Touching a Nerve

MDNG Pain Management, March/April 2009, Volume 2, Issue 2

Despite its proven track record of success, the "pacemaker for pain," still faces obstacles to acceptance that could leave many pain patients with no relief in sight.

Despite its proven track record of success, and coverage by many federal and private third-party payers, spinal cord stimulation technology, the “pacemaker for pain,” still faces obstacles to acceptance that could leave many pain patients with no relief in sight.

In the face of decades of success in the use of spinal cord stimulation (SCS) to treat certain forms of neuropathic pain, new threats are emerging to the use of this technology, frustrating both patients with nowhere else to turn and the physicians who might be barred from giving patients what they need.

Spinal cord stimulation—in layman’s terms a “pacemaker for pain”—has the coveted endorsement of the United Kingdom’s National Institute of Health and Clinical Excellence (NICE), one of the world’s foremost health technology assessment bodies. NICE said last fall that the implantable device “should be recommended as a treatment option for all chronic pain conditions of neuropathic origin.” In line with that assessment: Medicare, Medicaid, most private insurers, the military healthcare system, and 49 of 50 state workers’ compensation programs have covered this therapy for years.

Susan Pleas-Kanarick needs no seal of approval from anyone. She has lived what so many others only know about SCS. While working as a medical equipment secretary in 1985, Pleas-Kanarick fell and injured her back. Immediately after surgery, Pleas-Kanarick, of Ferndale, WA, was denied rehabilitation coverage by the Department of Labor and Industries (L&I), the state agency that governs workers’ compensation for the state of Washington. Then, after falling again less than a year later, she kept working, even though the excruciating pain kept her from sitting for even brief periods. Visits to a series of specialist physicians resulted in a constantly modified medication regimen that provided little in the way of relief.

Because L&I doctors said they found nothing wrong with Pleas-Kanarick, her claims for time lost were refused. Unable even to sleep, her life quickly devolved into a vicious cycle of constant pain and exhaustion. Eventually, fatigue forced her from her job. Over the years, Pleas- Kanarick kept trying one doctor after another. She turned to more medication, exercise, and cortisone injections. She even had metal plates bolted to her spine to stabilize her back. Still, nothing eased the pain.

After suffering for six years, she learned about spinal cord stimulators. But L&I continued to say no to coverage. After another four years of anguish, her husband’s insurance stepped in and paid for the stimulator. She says the best day of her life was when that device was turned on. For the first time in years, the back pain was gone. L&I offered Pleas-Kanarick nothing to help her get back to work and live a normal life. But in a legal case against L&I, Pleas-Kanarick eventually won approval of her stimulator, the only treatment that worked for her. “This little unit continues to save my life from pain and medications,” she said. “This truly is a wonderful unit, which essentially gave me my life back. I am able to do all the physical activities that I want to try and can enjoy life to the fullest.” Despite Pleas-Kanarick’s triumph, L&I and others continue to stand in the way and block relief to countless others who suffer as she did. This obstruction comes despite the treatment’s proven success and despite the technological advancements that are making the device even more effective.

Although Washington State is the exception and not the rule, recent guidelines from the American College of Occupational and Environmental Medicine (ACOEM) could threaten patient access in other states. The ACOEM guidelines “fl y in the face of evidence-based medicine and threaten access by injured workers throughout the country,” says Joshua Prager, MD, MS, chairman of the Neuromodulation Therapy Access Coalition (NTAC), a consortium of stakeholders dedicated to promoting appropriate access to SCS and other neuromodulation therapies. The same ACOEM guidelines for pain disorders that find insufficient evidence to recommend SCS also do not recommend over one-half-of all pain-related tests and treatments, many of which are considered standard of care in the medical community.

“ACOEM’s guidelines for the treatment of lower back pain, which recommend against the use of SCS, stand in total contrast to recent peer-reviewed studies including the UK’s NICE decision demonstrating the effectiveness of SCS for neuropathic pain,” adds Prager, who is also the director of the California Pain Medicine Center. Not only do these guidelines reach a conclusion that is out of step with Medicare, private payers, and peer-reviewed evidence, efforts are underway to make these guidelines "presumptively correct" by state workers’ comp programs around the country. That means that injured workers could very well end up at the bottom of a two-tier healthcare system. The NTAC and its members are working hard to ensure this doesn’t happen.

