One of the fastest growing and hottest topics among compounding pharmacies is the marketing of compounded pharmaceuticals by pharmacies to physician groups. More compound pharmacies are marketing directly to area physicians, but our experience shows that many pharmacies are not following Federal and State law relating to such marketing practices. The goal of the marketing is to educate physicians on the benefits of compounded prescriptions and ultimately increase physician referrals for compounded prescriptions. Given various Federal and State laws relating to kickbacks and limitations on marketing techniques, compounding pharmacies must tread cautiously when undertaking marketing practices. Intelligent pharmacy decision-makers are taking steps to ensure compliance with Federal and State laws and regulations. That’s where Frier Levitt comes in.
Recent decisions from the United States Supreme Court have had an enormous impact on the ability of a compounding pharmacy to legally market and advertise their products. However, pharmacies must still comply with the Anti-Kickback Statute, which imposes civil and criminal penalties for prohibited remunerations for referring or arranging for the provision of items or services covered under a Federal health care program. In order to market compound prescriptions and avoid liability under the Anti-Kickback Statute, a compounding pharmacy must carefully develop a marketing arrangement that fits within either a statutory exemption or a regulatory “Safe Harbor”, such as the Employee Exemption and Safe Harbor. The compounding pharmacy may be subject to scrutiny under the Federal Anti-Kickback Statute. A carefully crafted set of agreements and policies will assist in avoiding liability.
Recent events have placed compounders in the spot light and will result in guaranteed increased scrutiny of compound marketing, compound clinical practice and marketing practices. In the fall of 2012, the Centers for Disease Control and Prevention announced that the fungal meningitis outbreak attributed to a Massachusetts compounding pharmacy amounted to over 100 cases in eleven states with twelve deaths. The CDC allowed for the possibility that 13,000 patients might have received products from the company. Thus, we anticipate changes in the laws, or at the very least, greater scrutiny, making the pharmacy’s relationship with the agent even more important.
Frier Levitt drafts opinion letters to compounding pharmacy clients outlining the ability to market and advertise their services, and explaining the risks of the various options and recommending a marketing plan for the pharmacy. Frier Levitt also drafts contracts and agreements between the pharmacies and marketers, and has developed Standard Operating Procedures to ensure compliance by the marketers with Federal and State laws and regulations.
If your pharmacy is interested in advertising and marketing compound prescriptions, please contact Frier Levitt. We can help your pharmacy ensure compliance, save money and avoid future liability.
