Proposed LCD - MolDX: Molecular Biomarker Testing for Risk Stratification of Cutaneous Squamous Cell Carcinoma (DL39585)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityCurrent molecular biomarker tests that risk stratify individuals with cutaneous squamous cell carcinoma (cSCC) are non-covered by this contractor.General InformationAssociated InformationN/ASources of InformationN/ABibliographyLomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of wordwide incidence of nonmelanoma skin cancer.Br J Dermatol.2012;166(5):1069-1080. doi: 10.1111/j.1365-2133.2012.10830.xSchmults CD, Blitzblau R, Aasi SZ, et al. NCCN Guidelinesinsights: squamous cell skin cancer, version 1.2022.J Natl Compr Canc Netw. 2021;19(12):1382-1394. doi:10.6004/jnccn.2021.0059Muzic JG, Schmitt AR, Wright AC, et al. Incidence and trends of basal cell carcinoma and cutaneous squamous cell carcinoma: a population-based study in Olmsted County, Minnesota, 2000 to 2010.Mayo Clin Proc. 2017;92(6):890-898. doi:10.1016/j.mayocp.2017.02.015Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012.J Am Acad Dermatol. 2013;68(6):957-966. doi:10.1016/j.jaad.2012.11.037Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: incidence, risk factors, diagnosis, and staging.J Am Acad Dermatol. 2018;78(2):237-247. doi:10.1016/j.jaad.2017.08.059Waldman A, Schmults C. Cutaneous squamous cell carcinoma.Hematol Oncol Clin North Am. 2019;33(1):1-12. doi:10.1016/j.hoc.2018.08.001Stang A, Khil L, Kajter H, et al. Incidence and mortality for cutaneous squamous cell carcinoma: comparison across three continents.J Eur Acad Dermatol Venereol. 2019;33 Suppl 8(Suppl 8):6-10. doi:10.1111/jdv.15967NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Squamous Cell Skin Cancer. Version 1.2023.https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed April 18, 2023.Xiang F, Lucas R, Hales S, Neale R. Incidence of nonmelanoma skin cancer in relation to ambient UV radiation in white populations, 1978-2012: empirical relationships.JAMA Dermatol. 2014;150(10):1063-1071. doi:10.1001/jamadermatol.2014.762Juzeniene A, Grigalavicius M, Baturaite Z, Moan J. Minimal and maximal incidence rates of skin cancer in Caucasians estimated by use of sigmoidal UV dose-incidence curves.Int J Hyg Environ Health. 2014;217(8):839-844. doi:10.1016/j.ijheh.2014.06.002Rowe DE, Carroll RJ, Day CL Jr. Prognostic factors for local recurrence, metastasis, and survival rates in squamous cell carcinoma of the skin, ear, and lip. Implications for treatment modality selection.J Am Acad Dermatol. 1992;26(6):976-990. doi:10.1016/0190-9622(92)70144-5Eroglu A, Berberoglu U, Berreroglu S. Risk factors related to locoregional recurrence in squamous cell carcinoma of the skin.J Surg Oncol. 1996;61(2):124-130. doi:10.1002/(SICI)1096-9098(199602)61:2<124::AID-JSO6>3.0.CO;2-EMullen JT, Feng L, Xing Y, et al. Invasive squamous cell carcinoma of the skin: defining a high-risk group.Ann Surg Oncol. 2006;13(7):902-909. doi:10.1245/ASO.2006.07.022Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study.JAMA Dermatol. 2013;149(5):541-547. doi:10.1001/jamadermatol.2013.2139Oh Y, Zheng Z, Kim KY, et al. A nomogram combining clinical factors and biomarkers for predicting the recurrence of high-risk cutaneous squamous cell carcinoma.BMC Cancer. 2022;22(1):1126.Roscher I, Falk RS, Vos L, et al. Validating 4 staging systems for cutaneous squamous cell carcinoma using population-based data: a nested case-control study.JAMA Dermatol. 2018;154(4):428-434. doi:10.1001/jamadermatol.2017.6428Nelson TG, Ashton RE. Low incidence of metastasis and recurrence from cutaneous squamous cell carcinoma found in a UK population: do we need to adjust our thinking on this rare but potentially fatal event?.J Surg Oncol. 