POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Concert Genetic Testing: Aortopathies and Connective Tissue Disorders V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Hereditary connective tissue disorders affect tissues throughout the body that support various organs and structures
- Common features include joint hypermobility and cardiovascular issues, particularly affecting the aorta
- While diagnosis can sometimes be made through clinical examination, genetic testing is often valuable for accurate diagnosis and proper medical management - with the notable exception of hypermobile Ehlers-Danlos syndrome (hEDS), which currently has no known genetic markers and must be diagnosed clinically
- This policy outlines the Medical Necessity criteria for Aortopathies and Connective Tissue Disorders testing
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Cardiac Disorders V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Cardiac disorders like arrhythmias and cardiomyopathies can have genetic, environmental, or multiple causes
- While genetic testing may not always change treatment for diagnosed patients, identifying specific genetic variants enables testing of asymptomatic family members who might need preventive care
- For congenital heart defects (affecting 1-1.2% of births), genetic testing can help determine risks for family members, evaluate related conditions, and assess developmental delays
- Due to the complexity of cardiac genetic testing, interpretation should involve cardiac genetics experts
- New techniques like gene expression profiles and cell-free DNA testing are emerging as tools to monitor rejection risk in heart transplant patients
- This policy outlines the Medical Necessity criteria for genetic testing for cardiac disorders, focusing on cardiomyopathy, arrhythmia, congenital heart defects, cholesterol disorders, and assessment of organ rejection following a heart transplant
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Dermatologic Conditions V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Genetic testing for dermatologic conditions and disorders that have many dermatologic findings may be used to confirm a diagnosis in a patient who has signs and/or symptoms of the disease
- Confirming the diagnosis may alter some aspects of management and may eliminate the need for further diagnostic workup
- This policy outlines the Medical Necessity criteria for genetic testing for dermatological conditions
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Epilepsy, Neurodegenerative, and Neuromuscular Conditions V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Genetic testing for hereditary epilepsy, neurodegenerative, and neuromuscular disorders may be used to establish or confirm a diagnosis in a patient who has signs and/or symptoms of a genetic disorder, for whom clinical evaluation and other standard laboratory tests/imaging/etc. have been non-diagnostic or inconclusive
- Confirming a genetic diagnosis may inform clinical management and/or eliminate the need for further diagnostic workup
- This policy outlines the Medical Necessity criteria of genetic testing for epilepsy, neurodegenerative, and neuromuscular genetic diseases
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Exome and Genome Sequencing for the Diagnosis of Genetic Disorders V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Exome sequencing (ES) analyzes the protein-coding regions of DNA (about 1% of the genome) which contain approximately 85% of disease-causing variants
- Genome sequencing (GS) is more comprehensive, analyzing both coding and non-coding regions and better detecting various genetic variations
- GS has shown higher diagnostic yields as a first-line test compared to ES
- Both techniques are used when standard clinical workups don't provide answers, with rapid versions (rES/rGS) available for urgent cases, delivering preliminary results within 7 days
- Trio testing (including parents) is preferred when possible
- These tests can reveal secondary findings unrelated to the original purpose but potentially medically significant
- The ACMG has guidelines for reporting such findings across 59 genes
- Pre- and post-test genetic counseling is strongly recommended, including the option to "opt out" of receiving secondary findings
- If no diagnosis is found, periodic reanalysis of the genomic data is recommended using current ACMG standards
- This policy outlines the Medical Necessity criteria of Exome and Genome Sequencing for the diagnosis of genetic disorders
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Eye Disorders V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Scientists have identified about 500 genes linked to inherited eye diseases, which represent a significant portion of the approximately 4,000 known human diseases
- While genetic testing has advanced our understanding of eye disorders, its clinical utility varies by condition
- For age-related macular degeneration (AMD), the leading cause of blindness in adults over 65, genetic testing has limited clinical value despite the condition's known genetic components
- However, for inherited retinal dystrophy caused by RPE65 gene variants, genetic testing can identify candidates for gene therapy treatment, though evidence for long-term outcomes remains challenging to gather due to the condition's rarity
- This policy outlines the Medical Necessity criteria of genetic testing of eye disorders
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Gastroenterologic Disorders (non-cancerous) V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Genetic testing for gastroenterologic (non-cancerous) disorders may be used to confirm a diagnosis in a patient who has signs and/or symptoms of a specific gastroenterologic disorder
