A federal judge has ruled that a novel medical device called the Calmare “Scrambler” is effective at relieving pain and should be covered under Medicare. The decision could lead to Calmare’s non-invasive therapy becoming more affordable and more widely available to thousands of chronic pain patients.
The ruling involved a 69-year old breast cancer patient who suffered from chronic neuropathic pain after undergoing a mastectomy and chemotherapy. She was treated with the Scrambler in 2011 at a pain clinic in Staten Island, New York, but her Medicare claim was initially denied because Calmare therapy wasn’t included in the treatment code used when the claim was filed.
The pain clinic appealed the decision and Administrative Law Judge LeAnn R. Canter allowed the appeal, which permits the clinic to receive reimbursements for Calmare treatments on behalf of the woman.
“This ruling will help broaden Calmare’s patient reach and treatment efficacy,” said Conrad Mir, President and CEO of Competitive Technologies, Inc. (OTC: CTTC), a small Connecticut biotechnology company that distributes and leases the Scrambler device.
“Treatment reimbursement has been a challenge to the furtherance of Calmare. With this significant business milestone achieved, we anticipate greater treatment reimbursements moving forward, which may improve device sales to physicians.”
The Calmare device uses electricity to block pain signals without the use of drugs. A typical session on a Scrambler lasts 30 to 45 minutes, with the device sending low doses of electricity through electrodes placed on the skin of painful areas. The device “scrambles” or re-boots nerves left frayed and sensitized by chronic pain.
Studies by a Johns Hopkins researcher have found that Calmare therapy works for most neuropathic pain patients, with the average pain score falling by 95 percent within one month. Relief continued for several months after Scrambler therapy ended.
Although the studies and patient responses are promising, the biggest barrier to making the Calmare device more widely available is that the therapy has not usually been covered by Medicare or private insurance. As a result, many patients have to pay in cash, usually about $250 per treatment. That can add up to thousands of dollars after a standard course of 10 to 15 treatments.
Only about 120 Calmare devices are in use around the country, according to Mir, who says sales to physicians have been slowed by the lack of insurance reimbursement. He says the judge’s favorable ruling on Medicare coverage will help change that.
“It’s a great step forward for the company,” Mir told National Pain Report.