(Medicare National Coverage Determinations Manual)

Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above- listed standards and address the above- listed research questions.   The principal investigator must submit the complete study protocol, identify the relevant CMS research questions that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. through m. listed above), as well as the investigators contact information, to the address below. The information will be reviewed, and approved studies will be identified on t he CMS website.   Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services (CMS)  7500 Security Blvd., Mail Stop S3-02-01 Baltimore, MD 21244-1850  C. Nationally Non-Covered Indications  Effective for services performed on or after July 1, 1999, VNS is not reasonable and necessary for all other types of seizure disorders which are medically refractory and for whom surgery is not recommended or for whom surgery has failed.  VNS is non -covered for the treatment of TRD when furnished outside of a CMS-approved CED study.  All other indications of VNS for the treatment of depression are nationally non- covered.   D. Other   Patients implanted with a VNS device for TRD may receive a VNS device replacement if it is required due to the end of battery life, or any other device- related malfunction.   (This NCD last reviewed February 2019.)  160.19 - Phrenic Nerve Stimulator  (Rev. 1, 10-03-03) CIM 65 -13  The implantation of a phrenic nerve stimulator is covered for selected patients with partial or complete respiratory insufficiency.   The phrenic nerve stimulator provides electrical stimulation of the patients phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs).  The device has been used successfully to treat hypoventilation caused by a variety of conditions, including respiratory paralysis resulting from lesions of the brain stem and cervical spinal cord and chronic pulmonary disease with ventilatory insufficiency.  The phrenic nerve stimulator is intended to be an alternative to management of patients with respiratory insufficiency who are dependent upon the usual therapy of intermittent or permanent use of a mechanical ventilator as well as maintenance of a p ermanent tracheotomy stoma.  However, an implanted phrenic nerve stimulator can be effective only if the patient has an intact phrenic nerve and diaphragm.  Moreover, nerve injury may occur during the surgical procedure and if sufficient injury is incurred, the device will not prove useful to the patient.  Consequently, it is possible for such a device to be indicated for a patient but, due to injury sustained during implant, fail to assist the patient, resulting in a return to the use of mechanical ventilation.   Cross reference to 160.7, Electrical Nerve Stimulators.   160.20 - Transfer Factor for Treatment of Multiple Sclerosis  (Rev. 1, 10-03-03) CIM 45 -17  Transfer factor is the dialysate of an extract from sensitized leukocytes which increases cellular immune activity in the recipient.  It is not covered as a treatment for multiple sclerosis because its use for the purpose is still experimental.   160.21 - Telephone Transmission of EEGs  (Rev. 1, 10-03-03) CIM - 50-39  Telephone transmission of electroencephalograms (EEGs) is covered as a physicians service, or as incident to a physicians service when reasonable and necessary for the individual patient, under appropriate circumstances.  The service is safe, and may save time and cost in sending EEGs from remote areas without special competence in neurology, neurosurgery, and electroencephalography, by avoiding the need to transport patients to large medical centers for standard EEG testing.   Telephone transmission of EEGs has been most helpful in the following clinical situations:    Altered consciousness, such as stuporous, semicomatose, or comatose states;    A typical seizure variants in patients experiencing bizarre, distressing symptoms as seen with spike and wave stupor or other forms of seizure disorders;    Diagnosis of a suspected intracranial tumor;    Head injury, where a subdural hematoma may be identified;    Headaches during the acute phase where, for instance, in migraine syndrome, abnormal responses may be seen.   Telephonically transmitted EEGs should not be used for determining electrical inactivity (i.e., brain death), because of unavoidable signal interference.   160.22 - Ambulatory EEG Monitoring (Retired)  (Rev. 12299; Issued:10- 12-23; Effective:01 -01-23; Implementation:11 -13-23)  Effective January 1, 2023, the Centers for Medicare & Medicaid Services removed the national coverage determination (NCD) for Ambulatory EEG Monitoring. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act.   160.23 - Sensory Nerve Conduction Threshold Tests (sNCTs) (Effective April 1, 2004)  (Rev. 15, 06- 18-04)  A.  General   The sNCT is a psychophysical assessment of both central and peripheral nerve functions. It measures the detection threshold of accurately calibrated sensory stimuli.  This procedure is intended to evaluate and quantify function in both large and small cali ber fibers for the purpose of detecting neurologic disease.  Sensory perception and threshold detection are dependent on the integrity of both the peripheral sensory apparatus and peripheral -central sensory pathways.  In theory, an abnormality detected by this procedure may signal dysfunction anywhere in the sensory pathway from the receptors, the sensory tracts, the primary sensory cortex, to the association cortex.   This procedure is different and distinct from assessment of nerve conduction velocity, amplitude and latency.  It is also different from short -latency somatosensory evoked potentials.   Effective October 1, 2002, CMS initially concluded that there was insufficient scientific or clinical evidence to consider the sNCT test and the device used in performing this test reasonable and necessary within the meaning of section 1862(a)(1)(A) of the  law.   Therefore, sNCT was noncovered.   Effective April 1, 2004, based on a reconsideration of current Medicare policy for sNCT, CMS concludes that the use of any type of sNCT device (e.g., current output type device used to perform current perception threshold (CPT), pain perception threshold (PPT), or pain tolerance threshold (PTT) testing or voltage input type device used for voltage -nerve conduction threshold (v- NCT) testing) to diagnose sensory neuropathies or radiculopathies in Medicare beneficiaries is not reasonable and necessary.   B.  Nationally Covered Indications   Not applicable.   C.  Nationally Noncovered Indications   All uses of sNCT to diagnose sensory neuropathies or radiculopathies are noncovered.   (This NCD last reviewed June 2004.)   160.24  Deep Brain Stimulation for Essential Tremor and Parkinsons Disease  (Rev. 1, 10- 03-03) CIM  65- 19  Effective for services furnished on or after April 1, 2003, Medicare will cover unilateral or bilateral thalamic ventralis intermedius nucleus (VIM) deep brain stimulation (DBS) for the treatment of essential tremor (ET) and/or Parkinsonian tremor and unil ateral or bilateral subthalamic nucleus (STN) or globus pallidus interna (GPi) DBS for the treatment of Parkinsons disease (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 Exemptio n (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 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 Parkinsons Disease Rating Scale (UPDRS) part III motor subscale.  c. L-dopa responsive with clearly defined on periods.  d. Persistent disabling Parkinsons 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 Parkinsons disease or Parkinsons Plus syndromes.  2. Cognitive impairment, dementia or depression which would be worsened by or would interfere with the patients ability to benefit from DBS.   3. Current psychosis, alcohol abuse or other drug abuse.  Structural lesions such as basal ganglionic stroke, tumor or vascular malformation as etiology of the movement disorder.   Previous movement disorder surgery within the affected basal ganglion.  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:   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.   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 an d functional characteristics of the device.   Physicians specializing in movement disorders must be involved in both patient selection and post -procedure care.   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.   160.25 - Multiple Electroconvulsive Therapy (MECT)  (Rev. 1, 10- 03-03) CIM -  35-103  The clinical effectiveness of the multiple -seizure electroconvulsive therapy has not been verified by scientifically controlled studies.  In addition, studies have demonstrated an increased risk of adverse effects with multiple seizures.  Accordingly, MECT cannot be considered reasonable and necessary and is not covered by the Medicare program.  Effective for services provided on or after April 1, 2003.  160.26 - Cavernous Nerves Electrical Stimulation with Penile Plethysmography - Effective August 24, 2006  (Rev.61, Issued: 11- 24-06, Effective: 08 -24-06, Implementation: 01- 08-07)  A. General