Here’s how telehealth tools help hearing health professionals improve patient care

New technology is constantly being developed to improve our ability to diagnose, treat, and care for a variety of medical conditions. One up-and-coming technology trend is telehealth. Some of the telehealth tools that we have already seen include services that enable video conferencing between doctors and patients, and apps that assist in patient care. In the field of hearing care, such tools also improve healthcare delivery for both patients and service providers.

TeleHealth tools save time for professionals and patients

It is common practice in hearing care to bundle the cost of consultations and service provision into the price of the hearing aid.  As such, follow-up and fine-tuning appointments after hearing aid sales are often free of charge. Dedicated telehealth tools like texting apps offer a secure platform for patients and hearing care professionals (HCPs) to easily communicate and problem-solve in a few minutes without an office visit.  Hearing telehealth apps can even allow HCPs to remotely adjust the hearing aids’ settings.  This is convenient for the patient, but also saves the HCP valuable appointment time.

Telehealth apps can also contain simple instructional videos, FAQs, and troubleshooting guides so that patients have the information readily available to them on their smartphone. This way, they can often easily solve their problems before contacting the HCP and feel empowered with greater confidence in their new hearing experience.

Telehealth apps help hearing care professionals widen their reach

Telehealth apps can bring patients and HCPs closer than ever before.  With a reduced number of necessary in-office appointments eliminated by in-app messaging and calls, and remote hearing aid tuning features, HCPs can attract patients who live physically farther away, and are therefore less inclined to make repeated trips to the office. Similarly, they can provide services to less mobile patients who may be house-bound or live in care facilities.

Telehealth enables patient satisfaction monitoring

Patients buying new hearing aids typically have a two- to four-week home trial period before making the final purchase decision. Patient satisfaction during this time is crucial to the ultimate adoption of hearing aids. Unfortunately, this is also typically a “blind spot” for HCPs, because with the patient out of their office, they are not physically present to answer question and provide guidance when problems arise.

Telehealth apps for hearing aids allow wearers to rate their daily satisfaction. Apps can assign various listening activities for the patient to complete, such as “have dinner at a noisy restaurant” or “listen to music”, and then ask the patient to rate their satisfaction with the hearing aids in those situations.  Satisfaction ratings are sent to HCP via the app, so that the latter can actively intervene to address patient concerns in a timely manner without waiting until the next follow-up appointment.

Telehealth apps serve as a practice differentiator

The hearing care industry is a competitive field. Patients can choose from independent hearing care practices, those affiliated with physicians, hearing aid dispensing chains, “big box” wholesale stores, or even bypass the HCP altogether and choosing an amplification product online or “off the shelf.”

One of the ways a hearing care professional can stand out from the crowd is by offering exceptional service. With in-app text and call features, telehealth apps promise potential patients access to the hearing care professional’s expertise and guidance even outside of regular office hours, the convenience of fewer in-office visits, and in-app usage and troubleshooting information.  These advantages can be promoted as a part of the “white glove service” that HCPs can leverage to promote their practice.

Telehealth tools are good for business

Telehealth tools can help HCPs generate revenue in more than one way.  First of all, time is money. By reducing the number of follow-up visits, telehealth apps help free up more time for professionals to attend to revenue-generating tasks, such as diagnostics or new patient fittings. And the increasing number of younger, tech-savvy, and smartphone-dependent patients with hearing loss will be attracted to HCPs who offer conveniences like telehealth apps.

Ultimately, patient satisfaction leads to business success. By being able to monitor patient satisfaction with their new hearing aids during their home trial period, and intervene quickly when problems and doubts arise, professionals can use telehealth apps to minimize barriers that otherwise result in hearing aid returns.

Although there are smartphone apps now that help us with almost every aspect of our lives, telehealth tools that use such technology are still relatively new to the hearing care profession. As they become increasingly powerful and popular, we can expect them to bring even more benefits to patients and hearing care professionals in the future.

