Every payer has a somewhat unique technology review process to evaluate the clinical evidence as part of their coverage determination. Many other factors can influence a non-coverage decision, coverage with specific criteria, coverage without criteria, or whether a written policy is even needed.
Understanding the strengths and weaknesses of your clinical evidence in terms of US vs. outside the US studies, level of evidence, effectiveness, safety and durability are all major factors in determining potential existing gaps to coverage. Medical directors are more concerned with peer reviewed publications which are a key reference source. They are less concerned with marketing materials.
Impact of Coding
Does your technology have or need a procedural code from CMS or AMA? Could an unlisted code get you started? The type of code can directly impact your technology’s coverage status. Understanding and planning for this before your product launch is extremely valuable.
Impact of Financial Considerations
This is the most complicated and situational topic of the many varied ways in which either a provider or insurer manages their business. Medicare and many insurers are trying to move away from fee for service to value of the service. What is critical to understand is that low cost will not be a viable offset for any perceived clinical data weakness such as effectiveness, safety and durability.
Coverage Gap Analysis
Although you may believe your evidence is sufficient to achieve FDA success, there may be limitations to gaining coverage acceptance by payers based solely on the design of or data generated from your clinical trials. Uncovering, understanding and responding to existing coverage gaps can improve the probability of coverage success.
- What clinical utility does your technology provide?
- Does your technology improve the health outcome?
- Where does it fit into the continuum of care?
- Are competitors changing the continuum of care?
- Does your technology stop the need for further invasive and/or costly treatments or only delay the ultimate possibly more invasive and more costly solution?
Cost Effectiveness and Health Economic Outcomes (HEO)
Understanding how your technology can reduce the cost to both patients and providers is important and becoming more so as public pressure continues to increase. Cost advantages to payers in terms of reducing current expenditures, reducing the need for further expensive treatments and procedures, or reducing hospitalization days or emergency room treatments can all impact the cost effectiveness and value of your product.
Medical Director Communication, Messaging, and Best Practices
Payer Insights enables you to learn directly from the panel on how best to communicate with them. Payer Medical Directors have limited time or often no time to meet with companies to hear their “pitch” on their technology, their clinical data and coverage requests. Medical Directors may also work remotely. They may or may not have time to read information or take a phone call about your new product.
Payer Insights Focus Panels enable you to identify the potential coverage challenges of multiple payers, how to communicate effectively and ultimately how to position your product for a reasonable review.
Medical directors respond best to new coverage requests from their providers, but if the provider requests a new technology that has limited or weak clinical evidence, then the result could be a denial of coverage.