Clinical Policy Title: Brachytherapy for cancers other than prostate

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1 Clinical Policy Title: Brachytherapy for cancers other than prostate Clinical Policy Number: Effective Date: January 1, 2016 Initial Review Date: August 19, 2015 Most Recent Review Date: September 21, 2016 Next Review Date: September 2017 Policy contains: Brachytherapy. Cancer therapy. Mammosite. Related policies: CP# Brachytherapy for localized prostate cancer ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Pennsylvania s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Pennsylvania when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Pennsylvania s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Pennsylvania s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Pennsylvania considers the use of brachytherapy for cancers other than prostate cancer to be clinically proven and, therefore, medically necessary for treatment of the following conditions: Condition Breast cancer, including accelerated partial breast irradiation (APBI). Criteria for each condition As an additional conformal boost to the surgical bed and margins following standard whole breast radiotherapy; or Women > 50 years of age with infiltrating ductal carcinoma who are clinical stage T1 or T2 with no distant metastases. Genitourinary cancers (including cervical, endometrial and ovarian) Must have locally advanced cervical cancer, or As an adjunct to surgery and/or chemotherapy for advanced ovarian cancer, or 1

2 Condition Criteria for each condition As adjunctive therapy for endometrial or vaginal cancer after surgery with or without external beam radiation. Respiratory cancers (including lung cancer) When used for palliation of obstructing and inoperable endobronchial carcinomas, with or without external beam radiation. Digestive tract cancers Palliation for obstructing esophageal cancers not considered operative candidates; or Endoscopically treated patients with unresectable advanced gastric carcinoma. Head, neck and oral cancers As primary treatment of carcinomas involving the face, the oral cavity, the naso- and oropharynx, the paranasal sinuses including base of skull, incomplete resections impinging on important structures; or Palliation of head and neck tumors. Penile cancers Squamous cell carcinoma of the penis as an alternative to penectomy. There is no evidence of metastatic disease. Ocular diseases: chorodial melanoma and retinoblastoma Uveal melanoma as an alternative to enucleation or exenteration; or Retinoblastoma of less than stage American Joint Commission on Cancer (AJCC) stage T4 or International Classification D and E. Coverage for these conditions applies for either high-dose rate or low-dose rate brachytherapy. Limitations: Brachytherapy for all other cancers except as indicated above is considered investigational and therefore not medically necessary. Note: The following CPT/HCPCS codes are not listed in the Pennsylvania Medicaid fee schedule: Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed; lesion diameter up to 2.0 cm or 1 channel 2

3 Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed; lesion diameter over 2 or more cm and 2 or more channels, or multiple lesions Unlisted procedure, clinical brachytherapy +0190T - Placement of intraocular radiation source applicator (List separately in addition to primary procedure-67036) 0394T - High dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, when performed 0395T - High dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed C Brachytherapy needle C Brachytherapy source, non-stranded, gold-198, per source C Brachytherapy source, non-stranded, high dose rate iridium-192, per source C Brachytherapy source, non-stranded, non-high dose rate iridium-192, per source C Brachytherapy source, non-stranded, yttrium-90, per source C Brachytherapy source, non-stranded, high activity, iodine-125, greater than 1.01 mci (NIST), per source C Brachytherapy source, non-stranded, high activity palladium-103, greater than 2.2 mci (NIST), per source C Brachytherapy linear source, non-stranded, paladium-103, per 1 mm C Brachytherapy source, non-stranded, ytterbium-169, per source C Brachytherapy source, stranded, iodine-125, per source C Brachytherapy source, non-stranded, iodine-125, per source C Brachytherapy source, stranded, palladium-103, per source C Brachytherapy source, non-stranded, palladium-103, per source 3