Photo: IAN HOOTON, Getty Images

New Bos Sci acquisition raises question: Will the Lotus (valve) ever blossom?

Boston Scientific has long expected to be the third wheel to Medtronic and Edwards Lifesciences in the U.S. transcatheter aortic valve replacement (TAVR) marketplace.

It has sung the praises of it Lotus TAVR valve but the product line stands pulled from Europe because of device malfunctions. and has suffered delays in its regulatory pathway in the U.S. And now, while senior management of the company argue that Lotus valve’s introduction in the U.S. is still on track for mid 2018, a transaction announced last week may allow the company to introduce a wholly different TAVR device to the marketplace.

On Thursday, Marlborough, Massachusetts-based Boston Scientific shelled out $435 million in cash to purchase structural heart company Symetis. The Swiss company makes the Accurate and  Accurate neo/TF valve systems for patients suffering from severe and symptomatic aortic valve stenosis and those who have a high-risk of undergoing open-heart surgery.

“The steps we are taking reflect our commitment to being a leader in TAVI and structural heart technologies now and over the long-term, as we broaden our portfolio and pipeline to address the needs of our global health care providers and their patients,” said Ian Meredith, M.D., executive vice president and global chief medical officer, Boston Scientific in a news release. “The ACURATE family of valve products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings for varying patient pathologies and anatomy.” [TAVR is termed transcatheter aortic valve implantation (TAVI) inEurope]

Some analysts did not fully buy the line on Lotus being the cornerstone TAVR product

“… with Lotus being delayed multiple times, taken off the market in Europe, and with BSX yet to launch all five sizes, one has to wonder if this is a backup plan and if Lotus may not be as ready to go as the company hopes,” wrote Sean Lavin, an analyst with BTIG, in a research note on Thursday. “While BSX paid a hefty multiple and this deal may indicate Lotus isn’t quite ready at this point, we see having a backup option as a positive in this multibillion dollar growth market.”

Boston Scientific paid 12 times the 2016 revenue of Symetis, which was $38.2 million last year.

Another analyst — Danielle Antalffy of Leerink Partners —said that the purchase will provide “air cover” for the six-plus months that the Lotus valve is expected to be off of the market. Still, most analysts viewed the deal positively.

The transcatheter aortic valve space is dominated by Medtronic and Edwards Lifesciences in the U.S. though in Europe the two heavyweights have smaller rivals. It is also a place that has seen numerous legal fights over patent infringement.

Edwards Lifesciences prevailed over Medtronic in 2014 in its long battle and the saga ended with the Irish medtech company agreeing to pay royalty payments of at least $750 million to Edwards Lifesciences.

Meanwhile Boston Scientific and Edwards are in the midst of their own legal battle over TAVR. In Nov. 2015, the Massachusetts company slapped a  lawsuit against Edwards in Germany related to its European patents pertaining to outer seals of transcatheter heart valves. Edwards countersued, alleging patent infringement by the Lotus valve.

On March 3, a U.K court ruled that the Lotus valve did infringe on one of Edwards’ patents surrounding its TAVR valves but not the other. It also noted that the Sapien 3 valve from Edwards infringes two of Boston Scientific’s patents for outer seals of transcatheter heart valves. A German patent court issued a similar ruling days later. Edwards has promised to appeal.

In other words, the ” TAVI space is fluid and litigious,” wrote Lavin in the research note and he concluded that “With all the various IP issues, manufacturing issues, doctor preference, and different valves offering different benefits, the reasons for buying Symetis could be multifactorial.”

Photo: Ian Fung Koo / EyeEm, Getty Images

Reducing cardiovascular disease risk with omega-3s

Cardiovascular disease (CVD) remains the number one killer of Americans, and by 2030, nearly 44 percent of U.S. adults will have some form of the disease. [1] It has long been recognized that consumption of omega-3 fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can help reduce the risk of CVD. [2,3]  Indeed, joint recommendations from the American College of Cardiology (ACC) and the American Heart Association (AHA), [4] and the 2015-2020 Dietary Guidelines for Americans [5] advise dietary patterns that include fish and/or an increased intake of EPA and DHA.

