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Letter of Medical Necessity

PHARMACOGENETIC TESTING

Date: ________ _ Patient Name: _______________________ _

DOB: _______ _ Gender: □ M □ F

Insurance Company:, _____________________ _

Subscriber Name: ______________________ _

Policy#: __________________________ _

Dear Claims Specialist:

I am writing this letter on behalf of my patient, ------------------ to request coverage for the

Pharmacogenetic testing offered through Novomed Specialized Clinics. The Pharmacogenetic testing is performed in a high

complexity CUA certified laboratory located in Frisco, Texas.

My patient has not reached their therapeutic goal on the current regimen and may be experiencing adverse drug reaction(s)

to one or more medications. I am seeking to choose safer or more efficacious dosages. I request coverage for DNA

microarray and PCR analysis of targeted genes to identify genetic variants. This knowledge will help avoid

harmful and costly adverse drug events, optimize medication dose, and increase chances of patient's treatment success.

Test Information and Impact of Results on Medical Management:

The pharmacogenetics panel offered by Novomed Specialized Clinics targets genes that when mutated are known to

impact patient's response to medication.

The result of this pharmacogenetic testing will have a direct impact on this patient's medication management.

Genetics account for much of the variability seen in our patients' responses to drug therapies and the implications of

pharmacogenetics have been well documented. Currently there are at least 230 U.S. Food and Drug Administration (FDA)

approved drugs with Pharmacogenomic information in their labeling. The labeling for some of the products includes specific

actions to be taken based on the biomarker information. In order to choose the more suitable medication and avoid potential

but serious adverse drug events, it is extremely important to perform this panel of Pharmacogenetic tests.

Patient's personal and/or family history as well as current medication regimen are suggestive of high risk for adverse drug

events based on my evaluation and review of latest available literature. In this patient's case, pharmacogenetics testing is

crucial in order to establish and confirm a genetic diagnosis, guide appropriate and immediate medical management,

predict disease prognosis, and eliminate potential adverse drug events.

Informed Consent:

The patient has provided a signed informed consent for pharmacogenetic testing, based on my discussion of the personal

and/or family history, the potential test results, and the implications for medical management. The patient is aware of the

benefits, risks, and limitations of the testing and has voluntarily agreed to the pharmacogenetic test.

Conclusion:

Knowledge of this patient's genetic information is important for me to accurately assess patient's medication regimen and

will guide my recommendations for treatment plan. I have chosen to send the patient's test to Ayass Lung Clinic, PLLC with

highly sensitive, rapid, and cost-effective pharmacogenetic which will provide helpful medical treatment planning information

for my patient.

Thank you for your review and consideration. I hope you will support this request for genetic testing coverage for my patient.

If you have questions, or if I can be of further assistance, please do not hesitate to call me at:

Sincerely,

Physician's Name: _________________________________________ _

Signature:----------------------------------------------

Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100

Tests are performed in USA, results in one week.

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