4 C Brachytherapy source, stranded, cesium-131, per source C Brachytherapy source, non-stranded, cesium-131, per source C Brachytherapy source, stranded, not otherwise specified, per source C Brachytherapy source, non-stranded, not otherwise specified, per source C Placement of endorectal intracavitary applicator for high intensity brachytherapy C Placement and removal (if performed) of applicator into breast for radiation therapy Q Radioelements for brachytherapy, any type, each Alternative covered services: Chemotherapy External beam irradiation Radical cancer surgery Background Brachytherapy, or interstitial radiation, is a form of radiation therapy in which encapsulated sources of radiation ( seeds ) are implanted directly into or adjacent to tumor tissues, for various types of cancers. Introduced in the 1960s, brachytherapy was initially used as a treatment for prostate cancer, the most common non-cutaneous malignancy in men. Since then, it has been employed to treat a variety of cancers, as well as other conditions such as stenotic obstruction after lung transplant, peripheral vascular disease and angioplasty. The treatment can also be used in conjunction with surgery or external beam radiation. Brachytherapy can employ a variety of radioactive isotopes, including Palladium-103, Iodine-125 (used for permanent implantation), Iridium-192 and Cesium-137 (used for temporary implantation). High and low doses are used in brachytherapy. In some studies, high doses have been found the preferable form of treatment. High-dose therapy is associated with patient convenience, more individualized therapy, a more accurate radiation source and greater ability to treat on an outpatient basis (Liu 2014). Searches 4

5 AmeriHealth Caritas Pennsylvania searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on August, 17, The search term was brachytherapy. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings The long period of time that brachytherapy has been used has allowed numerous trials to be conducted assessing the efficacy of the treatment. Numerous randomized controlled trials (RCTs) serve as the basis for meta-analyses to be conducted for a variety of cancers and other disorders. Our assessment of the evidence of medical efficacy of brachytherapy for cancers (other than prostate) is based largely on these meta-analyses, involving thousands of patients. Meta-analyses assessing brachytherapy s effects on breast cancer showed the technique is commonly performed after lumpectomy to destroy residual tumor cells and found to be more effective than conventional radiotherapy (Hayes, 2011). Another systemic review followed women with early-stage breast cancer treated with APBI; the project, known as the American Society of Breast Surgeons MammoSite Breast Brachytherapy Trial, showed highly positive results in treatment efficacy, reducing toxicity and achieving excellent/good cosmetic results (Shah, 2013; Vicini, 2011). Some meta-analyses compared efficacy of high-dose rate and low-dose rate brachytherapy for certain cancers. While these were associated with positive outcomes, results led investigators to recommend high-dose rate therapy for cervical cancer (Liu, 2014; Viani, 2009) and oral cancer (Liu, 2013). Other large-scale reviews compared results of brachytherapy to external beam radiation therapy, for lung cancer (Reveiz, 2012) and ovarian cancer (Gubbala, 2014); no significant differences were observed in either of these two large reviews, in terms of symptom relief and avoiding future cysts and metastases. 5

6 Studies have evaluated the recently-developed electronic brachytherapy for certain cancers, with positive results (Beitsch, 2010). Electronic brachytherapy was developed to improve radiation safety to patients and clinical personnel (Park, 2010). Other meta-analyses have evaluated the literature on the efficacy of brachytherapy for conditions other than malignancies. These include peripheral vascular disease (Andras, 2014) and following (lower limb) percutaneous angioplasty (Mitchell, 2012). Results have yet to show a consistent pattern in which patients treated with brachytherapy achieved superior outcomes. A number of professional societies have issued guidelines on the use of brachytherapy: American Brachytherapy Society. American College of Radiology/American Brachytherapy Society (joint). American Society of Breast Surgeons. American Society for Radiation Oncology/American College of Radiology (joint). American Urological Association. California Technology Assessment Forum. National Institute for Health and Clinical Excellence (UK). Policy updates: Aridgides (2016) in a longitudinal study assessed 60 patients with primary or recurrent pelvic malignancies (i.e., rectal, vulvar, cervical and ovarian) were treated with interstitial brachytherapy at a single institution, with categorized disease as follows: thirty three patients had primary malignancies with 6.1 percent being stage I, 33.3 percent stage II, 45.5 percent stage III, and 15.2 percent stage IV. The remaining 27 patients were recurrent malignancies. Fifty four patients received external beam radiotherapy as part of their treatment course, while 38 patients received concurrent chemotherapy. The median follow-up was 37 months and initial CR was achieved in 91 percent. For primary cancers at diagnosis, 5-year local control, 5-year progression-free survival, 5-year overall survival were 65 percent, 64 percent, and 42 percent respectively. For recurrent cancers at diagnosis, 5-year local control, 5-year progression-free survival, and 5-year overall survival were 80 percent, 51 percent, and 37 percent, respectively.there was a significant difference in both overall survival and progression-free survival among different tumor sites (p < 0.05), with vaginal cancers having the best 5-year overall survival (55%) and progression-free survival (84 percent). Summary of clinical evidence: Citation Aridgides (2016) Content, Methods, Recommendations Institutional experience using interstitial brachytherapy for the Longitudinal study assessed 60 patients with primary or recurrent pelvic malignancies other than prostate were treated with interstitial brachytherapy. Thirty three patients had primary malignancies with 6.1% being stage I, 33.3% stage II, 6

