Download RESPONSE Letter of Med Necessity

March 11th, 2016
RE: Critical Test Coverage Request by the Treating Provider
Patient: [First Name, Last Name]
Insurance Provider: [Insurance Company Name]
Subscriber Name: [First Name, Last Name]
Policy #: [Subscriber’s Policy Number]
Dear Claim’s Specialist,
I am writing this letter on behalf of my patient, and your subscriber, [First, Last Name]
to request full coverage of a DNA-based variant analysis test. This patient presents with
an abnormally high risk of adverse drug event, as [He/She] is being treated for multiple
chronic health conditions [LIST HERE], and takes numerous prescription medications
on a daily basis. Without data that provides patient specific guidance as to the
appropriate drug regimen for this patient, I fear injury is inevitable.
Specifically, the RESPONSE® test identifies common variations in 22 genes known to
impact a patient’s response (and tolerance) to medication. This test relies on a scientific
body of evidence that has stood the test of time, as evidenced by the fact the FDA now
includes genetic-based dosing guidance directly on the drug label of more than 120
commonly prescribed medications. This label guidance often includes specific actions
that are to be taken for certain patients, based on their genetic test results.
Having RESPONSE® test results in-hand will undoubtedly help me select the proper
drug, at the proper dose for this patient. This patients clinical situation demands the use
of advanced tools, in order to prevent harmful and costly adverse drug events and
increase the overall odds of treatment success.
Thank you for your timely review and consideration. My patients well-being may rely
upon my access to data and guidance provided by the RESPONSE® test-- and I hope for
your full support in its coverage. If you have questions, or if I can be of any further
assistance, please do not hesitate to call me at [PHYSICIAN PHONE NUMBER].
Sincerely,
Ordering Clinician Signature ______________________________ Date ______________
(MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician
Assistant, Genetic Counselor*) *Authorized clinician requirements vary by state
Test Details:
The test includes data and/or clinical guidance for the following genes: CYP450 2C19,
CYP450 2D6, CYP450 2C9, MTHFR, FACTOR II, FACTOR V LEIDEN, UGT1A1,
VKORC1, DPYD, ADRA2A, CYP450 3A4, CYP450 3A5, TPMT, APO-E, SLCO1B1,
CYP4501A2, CYP450 2B6, CYP450 2C8, COMT, OPRM1, ANKK1/DDR and UGT2B15.
Laboratory Info:
Laboratory Information: LabSolutions LLC (NPI 1437585262), a high complexity, CLIAcertified clinical laboratory specializing in precision healthcare laboratory services. The
laboratory is located at 1451 Northside Dr NW, Atlanta, GA 30318.o