Medicare coverage conditions for bilateral deep-brain stimulation to treat Parkinson's disease should stipulate that procedures be performed by a "specialized team" of movement-disorder neurologists and neurosurgeons, Medicare Coverage Advisory Committee panel members concluded June 12.

The MCAC Medical & Surgical Procedures Panel proposed the coverage condition to help ensure patient safety for the technically demanding procedure. If practitioner experience is not mandated, neurosurgeons will be "living in a perpetual learning curve," temporary voting member Kim Burchiel, MD, Oregon Health Sciences University, observed.

Similarly, panelist Angus McBryde, MD, University of South Carolina, asserted: "You've got to look at the infrastructure.... You've got to have a hospital that has a full-service subspecialty availability. You've got to have a radiology department that has the in-depth MRI 3-D capacity, available in alternate areas."

The panelists' suggestions accompanied endorsement of national coverage for Medtronic's Activa for bilateral DBS.

In a unanimous vote, the MCAC panel found that existing clinical data demonstrate the effectiveness of both bilateral subthalamic nucleus (STN) and internal globus pallidus (GPi) deep-brain stimulation for "a well-defined set of Medicare patients with Parkinson's disease."

Despite the panel's consensus that the treatment was substantially effective, members also expressed concern about observed adverse events from the treatment, such as cardiovascular disorders, confusion, paresis, hemiplegia and intracranial hemorrhaging.

"There are a number of reasons for failure: number one is selecting the wrong patient," Medtronic presenter Roy Bakay, MD, stated. "There is potential for cognitive impairment from surgery.... [A surgeon] has to have experience, and with experience one gains the idea of what you can and cannot do."

Although some panelists were cautious about recommending that CMS mandate specific provider criteria - because the requirements would preclude patient access to certain centers - they extolled the value of proper patient selection, surgical technique and patient management.

Because "the technique is difficult, the follow-up is more difficult," Burchiel said. "It requires a huge amount of effort by the medical practitioners, physicians, nurse-practitioners and others, because the outcome ultimately on this may have more to do with how closely these patients are followed [than with] where the electrode is in the subthalamic nucleus."

Cliff Owens, VP and general manager of Medtronic Global Movement Disorders, confirmed for the panel that "the comments about having a team approach are critical." Medtronic provides other devices to facilitate the procedure, he added.

"We have devices for microelectrode-recording that are available," he noted. "We have surgical planning techniques and software that we encourage if they will improve the determination of the proper anatomical and functional targets that are specifically used by every surgeon. We are taking a very focused approach to functional stereotactic neurosurgeons."

Activa, nationally covered for the unilateral indication and covered in 33 states for the bilateral indication, was approved by FDA in 1997 as unilateral therapy for essential tremor and tremor associated with Parkinson's disease. Initially, coverage was not granted by CMS for the bilateral indication due to a lack of FDA approval and an insufficient amount of published literature (¹ Also see "CMS Reviewing Medtronic Activa Reimbursement For Bilateral Indication" - Medtech Insight, 29 October, 2001., p. 11). In January, FDA signed off on the bilateral indication.

Both STN and GPi deep-brain stimulation were categorized by the panel as "substantially more effective" than current therapies. The panel, dissatisfied with the MCAC executive board's definitions for effectiveness, created its own. The panel's new definition states: "The new intervention improves health outcomes by a substantial margin as compared to established services or medical items."

The panel also supported evidence for the effectiveness of "unilateral thalamic DBS for essential tremor and/or Parkinsonian tremor." However, two voting members abstained on the basis of a lack of information about the indication in the BlueCross BlueShield technology assessment, even though Medtronic and FDA presented studies related to the use. The MCAC executive board will review the panel's recommendation Sept. 25. CMS instructions could be issued by Jan. 1, 2003, according to the panel's CMS liaison, Steve Phurrough, MD.

MCAC Panel Recommends Coverage Decision Of Bilateral DBS For Parkinson’s

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