Over the past several years, pharmaceutical company corporate integrity agreements (CIAs) have routinely required needs assessments in connection with the engagement of health care professionals (HCPs) in various types of service arrangements. Virtually every CIA since 2010 has required a needs assessment for consultant arrangement activities. The vast majority of CIAs also have required needs assessments for research-related and publication activities. Given the pervasive nature of CIA needs assessment provisions, it is safe to say that the Office of Inspector General (OIG) views needs assessments as a best practice for companies that engage health care professionals in service arrangements.
Why then, have only five CIAs addressed needs assessments for speaker program activities? Does the OIG consider speaker program activities less risky or less prone to abusive practices than other service arrangements with HCPs?
Recent enforcement actions would seem to suggest otherwise.
In particular, a complaint filed against Novartis in April 2013 contains a litany of allegations of kickbacks paid to physicians participating in the company’s speaker programs. The complaint filed against Novartis in August 2010 contained similar allegations. The 2010 allegations ultimately led to a CIA in September of that year and a civil settlement to the tune of $422.5 million.
Many of the allegations in the 2013 Novartis complaint purportedly occurred after Novartis entered into its CIA. In fact, the complaint specifically alleges:
Yet even after entering into the CIA, Novartis’s compliance program was inadequate to prevent illegal payments and other perquisites to doctors in conjunction with Novartis’s speaker programs. Novartis did not adequately review its speaker program to determine whether the programs were being used for an illegitimate purpose.
Interestingly, the Novartis CIA does not require that the company conduct needs assessments for its speaker program activities. The CIA does require that Novartis maintain its Event Oversight Committee (EOC) to evaluate proposed consultant arrangements, specifically including speaker training programs, though not the actual speaker programs. As part of its review, the EOC must evaluate a needs assessment for all consulting arrangements and no arrangement can take place without EOC approval.
Only the Johnson & Johnson CIA (2013), the Amgen CIA (2012), the Serono CIA Addendum (2011) and the Ortho-NcNeil-Janssen CIA (2010) address needs assessments for speaker program activities.
It was only a bit over six months after Novartis signed its CIA in 2010 that EMD Serono agreed to an addendum to its CIA that extended its term for an additional three years as a result of allegations that Serono paid health care providers inducements to prescribe its products, including payments for speaker programs and speaker training. Unlike the Novartis CIA, the Serono CIA addendum requires the company to develop an annual budget plan and needs assessment for its speaker program activities. The budget plan/needs assessment must:
- Identify the business need for speaker program engagements
- Estimate the number of speaker programs and
- Identify the budgeted amounts to be spent on speaker program-related activities
The CIA further requires that Serono’s Compliance and/or Legal Department be involved in the review of the budget plan/needs assessment.
The closest the OIG has come again to requiring needs assessments for speaker program activities was in the Johnson & Johnson, Amgen and Endo Pharmaceuticals CIAs. According to the Johnson & Johnson and Amgen CIAs, the companies had, prior to the effective dates of the CIAs, implemented controls over their speaker program activities that required there to be a legitimate need for such activities. The CIAs require that Johnson & Johnson and Amgen maintain those controls for the term of the CIA. Similarly, the Endo Pharmaceuticals CIA requires that company to “maintain processes designed to ensure that there is a legitimate need for each speaker program.”
Before the Serono CIA addendum, the OIG required Ortho-McNeil-Janssen Pharmaceuticals to complete a business rationale form prior to the retention of, or payment to, a consultant – which the CIA defines more broadly than do more recent CIAs to include speakers. The business rational form is intended to justify the retention of the consultant and must identify the business need for the consultant engagement and provide details about the consulting arrangement. These details include:
- Information about the number of HCPs to be engaged
- Information about the qualifications of the HCPs to be engaged
- The agenda for any proposed meeting
- A description of the work to be done
- A description of any work product to be generated by the consultant
The OIG is obviously aware of and concerned about the potential for abuse with speaker program activities. Its CIAs routinely require that controls be put in place around such activities and that monitoring take place to verify the effectiveness of those controls. Moreover, Mary Riordan, Senior Counsel in the Office of Counsel to the Inspector General, suggested that pharmaceutical companies reassess the kickback risk of service arrangements with HCPs, including speaker programs, as a result of recent enforcement activities.
Even if the OIG does not routinely require needs assessments for speaker program activities in its CIAs, it would behoove companies to consider putting in place such a control mechanism to more effectively manage the kickback risk associated with paying HCP speakers to promote a product.