Here’s the latest entrant in the Internet of Things in healthcare market

The Breg Flex sensor device and mobile app for remote virtual rehabilitation

Physical therapy is a big part of orthopedic care, and as the era of bundled payments take hold, albeit with a pause here and there, virtual rehab is poised to take off.

Traditional widget makers are sensing an opportunity in this trend. Take Breg, the sports medicine manufacturer and distributor based in Carlsbad, California.

At the recently-concluded annual meeting of the American Academy of Orthpaedic Surgeons (AAOS), Breg executives were showing off a new sensor-device connected to a mobile app that can guide patients through their daily exercise routine following orthopedic surgery.

This is the first time the company has forayed into the digital health, Internet of Things space, confirmed Brad Lee, president and CEO, in a booth interview last week where demos of the Breg Flex system were being presented. Lee said the impetus for the product dates back seven years ago when the company underwent a strategic shift.

“Rather than focusing on the widgets we provide to an orthopedic caregiver, [we wanted to] focus on managing the pain points in their world in the orthopedic episode,” Lee said.

As providers are moving to a value-based system in healthcare, accelerated by alternative payment models especially in joint replacement, hospitals have scrambled to understand where you can take costs out. Everyone has landed squarely on post-acute care — once the joint replacement procedure is complete. One item on the cost chopping block is physical therapy.

“We are actively moving toward online physical therapy programs and our goal is to eliminate physical therapy for hips, only use in knees when we need it …,” said Richard Iorio, a hip and knee surgeon at NYU Langone Medical Center, at a panel discussion on orthopedic bundled payments last week at AAOS.

And that’s exactly where Breg’s Flex system fits in.

“This product Flex was developed for the post-surgical rehabilitation segment of the episode.”

Here’s what the product incorporates: A chargeable Bluetooth wireless sensor, worn by patients to track progress with prescribed PT exercises with a companion mobile app.

The sensor and app work in concert to record range-of-motion that is key to better clinical outcomes. The data is also shared in real time with providers such that clinicians can tweak exercise protocols. The interactive patient app has a virtual avatar that guides patients through exercises. The system can also collect patient-reported outcomes that are key to getting reimbursed for certain orthopedic procedures such as joint replacement under bundled care programs.

Lee explained that Breg Flex also works with the electronic medical record of a practice or a hospital.

“The entire recording of the rehabilitation episode is now documented in the patient’s history seamlessly,” he added.

Breg Flex is FDA-exempt because it simply monitors and tracks and does not offer clinical decision support.

In that context, the device is different from other virtual rehab programs on the market such as Reflexion Health’s Vera virtual rehab program. The San Diego-based company uses the Microsoft Kinect gaming console and the Vera avatar to guide patients through their at-home exercise regimen. The system received FDA clearance in 2015.

But like Breg, other companies also seem to feel that FDA clearance to use a digital product for remote physical therapy is not needed. Zimmer-Biomet, the Indiana company that holds the largest market share in hip and knee replacements acquired the RespondWell virtual rehab program that is also not FDA-cleared.

Aside from regulatory clearance that distinguishes companies in the field, another characteristic serves as a point of distinction. Companies like Jintronics and Reflexion Health use the Kinect platform thereby tying joint replacement patients to a console or a TV to do their daily rehab. All Breg Flex needs is a cell phone, or tablet and a sensor-device.

“We are measuring range of motion in the rehab process with a high degree of accuracy in a remote location that doesn’t require to be tethered to any other technology except the sensors on your knee and a phone, which is not a huge burden,” Lee said.

In other words, patients can be out and about, and still get their rehab done.

While that may be a distinguishing factor, the virtual rehab space is getting crowded with several companies vying to win. But Breg’s CEO shrugged it off.

“There is a huge market and there will be a lot of good players in the space,” he said.

Photo: Breg Inc.

The biggest takeaway from the annual meeting of orthopedic surgeons (AAOS)

If you walked through the sprawling exhibit floor of the San Diego Convention Center last week, you would have noticed products galore. Mannequins being pretend treated on hospital beds, and all kinds of medical devices being touted for surgeons and other buyers.

And yet the annual meeting of the American Academy of Orthopaedic Surgeons was less about rods and screws and the latest techniques in surgery, and more about bundled care and the shift from volume to value. And this despite the fact that the Trump administration appointees are putting a temporary pause on programs that expand or implement bundled care.

This is an important shift given that device vendors in the past would dazzle surgeons with the latest technologies as physician preference and large egos would rule hospital purchasing decisions. All of it without a thought placed on how much those shiny objects cost.

