Electronic Brachytherapy for Nonmelanoma Skin Cancer Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 01|01|2023 POLICY LAST REVIEWED: 08|20|2025 OVERVIEW Electronic brachytherapy is a form of radiotherapy designed to deliver high-dose rate radiation to treat nonmelanoma skin cancer (NMSC). This technique focuses a uniform dose of X-ray source radiation to the lesion with the aid of a shielded surface application.
MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION
Not applicable POLICY STATEMENT Medicare Advantage Plans Electronic brachytherapy for the treatment of nonmelanoma skin cancer is considered not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial Products Electronic brachytherapy for the treatment of nonmelanoma skin cancer is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for not medically necessary benefits/coverage.
BACKGROUND Nonmelanoma Skin Cancer Squamous cell carcinoma and basal cell carcinoma are the most common types of nonmelanoma skin cancer (NMSC) in the United States, affecting between 1 and 3 million people per year and increasing at a rate of 3% to 8% per year. Other types (e.g., T-cell lymphoma, Merkel cell tumor, basosquamous carcinoma, Kaposi sarcoma) are much less common. The primary risk factor for NMSC is sun exposure, with additional risk factors such as toxic exposures, other ionizing radiation exposure, and immunosuppression playing smaller roles. Although these cancers are rarely fatal, they can impact quality of life, functional status, and physical appearance. Treatment In general, the most effective treatment for NMSC is surgical. If surgery is not feasible or preferred, cryosurgery, topical therapy, or radiotherapy can be considered, though the cure rate may be lower. When considering the most appropriate treatment strategy, recurrence rate, preservation of function, patient expectations, and potential adverse events should be considered. Surgical The choice of surgical procedure depends on the histologic type and size and location of the lesion. Patient preferences can also play a factor in surgical decisions due to cosmetic reasons, as well as the consideration of comorbidities and patient risk factors, such as anticoagulation. Local excisional procedures, such as electrodessication and curettage or cryotherapy, can be used for low-risk lesions, while surgical excision is Medical Coverage Policy | Electronic Brachytherapy for Nonmelanoma Skin Cancer

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM indicated for lesions that are not low risk. Mohs surgery is a type of excisional procedure that uses microscopic guidance to achieve greater precision and sparing of normal tissue. In patients who meet criteria for Mohs surgery, 5-year cure rates for basal cell cancer range from 98% to 99%, making Mohs surgery the preferred procedure for those who qualify. Radiotherapy Radiotherapy is indicated for certain NMSCs not amenable to surgery. In some cases, this is due to the location of the lesion on the eyelid, nose, or other structures that make surgery more difficult and which may be expected to have a less desirable cosmetic outcome. In other cases, surgery may be relatively contraindicated due to clinical factors such as bleeding risk or advanced age. In elderly patients with a relatively large tumor that would require extensive excision, the benefit/risk ratio for radiotherapy may be considered favorable. The 5-year control rates for radiotherapy range from 80% to 92%, which is lower than that of surgical excision. A 1997 randomized controlled trial by Avril et al reported that radiotherapy for basal cell carcinoma resulted in greater numbers of persistent and recurrent lesions compared with surgical excision. When radiotherapy is used for NMSC, the primary modality is external-beam radiation. A number of different brachytherapy techniques have also been developed, including low-dose rate systems, iridium-based systems, and high-dose rate (HDR) systems. Electronic Brachytherapy Electronic brachytherapy is a form of radiotherapy delivered locally, using a miniaturized electronic X-ray source rather than a radionuclide-based source. A pliable mold is constructed of silicone or polymethyl- methacrylate and fitted to the tumor surface. This mold allows treatment to be delivered to nonflat surfaces such as the nose or ear. A radioactive source is then inserted into the mold to deliver a uniform radiation dosage directly to the lesion. Multiple treatment sessions within a short time period (typically within a month) are required. This technique is feasible for well-circumscribed, superficial tumors because it focuses a uniform dose of X- ray source radiation on the lesion with the aid of a shielded surface application. Advantages of this treatment modality compared with standard radiotherapy include a shorter treatment schedule, avoidance of a surgical procedure and hospital stay, less severe side effects because the focused radiation spares healthy tissue and organs, and the avoidance of radioisotopes. For individuals who have NMSC who receive electronic brachytherapy, the evidence includes 2 systematic reviews, 2 prospective cohort studies, and case series. Relevant outcomes are overall survival, disease-specific survival, change in disease status, and treatment-related morbidity. No controlled trials were identified that have compared electronic brachytherapy with alternative treatment options. A 2016 systematic review of case series found local control rates ranging from 83% to 100% and recurrence rates ranging from 0% to 17%. In most studies, the recurrence rate was less than 5%. A 2019 meta-analysis reported brachytherapy cosmesis grades and 5-year local control rates that were comparable to both Mohs micrographic surgery (MMS) and conventional excision. Preliminary results from a prospective matched pair cohort study reported no statistically significant difference in outcomes for the use of electronic brachytherapy compared to MMS in NMSC, but confidence in these findings is low due to study design and conduct limitations. In the absence of randomized controlled studies, conclusions cannot be drawn about the efficacy and safety of electronic brachytherapy compared with other treatments for NMSC. Controlled trials are needed in defined populations that compare electronic brachytherapy with alternatives, specifically other forms of radiotherapy or surgical approaches. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products, when filed with the ICD-10 diagnosis codes below.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

