Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies Form

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Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies

Indications

(1) Does the request meet this criterion: HeproDX (GoPath Laboratories) (CPT 0006M)? 
(2) Does the request meet this criterion: OncoTarget/OncoTreat (Darwin Health) (CPT 0019U)? 
(3) Does the request meet this criterion: EXaCT-1 Whole Exome Testing (Weill Cornell Medicine Clinical Genomics Lab) (CPT 0036U)? 
(4) Does the request meet this criterion: LC-MS/MS Targeted Proteomic Assay (OncoOmicDx Laboratory) (CPT 0174U)? 
(5) Does the request meet this criterion: oncoReveal™ DX Lung and Colon Cancer Assay (Pillar® Biosciences) (0448U, Deleted Code Effective 12/31/2024) MEDICAL CRITERIA Medicare Advantage Plans and Commercial Products Effective 9/1/2025, the following test(s) are considered medically necessary when the medical criteria in the? 

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM


EFFECTIVE DATE: 09|01|2025 POLICY LAST REVIEWED: 05|21|2025

OVERVIEW
Comprehensive genomic profiling offers the potential to evaluate a large number of genetic markers at a single time to identify cancer treatments that target specific biologic pathways. This policy focuses on “expanded” panels, which are defined as molecular panels that test a wide variety of genetic markers in cancers without regard for whether specific targeted treatment has demonstrated benefit. This approach may result in a treatment different from that usually selected for a patient based on the type and stage of cancer.

The following tests are addressed in this policy: • HeproDX (GoPath Laboratories) (CPT 0006M) • OncoTarget/OncoTreat (Darwin Health) (CPT 0019U) • EXaCT-1 Whole Exome Testing (Weill Cornell Medicine Clinical Genomics Lab) (CPT 0036U)
• LC-MS/MS Targeted Proteomic Assay (OncoOmicDx Laboratory) (CPT 0174U) • oncoReveal™ DX Lung and Colon Cancer Assay (Pillar® Biosciences) (0448U, Deleted Code Effective 12/31/2024)

MEDICAL CRITERIA Medicare Advantage Plans and Commercial Products Effective 9/1/2025, the following test(s) are considered medically necessary when the medical criteria in the online authorization tool for participating providers is met: • Oncomine™ Dx Target Test (Life Technologies Corp) (CPT 0022U)
• FoundationOne CDx™ (F1CDx) (Foundation Medicine) (CPT 0037U)
• Praxis (TM) Extended RAS Panel (Illumina) (CPT 0111U)
• myChoice® CDx (Myriad) (CPT 0172U)
• MI Cancer Seek™ NGS Analysis (Caris MPI d/b/a Caris Life Sciences) (CPT 0211U)
• FoundationOne® Liquid CDx (Foundation Medicine) (CPT 0239U)
• Guardant360® CDx (Guardant Health) (CPT 0242U)
• xT CDx (Tempus AI, Inc.) (CPT 0473U)

Medicare Advantage Plans and Commercial Products The following tests may be medically necessary when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, ordered by a treating physician and the medical criteria below are met:
• oncoReveal™ DX Lung and Colon Cancer Assay

Somatic (Acquired) Cancer:

  1. Patient has:
    A. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and B. not been previously tested with the same test using NGS for the same cancer genetic content, and C. decided to seek further cancer treatment (e.g., therapeutic chemotherapy). AND
  2. The diagnostic laboratory test using next generation sequencing (NGS) must have:
    A. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and, B. an FDA-approved or -cleared indication for use in that patient’s cancer; and, Medical Coverage Policy | Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

C. results provided to the treating physician for management of the patient using a report template to specify treatment options. OR Germline (Inherited) Cancer:

  1. Patient has: A. ovarian or breast cancer; and, B. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and, C. a risk factor for germline (inherited) breast or ovarian cancer; and D. not been previously tested with the same germline test using NGS for the same germline genetic content. AND
  2. The diagnostic laboratory test using NGS must have all of the following: A. FDA-approval or clearance; and, B. results provided to the treating physician for management of the patient using a report template to specify treatment options.

