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July 28, 2006

CMS seeking evidence review

Staying on the theme of guru's, and equipment in their role as panacea's for pain, we have a request by CMS seeking public comment on the determination that their is sufficient evidence to conclude that the use of infrared devices is not reasonable and necessary for treatment of Medicare beneficiaries for diabetic and non-diabetic peripheral neuropathy, wounds and ulcers, and similar related conditions.

The proposed national determination is:

The use of infrared and/or near-infrared light and/or heat, including monochromatic infrared energy (MIRE), is not covered for the treatment of diabetic and/or non-diabetic peripheral neuropathy, wounds and/or ulcers of skin and/or subcutaneous tissues in Medicare beneficiaries.

Almost a year ago, we had posts at EIM speculating that the reason Andodyne was so popular was the fact that it is being used on a very difficult population to treat and that they had convinced a large sector of podiatrists of its efficacy which in turn caused a flood of referrals to PT clinics.   Our speculation was that it was another example of marketing outpacing research and that there was scant evidence to support the modality. 

Now its time for the evidence to "speak out" and CMS would like your opinion before they fully put in place their national coverage policy.

Full disclosure, like many of you, some of our clinics do have Anodyne, use it on occasion as part of regiment and we get no reimbursement for it.  We had to get it-so many of our competitors did!!   Mysteriously, the referrals have wained and the Anodyne Treatment Center PT clinics are out of business.  Very predictable.

Larry

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Comments

Jon Newman

Very timely post Larry. The Anodyne folks are making their inroads in my neck of the woods and I'll be very interested to hear people's opinions. "Junction 13" had some good insights regarding mire in a related thread over at rehabedge back in April that is worth checking out.

David A. Arnall, PT, Ph.D., FACSM

I have just conducted a study on diabetic patients using infrared light therapy. It is published in Acta Diabetologica - a Eurpean Diabetes Journal. This study is a controlled and blinded study with 22 diabetic patients. These individuals had severe neuropathies in which most were totally anesthetic (no sensation). With eight weeks of 30 min of Infrared light therapy three days per week, these patients had their peripheral protective sensation restored to normal. It works and it is a viable therapy for the restoration of neuropathies in diabetics. For more information, see the article with this citation: Arnall, David A., Arnold G. Nelson, Laura López, Núria Sanz, Isabel Sanz, Laura Stambaugh, Sheridan B. Arnall.The Restorative Effects of Pulsed Infrared Light Therapy on Significant Loss of Peripheral Protective Sensation in Patients With Long Term Type 1 and Type 2 Diabetes Mellitus Acta Diabetologica 43:26-33, 2006.

This paper is a paper that adds credibility to the use of infrared light as a treatment modality - it is evidence based.

Dr. David Arnall

Scott Newton, PT, DPT, OCS, CWS

Interesting. I look forward to reviewing your study. Our study, The Effect of Monochronomatic Infrared Energy on Sensation in Subjects with Diabetic Peripheral Neuropathy: A Double Blind, Placebo-Controlled study, did not come to the same conclusion. The study can be found at Diabetes Care 28:2896-2900,2005 and responses 29:1186,2006.

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