Anthem Blue Cross Connecticut MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications Form

This document addresses magnetic resonance imaging (MRI) guided high intensity focused ultrasound (HIFU) ablation, also known as magnetic resonance guided focused ultrasound (MRgFUS), when used to treat any non-oncologic indications, including but not limited to uterine fibroids, essential tremor (ET), or benign prostatic hyperplasia (BPH). The ultrasound beam penetrates through the soft tissues and can be focused to targeted sites, using MR for guidance and monitoring.

Note: Please see the following related documents for additional information:

• CG-MED-81 Ultrasound Ablation for Oncologic Indications
• CG-SURG-28 Transcatheter Uterine Artery Embolization
• CG-SURG-91 Minimally Invasive Ablative Procedures for Epilepsy
• CG-SURG-108 Stereotactic Radiofrequency Pallidotomy
• SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation

Position Statement

Medically Necessary

1. Unilateral focused ultrasound thalamotomy is considered medically necessary for the treatment of adults with essential tremors when all of the following criteria are met:
   1. Moderate to severe tremor of the hand (as defined by a score of 2 or greater on the clinical rating scale for tremor [CRST]); and
   2. Failure of 2 or more tremor suppressant medications, as evidenced by persistent moderate to severe tremors, intolerable side effects of drug therapy or contraindications; and
   3. At least 1 of the medications failed was a first line agent (propranolol or primidone).
2. Unilateral focused ultrasound pallidotomy is considered medically necessary for the treatment of idiopathic Parkinson’s disease in individuals who meet all of the following criteria:
   1. Age 30 or older; and
   2. Unilateral pallidotomy is used as an adjunct to medication treatment of idiopathic Parkinson’s disease; and
   3. Levodopa responsive (as defined by a 30% or greater reduction in the Movement Disorder Society- Unified Parkinson's Disease Rating Scale [MDS-UPDRS] motor subscale in the on versus off levodopa medication state; and
   4. Moderate-to-severe motor complications as defined by at least one of the following:
      1. MDS-UPDRS score of 20 or greater in the meds off condition; or
      2. Motor complications on optimum medical treatment documented by at least one of the following:
         1. Dyskinesia (as defined by MDS-UPDRS item 4.2 score of 2 or greater in the meds on condition); or
         2. Motor fluctuations (as defined by MDS-UPDRS item 4.4 score of 2 or greater);
            and
   5. The individual is not a candidate for either the following procedures:
      1. Deep brain stimulation (DBS); or
      2. Radiofrequency (RF) thermoablation;
         and
   6. The absence of all of the following conditions:
      1. Central neurodegenerative disease other than Parkinson’s Disease (includes multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer’s disease); or
      2. Previous deep brain stimulation; or
      3. Previous basal ganglia ablation procedure; or
      4. Coagulopathy or current anticoagulant use which cannot be reversed; or
      5. Intracranial tumor with significant anatomic distortion.

Investigational and Not Medically Necessary:

MRI guided high intensity focused ultrasound ablation is considered investigational and not medically necessary when the criteria above are not met and for all other non-oncologic indications.