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Hako-Med machine (electromedical horizontal therapy)- 

is specifically considered experimental and investigational by Aetna, some Blue Cross insurers, and several other insurers.  Apparently it is a high frequency electrical stimulation

System that is advertised by the manufacturer for treatment of post-traumatic pain syndromes, management and relief of chronic pain and post surgical pain, relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation.  Some of their products appear to have pneumatic compression devices.

Hako-med is a device that has been named in fraud litigation against physicians that miscode the therapy to defraud insurers ostensibly due to lack of insurance coverage (http://www.justice.gov/usao/gan/press/2007/02-20-07.pdf).  Hako-med also advertised on their website that most insurers cover the device but in my research, some of the largest insurers do not.  There is some clinical evidence of effectiveness in spinal fractures  (http://www.hakomed.net/files/07_low_back.pdf) and for some arthritis treatments.  This appears to be used as a significant revenue generator for physician offices with one physician, Dr. Nevada Lee, MD on the manufacturers website claiming the hakomed “helped us survive the first two years of my practice”.

Hakomed also lost patent infringement lawsuits and appeals by a competitor in 2010 and 2011.   A chilling tale of how Hako-med treated a distributor who found he could not sell the devices due to physician’s concern over lack of reimbursement and with an independent assessment of appropriate billing codes resulted in much lower values for reimbursement if coded properly.  Hakomed effectively determined that the distributor could not lease the units out, demanded “recertification” fees in the amount of $10,000, and threatened physicians doing business with the distributor may be found at http://www.gas.uscourts.gov/usbc/publishedopinions/lwd/09-04002-LWD-95.pdf  

Painbytes assessment of Hakomed:  Two thumbs down based on their business dealings and lack of insurer coverage.  The machines were sold to distributors for $22,000 each to be sold at higher values to physicians.  With reimbursement from insurers lacking due to exclusion by insurers as “investigational”, physicians will likely pass on relatively high treatment costs to patients.  There are few clinical trials supporting this therapy.

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