Compliance with the provisions in this policy may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

**History/Background and/or General Information  **

Historically, ultrasound has largely been performed as an extracranial
diagnostic tool. However, more recently, intracranial therapeutic uses have
been explored. One such use has been in the treatment of essential tremor (ET)
that is refractory to more traditional treatment (e.g., medical therapy, deep
brain stimulation [DBS]) through the use of focused ultrasound techniques.
Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) is a non-
invasive thermal ablation treatment that delivers a spherical array of
converging beams using a cranial ultrasound unit that targets specific areas
in the brain and heats and ablates the areas that are felt to be responsible
for the ET.1

**Covered Indications  **

MRgFUS unilateral thalamotomy is considered medically reasonable and necessary
in patients with all five of the following criteria:

  1. Presence of medication refractory ET2,3 defined as refractory to at least two trials of medical therapy, including at least one first-line agent (i.e., propranalol or primidone);2 **and**
  2. Presence of a moderate to severe postural or intention tremor (defined by a score greater than or equal to 2 on the clinical rating score for tremor [CRST]2 or another nationally accepted clinical measure of tremor severity) of the dominant hand; **and**
  3. The tremor is disabling (defined by a score of greater than or equal to 2 on any of the eight items in the disability subsection of the CRST2 or another nationally accepted clinical measure of tremor severity); and
  4. The beneficiary is not a candidate for deep brain stimulation (DBS) (e.g., advanced age, anticoagulant therapy, surgical comorbidities, or has failed DBS, but has no retained cranial implants); **and**
  5. The beneficiary is 22 years of age or older3 

**Limitations  **

The following are considered not medically reasonable and necessary:

  1. Treatment of head or voice tremor
  2. Bilateral thalamotomy
  3. Treatment of beneficiaries who have an advanced neurodegenerative condition2
  4. Treatment of beneficiaries with unstable cardiac disease2
  5. Treatment of beneficiaries suffering from depression sufficiently severe to compromise their ability to provide informed consent and limit likely clinical benefit of the treatment
  6. Treatment of beneficiaries with severe cognitive impairment (defined by a score of less than 24 on the Mini-Mental State Examination)2
  7. A skull density ratio (SDR) (the ratio of cortical to cancellous bone) less than 0.402
  8. Treatment when contraindications to MRI are present (e.g. metallic foreign body in eye, pacemaker etc.) 

**Provider Qualifications**

  1. Consistent with the American Society for Stereotactic and Functional Neurosurgery (ASSFN) guidelines, physicians who perform MRgFUS must possess expertise and experience in functional and stereotactic neurosurgery. Additionally, physicians who perform these services should have underdone specialized training in MRgFUS.2

**Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in this LCD.

**Focused Ultrasound Thalamotomy Location Determines Clinical Benefits in
Patients with Essential Tremor  **

MRgFUS thalamotomy is a novel and minimally invasive ablative treatment for
essential tremor. This study examined relationships in patients with essential
tremor undergoing MRgFUS. They studied 66 patients with essential tremor who
underwent MRgFUS between 2012 and 2017. They assessed the Clinical Rating
Scale for Tremor (CRST) scores at 3 months after the procedure and tracked the
adverse effects (sensory, motor, speech, gait, and dysmetria) 1 day (acute)
and 3 months after the procedure. The results indicated the area of optimal
tremor response at 3 months after the procedure was identified at the
posterior portion of the ventral intermediate nucleus. Lesions extending
beyond the posterior region of the ventral intermediate nucleus and lateral to
the lateral thalamic border were associated with increased risk of acute
adverse sensory and motor effects, respectively.1

**Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Essential
Tremor: A Health Technology Assessment  **

In this study, a systematic review of the clinical literature published up to
April 11, 2017, that examined MRgFUS neurosurgery alone or compared with other
interventions for the treatment of moderate to severe, medication- refractory
essential tremor was performed. They assessed the risk of bias of each study
and the quality of the body of evidence according to the Grading of
Recommendations Assessment, Development, and Evaluation (GRADE) Working Group
criteria. The inclusion criteria was that they were all full text publications
in English, all published prior to April 11, 2017, were randomized controlled
trials, systematic reviews, and nonrandomized studies of MRgFUS neurosurgery
alone or MRgFUS neurosurgery compared with one or more of the following:
radiofrequency thalamotomy, deep brain stimulation (unilateral or bilateral),
gamma Knife thalamotomy, or control intervention.

The evidence shows that MRgFUS neurosurgery is generally safe and effective at
reducing tremor severity, improving quality of life, and helping people get
back to their daily activities.4 MRgFUS neurosurgery offers a treatment option
for people with essential tremor who otherwise have none if medication fails,
and it offers a noninvasive option for people considering surgery who cannot
safely have invasive surgery or who find the risks of invasive surgery
unacceptable.

**Acute and Chronic Effects of Propranolol and Primidone in Essential Tremor
(ET)  **

This is a 1989 study of the effects of these two drugs on ET. They studied the
acute and chronic effects of propranolol and primidone in essential tremor by
administering long-acting propranolol (80 to 160 mg/d) and primidone (50 to
250 mg/d) to 50 patients. They evaluated patients at 1,3,6,9 and 12 months
after treatment and assessed tremor by subjective rating by patients, clinical
scoring, and tremorgraphic (accelerometer) recordings.

The results indicated that acute adverse reactions occurred in 8% with
propranolol and 32% with primidone.5 Propranolol was without therapeutic
effect in 30% and 32% had no benefit from primidone. Significant chronic side
effects occurred in 17% taking propranolol and in 0% with primidone.3
Tolerance to drug effect occurred with chronic treatment in 12.5% of patients
with propranolol and 13.0% with primidone.

MRgFUS is a promising new treatment approach that has attributes, positive and
negative. It is noted that lesions larger than 170 mm were associated with an
increased risk of acute adverse effects.3 Tremor improvement and acute adverse
effects of MRgFUS for essential tremor are highly dependent on the location
and size of lesions. These novel findings could refine current MRgFUS
treatment planning and targeting, thereby improving clinical outcomes in
patients.

Also, people with essential tremor reported positive experiences with the
procedure and results experienced with MRgFUS neurosurgery.4 The reduction or
elimination of tremor in the dominant hand increased people's ability to
perform daily tasks and improved their quality of life.

In summary, MRgFUS is a promising new treatment approach that has attributes,
positive and negative, distinct from both traditional thalamotomy and DBS.
Given the support for traditional thalamotomy, generally, as an alternative
"if DBS is not available or practical", and the support for MRgFUS
thalamotomy, specifically, as an alternative in patients "who are not
candidates for DBS" by the American Association of Neurological Surgeons
(AANS), Congress of Neurological Surgeons (CNS) and the American Association
of Stereotactic and Functional Neurosurgery (ASSFN), First Coast considers
MRgFUS reasonable and necessary when performed within the indications and
limitations of this LCD.