Bacterial Vaginosis denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement for a Bacterial Vaginosis (BV) lab test. The standard diagnosis of BV involves office-based testing of samples of vaginal discharge using the Amsel criteria, with the presence of three of the following four criteria making the diagnosis of BV: a) homogeneous, thin, discharge that smoothly coats the vaginal walls; b) more than 20% clue cells on saline microscopy; c) pH of vaginal fluid greater than 4.5 and/or d) a positive potassium hydroxide (KOH) whiff test result. However, often in office settings where pH paper, KOH, and microscopy are not available, commercial tests have been approved by the U.S. Food and Drug Administration (FDA) as an alternative to clinical testing.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for laboratory service (infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers for Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, bacterial vaginosis associated bacteria-2 (BVAB-2), and Lactobacillus species). Workowski and colleagues report that guidelines for sexually transmitted infection (STI) screening include female patients over age 25 with a sex partner with concurrent partners. The guidelines do not specify the method of testing recommended. In this case, notes reported that the patient requested screening for STIs due to concern regarding possible exposure from a recent partner.

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 Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement for multitarget polymerase chain reaction (PCR) testing for the diagnosis of 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. The CDC advises the use of Amsel criteria if a gram stain is not available.

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 bacterial vaginosis, then check the rights and deadlines that apply to your plan.