Gardner Law supports, and even leads the Compliance function for clients.
Gardner Law has deep experience in assessing and mitigating regulatory risk created by the Sales, Marketing, Reimbursement, and Clinical functions. The firm regularly provides counsel on the impact of the law on company programs and how to minimize the risk presented by FDA regulations, the Anti-Kickback Statute, the False Claims Act, the Physician Payments Sunshine Act, HIPAA/HITECH, Stark, the Foreign Corrupt Practices Act, Federal Trade Commission Act and state laws. Enforcement of these laws has become much more aggressive. Companies must now disclose transfers of value made to physicians and teaching hospitals. Many states have additional requirements for nurses, technicians, and therapists. Prescriber data is also public.
Companies must be prepared. Leadership, from the Board down, must ensure that Sales and Marketing activities and claims, discounting practices, provision of reimbursement information, and any financial relationships between the company and physicians and hospitals, comply with all applicable laws, regulations and safe harbors.