In the pharmaceutical industry, maintaining compliance with the laws and regulations is paramount. The Anti-kickback (AKS) Law prohibits the exchange of any form of remuneration to induce or reward referrals of federal healthcare program business.
Violations can lead to severe penalties, including fines, imprisonment, and exclusion from federal healthcare programs. As such, pharmaceutical compliance professionals must ensure their contracting processes with healthcare professionals (HCPs) are not only efficient but also compliant. Here are a few strategies to improve these processes and ensure AKS compliance.
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1. Implement Comprehensive Compliance Training
The first step towards ensuring compliance is to provide comprehensive training to all stakeholders involved in the contracting process. This includes not only the compliance team but also sales, marketing, and other teams that interact with HCPs.
The training should cover the basics of the AKS, the importance of compliance, the potential consequences of violations, and the specific procedures to follow when contracting with HCPs. Regular refresher courses and updates on any changes in the law or company policy should also be part of the training program.
2. Develop Clear and Detailed Contracting Policies
Having clear, detailed, and well-documented contracting policies is crucial to prevent any ambiguity that could lead to violations. These policies should outline the process for selecting HCPs, the types of permissible remuneration, the approval process for contracts, and the documentation required.
They should also include specific guidelines for high-risk areas, such as speaker programs and consulting agreements. Regular audits should be conducted to ensure adherence to these policies.
3. Conduct Annual Needs Assessments
An annual needs assessment is a proactive way to identify the services required from HCPs and align them with the company’s strategic objectives. This assessment should consider the company’s current and future product portfolio, market dynamics, and regulatory environment.
It provides a clear rationale for engaging with HCPs and helps to ensure that contracts are based on legitimate needs rather than potential referrals. The results of the needs assessment should be documented and used as a basis for the contracting process.
4. Implement Rigorous Background Checks
Background checks are an essential part of the contracting process. They help to ensure that the HCPs the company engages with are reputable, qualified, and do not pose a risk of AKS violations. The checks should verify the HCP’s qualifications, professional standing, and any potential conflicts of interest.
They should also include a review of the HCP’s previous interactions with the pharmaceutical industry and any history of compliance issues. The results of the background checks should be documented and considered in the decision to contract with the HCP.
5. Establish Fair Market Value (FMV) for Services
The AKS stipulates that remuneration must not exceed the fair market value of the services provided. Therefore, it is crucial to establish a robust process for determining FMV. This could involve using external benchmarks, conducting surveys, or hiring independent valuation experts. The FMV should be clearly documented in the contract, and any deviations should be justified and approved by the compliance team.
6. Require Proof of Performance Prior to Payment
To ensure that payments are not seen as inducements for referrals, it is important to require proof of performance prior to payment. This means that the HCP must provide evidence that they have fulfilled their contractual obligations before they receive payment. This could include reports, presentations, or other deliverables, depending on the nature of the contract. The proof of performance should be reviewed and approved by the compliance team before payment is made.
7. Implement Robust Monitoring and Auditing Systems
Even with the best policies and procedures, there is always a risk of non-compliance. Therefore, it is crucial to have robust monitoring and auditing systems in place. These systems should track all interactions with HCPs, including contracts, payments, and other forms of remuneration.
Any anomalies or potential violations should be flagged for further investigation. Regular audits should also be conducted to verify compliance and identify any areas for improvement.
Conclusion
Ensuring compliance with the Anti-Kickback Statute is a complex but essential task for pharmaceutical compliance professionals. By conducting annual needs assessments, implementing rigorous background checks, establishing fair market value, requiring proof of performance, and implementing robust monitoring systems, companies can significantly improve their contracting processes with healthcare professionals and reduce the risk of violations.
These strategies not only protect the company from legal and financial penalties but also help to maintain its reputation and trust with patients, healthcare providers, and the public.
