A provision in Tennessee's assisted reproductive technology bill creates a new licensing requirement that most fertility clinic owners haven't heard about yet.
Most Tennessee health services owners focused on assisted reproductive technology haven't realized that HB2290 contains a significant operational requirement buried in its text: fertility clinics must now obtain a biennial state certificate to continue operating legally.
Under Section 68-1-2102(a) of the amended Tennessee Code, any facility operating as a fertility clinic—including locations that store embryos or provide ART services—must apply for and maintain a certificate from the Tennessee Department of Health every two years. This isn't optional paperwork. It's a licensing requirement that directly affects whether your clinic can legally operate.
To obtain this certificate, your clinic must demonstrate three things:
First: Verification of membership in SART (Society for Assisted Reproductive Technology). This is a professional membership organization, and verification requires active enrollment.
Second: A documented embryo emergency transfer plan. This is a protocol showing how your clinic would handle unexpected situations involving stored embryos—equipment failure, natural disaster, or other emergencies. You'll need to have this plan in writing and available for state review.
Third: Proof of passing a laboratory inspection by either CAP (College of American Pathologists) or JCAHO (The Joint Commission). These are third-party accreditation bodies that conduct facility inspections. You'll need current, passing inspection documentation to submit with your application.
This requirement applies to any business operating a fertility clinic in Tennessee. That includes standalone fertility practices, hospital-based reproductive medicine departments, and any other facility where ART procedures occur or embryos are stored. If you're in this space, you're affected.
The Tennessee Department of Health has rulemaking authority effective May 22, 2026—the date HB2290 was signed. The operational requirement itself takes effect January 1, 2027. That gives you roughly eight months from the signing date to understand the rules the state will publish and begin preparing your documentation.
Budget for recurring costs: SART membership fees, the cost of maintaining CAP or JCAHO accreditation (which involves inspection fees and facility compliance work), and staff time to compile and submit the biennial application. These aren't one-time expenses—they repeat every two years.
If you operate a fertility clinic in Tennessee, review your current accreditation status. Confirm whether you hold active SART membership or whether you'll need to apply. If you don't currently have CAP or JCAHO lab certification, understand the timeline and cost to obtain it before January 2027. Begin drafting your embryo emergency transfer plan now, rather than waiting until the state publishes detailed rules.
The Tennessee Department of Health will publish specific application procedures and forms as they develop rules under this new authority. Watch for those announcements in late 2026.
Source: HB2290, Section 68-1-2102(a), effective January 1, 2027.