Humana Genetic Testing - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type NCD LCD LCA LCD LCA Title ID Number Next Generation Sequencing MolDX: Molecular Diagnostic Tests (MDT) 90.2 L36807 Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57772 MolDX: Repeat Germline Testing L38429 Billing and Coding: MolDX: Repeat Germline Testing A57100 Molecular Pathology Procedures Billing and Coding: Molecular Pathology Procedures L35000 A56199 Jurisdiction Medicare Administrative Contractors (MACs) J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation J6 - National Government Services, Inc. (Part A/B MAC) JK - National Government Services, Inc. (Part A/B MAC Applicable States/Territories IA, KS, MO, NE IN, MI IL, MN, WI CT, NY, ME, MA, NH, RI, VT MolDX: Molecular Diagnostic Tests (MDT) Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) L38288 A56973 MolDX: Repeat Germline Testing L36021 Billing and Coding: MolDX: Repeat Germline Testing MolDX: Molecular Diagnostic Tests (MDT) Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) MolDX: Repeat Germline Testing Billing and Coding: MolDX: Repeat Germline Testing MolDX: Molecular Diagnostic Tests (MDT) Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57141 L35160 A57526 L38351 A57331 L36256 A57527 MolDX: Repeat Germline Testing L38353 Billing and Coding: MolDX: Repeat Germline Testing Biomarkers for Oncology Biomarkers Overview Billing and Coding: Molecular Pathology and Genetic Testing MolDX: Molecular Diagnostic Tests (MDT) A57332 L35396 L35062 A58917 L35025 A56853 LCD LCA LCD LCA LCD LCA LCD LCA LCD LCA Genetic Testing Page: 3 of 30 J15 - CGS Administrators, LLC (Part A/B MAC) KY, OH JE - Noridian Healthcare Solutions, LLC CA, HI, NV, American Samoa, Guam, Northern Mariana Islands JF - Noridian Healthcare Solutions, LLC AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY JH - Novitas Solutions, Inc. (Part A/B MAC) JL - Novitas Solutions, Inc. (Part A/B MAC) JJ - Palmetto GBA (Part A/B MAC) AR, CO, NM, OK, TX, LA, MS DE, D.C., MD, NJ, PA AL, GA, TN Genetic Testing Page: 4 of 30 JM - Palmetto GBA (Part A/B MAC) NC, SC, VA, WV L38274 A58017 L34519 A58918 JN - First Coast Service Options, Inc. (Part A/B MAC) FL, PR, U.S. VI Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) MolDX: Repeat Germline Testing Billing and Coding: MolDX: Repeat Germline Testing Molecular Pathology Procedures Billing and Coding: Molecular Pathology and Genetic Testing LCD LCA Description Deoxyribonucleic acid (DNA) is a molecule that carries instructions for the characteristics and functions of living organisms, including humans, and are transmitted from one generation to the next. An individual’s complete set of genetic instructions is referred to as the genome. Sometimes variants (mutations) take place and can disrupt an individual’s usual processes. This happens during DNA replication. The interference leads to a permanent alteration in the DNA sequence. Chromosomes, a single gene or multiple genes can mutate in a number of ways including substitutions, insertions (additions), deletions, duplications (copied at least one time) and repeat expansions (repetition of short DNA sequences). Variants can be insignificant or even beneficial; others are pathogenic (disease- causing). Variants can be detected with genetic testing by analyzing DNA with sequencing (sometimes referred to as next-generation sequencing [NGS]) or by analyzing deletions/duplications analysis and large genomic rearrangements. Some laboratories combine these methods, which is known as comprehensive testing. Germline (inherited) genetic testing refers to the identification of variants associated with inherited risk of disease which can be detected by evaluating an individual’s entire genome at a single time (referred to as whole genome sequencing [WGS]) or by targeting chromosomes, genes, gene regions or gene products within an individual’s genome that may play a role in the development or progression of an associated disease. An individual’s germline DNA is present at birth, is constant and is identical in all body tissue types. Almost any sample (eg, blood, saliva, buccal [cheek] smear, fresh or frozen tissues, formalin-fixed paraffin- embedded [FFPE] tissues, hair follicles and prenatal specimens) is suitable for germline testing. In general, germline testing for a particular disorder is performed once per lifetime; however, there are rare instances when repeat testing is appropriate. Somatic (tumor) testing differs from germline genetic testing. Genetic alterations in tumor tissue occur after birth and throughout the lifetime. As mentioned above, germline testing may be performed on essentially any sample; somatic analysis requires the applicable tumor tissue. Repeat somatic testing may be necessary when certain clinical situations arise. Genetic Testing Page: 5 of 30 Sometimes when tumor tissue is analyzed, a germline variant may be discovered. When this occurs the results should be validated with germline analysis, known as confirmatory testing. Laboratories may offer paired testing (somatic and germline analysis performed concurrently). Genetic testing may be used for a variety of purposes including, diagnostic to identify or rule out a suspected genetic condition in an individual who exhibits signs and symptoms of the disorder and pharmacogenomics testing which analyzes an individual’s unique genetic makeup to help determine response to a specific medication. Multigene (or expanded) panels analyze a broad set of genes simultaneously (as opposed to single gene testing that searches for variants in one specific gene) and have been proposed to evaluate the DNA of an individual with a personal and/or family history of more than one hereditary condition or syndrome or hereditary conditions/syndromes associated with more than one gene. Panels often include medically actionable genes but may also include those with unclear medical management. Targeted (or focused) multigene panels analyze a limited number of genes targeted to a specific condition. Exome sequencing, also referred to as whole exome sequencing (WES), is an alternative to whole genome sequencing (WGS). It is a laboratory test used to determine the sequence of the protein coding regions of the genome. The exome is the part of the genome that encodes protein, where roughly 85% of variants are known to contribute to diseases in humans. Exome sequencing has been proposed as a diagnostic method to identify these genetic variants in an individual not diagnosed by traditional diagnostic and genetic testing approaches. