53445 — Incontinence Control Devices

Incontinence Control Devices (NCD 230.10)

CMS: “To meet coverage criteria, the patient’s medical record must contain documentation that fully supports the medical necessity of services. Subsections 6.2.1 to 6.2.13 list the documentation requirements for example services. For detailed documentation requirements, providers who choose to submit a prior authorization request for a WISeR Select Item or Service should refer to the relevant NCDs and/or their MAC jurisdiction’s LCDs and Local Coverage Articles (LCAs), if available, for guidance. They can be found on the Medicare Coverage Database website.”

NCD 230.10 provides Medicare coverage and payment criteria for the use of mechanical/hydraulic incontinence control devices and collagen implants or injections. Given urethral bulking agents no longer contain collagen (as Contigen® has been discontinued), WISeR initially will focus on mechanical/hydraulic incontinence control devices for the purposes of treating Stress Urinary Incontinence (SUI). General documentation requirements for mechanical/hydraulic incontinence control devices are as follows:

• ❑Documentation of evaluation and diagnosis of SUI, such as but not limited to: a) Relevant history, in particular, elements that may impact placement of an incontinence control device such as prior prostate or pelvic surgery, pelvic radiation therapy, or urethral trauma (resulting in damage to the urethral sphincter), if applicable b) Physical examination, including pelvic or rectal exam, if applicable c) Urinalysis: Patients with an abnormal urinalysis, such as unexplained hematuria or pyuria, should undergo additional evaluation if being considered for surgical intervention. d) Result of a cough or bladder stress test or an objective demonstration of urinary incontinence with a comfortably full bladder e) Additional testing, if applicable o Voiding diary (at least 24 hours of symptoms) o Cystoscopy where there is a concern for urinary tract abnormalities o Urodynamic testing for complicated or mixed symptoms (e.g., patients with mixed incontinence in whom the predominant contributor is unclear) f) Assessment and exclusion of other etiologies of urinary incontinence (e.g., known or suspected urinary tract infection, high post-void residual volume concerning for overflow incontinence, high-grade pelvic organ prolapse if SUI is not demonstrated by pelvic organ prolapse reduction)
• ❑Documentation of adjunctive measures and treatments tried and failed (or contraindicated), such as but not limited to: a) Lifestyle modifications (e.g., addressing contributory medical conditions, limiting alcohol and caffeine consumption, weight reduction if overweight, modifying fluid intake) b) Pelvic floor muscle training (± biofeedback) c) Low-dose vaginal estrogen for patients with genitourinary syndrome of menopause (GSM) or evidence of hypoestrogenism by history or exam d) Support devices (e.g., continence pessaries, vaginal inserts, penile clamps) e) Prior surgery for SUI
• ❑Documentation for any planned concomitant procedures that may affect outcomes associated with placement of an incontinence control device (e.g., patients should not undergo concomitant urethral diverticulectomy, repair of urethrovaginal fistula, or urethral mesh excision and stress incontinence surgery with the exception of placement of autologous slings)