7 Citation treatment of primary and recurrent pelvic malignancies Liu (2014) High vs. low dose rate brachytherapy for uterine cervix cancer Gubbala (2014) Effectiveness of brachytherapy in ovarian cancer Andras (2014) Brachytherapy treatment for peripheral vascular disease Liu (2013) High vs. low dose rate brachytherapy for oral cancers Shah (2013) Efficacy, toxicity, cosmesis after accelerated partial breast irradiation Kong (2012) Brachytherapy treatment for stage I endometrial cancer Mitchell (2012) Endovascular brachytherapy following lower limb angioplasty Reveiz (2012) Content, Methods, Recommendations 45.5% stage III, and 15.2% stage IV The remaining 27 patients were recurrent malignancies. Fifty four patients received external beam radiotherapy as part of their treatment course. Thirty eight patients received concurrent chemotherapy. The median follow-up was 37 months (4-234 months) and initial complete response was achieved in 91%. For primary cancers at diagnosis, 5-year local control, 5-year progression-free survival, 5-year overall survival were 65%, 64%, and 42% respectively. For recurrent cancers at diagnosis, 5-year local control, 5-year progression-free survival, and 5-year overall survival were 80%, 51%, and 37%, respectively. There was a significant difference in both overall survival and progression-free survival among different tumor sites (p < 0.05), with vaginal cancers having the best 5-year overall survival (55%) and progression-free survival (84%). There was a total of 1 acute toxicity grade 3, 6 late grade 3 toxicities, and late grade 4 toxicity. Four trials, 1,265 participants. No significant difference in overall survival and relapse-free survival. Recommends using high dose brachytherapy for cervical cancer. Twenty-four trials, 892 participants. Surgery only vs. surgery + brachytherapy vs. surgery + external beam therapy. No difference in preserving ovarian function, avoiding cysts, avoiding metastases. Eight trials, 1,090 participants. Angioplasty with and without stenting, some with and some without brachytherapy. Primary outcomes potency and need for re-stenosis more data needed. Six trials, 607 patients. Therapy for early stage oral cancer. No significant difference in local recurrence. High-dose therapy may be the better choice. 1,449 cases of early-stage breast cancer, treated with MammoSite device. Average follow-up is five years. 3.8% tumor recurrence, 90% excellent/good cosmetic results, low toxicity. Eight trials, 4,273 participants. Vaginal intracavity brachytherapy vs. external beam radiotherapy. Lower recurrence in beam-treated patients; no difference in cancer-related deaths. Six trials, 687 participants. Percutaneous angioplasty with vs. without endovascular brachytherapy. Brachytherapy reduced restenosis after 12 months, no difference after 24 months. 7