    PRIOR AUTHORIZATION
    Medicare Advantage Plans and Commercial Products Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online tool for participating providers for the following tests: • Oncomine™ Dx Target Test
    • FoundationOne CDx™ (F1CDx)
    • Praxis (TM) Extended RAS Panel
    • myChoice® CDx
    • MI Cancer Seek™ NGS Analysis • FoundationOne® Liquid CDx
    • Guardant360® CDx
    • xT CDx

    Medicare Advantage Plans and Commercial Products Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products for the following tests: • oncoReveal™ DX Lung and Colon Cancer Assay

    POLICY STATEMENT Medicare Advantage Plans and Commercial Products Effective 9/1/2025, the following test(s) may be considered medically necessary when the medical criteria in the online authorization tool for participating providers is met: • Oncomine™ Dx Target Test • FoundationOne CDx™ (F1CDx) • Praxis (TM) Extended RAS Panel • myChoice® CDx • MI Cancer Seek™ NGS Analysis • FoundationOne® Liquid CDx
    • Guardant360® CDx
    • xT CDx

    Medicare Advantage Plans and Commercial Products The following tests may be considered medically necessary when the medical criteria above are met: • oncoReveal™ DX Lung and Colon Cancer Assay

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

The following tests are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as the evidence is insufficient to determine that the technology results in an improvement in the new health outcomes: • HeproDx • OncoTarget/OncoTreat • EXaCT-1 Whole Exome Testing • LC-MS/MS Targeted Proteomic Assay

Note: Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in the authorization, appeal or other administrative processes related to prior authorization/medical necessity.

In no circumstance shall a laboratory or a physician/provider use a representative of a laboratory or anyone with a relationship to a laboratory and/or a third party to obtain authorization on behalf of the ordering physician, to facilitate any portion of the authorization process or any subsequent appeal of a claim where the authorization process was not followed and/or a denial for clinical appropriateness was issued, including any element of the preparation of necessary documentation of clinical appropriateness. If a laboratory or a third party is found to be supporting any portion of the authorization process, BCBSRI will deem the action a violation of this policy and severe action will be taken up to and including termination from the BCBSRI provider network. If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member.

Commercial Products Some genetic testing services are not covered and a contract exclusion for any self-funded group that has excluded the expanded coverage of biomarker testing related to the state mandate, R.I.G.L. §27-19-81 described in the Biomarker Testing Mandate policy. For these groups, a list of which genetic testing services are covered with prior authorization, are not medically necessary or are not covered because they are a contract exclusion can be found in the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies. Please refer to the appropriate Benefit Booklet to determine whether the member’s plan has customized benefit coverage. Please refer to the list of Related Policies for more information.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable laboratory and not medically necessary benefits/coverage.

BACKGROUND Traditional Therapeutic Approaches to Cancer Tumor location, grade, stage, and the patient’s underlying physical condition have traditionally been used in clinical oncology to determine the therapeutic approach to a specific cancer, which could include surgical resection, ionizing radiation, systemic chemotherapy, or combinations thereof. Currently, some 100 different types are broadly categorized according to the tissue, organ, or body compartment in which they arise. Most treatment approaches in clinical care were developed and evaluated in studies that recruited subjects and categorized results based on this traditional classification scheme.

This traditional approach to cancer treatment does not reflect the wide diversity of cancer at the molecular level. While treatment by organ type, stage, and grade may demonstrate statistically significant therapeutic efficacy overall, only a subgroup of patients may derive clinically significant benefit. It is unusual for a cancer treatment to be effective for all patients treated in a traditional clinical trial. Spear et al (2001) analyzed the efficacy of major drugs used to treat several important diseases. They reported heterogeneity of therapeutic responses, noting a low rate of 25% for cancer chemotherapeutics, with response rates for most drugs falling in the range of 50% to 75%. The low rate for cancer treatments is indicative of the need for better identification of characteristics associated with treatment response and better targeting of treatment to have higher rates of therapeutic responses.

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

Targeted Cancer Therapy Much of the variability in clinical response may result from genetic variations. Within each broad type of cancer, there may be a large amount of variability in the genetic underpinnings of the cancer. Targeted cancer treatment refers to the identification of genetic abnormalities present in the cancer of a particular patient, and the use of drugs that target the specific genetic abnormality. The use of genetic markers allows cancers to be further classified as “pathways” defined at the molecular level. An expanding number of genetic markers have been identified. These may be categorized into 3 classes, (1) genetic markers that have a direct impact on care for the specific cancer of interest, (2) genetic markers that may be biologically important but are not currently actionable, and (3) genetic markers of uncertain importance.

A smaller number of individual genetic markers fall into the first category (ie, have established utility for a particular cancer type). The utility of these markers has been demonstrated by randomized controlled trials that select patients with the marker and report significant improvements in outcomes with targeted therapy compared with standard therapy. Testing for these individual variants with established utility is not covered in this evidence review. In some cases, limited panels may be offered that are specific to one type of cancer (eg, a panel of several markers for NSCLC). This review is also not intended to address the use of cancer-specific panels that include a few variants. Rather, this review addresses expanded panels that test for many potential variants that do not have established efficacy for the specific cancer in question.

