A provision in HB2290 creates a new biennial certification requirement for fertility clinics operating in Tennessee—and most owners haven't heard about it yet.
Most Tennessee health service owners operating fertility clinics don't realize they're about to face a new regulatory requirement. Buried in HB2290, which amended Tennessee law effective January 1, 2027, is a provision requiring fertility clinics to obtain a biennial state certificate from the Tennessee Department of Health. This isn't optional, and it carries real compliance obligations.
Under Section 1, § 68-1-2102(a) of HB2290, any facility operating as a fertility clinic—including locations that store embryos or provide assisted reproductive technology (ART) services—must apply for and maintain a certificate from the state every two years. This isn't a simple registration. The application requires three specific submissions:
First, SART membership verification. You'll need to demonstrate membership in the Society for Assisted Reproductive Technology, the professional standards organization for fertility practices.
Second, an embryo emergency transfer plan. You must submit a documented plan for transferring embryos in case of emergency—addressing scenarios like equipment failure, facility closure, or other disruptions to operations.
Third, proof of lab inspection. You'll need documentation showing your laboratory has passed inspection by either the College of American Pathologists (CAP) or the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
These requirements apply every two years. Missing a renewal or failing to submit required documentation could affect your ability to operate legally in Tennessee.
This requirement applies to any fertility clinic operating in Tennessee, regardless of size. That includes standalone fertility practices, hospital-based ART programs, and clinics that primarily focus on embryo storage or cryopreservation services. If you're providing assisted reproductive technology services or storing embryos in Tennessee, you're affected.
The effective date for most provisions of HB2290, including this certification requirement, is January 1, 2027. The Tennessee Department of Health will begin rule-promulgation upon the bill's signing (May 22, 2026), which means regulations clarifying the application process, documentation standards, and renewal procedures should be available before the January deadline.
Owners should begin preparing now. If you're not already SART members, that membership process takes time. Your embryo emergency transfer plan will need to be documented and ready for submission. And if your lab inspections are outdated, scheduling CAP or JCAHO certification should be a priority.
The biennial renewal cycle means this becomes an ongoing operational obligation—not a one-time compliance task. Budget for renewal applications, maintain current certifications, and track your renewal dates to avoid lapses.
Tennessee health service owners operating fertility clinics should review the full text of HB2290, Section 1, § 68-1-2102(a) and begin coordinating with their compliance and quality assurance teams. The Tennessee Department of Health will publish detailed guidance as regulations are finalized.
For a detailed breakdown of HB2290's fertility clinic provisions and what they mean for your practice, consult with your legal and compliance advisors or contact the Tennessee Department of Health.