An important consideration for companies doing business in France is that the disclosure law complements the "anti-gift" law.
Failure to structure physician contracts to comply with Stark and Anti-Kickback Statutes can easily result in seven-digit fines and repayments. Under Stark, if a physician or a member of the physician’s family has a contract or other financial relationship with a hospital or other health care provider, the physician may not refer patients to the provider for certain designated health services payable by Medicare, and the provider may not bill Medicare for such services, unless the arrangement is structured to fit within a regulatory safe harbor.
Such violations can also adversely affect the status of tax-exempt entities. Stark is a strict liability statute: even technical violations require repayments. The Anti-Kickback Statute (“AKS”) prohibits anyone from knowingly and willfully soliciting, offering, receiving, or paying any form of remuneration to induce referrals for items or services payable by government health care programs unless the transaction is structure to fit within a regulatory exception.
The Sunshine Act in the United States is but one physician payment disclosure obligation for manufacturers of drugs and devices to keep track of.
We recently wrote about Medicines Australia’s transparency code; additionally, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code sets out self-regulatory industry transparency standards for pharmaceutical companies operating in 33 European countries.
Providers who bill for services in violation of Stark or the AKS must repay payments received from government programs.