Reducing CVD Risk: Recent Findings

Numerous clinical studies and meta-analyses link intake of omega-3 fatty acids with reduced risks for CVD-related events and death. [6,7,8,9,10,11,12,13]  The most comprehensive assessment of the relationship of EPA and DHA (since both are typically found in fish, fish oil, and algal oil supplements) and coronary heart disease (CHD) was recently reported in the Mayo Clinic Proceedings . [14]  Drawing from more than 3,800 studies published from 1947 to 2015, the researchers identified 18 randomized controlled trials (RCTs) and 16 prospective cohort studies (PCSs) that reported CHD outcomes (e.g., myocardial infarction, angina, sudden cardiac death and coronary death) and met other criteria. The two groups of studies included approximately 93,000 and 732,000 participants, respectively.

Using meta-analysis models, the investigators calculated summary relative risk estimates (SRREs) for CHD outcomes. For the RCT analysis, they compared the risk of CHD events for intervention-group participants consuming EPA and DHA, primarily from supplements (a few RCTs used fatty fish), compared to control-group participants who did not; for the PCS analysis, they compared the risk of CHD events associated with high vs. low intakes of EPA and DHA from all sources, including diet and supplementation. The analysis showed EPA and DHA reduced the risk for CHD events, especially in people with high serum triglycerides or LDL cholesterol (see Figure).

“The 6 percent reduced risk among RCTs, coupled with an 18 percent risk reduction in prospective cohort studies — which tend to include more real-life dietary scenarios over longer periods — tell a compelling story about the importance of EPA and DHA omega-3s for cardiovascular health,” said lead author Dominik Alexander, PhD, MSPH, Principal Epidemiologist for EpidStat, Ann Arbor, MI. [15] An accompanying editorial in Mayo Clinic Proceedings also acknowledged the importance of the findings. [16]

Scaling Up Fish Intake

On average, Americans 19 years and older consume an average of only 23 mg EPA and 63 mg DHA per day, [17]  far below the 250 mg omega-3s per day recommended in the Dietary Guidelines for Americans. [18] Moreover, about 95.7 percent of Americans have plasma omega-3s below the concentration associated with cardiovascular protection. [19] Knowing the high prevalence of this nutrient gap should encourage practitioners to advise their patients on ways to increase omega-3 intake to recommended levels.

Dietary recommendations for omega-3 intake differ among local and regional authoritative bodies. In the US, the 2015-2020 Dietary Guidelines for Americans advises consuming about 8 ounces per week of a variety of seafood to obtain an average of approximately 250 mg per day of EPA and DHA, an amount associated with reduced cardiac deaths in people with and without preexisting CVD. [20]  The joint AHA/ACC guideline for secondary prevention recommends 1 g a day of omega-3 fatty acids from fish or fish oil capsules for CVD prevention and risk reduction in patients with coronary and other atherosclerotic vascular disease. [21]  For patients who need to lower triglyceride levels, the AHA recommends 2 to 4 g of EPA and DHA per day. [22]  Based on these recommendations, physicians should advise patients to achieve the intake of omega-3s appropriate for their health needs through simple measures, such as incorporating fish rich in omega-3s as part of a heart-healthy diet and/or taking a dietary supplement that provides adequate amounts of EPA and DHA.

To learn more about omega-3s and Know Your Ω™, an educational campaign by DSM Nutritional Products, visit www.KnowYourO.com or visit booth #1717 at the ACP Internal Medicine Meeting in San Diego, CA March 30 – April 1. The Know Your Ω™ website has helpful tools for both physicians and patients, sharing more information on how to best recommend omega-3 EPA and DHA and incorporate them into a balanced lifestyle.

                                                                                                                                                      

References

[1]Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26; 133(4):e38-e360. doi: 10.1161/CIR.0000000000000366.

