PORTSMOUTH, N.H. – July 10, 2025 – Effective July 1, 2025, Blue Cross Blue Shield of Michigan (BCBSM) has issued a new medical policy under CPT code 52284, extending coverage for Laborie Medical Technologies’ Optilume® Urethral Drug-Coated Balloon for Stricture to eligible Commercial HMO members. This new coverage reinforces Laborie’s ongoing commitment to enhancing patient outcomes through wider access to evidence-based medical technologies.
The BCBSM Medical Policy Statement is as follows:
“The use of a drug-coated balloon catheter system (i.e., Optilume® Urethral Drug Coated Balloon) is considered established. The evidence is sufficient to determine that the technology results in an improvement in net health outcomes.”
“Optilume appears to offer a safe and superior alternative to previous stricture treatments for our patients, said Dr. Jason Hafron, M.D., CMO, of Michigan Institute of Urology. “This aligns well with Blue Cross Blue Shield of Michigan and Michigan Institute of Urology’s commitment to offering our patients the highest level of care.”
Supported by findings from the ROBUST I and ROBUST III clinical trials, which evaluated the long-term efficacy of Optilume®, BCBSM’s medical policy marks a significant advancement in the treatment of recurrent bulbar urethral strictures (the narrowing of the urethra which can lead to weak urine flow, painful or frequent urination, recurrent infections, and potential damage to the bladder or kidneys).
Clinical results from both trials demonstrated that Optilume® offers a durable, minimally invasive alternative to standard treatments, with meaningful improvements in patient outcomes. These findings support Optilume® as a proven technology that enhances net health outcomes for affected individuals.
This decision also aligns with current guidelines from the American Urological Association (AUA), which conditionally recommend drug-coated balloons for recurrent bulbar urethral strictures <3 cm, and the European Association of Urology (EAU), which supports their use following multiple failed endoscopic treatments. The UK’s NICE also endorses Optilume® with ongoing data collection.
“Blue Cross Blue Shield of Michigan’s decision to cover this procedure significantly enhances our ability to care for patients with urethral strictures,” said Dr. Jason Evans, M.D. of Urological Services, P.C. in Flint, MI. “Optilume offers a more effective way of treating this disease process.”
Providers should review the full policy, confirm patient eligibility, and contact BCBSM Provider Services for additional information and support. For more information about Optilume®, visit www.optilume.com.
About Laborie Medical Technologies
Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on Urology, Urogynecology, Gastroenterology, Obstetrics, Gynecology & Neonatal Health. We manufacture and deliver high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals look to us as the market-leading experts in our business segments, and we support our products with a world-class clinical education & information program. Laborie is a portfolio company of Patricia Industries. For more information visit www.laborie.com.