CMS Pub. 100-04, ch. 32, § 50.1

Effective on or after April 1, 2003, Medicare will cover unilateral or bilateral thalamic VIM DBS for the treatment of

ET and/or Parkinsonian tremor and unilateral or bilateral STN or GPi DBS for the treatment of PD only under the

following conditions:

1. Medicare will only consider DBS devices to be reasonable and necessary if they are Food and Drug

Administration (FDA) approved devices for DBS or devices used in accordance with FDA approved protocols

governing Category B Investigational Device Exemption (IDE) DBS clinical trials.

2. For thalamic VIM DBS to be considered reasonable and necessary, patients must meet all of the following

criteria:

a. Diagnosis of essential tremor (ET) based on postural or kinetic tremors of hand(s) without other

neurologic signs, or diagnosis of idiopathic PD (presence of at least 2 cardinal PD features (tremor,

rigidity or bradykinesia)) which is of a tremor- dominant form.

b. Marked disabling tremor of at least level 3 or 4 on the Fahn-Tolosa-Marin Clinical Tremor Rating

Scale (or equivalent scale) in the extremity intended for treatment, causing significant limitation in

daily activities despite optimal medical therapy.

c. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

3. For STN or GPi DBS to be considered reasonable and necessary, patients must meet all of the following

criteria:

a. Diagnosis of PD based on the presence of at least 2 cardinal PD features (tremor, rigidity or

bradykinesia).

b. Advanced idiopathic PD as determined by the use of Hoehn and Yahr stage or Unified Parkinson’s

Disease Rating Scale (UPDRS) part III motor subscale.

c. L-dopa responsive with clearly defined “on” periods.

d. Persistent disabling Parkinson’s symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or

disabling “off” periods) despite optimal medical therapy.

e. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

The DBS is not reasonable and necessary and is not covered for ET or PD patients with any of the following:

1. Non-idiopathic Parkinson’s disease or “Parkinson’s Plus” syndromes.

2. Cognitive impairment, dementia or depression which would be worsened by or would interfere with the

patient’s ability to benefit from DBS.

3. Current psychosis, alcohol abuse or other drug abuse.

4. Structural lesions such as basal ganglionic stroke, tumor or vascular malformation as etiology of the

movement disorder.

5. Previous movement disorder surgery within the affected basal ganglion.

6. Significant medical, surgical, neurologic or orthopedic co-morbidities contraindicating DBS surgery or

stimulation.

Patients who undergo DBS implantation should not be exposed to diathermy (deep heat treatment including shortwave

diathermy, microwave diathermy and ultrasound diathermy) or any type of MRI which may adversely affect the DBS

system or adversely affect the brain around the implanted electrodes.

The DBS should be performed with extreme caution in patients with cardiac pacemakers or other electronically

controlled implants which may adversely affect or be affected by the DBS system.

For DBS lead implantation to be considered reasonable and necessary, providers and facilities must meet all of the

following criteria:

1. Neurosurgeons must: (a) be properly trained in the procedure; (b) have experience with the surgical

management of movement disorders, including DBS therapy; and (c) have experience performing stereotactic

neurosurgical procedures

2. Operative teams must have training and experience with DBS systems, including knowledge of

anatomical and neurophysiological characteristics for localizing the targeted nucleus, surgical and/or implantation

techniques for the DBS system, and operational and functional characteristics of the device.

3. Physicians specializing in movement disorders must be involved in both patient selection and post-procedure care.

4. Hospital medical centers must have: (a) brain imaging equipment (MRI and/or CT) for pre-operative

stereotactic localization and targeting of the surgical site(s); (b) operating rooms with all necessary equipment for

stereotactic surgery; and (c) support services necessary for care of patients undergoing this procedure and any

potential complications arising intraoperatively or postoperatively.