81354
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage; refer to the insurer's guidelines titled 'Medical Records Documentation Used for Reviews.' (Policy: medical records may be requested but documentation does not guarantee coverage.)
- Documentation that results are expected to directly influence medical management and clinical outcomes (clinical rationale/plan documenting how results would change management).
- Documentation that clinical presentation is nonspecific and does not fit a well-defined syndrome for which a specific/targeted gene test is available, or documentation that targeted testing was considered and not appropriate.
- Order must be placed by an approved specialty: medical geneticist, neonatologist, neurologist, immunologist, or developmental pediatrician (document ordering provider specialty).
Key Coverage Criteria
- Whole Exome Sequencing (WES) is proven and medically necessary for diagnosing or evaluating a genetic disorder when the results are expected to directly influence medical management and clinical outcomes, and ALL of the following criteria are met: clinical presentation is nonspecific and does not fit a well-defined syndrome for which a specific/targeted gene test is available; WES is ordered by a medical geneticist, neonatologist, neurologist, immunologist, or developmental pediatrician; and one [...]
- WES indication — clinical history strongly suggests a genetic cause AND one or more of: multiple congenital anomalies (must affect different organ systems); moderate, severe, or profound intellectual disability diagnosed by 18 years of age; global developmental delay; epileptic encephalopathy with onset before three years of age.
- WES indication — clinical history strongly suggests a genetic cause AND two or more of: congenital anomaly; significant hearing or visual impairment diagnosed by 18 years of age; laboratory abnormalities suggestive of an inborn error of metabolism (IEM); autism spectrum disorder; neuropsychiatric condition (e.g., bipolar disorder, schizophrenia, obsessive-compulsive disorder); hypotonia or hypertonia in infancy; dystonia, ataxia, hemiplegia, neuromuscular disorder, movement disorder, or other ne [...]
- Comparator (e.g., parents or siblings) WES is proven and medically necessary for evaluating a genetic disorder when the above WES criteria have been met and comparator WES is performed concurrently or has been previously performed on the individual.
- Reanalysis of WES is proven and medically necessary after at least 18 months when the above criteria for initial WES were met AND either: the individual experiences additional symptoms after initial WES that cannot be explained by the initial WES results; or new data or new family history emerges which suggests a link between the individual's symptoms and specific genes.
- Prenatal WES is proven and medically necessary for diagnosing or evaluating a genetic disorder when ALL of the following criteria are met: chromosome microarray analysis (CMA) and/or karyotyping have been performed but were uninformative; WES is ordered by or in consultation with a medical geneticist or maternal-fetal medicine specialist (perinatologist); sample for WES testing is obtained from amniotic fluid and/or chorionic villi, cultured cells from amniotic fluid/chorionic villi, or DNA extr [...]
10 Active Policies
CGS-L38288 — MolDX: Repeat Germline Testing
J18 MAC Part B
CGS-L36021 — MolDX: Molecular Diagnostic Tests (MDT)
J18 MAC Part B
WPS-L38429 — MolDX: Repeat Germline Testing
J8 MAC Part B
WPS-L36807 — MolDX: Molecular Diagnostic Tests (MDT)
J8 MAC Part B
Related Codes
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