Washington, D.C. partner Jesse Witten was quoted in the Bloomberg BNA article “HHS Yanks Compliance Endorsement for Patient Assistance Program,” which discusses the November 28 action by the Department of Health and Human Services (HHS) Office of Inspector General to rescind an advisory opinion. This is the first time that the HHS-OIG has ever rescinded an advisory opinion.
The HHS-OIG rescinded its opinion after concluding that the recipient of the opinion, charity that helps low-income Medicare beneficiaries pay their copayment and other cost-sharing amounts, was inappropriately influenced by drug company donors in the design of the charity’s disease funds and that it provided information to donors about how their donations were used. According to the HHS-OIG, this conduct violated the terms of the charity’s advisory opinions.
The article reports that the Department of Justice has been investigating pharmaceutical companies over alleged improper relationships with patient assistance programs (PAPs), which provide financial assistance to patients with chronic diseases. Jesse noted that “[a]s pharmaceutical companies decide how to provide patient assistance, it’s important to consider the compliance measures that PAPs have in place.”