In the United States, the incidence of skin cancers outnumbers all other cancers combined, and basal cell cancers are twice as common as squamous cell skin cancers. While the two types share many characteristics, risk factors for local recurrence and for regional or distant metastases differ somewhat. Both types tend to occur in skin exposed to sunlight, and share the head and neck region as the area having the greatest risk for recurrence. Both occur more frequently and be more aggressive in immunocompromised transplant patients. In general, it is the squamous cell cancers that tend to be more aggressive, with a greater propensity to metastasize or to recur locoregionally. A squamous cell cancer is more likely to possess one or more high risk factors.

Risk factors for recurrence, as outlined by the NCCN®, vary according to several factors including histology, presence of perineural involvement, location, size, quality of the borders, presence of immunosuppression and whether the lesion is recurrent. Classification of low- vs. high-risk according to these variables is further defined in the NCCN guideline.

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

1. Technique
   1. Electron beam, superficial photon radiation or high-dose rate (HDR) brachytherapy is medically necessary for the treatment of localized basal cell and squamous cell cancers of the skin for any of the following:
      1. Definitive treatment
         1. When the member is inoperable or declines surgical resection
         2. When surgery would be disfiguring or result in functional compromise
      2. Postoperative treatment in the setting of
         1. Close or positive margins
         2. Gross perineural or large-nerve involvement
         3. Recurrent or T3-4 squamous cell carcinoma of the skin
   2. The use of radiation therapy is contraindicated in members with
      1. Genetic conditions predisposing them to heightened radiosensitivity
      2. Poorly controlled connective tissue disorders
   3. When multiple skin cancers are to be treated with radiation therapy, only treatment concurrently, rather than sequentially, is considered medically necessary
   4. The use of 3D conformal radiation is considered medically necessary when treating regional adenopathy
   5. Electronic brachytherapy is considered investigational
   6. The use of IGRT (Image Guided Radiation Therapy) including the use of ultrasound is considered not medically necessary
2. Dose
   1. Treatment schedules should be matched to the clinical circumstance, including size and depth of the lesion, histology, cosmetic goal, and risk of damage to underlying structures.
   2. In the treatment of localized disease, both conventional and hypofractionated regimens are utilized. In particular, the use of brachytherapy "lend themselves particularly well to moderate and extreme hypofractionation."
      1. Hypofractionation - examples of regimens considered medically necessary include, but are not limited to,
         1. 30 Gy in 5 fractions (i.t., for tumors < 2 cm in diameter)
         2. 40 Gy in 8 fractions
         3. 45 Gy in 15 fractions
         4. 50 Gy in 20 fractions
      2. Conventional fractionation - a dose of 60-70 Gy is considered medically necessary
   3. For members with nodal involvement, a dose of 50-70 Gy is considered medically necessary depending on the margin status and the presence of extranodal extension.
   
   

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE:
Management

Treatment should be customized, taking into account specific factors and also patient preferences. The primary goal is to completely remove the tumor and to maximize functional and cosmetic preservation. Surgery is usually the most efficient and effective means to achieve these goals. Radiation therapy may be selected when cosmetic or functional outcome with surgery is expected to be inferior. In very low risk, superficial cancers, topical agents may be sufficient and cautiously used. When surgery is utilized, margin assessment using Mohs micrographic technique should include examining vertical sections of the specimen to assess deep margin and stage/depth of invasion.

The ASTRO Clinical Practice Guideline on definitive and postoperative radiation therapy for basal and squamous cell cancers of the skin discourages the use of definitive radiation "in patients with genetic conditions predisposing them to heightened radiosensitivity, such as ataxia telangiectasia, nevoid basal cell carcinoma syndrome (Gorlin syndrome), or Li-Fraumeni syndrome." In addition, "poorly controlled connective tissue disorders are a relative contraindication to treatment."

The ASTRO clinical Practice Guideline also addresses the use of IGRT (Image Guided Radiation Therapy). They indicated that "for local treatment of skin targets, the task force emphasizes the importance of regular and frequent visual confirmation of surface coverage by the treating radiation oncologist (i.e., biweekly "see-on-table verification"). Daily imaging is neither necessary nor useful..."