[2]Mozaffarian D, Lemaitre Rn, King IB et al. Plasma phospholipid long-chain ?-3 fatty acids and total and cause-specific mortality in   older adults: a cohort study. Ann Intern Med. 2013;158:515-25. doi: 10.7326/0003-4819-158-7-201304020-00003.

[3]Krauss RM, Eckel RH, Howard B et al. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the  Nutrition Committee of the American Heart Association. Circulation. 2000;102:2284–99. doi: 10.1161/01.CIR.102.18.2284.

[4]Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S76-99. doi: 10.1161/01.cir.0000437740.48606.d1.

[5]U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at: http://health.gov/dietaryguidelines/2015/guidelines/chapter-2/a-closer-look-at-current-intakes-and-recommended-shifts/.

[6]Delgado-Lista J, Perez-Martinez P, Lopez-Miranda J, Perez-Jimenez F. Long chain omega-3 fatty acids and cardiovascular disease: a systematic review. Br J Nutr. 2012;107(Suppl 2):S201-S213. doi: 10.1017/S0007114512001596.

[7]Kotwal S, Jun M, Sullivan D, Perkovic V, Neal B. Omega 3 fatty acids and cardiovascular outcomes: systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2012;5(6):808-818. doi: 10.1161/CIRCOUTCOMES.112.966168.

[8]Kwak SM, Myung SK, Lee YJ, Seo HG; Korean Meta-analysis Study Group. Ef?cacy of omega-3 fatty acid supplements  eicosapentaenoic acid and docosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials. Arch Intern Med. 2012;172(9):686-694. doi: 10.1001/archinternmed.2012.262.

[9]Rizos EC, Ntzani EE, Bika E, Kostapanos MS, Elisaf MS. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis. JAMA. 2012;308(10):1024-1033. doi: 10.1001/2012.jama.11374.

[10]Chen Q, Cheng LQ, Xiao TH, et al. Effects of omega-3 fatty acid for sudden cardiac death prevention in patients with cardiovascular disease: a contemporary meta-analysis of randomized, controlled trials. Cardiovasc Drugs Ther. 2011; 25(3):259-265. doi: 10.1007/s10557-011-6306-8.

[11]Wen YT, Dai JH, Gao Q. Effects of Omega-3 fatty acid on major cardiovascular events and mortality in patients with coronary heart disease: a meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2014;24(5):470-475. doi: 10.1016/j.numecd.2013.12.004.

[12]Casula M, Soranna D, Catapano AL, Corrao G. Long-term effect of high dose omega-3 fatty acid supplementation for secondary prevention of cardiovascular outcomes: a meta-analysis of randomized, placebo controlled trials [corrected]. Atheroscler Suppl. 2013;14(2):243-251. doi: 10.1016/S1567-5688(13)70005-9.

[13]Wang C, Harris WS, Chung M, et al. n-3 Fatty acids from fish or fish-oil supplements, but not alpha-linolenic acid, benefit  cardiovascular disease outcomes in primary- and secondary prevention studies: a systematic review. Am J Clin Nutr. 2006; 84(1):5-17. Available at: http://ajcn.nutrition.org/content/84/1/5.long.

[14]Alexander DD, Miller PE, Van Elswyk ME, Kuratko CN, Bylsma LC. A Meta-Analysis of Randomized Controlled Trials and Prospective Cohort Studies of Eicosapentaenoic and Docosahexaenoic Long-Chain Omega-3 Fatty Acids and Coronary Heart Disease Risk. Mayo Clin Proc. 2017 Jan;92(1):15-29. doi: 10.1016/j.mayocp.2016.10.018. doi: 10.1016/j.mayocp.2016.10.018.

[15]Global Organization for EPA and DHA Omega-3 (GOED). Press Release. New Study Finds EPA and DHA Omega-3s Lower Risk of Coronary Heart Disease. January 3, 2017. Available at: http://www.prnewswire.com/news-releases/new-study-finds-epa-and-dha-omega-3s-lower-risk-of-coronary-heart-disease-300384474.html.  

