Pacira’s Fight for the NoPain Act: Device Manufacturers Gain, Too

The Non-Opioids Prevent Addiction in the Nation Act (NOPAIN Act), which went into effect on January 1, has direct and indirect opportunities for manufacturers of pain management technologies working in the field of preventing opioid addiction.

Congress passed the act in 2022, mandating that Medicare separate and increased payments for qualifying non-opioid pain management drugs and devices in the outpatient and ambulatory surgery center (ASC) settings from bundled payments. It is part of a series of initiatives Congress has put in place to stem the nation’s ongoing opioid crisis, which kills more than 100,000 people a year in the US, according to the US Centers for Disease Control and Prevention (CDC).

Currently, post-surgery non-opioid analgesics in hospital inpatient and outpatient settings are included in bundled payments, which are the single payment that hospitals receive for all services and equipment used in a procedure. Because these are capped, they encourage providers to use cheaper opioids. The new terms, set last year by the Centers for Medicare and Medicaid Services (CMS), are based on the average sales price (ASP) of the therapy, plus six percent when it is used in outpatient procedures covered by Medicare. Currently, 11 therapies, including five devices, are on the qualified list (see Figure 1). The agency rejected several device manufacturers’ applications last fall, due to lack of supporting peer-reviewed data that their devices demonstrated the ability to reduce opioid consumption. Medical device companies continue to explore ways to get their products on the list.

No company has pushed harder for passage of this law than Pacira Biosciences, which began organizing lobbying efforts for it in 2017. The company’s long-acting analgesic Exparel (bupivacaine liposome injectable suspension) is one of six covered non-opioid medications—two of which are specific to ophthalmology—on the qualifying list.