Six Reimbursement Tips For Medtech Manufacturers

Gaining FDA approval for your medical device may be the primary goal of most start-up medical device manufacturers, but any successful medtech company will tell you that’s only the first step. The next, and sometimes far greater, challenge is establishing reimbursement, either from CMS or private payers. If you’re a start-up medical device manufacturer, you might find reimbursement confusing, challenging, and altogether daunting. Thankfully, plenty of companies have blazed a trail for you, and left their followers tips and tricks to simplify the reimbursement process.

1. Start Early
Reimbursement can be a complicated and lengthy process, so it’s important to start early. You can begin the process while your product is in its design phase in order to ensure reimbursement is factored into the very nature of your product. Starting early will allow you to see how your product will fit into payment methodologies like bundled payments or diagnosis-related groups. This will help you form a long-term reimbursement strategy rather than scrambling to get documentation together once you’ve launched.

2. Problem First
Reimbursement depends on product adoption, which in turn depends on your product being practical. If you’re developing a solution in search of a problem, it will be harder to convince investors it’s valuable and harder to market to consumers, leaving your design dead in the water. Identify a specific clinical problem your design will solve and develop around that, rather than settling on a design and trying to force it onto a problem.

3. Make It Useful
Identifying a problem first should start you on the track to making a clinical useful product. Investors and payors alike are seeking products that are effective in actual practice, not in theory, so it’s important to bear that in mind in the development process. This is why so many medtech companies invest huge sums of money in reliable, reproducible trials with leading medical centers and highly-qualified practitioners. Ensure no one can doubt the credibility of your product.

4. Real-World Evidence
If you’ve designed your product around a problem and made sure it has clinical utility, it should be easier to have it adopted. However, you also need to prove adoption with real-world evidence. Also known by the acronym RWE, this is the catch-all term for provable, trackable data regarding the adoption of your product. Many payors now ask for real-world evidence to determine their coverage decisions. This might include:

• Insurance claims
• Medical records
• Patient registries
• Hospital charges
• Post-marketing surveillance

Jose van Bloop, a reimbursement expert at Essayroo and OXEssays, emphasizes that “developing a range of evidence is essential for a strong reimbursement proposal. Compile various studies from different sources, geographic areas and time frames so that you can prove the adoption of your product without a doubt.”

5. Think Like A Health Plan
At the end of the day, even though doctors, nurses, and patients will be the ones using your product, it’s the health plan’s medical director that will determine whether you are successfully reimbursed or not. They hold the cards when it comes to deciding what medtech products are adopted, so you should develop your proposal with them in mind.

“Think about what your product, evidence, and reimbursement prospects look like to a health plan,” says Ura Kunt, a medical writer at Paperfellows and Stateofwriting. “Consider what objections they might have, what delivery issues they might anticipate, and what individual biases they might be subject to. Marketing to your health plan and their director is a more reliable way to get your product reimbursed.”

6. Pilot Like A Pro
If you’re struggling with developing a reimbursement plan, try approaching payors early on for a pilot program. Running a pilot with specific providers in the area you hope to launch in could give you an indication of what could be improved with your product. Of course, a pilot isn’t always an easy decision: healthcare costs are higher than ever, and it will take strong reasoning and clear, focused objectives to get a pilot off the ground. Prepare for your product to be on a patient-pay basis until it’s proved successful enough to be selected for coverage.

The Takeaway: Prove Yourself
Throughout the product development and launch stages, the ongoing challenge is to prove yourself and your product. Always ask yourself if you can prove its effectiveness, and if you can’t, make changes to correct that.

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Katherine Rundell is a medical writer at Academic Writing Services and UK Writings services. She writes about medical care and product development.