Below is an excerpt of a contributed article co-authored with Robinson+Cole Business Litigation Group lawyer Ben Daniels published in Physicians Practice on September 16, 2022.
On July 25, 2022, the U.S. Court of Appeals for the Second Circuit rejected an appeal brought by Pfizer, Inc. in a case that examines whether a “corrupt” intent is required to violate the Anti-Kickback Statute (AKS). The decision addressed a proposed direct copayment assistance program of a pharmaceutical manufacturer which sought to help patients pay for an expensive drug, and whether such a program may be subject to sanctions under the AKS’ prohibition on transfers of remuneration inducing referrals of drugs and other items or services reimbursed by federal health care programs. Funding of copayment assistance programs by pharmaceutical manufacturers to increase access to drugs for certain conditions has become a common practice following prior governmental guidance sanctioning the practice as long as certain safeguards are in place, but the Pfizer program posed a distinct issue for the government because the program provided direct assistance to patients looking to purchase Pfizer’s own drug. In short, the government has concerns that without sufficient independence and safeguards in place, such assistance programs can become alleged conduits for improper payments from pharmaceutical manufacturers to patients to influence purchase of the manufacturers’ drugs. Read the article.