Electronic Brachytherapy for Nonmelanoma Skin Cancer

POLICY NUMBER

A.8.01.62

DESCRIPTION

Electronic brachytherapy is a form of radiotherapy designed to deliver high-dose rate radiation to treat nonmelanoma skin cancer. This technique focuses a uniform dose of X-ray source radiation to the lesion with the aid of a shielded surface application.

Nonmelanoma Skin Cancer

Squamous cell carcinoma and basal cell carcinoma are the most common types of nonmelanoma skin cancer in the United States, affecting between 1 million and 3 million people per year, respectively, and increasing at a rate of 3% to 8% per year. 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. 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 nonmelanoma skin cancer 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.

TreatmentIn general, the most effective treatment for nonmelanoma skin cancer 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.

SurgicalThe 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%, making Mohs surgery the preferred procedure for those who qualify.

RadiotherapyRadiotherapy is indicated for certain nonmelanoma skin cancers 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 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 nonmelanoma skin cancer, 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.

Electronic BrachytherapyElectronic 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. 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.

Electronic brachytherapy systems for the treatment of nonmelanoma skin cancers 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. FDA product code: JAD.

POLICY

Electronic brachytherapy for the treatment of nonmelanoma skin cancer is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

07/16/2015: Approved by Medical Policy Advisory Committee.

12/31/2015: Code Reference section updated to add new 2016 CPT code 0394T.

05/26/2016: Policy number A.8.01.62 added.

08/23/2016: Policy description updated. Policy statement unchanged.

08/15/2017: Policy description updated. Policy statement unchanged. Code Reference section updated to remove deleted CPT code 0182T.

08/15/2018: Policy description updated regarding nonmelanoma skin cancer treatment and electronic brachytherapy. Policy statement unchanged. Policy Guidelines updated.

08/22/2019: Policy reviewed; no changes.

09/03/2020: Policy reviewed; no changes.

12/03/2021: Policy description updated regarding devices. Policy statement unchanged.

08/25/2022: Policy description updated regarding skin cancer. Policy statement unchanged.

08/15/2023: Policy reviewed; no changes.

08/15/2024: Policy reviewed; no changes.

09/16/2025: Policy description updated regarding electronic brachytherapy systems. Policy statement unchanged.

01/01/2026: Code Reference section updated to add new CPT codes 74436 - 74439.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 8.01.62

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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