[16]O’Keefe JH, Jacob D, Lavie CJ. Omega-3 Fatty Acid Therapy: The Tide Turns for a Fish Story. Mayo Clin Proc. 2017 Jan;92(1):1-3. doi: 10.1016/j.mayocp.2016.11.008.

[17]Papanikolaou Y, Brooks J, Reider C, Fulgoni VL. U.S adults are not meeting recommended levels for fish and omega-3 fatty acid intake: results of an analysis using observational data from NHANES 2003-2008. Nutrition Journal. 2014;13:31. doi: 10.1186/1475-2891-13-31. doi: 10.1186/1475-2891-13-31.

[18]U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at: http://health.gov/dietaryguidelines/2015/guidelines/chapter-2/a-closer-look-at-current-intakes-and-recommended-shifts/.

[19]Murphy RA, Yu EA, Ciappio ED, Mehta S, McBurney MI. Suboptimal Plasma Long Chain n-3 Concentrations are Common among Adults in the United States, NHANES 2003–2004. Nutrients. 2015;7:10282-9. doi: 10.3390/nu7125534.

[20]U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at: http://health.gov/dietaryguidelines/2015/guidelines/chapter-2/a-closer-look-at-current-intakes-and-recommended-shifts/.

[21]Smith SC Jr, Benjamin EJ, Bonow RO et al. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2011 Update: A Guideline From the American Heart Association and American College of Cardiology Foundation. Circulation. 2011;124:2458-73. doi: 10.1161/CIR.0b013e318235eb4d.

[22]Kris-Etherton PM, Harris WS, Appel LJ. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002;106:2747-57. doi: 10.1161/01.CIR.0000038493.65177.94.

What do small business owners think of the AHA, AHCA?

Everyone has an opinion on the American Health Care Act, the new GOP plan to replace the ACA.

A new poll from the Small Business Majority surveyed 500 small business owners from across the country on their opinions on the AHCA. The survey was conducted online between March 17 and March 20 and had a +/- 4.5 percent margin of error.

Survey respondents came from a variety of backgrounds. Forty-eight percent were as male, while 52 percent were female. The majority of respondents (33 percent) were between the ages of 30 and 44, with the next largest proportions coming from the 45 to 54 age range (21 percent) and the 55 to 64 age range (20 percent).

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In a tele-press conference on March 23, Small Business Majority founder and CEO John Arensmeyer discussed what prompted the poll. “We’ve been intimately involved for years talking with small business owners about the ACA,” he said. “With the proposed changes in Congress, we knew this was a huge issue for small business owners.”

Near the beginning of the survey, respondents were asked about their existing knowledge of the ACA. Forty-eight percent of respondents admitted to only knowing “some” about the ACA. Another 24 percent said they knew “a great deal” about it, and 20 percent said they knew “not too much.” Five percent indicated they knew “nothing at all” about the ACA.

Next, the survey questioned respondents as to whether they support or oppose the ACA. Initially, 25 percent of respondents said they strongly support the ACA, while 29 percent said they strongly oppose it.

However, after answering a series of questions about their opinions on certain provisions of the ACA, respondents’ opinions changed slightly. Thirty-one percent said they strongly support the ACA and 24 percent said they strongly oppose it.

The poll then added the AHCA to the mix, initially asking respondents how much they knew about it. Thirty-five percent admitted to knowing “some” about it. Another 16 percent said they knew “a great deal” about the AHCA, and 28 percent said they knew “not too much.” Eighteen percent of respondents admitted to knowing “nothing at all” about the proposed plan.

Once again, the survey asked respondents whether they support or oppose the AHCA. Initially, 14 percent said they strongly support it and 27 percent said they strongly oppose it. After answering questions about specific provisions of the AHCA, respondents’ opinions changed. Fourteen percent of respondents said they strongly support the AHCA, and 33 percent said they strongly oppose it.

