Cancer: Medically Necessary: Permanent radioactive seed implantation for prostate cancer with or without external beam radiation therapy (EBRT) is considered medically necessary. High dose rate (HDR) brachytherapy, a temporary seed implantation, is considered medically necessary for locally advanced prostate cancer (T1C, PSA 10, or T2/T3). Soft Tissue Sarcoma: Medically Necessary: as part of combination therapy, is considered medically necessary in patients with soft tissue sarcoma who have positive margins or margins <5mm. Uterine, Cervical, Endometrial and Vulvar/Vaginal Cancer: Medically Necessary: is considered medically necessary in patients with uterine, cervical, endometrial or vulvar/vaginal cancer. Investigational and Not Medically Necessary: is considered investigational and not medically necessary in tumors not listed above. For all diagnoses: 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. Page 2 of 17

3 Rationale 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 patients, irradiation of the whole breast is not necessary. For example, randomized trials comparing lumpectomy alone vs. 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%-4.4%, which is comparable to external beam radiation. (Benitez, 2004; Keisch, 2003; King, 2000; Polgar, 2002; 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. Currently, there are ongoing randomized studies of partial breast irradiation with brachytherapy to confirm the results of initial phase II studies suggesting that the local control rates of partial and whole breast irradiation are equivalent. (University of Wisconsin, 2005) However, at the same time, the American Society and the American Society of Breast Surgeons have published recommendations regarding patient selection criteria for breast brachytherapy, indicating the general acceptance of brachytherapy as an alternative to whole breast irradiation. (American Society of Breast Surgeons, 2005; Arthur, 2003) This position indicating that partial breast irradiation with breast brachytherapy is considered medical necessary in certain patients reflects the general acceptance of these techniques among the medical community. The patient selection criteria in this document are similar to the patient selection criteria included in the large randomized study of breast brachytherapy sponsored by the National Cancer Institute. (University of Wisconsin, 2005). Methods of providing partial breast irradiation include interstitial catheters, needles or implanted balloons (Mammosite RTS device, Proxima Therapeutics, Alpharetta, GA) placed into the breast and afterloaded with radioactive material. 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 large tumors or when vision loss is anticipated as a result of other treatment modalities (American Cancer Society, 2006). The Collaborative Ocular Melanoma Study Group (COMS, 2006) studied enucleation versus brachytherapy in a multicenter randomized trial enrolling 1,317 patients. 252 patients died within the first 5 years with 19% (127) in the enucleation group vs. 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 Page 3 of 17

4 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. 45% of all patients treated by either brachytherapy or enucleation were alive and disease free at the 12 year followup. Melia and Colleagues (2006) reported results of a 5 year quality of life study on 209 patients 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. Endobronchial Tumors There are two categories of patients who may be considered candidates for endobronchial brachytherapy. Primary treatment Candidates for primary treatment have principally included patients 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 treatment Many patients with non-small cell carcinoma are initially treated with external beam radiation therapy but ultimately experience local recurrence. Unfortunately, many 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. Short-term outcomes, 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 patients. (Villanueva, 1995) The median survival of these patients is typically less than 9 months; no study has shown that endobronchial brachytherapy improves survival rate. For either palliative or primary treatment, no trials have directly compared different methods of local control (i.e., endobronchial brachytherapy, photodynamic therapy, laser therapy, and cryotherapy) to determine if any one method is superior to another in different subsets of patients or if combinations of therapy provide improved results. The choice of modality may depend on local availability and expertise. has also been investigated as a technique to deliver a boost to patients undergoing primary external beam radiation therapy. External beam radiation therapy is typically the primary treatment for the majority of patients with non-small cell carcinoma of the lung (NSCCL) because patients usually present with surgically unresectable disease and that NSCCL is unresponsive to chemotherapy. Huber and colleagues (1997) reported on the results of a trial that randomized 98 patients 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. Page 4 of 17