8 Citation Brachytherapy for nonsmall cell lung cancer Hayes (2011) Brachytherapy for breast cancer Vicini (2011) Brachytherapy for breast cancer Viani (2009) Content, Methods, Recommendations Fourteen trials, 953 participants. Endobronchial brachytherapy vs. external beam radiation therapy symptom relief. No conclusive evidence brachytherapy relieved symptoms more effectively. Generally performed after lumpectomy, destroying residual tumor cells. Provides treatment over a shorter time span vs. conventional radiotherapy. 1,449 cases of early-stage breast cancer, receiving breast-conserving therapy. Five-year follow-up after treatment. 3.8% tumor recurrence, 90% excellent/good cosmetic results, low toxicity. Brachytherapy for cervical cancer Five trials, 2,065 participants. High- vs. low-dose brachytherapy for cervical cancer patients treated only with radiotherapy. High-dose group not significantly different for mortality, local recurrence, complications. Use of high-dose brachytherapy recommended. Glossary Brachytherapy A form of radiation therapy in which encapsulated sources of radiation ( seeds ) are implanted directly into or adjacent to tumor tissues. Intensity-modulated radiation therapy Techniques that deliver therapeutic radiation more precisely to maximize exposure of tumors while avoiding surrounding tissue. Interstitial radiation See brachytherapy. References Professional society guidelines/other: American College of Radiology (ACR) and the American Brachytherapy Society. ACR-ABS practice parameter for the performance of radionuclide-based high-dose rate brachytherapy (Also low dose). Revised Website. Accessed August 21, American Society of Breast Surgeons. Consensus statement for accelerated partial breast irradiation. Revised Website. Accessed August 21,

9 American Urological Association. Prostate Cancer. Reviewed and validated Website. Accessed August 21, Beriwal S, Demanes DJ, Erickson B, et al.; American Brachytherapy Society. American Brachytherapy Society consensus guidelines for interstitial brachytherapy for vaginal cancer. Brachytherapy. 2012;11(1): 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): Davis BJ, Horwitz EM, Lee WR, et al. American Brachytherapy Society consensus guidelines for transrectal ultrasound-guided permanent prostate brachytherapy. Brachytherapy. 2012;11(1):6 19. 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): Gaspar LE, Nag S, Herskovic A, et al. American Brachytherapy Society (ABS) consensus guidelines for brachytherapy of esophageal cancer. Clinical Research Committee, American Brachytherapy Society, Philadelphia, PA. Int J Radiat Oncol Biol Phys. 1997;38(1): Hayes Inc. Directory pocket summary. Brachytherapy for breast cancer. Lansdale, Pa. Hayes Inc.; March 25, Nag S, Beyer D, Friedland J, et al. American Brachytherapy Society (ABS) recommendations for transperineal permanent brachytherapy of prostate cancer. Int J Radiat Oncol Biol Phys. 1999;44(4): Nag S, Cano ER, Demanes DJ, et al. The American Brachytherapy Society recommendations for highdose-rate brachytherapy for head-and-neck carcinoma. Int J Radiat Oncol Biol Phys. 2001;50(5): Nag S, Shasha D, Janjan N, et al. The American Brachytherapy Society recommendations for brachytherapy of soft tissue sarcomas. Int J Radiat Oncol Biol Phys. 2001;49(4): Nag S, Chao C, Erickson B, et al. The American Brachytherapy Society recommendations for low-doserate brachytherapy for carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2002;52(1): 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):

10 National Institute for Health and Clinical Excellence (NICE). Interventional procedures overview of high dose rate (HDR) brachytherapy for carcinoma of the cervix. London, UK: NICE; Rosenthal SA, Bittner NH, Beyer DC, et al.; American Society for Radiation Oncology; American College of Radiology. American Society for Radiation Oncology (ASTRO) and American College of Radiology (ACR) practice guideline for the transperineal permanent brachytherapy of prostate cancer. Int J Radiat Oncol Biol Phys. 2011; 79(2): Tice JA. Brachytherapy as Primary Radiation Therapy Following Breast-conserving Surgery for Stage I or II Breast Cancer. California Technology Assessment Forum (CTAF). San Francisco, CA: CTAF; Yamada Y, Rogers L, Demanes DJ, et al. American Brachytherapy Society. American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. Brachytherapy. 2012; 11(1): Peer-reviewed references: Andras A, Hansrani M, Stewart M, Stansby G. Intravascular brachytherapy for peripheral vascular disease. Cochrane Database Syst Rev. 2014;1:CD Aridgides P, Onderdonk B, Cunningham M, et al. Institutional experience using interstitial brachytherapy for the treatment of primary and recurrent pelvic malignancies. Jnl Contemp Brach. 2016;8(3): Arthur DW, Vicini FA, Kuske RR, et al. Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Brachytherapy. 2003;2(2): Beitsch PD, Patel RR, Lorenzetti JD. Post-surgical treatment of early-stage breast cancer with electronic brachytherapy: An intersociety, multicenter brachytherapy trial. Onco Targets Ther. 2010;3: 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): Cardona AF, Reveiz L, Ospina EG. Palliative endobronchial brachytherapy for non-small cell lung cancer. Cochrane Database Syst Rev. 2008;(2):CD Dickler A, Dowlatshahi K. Xoft Axxent electronic brachytherapy. Expert Rev Med Devices. 2009;6(1): Dickler A, Puthawala MY, Thropay JP. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010;5:67. 10

