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.
For individuals who have nonmelanoma skin cancer (NMSC) who receive electronic brachytherapy, the evidence includes 2 systematic reviews, a comparative prospective cohort study , and non-comparative observational studies. 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 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 Mohs micorgraphic surgery (MMS) in NMSC. 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.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Electronic brachytherapy for the treatment of nonmelanoma skin cancer is considered investigational.
| CPT | 77436 | Surface radiation therapy; superficial or orthovoltage, treatment planning and simulation-aided field setting (new eff 1/1/26) |
| 77437 | Surface radiation therapy; superficial, delivery, ≤150 kV, per fraction (eg, electronic brachytherapy) (new eff 1/1/26) | |
| 77438 | Surface radiation therapy; orthovoltage, delivery, >150-500 kV, per fraction (new eff 1/1/26) | |
| 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 eff 1/1/26) | |
| 0394T | High-dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, when performed. (delete eff 12/31/25) |
| ICD-10-CM | Investigational for all relevant diagnoses. | |
| Codes for basal cell and squamous cell carcinomas of the skin (C44.00-C44.99) are dependent on the anatomic location of the lesion. There are too many to list here so the following codes are just examples. | ||
| C44.211-C44.219 | Basal cell carcinoma of skin of ear and external auricular canal code range. | |
| C44.221-C44.229 | Squamous cell carcinoma of skin of ear and external auricular canal code range. | |
| C44.310-C44.319 | Basal cell carcinoma of skin of other and unspecified parts of face code range (includes nose). | |
| C44.320-C44.329 | Squamous cell carcinoma of skin of other and unspecified parts of face code range (includes nose). | |
| C44.41 | Basal cell carcinoma of skin of scalp and neck. | |
| C44.42 | Squamous cell carcinoma of skin of scalp and neck. |
Squamous cell carcinoma and basal cell carcinoma are the most common types of nonmelanoma skin cancer (NMSC) in the United States, affecting between 1 million and 3 million people per year,1,2, respectively and increasing at a rate of 3% to 8% per year.2, Other types (eg, T-cell lymphoma, Merkel cell tumor, basosquamous carcinoma, Kaposi sarcoma) are much less common. Skin cancer can affect anyone, regardless of skin color; however, the incidence of skin cancer among non-Hispanic White individuals is approximately 30 times higher than that among non-Hispanic Black or Asian/Pacific Islander individuals.3, In individuals with darker skin tones, skin cancer is often diagnosed at a later stage when it is more difficult to treat. Additionally, these individuals are prone to skin cancer in areas not commonly exposed to the sun such as the palms of the hands, soles of the feet, the groin, and inside of the mouth.
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.2, Although these cancers are rarely fatal, they can impact quality of life, functional status, and physical appearance.
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.4, When considering the most appropriate treatment strategy, recurrence rate, preservation of function, patient expectations, and potential adverse events should be considered.
The choice of surgical procedure depends on the histologic type, 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 electrodesiccation and curettage or cryotherapy, can be used for low-risk lesions, while surgical excision is indicated for lesions that are not low risk. Mohs surgery is an 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%,5, making Mohs surgery the preferred procedure for those who qualify.
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.5, A randomized controlled trial by Avril et al (1997) reported that radiotherapy for basal cell carcinoma resulted in greater numbers of persistent and recurrent lesions compared with surgical excision.6,
When radiotherapy is used for NMSC, the primary modality is external-beam radiotherapy. A number of different brachytherapy techniques have also been developed, including low-dose rate systems, iridium-based systems, and high-dose rate systems.5,
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, constructed of silicone or polymethyl-methacrylate, is 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.5, 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.5,
Electronic brachytherapy systems for the treatment of NMSCs are designed to deliver high-dose rate brachytherapy to treat skin surface lesions. This technique focuses a uniform dose of X-ray source radiation to the lesion with the aid of a shielded surface application. The Superficial X-Ray Radiation Therapy SRT-100 Vision™ System (Sensus Healthcare), Esteya® Electronic Brachytherapy System (Nucletron BV [now Elekta]), and the Xoft® Axxent® Electronic Brachytherapy System (iCAD; now Elekta Xoft® Axxent® Electronic Brachytherapy (eBx®) System® [Elekta] are systems that have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process.
U.S. Food and Drug Administration product code: JAD.
