Penlac denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 47-year-old woman who has a history of painful hammertoe and toenail fungus. A KOH preparation of her toenail was negative. The patient has elected not to take oral antifungals due to her concern about side effects, especially those involving the function of the liver. The patient’s provider recommended topical Penlac to treat the patient’s toenails and requested authorization from the Health Plan. The Heath Plan determined the medication was not medically necessary, and denied the provider’s request. Medically appropriate treatments for fungal nail infections include oral antifungals, fungoid solution, and Penlac solution. Oral antifungal medications are typically more effective than topical medications however, Penlac solution has shown some success and the risk of systemic side effects is less than minimal.

The patient is a 56-year-old female with painful onychomycosis of the fingernails. She is currently taking Remicade and methotrexate for ankylosing spondylitis. Her blood tests, including liver function tests, have been normal. Use of Penlac solution topically has been denied by the Health Plan because the patient has not tried and failed a course of oral Lamisil. The Health Plan further states that Lamisil is not contraindicated in a patient taking Remicade. The treating dermatologist’s records document the patient is taking both Remicade and methotrexate. The patient’s letter of June 2006 indicates it is the methotrexate she is taking that is a contraindication to Lamisil.Lamisil tablets are contraindicated for patients taking methotrexate. Both medications are potential causes of hepatotoxicity and use of both medications concurrently would increase the risk of hepatotoxicity.

Where the denial was upheld

The patient is a 22-year-old woman who was seen by a podiatrist for thickening, discoloration, and significant discomfort of her left first toenail. She was reportedly treated for nail fungus with nail debridement and topical antifungals in the past with modest improvement. Treatment options of nail avulsion, topical antifungals, and oral antifungals were discussed. The patient opted for topical treatment because she was concerned about side effects of oral antifungals. The patient’s provider has recommended Penlac for the patient. The Health Plan indicates the patient does not meet medical necessity criteria for authorization of Penlac.The Health Plan’s denial should be upheld at this time. The submitted information does not include a record of a microscopic exam for fungus or a fungus culture. If either test is performed and is positive, treatment with Penlac should be authorized.

The patient is a 61-year-old female with presumed fingernail onychomycosis. A fungal culture has not been performed to confirm the diagnosis. There is no functional impairment noted. The patient has a reported history of hepatitis and has declined treatment with Lamisil. The patient’s request for authorization of Penlac was denied by the Health Plan citing a lack of medical necessity.The diagnosis of onychomycosis has not been confirmed. While it is medically appropriate to select treatment with Penlac rather than Lamisil due to the patient’s history of liver disease, it is not reasonable to treat her condition without a definitive diagnosis. In the absence of a confirmatory fungal culture, I have determined the requested medication is not medically necessary for treatment of the patient’s medical condition. The Health Plan’s denial should be upheld.

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