IG highlights central areas in pharma guidance

At the joint American Health Lawyers Association/Health Care Compliance Association conference in Washington, DC, Health and Human Services (HHS) Inspector General Janet Rehnquist highlighted three central areas in the recently released draft guidance for pharmaceutical companies:

  • Average Wholesale Price. The first area cited by Rehnquist is the pricing issue where there is considerable focus on average wholesale price, the methodology used to pay for drugs. "Companies are responsible for the integrity of the data that they provide to the clearinghouse, which establish the base for reimbursement," she explains.
  • Kickbacks. The OIG’s second main area of concern is kickbacks, Rehnquist says. "Employees and agents must be aware of the anti-kickback statute and the constraints that that statute places on marketing and promotion of their product," she warns.

"Manufacturers need to pay particular attention to payments for consulting, meals, and entertainment in conjunction with marketing, gifts, and business courtesies and the sponsorship of education and grants," she adds.

  • Samples. "Last but not least, we provide guidance on the use of free samples," says Rehnquist. "Free means free," she asserts. "If a sample is given free to a physician, it should be free to the patient, and it should be free to the government."