And now the pendulum has swung to where device manufacturers are casting themselves as partners to help solve hospital’s problems.

Take Johnson & Johnson’s DePuy Synthes for instance.

“We have more than 25 people in supply chain that goes to the hospital and help hospital management looking at end-to-end supply chain to look for opportunities for efficiencies and in inventory management,” declared Juan-Jose Gonzalez, president of DePuy Synthes, in an interview at AAOS in an enclosed area of its exhibit. “And outside you will see the Johnson & Johnson Care Advantage that are looking at supporting patients before a procedure, during a procedure, and in the recovery phase.

Care Advantage is J&J’s services business and this year at AAOS, all the major orthopedics players were eager to flex their services muscle.

In fact, even when Stryker launched its total knee on the reportedly million-dollar Mako surgical robot — that a Zimmer-Biomet executive dismissed as a “showbot” without directly naming it — the Kalamazoo, Michigan company was stressing the economic evidence and value to surgeons rather than a feat of engineering.

Here’s Stuart Simpson, vice president and general manager, Stryker, explaining how doing a partial knee replacement using the Mako robot has proved value, in a phone interview last week.

“We have seen the 30-day complication rate reduced by 36 percent with Mako versus nonMako. And we have seen the cost of complications and readmissions for Mako cases 66% lower than nonMako cases in the 90-day period,” he said. “And that’s even accounting for the additional cost of using Mako.”

The hope is the economic value will extend to the robotic use of total knee replacements as well.

Plus, just as J&J DePuy Synthes has its Care Advantage services platform and its own strategy to gain market share, Stryker has its Performance Solutions business aimed at improving hospital and OR efficiency, among other things.

Not to be outdone, the biggest hip and knee company by market share — Warsaw, Indiana-based Zimmer-Biomet — has also tweaked its consulting business to highlight its services chops. It’s called Signature Solutions. At AAOS, the company’s exhibit contained an impressive circular zone that showed off how the company is leveraging both new technology and partnerships to stay with the patient and the hospital from before a joint replacement or orthopedic procedure all the way to recovery at home.

Patient engagement is part of the new focus at Zimmer-Biomet’s services business. The company has partnered with a firm called HealthLoop for better supporting patients who have to deal with information overload as they get ready for a joint replacement

“What HealthLoop does is really two key components – no. 1, it helps to break down that information so the patient gets messages before the stay and then also afterwards. So their care plan is sent to their phone, tablet or computer,” explained Joe Tomaro who leads the go-to-market strategy of the Signature Solutions business, in a booth interview at AAOS. “The other part that Health Loop does is that it collects patient-related outcomes information as well as information post-surgery as to the number of physical therapy visits, home care visits, when did home care start – all of which is real important to estimate how much [the procedure] costs and all of that information you don’t get from the payer until six months later.”

The latter becomes exceedingly important in the Comprehensive Care for Joint Replacement Program which reimburses hospitals for collecting patient-reported outcomes. Zimmer-Biomet has also acquired a virtual rehab company called RespondWell to help joint replacement patients perform their daily physical therapy at home, thus reducing the need to go to a physical therapist.

Meanwhile, all this focus on services and value-based care by all the major players have not gone unnoticed by surgeons at AAOS.

“If you go out to the floor right now in Technical Exhibits, the big booths within all the large total joint companies — Zimmer, DePuy, Smith & Nephew — are all taken up with their programs to manage the bundles because they have now seen that managing the bundle is really important,” declared Thomas Barber, an orthopedic surgeon with Kaiser Permanente and chair of AAOS’ Council on Advocacy

And that’s a sea from just being focused on titanium and steel implants and products.

Photo: Gregory Kramer, Getty Images

CMS pushes back CJR expansion, cardiac bundled payment initiatives by 3 months

With the Trump administration in office, it comes as no surprise that the Centers for Medicare and Medicaid Services have delayed a number of bundled payment initiatives.

In an interim rule posted in the Federal Register, CMS delayed the expansion of the Comprehensive Care for Joint Replacement Model as well as the implementation of cardiac bundled payment initiatives from July 1, 2017 to October 1, 2017. Additionally, the rule pushes back the effective date of the Cardiac Rehabilitation Incentive Payment Model from July 1 to October 1.

The interim rule does one other thing: For the second time, it delays the effective date of a final rule that outlines the implementation of CJR and other bundled payment initiatives. In February, the effective date was delayed from February 18 to March 21. Now the effective date has been pushed back from March 21 to May 20.


