What are CLIA "waived" tests? Do I need to become a Lab Director for tests like Salivary hormone tests or Finger-prick food allergy tests?

In California, NDs must become a Lab Director to perform certain specimen tests in office, called CLIA "waived" tests (examples are listed below). Applications for the Lab Director's License are available through the Laboratory Field Services division of the CA Department of Public Health. For instructions on applying for Lab Director status, refer to this page from the Centers for Medicare & Medicaid Services.

Specimens collected in office but sent out for analysis are not considered CLIA waived tests, and therefore do not require lab director status. The waived tests are any test that are over the counter and pose no risk to the patient, with very reliable results that are difficult to misinterpret. Basically, any test that a patient could take home and do themselves, including interpreting the results, is a CLIA waived test. More information about these tests can be found on the CDC's Waived Tests page.

A complete list of CLIA waived tests can be found here. Common CLIA waived tests include:

1. Dipstick or Tablet reagent urinalysis (non-automated) for the following: Bilirubin, Glucose, Hemoglobin, Ketone, Leukocytes, Nitrite, pH, Protein, Specific gravity, or Urobilinogen
2. Fecal occult blood
3. Ovulation tests - visual color comparison tests for luteinizing hormone
4. Urine pregnancy tests - visual color comparison tests
5. Erythrocyte sedimentation rate-non-automated
6. Hemoglobin-copper sulfate - non-automated
7. Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
8. Spun microhematocrit
9. Hemoglobin by single analyte instruments with self contained or component features to perform specimen/reagent interaction, providing direct measurement and readout

Can I order labs for a Medicare Patient? For a Medicaid Patient?

For Medicare patients, only doctors that are registered with PECOS may order labs run through Medicare and, at this time, NDs are not able to register for this status. Even if they retain a secondary private insurance you still cannot order labs, as they must go through Medicare first. For Medicaid patients, you can register as a MediCal provider to received coverage for medically necessary labs only, but office visits are not covered and will not be reimbursed. For both types of patients, the best course of action is to run the labs through a cash-pay provider, or have their Medicare/Medicaid provider order the tests on your behalf.

Is it possible for labs I order to be covered by my patients' insurance?

Yes, if your patients have a PPO and if the lab is contracted with the insurance provider. Basic blood orders are covered, however saliva hormone panels, nutrient panels, food Elisa sensitivity panels and other “functional medicine” labs are often deemed outside the conventional medicine standard of care or “not medically necessary" and are usually not covered by insurance. Labs will not be covered with patients that have HMO insurance.