For background, this link defines CLIA-waived tests as
simple laboratory examinations and procedures that ... employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124202.htmThen, for specifics, we turn to this link and read on Page 2:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/howobtaincertificateofwaiver.pdfQ: I am a physician performing urine dip sticks and finger sticks for blood glucose in my office as part of the patient's visit. Am I considered to have a laboratory and do I need a CLIA certificate?
A: Yes, the testing you perform qualifies as waived laboratory testing and you need a CLIA Certificate of Waiver. This testing requires a CLIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances.
Per Medicare, there can be a Physician Owned Laboratory (POL), or a clinical laboratory. One laboratory or the other may bill for a given test, but both cannot bill for the same test at the same time. If the doctor has a POL, he must have a CLIA number for that laboratory. The clinical laboratory must have it's own CLIA number. When the doctor uses his POL, he must bill that lab testing under his own CLIA number for his POL. Even if the doctor has a POL, he may send the labs out to a clinical laboratory instead of using his POL (note that the doctor must inform his patients that they can use a lab of their own choice; they cannot be compelled to use the doctor's POL). If the doctor sends the labs to a clinical laboratory, the clinical laboratory must bill for the tests, using their own CLIA number.
Under the Medicare rules, a doctor may not bill for a lab test(s) using his own CLIA number and then send the same specimen samples to an outside lab - where they run the exact tests the doctor ran, and bill for the testing using their own CLIA number. Medicare edits will catch that two different CLIA numbers are billing for the same series of tests for the same patient for the same date of service. However, the doctor
can run a series of tests in his POL and then send the specimen samples to an outside lab for a different series of tests. That situation will pass the Medicare edits because the two different CLIA numbers are billing for two different sets of tests.
Finally, a doctor may send the specimen samples to an outside lab - and the lab runs the tests / creates the slides and sends the results back to the doctor for the doctor to interpret (xray, nuclear testing, pathology - but not urine or blood). In this instance, the clinical lab will bill the technical component (TC) using their CLIA number, and the doctor will bill the professional component (PC), no CLIA numer required. (The regulations re. TC and PC are changing as we speak, but that is beyond the scope of your question.)
Those are the definitions and regulations for Medicare. They apply to all instances where the doctor sees Medicare patients. But some states (California for example) have their own regulations that impose the Medicare regulations on all Insurance Carriers. So what you just read would apply to W/C or Blue Cross or HealthNet patients in California, as well as to Medicare patients.
If you are working in California, I can tell you that the Medicare regulations do apply to your doctors and your lab even though your doctors only see W/C and PiP patients. That is because I know the California regulations . But I don't know the state law for whatever state you actually work in. That is why you need to speak with a Health Care Attorney about the laws for your state. What you described in your original post may be a legitimate issue, or it may be nothing. Only the appropriate legal counsel can tell you.
