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 upheld.

This is a male patient who had generalized anxiety who has had years of chronic depression and hair pulling and nail biting. He has right shoulder twitching, and he does not have panic attacks anymore, and is afraid to talk to friends because he does not trust his memory.  He is afraid to read emails, he had a suicide attempt and was admitted with catatonia, and he was treated with Electroconvulsive therapy (ECT).  He suffered anemia after a complicated bowel surgery, and his memory has been failing him for years.  Possibility of deep brain stimulation (DBS) was discussed.  On exam his behavior was cooperative.

Another note indicate that the patient had improved slightly with olanzapine and he has agreed to consider DBS. He is less suicidal therefore, further treatment is indicated.

Documentation  show that the patient has had depression at a later age, he has had hair pulling and nail biting as a teen, and he used to have panic attacks. He also underwent lap banding and appendectomy.  Magnetic Resonance imaging (MRI) brain suggests "chronic small vessel ischemic changes" and it was felt that DBS surgery might help.  For DBS surgery he would need to taper Depakote.

The doctor noted that the patient has depression and is being evaluated for possible DBS.  It was noted "he has been tried with virtually every form of pharmacological intervention for depression without any persistent benefit" and he had 18 trials of ECT that led to quick recurrence.  On exam, the patient was noted to have a flat affect.  He offered DBS placement under.

Notes show that the patient "is neurologically nonfocal" and he continues to have depression. Plan for DBS placement was affirmed.

"DBS may show promise for treatment-resistant depression but remains an experimental treatment until further data are available" (Kisely et al 2018).      

In this particular case, the procedure will be performed as part of an ongoing clinical trial and therefore, the DBS surgery codes do have approval from the local Institutional Review Board (IRB). The study is an open label study of 10 patients with depression to be completed in the next few years. There is no control group. It is using an experimental prototype  by Medtronic. 

As noted by the treating provider, the patient has not responded to medical therapy and several rounds of electroconvulsive therapy (ECT) and might be able to resume work if his depression could be controlled.  

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. While the patient is a good candidate for DBS given that some reports in the literature suggest it is safe and effective, and this is part of a clinical trial, some studies cited below note that depression is improved with DBS. However, most of the studies suggest that the effects on depression are not reliable or sustained.  In general, DBS for depression is unproven. 
    
Based on the current literature it cannot be said that DBS is likely to be more beneficial than any standard therapies for the patient's diagnosis as this area is still under study. Hence the trial. With regard to the adverse risk of the procedure, Kisely noted that of 190 patients in their review, "84 participants experienced a total of 131 serious adverse effects, although not all could be directly associated with the device or surgery" (Up to Date).                                              

The carrier's denial of coverage for deep brain stimulation (DBS) surgery (codes 61867 x2 and 61886) and the associated inpatient stay should be upheld.