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Genetic tests must demonstrate clinical utility, analytical and clinical validity and fulfill the CMS “reasonable and necessary” criteria. Analytic validity (test accurately identifies the gene variant), clinical validity (test identifies or predicts the clinically defined disorder) and clinical utility (test measurably improves clinical outcomes) of the genetic test is supported by generally accepted standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, specialty society recommendations, and views of physicians practicing in relevant clinical areas. The test must be ordered by a physician who is treating the beneficiary and the results will be used in the management of a beneficiary’s specific medical problem. For jurisdictions with no Medicare guidance, Humana will utilize the MolDX program and Technical Assessments for molecular assays as the standard to evaluate clinical utility, analytical and clinical validity in conjunction with adhering to Medicare’s reasonable and necessary requirement. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Genetic Testing Page: 6 of 30 General Criteria for Genetic Testing Apply General Criteria for Genetic Testing when test specific criteria are not available on any medical coverage policy. Genetic testing will be considered medically reasonable and necessary when the following requirements are met: • Analytic validity (test accurately identifies the gene variant), clinical validity (test identifies or predicts the clinically defined disorder) and clinical utility (test measurably improves clinical outcomes) of the genetic test is supported by the MolDX Program or by generally accepted standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, specialty society recommendations and views of physicians practicing in relevant clinical areas; AND • Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or results are clearly equivocal; AND • Results of the genetic testing must directly impact treatment or management of the Medicare beneficiary; AND • A multigene panel is defined as a test that analyzes more than one gene simultaneously. A panel will be considered medically reasonable and necessary if more than one gene impacts the clinical management of the individual being tested. The panel must evaluate genes and/or alleles in accordance with the panel’s indicated use. Exome Sequencing Exome sequencing will be considered medically reasonable and necessary when the following requirements are met:54 • Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or results are clearly equivocal; AND • Analytic validity (test accurately identifies the gene variant), clinical validity (test identifies or predicts the clinically defined disorder) and clinical utility (test measurably improves clinical outcomes) of the genetic test is supported by the MolDX Program or by generally accepted standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, specialty society recommendations and views of physicians practicing in relevant clinical areas; AND • Results of the genetic testing must directly impact treatment or management of the Medicare beneficiary Known Familial Pathogenic or Likely Pathogenic Variant Genetic Testing Page: 7 of 30 Known familial variant (KFV) genetic testing will be considered medically reasonable and necessary when the individual to be tested is affected and has a first- second-or third-degree relative with a pathogenic or likely pathogenic variant. Genetic testing should be limited to the KFV. Repeat Germline Genetic Testing Repeat germline genetic testing will be considered medically reasonable and necessary when the following requirements are met:18 • Individual to be tested is affected with a condition known to be relevant to germline testing and a pathogenic or likely pathogenic KFV identified has been identified in a separate first- second-or third- degree relative not involved in the initial analysis and has not received prior genetic testing for the condition that would have found the KFV; OR • Technological advancements for genetic testing may detect previously missed pathogenic variants (eg, evaluation of deletions and large genomic rearrangement has become available and initial testing included sequencing only or new methods for capturing and sequencing DNA) Repeat Somatic Genetic Testing Repeat somatic genetic testing will be considered medically reasonable and necessary when the following requirements are met: • Examination of a new sample of the primary tumor; AND • Individual diagnosed with recurrence, relapse, is nonresponsive to treatment or experiences progression of disease while off treatment The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage The following tests may not be considered a benefit (statutory exclusion): • Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law;106 OR Genetic Testing Page: 8 of 30 • Tests performed to determine carrier screening;41 OR • Prenatal diagnostic testing;41 OR • Tests that confirm a diagnosis or known information;106 OR • Tests to determine risk for developing a disease or condition;106 OR • Tests performed to measure the quality of a process;106 OR • Tests without diagnosis specific indications;106 OR • Tests identified as investigational by available literature and/or the literature supplied by the developer and are not a part of a clinical trial106 These treatments and services fall within the Medicare program’s statutory exclusion that prohibits payment for items and services that have not been demonstrated to be reasonable and necessary for the diagnosis and treatment of illness or injury (§1862(a)(1) of the Act). Other services/items fall within the Medicare program’s statutory exclusion at 1862(a)(12), which prohibits payment. The following items for genetic testing will not be considered medically reasonable and necessary: • Any laboratory test that investigates the same germline genetic content, for the same genetic information, that has already been tested in the same individual • Deletion/duplication information is obtained as part of the sequencing procedure but submitted as an independent analysis • Genetic tests that have not demonstrated clinical utility, analytical and clinical validity via the MolDX Program • Individual to be tested has an affected first-, second- or third-degree relative with an uninformative (negative or variant of unknown significance [VUS]) genetic test result for the associated condition • KFV detection analysis if the individual to be tested previously received KFV testing, single gene analysis or multigene panel testing that would have detected the KFV • Repeat somatic genetic testing of the same tissue sample as the original somatic genetic test • Role of the gene to be analyzed has no known disease relationship A review of the current medical literature shows that the evidence is insufficient to determine that these services are standard medical treatments. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management. Genetic Testing Page: 9 of 30