Sample Letter of Medical Necessity for Fulgent Diagnostics XLID NGS Panel

Sample letter of medical necessity for Fulgent Diagnostics’ XLID NGS Panel

<Date>

ATTN:<Medical Director/ Physician Name>, MD

Re: <Patient Full Name>DOB: <MM/DD/YYYY>

Member ID: <Enter Member ID>Group ID: <Enter Group ID>

Dear <Medical Director/Physician Name>:

I am writing on behalf <Patient Name>, my patient and your subscriber, to request coverage for the XLID NGS Panel offered through Fulgent Diagnostics, a CLIA certified and CAP accredited laboratory located in Temple City, CA. This is a panel that tests 107 genes that are associated with X-linked Intellectual Disability (XLID). The genes included can be found at: letter documents the medical necessity of utilizing this test to confirm the diagnosis of a XLIDcondition and includes pertinent information relevant to this patient’s medical history and family history.

Medical History

Patient is a <Age> -year-old <Gender> with a suspected diagnosis of a XLIDconditon based on the following symptoms:

____Symptom 1 with ICD code

____Symptom 2 with ICD code

____Symptom 3 with ICD code

Family History

The family history is as follows:

Maternal:

Paternal:

Rationale for Testing

Intellectual disability (ID) is a common neurodevelopmental disorder characterized by limitations of both intellectual functioning and adaptive behavior1. Intellectual disability affects approximately 1-2% of children, with more males affected than females1-2. The skewed prevalence of intellectual disability in males of approximately 30% suggests an X-linked etiology2. Recognizable syndromic patterns can accompany genetic causes of intellectual disability, but they can also have phenotypic overlap. For example, about one-third of the XLID syndromes have significant eye or ocular adnexa abnormalities1. Nystagmus, optic atrophy, and strabismus are among common and nonspecific ocular manifestations that can be seen in genetic intellectual disability conditions2. The phenotype associated with conditions caused by ATRX mutations is usually associated with severe mental retardation, absent speech, microcephaly, hypotonia, spasticity, seizures, growth retardation, or skeletal abnormalities2. However, mutations in ATRX has been shown to have intra-familial variation and has even been identified in families with non-syndromic mental retardation alone2. A clinical diagnosis for syndromes associated with X-linked intellectual disability based on phenotype alone can therefore be challenging, but is important because it will impact medical management, screening, and prevention of potential complications of the disease. For example, families with mutations in the OPHN1 gene were initially described as having non-syndromic intellectual disability, but actually are found to have significant reduction in cerebellum size2. If the gene mutation was left unknown, families with this mutation may not receive proper care. Syndromes such as Goltz, Lenz, and Lowe are known for their ocular manifestations and would require routine care by an ophthalmologist1.

The clinical diagnosis of XLID is generally a diagnosis of exclusion of other causes of developmental delay in a male2. Only rarely does a new family present with a male sufficiently affected for a confident clinical diagnosis to be made2. However, establishing a diagnosis is imperative because it will alter medical management for patients with XLID. This genetic test will help clarify <Patient Name>’s diagnosis and, more importantly, guide my recommendations for medical care. A positive test result would ensure my patient is getting appropriate management before the symptoms become severe.

While there are many options for genetic testing, a multi-gene panel for XLID is the most cost efficient test for <Patient Name>. In the past, systematic screening of all X-linked genes that can be associated with XLID was not feasible2. However,a multiple gene panel possesses the ability to analyze many genes that are known to cause XLID simultaneously and has a high probability of identifying a diagnosis for <Patient Name>. I have determined that this test is medically necessary based off <Patient Name>’s personal and family history.

In summary, I am requesting that <Patient Name> be approved for the XLID NGS Panel offered by Fulgent Diagnostics. The CPT codes are as follow:

Seq / 81243x1, 81302x1, 81401x1, 81404x5, 81405x11, 81406x5, 81407x2, 81408x1, 81479x80
Del/Dup / 81161x1*, 81243x1, 81304x1, 81401x2, 81403x2, 81404x6, 81405x11, 81406x1, 81407x2, 81479x80
Seq & Del/Dup / 81161x1*, 81243x1, 81302x1, 81304x1, 81401x2, 81403x2, 81404x9, 81405x15, 81406x5, 81407x2, 81408x1, 81479x160

CPTs listed under CLAB2016 can be found on CMS.gov Fee Schedule released in January 2016. (Reference: Alternative:

* CPTs are based on the genes listed. Adding or removing genes will change the CPTs. In some cases, a CPT may require a specific list of genes while performing both sequencing and del/dup to qualify. Fulgent bases the CPT for each Gene on multiple sources: CLAB2016v1, AMA Molecular Pathology Tier 2 Gene Designation Chart, and AMA CPT 2016. Call for more details.
Laboratory:
Fulgent Diagnostics
4978 Santa Anita Ave
Temple City, CA, 91780
I thank you for your review and I hope you will support my recommendation of Fulgent Diagnostics’ XLID NGS Panel for <Patient's full name>. 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. If you have any questions, please do not hesitate to contact me using the contact information below.

Sincerely,
<Physician Name>, MD

NPI #: <Physician NPI#>

Contact information:

< Address>

Contact Phone No.: <phone number>

References

Couser, N. L., Masood, M. M., Aylsworth, A. S., & Stevenson, R. E. (2017). Ocular manifestations in the X-linked intellectual disability syndromes.Ophthalmic Genetics,, 1-12. doi:10.1080/13816810.2016.1247459 [doi]
Raymond, F. L. (2006). X linked mental retardation: a clinical guide.Journal of Medical Genetics,43(3), 193–200.