The FDA policy specified that CLIA waived tests are the simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; 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.
Now the CLIA waiver requirements are corrected and this is clear that test devices approved for home use by the Food and Drug Administration mechanically become the CLIA waived. Professional use versions of home use tests are not automatically waived. On the other hand, professional edition of such test kits do become qualified for simple waiver evaluation if the only differences between tests versions need to be studied to conclude whether the professional version qualifies for waiver.
CPT Codes and
Reimbursement Information for the CLIA Waived Test Kits
Strep A Test Kit Strip or Device
Drugs of Abuse Urine
Multi Drug Panel, Cassette or Cups
For Medicare/Medicaid G0434QW
For Private Insurers 80104
Fecal Occult Blood Test
Saliva Alcohol Test Strip
Urinary Tract Infections
Urinalysis Reagent Strips
CLIA Waived HCG Urine test
* - The above listed Average Reimbursement Limit are provided for estimates
only and are subject to change and not guaranteed. For the current actual
state by state rates schedule, please visit: www.cms.hhs.gov
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