Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Treatment Resistant Depression.
Treatment: Deep brain stimulation (DBS) surgery (codes 61867 x2 and 61886) and the associated inpatient stay.
The insurer denied coverage for deep brain stimulation (DBS) surgery (codes 61867 x2 and 61886) and the associated inpatient stay.	
The denial is overturned.

This is a male patient who has a history of treatment-resistant depression.  The patient has tried medications including Ketamine infusion, as well as 18 electroconvulsive therapy (ECT) sessions.  The patient is severely impaired and has the possibility of being able to return to work full-time with treatment.

The patient has generalized anxiety, compulsive hair pulling and nail biting since high school, and in the past five years with chronic depression.  The patient denies any other compulsive or impulsive behaviors. The reports he used to have panic attacks, but not in recent years. Reports fears of talking to friends because he does not trust his memory, worries about having memory problems, short and long term.  He is afraid to be alone or far from home for which he can't explain.  He is also afraid to read emails, or that he won't fall asleep.  He is tense and restless as soon as he wakes up. Feels upset and worries he may do or have done something wrong.  Though he does report he has slept better in the last few days with the new medication he is taking.  A few years ago, he was worrying significantly, feeling guilty that he became depressed and suicidal. He was admitted twice in the past. More recently, he was transferred to a facility because he was too claustrophobic for magnetic resonance imaging (MRI), because of catatonia. He was agitated, on tube feedings, and was restrained to the bed.  He remained catatonic for four months, he doesn't remember any of it, and was not responsive to benzodiazepines, and came out of the catatonic state after eighteen ECT treatments; however, this did not have any effect on the debilitating anxiety and depression.  He is closing his businesses due to not being able to focus, remember or organize, and is lacking motivation and energy.


The patient meets inclusion criteria for a clinical study involving deep brain stimulation (DBS) surgery.  However, this is by definition is a procedure without established clinical efficacy.      

"Even with the multitude of methods used to treat depression, a significant portion of patients fails to respond, resulting in an estimated 13 % [percent] prevalence of treatment-resistant depression (TRD) [4].  The most widely used therapeutic alternatives for pharmacologically refractory depression are electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS) and transcranial magnetic stimulation, with ECT being the oldest technique and showing the best results [5].  However, even ECT is efficacious in only about half of TRD cases [5]..." (Drobisz et al 2019).     

This patient is a good candidate for DBS surgery (codes 61867 x2 and 61886), as the patient has tried medications including Ketamine infusion, as well as 18 ECT sessions without clear benefit. This is the best available option for this patient with refractory depression, who has failed all previous modalities.  Although DBS is an established treatment choice for Parkinson's disease (PD), essential tremor and movement disorders, its effectiveness for the management of treatment-resistant depression (TRD) remains unclear, hence the trial.

This service - DBS for refractory depression is likely to be more beneficial than any of the standard treatments/procedures for this patient.  However, it remains an unproven treatment, and this patient is being enrolled into a trial for the use of DBS in refractory depression and meets the criteria for the trial as he has been accepted to participate.
                      
The carrier's denial of coverage for deep brain stimulation (DBS) surgery (codes 61867 x2 and 61886) and the associated inpatient stay should be overturned.