When advanced cancers are tested with expanded molecular panels, most patients are found to have at least one potentially pathogenic variant. The number of variants varies widely by types of cancers, different variants included in testing, and different testing methods among the available studies. In a study by Schwaederle et al (2015), 439 patients with diverse cancers were tested with a 236-gene panel. A total of 1813 molecular alterations were identified, and almost all patients (420/439 [96%]) had at least 1 molecular alteration. The median number of alterations per patient was 3, and 85% of patients (372/439) had 2 or more alterations. The most common alterations were in the TP53 (44%), KRAS (16%), and PIK3CA (12%) genes.

Some evidence is available on the generalizability of targeted treatment based on a specific variant among cancers that originate from different organs. There are several examples of variant-directed treatment that is effective in one type of cancer but ineffective in another. For example, targeted therapy for epidermal growth factor receptor variants have been successful in non-small-cell lung cancer but not in trials of other cancer types. Treatment with tyrosine kinase inhibitors based on variant testing has been effective for renal cell carcinoma but has not demonstrated effectiveness for other cancer types tested. “Basket” studies, in which tumors of various histologic types that share a common genetic variant are treated with a targeted agent, also have been performed. One such study was published in 2015 by Hyman et al. In this study, 122 patients with BRAF V600 variants in nonmelanoma cancers were treated with vemurafenib. The authors reported that there appeared to be antitumor activity for some but not all cancers, with the most promising results seen for non-small-cell lung cancer, Erdheim-Chester disease, and Langerhans cell histiocytosis.

NGS for Somatic (Acquired) and Germline (Inherited) Cancer Clinical laboratory diagnostic tests can include tests that, for example, predict the risk associated with one or more genetic variations. In addition, in vitro companion diagnostic laboratory tests provide a report of test results of genetic variations and are essential for the safe and effective use of a corresponding therapeutic product. Next Generation Sequencing (NGS) is one technique that can measure one or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic test.

Patients with cancer can have recurrent, relapsed, refractory, metastatic, and/or advanced stages III or IV of cancer. Clinical studies show that genetic variations in a patient’s cancer can, in concert with clinical factors, predict how each individual responds to specific treatments.

In application, a report of results of a diagnostic laboratory test using NGS (i.e., information on the cancer’s genetic variations) can contribute to predicting a patient’s response to a given drug: good, bad, or none at all. Applications of NGS to predict a patient’s response to treatment occurs ideally prior to initiation of such treatment.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when the criteria above are met.

The evidence for cancers of the breast and ovary suggests that the use of NGS can identify germline mutations which will lead to better treatment and health outcomes for patients with inherited cancers of the breast and ovary. The evidence for cancer of the breast and ovary indicates that NGS as a diagnostic tool can identify the germline mutations most likely to be targeted by a treatment regimen tailored to certain germline mutation. It is likely that the identification of such tailored treatment regimens in the clinical management of inherited cancers of the breast and ovary diagnosed by NGS will improve health outcomes of Medicare beneficiaries. Use of NGS as a diagnostic test has utility for patients in the discovery of new targeted therapies for inherited cancers and in the physician management of inherited cancers of the breast and ovary in Medicare beneficiaries.

For individuals who have advanced cancer that is being considered for targeted therapy who receive comprehensive genomic profiling of tumor tissue, using some of the tests referenced in this policy, the evidence includes a randomized controlled trial, nonrandomized trials, and systematic reviews of these studies. Relevant outcomes are overall survival, disease-specific survival, test validity, and quality of life. A large number of variants and many types of cancer preclude determination of the clinical validity of the panels as a whole, and clinical utility has not been demonstrated for the use of expanded molecular panels to direct targeted cancer treatment. The 1 published randomized controlled trial (SHIVA trial) that used an expanded panel reported no difference in progression-free survival compared with standard treatment. Additional randomized and nonrandomized trials for drug development, along with systematic reviews of these trials, have compared outcomes in patients who received molecularly targeted treatment with patients who did not. Generally, trials in which therapy was targeted to a gene variant resulted in improved response rates, progression-free survival, and overall survival compared to patients in trials who did not receive targeted therapy. A major limitation in the relevance of these studies for comprehensive genomic profiling is that treatment in these trials was guided both by the tissue source and the molecular target for drug development, rather than being matched solely by the molecular marker (ie, basket trials). As a result, these types of studies do not provide evidence of the benefit of broad molecular profiling compared to more limited genetic assessments based on known tumor-specific variants. Basket trials that randomize patients with various tumor types to a strategy of comprehensive genomic profiling followed by targeted treatment are needed, and several are ongoing. 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 codes may be considered medically necessary for Medicare Advantage Plans and Commercial Products when the medical criteria in the online authorization tool for participating providers is met: • Oncomine™ Dx Target Test – CPT Code 0022U • FoundationOne CDx™ (F1CDx) – CPT Code 0037U • Praxis(™) Extended RAS Panel – CPT Code 0111U • myChoice® CDx – CPT Code 0172U • MI Cancer Seek™ NGS Analysis – CPT Code 0211U
• FoundationOne® Liquid CDx – CPT Code 0239U • Guardant360® CDx – CPT Code 0242U • xT CDx – CPT Code 0473U

