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SAMPLE LETTER OF MEDICAL NECESSITY FOR COMPREHENSIVE EPILEPSY GENETIC TESTING (EPINEXT) Date: Date of service/claim To: Utilization Review Department Insurance Company Name Address, City, State, Zip Re: Patient Name, DOB, ID # ICD-10 Codes: (list codes) Dear Medical Director: I am writing this letter on behalf of my patient and your subscriber, [First Last Name], to request coverage of medically-indicated genetic testing for epilepsy (EpiNext) offered by Ambry Genetics Corporation. Most epilepsy syndromes have a genetic component, including emerging evidence of a greater genetic contribution to epilepsy than previously thought.1 Clinical and genetic overlap between epilepsy syndromes is considerable, making a precise diagnosis difficult. Epilepsy syndromes with a known genetic etiology include: Benign Familial Neonatal Seizures (BFNS), Dravet syndrome, Genetic Epilepsy with Febrile Seizures Plus (GEFS+), childhood absence epilepsy with febrile seizures, familial hemiplegic migraine, early infantile epileptic encephalopathy, infantile spasms, West syndrome, autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE), autosomal dominant partial epilepsy with auditory features (ADPEAF), familial partial epilepsy with variable foci (FPEVF), progressive myoclonus epilepsy, myoclonic epilepsy myopathy sensory ataxia (MEMSA), pyridoxine-dependent epilepsy, tuberous sclerosis complex, and neuronal ceroid lipofuscinosis (Batten disease). Recent discoveries regarding the genetics of epilepsy have highlighted two important patterns: 1) One gene can be associated with multiple epilepsy syndromes, and 2) One epilepsy syndrome can be associated with multiple genes.1 Taken together, these findings support the use of a broad multigene panel for genetic testing, especially in patients with an unclear history or atypical presentation. Genetic testing can assist with establishing the correct diagnosis. Additionally, genetic testing is increasingly relevant to the clinical management of epilepsy. For this patient, I have determined that this genetic test is medically necessary based on [his/her] clinical symptoms, EEG findings, and/or clinical history. My patient is suspected to have a genetic form of epilepsy. [His/Her] clinical history is suggestive of epilepsy, outlined below as applicable (Alternative: My patient presented to clinic with the following history consistent with epilepsy): This genetic test (EpiNext) analyzes 100 genes associated with epilepsy: ALDH7A1, ARHGEF9, ARX, ATP1A2, ATP13A2, CACNA1A, CASK, CDKL5,CHD2, CHRNA2, CHRNA4, CHRNB2, CLN3, CLN5, CLN6, CLN8, CNTNAP2, CSTB, CTSD, DEPDC5, DNAJC5, DNM1, DYNC1H1, EPM2A, FOLR1, FOXG1, GABRA1, GABRB3, GABRG2, GAMT, GATM, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, HCN1, HNRNPU, KCNC1, KCNJ10, KCNQ2, KCNQ3, KCNT1, KCTD7, LGI1, MECP2, MEF2C, MFSD8, NHLRC1, NRXN1, PCDH19, PIGA, PNKP, PNPO, POLG, PPT1, PRICKLE1, PRRT2, SCARB2, SCN1A, SCN1B, SCN2A, SCN8A, SLC13A5, SLC25A22, SLC2A1, SLC35A2, SLC9A6, SNAP25, SPTAN1, ST3GAL3, STXBP1, SYN1, SYNGAP1, SZT2, TBC1D24, TCF4, TPP1, TSC1, TSC2, UBE3A, ZEB2, PLCB1, CRH, STX1B, CTSF, IQSEC2, GRN, EEF1A2, KCNA2, SIK1, SLC6A1, TBL1XR1, DCX, DYRK1A, FLNA, KIAA2022, PURA, SMC1A, and WDR45. This multi-gene test is an efficient and cost-effective way to analyze numerous genes implicated in epilepsy, and has significant potential to identify a causative gene mutation in my patient. As my patient has unexplained epilepsy, there is a reasonable probability of detecting a mutation with this test. This genetic testing will help clarify my patient’s diagnosis and more importantly, guide my recommendation for further medical care. This genetic test will impact medical management, screening, and prevention of potential complications of this disease. Examples of this include2,3: Treatment with sodium channel blocking anticonvulsants (such as carbamazepine and phenytoin) is contraindicated in patients with mutations in channelopathy genes (like SCN1A), due to associations with seizure aggravation. Certain mutations in progressive myoclonus epilepsy genes may lead to targeted therapy with a premature stop codon read-through drug (such as gentamicin) and/or avoidance of drugs that can exacerbate myoclonus and dementia (such as sodium channel blocking anticonvulsants and GABAergic drugs). Patients with the CHRNA4 mutation p.Ser284Leu are more responsive to zonisamide than carbamazepine for treatment. Specifically for this patient, the results of the genetic test are necessary to consider in the following areas [check all that apply]: Genetic testing will lead to changes in my medical management strategies; AND/OR Genetic testing will lead to changes in diagnostic procedures such that more potentially invasive alternative procedures could be avoided, reducing unnecessary tests and cost; AND/OR Genetic testing will lead to informed decisions for other family members with similar conditions, or that may be at risk for similar conditions EpiNext includes full gene sequencing and deletion/duplication analysis of 98 genes (listed earlier). Due to the medical risks associated with these mutations and the available interventions, this genetic test is medically warranted. As such, I am ordering this test as medically necessary and affirm that my patient (Alternative: authorized representative, if a minor) has provided informed consent for genetic testing. A positive test result would confirm a genetic diagnosis and would ensure my patient is being managed appropriately. I am specifying Ambry Genetics Corporation because this laboratory has highly-sensitive and cost-effective testing for unexplained epilepsy, along with a large database of tested patients to ensure highly validated, accurate, and informative test interpretation. Please review this information and provide support for this request for coverage of diagnostic genetic testing for my patient. Coordinating and completing complex testing of this nature can take up to several months; we are requesting that the authorization be valid for at least 6 months. Thank you for your time and further consideration. If you have any questions, please do not hesitate to contact me at the numbers indicated below. Sincerely, Ordering Clinician Name (Signature Provided on Test Requisition Form) (MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant, Genetic Counselor*) *Authorized clinician requirements vary by state [Clinician Address] [Clinician Phone Number] Test Details CPT codes: 81302, 81304, 81403x2, 81404x7, 81405x10, 81406x13, 81407x3, 81479x71 Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAPaccredited and CLIA-certified laboratory located at 15 Argonaut, Aliso Viejo, CA 92656 References 1. Thomas RH and Berkovic SF. The hidden genetics of epilepsy – a clinically important new paradigm. Nat Rev Neurol. 2014 May;10(5):283-92. 2. Miller IO and de Menezes MAS. SCN1A-Related Seizure Disorders. 2007 Nov 29 [Updated 2014 May 15]. In: Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014. 3. Kurahashi H and Hirose S. Autosomal Dominant Nocturnal Frontal Lobe Epilepsy. 2002 May 16. [Updated 2014 Feb 19]. In: Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014.