As is often the case in workers' compensation, various stakeholders in the drug delivery process exploit loopholes or create new variations of drugs to bypass existing controls. This has proven true with topical custom compound drugs. After Healthesystems, a Tampa-Fla.-based PBM and ABM, affected a decrease in the volume of topical custom compounds, it wasn't surprised to see a corresponding rise in the number of prescriptions for two other kinds of topical products. As a result, the company deployed program adjustments to curb the growing trend.
Prescriber Outreach is Critical
According to Robert Goldberg, MD, FACOEM, chief medical officer at Healthesystems, and a past president of the American College of Occupational and Environmental Medicine, the growing trend should cause payers concern on several fronts. "We are seeing prescribers shift away from topical custom compounds toward the next generation of topical products -- private-labeled and homeopathic topicals prescribed to treat pain. When we reach out to prescribers to educate them about the lack of proven efficacy, potential risks to patients and the high cost of these formulations, they generally welcome the information and adjust their prescribing habits. However, this doesn't remove the concern of the limited understanding about these products." The market for these topical products is growing fast along with their price tags.
Private-labeled and homeopathic topical products are fraught with some of the same financial and patient safety concerns as topical custom compounds -- and carry their own considerations. They are generally billed to the insurance payer on paper bills and, depending on the bill processing workflow, likely escape the normal drug review edits that could identify harmful interactions and other adverse therapy risks. None are FDA-approved or have been tested for efficacy. And based on a lack of clinical study results, patients using these products are not likely to experience pain relief. Yet, due to the lack of systematic oversight, they are frequently approved and/or paid despite their exclusion from drug plans.
Private-labeled topicals exploit a loophole in the FDA regulations regarding dietary supplements and the 1962 amendment to the Food Drug & Cosmetic Act. They contain only over-the-counter (OTC) ingredients such as high-potency methyl salicylate, menthol, camphor or homeopathic agents which are found in products such as Icy Hot(r).
-- These mixtures largely approximate OTC formulations but come with substantially higher prices justified by the manufacturer because of the higher concentrations of some ingredients contained in their OTC counterparts.
-- Methyl salicylate and menthol products present safety concerns because rare but severe skin burns have been reported. This resulted in an FDA warning for over-the-counter products, all of which contain much lower concentrations of the ingredients than the private-labeled versions.
-- Their brand names confer legitimacy that can mislead prescribers into thinking they contain prescription drugs.
Homeopathic topical products contain extremely dilute substances and may not pose a direct harm to patients. Homeopathic theory purports that these products stimulate the body's own healing, which runs counter to the findings of evidence-based medicine.
-- There is no expiration dating required on the products.
-- These topicals are expensive and prices vary widely.
Before they can manage and control these next generation topicals, payers must first acknowledge the problems they present and develop strategies to uncover their existence. These products are akin to several other hidden cost drivers in workers' compensation that fly under the radar. The complexities involved in identifying and managing them take special expertise.
Explained Dr. Goldberg, "At Healthesystems, our clinical team works closely with our technology team to create the complex system logic and edits needed to identify and manage these cost drivers."
Due to the serious patient safety concerns, lack of proven efficacy and the inflated costs associated with these compounds, Healthesystems recommends that payers question the medical necessity for these topical products and seek clarification from the prescriber for the choice of these products.
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(The above piece is part of our continuing Insights series designed to highlight key products and services to our readers. This paid-for Insights
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September 11, 2013
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