11 Gubbala K, Laios A, Ballos I, Patthiraia P, Haldar K, Ind T. Outcomes of ovarian transposition in gynaecological cancers; a systematic review and meta-analysis. J Ovarian Res. 2014;7:69. Haffty BG, Vicini FA, Beitsch P. Timing of Chemotherapy after MammoSite radiation therapy system breast brachytherapy: Analysis of the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Int J Radiat Oncol Biol Phys. 2008;72(5): Kong A, Johnson N, Kitchener HC, Lawrie TA. Adjuvant radiotherapy for stage I endometrial cancer. Cochrane Database Syst Rev. 2012;4CD Lawton CA, Yan Y, Lee WR, et al. Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2012;82(5):e795 e801. Liu R, Wang X, Tian JH, et al. High dose rate versus low dose rate intracavity brachytherapy for locally advanced uterine cervix cancer. Cochrane Database of Syst Rev. 2014;(10):CD Liu Z, Huang S, Shang D. High dose rate versus low dose rate brachytherapy for oral cancer a meta analysis of clinical trials. PLoSOne. 2013;8(6):e Mattiucci GC, Autorino R, Tringali A, et al. A Phase I study of high-dose-rate intraluminal brachytherapy as palliative treatment in extrahepatic biliary tract cancer. Brachytherapy. 2015;14(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): Mitchell D, O'Callaghan AP, Boyle EM, et al. Endovascular brachytherapy and restenosis following lower limb angioplasty: Systematic review and meta-analysis of randomized clinical trials. Int J Surg. 2012;10(3): 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): Reveiz L, Rueda JR, Cardona AF. Palliative endobronchial brachytherapy for non-small cell lung cancer. Cochrane Database Syst Rev. 2012;(12):CD

12 Shah C, Badiyan S, Ben Wilkinson J, et al. Treatment efficacy with accelerated partial breast irradiation (APBI): final analysis of the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Ann Surg Oncol. 2013;20(10): Viani GA, Manta GB, Stefano EJ, de Fendi LI. Brachytherapy for cervix cancer: Low-dose rate or high-dose rate brachytherapy - a meta-analysis of clinical trials. J Exp Clin Cancer Res. 2009;28:47. Vicini F, Beitsch P, Quiet C, et al. Five-year analysis of treatment efficacy and cosmesis by the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in patients treated with accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2011;79(3): Zannis V, Beitsch P, Vicini F, et al. Descriptions and outcomes of insertion techniques of a breast brachytherapy balloon catheter in 1403 patients enrolled in the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Am J Surg. 2005;190(4): Clinical trials: Searched clinicaltrials.gov on August 21, 2016 using term brachytherapy Open Studies. 59 studies found, 5 relevant. Memorial Sloan Kettering Cancer Center. Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma. ClinicalTrials.gov Web site. Published May 5, Updated June Accessed August 21, Memorial Sloan Kettering Cancer Center. Dose Escalation Trial of Endoluminal High-Dose-Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management. ClinicalTrials.gov Web site. Published July 22, Updated July Accessed August 21, Gynecologic Oncology Group. Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer. ClinicalTrials.gov Web site. Published August 10, Updated March Accessed July 15, Xoft, Inc. Electronic Brachytherapy for the Treatment of NMSC. ClinicalTrials.gov Web site. Published November 13, Updated July Accessed August 21, National Cancer Institute (NCI). Radiation Therapy and Cisplatin With or Without Triapine in Treating Patients With Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer. 12

