Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Mental Health/Obsessive Compulsive Disorder/OCD.
Treatment: Pharmacy/Prescription Drugs/L-Methylfolate Forte 15 mg (milligrams) CAP (capsule).

The health plan denied the requested prescription medication L-Methylfolate Forte 15 MG CAP as not medically necessary.  The health plan's determination is overturned.

This case involves an adult male diagnosed with obsessive-compulsive disorder (OCD). The patient has been prescribed L-Methylfolate Forte 15 mg (milligrams) daily in order to supplement his psychotropic regimen. There is no information provided with regard to any co-occurring substance use disorder, or other comorbid psychiatric conditions or general medical issues in this case. The patient has had pharmacogenomic testing with a Genomind Assay indicating that the patient has a genetic deficit with the methylenetetrahydrofolate reductase (MTHFR) gene that regulates folate synthesis and supporting the use of L-Methylfolate in order to facilitate normal synthesis of folate.
Records Reviewed: Health plan documents including correspondence and appeal documents were reviewed, as well as the plan guidelines and plan formulary for dietary products. The Genomind pamphlet outlining the extent of the pharmacogenomic testing and the Genomind report for the patient were reviewed.

Issue under review: L-Methylfolate Forte 15 mg capsule.

The health plan's determination of medical necessity is overturned, in whole.

Yes, the requested health service/treatment of L-Methylfolate Forte 15 mg capsule is medically necessary for this patient.

In this case, the patient is diagnosed with OCD and underwent genetic testing that identified and genetic pleomorphism involving MTHFR, implicating intermediate activity pertaining to folate synthesis, which impacts a patient's response to antidepressant medications or other medications that affect serotonin, norepinephrine or dopamine. Thus, the use of L-Methylfolate at the effective dose of 15 mg is reasonable and clinically appropriate in this case scenario. Moreover, The use of L-Methylfolate in this patient is in keeping with prevailing standards of medical practice for the condition under treatment with an evidence-based treatment; and the requested services/treatment being provided in this case are clinically appropriate and are backed by credible scientific evidence known to benefit patients with the condition diagnosed in this case.

In this case scenario, augmentation treatment with L-Methylfolate at a dose of 15 mg is providing reasonable clinical benefit based upon pharmacogenetic testing results that shows a deficit impacting folate synthesis. Thus, medical necessity for the patient to receive the requested benefit of L-Methylfolate at the current dosage of 15 mg daily for the purpose of augmentation of the patient's psychotropic medications targeting symptoms of OCD. Additionally, the suggested formulary alternative, treatment with folate, is not interchangeable with L-Methyl folate and would not be expected to provide the same clinical benefit in view of the genetic deficit in this patient.

The use of L-Methylfolate supplementation for the treatment of OCD is consistent with the scientific literature, referenced below, and with prevailing standards of medical practice, as well as the New York State instruction for this binding review.