Medical implants and biologics are a critical part of modern healthcare, but the FDA approval process for these devices is flawed creating provider and payor policy coverage confusion. Many implants are approved through the 510(k) pathway, which allows new devices to be cleared based on similarity to existing products and real world evidence data, rather than requiring clinical trials to demonstrate safety and efficacy.
This presentation will provide an in-depth look at the issues with the current FDA approval framework for implantable devices. We will examine case studies of problematic implants that have led to patient complications, and discuss the lack of reliable evidence required for many products. Attendees will learn about the criteria for reliable evidence that health plans should utilize to create coverage policies.
The session will address considerations for payors to protect members and ensure appropriate care, highlighting the role of payment integrity teams in identifying and validating implant charges.
By the end of this session, attendees will have a comprehensive understanding of the systemic issues with medical implant and biologics regulation, and practical approaches their organizations can implement to ensure appropriate utilization.
Learning Objectives/Key Takeaways of the Session (max 50 words, 2-3 bullet points):
- Understand the disconnect between the real world evidence required by the FDA versus reliable evidence necessary for approval.
- Explore the role of payment integrity in identifying overpayment related to these issues.
- Develop strategies to enhance payer policies and review processes to mitigate risks and manage biologics and implant coverage effectively
Ellen Catania
Ellen is a registered nurse with extensive experience spanning clinical care and the health insurance industry, making her an expert in payment integrity and claims review. She has served as a clinical leader and consultant for payors and payment integrity companies. She excels in auditing high-value claims for third-party administrators and stop-loss carriers, while also providing clinical support to clients and addressing claim-related inquiries.
At MedReview, Ellen oversees the planning and development of Medicare and Medicaid hospital bill and DRG validation reviews and is also responsible for the oversight of the foreign and domestic nurse auditor teams conducting those reviews. An authority on Medicare and Medicaid policies, Ellen’s expertise also includes quality assurance oversight, peer review programs, and health plan contract interpretation.