- Confirming the diagnosis may alter aspects of management and may eliminate the need for further diagnostic workup
- The policy outlines the Medical Necessity criteria for genetic testing of common gastroenterologic (non-cancerous) conditions
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: General Approach to Genetic and Molecular Testing V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Genetic testing identifies various genetic variations for medical purposes, including two main types of variants: Germline variants - present in reproductive cells, affect every cell, and are hereditary, Somatic variants - occur in specific cells/tissues and are not inherited
- Medical conditions can be: Single-gene disorders (like sickle cell disease), Multifactorial conditions (like diabetes) influenced by both genetic and environmental factors
- Targeted mutation testing focuses on analyzing specific known variants, typically when there's a family history
- However, broader testing may be recommended based on clinical history
- The policy outlines the Medical Necessity criteria for a general approach to genetic and molecular testing
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Hearing Loss V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Hereditary hearing loss manifests in two distinct forms
- Syndromic hearing loss encompasses both hearing impairment and additional medical or physical symptoms, including visible ear abnormalities, making it more readily identifiable as hereditary due to these multiple manifestations
- In contrast, nonsyndromic hearing loss presents solely as hearing impairment without other symptoms, accounting for 70-80% of genetic deafness cases, though it can be more difficult to determine whether its origin is genetic or acquired
- The policy outlines the Medical Necessity criteria for genetic testing to identify a cause of suspected hereditary hearing loss
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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Concert Genetic Testing: Hematologic Conditions (non-cancerous) V1.2025
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Genetic testing for hematologic (non-cancerous) conditions may be used to confirm a diagnosis in a patient who has signs and/or symptoms of a specific hematologic condition
- Confirming the diagnosis may alter aspects of management and may eliminate the need for further diagnostic workup
- The policy outlines the Medical Necessity criteria for genetic testing for common hematologic (non-cancerous) conditions
- This policy criteria is sourced from Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles
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V1.2025 Concert Genetic Testing: Immune, Autoimmune, and Rheumatoid Disorders
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Immunodeficiency disorders may arise from a chronic disorder, use of a drug, and a subset are inherited
- Immunodeficiency disorders weaken the immune system, which can result in infections or cancers to develop
- This policy contains coding implications, medically necessary related criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Kidney Disorders
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Inherited kidney disorders can be common, and identifying the genetic cause may help direct treatment and overall understanding of the genetic etiology
- More advanced sequencing are emerging as first-line diagnostic methods for patients with chronic kidney disease
- This policy contains a reference table, criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Lung Disorders
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- One of the most common inherited lung disorders is alpha-1 antitrypsin deficiency, which results in decreased production of the alpha-1 antitrypsin protein, or functionally deficient types of the protein
- Genetic testing to diagnose alpha-1 antitrypsin deficiency helps direct treatment as well as identify at-risk family members
- This policy includes a reference table, criteria, and background
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V1.2025 Concert Genetic Testing: Metabolic, Endocrine, and Mitochondrial Disorders
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Hereditary metabolic disorders are genetic disorders that interfere with the body’s metabolism
- Many are screened for at birth through newborn, while others are identified after a child or adults shows symptoms of the disorder
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Multisystem Inherited Disorders, Intellectual Disability, and Developmental Delay
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Genetic testing for rare diseases may be used to establish or confirm a diagnosis in a patient who has symptoms of a genetic disorder where other standard testing have been non-diagnostic or inconclusive
- Establishing or confirming genetic diagnosis may provide associated medical and behavioral information and/or eliminate the need for further diagnostic workup
- This policy contains a reference table, criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Prenatal Cell-Free DNA Testing
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Prenatal cell-free DNA testing (prenatal cfDNA) is a sequencing test performed on placental cell-free DNA found in maternal serum
- Prenatal cfDNA testing has expanded to include microdeletion and microduplication syndromes, as well as single-gene disorders, although this is an area of ongoing research
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Pharmacogenetics (Version A)
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Pharmacogenetic tests are germline genetic tests that are developed to aid in assessing an individual's response to a drug treatment or to predict the risk of toxicity from a specific drug treatment