2017;116(6):783-788. doi:10.1002/jso.24707Matsumoto A, Li JN, Matsumoto M, Pineider J, Nijhawan RI, Srivastava D. Factors predicting outcomes of patients with high-risk squamous cell carcinoma treated with Mohs micrographic surgery.J Am Acad Dermatol. 2021;85(3):588-595. doi:10.1016/j.jaad.2021.01.063Thompson AK, Kelley BF, Prokop LJ, Murad MH, Baum CL. Risk factors for cutaneous squamous cell carcinoma recurrence, metastasis, and disease-specific death: a systematic review and meta-analysis.JAMA Dermatol. 2016;152(4):419-428. doi:10.1001/jamadermatol.2015.4994Baum CL, Wright AC, Martinez JC, et al. A new evidence-based risk stratification system for cutaneous squamous cell carcinoma into low, intermediate, and high risk groups with implications for management.J Am Acad Dermatol. 2018;78(1):141-147. doi:10.1016/j.jaad.2017.07.031Farasat S, Yu SS, Neel VA, et al. A new American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: creation and rationale for inclusion of tumor (T) characteristics.J Am Acad Dermatol. 2011;64(6):1051-1059. doi:10.1016/j.jaad.2010.08.033Lydiatt WM, Patel SG, O'Sullivan B, et al. Head and neck cancers-major changes in the American Joint Committee on Cancer eighth edition cancer staging manual.CA Cancer J Clin. 2017;67(2):122-137. doi:10.3322/caac.21389Karia PS, Jambusaria-Pahlajani A, Harrington DP, Murphy GF, Qureshi AA, Schmults CD. Evaluation of American Joint Committee on Cancer, International Union Against Cancer, and Brigham and Women's Hospital tumor staging for cutaneous squamous cell carcinoma.J Clin Oncol. 2014;32(4):327-334. doi:10.1200/JCO.2012.48.5326Stratigos AJ, Garbe C, Dessinioti C, et al. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: part 1. epidemiology, diagnostics and prevention.Eur J Cancer. 2020;128:60-82. doi:10.1016/j.ejca.2020.01.007Brunner M, Ng BC, Veness MJ, Clark JR. Comparison of the AJCC N staging system in mucosal and cutaneous squamous head and neck cancer.Laryngoscope. 2014;124(7):1598-1602. doi:10.1002/lary.24549Ruiz ES, Karia PS, Besaw R, Schmults CD. Performance of the American Joint Committee on Cancer Staging Manual, 8th Edition vs the Brigham and Women's Hospital Tumor Classification System for cutaneous squamous cell carcinoma.JAMA Dermatol. 2019;155(7):819-825. doi:10.1001/jamadermatol.2019.0032Patel VA, McCullum C, Sparks AD, Schmults CD, Arron ST, Jambusaria-Pahlajani A. Cutaneous squamous cell carcinoma staging may influence management in users: a survey study.Cancer Med. 2022;11(1):94-103. doi:10.1002/cam4.4426Stevens JS, Murad F, Smile TD, et al. CLO22-085: A dual-center retrospective cohort validation of the 2021 NCCN risk stratification for cutaneous squamous cell carcinoma.J Natl Compr Canc Netw. 2022;20(3.5):CLO22-085-CLO22-085. doi:10.6004/jnccn.2021.7281Venables ZC, Tokez S, Hollestein LM, et al. Validation of four cutaneous squamous cell carcinoma staging systems using nationwide data.Br J Dermatol. 2022;186(5):835-842. doi:10.1111/bjd.20909Caueto J, Burguillo J, Moyano-Bueno D, et al. Comparing the eighth and the seventh editions of the American Joint Committee on Cancer staging system and the Brigham and Women's Hospital alternative staging system for cutaneous squamous cell carcinoma: implications for clinical practice.J Am Acad Dermatol. 2019;80(1):106-113.e2. doi:10.1016/j.jaad.2018.06.060Puebla-Tornero L, Corchete-Snchez LA, Conde-Ferreirs A, et al. Performance of Salamanca refinement of the T3-AJCC8 versus the Brigham and Women's Hospital and Tbingen alternative staging systems for high-risk cutaneous squamous cell carcinoma.J Am Acad Dermatol. 2021;84(4):938-945. doi:10.1016/j.jaad.2020.12.020Conde-Ferreirs A, Corchete LA, Puebla-Tornero L, et al. Definition of prognostic subgroups in the T3 stage of the eighth edition of the American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: tentative T3 stage subclassification.J Am Acad Dermatol. 2021;85(5):1168-1177. doi:10.1016/j.jaad.2020.03.088