13 ClinicalTrials.gov Web site. NCT Published June 5, Updated June Accessed August 21, CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy concurrent with partial mastectomy (List separately in addition to code for primary procedure) 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 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) Placement of needles, catheters, or other device(s) into the head and/or neck region (percutaneous, transoral, or transnasal) for subsequent interstitial radioelement application Laparoscopy, surgical; with biopsy Laparoscopy, surgical; with placement of interstitial device(s) for radiation therapy guidance (eg, fiducial markers, dosimeter), intraabdominal, intrapelvic, and/or retroperitoneum, including imaging guidance, if performed, single or multiple (list separately in addition to code for primary procedure) Placement of interstitial device(s) for radiation therapy guidance (eg, fiducial markers, dosimeter), open, intra-abdominal, intrapelvic, and/or retroperitoneum, including image guidance, if performed, single or 13

14 CPT Code Description Comment multiple (list separately in addition to code for primary procedure) 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 a vaginal radiation afterloading apparatus for clinical brachytherapy Stereotactic localization, including burr hole(s), with insertion of catheter(s) or probe(s) for placement of radiation source Brachytherapy isodose plan; simple (calculation[s] made from 1 to 4 sources, or remote afterloading brachytherapy, 1 channel), includes basic dosimetry calculation(s) Brachytherapy isodose plan; intermediate (calculation[s] made from 5 to 10 sources, or remote afterloading brachytherapy, 2-12 channels), includes basic dosimetry calculation(s) Brachytherapy isodose plan; complex (calculation[s] made from over 10 sources, or remote afterloading brachytherapy, over 12 channels), includes basic dosimetry calculation(s) Infusion or instillation of radioelement solution (includes 3- month followup care) Intracavitary radiation source application; simple Intracavitary radiation source application; intermediate Intracavitary radiation source application; complex Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed; lesion diameter up to 2.0 cm or 1 channel Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed; lesion diameter over 2 or more cm and 2 or more channels, or multiple lesions Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry when performed; 1 channel Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry when performed; 2-12 channels Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry when performed; over 12 channels 14

15 CPT Code Description Comment Interstitial radiation source application; complex Surface application of radiation source Unlisted procedure, clinical brachytherapy +0190T 0395T Placement of intraocular radiation source applicator (List separately in addition to primary procedure-67036) High dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed ICD-10 Code Description Comment C15.3-C15.9 C16.0-C16.9 C34.00-C34.92 Malignant neoplasm of esphagus Malignant neoplasm of stomach Malignant neoplasm of lung C C Malignant neoplasm of breast C53.0 Malignant neoplasm of endocervix C53.1 Malignant neoplasm of exocervix C53.8 Malignant neoplasm of overlapping sites of cervix uteri C53.9 Malignant neoplasm of cervix uteri unspecified C60.0-C60.9 C69.90-C69.92 Malignant neoplasm of penis Malignant neoplasm of eyeball HCPCS Code Description Comment C1715 C1716 C1717 C1719 C2616 C2634 C2635 C2636 C2637 Brachytherapy needle Brachytherapy source, non-stranded, gold-198, per source Brachytherapy source, non-stranded, high dose rate iridium-192, per source Brachytherapy source, non-stranded, non-high dose rate iridium-192, per source Brachytherapy source, non-stranded, yttrium-90, per source Brachytherapy source, non-stranded, high activity, iodine-125, greater than 1.01 mci (NIST), per source Brachytherapy source, non-stranded, high activity palladium-103, greater than 2.2 mci (NIST), per source Brachytherapy linear source, non-stranded, paladium-103, per 1 mm Brachytherapy source, non-stranded, ytterbium-169, per source 15

16 HCPCS Code Description Comment C2638 C2639 C2640 C2641 C2642 C2643 C2698 C2699 C9725 C9726 Q3001 Brachytherapy source, stranded, iodine-125, per source Brachytherapy source, non-stranded, iodine-125, per source Brachytherapy source, stranded, palladium-103, per source Brachytherapy source, non-stranded, palladium-103, per source Brachytherapy source, stranded, cesium-131, per source Brachytherapy source, non-stranded, cesium-131, per source Brachytherapy source, stranded, not otherwise specified, per source Brachytherapy source, non-stranded, not otherwise specified, per source Placement of endorectal intracavitary applicator for high intensity brachytherapy Placement and removal (if performed) of applicator into breast for radiation therapy Radioelements for brachytherapy, any type, each 16