5 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, brachytherapy using permanently implanted seeds is a well accepted treatment option for clinically localized prostate cancer. High dose rate or temporary brachytherapy is a treatment option, which has been primarily investigated as an adjunct to external beam radiation therapy in patients with poor prognostic factors. Several large case series have been reported. Martinez and colleagues reported on the outcomes of a series of 207 patients treated between 1991 and (Martinez, 2003) All patients 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 high-dose rate 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 were present, and 50% if all 3 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 high-dose rate brachytherapy boost versus external beam radiation therapy alone. (Kestin, 2000) A total of 161 patients received a high-dose rate boost; they were randomly matched with a unique patient who received EBRT alone. Patients were matched according to PSA level, Gleason score, T stage, and follow-up of duration. 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 summarized the experience reported in 8 other case series of locally advanced prostate cancer totaling just over 1,000 patients. (Vicini, 2003) The biochemical control rate ranged from 74% to 97% with median follow-ups ranging from 11 to 74 months. Finally, 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 patients. (Galale, 2004) A total of 209 patients were treated at William Beaumont Hospital, and thus it is likely that there are overlapping patients 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 causespecific survival. 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. is commonly utilized in conjunction with surgical resection with positive or close margins to improve therapeutic results (National Comprehensive Cancer Network, 2008). The American Society identifies soft tissue sarcoma as an indication for brachytherapy applications. Uterine, Cervical, Endometrial, and Vulvar/Vaginal Tumors is considered the standard of care in patients with gynecologic malignancies, including uterine, cervical, endometrial, and vulvar/vaginal tumors. Electronic In December 2005, Xoft, Inc. (Fremont, CA) received U.S. Food and Drug Administration (FDA) 510K approval for the Axxent Electronic 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 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 Page 5 of 17

6 X-ray tube. 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 safety and efficacy of the high dose rate electronic brachytherapy procedure for the treatment of breast cancer or other carcinomas have not been determined. Background/Overview Breast 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 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 patients, for example those living in remote locations, or the elderly or disabled. usually is delivered over a week. This shortened treatment course, which has been termed accelerated partial-breast irradiation, may increase the proportion of patients choosing breast-conserving surgery. Various brachytherapy techniques have been investigated. They differ in the timing of implantation relative to other components of breast-conserving therapy, the radiation dose rate, the loading technique, the number and volumetric distribution of radioactive sources, and the radioisotopes used. Most older studies of local boost brachytherapy included temporarily implanted needles, wires, or seeds after patients recovered from surgery and completed wholebreast 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 postoperative, these methods are collectively termed interstitial brachytherapy and use multiple radioactive sources placed to deliver a prescribed radiation dose to a defined target volume. Both low-dose rate and high-dose rate interstitial techniques have been used, with high-dose rate techniques increasing in popularity. In the low-dose rate technique, temporarily implanted radioactive seeds deliver radiation Page 6 of 17

7 therapy continuously over a course of 4 days and then are removed. This treatment is generally an inpatient procedure. In the high-dose rate technique, a computer-controlled device pushes a highly radioactive isotope into a catheter that has been placed into the tumor bed. The patient is exposed to the radiation therapy for a brief period 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. In addition, phase II studies have suggested that in patients 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 patients 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 (Proxima Therapeutics, Alpharetta, GA). The device is implanted in the lumpectomy cavity during or shortly after breastconserving 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. 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, 2006). 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., external radiation therapy, laser surgery and chemotherapy are therapeutic options. Treatment decisions are determined by the location and size of the tumors. Endobronchial 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 highdose 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 patients 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 patient 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 Page 7 of 17

8 machine. Patients 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. Prostate is a common treatment option of the treatment of 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 patients 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 patient 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 patients with locally advanced prostate cancer. There exists some risk of urethral strictures with HDR treatment (4% 8% of patients) 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 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. Page 8 of 17

9 Uterine, Cervical, Endometrial, and Vulvar/Vaginal Tumors rachytherapy 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. 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 patient 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 patient is discharged from the hospital once the device is removed from the cervix. Primary vaginal cancer is rare and occurs in approximately 2% - 3% of all gynecologic cancers (ACS, 2008). Intracavitary vaginal brachytherapy alone may be used for selected patients with superficial disease. Tumors that are more extensive may require interstitial brachytherapy to achieve adequate tissue doses (Bradley, 2006). Electronic 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 efficacy and safety of utilizing electronic brachytherapy versus conventional radioactive sources to provide brachytherapy have not been published. Definitions 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 (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) (also known as teletherapy): a form of therapy using radiation to stop the growth of cancer cells; a linear accelerator directs a photon or electron beam from outside the body through normal body tissue to reach the cancer; the radiation is given 5 days a week for a period of 3 to 8 weeks 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 Page 9 of 17

