WASHINGTON, DC – Getting insurers to reimburse for novel ophthalmic devices and procedures has been getting harder, but by planning early, involving the right employees, and having a defined path to reimbursement, companies can still achieve success. This was the advice given by panelists at OIS@ASCRS 2018. Here are seven takeaways from the session on reimbursement.
1. Determine If Your Innovation Is Medical or Elective
In the process of defining a reimbursement pathway, it’s critical to determine if your offering is for a medical condition or an elective or cosmetic procedure, said Raj Rajpal, MD, chief medical officer at Avedro. “If it’s truly for a medical condition, then certainly patients are going to demand that it’s ultimately covered, and carriers will follow suit,” he said. Carriers will jump quicker if you can justify the expense – for example, how his company’s corneal cross-linking procedure could reduce rates of corneal transplants for keratoconus patients. If the product is truly elective, determine if it will stay that way or change over time.
2. Start Strategizing Reimbursement Early On
Both larger companies and smaller start-ups are beginning to think more critically about reimbursement and how to do it right, said Allison Shuren, an attorney and partner with Arnold & Porter. “In my mind, that means the earlier the better,” she said. “I’ve had companies call me during animal studies thinking of what the pathway looks like for their device.”
3. Have Regulatory, R&D Talk
In addition, Shuren said, get the “right people on the bus” in your path toward reimbursement. As companies grow, sometimes the regulatory work becomes siloed from research and development, posing a potential disadvantage for the company; sometimes what is in the product’s pivotal studies and data collection matters when determining reimbursement. As the field moves more toward risk-based contracting, payers and patients will be looking for added value in return for paying a premium for products. Companies also need to think beyond how to get paid to how to deliver their technology and how it’s going to be used with patients and across the continuum of providers in this space, she said.
4. Choose the Right Category
Greg Kunst, senior director of global market access and business development for Glaukos, echoed the advice to plan early, relating a tale of woe about a wound-healing company that tried to position a disposable negative pressure home device under the durable medical equipment category and faced problems for years seeking reimbursement until Congress created a new category in which the device fit. Sometimes small engineering changes or repositioning can go a long way toward reimbursement, he said.
5. Understand What Payers Are Looking For
Payers look at technologies and services through a different prism, said Kuo Tong, managing director of Navigant Consulting. Understanding exactly what payers will require in terms of outcomes and evidence ultimately should determine your business model, as should knowing what options are available regarding reimbursement.
6. Sweat the Evidence; the Code Will Follow
“The fundamental thing most innovators and entrepreneurs fail to really try and understand is what is the type and level of evidence and types of outcomes that payers want to see,” Tong said. By defining your end zone, you can decide what to pursue, such as how many iterations of your product to manufacture or whether there should be a consumer-pay piece, and commercialize it in a way that spends your working capital wisely. “Many companies think, ‘I will build it and the payers will come,’” he said. “Those are the ones that often face really challenging circumstances. Putting lipstick on the pig doesn’t make it look any better.” Everyone tells early stage entrepreneurs to get a code, Tong said, but there are times when a technology or service is a brand-new category. “It’s not about the code; it’s about having the right studies and right evidence,” he said. “The codes will come.”
7. Get Ready to Play Whac-A-Mole
Other companies view reimbursement as a binary event, Kunst said: Get the code, the reimbursement, and you’re done. In truth, “reimbursement is a little bit of a game of Whac-A-Mole. You knock one problem down, another one pops up,” he said. Often after getting reimbursement, utilization rises, and in response payers tighten their purse strings and utilization declines. It’s a “constant battle,” Kunst said. “You’ve got to keep fighting as you go.”
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