“Total penalties from compliance-related violations have crossed over $20 Billion since 2000.”
Ethical and law-compliant interaction between life sciences companies and healthcare professionals (HCPs) is key to avoiding the risk of regulatory penalties, fines, and other consequences.
Authorities such as the U.S Department of Justice (DOJ) and the Office of Inspector General (OIG) have made it clear that the interactions between companies and HCPs must be conducted in accordance with strict compliance standards.
This involves adherence to stringent laws such as anti-kickback statutes, transparency requirements, and other ethical guidelines that demonstrate integrity and prevent undue influence or conflicts of interest.
Despite the stringent regulatory framework, occasional lapses occur.
As we dive into the depths of HCP engagements, it becomes clear that the stakes and responsibilities of compliance officers are high.
Tasked with managing complex compliance terrain, compliance officers must realize the challenges, address them proactively, and find opportunities to uphold the highest standards of ethical conduct within the industry.
Let us look at the intricacies of engaging HCPs, gain regulatory insights, and learn the seven actionable steps to ensure compliant HCP Engagements.
Key Guidelines and Regulations That Govern HCP Engagements
- Pharmaceutical Research and Manufacturers of America (PhRMA) Code: Guides ethical interactions between life sciences companies and healthcare professionals. It covers topics like gifts, meals, and other forms of compensation provided to HCPs.
- U.S Anti-Kickback Statute (AKS): Prohibits HCPs from referring patients for certain designated health services to entities where the HCP or their immediate family member has a financial interest.
- Anti-Bribery | Anti-Corruption (ABAC): Aims to prevent and punish bribery and corrupt practices in various contexts.
The Need for Collaborative Working Between Life Sciences Companies and HCPs
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), collaborative work between the life sciences industry and HCPs over the past 50 years has significantly increased life expectancy by almost a decade on the continent.
Below are a few reasons why Life Sciences companies engage HCPs:
The Importance of Ensuring Compliant HCP Engagements
The stakes are high, with penalties and reputational risks looming for non-compliance. Let us take a closer look at some eye-opening data to determine the importance of ensuring compliant HCP Engagements for life sciences companies:
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Challenges Compliance Officers Face While Ensuring Compliant HCP Engagements
- Ensuring compliance with the AKS through monitoring to prohibit the offer, payment, solicitation, or receipt of remuneration to induce or reward referrals for items or services reimbursable by Federal health care programs.
- Accurately determine fair market value for HCP engagements, especially in speaker programs, to avoid overpayment, underpayment, and potential compliance risks.
- Identifying debarred HCPs is a challenge. Data inconsistencies, limited search options, and siloed information complicate the process and hinder efficient workflows and compliance, leading to costly penalties.
- Establishing transparent and objective criteria for selecting HCPs for various engagements, i.e., speaker programs, and avoiding situations where high-prescribing HCPs are rewarded with lucrative offers.
- Accurate and informed documentation of proof of performance for approved HCP activities.
- Clearly document the intent behind HCP engagements and maintain transparency in the selection process to demonstrate compliance with applicable regulations.
- Preventing undue influence from sales or marketing business units in selecting HCPs to promote the company product.
- Tracking history of changes in engagements, e.g., FMV (Fair Market Value) rates, etc.
The 7 Steps to Ensure Compliant HCP Engagements
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Plan Annual Needs Assessment
Leveraging automation for assessing business needs and planning annual needs assessments is the first step to ensuring compliant engagement of HCPs.
Automation can reduce manual effort, enhance process efficiency, and allow compliance officers to shift focus from managing administrative tasks to ensuring compliant alignment of the annual needs assessment with organizational objectives.
To further augment this step, combine automation with a systematic budgeting process.
The systematic budgeting process would enable compliance officers to effectively track services provided enabling companies to align expenditures with predefined business needs.
The strategic combination of automation and systematic budgeting process would set the foundation for ethical and compliant practices.
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Streamline the HCP Engagement Process
The second step involves streamlining the entire HCP engagement process to ensure consistency across various departments involved in the process.
This includes compliance, marketing, medical affairs, and other teams who generally collaborate in the process.
This collaboration and alignment among teams would allow compliance officers to get a consolidated view of compliance and timely mitigate risks associated with FMV rates, document proof of performance, or other related aspects.
By implementing robust processes and systems that provide visibility and oversight throughout the engagement lifecycle, companies can minimize risks while optimizing the effectiveness of their HCP engagement process.
