Navigating Reimbursement Support Compliance in Med Tech
Reimbursement support programs are essential for helping patients access innovative medical technologies, but they also operate at the intersection of some of the most consequential regulatory frameworks in healthcare: the Anti-Kickback Statute, False Claims Act, HIPAA, and FDA promotional regulations.
Gardner Law and JDL Access recently hosted a webinar addressing how companies can structure these programs to facilitate patient access while maintaining rigorous compliance standards.
Key topics covered:
The regulatory rationale for maintaining strict separation between commercial and reimbursement functions
Evaluating in-house versus third-party program models, including oversight and infrastructure considerations
Operational safeguards for PHI protection, particularly with remote workforces
Defining appropriate boundaries for sales team involvement in reimbursement discussions
Determining when market conditions warrant scaling back or concluding support programs
A core principle from the discussion: These programs exist to support patient access to therapy, not to serve as a sales tool. When that distinction becomes unclear, compliance risk increases substantially.
The session also addresses practical questions around nurse navigator involvement, program duration, and how to distinguish legitimate support from conduct that could be characterized as inducement.
Recommended for reimbursement professionals, compliance officers, commercial leaders, and legal counsel supporting med tech organizations.