While ATD’s lab testing system represents a significant advance in the field of ocular surface diagnostics, many eyecare physicians may not be familiar with research into the diagnostic utility of ocular lactoferrin and IgE, or the applicable federal and state licensing rules and regulations necessary for properly operating an on-site medical laboratory, compliance requirements or reimbursement for lab testing services.
It is for this reason, we have included the sections “Papers & Articles” and “Reimbursement” for your review.
On the regulatory side, any physician operating a laboratory, whether in-office or not, waived or not, must be properly licensed.
A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems into one of three CLIA regulatory categories based on their potential for risk to public health:
- Class I: Waived tests
- Class II: Tests of moderate complexity, and
- Class III: Tests of high complexity
ATD’s tests are considered Class II tests (Moderate Complexity) and as such, management understands the need to provide accurate and timely information to any physician interested in investigating the use of our system. It is for this reason we provide focused and personalized support resources designed to make this process as easy as possible.
Whether you need help understanding CLIA regulations, assistance in completing your CLIA application or guidance on reimbursement issues, ATD helps you through it all.
Sounds onerous, but it’s not. In fact it is very straight-forward and quite simple.
We have included topic links covering several regulatory and reimbursement issues for your review. If you should have any additional questions after reviewing the information provided, all you have to do is email or call.