Understanding Medical Device Reimbursement

The first step for a medical device’s access to any global market is for regulatory clearance. In the US, it typically comes through the 510(k) or PMA process. In the European Union, it’s a CE Mark. And there are many other flavors of market registration/clearance in other countries and regions around the world.

Once a product has its marketing clearance, its ability to actually get into use in a specific market and subsequently do well depends on many factors. One of the most important is how and if the product will be paid for through the reimbursement process. And if a product’s reimbursement pathway and strategy are not clearly established, then the chances for its success in any market will be poor. It is critically important that the process of establishing a product’s reimbursement pathway and strategy is started early in the product development lifecycle. This process should be finished, and its strategy should be well underway before the product receives its marketing clearance.

Addressing product reimbursement in just one country is very complex. For example, in the US, a medical device manufacturer must deal with CMS for Medicare and Medicaid coverage, the DoD and VHA for military-related coverage, and numerous private payers. With Medicaid, each of the 50 US states administer their own version of the program with their own set of rules and procedures. Doing the same for multiple countries and regions around the world adds a whole other level of complexity, with varying sets of rules, individual and bundled payment schemes, coding methods, stakeholders, and processes in each country/market. This multiple market approach of course adds a significant amount of cost and time to the product’s market access process. Medical device manufacturers need to factor this into their product development plans and can safely assume that initial cost and time assessments will need to be substantially increased.

The PICO Approach for Reimbursement Strategy

Medical device regulatory and reimbursement consultants often recommend taking the PICO approach when developing a pathway and strategy for a product’s reimbursement. This means having a strong understanding of the Patient, Population, and Problem (P); Intervention (I); Comparator (C); and Outcome (O) for the product and effectively communicating this information to all reimbursement-related stakeholders. Patient, Population, and Problem cover the group of patients that a product will be used on or with. This includes age, sex, race, and patient health conditions the product will be used for. Intervention is what the product is designed to do (e.g., monitor a physiologic parameter or deliver a specific therapy). Comparator explains what other technologies or methods the product will be compared to and/or is an alternative for. And finally, Outcome covers how the device performs (e.g., compared to traditional methods and/or products in the same or similar device category).

There is a tremendous amount of data, research, and analysis that needs to go into the PICO defining process for a product. This requires a clear understanding of how the product fits into and will impact the clinical workflow in each market it will be used in. In some markets, for example, the product may be a good fit and other markets may not be ready for it. Related to the product’s Outcome, stakeholders (e.g., reimbursement-related decisionmakers) will expect to see clinical evidence that clearly shows how the product performs against its claims and the products or methods the product hopes to replace.

As noted above, the medical device reimbursement-related process is complex. Some product types are paid for through bundled payments for the diagnosis related group (DRG) categories that they will be used for. However, the payment scheme may differ from market to market. Brand new product types will typically require new reimbursement codes and a greater level of clinical research rigor to show their value, especially compared to their alternatives. Because it is so complex, it is very difficult for medical device manufacturers to manage the reimbursement process on their own, especially for new companies and/or those planning to sell in multiple markets around the world.

Leveraging Expertise and Resources

Explore our Global Regulatory Intelligence Platform (GRIP) for a wealth of information on medical technology, including reimbursement-related resources. With expertise in medical device reimbursement, global regulations, and clinical trial development, we provide invaluable insights into the reimbursement process.

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Contact us for personalized online overviews, and let us assist you in navigating this critical aspect of your product development journey. Our medical device regulatory consulting services provide expert guidance on the complexities of clinical trial development and regulatory compliance, ensuring a smooth path to market success.