From the Clinic to Coverage: A Conversation with Shane Mull, M.D.

This article is part of the Rubrum Exchange series — conversations with Rubrum’s clinical and policy experts on the issues shaping healthcare today.

There’s a moment that arrives later than it should for many healthcare innovators: the realization that regulatory clearance and payer coverage are two separate processes. A device can earn FDA approval, secure a billing code and pricing, and still fail to reach a single patient, because reaching those milestones does not necessarily answer the questions payers are asking.

For this installment of Rubrum Exchange, we sat down with Shane Mull, M.D., M.H.A., F.A.A.F.P., C.P.C., who recently joined the firm as a principal consultant. Mull’s career spans clinical practice and work inside a Medicare Administrative Contractor (MAC), evaluating innovative products for local coverage across every stage and form they take. The result is a rare view of both the clinic and the coverage decision.

The Misunderstanding That Costs Innovators the Most

For most new technologies, the first realistic path to coverage and payment runs through fee-for-service Medicare—a landscape that operates differently from private payers, Medicaid, and even Medicare Advantage. And it’s a landscape many innovators enter with a costly assumption.

“A frequent misunderstanding is that FDA clearance or approval equals coverage, or having a code and pricing equals coverage,” Mull said. “You can have all those things and still not have coverage.”

Coverage in fee-for-service Medicare comes down to the “reasonable and necessary” standard—and pulling that standard apart leads to one place: clinical evidence.

“What you need is good clinical evidence to support your technology,” Mull said.

Understanding how MACs apply that standard, and building the evidence to meet it, is what separates products that get paid for from products that merely get cleared.

The Discipline That Keeps Companies on the Right Path

If strong clinical evidence is the destination, Mull argues that the pathway starts at founding. Most healthcare technologies begin with a real clinical problem: curing a disease, alleviating its symptoms. The patient comes first. The discipline, Mull says, is keeping it that way as the business grows.

“When you start to get the business aspect involved, you’re thinking about scalability and expanding the patient population, and you start to lose sight of what the real end goal was,” Mull said. “My biggest advice is keeping the patient in mind, always. The end results will come from that.”

That focus has a practical corollary: the physicians who use the technology every day. A tool that’s complicated or painful to integrate into clinical workflow won’t get used, however sound the science.

“A key to success is getting that physician buy-in,” Mull said. “Things will fall into place more easily after that.”

Rubrum Advising helps innovators navigate the path from clearance to coverage. To learn more about working with our team, drop us a line.