Recap: Key Insights for Reimbursement Support Success

Gardner Law, in partnership with JDL Access, recently presented a CLE program titled "Reimbursement Support Essentials: Compliance Insights and Practical Solutions." This session provided comprehensive guidance on designing and managing compliant reimbursement support programs, highlighting best practices for navigating regulatory challenges while supporting patient access to new medical technologies.

You can watch the full program on-demand here.

Key Takeaways from the Program

Bridging the Gap Between Approval and Coverage

Kimberly Norton of JDL Access described the challenges faced by new technologies after FDA approval or clearance but before payer acceptance. Without established codes or policies, providers often hesitate to adopt these technologies. Reimbursement support programs, including hotlines, prior authorization, benefit verification, and appeals, are crucial in overcoming these barriers and building confidence among providers.

The Critical Role of Prior Authorizations

For emerging technologies, obtaining prior authorization is essential—even if payers initially deny coverage.

As Kimberly Norton, President of JDL Access, explained, “A written denial is the gateway to appealing decisions and pressuring payers toward positive medical policies.” She emphasized the importance of persistence and expertise in navigating this process, which is often beyond the capacity of provider offices.

Compliance Guardrails for Reimbursement Programs

Below are some practical strategies to mitigate legal risks:

• Ensure programs focus exclusively on the company's products and do not extend benefits to other services.
• Prohibit support for off-label uses to avoid off-label promotion concerns.
• Implement clear policies to prevent reimbursement programs from being considered “remunerations” for providers.
• Regularly audit reimbursement support programs to identify and correct potential compliance gaps.

Mark Gardner, Founder and Managing Partner of Gardner Law, cautioned, “Reimbursement support programs come with unique risks, from privacy concerns to potential inducement issues. Structuring your program with clear guardrails and auditing it regularly are essential to avoiding regulatory pitfalls.”

In-House vs. Third-Party Hubs

The pros and cons of building an in-house reimbursement support program versus partnering with third-party vendors was outlined:

• In-house programs may provide greater control and scalability but require significant resource, staffing, and compliance infrastructure investments.
• Third-party hubs offer expertise, faster implementation, and less administrative burden but could involve higher costs and less operational control.

Amanda Johnston, Partner at Gardner Law, noted, “The choice between in-house and third-party hubs depends on your organization’s resources and risk appetite. Each approach has pros and cons, but the goal should always be providing compliant and patient-focused support.”

Privacy and Patient Focus

Both in-house and third-party programs must prioritize robust privacy safeguards to protect patient health information (PHI). Ensuring compliance with HIPAA and other applicable laws, along with using secure data-sharing technologies, is vital to maintaining trust and mitigating risk.

Contact Gardner Law

Reimbursement support programs are indispensable for helping patients access innovative therapies, but they must be carefully structured to mitigate compliance risks. As industry best practices evolve and regulatory expectations change over time, ensuring your program remains aligned with current standards is critical. Whether building a program from the ground up or reviewing an existing one, expert guidance can help you navigate these complexities and adapt to emerging trends.

If you have questions about structuring or auditing your reimbursement support program, or if you’d like assistance navigating compliance challenges, reach out to Gardner Law.