<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 Atrial Fibrillation NGS Panel offered through Fulgent Diagnostics, a CLIA certified and CAP accredited laboratory located in Temple City, CA. This letter documents the medical necessity of utilizing this test to confirm the diagnosis of Atrial Fibrillation 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 Amyotrophic Lateral Sclerosis 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

Atrial Fibrillation (AF) is an irregular heartbeat that can lead to heart failure, stroke, dementia or death. A cause for AF can be often found in an undetected cardiovascular disorder, including coronary artery disease, hypertension, heart failure, or valvular heart disease (Camm et al., 2010). When an underlying cause cannot be identified, the condition is considered idiopathic, or isolated. Familial AF may be diagnosed in the presence of one or more family members with isolated AF, a condition that is inherited in an autosomal dominant pattern (Fuster et al., 2011). For this reason, it is important to identify a molecular cause in affected individuals, so that management can be guided for both the patient and their at-risk family members.

Atrial Fibrillation exhibits genetic heterogeneity and has been associated with mutations in 24 genes (Darbar et al., 2003). Due to Atrial Fibrillation’s heterogeneous nature, it is more time and cost effective to perform large scale sequencing of multiple genes, through Next Generation Sequencing (NGS), rather than traditional Sanger sequencing for specific mutations (ACMG Board of Directors, 2013). It will also allow us to refine the clinical diagnosis and know which management plan is most appropriate in this case, including the possibility of antithrombotic therapy and control of ventricular rate (Camm et al., 2010).

This test is appropriate based on the patient’s <phenotype and family history>, which is suggestive of Atrial Fibrillation. The results from this test will be used to confirm the suspected diagnosis of Atrial Fibrillation and will help direct treatment for the patient. A confirmatory diagnosis of Atrial Fibrillation can ensure that the patient receives the most appropriate and beneficial medical care. The results of this test could also be helpful to avoid other potentially unnecessary, time-consuming, and costly procedures. The results of this test may also be helpful in the avoidance of prescribing medications that might be ineffective or contraindicated for this condition. The information this test provides will also be beneficial when making arrangements for this patient in the future

Besides impacting the medical management of this patient, this test will provide useful information for other at-risk family members. Once the family mutation is identified, family members can pursue targeted testing for the specific variant. A positive result in a family member will allow appropriate management and informed decisions regarding family planning.

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

Seq / 81403x1, 81404x1, 81406x4, 81407x1, 81408x1, 81479x16
Del/Dup / 81403x1, 81404x1, 81406x4, 81407x1, 81408x1, 81479x16
Seq & Del/Dup / 81403x1, 81404x1, 81406x4, 81407x1, 81408x1, 81479x32

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’ Atrial Fibrillation NGS Panel for patient’s full name>. Since coordinating and completing complex testing of this nature can take up to several months, we request that the authorization is made valid for at least 6 months.Please feel free to contact me at <Physician Phone> if you have additional questions or would like to further discuss this request.

Sincerely,

Physician Name>, MD

NPI #: Physician NPI#>

Contact information:

< Address>

<City>, <State> <Zip>

Contact Phone No.: <phone number>

References

1. ACMG Board of Directors. (2012). Points to consider in the clinical application of genomic sequencing. Genet Med. 14:759-761.

2. Camm, A. J., Kirchhof, P., Lip, G. Y. H., Schotten, U., Savelieva, I., Ernst, S.,…Rutten, F. H. (2010). Guidelines for the management of atrial fibrillation of the european society of cardiology. European Heart Journal, 31, 2639-2429.

3. Darbar, D., Herron, K. J., Ballew, J.D., Jahangir, A., Gersh, B. J., Shen, W. K.,… Olson, T. M. (2003). Familial atrial fibrillation is a genetically heterogenous disorder.

3. Fuster, V., Ryden, L. E., Cannom, D. S., Crijins, H. J., Curtis, A. B., Ellenbogen, K. A.,… & Wann, S. (2011). 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/ AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. Journal of the American College of Cardiology, 57(11), 101-198.