Calmare Therapy Gets Favorable Medicare Ruling

Calmare Therapy Gets Favorable Medicare Ruling

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.

woman and doc (calmare)woman and doc (calmare)scramblerThe 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.

Authored by: Pat Anson, Editor

There are 3 comments for this article
  1. Dr. Theresa Burke at 3:48 pm

    I was diagnosed with Reflex Sympathetic Dystrophy in 2011 after breaking my foot. I was misdiagnosed and put on prescription drugs I was highly allergic to and spent a year in a wheel chair with hypertension of my spinal chord. A clinical psychologist told my husband I had a fantasy illness and was seeking attention! I went to a Calmare Pain Clinic in Rhode Island run by Dr. D’Amato. He was the FIRST and only doctor to look at my x rays to see that the hardware put in my 5th metatarsal for broken foot was sticking right through the bone and popping out hitting the nerves alongside my bone. No wonder I could not get better! I saw a zillion specialists who did nothing to help and my RSD was systemic. Calmare therapy works — especially for all those with drug allergies. I found a surgeon from University of Pennsylvania remove the six screws and spent months doing acupuncture, myofacial release, chiropractic care and special diet for inflammation. INSURANCE covered none of this but it was well worth the cost of unscrewing my life and getting back on my feet and back to my job as a trauma specialist who works with veterans, sexual abuse and abortion trauma.

  2. dave at 5:30 pm

    Frequency specific microcurrent, athermic ehf, pemf, ces microwave resonance therapy, laserpuncture, chiken, chirey, ultrasound patch- to name a few are other devices in use for pain which should be tested more thoroughly. It’s unfortunate that NIH and Dr. Collins have recently announced more of the same biomedical research for lupus, rheumatoid arthritis, and Alzheimers to the tune of $250 million. More of the same “pills for pain campaign”; which he admits has yielded little benefit for the public and right after he admitted that efforts to ensure reproducibility for research are “hobbled”. I guess the more things change in medical research the more they remain the same. But it is of some good that every once in awhile the Federal government will allow treatments like Clamare.

  3. Stephen S. Rodrigues, MD at 9:08 am

    This is good news!
    Although my impression of why and how the machine works is completely different. It can help!

    This machine could possibly cover 25-50% of complex pain sufferers. If this machine is ineffective or only partly effective add in the rest of alternatives as in Chiropractors, Active Tissue Release, Acupuncture, dry/wet needling as per Travell/Simons, Prolo-Therapy, and the less ideal, Botox and Biopuncture.