Electronic brachytherapy

The American Brachytherapy society published "The American Brachytherapy Society Consensus Statement for Electronic Brachytherapy" to serve as a guideline for the appropriate use of electronic brachytherapy (Tom et al., 2019), In the consensus statement, the authors note concerns in extrapolating data from traditional brachytherapy techniques to electronic brachytherapy regarding "clinical outcomes, toxicity profiles, and indications." The consensus statement notes that there has been a rapid adoption of electronic brachytherapy in the treatment of nonmelanomatous skin cancers without meaningful comparison to standard radiation therapy techniques and without long term outcome data. The consensus statement recommends that until long term data from large prospective studies are available treatment with electronic brachytherapy for nonmelanomatous skin cancers should be performed on a clinical registry or trial. NCCN® also states that "there are insufficient long-term efficacy and safety data to support the routine use of electronic surface brachytherapy."

IGRT

The American Society for Radiation Oncology published "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" (Likhacheva et al, 2020). The guidelines state that "Daily imaging is neither necessary nor useful when treating with electron beam, low-energy radiation sources, or skin surface brachytherapy." As noted in the guidelines, "localization of the target can be achieved by "regular and frequent visual confirmation of skin coverage...(i.e., biweekly "see-on-table" verification)" (Likhacheva et al, 2020).]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Radiation Therapy for Skin Cancer - Basal Cell and Squamous Cell
Skin Cancer - Basal Cell
Skin Cancer - Squamous Cell
Basal Cell Skin Cancer
Squamous Cell Skin Cancer
Cancers of the skin - Basal Cell and Squamous Cell
Skin Cancer, Radiation Therapy for

References:

1. Abbas M and Kalia S. Trends in non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) in Canada: a descriptive analysis of available data. J Cutan Med Surg. 2016 Mar-Apr; 20(2):166-75.
2. 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. 2011 Aug; 65(2):377-388.
3. American Cancer Society: Skin cancer: Basal and Squamous Cell Skin Cancer.
4. Bhatnagar A. Clinical outcomes and patient-reported outcomes following electronic brachytherapy for the treatment of non-melanoma skin cancer. J Radiat Oncol Biol Phys. 2016 Oct; 96(2 Suppl):E713.
5. Devlin PM, Gaspar LE, Buzurovic I, et al. American College of Radiology - American Brachytherapy Society practice parameter for electronically generated low-energy radiation sources. Brachytherapy. 2017 Nov-Dec; 16(6):1083-1093.
6. Likhacheva M, Awan M, Barker C, 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. Practical Radiation Oncology. 2020 January - February; 10(1), pp. 8-20.
7. Mendenhall WM, Mancuso AA, Kiowan JM et al. Skin: principles and practice of radiation oncology. In: Halperin EC, Wazer DE, Perez CA, Brady LW, eds. Perez and Brady's Principles and Practice of Radiation Oncology. 6^th Edition. Philadelphia, PA: Lippincott Williams & Wilkins, a Wolters Kluwer business, 2013:626-637.
8. National Comprehensive Cancer Network NCCN Radiation Therapy Compendium™.
9. National Comprehensive Cancer Network (NCCN) Guidelines^©. Version 1.2020 - October 24, 2019. Basal Cell Skin Cancer. Accessed February 3, 2020. https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^©) for Basal Cell Skin Cancer Version 1.2020. 2019 National Comprehensive Cancer Network, Inc. All right reserved. The NCCN Guidelines^© and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN^©. To view the most recent and complete version of the NCCN Guidelines^©, go online to NCCN.org.
10. National Comprehensive Cancer Network (NCCN) Guidelines^©. Version 1.2020 - October 2, 2019. Squamous Cell Skin Cancer. Accessed February 3, 2020. https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^©) for Squamous Cell Skin Cancer Version 1.2020. 2019 National Comprehensive Cancer Network, Inc. All right reserved. The NCCN Guidelines^© and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN^©. To view the most recent and complete version of the NCCN Guidelines^©, go online to NCCN.org.
11. 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. 2017 Apr; 9(4):338-344.
12. Seegenschmeidt MH, Tepper JE,, Gunderson LI. Chapter 65: Benign Diseases. In: Gunderson L, Tepper J, eds. Clinical Radiation Oncology. 3^rd edition. Philadelphia, PA: Churchill Livingstone; 2012:1400.
13. Tom MC, Hepel JT et al. The American Brachytherapy Society consensus statement for electronic brachytherapy. Brachytherapy. 18(2019) 292-298.


Codes:

Enter Codes Here.

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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