Medical device insurance: Why evidence matters for payer coverage decisions

At the 2019 MedTech Conference, Baker Tilly moderated a panel of medical directors to shed light on how coverage decisions are really made for medical devices. The discussion revealed what insurers look for when determining whether to provide medical device insurance coverage, and how companies can better align their evidence strategies with payer expectations.

Beyond FDA approval

One of the first misconceptions addressed was the belief that FDA approval guarantees insurance coverage. Panelists emphasized that approval only establishes a baseline of safety and efficacy. Payers demand more robust data, larger sample sizes and extended follow-up periods that demonstrate long-term patient outcomes. Without this additional evidence, medical device insurance is far from guaranteed.

Level one evidence: ideal but not always realistic

Randomized clinical trials remain the gold standard, but panelists acknowledged they are not always practical for medical devices. For instance, blinding patients in surgical procedures is rarely feasible. Well-designed level two studies, however, can still carry weight with insurers, provided they include large patient numbers and longer follow-up.

The value of real-world evidence

While clinical trials show that a device works in controlled environments, insurers increasingly look for real-world evidence. Data on reduced hospitalizations, fewer complications, and better functional outcomes demonstrate practical impact and help justify payer adoption. For many payers, this type of evidence is more persuasive than cost savings alone.

Economic arguments reframed

Panelists agreed that economic value must be communicated in clinical terms. Simply stating that a device saves a certain amount per patient may not resonate. Instead, translating the economic impact into patient-centered benefits, such as fewer readmissions or improved function, makes the value clearer to insurers and strengthens the case for coverage.