77436 Surface radiation therapy; superficial or orthovoltage, treatment planning and simulation-aided field setting (New Code Effective 1/1/2026) 77437 Surface radiation therapy; superficial, delivery, </=150 kv, per fraction (eg, electronic brachytherapy) (New Code Effective 1/1/2026) 77438 Surface radiation therapy; orthovoltage, delivery, >150-500 kv, per fraction (New Code Effective 1/1/2026) 77439 Surface radiation therapy; superficial or orthovoltage, image guidance, ultrasound for placement of radiation therapy fields for treatment of cutaneous tumors, per course of treatment (list separately in addition to code for primary procedure) (New Code Effective 1/1/2026) 0394T High dose rate electronic brachytherapy, skin surface application, per fraction, includes basic

dosimetry, when performed (Code Deleted Effective 12/31/2025)

ICD-10 Diagnosis Code Range C44.00 - C44.99

RELATED POLICIES None

PUBLISHED Provider Update, October 2025 Provider Update, October 2024 Provider Update, October 2023 Provider Update, November 2022 Provider Update, September 2021

REFERENCES

1. Bhatnagar A. Nonmelanoma skin cancer treated with electronic brachytherapy: results at 1 year. Brachytherapy. 2013; 12(2): 134-40. PMID 23312675
2. Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. Feb 20 2010; 375(9715): 673-85. PMID 20171403
3. American Academy of Dermatology Association. Skin cancer. Updated March 25, 2025. https://www.aad.org/media/stats-skin-cancer. Accessed May 21, 2025.
4. Kim JYS, Kozlow JH, Mittal B, et al. Guidelines of care for the management of basal cell carcinoma. J Am Acad Dermatol. Mar 2018; 78(3): 540-559. PMID 29331385
5. Alam M, Nanda S, Mittal BB, et al. The use of brachytherapy in the treatment of nonmelanoma skin cancer: a review. J Am Acad Dermatol. Aug 2011; 65(2): 377-388. PMID 21496952
6. Avril MF, Auperin A, Margulis A, et al. Basal cell carcinoma of the face: surgery or radiotherapy? Results of a randomized study. Br J Cancer. 1997; 76(1): 100-6. PMID 9218740
7. Lee CT, Lehrer EJ, Aphale A, et al. Surgical excision, Mohs micrographic surgery, external-beam radiotherapy, or brachytherapy for indolent skin cancer: An international meta-analysis of 58 studies with 21,000 patients. Cancer. Oct 15 2019; 125(20): 3582-3594. PMID 31355928
8. Delishaj D, Rembielak A, Manfredi B, et al. Non-melanoma skin cancer treated with high-dose-rate brachytherapy: a review of literature. J Contemp Brachytherapy. Dec 2016; 8(6): 533-540. PMID 28115960
9. Patel R, Strimling R, Doggett S, et al. Comparison of electronic brachytherapy and Mohs micrographic surgery for the treatment of early-stage non-melanoma skin cancer: a matched pair cohort study. J Contemp Brachytherapy. Aug 2017; 9(4): 338-344. PMID 28951753
10. Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. Mar 30 1995; 31(5): 1341-6. PMID 7713792
11. Cheng J, Henry GV, Lyden MR, et al. The Elekta Esteya ® electronic brachytherapy system in non- melanoma skin cancers: A post-market observational study. J Contemp Brachytherapy. Dec 2024; 16(6): 478-488. PMID 39943976

