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

<Date>

ATTN:<Medical Director/ Physician Name>, MD

<Institution/Insurance Company>

<Street Address>

<City>, <State> <Zip>

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 Holoprosencephaly NGS Panel offered through Fulgent Diagnostics, a CLIA certified and CAP accredited laboratory located in Temple City, CA. This is a panel that tests 7 genes that are associated with Holoprosencephaly. The panel includes the following genes: CDON, GLI2, PTCH1, SHH, SIX3, TGIF1, ZIC2.This letter documents the medical necessity of utilizing this test to confirm the diagnosis of a Holoprosencephaly disorder 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 Holoprosencephaly disorder 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

Holoprosencephaly is a structural anomaly of the brain in which there is a failed or incomplete separation of the forebrain early in gestation1. It is considered the most common malformation of the brain and face in humans2. Holoprosencephaly is accompanied by a spectrum of characteristic craniofacial anomalies in approximately 80% of individuals with holoprosencephaly1. Noncraniofacial anomalies may be seen with holoprosencephaly, including genital defects, postaxial polydactyly, vertebral defects, limb defects, and transposition of the great arteries2. Developmental delay is present in almost all individuals and seizures or pituitary dysfunction are common1. 10% of individuals with holoprosencephaly have defects in cholesterol biosynthesis. Holoprosencephaly has a multifactorial etiology, causing difficulty when estimating recurrence risk for families. Chromosomal and genetic abnormalities, teratogen exposures, and syndromic association have all been observed2.

In many individuals with holoprosencephaly there is a correlation between the facial anomalies and the gene involved, however, often no correlation can be made. There is overlap and variability between the symptoms seen in patients with holoprosencephaly conditions, making a clinical diagnosis difficult. However, a diagnosis is imperative because establishing a diagnosiswillimpact medical management, screening, and prevention of potential complications of the disease.For example, individuals with GLI2 mutations can have facial features and hypopituitarism, but no CNS findings associated with holoprosencephaly1. Those with SHH or ZIC2 mutations are at an increased risk for renal/urinary anomalies1.As you can see, establishing a diagnosis is imperative because it will alter medical management for patients with holoprosencephaly. 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 holoprosencephaly is the most cost efficient test for <Patient Name>. A multiple gene panel possesses the ability to analyze many genes that are known to cause holoprosencephaly 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 Holoprosencephaly NGS Panel offered by Fulgent Diagnostics. The CPT codes are as follow:

Seq / 81479x7
Del/Dup / 81479x7
Seq & Del/Dup / 81479x14

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’ Holoprosencephaly 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>

<City>, <State> <Zip>

Contact Phone No.: <phone number>

References

  1. Solomon, B. D., Gropman, A., & Muenke, M. (1993). Holoprosencephaly overview. In R. A. Pagon, M. P. Adam, H. H. Ardinger, S. E. Wallace, A. Amemiya, L. J. H. Bean, . . . K. Stephens (Eds.),Genereviews(r)(). Seattle (WA): University of Washington, Seattle. GeneReviews is a registered trademark of the University of Washington, Seattle. All rights reserved. doi:NBK1530 [bookaccession]
  2. Winter, T. C., Kennedy, A. M., & Woodward, P. J. (2015). Holoprosencephaly: A survey of the entity, with embryology and fetal imaging.Radiographics : A Review Publication of the Radiological Society of North America, Inc,35(1), 275-290. doi:10.1148/rg.351140040 [doi]