- Testing may be performed prior to initiation of treatment to identify if an individual has genetic variants that could either affect response to a particular drug and/or increase the risk of adverse drug reactions
- This policy includes a reference table, criteria, and background
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V1.2025 Concert Genetic Testing: Preimplantation Genetic Testing
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Preimplantation genetic testing involves analysis of biopsied cells from an embryo as a part of an assisted reproductive procedure
- Preimplantation genetic testing for monogenic disorders (PGT-M) and preimplantation genetic testing for structural rearrangements (PGT-SR) are used to detect a specific inherited disorder in conjunction with in vitro fertilization (IVF)
- Preimplantation genetic testing for aneuploidy (PGT-A) is used to screen for potential chromosomal or subchromosomal abnormalities (e.g., chromosomal aneuploidy) in conjunction with IVF for couples
- This policy contains a reference table, criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Prenatal and Preconception Carrier Screening
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- There are more than 1,300 inherited recessive disorders (autosomal or X-linked) that affect 30 out of every 10,000 children
- Carrier screening is performed to identify individuals at risk of having offspring with inherited recessive or X-linked single-gene disorders
- Expanded carrier screening (ECS) involves screening individuals or couples for disorders in many genes simultaneously (up to 100s) by next-generation sequencing
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Prenatal Diagnosis (via Amniocentesis, CVS, or PUBS) and Pregnancy Loss
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Prenatal diagnostic testing may be used to identify genetic conditions in fetuses at an increased risk based on prenatal screening or for women who choose to undergo diagnostic testing due to other risk factors
- In most cases, prenatal genetic testing for single gene disorders using molecular genetic testing requires knowledge of the familial genetic variant which has been identified in a family member
- This policy contains a reference table, criteria, definitions, and background
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V1.2025 Concert Genetic Testing: Skeletal Dysplasia and Rare Bone Disorders
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Skeletal dysplasias are a category of rare genetic disorders that affect bones and joints and are estimated to affect 2.4 per 10,000 births, and some forms of skeletal dysplasia can be suspected based on prenatal ultrasound
- Genetic testing has allowed for gene identification in more than two thirds of the skeletal dysplasias
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetics Oncology: Algorithmic Testing
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Oncology diagnostic, prognostic and algorithmic tests combine biomarkers and/or clinical data into an algorithm to generate a disease risk assessment, prognostic result, or clinical recommendation for treatment
- Results of oncology algorithmic tests are often reported as a recurrence score, probability of distant disease recurrence, malignant potential, probable site of origin, or cancer risk score
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetics Oncology: Cancer Screening
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- This policy relates to genetic and biomarker tests that aim to screen for specific cancers in individuals who are at risk to develop them
- It is important to note that screening tests are not diagnostic tests
- The results from a screening test put an individual into a lower risk or higher risk status
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetics Oncology: Circulating Tumor DNA and Circulating Tumor Cells (Liquid Biopsy)
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Cell-free circulating tumor DNA (ctDNA or cfDNA) originates directly from the tumor tissue (primary or metastasis)
- As tumor cells die the contents are released into the bloodstream
- Genetic tests performed on circulating tumor DNA (ctDNA), also referred to as a liquid biopsy, potentially offer a noninvasive alternative to tissue biopsy for detection of “driver mutations” or acquired genetic mutations that may guide targeted therapy, and may also be used to track progression of disease
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetics Oncology: Cytogenetic Testing
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- Cytogenetic analysis of solid tumors and hematologic malignancies aims to both classify the type of tumor or cancer present and identify somatic oncogenic mutations in cancer
- These mutations, often called “driver” mutations, are becoming increasingly useful for targeted therapy selection, and may give insight into prognosis and treatment response in a subset of cancers
- This policy includes a reference table, criteria, definitions, and background
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V1.2025 Concert Genetics Oncology: Molecular Analysis of Solid Tumors and Hematologic Malignancies
| Wellcare By Allwell (Medicare)
| New Policy Overview:
- The molecular analysis of solid tumors and hematologic malignancies aims to identify somatic oncogenic mutations in cancer
- These mutations, often called “driver” mutations, are becoming increasingly useful for targeted therapy selection, and may give insight into prognosis and treatment response in a subset of cancers
- Information from tumor molecular testing can also be useful for monitoring measurable (minimal) residual disease (MRD) in both solid tumors and hematologic malignancies
- This policy includes a reference table, criteria, definitions, and background
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