Proceedings from 12th Biennial Meeting of the International Andreas Gruentzig Society: Brazil – 2014
From SESSION 11 – Industry Roundtable
Moderator: Jeff Marshall, MD
Panelists: Sam Conaway, Matt Franklin, Lillian Garcia Palmer, Melissa Gindling, Paul Goodman, David Kallend, Richard Shaw, Jason Struck, Mike Vonesh
Framing the question at hand, what is the state of the current knowledge?
There are several interventional technologies developed over the last 10 years that have shown clinical efficacy that governments and payers have chosen not to reimburse or to reimburse at very low rates. Additionally, payers and government agencies have limited the patient population that can receive certain interventional treatment modalities and what seems to be random and not supported by the clinical data.
One example of this disconnect is the national coverage decision in the United States on carotid stenting. There are significant data demonstrating clinical equipoise between carotid stenting and carotid endarterectomy in several patient groups, yet reimbursement and indications for the procedure are dictated by the government and other payers. It is recognized that this disconnect is quite complex and that oftentimes devices are approved and then meaningful data are obtained later. In a world where physicians and other care providers and/or industry partners are increasingly mistrusted, it is difficult to see how the “physician/industry” team could affect changes dictated by payers without multiple professional societies, patient advocates and the political process to help intervene.
What are the Gaps in the current knowledge?
Several gaps in the knowledge base exist. The competitive nature of companies make it difficult to disseminate and reimburse small but meaningful technological advances. Only with good data will there be support of new or expensive devices and we should learn a lesson from the rigor of trial design, and data collection that large pharmaceutical companies utilize. There is some lack of codified guidelines that direct companies and inventors towards the data necessary to support reimbursement. Often times the rationale for" non-coverage" is vague.
Our Summary and Recommendations:
There have been examples where carefully constructed processes for interventional device approval have resulted in partnerships between different subspecialties and the payers. Structural heart disease treatments like TAVR are certainly a model to emulate. Early, proactive involvement of all stakeholders is beneficial in preventing approval/reimbursement mismatch. The variability in the approval process for devices creates many of these disconnects between the payers and the other stakeholders. The possibility of holding a forum that would bring stakeholders (CMS, FDA, industry, providers and patients) together where the processes could be standardized might be a first step in preventing this serious disconnect. The complex issues of off- label use of devices for rare diseases or clinical situations is even more complex but might also benefit from such a forum.