Compound drugs are drugs combined by a pharmacy for a specific medical condition. A medical food is any food that is used to treat pain and other symptoms of an on-the-job injury. A co-pack is a medical food combined with a generic prescription pain reliever and sold in a “convenience pack” with a medical food.
According to the Food and Drug Administration (FDA), a medical food product must be formulated and processed for use in treatment of an injury (and/or other medical conditions) and be used as a treatment modality. It must be:
- A food for oral or tube feeding
- Provide for the nutrient needs resulting from a specific medical disorder
- Is for use under a physician’s supervision
Be labeled with a statement of identity and content (but is exempt from the FDA guidelines for health claims and nutrient content claims
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For workers compensation, the most often sold medical food in California is Theramine. Its stated purpose is to aid in the nutritional management of chronic pain syndromes including fibromyalgia. The ingredients listed on the Theramine packaging states it includes GABA, arginine, choline, glutamine, grape seed extract, cocoa, cinnamon, histidine, serine, 5-HTP, and hydrolyzed whey protein.
Theramine is often sold in the co-pack where it is combined with tramadol with the combination being called Theratramadol for use in management of moderate to severe pain in adults. When Theramine is combined with naproxen, it is called Theraproxen, and is used for pain management for tendonitis and other similar medical conditions. When Theramine is combined with hydrocodone and acetaminophen, it is called Theracodophen and is used to treat moderate to severe pain. As tramadol, naproxen, hydrocodone and acetaminophen have the exact same uses when not combined with Theramine, the question is: should the insurer of the worker’s compensation claim pay more for the medical food or co-pack? If Advil is mixed with a casserole, would the insurer be responsible for the cost of the casserole? Maybe so if the need for oral medication is necessary due to the work-related injury.
One question at issue is where will the injured employee obtains medical foods. Since there are no medical food stores, the medical foods are sold by the treating physician. There is a built-in conflict of interest when the treating physician stands to profit from one treatment method over another.
To help us provide as much information as possible so that physicians, patients and payors understand the purpose of medical foods in clinical care, the make primary manufacturer of the Theramine, Physician Therapeutics, has provided information about the clinical trials, the safety and efficacy in clinical care and data that supports its use in clinical care. We urge our readers to learn more about the products at these three links:
http://www.ptlcentral.com/Clinical-Trials.php
http://www.ptlcentral.com/product-monographs.php
http://www.ptlcentral.com/Editorial-Articles.php
In the states where the employee can select the treating physician for their workers compensation claim, the use of medical foods is booming. In California, the employer selects the doctor, but after 30 days the employee can select their own doctor. The employee selected physicians are doing a much bigger business in medical foods then the medical providers selected by the employers, regardless of the state.
Per the FDA, the medical food must be “intended for the specific dietary management (of an injury) for which distinctive nutritional requirements, based on recognized scientific principles, and are established by medical evaluation.” If these guidelines were being universally recognized, then you would anticipate the dispensing of medical foods by physicians chosen by the employers and physicians chosen by the employees would be approximately the same.
Consider for example the treatment of pain. When the choice is between prescription drugs available only in a pharmacy, referral of the injured employee to a pain management clinic, or selling the employee either medical foods or co-pack (medical foods + a generic prescription pain reliever), is the doctor making the best choice for the injured employee, or is the doctor selling the medical foods or co-pack making the best choice for the doctor’s income?
There is medical evidence that proper nutrients can speed healing and improve outcomes. The treating physician has always been allowed and willing to tell the injured employee the benefits of proper nutrients in the appropriate amounts. However, the question with medical foods is does the cost of medical foods outweigh the additional benefit they provide?
Medical foods also present other issues including safety concerns as they are not required to meet the FDA drug regulations. Another issue (and definitely associated with the physicians selling medical foods) is their price is not controlled by medical fee schedules. Also, until recently the medical food utilization has been outside the normal cost restraints of utilization review. Some pharmacy benefit management (PBM) programs are beginning to audit the use of medical foods by tracking the use. The PBMs are looking for duplication of therapy, being prescribed by multiple physicians and excessive duration or excessive use.
If your injured employee is being sold medical food that is in turn being billed to the workers compensation insurer, it is eventually going to have an impact on the cost of your workers compensation coverage. When the medical food cost begins to rise, consider another strategy besides the PBM program. Ask your utilization review company to address the issue with prospective, concurrent and retrospective utilization reviews. (WCxKit) (open-ended)
Medical foods look like they are going to be an issue in the future in workers compensation. Knowing how to manage medical foods and the associated issues will be necessary. Now where is my Snickers bar?
If you would like more information about the product or the issues surrounding it, the Director of Marketing and Distributor Relations is Marcus Charavastra who can be contacted at: marcusch@ptlcentral.com
Mr. Charavastra emailed us and wanted to point out the following, so in an effort to make this article balanced, we have included his comments and contact information:
“Our products are regulated by the FDA, and do not require FDA approval because they contain only GRAS ingredients. Our products are also regulated by the California Medi-cal fee schedule. I think the confusion here is that the RAND study has really confused the issues and has succeeded in lumping medical foods and compound creams together, when in fact they are much different. Medical Foods, ours specifically are quite regulated by the FDA, as they visit our facility once every two years; inspect all of our labels, bottles, and marketing material as well as analyze our products compared to the certificate of analysis. Compound creams are not regulated or inspected by the FDA for safety and or efficacy.”
* The paper was written by Barbara Wynn of the Rand Corporation and published on the California Department of Industrial Relations. Here is a link to it: http://www.dir.ca.gov/chswc/Reports/2011/CHSWC_UseofCompoundDrugsMedicalFoodsCo-Packs.pdf
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Author Rebecca Shafer, JD, President of Amaxx Risks Solutions, Inc. is a national expert in the field of workers compensation. She is a writer, speaker, and website publisher. Her expertise is working with employers to reduce workers compensation costs, and her clients include airlines, healthcare, printing/publishing, pharmaceuticals, retail, hospitality, and manufacturing. See www.LowerWC.com for more information. Contact: RShafer@ReduceYourWorkersComp.com.
WORK COMP CALCULATOR: http://www.LowerWC.com/calculator.php
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