In the study, the authors said charges for medication co-packs submitted on workers' comp claims have been billed under a single national drug code, and "claims administrators generally reimburse the prescription drug and the medical food (if medically necessary) separately."
"According to the FDA, national drug code numbers are intended for uniquely identifying drugs and should not be used on the labels of products such as medical foods, which are not drugs," the study went on. "The presence of an NDC number on a product that is not a drug may be a false or misleading representation that misbrands the product under Section 403(a)(1) of the Federal Food, Drug and Cosmetic Act. Nevertheless, some medical foods that have been prescribed for injured workers have been billed under national drug codes that have been assigned by a labeler."
In the study, co-packs and medical foods were identified using the labeler code portion of the national drug code -- the first five digits of the standard NDC composition -- used by the primary manufacturer of these substances for California injured workers.
The authors identified the following as medical foods:
- Theramine - 60 (tablets).
- Theramine - 90.
- Gabadone - 60.
- Sentra PM - 60.
- Sentra AM - 60.
- Apptrim - 120.
- Apptrim-D - 120.
- Trepadone - 60.
- Pulmona - 90.
- Virilex - 60.
- Hypertensa - 60.
- Hypertensa - 90.
September 27, 2011
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