Over the past several months, a new brand of marketing has emerged in the compound pharmacy space, shifting from marketing aimed at prescribing physicians, to direct-to-consumer marketing of compounded pain creams. Using telemarketing techniques or other lead generation strategies, these companies contact potential patients directly, and inquire about whether they might be interested in or be appropriate candidates for receiving certain medications, including compounded preparations. While this may be a very effective way in educating patients suffering from various conditions in learning about new products, it may present certain issues for the pharmacy, particularly when the solicitation involves a compounded medication.
First, pharmacies considering these direct-to-patient marketing opportunities must be careful as to how these companies generate the leads for the patients, and must ensure that all HIPAA and HITECH rules and regulations are followed. Second, when compounded medications are involved, pharmacies must be careful about the representations made by the marketing representatives about the safety or efficacy of the products, as FDA rules and regulations may be implicated. This can be a far more delicate balance than traditional marketing activities performed within a prescribing physician’s office, since unlike a doctors who have a medical and scientific understanding and can make a professional decision about the products, patients do not possess the same level of medical expertise and understanding. Third, pharmacies must be mindful of Anti-Kickback considerations and compliance with such rules and regulations when engaging with and compensating these companies. These are issues that must be seriously considered and vetted before engaging in such marketing activities.
However, a new consideration has recently emerged, which pharmacies must also consider. Earlier this month, a major PBM issued an alert to pharmacies indicating its awareness of a growing trend to contact and solicit patients about potential medications such as topical compounded prescriptions. The PBM indicated that it was the PBM’s position that its Manual prohibited these types of activities, and warned of audits, recoupments and terminations for pharmacies that conducted these activities or hired third parties to do this on their behalf.
Therefore, pharmacies must be extremely careful in developing their marketing practices and engaging with these types of entities. Frier Levitt routinely advises clients on the contours of various marketing relationships, and their legality from many perspectives, including Anti-Kickback Statutes, FDA rules and regulations, HIPAA/HITECH and PBM contracts and manuals. Contact Frier Levitt to speak to one of our attorneys.