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

12. Doggett SW, Willoughby M, Miller KA, et al. Long-term clinical outcomes of non-melanoma skin cancer patients treated with electronic brachytherapy. J Contemp Brachytherapy. Feb 2023; 15(1): 9-14. PMID 36970438
13. Kuo AM, Lee EH, Rossi AM, et al. A Multicenter Prospective Trial of Electronic Skin Surface Brachytherapy for Keratinocyte Carcinoma: Early Cosmesis, Quality of Life, and Adverse Events. Int J Radiat Oncol Biol Phys. Jul 01 2023; 116(3): 544-550. PMID 36586493
14. Pellizzon ACA, Fogaroli R, Chen MJ, et al. High-dose-rate brachytherapy using Leipzig applicators for non-melanoma localized skin cancer. J Contemp Brachytherapy. Oct 2020; 12(5): 435-440. PMID 33299432
15. Paravati AJ, Hawkins PG, Martin AN, et al. Clinical and cosmetic outcomes in patients treated with high- dose-rate electronic brachytherapy for nonmelanoma skin cancer. Pract Radiat Oncol. 2015; 5(6): e659-
16. PMID 26432680
17. Delishaj D, Laliscia C, Manfredi B, et al. Non-melanoma skin cancer treated with high-dose-rate brachytherapy and Valencia applicator in elderly patients: a retrospective case series. J Contemp Brachytherapy. Dec 2015; 7(6): 437-44. PMID 26816500
18. Tormo A, Celada F, Rodriguez S, et al. Non-melanoma skin cancer treated with HDR Valencia applicator: clinical outcomes. J Contemp Brachytherapy. Jun 2014; 6(2): 167-72. PMID 25097557
19. Bhatnagar A, Loper A. The initial experience of electronic brachytherapy for the treatment of non- melanoma skin cancer. Radiat Oncol. Sep 28 2010; 5: 87. PMID 20875139
20. Gauden R, Pracy M, Avery AM, et al. HDR brachytherapy for superficial non-melanoma skin cancers. J Med Imaging Radiat Oncol. Apr 2013; 57(2): 212-7. PMID 23551783
21. Guix B, Finestres F, Tello J, et al. Treatment of skin carcinomas of the face by high-dose-rate brachytherapy and custom-made surface molds. Int J Radiat Oncol Biol Phys. Apr 01 2000; 47(1): 95-
22. PMID 10758310
23. Kim JYS, Kozlow JH, Mittal B, et al. Guidelines of care for the management of cutaneous squamous cell carcinoma. J Am Acad Dermatol. Mar 2018; 78(3): 560-578. PMID 29331386
24. Tom MC, Hepel JT, Patel R, et al. The American Brachytherapy Society consensus statement for electronic brachytherapy. Brachytherapy. 2019; 18(3): 292-298. PMID 30497939
25. Shah C, Ouhib Z, Kamrava M, et al. The American Brachytherapy society consensus statement for skin brachytherapy. Brachytherapy. 2020; 19(4): 415-426. PMID 32409128
26. Likhacheva A, Awan M, Barker CA, et al. Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: Executive Summary of an American Society for Radiation Oncology Clinical Practice Guideline. Pract Radiat Oncol. 2020; 10(1): 8-20. PMID 31831330
27. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer. Version 2.2025. https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf. Accessed May 22, 2025.

28. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Squamous Cell Skin Cancer. Version 2.2025. https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed May 27, 2025.

    i

    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS