Copay Coupons on 510(k) Medical Devices and Dietary Supplements

PBMs have historically accepted pharmaceutical manufacturer coupons so long as the usage of such coupons complies with both state and federal law.  Recently, however, PBMs have begun to allege technical breaches of the contract for a pharmacy’s use of a coupon on specific classes of medication. For example, even if a coupon were otherwise in full compliance with applicable regulations, if the pharmacy did not apply the coupon within the confines of a specific PBM’s Provider Agreement, such claims could be subject to full recoupment and/or termination.

Specifically, Frier Levitt has observed a trend with PBM audits and recoupment on pharmacy applications of coupons on 510(k) medical devices and dietary supplements. Even though 510(k) medical devices are FDA approved, some PBMs have taken the stance that since these products are not approved through a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), they do not qualify as a contractually acceptable pharmaceutical manufacturer coupon. In addition, PBMs have targeted dietary supplements as being contractually disqualified for the application of a pharmaceutical manufacturer coupon due to being non-FDA approved.

How Frier Levitt Can Help

Though a PBM contract may limit how and when a pharmacy may apply a pharmaceutical manufacturer coupon, additional factors do require consideration such as course of dealing between the parties and controlling state and federal laws, which modify a PBM contract. If your pharmacy is currently undergoing an audit relating to the pharmacy’s application of coupons, or your pharmacy is currently accepting coupons on 510(k) medical devices or dietary supplements, contact us to speak to an attorney today.

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