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HCP Selection and Background Checks
Implementing an automated debarment screening process is essential as it reduces the effort required to select HCPs and perform background checks.
Compliance officers can swiftly identify disqualifying factors and mitigate the risk of engaging debarred HCPs by integrating databases like FSMB, OIG, SAM, and FDA into an end-to-end solution.
This automated screening process saves time and ensures thorough vetting of HCPs against regulatory requirements.
The centralized approach enhances efficiency and consistency throughout the selection process, facilitating a thorough evaluation of potential candidates.
Compliance officers can also employ a database system to maintain consistent information across internal departments. This would foster process uniformity in HCP qualification, minimizing discrepancies.
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Fair Market Value Assessments
An effective approach to determine fair market value involves integrating algorithms, data analytics, and leveraging automation to streamline and determine FMV rates for HCPs.
Automated processes enable compliance officers to intelligently streamline and determine fair market value (FMV) rates, minimizing the risk of human error and ensuring compliance with regulatory requirements.
This approach enhances efficiency and fosters transparency and integrity in compensation practices, ensuring fair and compliant engagements with HCPs.
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Effectively Manage HCP Contracts
Utilizing a platform with integration for centralized storage of executed contracts is essential to manage all HCP contracts effectively.
Integration with the legal contract management system would allow seamless access to contract documentation, facilitating compliance with regulatory requirements.
Life sciences companies can also leverage automation to further streamline the contract management process and automate repetitive tasks such as contract creation, approval workflows, tracking, etc.
Additionally, creating a process that links the actual HCP engagement request with the appropriate contract would ensure alignment between the engagement activities and the contractual agreements in place.
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Document Proof of Performance
Compile comprehensive documentation of HCP activities and generate detailed performance reports. This would ensure transparency and allow compliance officers to monitor compliance while engaging HCPs.
Pro Tip: Compliance officers can conduct a final check to ensure compliance with regulatory requirements and internal policies, decreasing the risk of non-compliance.
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Appropriate & Timely Payments
Implement effective payment controls and integrate them with the accounts payable system to substantiate proper and timely payments to HCPs.
This step would ensure accuracy and efficiency in processing payments, reducing errors that generally cause delays in payment reimbursements.
Prioritizing robust payment controls upholds transparency and integrity in financial transactions with HCPs, fostering trust and compliance with regulatory authorities.
How Data-Driven HCP Engagement Triumphs Conventional HCP Engagements
| Conventional HCP Engagement | Data-Driven HCP Engagement |
| Defining clear and measurable business needs for HCP engagement can be challenging and result in potentially non-compliant engagements. | HCP Engagement solution can enable compliance, marketing, medical affairs, and other teams to collaborate on the business’s annual needs assessments for HCP engagement. |
| Manual analysis and debarment screening of HCPs from multiple databases and other systems involved in the engagement process can be complex, time-consuming, and prone to errors. | Automate the HCP engagement process, including debarment screening from FSMB, OIG, SAM, and FDA databases. Enhance accuracy, mitigate risks, and assure compliant HCP engagements. |
| Establishing fair compensation rates for HCPs can be subjective and vary across different specialties and locations. | Utilizing data to assess specialties and credentials can help in objectively establishing fair compensation rates for HCPs, ensuring consistency and compliance. |
| Managing multiple engagements and revisions with the same or different HCPs can be cumbersome and prone to errors, lacking proof of HCP performance. | Manage HCP Engagements in a single source that provides visibility into all the engagements to monitor changes such as FMV Rates, proof of performance, and compliance with Internal policies. |
| Documentation is in multiple places, with limited analytical capabilities that restrict the tracking of changes and get comprehensive visibility to assure adherence to the process. | Automate the entire engagement process into a single source, streamline documentation, and get complete analytical visibility to ensure the process is effective and efficient. |
Over to You
The stakes are higher than ever, with regulatory penalties surpassing $20 billion since 2000. By following the seven steps outlined in this blog, companies can ensure compliant HCP engagements and minimize the risk of regulatory fines, sanctions, and penalties.
From planning annual needs assessments to ensuring appropriate and timely payments, each step plays a critical role in upholding ethical conduct and regulatory compliance.
By embracing a data-driven approach to ensuring compliant engagement of HCPs, companies can overcome traditional challenges and compliantly achieve business objectives.
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