Humana Pharmacogenomic Testing - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories NCD Pharmacogenomic Testing for Warfarin Response MolDX: Pharmacogenomics Testing LCD MolDX: Repeat Germline Testing 90.1 L38435 L38429 LCD Molecular Pathology Procedures L35000 LCD LCD LCD LCD LCD LCD MolDX: Pharmacogenomics Testing MolDX: Repeat Germline Testing MolDX: Pharmacogenomics Testing MolDX: Repeat Germline Testing MolDX: Pharmacogenomics Testing L38435 L38429 L38394 L38288 L38335 MolDX: Repeat Germline Testing L38351 MolDX: Pharmacogenomics Testing L38337 MolDX: Repeat Germline Testing L38353 Pharmacogenomics Testing MolDX: Pharmacogenomics Testing MolDX: Repeat Germline Testing L39063 L38294 L38274 L35000 LCD Molecular Pathology Procedures LCD Pharmacogenomics Testing L39063 Pharmacogenomics Testing Page: 2 of 23 J5 - Wisconsin Physicians Service Insurance Corporation J6 - National Government Services, Inc. IA, KS, MO, NE IL, MN, WI J8 - Wisconsin Physicians Service Insurance Corporation IN, MI J15 - CGS Administrators, LLC KY, OH JE - Noridian Healthcare Solutions, LLC JF - Noridian Healthcare Solutions, LLC CA, HI, NV, American Samoa, Guam, Northern Mariana Islands AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY JH - Novitas Solutions, Inc. AR, CO, NM, OK, TX, LA, MS JJ - Palmetto GBA AL, GA, TN JK - National Government Services, Inc. JL - Novitas Solutions, Inc. CT, NY, ME, MA, NH, RI, VT DE, D.C., MD, NJ, PA Pharmacogenomics Testing Page: 3 of 23 MolDX: Pharmacogenomics Testing LCD MolDX: Repeat Germline Testing L38294 L38274 JM - Palmetto GBA NC, SC, VA, WV LCD Pharmacogenomics Testing L39073 JN - First Coast Service Options, Inc. FL, PR, U.S. VI Description Pharmacogenomics testing is laboratory testing which has the potential to determine how an individual’s genetic factors may affect the safety and effectiveness of that individual’s response to a specific medication. The goal of pharmacogenomics testing is to reduce the incidence of adverse medication reactions while improving an individual’s positive response to the medication. Additionally, some tests may help provide information on how well a specific treatment may work for an individual. Cytochrome P450 enzymes are a group of enzymes that account for approximately 75 percent of drug metabolism in the human body. Enzymes encoded by the P450 genes (eg, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5) are found primarily in the liver. The action of the P450 enzymes affects the blood levels of many drugs. Genotyping for cytochrome P450 has been proposed for possible use in medical management of drug therapies including, but may not be limited to, anticoagulants, antiplatelet, barbiturates, opioid analgesics, proton pump inhibitors, psychotropic medications and selective estrogen receptor modulator (SERM). Examples of pharmacogenomics testing include, but may not be limited to, GeneSight Psychotropic, IDGenetix, Neuropsychiatric Panel EffectiveRX, PersonalisedRX, Roche Amplichip CYP450 Test, STA2R SureGene, VerifyNow and Warfarin Response Genotype. Pharmacogenomics testing is considered reasonable and necessary in limited circumstances as described below as an adjunctive personalized medical decision-making tool once a treating clinician has narrowed treatment possibilities to specific medications under consideration for use, or is already using a specified medication, based on other clinical considerations including the patient’s diagnosis, the patient’s other medical conditions, other medications, professional judgment, clinical science and basic science pertinent to the drug, and the individual’s preferences and values. 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). 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. Coverage Determination Pharmacogenomics Testing Page: 4 of 23 Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or 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 for a particular test, 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 following criteria: Pharmacogenomics testing (including single gene, multigene panels, and combinatorial tests) will be considered medically reasonable and necessary when all the following requirements are met: • Medical records show the individual’s diagnosis requires medication; AND • Medication the provider is using or considering for the treatment of the individual’s diagnosis is: o Known to have a gene(s)-drug interaction per the U.S. Food and Drug Administration (FDA) or Clinical Pharmacogenetic Implementation Consortium (CPIC) category levels A or B; AND o Gene is included on this test; AND • Test results would directly impact drug management of the individual’s condition; AND • If considering a multigene panel, the multi-gene panel is considered reasonable and necessary if more than one single gene on that panel would be considered reasonable and necessary for safe use of the medication in question or if multiple drugs are being considered (each fulfilling the criteria of actionable gene-drug interactions identified above) that have different relevant genes. Additionally, a gene panel must contain at a minimum all the necessary relevant gene/allele content required for their indicated use to meet clinical utility requirements. Such minimum criteria are determined by experts including relevant associations such as the Association for Molecular Pathology and are considered during the technical assessment; AND • The provider requesting this test has all of the following: Pharmacogenomics Testing Page: 5 of 23 o The licensure, qualifications, and necessary experience/training to diagnose the condition; AND o The ability to prescribe medications; AND o The ability to guide treatment with the test information 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 services/items will not be considered medically reasonable and necessary: • Genetic tests that have not demonstrated clinical utility, analytical and clinical validity via the MolDX Program • Genes not identified as having actionable use are not considered reasonable and necessary. The algorithms employed in combinatorial testing are also not currently considered reasonable and necessary components of multi-gene testing • Multi-gene panel if only a single gene on the panel is considered reasonable and necessary • Treating clinician is not considering treatment with a medication that has an actionable drug-gene interaction, or when the use of a medication with a drug-gene interaction is not reasonable and necessary • Diagnosis for which pharmacologic therapy is not indicated and the drug(s) under consideration are not indicated for the treatment of the individual’s diagnosis • Testing solely to predict an individual’s response to medication therapy to formulate a treatment plan • Asymptomatic individuals or diagnosis for which the individual is not currently seeking treatment • Testing that investigates the same germline genetic content, for the same genetic information, that has already been tested in the same individual A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment for these indications. There remains an absence of randomized blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management for these indications. Pharmacogenomics Testing Page: 6 of 23 Screening services such as presymptomatic genetic tests and services used to detect and undiagnosed diseased or disease predisposition are not a Medicare benefit and are not covered. The following test types are examples of testing services that may not be considered a benefit (statutory excluded) and denied as Medicare Excluded tests93: • Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law; OR • Tests that confirm a diagnosis or known information; OR • Tests to determine risk for developing a disease or condition; OR • Tests performed to measure the quality of a process; OR • Tests without diagnosis specific indications; OR • Tests identified as investigational by available literature and/or the literature supplied by the developer and are not a part of a clinical trial