Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Vaginal itching
Treatment: DNA (deoxyribose nucleic acid) Testing 
The insurer denied the DNA (deoxyribose nucleic acid) Testing.
The denial is upheld. 

The patient is a female. She presented with complaint of vaginal itching. She had used a left-over yeast medication. The patient declined a vaginal examination, but she self-swabbed her genital area. The patient was started on a treatment for bacterial vaginitis. The swab was sent for PCR (polymerase chain reaction) test for candida trichomonas and Gardnerella. They came back negative.

No, the DNA (deoxyribose nucleic acid) Testing was not medically necessary.

This patient presented with vaginal itching yet refused a pelvic examination. She had already treated herself with an antifungal. Prior to obtaining the result of the PCR (polymerase chain reaction) test, she was treated with MetroGel, which would be reasonably expected to manage both Trichomonas and Gardnerella. Based on the above, the result of the test did not make any difference, and the medical necessity of the test is not established. 

Diagnosis of vaginitis is based on clinical symptoms, pH (potential of hydrogen) of the vaginal fluid and microscopic examination of the discharge. Ideally, a diagnosis of BV (bacterial vaginosis) is made if 3 out of 4 of "Amsel's criteria" are met: A strong fishy odor on adding alkali to vaginal fluid (positive amine test); Clue cells (vaginal epithelial cells heavily coated with bacilli) on microscopy; Thin, white, homogenous discharge; and Vaginal pH (potential of hydrogen) 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 BV (bacterial vaginosis), since it is present in approximately 50 % of healthy women. 

Culture of trichomonas and candida may be helpful if clinical symptoms are suggestive and microscopy is negative. Mixed infections are also common, with trichomonas, candida or both coexisting with BV (bacterial vaginosis). DNA (deoxyribose nucleic acid) probes have been developed to directly detect the presence of candida, trichomonas and Gardnerella.

According to ACOG (American College of Obstetricians and Gynecologists), microscopy is the first line for diagnosing vulvovaginal candidiasis and trichomoniasis. The Centers for Disease Control and Prevention also recommend the gram stain as the gold standard for diagnosis of vaginal infections and recommend use of Amsel's criteria if a gram stain is not available.
The CDC states that the DNA (deoxyribose nucleic acid) probes "have acceptable performance characteristics" compared to the gram stain but make no recommendation for their use. 

There are no high-grade evidence-based peer reviewed studies published in the medical literature to support the safety and efficacy of the technology, which consists of the following: 
a. Meta-analyses of randomized trials; or 
b. Randomized controlled trials.

Based on all of the above, the testing that was done was not medically necessary, and it is still considered to be unproven. Adequate history, physical examination and office microscopy should rule out the presence of these infections.