FREQUENTLY ASKED QUESTIONS Who can collect the specimen samples? Any person employed by the physicians office may collect the sample after watching a 4 minute instructional video and taking the 3 question quiz. An email is sent to the specimen collector authorizing them to collect samples.
Can we bill for this test? Yes. Laboratories may bill for the test with a 90 modifier provided that the lab or entity does not outsource more than 30% of its total testing to reference laboratories. In general, payment for clinical laboratory tests subject to schedules is only made to the person or entity that performed or supervised the performance of the tests. An exception to this policy allows payment to be made to one independent or hospital laboratory for tests performed by another lab (the referring lab). However, the Omnibus Budget Reconciliation Act of 1989 (OBRA) has amended this exception by restricting payment to referring laboratories. In accordance with S6111(b) of OBRA of 1989, a referring lab can bill for tests performed by a reference lab only if it meets any one of the following three exceptions: The referring laboratory is located in or is part of a rural hospital • The referring lab and the reference lab are subsidiary related. That is: • The referring lab is a wholly owned subsidiary of the reference lab ◦ The referring lab wholly owns the reference lab ◦ Both the referring lab and reference lab are wholly owned subsidiaries of ◦ the same entity Not more than 30 percent of the clinical laboratory tests billed annually by the re• ferring lab are performed in another lab, other than a subsidiary related lab
Who submits positive results to the CDC? By law, we are required to submit all positive results to the Centers for Disease Control.
Is this considered a Temporary Testing Site or Direct Access Testing? These rules vary from state to state. Pinnacle In Vitro Diagnostics HCL may authorize an unlimited number of Temporary Testing Sites under its CLIA Number, if required. Our regulatory team will ensure testing meets or exceeds CLIA guidelines in your state. After orders are accepted with an order acknowledgement, we will access and address the regulatory requirements on a site by site basis.
Are the covID APEX suite of tests EUA authorized? No. As the landscape continues to shift, HHS recently directed FDA to allow any validated LDT to be used for COVID testing provided that the laboratory in question in authorized to test COVID specimens according to the Clinical Laboratory Improvement Amendment Act of 1988. We intend to pursue EUA applications on all three validated assays, but it is unclear if FDA will review these EUA requests.
Is a certain EMR or computer system required? No. Our platform integrates into your existing technology investments. Any tablet or smartphone running IOS or Android technology can be used to send and receive patient data though the lab.