NEWTON, Mass.–(BUSINESS WIRE)– Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that Highmark Blue Cross Blue Shield (Highmark BCBS) and Blue Cross Blue Shield of North Dakota (BCBS of ND) have both added the Leva® Pelvic Health System as a covered benefit for their members suffering with urinary incontinence. Highmark BCBS is one of the largest Blue Cross Blue Shield Association plans, serving approximately seven million members across Pennsylvania, Delaware, New York and West Virginia. The Leva System was reviewed favorably by Highmark BCBS’s New Technology Assessment Committee. BCBS of ND is the largest Blue Cross Blue Shield plan in North Dakota, serving over 300,000 members. Both positive coverage decisions became effective on April 1, 2024.

The Leva Pelvic Health System (HCPCS Level II code, S9002) is a small, flexible intra-vaginal probe, embedded with multiple accelerometer motion sensors, that communicates with the patient via integrated software to provide guidance during pelvic floor muscle treatment. Affecting 62% of adult women in the U.S., urinary incontinence (UI) is a progressive disorder that typically worsens without treatment. Untreated, UI can severely impact a woman’s quality of life and lead to significant negative comorbidities. The Leva System is U.S. Food and Drug Administration (FDA)-cleared to treat stress, mixed and mild-to-moderate urgency UI (including overactive bladder) in women. It is also FDA-cleared for the first-line treatment of chronic fecal incontinence in women. The Leva System is available by prescription only, ensuring clinicians remain directly engaged with patients’ care. It requires just five minutes of use per day, typically over eight to twelve weeks, which women can do at home, on their own schedule.