What is Personalized Medicine?
Personalized Medicine is a rapidly developing healthcare science that takes into account each person’s unique genetic profile when determining treatment options for a variety of conditions. Its goal is to optimize preventive healthcare and drug therapies that hold immense potential for human health. Personalized Medicine will help healthcare providers to better determine risk-and-reward scenarios and give them more knowledge to prescribe pharmaceuticals with demonstrated safe and effective results.
What are my privacy rights with Personalized Medicine?
The results of your DNA drug-response testing will be seen only by your designated healthcare providers. Test results are protected by a federal law called GINA, the Genetic Information Non-Discrimination Act of 2008, enacted to prohibit discrimination in health coverage and employment based on genetic information. For comprehensive information on GINA, click here.
What is Pharmacogenomics?
Although the term genetics was coined in the early 1900’s, much of the development and activity around Pharmacogenomics has occurred in the last decade. Pharmacogenomics is a science that examines the inherited variations in genes that dictate drug response and explores the ways these variations can be used to optimize drug therapy by assisting in the selection of drug therapy, maximizing efficacy, and minimizing adverse effects. Stated more simply, Pharmacogenomics is the study of variations in DNA and RNA characteristics related to drug response.
Why should I or a family member have our DNA tested?
Each individual is unique. Hence, two people may have very different responses to drug therapy. Testing for one’s genetic variations could help you (or, a family member), and your doctor make better decisions regarding drug choice and dose to ensure you are receiving the maximum benefit and minimal adverse effects of a prescribed drug.
Genetworx would encourage you to seek the advice of your physician and/or pharmacist to determine if pharmacogenomic testing can benefit you. However, we believe that every patient can benefit from DNA testing, both as a preventive measure and as a central part of your ongoing personal health management plan.
Where and how can I obtain a test kit?
Genetworx promotes a patient-centric model and team approach with you, your physician, your pharmacist, and your DNA. Contact Us and we will be happy to reach out to your physician and/or pharmacist and send a test kit to them.
Who performs the DNA testing?
Genetworx is a clinical laboratory that has met stringent accreditation requirements as set forth by CLIA and CAP to assure quality and test data integrity (CAP Number: 8732425; CLIA Number: 49D2060159). Genetworx coordinates and performs laboratory services on behalf of physicians, pharmacists, and patients in an effort to remove much of the administrative burden, while providing access to the most advanced DNA technology available; allowing for high quality reportable results with a rapid turnaround time.
What is required to obtain a patient sample?
With Genetworx testing kits, the traditional means of collecting a patient sample by obtaining a blood sample is no longer required. Genetworx test kits will include a buccal (cheek) swab delivering the same results as a blood sample. This provides a source sample that is simple, non-invasive, and can be obtained in any setting. For details on the Collection Process, Click Here.
How will I receive test results?
Your test results will be sent to your healthcare professional within 3-5 days after the sample is received. Your healthcare professional will discuss and/or send test results to you, and determine the best course of action based on your DNA results.
Can an insurer, or my employer, deny me coverage based on the results of genetic testing?
In 2008, Congress passed the Genetic Information Nondiscrimination Act (GINA). GINA prohibits health insurance companies from denying coverage or charging higher premiums to an individual based solely on genetic information. GINA also prohibits employers from using your genetic information when making hiring, firing, job placement or promotion decisions. For details on GINA, Click Here.
Who pays for the test?
The test will be billed to the patient's health insurance plan upon a written order from their healthcare provider.
What is the patient’s financial responsibility?
This will depend on the specifics of your health insurance plan and coverage. We recommend contacting your health plan administrator to determine your financial responsibility.
What is Medical Necessity?
The Medicare definition of “Medical Necessity” requires that the item or service be “reasonable and necessary” for the diagnosis or treatment of illness or injury for Medicare payment to be made. It is important to note that a service may be covered, but may be limited to certain diagnoses, and denied if one of those diagnoses is not present.
What is an Advance Beneficiary Notice (ABN)?
An Advance Beneficiary Notice (ABN) allows a beneficiary to make an informed consumer decision by knowing in advance that the beneficiary may have to pay out-of-pocket. An ABN is used when the physician/practitioner believes that Medicare will not make payment.
What if Insurance denies reimbursement for testing?
Genetworx believes it is important for all patients to have access to testing. Genetworx will consider providing financial assistance to eligible patients.
Can I pay for the test myself?
Yes. If your health insurance plan deems this testing as research or investigational and you believe the clinical benefits outweigh the financial cost, you can pay out-of-pocket for testing.
What if I have more questions?
To learn more please contact us.