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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
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. 
For thalamic VIM DBS to be considered reasonable and necessary, patients must meet all of the following 
criteria: 
a. Diagnosis of 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. For STN or GPi DBS to be considered reasonable and necessary, patients must meet all of the following 
criteria: 
d. Diagnosis of PD based on the presence of at least 2 cardinal PD features (tremor, rigidity or 
bradykinesia). 
e. 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. 
f. L-dopa responsive with clearly defined "on" periods. 
g. Persistent disabling Parkinson's symptoms or drug side effects (e.g., dyskinesias, motor 
fluctuations, or disabling "off" periods) despite optimal medical therapy. 
h. 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. 
You can find this information in the National Coverage Determination (NCD): Electrical Nerve Stimulators 
(160.7) 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.