Article by Gregory D Seeley Esq
On July 30, the OIG released a report titled "CLIA Regulation of Unestablished Laboratory Tests." Such tests include but are not limited to: Live Blood Cell Analysis (LBA), Biological Terrain Assessment, Thromboelastograph, dental sensitivity testing, food allergy testing and hair analysis to assess nutritional deficiencies. The OIG examined how the Centers for Medicare and Medicaid Services (CMS, formerly HCFA) regulates these tests and found that labs performing such tests are not able to meet all of CLIA’s requirements. They are aware of a number of labs operating without CLIA certificates, which has raised concern.
The OIG determined that unestablished tests do not "fit well into the current CLIA regulatory framework." OIG did admit that exemption from CLIA does exist in some circumstances, such as certain tests where results are not reported to patients. It also acknowledged that physicians practicing alternative and complementary medicine
