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Effective December 1, 2025, Tennessee will transition four services now subject to certificate of need (CON) requirements—Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), burn units and Neonatal Intensive Care Units (NICUs)—to the Tennessee Health Facilities Commission's (HFC) new Quality Service License framework. This represents the HFC's most significant step to date in implementing Public Chapter No. 985's overhaul of Tennessee's CON program, which began in July 2024 and continues through December 2029. For a detailed summary of Public Chapter No. 985 and its changes to Tennessee's CON program, see our previous content and summary chart.
What Changes on December 1, 2025?
Beginning December 1, 2025, a CON will not be required to initiate MRI, PET, burn unit or NICU services. Instead, all healthcare facilities and physician offices in Tennessee—both providers currently offering these services under a CON or CON exemption and providers seeking to initiate these services—must obtain a Quality Service License from the HFC. Providers currently operating under CON approval or a CON exemption may continue to do so while their Quality Service License applications are pending. New providers must obtain a provisional license before initiating services.
Key Compliance Dates and HFC Meeting Schedule
Providers aiming to maintain or begin services as soon as the new framework takes effect must submit Quality Service License applications no later than December 30, 2025. The HFC recommends submitting applications as close to December 1, 2025, as possible. The HFC will not begin reviewing applications until December 1, 2025. Complete applications received by December 30, 2025, will be considered for ratification at the HFC's meeting on January 28, 2026.
Application Submission and Scope
The HFC has two application forms, one for hospitals and outpatient diagnostic centers (ODCs) and one for physician offices. Application forms are available here. One application is required per location. A provider can submit one application for multiple services at the same location; however, a separate license will be issued for each service. For example, a hospital providing MRI, PET, burn unit and NICU services at one campus may submit one application, resulting in distinct licenses for each service. If the hospital also operates a satellite location offering any of these services, the satellite must submit a separate application for that location. Applications are submitted electronically to hfc.service@tn.gov and require annual renewal.
Application Review, Provisional Approval and Ratification
The HFC will review applications for completeness. Once an application is deemed complete, the HFC will issue a service license number and invoice the provider for the applicable licensing fee. After the HFC receives payment, providers will receive a provisional approval letter. The application will be presented for ratification at the next regularly scheduled HFC meeting. Physical licenses will be mailed approximately 10–14 days after ratification. If an application is not ratified, the HFC will provide an explanation and instructions for seeking further review. Additional review steps apply to burn units and NICUs, as described below.
Licensing Fees
The HFC will invoice providers based on the level of services indicated in the application. Providers should not submit payment before receiving an invoice.
- Fee for burn units/NICUs: $1,040
- Fee for MRI/PET (per unit): $500 (fees for ODCs are included within standard ODC licensing fees)
MRI and PET: Additional Licensure Considerations
MRI and PET services are subject to specific requirements under the Quality Service License framework:
- Medical equipment registry: MRI and PET units remain subject to the HFC's annual medical equipment registry requirements under T.C.A. § 68-11-1607(h). See here for the HFC's medical equipment registry.
- Elimination of prior CON conditions: After December 1, 2025, any conditions attached to a CON for MRI or PET—such as patient age restrictions or practice-related limitations—will no longer apply.
- CT scanners: CT scanners do not require a Quality Service License but remain subject to the HFC's medical equipment registry requirements.
- Accreditation: Each MRI and PET unit must be accredited by a Centers for Medicare & Medicaid Services-approved accreditation organization within two years of licensure or acquisition. Providers accredited by organizations that cover all services, such as The Joint Commission or DNV, need not obtain separate accreditation for MRI/PET.
- Units serving multiple providers: If an MRI/PET unit services multiple providers, such as a mobile MRI/PET or shared MRI/PET, each provider using the unit must obtain a Quality Service License.
HFC's FAQs specific to MRI and PET services can be found here.
Burn Units and NICUs: Additional Licensure Considerations
Burn unit and NICU services are subject to specific requirements under the Quality Service License framework:
- Plans review and survey process: Hospitals seeking to initiate burn unit or NICU services, or to modify the scope or scale of existing burn unit or NICU services, must submit architectural plans to the HFC's Plans Review division and complete any required survey and inspection processes before the HFC will process the Quality Service License application.
- Comprehensive licensing requirements: As part of the Quality Service License framework, the HFC revised the regulations for hospitals offering burn unit and NICU services. Specifically, Chapter 0720-14-.07 adds licensure requirements for hospitals providing burn unit, NICU and perinatal and/or neonatal care services, including but not limited to obtaining verifications outlined below, complying with certain administrative and staffing requirements and participating in quality initiatives.
- Burn unit verification: To receive a full license, a burn unit must obtain and maintain American Burn Association (ABA) verification. For hospitals initiating burn unit services for the first time, ABA verification must be obtained within five years of provisional licensure. New burn unit providers will be subject to annual on-site visits by the HFC until verification is achieved. Hospitals operating ABA-verified burn units at the time of initial licensure are eligible for full licensure without annual site visits.
- NICU verification: To receive a full license, a NICU must achieve state-level verification or verification through the American Academy of Pediatrics (AAP) within three years of provisional licensure. Verification requirements vary based on a hospital's self-designated NICU level of care (Levels II-IV) and evaluate a NICU's compliance with the Tennessee Perinatal Care System Guidelines for Regionalization, Hospital Care Levels, Staffing, and Facilities. In Spring 2026, the HFC expects to approve third party site reviewer organizations and publish uniform standards for state- or third party-conducted verification site reviews.
HFC's FAQs for burn units are here and NICUs here.
HFC Resources and Ongoing Updates
The HFC has published revised regulations, application forms, FAQs and guidance, including webinars, on its Quality Service License webpage available here. Providers should monitor these resources for the latest updates, including additional clarifications and upcoming trainings.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.