Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Incontinence/Urinary/Bladder Control. 
Treatment: Injection of periurethral bulking agents (procedure code 51715). 
The health plan denied injection of periurethral bulking agents (procedure code 51715). 
The determination is upheld. 

The patient is a female with a diagnosis of stress incontinence. Her prior attempted therapy includes pelvic floor physical therapy. 
At issue is whether or not the proposed health service or treatment, injection of periurethral bulking agents, is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

The health plan's determination regarding the proposed health service or treatment is upheld, in whole. 

The proposed health service or treatment, injection of periurethral bulking agents, is not likely more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 
European Association of Urology (EAU) Guidelines on Urinary Incontinence, 2022 states "Offer supervised intensive pelvic floor muscle training (PFMT), lasting at least three months, as first-line therapy to all women with stress urinary incontinence (SUI) or mixed urinary incontinence (including elderly women and pre- and postnatal women). Offer urethral bulking agents to women with SUI who request a low-risk procedure with the understanding that efficacy is lower than other surgical procedures, repeat injections are likely, and long-term durability and safety are not established." 
American Urological Association (AUA) Guidelines on Stress Urinary Incontinence, 2017 states, "The Panel believes that bulking agents are viable treatments for SUI; however, little long-term data exists for them. Re-treatment tends to be the norm for bulking agent therapy, and determination of absolute outcomes accordingly becomes challenging. There is inadequate data to allow the recommendation of one injectable agent over another. Still, the role for bulking agents may best be considered in patients who wish to avoid more invasive surgical management or who are concerned with the lengthier recovery time after surgery or who experience insufficient improvement following a previous anti-incontinence procedure. Patients should be counseled on the expected need for repeat injections." 
Canadian Urological Association (CUA) Guidelines on Adult Urinary Incontinence 2012 state, "Periurethral bulking agents are an option for patients who do not wish to undergo more invasive surgery. Other indications include elderly and patients with a high anesthetic risk. The benefit of bulking agents is limited and short-term. Patients should be aware that repeat injections are likely to be required and that efficacy (48 percent (%) at 12-23 months to 32% at 24-47 months) is inferior to conventional surgical techniques and diminishes over time (dry rate on a 24-hour pad test)." 
As such, use of periurethral bulking agents is not considered a long term curative option for treatment of stress urinary incontinence in women. Current medical documentation does not support discussion of alternative therapies and the rationale for using bulking agents over other curative treatment options.