Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Depression.

Treatment: procedure code 96365 (intravenous infusion, for therapy, prophylaxis or diagnosis; initial, up to 1 hour); ketamine intravenous infusion therapy.

The insurer denied coverage for procedure code 96365 (intravenous infusion, for therapy, prophylaxis or diagnosis; initial, up to 1 hour); ketamine intravenous infusion therapy.

The denial is overturned.

This patient had depression and anxiety and had diagnoses of Major Depressive Disorder, post traumatic stress disorder (PTSD), and Generalized Anxiety Disorder. He reportedly had a history of being bullied and reportedly had an abusive father. He reportedly had tried and failed Lexapro, Zoloft, Wellbutrin, Lamictal, Latuda, and Buspirone. He reportedly had a reduction in symptoms when treated with Spravato. The request was for esketamine 84 mg (milligrams) weekly for 4 weeks.
    
This reviewer disagrees with the decision to deny coverage for esketamine 84 milligrams(mg) weekly for 4 weeks for procedural code 96365 for intravenous infusion therapy. The United States (U.S.) Food and Drug Administration (FDA) approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them-treatment-resistant depression. Under the FDA new release from the U.S. Food and Drug Administration (FDA) it stated that the FDA approve a new nasal spray in conjunction with an antidepressant for treatment resistant depression and is only available at a certified doctor's office or clinic. It also stated that it is only available through a restricted distribution system under the Risk Evaluation and Mitigation System (REMS) because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by esketamine administration and the potential for abuse and misuse of the drug. It is available only at a certified doctor's office or clinic. Because of safety concerns, the drug will only be available through a restricted distribution system, and it must be administered in a certified medical office where the health care provider can monitor the patient. The labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug. Because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their dose. He was considered a candidate for esketamine 84 mg weekly for 4 weeks and this does have FDA approval for the treatment of Major Depressive Disorder as the U.S. Food and Drug Administration approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them-treatment-resistant depression. 

This was the case for this patient. Also, he reportedly had a reduction in symptoms when treated with Spravato so it was also more likely to be beneficial for this patient's diagnosis than standard treatments and there is scientific literature supporting improvement in health outcomes. He was considered a good candidate for this treatment again and it was considered the best available treatment at the time as he responded to this before. There are potential adverse effects for this treatment including the above-mentioned possible side effects but it was not reported that he had these side effects with prior treatment, so the adverse effects were not considered increased over standard treatments. 

The carrier's denial of procedure code 96365 (intravenous infusion, for therapy, prophylaxis or diagnosis; initial, up to 1 hour) rendered (ketamine intravenous infusion therapy) should be overturned.