On May 25, Gov. Bill Lee signed a laboratory licensure deregulation bill (SB 982) to codify waiver elements of Tennessee’s COVID-19 executive order, which repealed the medical laboratory licensure act and laboratory personnel licensure requirements. The Tennessee Society of Pathologists (TSP) and the CAP supported the legislation to decrease administrative burdens and costs on clinical laboratory operations with the deferral to rigorous federal oversight under the federal CLIA program.

The law exempts Tennessee-licensed pharmacies with active CLIA-certificate of waivers from the Tennessee Medical Laboratory Act authorizes medical laboratory directors to monitor medical laboratory personnel remotely, redefines “waived” testing as laboratory test systems cleared by the FDA for home use, and waived testing under CLIA.

Importantly, the TSP and the CAP worked together to amend the bill to include amendments that provide that “hospital-based laboratories within the bill’s definition of ‘private laboratory’ exempt from state laboratory licensure, clarify the Act applies to medical personnel employed by and performing testing at a private laboratory.”

Additionally, the amendments retain the prohibition to “solicit the referral of specimens to the person's or another medical laboratory or contract to perform medical laboratory examinations of specimens in a manner that offers or implies an offer of rebates to any person submitting specimens, other fee-splitting inducements, participation in fee-splitting arrangements, or other unearned remuneration,” and ensures prohibition “applies to medical personnel employed by and performing testing at a private laboratory.”

With the revised law, laboratories are equitably applicable and it preserves a prohibition of bribes, rebates, fee-splitting, and other unethical forms of remuneration in exchange for referrals of patient specimens.

The TSP requested an additional amendment to support the maintenance of laboratory personnel requirements and licensure as Tennessee’s educational and credentialing standards are paramount compared to federal standards. However, the amendment was not included in the final bill. The newly enacted law will significantly decrease state regulatory burdens and expenses on laboratories beyond the COVID-19 pandemic.