10 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 in-patient 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 Coding 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: CPT Placement of radiotherapy afterloading balloon catheter into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy Placement of radiotherapy afterloading balloon catheter into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; concurrent with partial mastectomy Placement of radiotherapy afterloading brachytherapy catheters (multiple tube and button type) into the breast for interstitial radioelement application following (at the time of or subsequent to) partial mastectomy, includes imaging guidance Malignant neoplasm of female breast Malignant neoplasm of male breast Secondary malignant neoplasm of breast Carcinoma in situ of breast 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. Choroidal melanoma, specific procedures When Services may be Medically Necessary when criteria are met: Page 10 of 17

11 CPT Destruction of localized lesion of retina (e.g., macular edema, tumors), one or more sessions; radiation by implantation of source (includes removal of source) Malignant neoplasm of eyeball, except conjunctiva, corneal, retina, and choroid Malignant neoplasm of choroid When Services are Investigational and Not Medically Necessary for the treatment of choroidal melanoma: 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: CPT Bronchoscopy; with placement of catheter(s) for intracavitary radioelement application Malignant neoplasm of bronchus and lung Secondary malignant neoplasm of lung (bronchus) Malignant carcinoid tumor of the bronchus and lung Carcinoma in situ of bronchus and lung Carcinoma in situ of respiratory system; part unspecified 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. Prostate cancer, specific procedures When Services are Medically Necessary: CPT Exposure of prostate, any approach, for insertion of radioactive substance Exposure of prostate, any approach, for insertion of radioactive substance; with lymph node biopsy(s) (limited pelvic lymphadenectomy) Exposure of prostate, any approach, for insertion of radioactive substance; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric and obturator nodes Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy Echography, transrectal; prostate volume study for brachytherapy treatment planning 185 Malignant neoplasm of prostate Carcinoma in situ of prostate Page 11 of 17

12 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. Soft tissue sarcoma, specific procedures When Services may be Medically Necessary when criteria are met: CPT Placement of needles or catheters into muscle and/or soft tissue for subsequent interstitial radioelement application (at the time of or subsequent to the procedure) Malignant neoplasm of connective and other soft tissue Secondary malignant neoplasm of other specified sites, other (specified as soft tissue) 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: CPT Placement of needles or catheters into pelvic organs and/or genitalia (except prostate) for subsequent interstitial radioelement application Insertion of uterine tandems and/or vaginal ovoids for clinical brachytherapy Insertion of Heyman capsules for clinical brachytherapy HCPCS S2270 Insertion of vaginal cylinder for application of radiation source or clinical brachytherapy 179 Malignant neoplasm of uterus, part unspecified Malignant neoplasm of cervix uteri Malignant neoplasm of body of uterus Malignant neoplasm of vagina and vulva Secondary malignant neoplasm of genital organs (when specified as uterine, cervical, endometrial or vulvar/vaginal) Carcinoma in situ of cervix uteri Carcinoma in situ of other and unspecified parts of uterus Carcinoma in situ of vagina, vulva Page 12 of 17

