Managed Care - August 2008 - (Page 49) TOMORROW’S MEDICINE When the heel lifts, wireless signals from the gait sensor, which automatically adjust to changes in speed and terrain, are sent to the leg cuff stimulator, causing the foot to dorsiflex (the movement that decreases the angle between the foot and the leg) with just a bit of eversion (the movement of the sole of the foot away from the median plane). Patient parameters including stimulation intensity, waveform, and stimulation ramping are set wirelessly by a trained clinician. The small hand-held control unit captures patient-specific parameters such as intensity and waveform. It is given to the patient for home use where it can be used to turn the device on and off as well as to make minor stimulation adjustments. The control unit tracks the number of steps a patient takes in a given day as a well as the time it took to travel that distance. A recent study published in the American Journal of Physical Medicine & Rehabilitation demonstrated statistically significant improvements in gait speed, stability, and symmetry in patients who suffered a stroke or traumatic brain injury. FDA clearance All of the devices currently available are cleared by the Food and Drug Administration under a process that determines that the device was “substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act that do not require approval of a pre-market approval application.” There is no efficacy process for this clearance review that corresponds to the rigid criteria used for new drug approvals, forcing most health plans to look at the available data to make coverage determinations. to defy the results of aging at all costs, placing the health care decision makers directly in their sights. Devices such as the NESS L300 and the WalkAide improve function and allow more freedom. Devices described in this article are bound to be popular with physicians and patients alike as they offer the hope of normalized function. They also cost more, a lot more than alternatives. A traditional AFO costs a few hundred dollars, but an electrical or neuromuscular stimulator runs $4,500–$6,000. A number of studies have been published by rehabilitative specialists, yet medical policy for several of the largest national health plans states that this technology is considered investigational or unproven. Other plans are paying for it, creating a problem for physicians caring for these patients. Why are there great differences between coverage criteria and approval? What evidence will health plans require before these products are considered medically necessary? Are studies demonstrating enhanced gait or dynamic stability sufficient? Will there be special requirements for the inevitable software updates? Are there specific functional measures managed care organizations will desire? What about patient satisfaction and quality of life — are they compelling for managed care organizations to approve payment? What will be the response to denials by patients who demand these devices? We are now entering into the age where microprocessors can replace damaged nervous system processes. As more function-improvement devices are developed to replace simple adaptive devices, it is obvious that these and other questions will continue to fill the pages of Tomorrow’s Medicine. MC The author is a director in the value-based health department at Genentech Inc. During the last three years, before taking the Genentech position, he received honoraria or other financial benefits from: Amgen, Amylin Pharmaceuticals, AstraZeneca, Biogen Idec, Centocor, Galderma, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Procter & Gamble, Q-Med, Sanofi-Aventis, Teva Pharmaceuticals Industries, UCB, and Wyeth. The views expressed in Tomorrow’s Medicine are the author’s alone. Managed care implications The baby boomers are unlikely to accept the inevitable consequences of stroke and other causes of foot drop. This group is determined AUGUST 2008 / MANAGED CARE 49
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