Last week, the MediSpend team was in Washington, DC for the annual Pharmaceutical Compliance Congress. During the conference we had the opportunity to network, share product demonstrations of Engagement Manager and hear from industry leaders about a variety of pressing pharmaceutical compliance topics.
One of the most interesting sessions featured current and former federal prosecutors who participated in the “Past and Present Prosecution Parley” panel discussion. The discussion focused on recent trends in enforcement and healthcare compliance. While the views and opinions expressed do not represent those of the respective government agencies, their comments are nonetheless very informative and provide insight as to the lens in which the government views healthcare compliance.
- Use of Open Payments Data for government investigations
The panel confirmed their continued use and reliance on publicly available Open Payments data. This data continues to be used to identify existing relationships between manufacturers and HCPs/HCOs. Defense attorneys confirmed that all existing cases include evidence derived, in part, from the Open Payments database, which is why it is an essential component to enforcement actions.
Compliance Tip: Proactively analyze and monitor spend data to understand existing relationships and potential violations of company and industry policies and codes of conduct.
- The Opioid Crisis
The opioid crisis continues to be a top priority for the DOJ. In districts that are adversely impacted by the opioid crisis, the federal government is coordinating efforts across criminal and civil departments with opioid coordinators. The government has focused increased scrutiny on opioid manufacturers and distributors as well as over prescribers. The government will continue to use data analytics to identify outliers.
Compliance Tip: Manufacturers and distributors involved in the production and distribution of opioid products should review existing policies and processes to identify areas of risk leading to inappropriate prescribing practices. When possible, proactively leverage data analytics and real-time compliance monitoring.
- Off-label Marketing
The era of massive off-label marketing enforcement actions has abated as big pharma has succeeded in implementing the necessary policies and procedures to reduce risk. When one door closes, another door opens. Specifically, the DOJ has changed its focus from large pharma to emerging and small pharmaceutical and medical device companies. Small and emerging companies have several ingredients that, when combined, serve as a recipe for increased risk. Those risk factors are:
- Management teams leading emerging growth companies are entrepreneurial in nature and may be willing to take on increased risk
- Venture backed healthcare companies may be more aggressive due to on-going operating losses and the need to reach profitability
- Emerging growth companies have limited resources and may “cut corners” in compliance
- Aggressive sales practices are encouraged to drive top-line growth to attract acquirers
- The marketing and distribution of orphan drugs to address limited patient populations
Compliance Tip: Implement a robust compliance program designed to address identified areas of risk. Demonstrate compliance through adherence to documented policies and procedures.
- Anti-Kickback Statute
The DOJ continues to focus on the following areas that implicate the anti-kickback statute:
- Speaker programs:
Does the organization follow sound compliance practices surrounding speaker programs to include the collection of sign-in sheets and the monitoring of attendees? Are the same HCPs attending the same speaker event on multiple occasions?
- Complex relationships between HCPs and HCOs:
In addition to traditional practices invoking the anti-kickback statute, the DOJ is looking into more complex arrangements such as joint ventures with physicians and the provision of training or other services to HCPs or their practices.
Compliance Tip: Examine all arrangements with HCPs and HCOs in which there is a transfer of value. Do the transfers of value fall within the safe harbor provisions of the Anti-kickback statute.
- Patient Assistance Programs
Patient Assistance Programs are facing increased scrutiny from the DOJ. While Patient Assistance Programs can provide significant benefits to patients including greater access to needed medications, they also pose a significant risk for violations of the Anti-Kickback Statute. The DOJ will continue to look for any inappropriate coordination between the manufacturer and the charity.
Compliance Tip: Closely scrutinize all communication and data sharing between your company and the charity running the patient assistance program.
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