This Q&A session, with an active Regional Medical Director involved in traditional health plan policy and payment development, as well as emerging value-based models, reveals important information and attitudes toward coverage of new/existing technologies and standards of evidence.
Billing in clinical trials has changed recently, so here is a summary of where it has been and where it is heading.
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?
Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.
The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?
Reimbursement strategy can no longer be overlooked when planning the regulatory and clinical strategy for a product, particularly if it is a 510(k) product.
Presenting clinical evidence to payers is the most efficient method of gaining coverage. But when this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology.
Ever since the advent of laparoscopic surgery some 25 years ago, payers have become wary of minimally invasive surgery. What should device manufacturers do?
No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.