The following CPT code(s) may be considered medically necessary for Medicare Advantage Plans and
Commercial Products when the above medical criteria are met:

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 6 (401) 274-4848 WWW.BCBSRI.COM

This code can be used for oncoReveal™ DX Lung and Colon Cancer Assay: 0448U Oncology (lung and colon cancer), DNA, qualitative, next-generation sequencing detection of single- nucleotide variants and deletions in EGFR and KRAS genes, formalin-fixed paraffin-embedded (FFPE) solid tumor samples, reported as presence or absence of targeted mutation(s), with recommended therapeutic options (Deleted Code Effective 12/31/2024)

The following CPT codes are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:

This code can be used for Hepro Dx:
0006M Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier

This code can be used for OncoTarget/OncoTreat: 0019U Oncology, RNA, gene expression by whole transcriptome sequencing, formalin-fixed paraffin embedded tissue or fresh frozen tissue, predictive algorithm reported as potential targets for therapeutic agents

This code can be used for EXaCT-1 Whole Exome Testing:
0036U Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses

This code can be used for LC-MS/MS Targeted Proteomic Assay: 0174U Oncology (solid tumor), mass spectrometric 30 protein targets, formalin-fixed paraffin-embedded tissue, prognostic and predictive algorithm reported as likely, unlikely, or uncertain benefit of 39 chemotherapy and targeted therapeutic oncology agents

RELATED POLICIES Biomarker Testing Mandate
Proprietary Laboratory Analysis (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA)

PUBLISHED Provider Update, July 2025 Provider Update, January 2025 Provider Update, November 2023 Provider Update, June 2023 Provider Update, February 2023

REFERENCES

  1. Centers for Medicare and Medicaid Services. National Covered Determination (NCD) for Next Generation Sequencing (NGS) (90.2)
  2. Centers for Medicare and Medicaid Services. National Coverage Analysis (NCA) - Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) - Decision Memo. (2018, March 16). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision- memo.aspx?proposed=N&ncaid=290
  3. Spear BB, Heath-Chiozzi M, Huff J. Clinical application of pharmacogenetics. Trends Mol Med. May 2001; 7(5): 201-4. PMID 11325631
  4. Dienstmann R, Rodon J, Barretina J, et al. Genomic medicine frontier in human solid tumors: prospects and challenges. J Clin Oncol. May 20 2013; 31(15): 1874-84. PMID 23589551
  5. Drilon A, Wang L, Arcila ME, et al. Broad, Hybrid Capture-Based Next-Generation Sequencing Identifies Actionable Genomic Alterations in Lung Adenocarcinomas Otherwise Negative for Such Alterations by Other Genomic Testing Approaches. Clin Cancer Res. Aug 15 2015; 21(16): 3631-9. PMID 25567908

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 7 (401) 274-4848 WWW.BCBSRI.COM

