Frequently asked questions
All Clarifi ASD samples are processed at a CLIA (Clinical Laboratory Improvement Amendments) certified and CAP (College of American Pathologists) accredited lab (Admera Health).
For health care providers
Cost & insurance
It is our mission to make Clarifi ASD affordable and accessible to anyone who needs it, which is why coverage for this test is a high priority for us. To help with the cost of Clarifi ASD in the short term, it is offered at an introductory price of $989, a significant discount relative to other tests using next generation sequencing technology.
At this time, it is the responsibility of the patient to pay for this test, and all billing will be handled directly with our company. The Clarifi ASD test requires a prescription, and is ordered by your health care provider. The Clarifi kits can be ordered online by your provider, and they will be shipped directly to the ordering provider at no cost. After your health care provider orders the Clarifi ASD test, you will make payment via the Clarifi website. The test results will be sent to your provider, who will explain them to you. After your provider explains your results, they will be available to you via the Clarifi website.
Clarifi ASD represents a new approach to aid in the diagnosis of autism, so it is patient-pay at this time. We encourage insured patients to independently submit a claim for potential reimbursement using the Clarifi™ CPT Proprietary Laboratory Analyses (PLA) Code, which was issued by the American Medical Association for the Clarifi ASD test. The PLA Code for Clarifi ASD is 0170U.
Using the Clarifi PLA Code in requesting reimbursement from your insurer will assist the insurer in identifying the correct classification for the Clarifi ASD test, but it will not affect the insurer’s decision on whether or not the Clarifi test will be reimbursed. Reimbursement for Clarifi ASD will depend, in part, on your health care provider carefully documenting the applicable diagnosis codes to demonstrate the medical necessity for the Clarifi ASD test.
The Office of Inspector General (OIG) requires determinations of medical necessity to be made by health care providers, and therefore neither Quadrant Biosciences or Admera Health, the laboratory that performs the Clarifi test, can determine whether the Clarifi autism saliva test is medically necessary for you, for purposes of claiming reimbursement.
Families can also utilize their HSA or FSA accounts to help cover the expense of Clarifi ASD.
If you have additional questions about reimbursement, please contact us.