“I could hardly get through the day”

Every day she wakes up, Kim Hansen is grateful for the stimulator that has pulsed in her lower back for the past four years and returned her to the golf course, the running path, and a productive work life.

When Hansen’s pain first surfaced more than five years ago, doctors found and removed a lesion on her spine, a complication from spina bifida. But the tumor caused permanent damage that left her with “shooting sciatic pain” in her lower back and a left leg that often went numb. She tried everything: massage, acupuncture, cortisone shots, and addictive narcotics. “That’s exactly what I didn’t want,” says Hansen, referring to the Vicodin and Oxycodone that she had been taking. “I was praying to stay away from that medication and avoid that narcotic haze.”

Nothing brought her the relief she needed. “I could hardly get through a day,” she said. “I had to just keep popping pills.” Finally, her doctor told her of a device, which she can adjust with a remote control, that just might work for her. But her first insurance provider refused to pay for SCS, saying it was “experimental.”

She didn’t know they could say no

“I didn’t realize that my insurance company could say no to something that would make me better,” said Hansen, who sells health insurance in northwestern Washington, the only state whose workers’ compensation program denies this treatment for injured workers. I thought I would be left to taking drugs all my life.”

Fortunately, her employer switched insurers, and new provider Group Health approved the device. In an out-patient procedure, she had the stimulator attached externally and “in the first hour, I had at least 75 percent relief.” After a week, “I knew I wanted to do the [permanent] surgery” and have the device implanted. From that first day with the implant until now, Hansen estimates, “I have 80 percent coverage of my pain. What little I have left is completely manageable. I have no other form of pain management.”

Now the wife and mother of an eight-year-old son is convinced she would never be able to have another child without the device, because it would leave her to rely on the narcotics she abhorred taking. “It was hard to believe,” said Hansen, who is expecting her second child this summer. “How was I missing out on this?”

Washington: A state in a state of denial

Many others in Washington State sidelined by back and leg pain have the right to ask why they are still missing out. Despite the clear benefits of SCS, the agency in charge of the workers’ compensation program has for more than a decade steadfastly refused to cover the device. Physicians, pain patients, and their advocates throughout the state are frustrated by this decision because the agency is not compelled to review a position that denies so many the same level of care given to Medicare recipients, military personnel and their families, and patients covered by commercial insurance.

This refusal by L&I highlights the need for better awareness and advocacy. “A couple of decades ago, Washington State was a leader in pain management education and treatment,” says Joe Jasper, MD, a leading interventional pain physician practicing in Tacoma. “Now, Washington is one of the worst states in which to seek interventional pain care. Washington’s workers’ compensation program is a true outlier, clearly at odds with the standard of care for chronic pain in its refusal to allow coverage for neurostimulation, pain pumps, and several other procedures. I see many patients in my practice, including injured workers, who could benefit from SCS. Unfortunately, the workers’ compensation program denies them this option. It’s bad policy and bad health care.”

Prager says the good news is that physician societies and patient advocates have never been better organized to educate policymakers and advocates to ensure appropriate access. “The days are probably over of simply knowing a therapy works and expecting that payers and policymakers will cover it,” Prager says. “We have to promote the best possible evidence at our disposal and advocate to ensure that patients have access to therapies, like SCS, in order to alleviate their pain and improve their quality of life.”

Eric Hauth is the executive director of the Neuromodulation Therapy Access Coalition (NTAC), a national coalition initiated by leading interventional medical professional societies to ensure appropriate access to neuromodulation therapies through advocacy, quality initiatives, and public education. The mission and purpose of NTAC is to promote appropriate patient access to neuromodulation therapies, implantable therapies that are vital in treating a range of debilitating, chronic conditions such as neuropathic pain, seizure disorders, and Parkinson’s disease. For more information, contact Eric Hauth at 651-278-4238 or eric@neuromodulationacess.org.