  1. Johnson DB, Dahlman KH, Knol J, et al. Enabling a genetically informed approach to cancer medicine: a retrospective evaluation of the impact of comprehensive tumor profiling using a targeted next-generation sequencing panel. Oncologist. Jun 2014; 19(6): 616-22. PMID 24797823
  2. Schwaederle M, Daniels GA, Piccioni DE, et al. On the Road to Precision Cancer Medicine: Analysis of Genomic Biomarker Actionability in 439 Patients. Mol Cancer Ther. Jun 2015; 14(6): 1488-94. PMID 25852059
  3. O'Brien CP, Taylor SE, O'Leary JJ, et al. Molecular testing in oncology: problems, pitfalls and progress. Lung Cancer. Mar 2014; 83(3): 309-15. PMID 24472389
  4. Hyman DM, Puzanov I, Subbiah V, et al. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. Aug 20 2015; 373(8): 726-36. PMID 26287849
  5. Le Tourneau C, Kamal M, Tredan O, et al. Designs and challenges for personalized medicine studies in oncology: focus on the SHIVA trial. Target Oncol. Dec 2012; 7(4): 253-65. PMID 23161020
  6. Le Tourneau C, Delord JP, Goncalves A, et al. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of- concept, randomised, controlled phase 2 trial. Lancet Oncol. Oct 2015; 16(13): 1324-34. PMID 26342236
  7. Belin L, Kamal M, Mauborgne C, et al. Randomized phase II trial comparing molecularly targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer: cross- over analysis from the SHIVA trial. Ann Oncol. Mar 01 2017; 28(3): 590-596. PMID 27993804
  8. Schwaederle M, Zhao M, Lee JJ, et al. Impact of Precision Medicine in Diverse Cancers: A Meta-Analysis of Phase II Clinical Trials. J Clin Oncol. Nov 10 2015; 33(32): 3817-25. PMID 26304871
  9. Jardim DL, Fontes Jardim DL, Schwaederle M, et al. Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval. J Natl Cancer Inst. Nov 2015; 107(11). PMID 26378224
  10. Zimmer K, Kocher F, Spizzo G, et al. Treatment According to Molecular Profiling in Relapsed/Refractory Cancer Patients: A Review Focusing on Latest Profiling Studies. Comput Struct Biotechnol J. 2019; 17: 447-453. PMID 31007870
  11. Wheler JJ, Janku F, Naing A, et al. Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study. Cancer Res. Jul 01 2016; 76(13): 3690-701. PMID 27197177
  12. Tsimberidou AM, Hong DS, Ye Y, et al. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT): An MD Anderson Precision Medicine Study. JCO Precis Oncol. 2017; 2017. PMID 29082359
  13. Murciano-Goroff YR, Drilon A, Stadler ZK. The NCI-MATCH: A National, Collaborative Precision Oncology Trial for Diverse Tumor Histologies. Cancer Cell. Jan 11 2021; 39(1): 22-24. PMID 33434511
  14. Damodaran S, Zhao F, Deming DA, et al. Phase II Study of Copanlisib in Patients With Tumors With PIK3CA Mutations: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1F. J Clin Oncol. May 10 2022; 40(14): 1552-1561. PMID 35133871
  15. Kalinsky K, Hong F, McCourt CK, et al. Effect of Capivasertib in Patients With an AKT1 E17K- Mutated Tumor: NCI-MATCH Subprotocol EAY131-Y Nonrandomized Trial. JAMA Oncol. Feb 01 2021; 7(2): 271-278. PMID 33377972
  16. Salama AKS, Li S, Macrae ER, et al. Dabrafenib and Trametinib in Patients With Tumors With BRAF V600E Mutations: Results of the NCI-MATCH Trial Subprotocol H. J Clin Oncol. Nov 20 2020; 38(33): 3895-3904. PMID 32758030
  17. American Society of Clinical Oncology (ASCO) TAPUR Study Analysis Plan and Current Status https://old-prod.asco.org/research-data/tapur-study/study-results Accessed September 28, 2023.
  18. Hoes LR, van Berge Henegouwen JM, van der Wijngaart H, et al. Patients with Rare Cancers in the Drug Rediscovery Protocol (DRUP) Benefit from Genomics-Guided Treatment. Clin Cancer Res. Apr 01 2022; 28(7): 1402-1411. PMID 35046062
  19. Chakravarty D, Johnson A, Sklar J, et al. Somatic Genomic Testing in Patients With Metastatic or Advanced Cancer: ASCO Provisional Clinical Opinion. J Clin Oncol. Apr 10 2022; 40(11): 1231-1258. PMID 35175857
  20. Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. J Thorac Oncol. Mar 2018; 13(3): 323-358. PMID 29396253

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 8 (401) 274-4848 WWW.BCBSRI.COM

  1. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2024; https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed August 26, 2024.
  2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 5.2024; https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed August 27, 2024.
  3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 8.2024; https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed August 28, 2024.
  4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Cutaneous Melanoma. Version 2.2024; https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Accessed August 30,
  5. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer. Version 3.2024; https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed August 29, 2024.
  6. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Pancreatic Adenocarcinoma. Version 3.2024; https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed August 31, 2024.
  7. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 4.2024; https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed August 25, 2024.

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    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

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