Becoming educated about medical foods, knowing how to spot warnings, and understanding whether they should be used in a given case is imperative to controlling this up-and-coming challenge in the workers' comp system, said Tron Emptage. The chief clinical compliance officer for Progressive Medical in Westerville, Ohio, said the issue of medical foods isn't quite as big a problem in the workers' comp system as physician dispensing of medications -- yet.
"It's an area that's growing," Emptage said. "It's going to be a subset of physician dispensing and medication compounding."
What are medical foods?
Medical foods are intended to help medications work more effectively in people who might otherwise have a problem properly absorbing certain medications. The exact meaning of the term "medical foods" is somewhat vague.
The Food and Drug Administration says it is a food to be taken orally under the supervision of a physician and which is intended "for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
The FDA's Center for Food Safety and Nutrition also says medical foods are "developed to address the different or altered physiologic requirements that may exist for individuals with distinctive nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth associated with inflammation and other medical conditions, as well as from pharmaceutical therapies."
"Part of the challenge is based on the different definitions of medical foods and the regulations for the FDA and all the government agencies," Emptage said. "There has not been a lot of regulation around them. They don't necessarily have to go through the same clinical trials that traditional medicine would."
Emptage said medical foods are not necessarily new, but they are becoming more prevalent as people use different treatments and therapies. "There is a bit of mystique and misunderstanding about them."
There are studies under way by some companies that advocate the use of medical foods. Emptage said these companies are taking more traditional paths as they seek approval for them. Other companies, however, are just packaging them with medications to come up with a new delivery and dispensing process.
"We're seeing it more and more, and people don't have the knowledge to approve or not approve, 'Is it reasonably necessary on our particular claims for our particular patients?'" Emptage said.
the comp system. It's unclear just how prevalent they are in the workers' comp system. A study released last year by the California Workers' Compensation Institute documented the rise in spend on medical foods, repackaged drugs, and compound drugs from 2006 to 2009. It found that those three categories accounted for almost 12 percent of drug spend in California in the first quarter of 2009 with medical food reimbursement at $233 per prescription in that quarter.
"It's one of those situations we want to get ahead of before it becomes a big problem," Emptage said. "The purpose of the talk is to help educate, give [attendees] red flags, and some pearls of wisdom to be able to identify on a file when these types are being dispensed, where there could be a place in therapy for them, and when it's time to ask a question of a nurse case manager, medical director, etc."
Workers' comp managers and other executives should also become informed about medical foods, Emptage said. "They should know enough about them to get their staffs educated, so their staffs know what questions to ask."
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September 27, 2011
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