PLEASANTON, Calif. – November 10, 2014 – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, announced today that the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), has approved two new Category I Current Procedure Terminology (CPT®) codes for the UroLift® System treatment for benign prostatic hyperplasia (BPH), effective January 1, 2015.
BPH, also known as enlarged prostate, is a medical condition in which the prostate gland that surrounds the male urethra becomes enlarged with advancing age and begins to obstruct the urinary system. The condition is common, affecting approximately 37 million men in the United States alone. BPH symptoms include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life. About one in four men experience BPH-related symptoms by age 55, with 90 percent of men over 70 symptomatic.
Medication is often the first line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts or ablates prostate tissue to open the blocked urethra. While current surgical options, such as TURP, can be very effective in relieving symptoms, it can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
Treatment with the FDA-cleared UroLift System, the only transprostatic implant system indicated for BPH, involves an outpatient procedure with no cutting, heating, or removing prostate tissue. Category I status, which is reserved for procedures consistent with contemporary medical practice and performed by many physicians in multiple locations, was awarded based on the numerous peer-reviewed publications detailing top-tier clinical studies of the UroLift implant procedure, which demonstrate rapid and durable relief from the urinary symptoms associated with BPH without compromising sexual function.
“The establishment of CMS reimbursement for UroLift is a major milestone for NeoTract and the clinical community, and comes on the heels of positive coverage decisions from Aetna and Coventry earlier this year,” said Dave Amerson, president and CEO of NeoTract. “We are excited about the opportunity this presents for millions of men in the U.S. who are suffering from the symptoms of enlarged prostate, which often greatly impacts quality of life.”
CPT codes 52441 and 52442 were approved by the American Medical Association (AMA) to describe the UroLift transprostatic implant procedure, also known as Prostatic Urethral Lift (PUL). Because of the minimally invasive nature of the treatment, the new codes have been assigned a zero-day global period.
|52441||Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant|
|52442||Each additional permanent adjustable transprostatic implant (list separately in addition to code for primary procedure)|
About the UroLift System
The UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., Europe, Australia and Canada. Learn more at www.UroLift.com.
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com.