The interim rule states,

This interim final rule with comment period (IFC) further delays the effective date of the final rule entitled “Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model” published in the January 3, 2017 Federal Register(82 FR 180) from March 21, 2017 until May 20, 2017. This IFC also delays the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to October 1, 2017 and effective date of the specific CJR regulations itemized in the DATES section from July 1, 2017 to October 1, 2017.

CMS added that it may consider pushing back CJR expansion and the implementation of cardiac bundled payments until next year. “We seek comment on the appropriateness of this delay, as well as a further applicability date delay until January 1, 2018,” the interim rule says. The comment period on the rule is open until April 19.

For avid followers of healthcare policy, the delays are far from shocking. “I’m not surprised at all,” said naviHealth COO Carter Paine in a phone interview. “From a timing perspective, with Secretary Price only holding his seat for a couple weeks and Seema Verma getting confirmed last week, the prudent thing for them is to dig into these issues. I’m not surprised they’re delaying it and going through the implications.”

Tom Price, the newly minted secretary of the Department of Health and Human Services, has expressed his vehement opposition to bundled payment initiatives. In a letter to CMS last fall, he claimed that through such mandatory initiatives, the Center for Medicare and Medicaid Innovation was “experimenting with Americans’ health.”

Though the comment period on the interim final rule remains open for another month, observers have already started to take guesses on what will happen next. “The mandatory side of the bundles is, we think, probably unlikely,” said Paine. “We think the voluntary bundles will continue on, and we’ll see an advanced BCPI program come through in the next few months.” Paine noted that moving forward with the BCPI program and keeping bundled payments voluntary are Republican ideas that are likely to occur with Secretary Price and and CMS Administrator Seema Verma in office.

“I think you’ll continue to see private insurers seek ways to create better value for patients,” Paine added. “It’s a no-brainer when you see some of the results with our providers participating in the BCPI program.”

For right now, the future remains uncertain. But given what we know of the new administration, a push for mandatory bundled payments seems improbable.

Photo: atibodyphoto/ Getty Images

Editor’s note: This article previously included the word “payers” instead of “providers” in Paine’s last quote.

Surgeons wary of ortho bundles delay and deny procedures

The annual meeting of the American Academy of Orthopaedic Surgeon kicks off Tuesday and in advance of it, a new analyst report shows that when it comes to bundled care, surgeons are being cautious to do joint replacement procedures.

The Comprehensive Care for Joint Replacement (CJR) rolled out to several areas nationwide last April, in a bid to control costs related to hip and knee replacement. Through this, Medicare gives hospitals a lump sum amount for a 90-day period involving each patient’s procedure. If the cost of the procedure and associated care is below that amount, hospitals come out on top. If not, hospitals have to stomach the extra expenditure and repay Medicare although that is not required in the first year of the five-year-program.

“There will be no responsibility to repay Medicare in Performance Year 1,” the report confirmed. “However, responsibility will be capped at 5% of target prices in Performance Year 2, 10% in Year 3, and 20% in Years 4 and 5.”

The goal is to pay for good outcomes. At the 2016 annual meeting of the AAOS, there were worries about how there might be reticence among physicians to treat certain kinds of patients.

And a report from Brandon Henry, an analyst with RBC Capital Markets who surveyed surgeons ahead of the AAOS meeting found that surgeons are denying or delaying the procedure on average to 14 percent more of their hip/knee patients. Of the 51 surgeons surveyed, 56 percent, a majority, said they are part of the CJR program.

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So who are these patients that are being denied the procedure or being asked to delay it?

Surgeons answered in a variety of ways, but there’s a clear indication of who surgeons feel are high-risk patients who are likely to have poor outcomes after the procedure: They are those who are morbidly obese, heavy smokers, with poorly controlled diabetes.

Aside from these, patients who have multiple comorbidities, as well as those surgeons deem to be at a higher risk of infection are also being denied.

Meanwhile, paradoxically, Henry noted that even though the trend to deny or delay is present, he has not noticed it reflected in lower volume of hip/knee procedures. Indeed, surgeons say there is interest in clearing a backlog in the next six to 12 months.

The CJR program is not the first bundled payment program that the ortho industry has seen although it is not a voluntary program given that it is in effect in 67 metropolitan statistical areas. Its previous version, Bundled Payments for Care Improvement (BPCI) was optional.

Photo: BrynDonaldson, Getty Images