Event Recap: Guardrails that Work

Medical products companies increasingly rely on patient support and reimbursement assistance to help patients access innovative therapies and devices. At the same time, enforcement risk remains significant where reimbursement activities overlap with kickback and false claims laws, FDA requirements, and privacy obligations.

On January 22, Gardner Law partnered with JDL Access’ CEO Kim Norton to present Guardrails that Work: Practical Reimbursement Rules for the Field, a detailed discussion focused on how life sciences companies design and operate compliant reimbursement support programs that are operationally effective and legally defensible.

The program featured Mark Gardner, Managing Partner at Gardner Law and co-founder of JDL Access, Amanda Johnston, Partner at Gardner Law, and Kim Norton, Chief Executive Officer of JDL Access.

Why Reimbursement Support Creates Legal Risk

The speakers began by examining why reimbursement support is a legally sensitive activity. While these programs are widely recognized, e.g., by AdvaMed, as a legitimate means of helping patients navigate coverage challenges, they frequently implicate multiple legal frameworks when not carefully structured.

The discussion highlighted the key areas of law that shape reimbursement support activities, including the Anti-Kickback Statute, the False Claims Act, FDA promotional requirements, and HIPAA and state privacy laws. Presenters emphasized that reimbursement support programs must be designed to support patient access rather than function as a sales or marketing tool. The overarching goal of such support is to expand patient access to care.

Operational Guardrails for the Field

A central focus of the program was how compliance expectations translate into day-to-day field execution. Speakers emphasized the importance of clearly separating sales and reimbursement functions to reduce enforcement risk and avoid the appearance that reimbursement support is being used to drive purchasing or utilization decisions.

The panel discussed practical guardrails, including:

• How to compliantly structure reimbursement support programs
• Documenting and enforcing clear roles and responsibilities for sales teams, reimbursement specialists, and third-party vendors
• Establishing standardized and well-documented handoff processes between sales and reimbursement functions
• Limiting and monitoring sales involvement in coding, coverage determinations, and payer communications
• Implementing technology and data controls to protect patient information and support compliance oversight and audit readiness
• How to avoid legal challenges and other problems with reimbursement support programs

The presenters also reviewed common missteps observed in enforcement actions and internal audits, such as, (1) informal reimbursement guidance provided by sales representatives, (2) undocumented payer interactions, and (3) insufficient oversight of reimbursement vendors.

Legal and Operational Perspectives

The program combined legal and operational viewpoints to illustrate how compliant reimbursement support programs operate in practice. Gardner Law attorneys Gardner and Johnston addressed how enforcement agencies evaluate reimbursement support activities, while JDL Access provided insight into how patient access programs are implemented in complex payer environments.

Key Takeaways

The discussion underscored that reimbursement support programs can meaningfully expand patient access, but only when they are designed and executed with clear compliance guardrails.

Several consistent themes emerged from the program:

• Reimbursement support should be structured to facilitate patient access and not to induce sales.
• These programs implicate the Anti-Kickback Statute, the False Claims Act, FDA rules, and privacy laws, requiring coordinated legal and operational oversight.
• Clear separation between sales and reimbursement functions is a foundational compliance expectation and a frequent focus of enforcement scrutiny.
• Sales teams should connect providers to reimbursement resources but should not participate in coding, coverage determinations, documentation, or payer communications.
• Consistent documentation, defined handoff processes, and disciplined escalation pathways reduce audit and enforcement risk.
• Technology architecture and data segregation play an important role in protecting patient information and supporting compliant program execution.
• Both in-house and third-party reimbursement support models can be compliant when supported by clear policies, ongoing training, and regular monitoring and annual auditing.

Thoughtful program design, clear role definition, and disciplined execution allow companies to support patient access while maintaining defensible compliance positions. As reimbursement pathways continue to evolve, manufacturers should periodically reassess their reimbursement support programs to ensure continued alignment with legal and regulatory expectations.

How We Can Help

Gardner Law advises medical products companies on the design, implementation, and auditing of reimbursement and patient support programs. Our team provides integrated FDA, fraud and abuse, and privacy guidance to help organizations build field-ready support models with defensible compliance guardrails. We routinely assist with program structuring, vendor oversight, policy development, training, and risk assessments. If you are evaluating or updating a reimbursement support program, we would be glad to discuss practical compliance strategies tailored to your organization.