We Represent Pharmacies Nationwide in Business Formation, Transactions, Compliance and Enforcement Matters, Payor Disputes, and Investigations
As a pharmacy owner or executive, you are well aware of the operational challenges your business faces on a day-to-day basis. But, you might not clearly understand the laws applicable to your pharmacy operations and the steps your business should be taking to manage its risk effectively. At Silverman Bain, LLP, our lawyers have decades of combined experience representing pharmacies across the country. We work closely with our clients to help them maintain compliance, avoid unnecessary issues, and favorably resolve disputes with private and governmental entities when necessary.
Our Services for Pharmacies
We provide a comprehensive suite of legal services to pharmacies across the country. This includes (but is not limited to) representing pharmacies with regard to:
Buying or selling a pharmacy? We help providers understand the nuances between asset and stock purchases, and draft and negotiate all relevant agreements giving due consideration not only to the contractual risks involved but also to the restrictions of the Anti-Kickback Statute, Stark Law, and other pertinent healthcare regulations.
Pharmacies are subject to extensive regulatory compliance obligations, and meeting these obligations on an ongoing basis presents several challenges. We help pharmacies implement comprehensive and custom-tailored regulatory compliance policies and procedures, and we work with our clients as necessary to allow them to monitor, audit, and enforce compliance internally.
State Board of Pharmacy Licensure
Pharmacies are required to be licensed in their home state and generally every state they dispense medications into. We work closely with our pharmacy clients to identify all pertinent pharmacy and pharmacist requirements implemented by the various states and to guide them through the relevant licensure processes as efficiently as possible.
340B program compliance is essential for many pharmacies. If your pharmacy is seeking to purchase discounted medications from a Medicaid-participating pharmaceutical manufacturer, our lawyers can assist with registration and enrollment, and we can provide the documentation your pharmacy needs to establish and maintain compliance.
Pharmacies frequently encounter issues with pharmacy benefit managers. Our lawyers have significant experience representing pharmacies in payor contracting, audits, investigations, disputes, appeals, and other payor matters.
Operating a pharmacy necessarily involves interacting with the U.S. Drug Enforcement Administration (DEA). We assist pharmacies with DEA registration and in adopting, implementing, and enforcing comprehensive and custom-tailored DEA compliance programs; we also provide representation for DEA inspections, audits, and investigations.
Direct to Consumer Marketing
While there is nothing inherently unlawful about consumer-targeted marketing, pharmacies that engage in such targeted marketing must prioritize compliance and often face scrutiny from regulators and payors. If your pharmacy markets to (or intends to market to) directly to patients, our lawyers can help advise on how to mitigate risk.
Fraud and Abuse
A significant portion of our practice is devoted to representing pharmacies and other healthcare entities in fraud and abuse investigations. If your pharmacy is under investigation, or if you are concerned that your pharmacy could be at risk in the event of an investigation, we encourage you to contact us promptly.
Speak with a Pharmacy Lawyer at Silverman Bain, LLP
How can we help your pharmacy? Please contact us today to speak with one of our lawyers about your pharmacy’s legal needs in confidence.