ICYMI: Smart Ortho Implants’ Moment to Shine

Companies operating in remote patient monitoring (RPM) have always faced two major challenges: one, reimbursement, or how otherwise to get paid for enabling superior medical care; and two, changing the practice of medicine, which evolves at a notoriously slow pace.

But because of the COVID-19 pandemic, those challenges are becoming less daunting.The CMS, which had already begun to recognize RPM as a valuable service with new CPT codes that went into effect in late 2019 aggressively loosened restrictions in mid-March so that more patients could be served during the COVID-19 emergency. 

In early April, a survey conducted by Xtelligent Healthcare found that 90% of physicians had adopted some form of telehealth, with 60% claiming that they would continue to practice it after the emergency. For once, the incentives for payors, providers, and patients are aligned, the latter group now having to consider the infection risk of going to a medical facility for a follow-up visit.

These pandemic-wrought changes bring the developers of smart orthopedic implants much closer to the realization of their market potential. These are sensors used with or incorporated into joint reconstruction implants to give surgeons objective information in situations where today they are forced to use their best guess.

These sensors, used with or incorporated into joint reconstruction implants to give surgeons objective data and relay it into information platforms, can immediately address two areas in orthopedic surgery that today are potential sources of variability and compromised outcomes: how the implant fits the patient (a goal for which OrthoSensor Inc., for example, created its line of Verasense intraoperative sensors) and what the patient does after the surgery

In the future, the information from sensors could help the orthopedics specialty develop specific, evidence-based indications for total joint replacement and standardized metrics for follow-up, both still open to interpretation.

It’s clear how these sensors could help improve care. With new sources of more accurate and reliable information from the patient, surgeons can track a patient’s recovery after surgery and potentially intervene when problems are flagged to keep patients out of the hospital. Furthermore, in the process, surgeons will be building bodies of data from which to draw future conclusions about what works and what doesn’t for particular kinds of patients, bringing evidence-based medicine to the orthopedic specialty.

Start-ups and other innovators have proven that they can build the technology to do this job. However, reimbursement is complicated in this space, and the new remote patient monitoring reimbursement codes only assure that doctors get paid for using the information devices provide, although that does provide a mechanism whereby companies could charge a monthly fee for access to their data and still leave a profit margin for clinicians.

Device companies are still struggling with the models that recognize the value of their innovative devices. Bundling them in with the cost of the orthopedic implant itself isn’t really feasible, with hospitals pushing implant prices ever lower. Noted one CEO of an orthopedic sensor company “It can be difficult to justify a $500 sensor when the hospital has already asked for a $500 reduction in the cost of the implant.”

One company has already run up against the challenges of getting a new reimbursement code that rewards its innovation.Consensus Orthopedics Inc. was the first to seek a new code for its wearable device, the TracPatch, which is applied before total knee arthroplasty to measure range of motion, activity levels, and temperature (an indicator of potential infection) and, paired by Bluetooth to a smartphone, also allows the patient to record pain levels and other key metrics.

Although many surgeon users gave positive testimonials as to the value of TracPatch during the CMS hearing, the company’s application for a new HCPCS code was turned down in November 2019, for several stated reasons, one being the fact that it’s a wearable, not an implant, and another, an insufficient level of data quantifying its benefits. The company will appeal and, competitors have noted, will likely succeed in time, but it’s an example of one of the challenges that developers face here.

A number of companies, including Canary Medical Inc., in total knee replacement, and Intelligent Implants Ltd., in spine surgery, are betting that embedding sensors in implants takes the burden of information gathering off of patients and increases the odds that they’ll be used in ways that meet the requirements for reimbursement (i.e. continuous monitoring that’s not disrupted by patient non-compliance). Intelligent Implants is further unique in also offering bone-healing electrical stimulation through its implant.

In addition to the tailwinds created by the pandemic, these companies are benefiting from other new payment models that could potentially recognize their value and help them command the pricing they seek. First, there are bundled payment models that embrace 90-day episodes of care, like the Comprehensive Care for Joint Replacement Model offered by CMS for Medicare patients. These reward providers for achieving better outcomes at a lower cost. Other trends favoring adoption of these new data-gathering sensors include implant pricing pressure and the move to lower-cost care settings like ambulatory surgery centers, the incorporation of patient reported outcomes into FDA regulatory pathways and clinical trials, and the rise of risk-sharingagreements.

Excerpted from Smart Orthopedic Implants’ Moment to Shine, MedTech Strategist, July 8, 2020.

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