A six-year-old lawsuit against California’s State Compensation Insurance Fund, EK Health services – their utilization review vendor – and over a dozen utilization review physicians, recently settled. The case was filed by Electronic Waveform Lab, Inc., maker of H-Wave® – a physician prescribed drug-free medical device that helps those with chronic pain.

In 2011, Electronic Waveform Lab filed a lawsuit against EK Health and eleven Utilization Review Physicians alleging improper conduct in denying the H-Wave® Electrotherapy Device in Utilization Review. The lawsuit was amended to add State Compensation Insurance Fund and three additional Utilization Review Physicians as a party to the action and the case proceeded in federal court with a third amended complaint..

The case alleged, for the first time ever, a RICO statue violation accusing the groups of conspiring to deny physician treatment requests for the FDA cleared H-Wave® device, which can be prescribed by doctors as an alternative to opioids. The parties reached a confidential financial settlement in October 2017.

H-Wave®, a device made by Electronic Waveform Lab, Inc. of Huntington Beach, California, claimed that California’s State Compensation Insurance Fund, allegedly conspired with their contracted utilization review vendor and their independent contractor physicians who are responsible for approving or denying the use of any device for patients on a case-by-case basis, to deny all H-Wave® requests no matter what the medical necessity issues were.

As a result of the litigation settlement, State Fund, EK Health and EK Health’s Utilization Review Physicians will now recognize that Home H-Wave® is a drug-free treatment option, medically necessary in appropriate circumstances, and may be approved for use by injured patients pursuant to current evidence-based medicine and prevailing guidelines.

Authorization requests that prescribe Home H-Wave® should be evaluated on a case-by-case basis, focusing on the needs of the injured patient.

This could be perceived as a big win for medical device makers which deal with denials from claims adjusters on a daily basis. With today’s widespread focus on the national opioid epidemic, this case is encouraging for patients and their physicians who are demanding alternative treatments for chronic pain.

H-Wave, a scientifically-reviewed device that uses electrotherapy to treat chronic pain and speed recovery from injury, has been used by physicians and their patients for more than 35 years.

Most patients who are prescribed H-Wave have been suffering with chronic pain for more than 500 days and have exhausted other conservative treatments, according to the company. Besides being prescribed by doctors for work-related injuries or pain, H-Wave is currently used by more than 70 professional sports teams. More than 200,000 thousand people have been prescribed H-Wave over the last 35 years.