PNS Community Reacts to Reimbursement Obstacles

by Jeremy Koff, senior consulting editor

March 2024 issue

Manufacturers of implanted and noninvasive peripheral nerve stimulation systems see tremendous opportunity in the years ahead for treating a wide variety of neurological conditions that are not well served by existing neuromodulation devices and pharmaceutical therapies. But the wide-open market opportunity for PNS is tempered by challenges new vendors face obtaining reimbursement for their products.

Perhaps the greatest obstacle confronting PNS vendors is the relatively low levels of payment offered by the Centers for Medicare and Medicaid Services, which often sets the standard for private payers. We reported previously on the struggles that vendors of noninvasive neuromodulation systems such as Cala Health have endured when trying to get adequate payment levels from CMS [NBR Oct22 p1]. One bit of positive news emerged this month when the company announced that CMS had reversed their earlier non-coverage recommendation issued by two local administrative contractors [NBR Oct23 p3].

But vendors of implanted pain PNS systems, including Curonix, Bioventus, Nalu Medical, and SPR Therapeutics, have not been so fortunate. There is wide variability in payment levels for PNS devices. Percutaneous leads for posterior tibial nerve stimulation receive the lowest reimbursement at just $300, while other percutaneous leads, such as those used for treating pain in the shoulder, knee, or low back, are reimbursed at about $700. By contrast, sacral nerve stimulation leads receive between $1500 and about $3400.

One medical society, The New York Society of Interventional Pain Physicians, recently issued a position statement calling for more widespread and uniform coverage of PNS devices. “NYSIPP strongly supports the use of PNS for those patients with intractable neuropathic pain who have failed previous conservative and/or invasive modalities,” the statement says. “Patients in this category have no credible alternatives. Based upon review of the body of peer reviewed published evidence, approval by the FDA, real world experience, and long term patient outcomes, NYSIPP recommends qualified physicians consider the use of this modality based upon clinical need and presentation. Because of proven safety and durable effectiveness, PNS systems are within the standard of care for their indicated use.”

The position paper also pointed to studies demonstrating the cost-effectiveness of PNS therapies compared to other treatment options. One study the society mentioned demonstrated reductions in physician office visits, nerve blocks, radiologic imaging, emergency department visits, hospitalizations, and surgical procedures. This translated to a net annual savings of $30,221 and a savings of $93,685 over the three-year implant duration.

NYSIPP concluded its position paper with a call to action to clinicians, regulators, and payers. “The body of published evidence, long term outcomes demonstrating durable treatment effect, low complication rate, as well as cost effectiveness makes this an essential tool in the management of refractory neuropathic pain syndromes. Additionally, with the support of Medicare National Coverage Determinations and the National Institutes of Health, it has become the standard of care within the pain management community. Policymakers and payers are strongly encouraged to enable timely access to FDA approved technologies when deemed medically necessary and indicated.”