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.
MedReview
Website: https://www.medreview.us/
MedReview sets itself apart with over 50 years of experience delivering physician-approved pre-pay and post-pay payment integrity services that prioritize billing and payment quality, accuracy, and precision. Every claim reassigned by MedReview is reviewed, approved, and documented by a team of physicians, resulting in the industry’s lowest appeal overturn rate.
Utilizing proprietary technology combined with extensive subject matter clinical and administrative expertise, we achieve a 40% or greater reassignment rate focused on our clients’ specific needs. MedReview provides the full spectrum of payment integrity solutions including DRG and clinical reviews, cost outlier audits, re-admission reviews, data mining and itemized bill reviews.
Partnered with clients across the country, MedReview offers a flexible approach, supporting both complete outsourcing and supplemental enhancements to existing programs. By optimizing recoveries, preventing overpayments, and improving the provider experience, MedReview empowers payors to navigate the complexities of payment integrity with confidence and measurable success.
