The Centers for Medicare and Medicaid Services is seeking public comment on its proposed ruling that there 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 comment period is open until August 25, 2006, and can be accessed by visiting http://www.cms.hhs.gov/mcd/viewnca.asp?where=whatsnew&nca_id=176&basket=nca:00291N:176:Infrared+Therapy+Devices:Open:New:4.

After considering public comments along with any additional evidence, CMS will make a final determination and issue a final decision memorandum.

According to CMS, there is currently no National Coverage Determination concerning the use of infrared therapy devices for the proposed indications. Infrared therapy devices are currently non-covered by the local Medicare Durable Medical Equipment Contractors (DMERCs) that have identical Local Coverage Determinations:

“There are no indications for which these devices have been demonstrated to have any therapeutic effect. The device and any related accessories will be denied as not medially reasonable and necessary,” according to the CMS proposal.

Anodyne Therapy has established a link on its Web site directing visitors to the CMS comment page, urging health care professionals who use their product to comment on the proposed Non-Coverage Draft Policy.

“A national Non-Coverage Policy will affect you and your patients if implemented as written,” according to a statement on Anodyne Therapys Web site. “Therapists and physicians will no longer be able to bill Medicare for Anodyne Therapy treatments and we will no longer be able to bill Medicare for Anodyne Home Systems for patients who need them. Therefore, it is critical that you contact Medicare, your professional association, and your congressional representatives to express your concern over this policy.”

[SOURCES: CMS; Anodyne Therapy, August 2006]