Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Vulvar Pain
Treatment: Pain Management (H-Wave Therapy)
The health plan denied the requested H-Wave Therapy. 
The health plan's determination is upheld.

This patient is a female who underwent H-Wave Therapy for the diagnosis of chronic vulvar pain. She is noted to have a long history of chronic and recurrent vulvitis, vestibulitis and vulvodynia. The patient is reported to have been treated with androgens, DHEA (dehydroepiandosterone), progesterone, estrogen and testosterone therapies. All of these were reported to have minimal effect. She had a nonspecific result on biopsy of the affected area. The patient was using H Wave Therapy for the chronic vulvar pain.

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

In this case, the proposed health service/treatment with the H-Wave therapy is not likely to be more beneficial than standard treatments for the patient's vulvar pain. This therapy is not studied or approved for use in this anatomic area or for this condition. There are no prospective, randomized studies that have evaluated this therapy for vulvar pain.
Vulvodynia refers to chronic vulvar discomfort including burning, stinging, irritation, or rawness for more than 3 months without other dermatological or gynecological causes. According to the International Society for the Study of Vulvovaginal Disease, the classification of vulvodynia is based on the site of the pain, whether it is localized or generalized; and whether the pain is provoked, unprovoked, or mixed. Despite its high prevalence and associated distress, the pathophysiology, diagnosis and clinical management of vulvodynia have not been clearly delineated. Diagnosis is usually made after a detailed medical history has been taken, infectious or dermatological abnormalities has been ruled out, and pain is elicited in response to light pressure on the labia, introitus, or hymenal remnants. It is difficult to discern if localized vulvodynia (previously known as vestibulitis) and generalized vulvodynia are different manifestations of the same disease process since the etiology of vulvodynia is still unclear.
The American College of Obstetricians and Gynecologists (ACOG) Committee Opinion on vulvodynia (2006) was adapted from the 2005 ASCCP (risk-based consensus management ) guideline. It stated that most of the available evidence for the treatment of vulvodynia is based on clinical experience, descriptive studies, or reports of expert committees. There are few randomized controlled trials (RCTs) of vulvodynia treatments. Vulvodynia is a complex disorder that is difficult to treat, and rapid resolution is unusual even with proper treatment. Decrease in pain may take weeks to months and may not be complete. No single treatment is successful in all women. In this case, the member is considered for H-Wave electrical stimulation for treatment of vulvar pain. This device is not Food and Drug Administration (FDA) approved or studied for application in the vulvar area. Thus, the therapy has not been proven to be safe or effective and would remain experimental and investigational and would not be recommended as a treatment for vulvar pain. This therapy would not be more beneficial than the standard and usual therapies for vulvar pain.