Actinic Keratosis denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for photodynamic therapy (CPT 96567 and J7308) provided on 12/19/17. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee’s actinic keratosis.Findings: PDT is an effective therapy for AK that consists of topical application of a photosensitizer followed by exposure of the treatment area to a visible wavelength light source. It is a U.S. Food and Drug Administration (FDA) approved therapy for AK of the scalp and face. The patient in this case has tried and failed several other standard therapies and so it was medically appropriate to use PDT for treatment of his skin pre-cancers. Multiple trials and meta-analyses have compared PDT with other therapies for AK.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Picato for treatment of his medical condition. Findings: The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. This patient has a history of facial basal cell carcinoma. His occupation involves performing procedures which produce a non-sterile environment. Treatment with Picato gel is preferred due to the limited downtime associated with the treatment. Picato gel is a U.S. Food and Drug Administration (FDA) approved three-day treatment for actinic keratosis. The first-line therapy typically involves a 21-day course of therapy. Significant cutaneous inflammation is associated with use of these medications. As the patient is considered to be at risk for airborne infectious exposures due to his occupation, a concise treatment period is appropriate.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for photodynamic therapy. Patients with multiple actinic keratoses can benefit from the use of field treatment with multiple modalities including 5-fluorouracil cream, imiquimod, ingenol mebutate, and photodynamic therapy. Current guidelines recommend 5-fluorouracil cream and imiquimod as first-line treatments for actinic keratoses. A recent comparison study reported the greatest efficacy from 5-fluorouracil cream over other modalities (Jansen, et al.). This patient presents with a history of basal cell carcinoma of the right cheek and recurrent actinic keratoses on his face. Although the patient achieved adequate results with photodynamic therapy in the past, there is a lack of data supporting retreatment with photodynamic therapy for retreatment in this clinical setting.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Carac 0.5% cream for treatment of the enrollee’s actinic keratosis. Findings: The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the medication at issue. This patient has been diagnosed with actinic keratosis, and she has tried and failed therapy with Picato. The Health Plan coverage criteria requires a treatment trial and failure of generic fluorouracil cream, generic fluorouracil solution or generic imiquimod cream prior to coverage of brand name Carac. These medications are useful for the treatment of pre-cancerous actinic keratosis, which has the potential to develop into squamous cell carcinoma if untreated. Thus, there were other effective, preferred formulary agents for the treatment of this patient’s condition.

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