Vaginal Infection denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient requested reimbursement for lab work provided by Atrius Health Inc.Vaginitis is a spectrum of disorders of the vagina caused by infection, inflammation, or changes in the normal vaginal flora with infection being the most common. Symptoms include abnormal vaginal discharge, odor, pruritus, and/or discomfort. The workup for vaginitis typically includes a comprehensive approach that integrates patient history, physical examination, and laboratory testing. Vaginal discharge is usually tested for evidence of bacterial vaginosis, candida species, and trichomonas in symptomatic patients. The two main test strategies include pH and microscopy or laboratory testing, typically with nucleic acid amplification tests (NAATs) and in some cases, vaginal culture. An accurate diagnosis is crucial for effective treatment.

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for the medication, estradiol 0.01% cream for complaints of burning with urination and suprapubic pain over the last two months. A urinalysis showed a white blood cell count of six to ten. Urine culture showed urogenital flora, consistent with contamination. There was no evidence of urinary tract infection. The prescriber diagnosed atrophic urethritis and recommended locally acting Estrace (estradiol) cream to decrease the side effects from oral formulations. This enrollee was prescribed topical estrogen cream for the treatment of atrophic urethritis. The enrollee was not prescribed Vagifem tablets because it is not the best treatment for her condition. This enrollee’s main complaint is burning pain with urination.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for a bacterial vaginosis diagnostic test. The diagnosis of vaginitis is based on clinical symptoms, pH of the vaginal fluid, and microscopic examination of the discharge. A diagnosis of bacterial vaginosis can be made if three out of four of the following Amsel's criteria are met: (1) a strong fishy odor on adding alkali to vaginal fluid, (2) Clue cells on microscopy, (3) thin, white, homogenous discharge, and/or (4) vaginal pH greater than 4.5. Microscopic examination may also reveal motile trichomonads or candida hyphae. The presence of Gardnerella vaginalis on culture cannot be used to diagnose bacterial vaginosis as it is present in approximately 50% of healthy women. A culture of trichomonas and candida may be helpful depending on clinical symptoms and if a microscopy is negative.

Findings: The physician reviewer found that an enrollee has requested reimbursement for laboratory testing. The enrollee underwent testing including infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, utilizing vaginal-fluid specimens, algorithm reported as a positive or negative result for bacterial vaginosis. As noted in the medical literature, the diagnosis of vaginitis is based on clinical symptoms, pH of the vaginal fluid, and microscopic examination of the discharge. According to the American College of Obstetricians and Gynecologists (ACOG), microscopy is the first line for diagnosing vulvovaginal candidiasis and trichomoniasis. The Centers for Disease Control and Prevention (CDC) also recommend the gram stain as the gold standard for diagnosis of vaginal infections.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving vaginal infection, then check the rights and deadlines that apply to your plan.