MEDICAL TECHNOLOGY
The Persona IQ product adds a sensor from Canary Medical into a stem extension on the implant, which is usually a “solid hunk of metal,” said Dr. Bill Hunter, a founder and CEO of Canary Medical. It made sense for Zimmer Biomet and Canary Medical to start with a smart knee, since the sensor and electronics are roughly the size of a AAA battery—and a knee is big enough to accommodate that without changing the implant’s size.
The sensor doesn’t have software that needs to be updated, according to Hunter. The implant is mainly collecting and transmitting the data, while data analysis takes place outside the implant.
The push to get sensors into implants also coincides with a growing interest in outfitting patients with connected devices that move more care and monitoring into the home.
The COVID-19 crisis spurred new efforts to keep care out of the hospital—replacing some office visits with video visits and enlisting remote patient-monitoring tools to alert care teams when patients are deteriorating. Health systems and companies in recent months have formed coalitions to lobby for “hospital-at-home” programs.
The Centers for Medicare and Medicaid Services had already aligned some incentives for monitoring patients after joint replacement procedures with the Comprehensive Care for Joint Replacement Model, a bundled payment model that covers a patient’s episode of care from admission to 90 days after discharge—creating an opportunity for technologies that developers say can help surgeons improve outcomes.
CMS in recent years has also released codes to bill for remote patient monitoring, paving the way for clinicians to spend more time with this data.
“That did open, much more widely, the opportunity for physician offices and clinicians to be paid for another vector (of care),” after performing the actual surgery, said Matt Miksic, an analyst at Credit Suisse who covers medical supplies and devices, citing an estimate that surgeons could get reimbursed $200 per month per knee patient with remote patient
monitoring codes.
“I think we’re definitely going to start to see that more,” said Dr. Yale Fillingham, an orthopedic surgeon at Philadelphiabased Rothman Orthopaedic Institute who specializes in hip and knee replacements, of smart implants. “There’s lots of future applications to (smart implants) that could help us identify problems … before they would clinically present themselves.”
WHAT’S THE VALUE PROPOSITION?
But for the smart implants market to take off, orthopedic devicemakers will have to pitch concrete benefits, showing that a sensor can really improve outcomes and cut costs by avoiding complications. Smart implants in orthopedics are “new territory,” Miksic said. The industry is still figuring out how the new market will play out.
“What’s the clinical and economic rationale?” Miksic said. “That’s the kind of equation I think that’s missing from where we are now.”
The cost of a total knee replacement varies, but the average cost in the U.S. is more than $37,000, according to an analysis of claims data from Guroo, a service of the Health Care Cost Institute. In addition to the procedure itself, there are costs associated with pre- and postoperative visits, as well as physical therapy after the surgery.
The procedure—a total knee
replacement—is the same regardless of whether a surgeon is implanting a smart implant or not, so would follow the same reimbursement pathway from insurers, according to Liane Teplitsky, president for global robotics and technology and data solutions at Zimmer Biomet. After the procedure, surgeons can bill the patient’s insurance for payment related to time they spend on remote patient monitoring using data from the sensor.
Teplitsky declined to share additional details on the cost of the Persona IQ product.
At Hospital for Special Surgery, Cushner and Sculco said they expect data management and telehealth appointments spurred by the smart implant to be handled like other patient visits that would take place after a procedure. A patient may be responsible for deductibles and copays for those services, depending on their insurance provider.
Ideally, a smart implant could lead to cost savings, according to Canary Medical’s Hunter, if the sensor is proven to help identify patients who are doing poorly and can flag patients at risk for having poor outcomes. If a surgeon can intervene and adjust treatment plans proactively, that could reduce costs for the full episode of care, he said.
A smart implant could also shift more care to the home, if patients who are recovering well can do virtual check-ins, while patients who need support visit the office, according to Teplitsky.
But that hasn’t been proven yet. Zimmer Biomet on a webpage warns that Persona IQ is designed to provide objective data—but that data isn’t intended to support clinical decisionmaking and hasn’t been shown to provide clinical benefit.
“I think that they’ve got a lot of great potential to help out patients,” Fillingham said. But, until they’ve demonstrated that, “is this going to add cost without additional value?”
If a smart implant is more expensive than a standard implant, it must create value that improves outcomes or drives down costs in other ways. As more smart implants hit the market, Fillingham said he’s interested in learning more about whether the products lead to earlier interventions for patients.
Orthopedic surgeons like to see longterm data on the products they use, said Chen at Brigham and Women’s Hospital. She said she’s excited about the potential for a smart implant like Zimmer Biomet’s that would provide objective data on a patient’s step count and range of motion— but isn’t ready to use it yet.
One of the implants she often uses with patients has been on the market for 15 years—the other has been available for 30 years, she said.
She would want to see more evidence of how the smart implant performs before using it with her patients.
“The downside about a new implant or product every time is we don’t know how it’s going to fare in the long run,” she said. “If I see a benefit, I’d be happy to use it— but I’m not at that point yet.” ■