13 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: CPT Ultrasonic guidance for interstitial radioelement application isodose calculation (includes codes 77326, 77327, 77328) Intracavitary radiation source application (includes codes 77761, 77762, 77763) Interstitial radiation source application (includes codes 77776, 77777, 77778) Remote afterloading high-intensity brachytherapy (includes codes 77781, 77782, 77783, 77784) Supervision, handling, loading of radioelement HCPCS Q3001 Radioelements for brachytherapy, any type; each ICD-9 Procedure Implantation or insertion of radioactive element 179 Malignant neoplasm of uterus, part unspecified Malignant neoplasm of cervix uteri Malignant neoplasm of body of uterus Malignant neoplasm of vagina, vulva 185 Malignant neoplasm of prostate Secondary malignant neoplasm of genital organs (when specified as uterine, cervical, endometrial or vulvar/vaginal) Carcinoma in situ of cervix uteri Carcinoma in situ of other and unspecified parts of uterus Carcinoma in situ of vagina, vulva Carcinoma in situ of prostate When services may be Medically Necessary when criteria are met: For the procedure codes listed above, for the following diagnosis codes Malignant neoplasm of bronchus and lung Malignant neoplasm of connective and other soft tissue Malignant neoplasm of female breast Malignant neoplasm of male breast Malignant neoplasm of eyeball, except conjunctiva, cornea, retina, and choroid Malignant neoplasm of choroid Secondary malignant neoplasm of lung (bronchus) Page 13 of 17

14 Secondary malignant neoplasm of breast Secondary malignant neoplasm of other specified sites, other (specified as soft tissue) Malignant carcinoid tumor of the bronchus and lung Carcinoma in situ of bronchus and lung Carcinoma in situ of respiratory system, part unspecified Carcinoma in situ of breast 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: CPT Placement of needles, catheters, or other device(s) into the head and/or neck region (percutaneous, transoral, or transnasal) for subsequent interstitial radioelement application 0182T High dose rate electronic brachytherapy, per fraction All diagnoses References 1. Arthur DW, Vicini FA, Kuske RR, et al. Accelerated partial breast irradiation: An updated report from the American Society. 2003; 1: Benitez PR, Chen PY, Vicini, et al. Partial breast irradiation in breast conserving therapy by way of interstitial brachytherapy. Am J Surg. 2004; 188: Bradley KA, Petereit DG. Radiation therapy for gynecologic malignancies. Hematol Oncol Clin N Am 20 (2006): 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): 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): Hematology/Oncology of North America. Radiation Therapy for Breast Cancer. Hematol Oncol Clin N Am 20. (2006); Hematology/Oncology of North America. The emergence of advanced brachytherapy techniques for common malignancies. Hematol Oncol Clin N Am 20. (2006); Huber RM, Fischer R, Hautmann H, et al. Does additional brachytherapy improve the effect of external irradiation? A prospective, randomized study in central lung tumors. Int J Radiat Oncol Biol Phys. 1997; 38(3): 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: Page 14 of 17

15 10. 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): 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: 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): 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): Perol M, Caliandro R, Pommier P, et al. Curative irradiation of limited endobronchial carcinomas with highdose rate brachytherapy. Results of a pilot study. Chest. 1997; 111(5): Polgar C, Sulyok Z, Fodor J, et al. Sole brachytherapy of the tumor bed after conservative surgery for T1 breast cancer; five year results of a phase I-II study and initial findings of a randomized phase III trial. J Surg Oncol. 2002; 80: Raben A, Mychalczak B. for non-small cell lung cancer and selected neoplasms of the chest. Chest.1997; 112(4 suppl):276s-286s. 17. 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 (11): Tam Truong, M. Hematology/Oncology Clinics of North America. Current role of radiation therapy in the management of malignant brain tumors. Hematol Oncol Clin N Am. 2006; (20): The American Society of Breast Surgeons. Consensus statement for accelerated partial breast irradiation. Revised December 8, Available at: Accessed on April 3, Ung C, Yu E, Falkson C, et.al. The role of high-dose-rate brachytherapy in the palliation of symptoms in patients with non-small-cell lung cancer: A systematic review ; 5( ). 21. University of Wisconsin. Phase II Multicatheter HDR breast brachytherapy. NCT : Last update October 27, Available at: Accessed on April 3, Vicini FA, Kestin L, Chen P, et al. Limited filed radiation therapy in the management of early stage breast cancer. J Nat Canc Instit. 2003; 95: Vicini FA, Beitsch P, Quiet C, et al. First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity. Results of the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Cancer. 2005; 104(6): ). Available at: Accessed on April 3, 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): Villanueva AG, Lo TC, Beamis JF. Endobronchial brachytherapy. Clin Chest Med. 1995; 16(3): Government Agency, Medical Society, and Other Authoritative Publications: 1. American Society. Breast Cancer. Available at: Accessed on April 3, Blue Cross Blue Shield Association. for accelerated partial breast irradiation after breastconserving surgery for early stage breast cancer. TEC Assessment 2002; 17(18). Page 15 of 17

