Key Points
- The American Medical Association has issued three Category I CPT® codes for Profound Medical’s prostate ablation TULSA-PRO device.
- CPT codes are used by insurance companies to reimburse medical procedures.
- This is the first time an MRI-guided therapeutic ultrasound procedure has been granted a Category I CPT code.
Profound Medical has announced that the American Medical Association (AMA) has issued three new Current Procedural Terminology (CPT®) Category I codes for MRI-monitored Transurethral Ultrasound Ablation (TULSA) of prostate tissue, performed using the company’s TULSA-PRO® system. This is the first time a CPT Category I code has been granted to an MRI-guided therapeutic ultrasound procedure.
CPT codes are used by insurance companies to reimburse medical procedures. There are three levels of CPT codes, with a Category I code being the most challenging to acquire, because it requires a significant amount of data and society support for a procedure. Category I is a permanent code that designates the procedure has full US Food and Drug Administration (FDA) clearance and demonstrated clinical efficacy to support broad adoption and coverage.
Profound’s press release explains why three codes were issued: “The first CPT Code describes the complete TULSA procedure when furnished by a single physician, such as a urologist. The other two CPT codes each describe a part of the TULSA procedure when TULSA is furnished by two physicians, such as a urologist in collaboration with a radiologist.”
The codes will take effect on January 1, 2025. Until then, hospitals performing the TULSA procedure on Medicare patients in the US should continue to use the current Healthcare Common Procedure Coding System C code, C9734.
“The establishment of these permanent codes specific to TULSA is a critical milestone for the broader adoption of the technology to treat prostate diseases in the United States,” said Profound’s CEO and Chairman, Arun Menawat PhD, MBA. “The application was independently sponsored and submitted without the direct involvement of Profound, which is a testament to the level of physician support for this new procedure.”
“Establishing CPT codes for this unique technology will make it easier for patients to get treated and physicians to bill insurance companies for the procedure, furthering the use of this minimally invasive and effective treatment,” said Mark Carol, MD, a senior consultant to the Foundation.
Profound’s TULSA-PRO device earned FDA 510(k) clearance to ablate prostate tissue in August 2019. It uses real-time MRI guidance and temperature feedback control combined with radiation- and incision-free ultrasound to allow physicians to predictably ablate whole-gland or partial prostate tissue. TULSA-PRO is the only FDA-cleared device that uses therapeutic ultrasound in a transurethral manner to treat the prostate.