This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Epilepsy Single Gene Tests

Epilepsy single gene tests may be considered medically necessary when ALL of the following criteria are met:

• The member has a condition that will benefit from information provided by the requested epilepsy gene testing based on ONE of the following:
  • The member displays clinical features of the condition for which testing is being requested and a particular treatment is being considered for the member that requires a genetic diagnosis; or
  • A particular antiepileptic drug (AED) is being considered for the member and the AED is contraindicated for individuals with mutations in that gene by ONE of the following:
    • A neurology therapy FDA label requires results from the genetic test to effectively or safely use or avoid the therapy for the member’s epilepsy type and the member has not previously had a trial of the therapy; or
    • An American neurological society specifically recommends the testing for the safe and effective use or avoidance of a therapy and the member has not previously had a trial of the therapy; or
  • The member meets all criteria in a test-specific guideline, if available (see Table 1 for a list of genes, associated conditions, and applicable policy); and
• The member does not have a known underlying cause for their seizures (e.g. tumor, head trauma, known genetic condition).
  

Epilepsy Multi-Gene Panels

Note: Evaluate individual procedure codes reported for different epilepsy genes separately (e.g., Tier 1 MoPath codes 81200-81355 or Tier 2 MoPath codes 81400-81408).

Epilepsy multi-gene panels may be considered medically necessary when the following criteria are met:

• The member has a condition that will benefit from information provided by the requested epilepsy gene testing based on ONE of the following:
  • The member displays clinical features of the condition for which testing is being requested and a particular treatment is being considered for the member that requires a genetic diagnosis; or
  • A particular AED is being considered for the member and the AED is contraindicated for individuals with mutations in that gene by ONE of the following:
    • A neurology therapy FDA label requires results from the genetic test to effectively or safely use or avoid the therapy for the member’s epilepsy type and the member has not previously had a trial of the therapy; or
    • An American neurological society specifically recommends the testing for the safe and effective use or avoidance of a therapy and the member has not previously had a trial of the therapy; or
  • The member meets all criteria in a test-specific guideline, if available, (see Table 1 for a list of genes, associated conditions, and applicable policy); and
• The member does not have a known underlying cause for their seizures (e.g. tumor, head trauma, known genetic condition).

If the member meets ONE of the following criteria, the entire panel will be approved:

• The member has a diagnosis of early infantile epileptic encephalopathy; or
• The member has a diagnosis of infantile spasms; or
• The member has a diagnosis of intractable, neonatal seizures; or
• The member has a diagnosis of febrile seizures with at least one episode of status epilepticus; or
• The member has a progressive neurological disease defined by the following:
  • Member has epilepsy with persistent loss of developmental milestones; and
  • Member’s seizures are worsening in severity and/or frequency despite treatment; or
• A particular AED is being considered for the member and there are 2 or more genes on the panel for which the AED is contraindicated for individuals with mutations in that gene by ONE of the following:
  • A neurology therapy FDA label requires results from the genetic test to effectively or safely use or avoid the therapy for the member’s epilepsy type and the member has not previously had a trial of the therapy; or
  • An American neurological society specifically recommends the testing for the safe and effective use or avoidance of a therapy and the member has not previously had a trial of the therapy; and
• The member does not display clinical features of a specific condition for which testing is available (e.g. Tuberous Sclerosis, Angelman Syndrome, Rett Syndrome, etc.); and
• The member does not have a known underlying cause for their seizures (e.g. tumor, head trauma, known genetic condition).

A multi-gene panel billed with a single panel CPT code, may be considered medically necessary when ONE of the following criteria are met:

• The member has a diagnosis of early infantile epileptic encephalopathy; or
• The member has a diagnosis of infantile spasms; or
• The member has a diagnosis of intractable, neonatal seizures; or
• The member has a diagnosis of febrile seizures with at least one episode of status epilepticus; or
• The member has a progressive neurological disease defined by the following:
  • Member has epilepsy with persistent loss of developmental milestones; and
  • Member’s seizures are worsening in severity and/or frequency despite treatment; or
• A particular AED is being considered for the member and there are two or more genes on the panel for which the AED is contraindicated for individuals with mutations in that gene by ONE of the following:
  • A neurology therapy FDA label requires results from the genetic test to effectively or safely use or avoid the therapy for the member’s epilepsy type and the member has not previously had a trial of the therapy; or
  • An American neurological society specifically recommends the testing for the safe and effective use or avoidance of a therapy and the member has not previously had a trial of the therapy; and
  • The member does not display clinical features of a specific condition for which testing is available (e.g. Tuberous Sclerosis, Angelman Syndrome, Rett Syndrome, etc.); and
• The member does not have a known underlying cause for their seizures (e.g. tumor, head trauma, known genetic condition).

Table 1: Common epilepsy genes, associate conditions, and applicable policies.

This list not all inclusive:

*90% of Unverrict-Lundborg syndrome is due to a repeat expansion in CSTB that may not be detected on next-generation sequencing.

ADNFLE = Autosomal Dominant Frontal Lobe Epilepsy; BFIS = Benign Familial Infantile Seizures; BFNS = Benign

Familial Neonatal Seizures; EOEE = Early-Onset Epileptic Encephalopathy; GEFS+ = Generalized Epilepsy with Febrile Seizures Plus; PME = Progressive Myoclonic Epilepsy

Note:  Genetic testing is only necessary once per lifetime. 

Genetic testing for epilepsy is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

05/2018, REMINDER: Molecular and Genomic Testing

• Link to References