16 3. Collaborative Ocular Melanoma Study (COMS) Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma. Arch Ophthalmol. 2006; 124(12): 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): Hayes Inc. Medical Technology Directory. Simultaneous Irradiation (ProstRcision ) for Localized Prostate Cancer. Lansdale, PA: Hayes, Inc.; August 23, Hayes Inc. Medical Technology Directory. for Breast Cancer. Lansdale, PA: Hayes, Inc.; April 11, Hayes Inc. Medical Technology Directory. Transperineal Ultrasound- Guided for Early Stage Prostate Cancer. Lansdale, PA: Hayes, Inc.; September, Search updated August 14, National Comprehensive Cancer Network (NCCN). Breast Cancer. Clinical Practice Guidelines in Oncology V Last update January 28, Available at: Accessed on April 3, National Comprehensive Cancer Network (NCCN). Soft Tissue Sarcoma. Clinical Practice Guidelines in Oncology V September 11, Available at: Accessed on April 3, U.S. Food and Drug Administration 510(k) Premarket Notification Database. Axxent Electronic System. No. K Rockville, MD: FDA. Available at: Accessed on April 3, Web Sites for Additional Information 1. American Cancer Society. Radiation therapy guide for patients and families. Revised October 2, Available at: Accessed on April 3, National Cancer Institute (NCI). Radiation therapy for cancer: Questions and Answers. Reviewed August 24, Available at: Accessed on April 3, National Cancer Institute. Breast cancer physician data query (PDQ ): Treatment. Last modified March 5, Available at: Accessed on April 3, National Cancer Institute. Intraocular (Eye) Melanoma Treatment (PDQ ). Last modified September 28, Available at: Accessed on April 4, Index Axxent Electronic System Breast Electronic High Dose Rate Temporary Implant Radiation Internal Radiation Page 16 of 17

17 Interstitial Seed MammoSite Radiation Therapy Systems ProstRcision 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. Document History Status Date Action Reviewed 10/01/2008 Updated coding section with 10/01/2008 ICD-9 and HCPCS changes. Revised 05/15/2008 Medical Policy and Technology Assessment Committee (MPTAC) Revised 05/14/2008 Hematology/Oncology Subcommittee review. Title changed to for Oncologic Indications. Added medically necessary criteria for ocular melanoma, vulvar/vaginal carcinoma and soft tissue sarcoma. Updated rationale, coding, references and websites. Reviewed 01/01/2008 Updated coding section with 01/01/2008 CPT changes. The phrase investigational/not medically necessary was clarified to read investigational and not medically necessary. This change was approved at the November 29, 2007 MPTAC meeting. Revised 05/17/2007 MPTAC review. Revised 05/16/2007 Hematology/Oncology Subcommittee review. Electronic brachytherapy added to list of investigational and not medically necessary.. Updated rationale, references and coding. Added new CPT code 0182T. Reviewed 12/07/2006 MPTAC review. Reviewed 12/06/2006 Hematology/Oncology Subcommittee review. References updated. Coding updated; removed CPT deleted 12/31/06. Reviewed 01/01/2007 Updated coding section with 01/01/2007 CPT/HCPCS changes; removed CPT deleted 12/31/2006, and HCPCS G0256, G0261 deleted 12/31/2003. Revised 12/01/2005 MPTAC review. Revised 11/30/2005 Hematology/Oncology Subcommittee review. Added medically necessary position statement for uterine, cervical and endometrial cancers. Added all other tumors not listed are investigational and not medically necessary. Reviewed 09/22/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. Pre-Merger Organizations Last Review Document Title Date Number Anthem, Inc. 10/27/2004 for Breast Cancer and Prostate Cancer Treatment WellPoint Health Networks, Inc. 04/28/ Breast 06/24/ Radioactive Seed Implantation for Prostate Cancer 06/24/ Endobronchial Page 17 of 17