Compliance and Legal Departments Take Note: Novel Speaker Program Restrictions in Pharmaceutical Corporate Integrity Agreement

A corporate integrity agreement (CIA) published by the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) last week sets forth novel and detailed restrictions relating to pharmaceutical speaker programs and employee incentive compensation. While these obligations apply only to the manufacturer that entered into the CIA, the pharmaceutical and device industries may choose to consider these novel restrictions and whether and to what extent they may affect perceptions of what constitutes an effective compliance program in these key areas.

Speaker Programs

New speaker programs are defined to include and are subject to the following restrictions:

• All Speaker Programs. Speaker programs cannot take place at restaurant venues, and alcohol may not be served or be available for purchase at these events.
• External Speaker Programs. As defined by the CIA, these programs involve a healthcare professional speaker who is not a company employee.
  • Remote-Only Events: These programs can be held only virtually, meaning that “the External Speakers shall be remote and shall not be in the same location as any audience member.”
  • No Sales Involvement: Sales representatives are not to be involved in the selection of external speakers, including the provision of nominations or recommendations.¹
  • Must Follow New Product or Indication: The programs must be completed within 18 months of Food and Drug Administration approval of a new product or indication. 
  • Remuneration Cap on Programs: These programs are subject to a total $100,000 cap on remuneration for each new product or indication, with each nonemployee speaker allowed a maximum of $10,000 payment for each new product or indication.
  • “Real-Time” Q&A Sessions: The CIA allows for such programs to provide for “real-time discussion of questions and answers” and also allows the program (including question and answers) to be recorded and available during and following the expiration of the 18-month period.
• Internal Speaker Programs. As defined by the CIA, internal speaker programs involve a company employee who is a healthcare professional. In addition to maintaining records and ensuring appropriate training of internal speakers, the CIA requires that internal speakers certify that the program complies with company policies.

Employee Incentive Compensation

The CIA also sets forth novel provisions aimed at implementing controls around employee incentive compensation. Most significantly, if an employee is found to have violated an applicable law or company policy, the employee will be ineligible to receive future incentive payments for a period of up to “two future selling cycles” from the date the violation was discovered. In addition, if the company determines the violation was “material,” incentive payments for any prior period in which such violations occurred must be rescinded and, if already paid to the employee, repaid by the employee. The CIA does not define the term “material.”

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CIAs continue to be a source of information that can inform the evolution of effective compliance program design and implementation. At the same time, CIAs are the product of the allegations contained in the underlying matter and do not typically reflect actions or activity required by law.

 

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¹ The same limitation applies with respect to the selection of consultants.

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