Finally, the survey asked respondents whether they would choose the ACA or the AHCA. Thirty-nine percent of respondents were strongly in favor of choosing the ACA, and 10 percent said they would choose the ACA but weren’t as strongly for it. Meanwhile, 16 percent said they were strongly in favor of the AHCA, and 10 percent said they would choose the AHCA but weren’t as strongly for it. Interestingly, 14 percent said they’d choose neither the ACA or the AHCA.

In a press release, the Small Business Majority noted that survey respondents were “politically diverse.” They seem to be, as 28 percent of respondents identified as Democrats, 27 percent identified as Republicans and 38 percent identified as Independents. The remaining 5 percent either indicated “other,” “don’t know” or refused to answer.

However, it’s important to note that a contributor to Forbes and The New York Times has said the Small Business Majority is left-leaning.

Photo: prinaka, Getty Images 

Editor’s note: This article has been updated to reflect that the same contributor wrote in Forbes and The New York Times that the Small Business Majority is left-leaning. A spokesperson for the Small Business Majority also told MedCity that the polling firm used for the survey, Chesapeake Bay Consulting, is right-leaning.

Here’s what C-suite leaders plan to focus on under the Trump administration

President Donald Trump, his administration and a Republican Congress have big plans for changing healthcare. For now, the future of the American healthcare system is up in the air. But healthcare leaders across the country have already started to make initial plans.

Charlotte, North Carolina-based Premier Inc. decided to find out what is top of mind for C-suite leaders now that the new administration has taken the helm. The company conducted an online survey of 63 healthcare C-suite leaders, including CEOs, CFOs, CMOs, COOs, CIOs and CTIOs, between January 3 and February 6.

The results found leaders zeroed in on five primary areas on which they will focus under the Trump administration, according to a press release from Premier. In priority order, they are:

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1. Controlling costs and focusing on drug spending

Sixty-five percent of survey respondents said they will increase their focus on ways of managing the cost of care. Another 61 percent said they plan to concentrate on managing rising drug costs and pharmaceutical spending, which aligns with President Trump’s claims that he wants to decrease drug prices.

2. Heading from meaningful use to meaningful insight

Rather than a sole focus on putting data in EHR systems, respondents indicated they plan to focus on analytic capabilities. Half of the respondents said they will work to increase interoperability, and 53 percent plan to improve data integration and invest in analytics.

3. Consumer engagement

Even with the transition to a new administration, healthcare leaders are increasingly looking for ways to both engage and satisfy consumers. As such, 56 percent of respondents said they want to use telehealth to improve patients’ access to physicians. Another 45 percent plan to build on their organization’s patient engagement initiatives.

4. Movement toward population health efforts

Respondents indicated their interest in the value-based care initiatives lauded by the Obama administration. Of the leaders surveyed, 40 percent said they plan to expand the healthcare team to include nurse practitioners, care coordinators and others. Another 45 percent indicated they will increase their use of post-acute care services.

5. Ongoing focus on clinical quality

Though it’s becoming a standard for healthcare leaders, respondents indicated they will continue to concentrate on quality reporting. While 46 percent of respondents said their organization will increase the use of quality reporting systems such as the Merit-Based Incentive Payment System, 2 percent of respondents said they plan to decrease their investment in such systems.

The results of the survey hint at a future that will revolve around lowered costs and improved quality, according to Premier COO Mike Alkire. “These findings highlight how providers are taking the long view — not just focusing on the here and now, but ultimately on what will be most beneficial to patients and sustain the viability of our nation’s hospitals,” he said in an email to MedCity.

Photo: MANDEL NGAN/AFP/Getty Images

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.

Mass General is giving patients a new way to navigate its campus

Forget the paper maps. Massachusetts General Hospital in Boston has unveiled a new interactive map of its campus for patients, visitors and employees to use.

The map is powered by concept3D’s atlas3D technology. concept3D, a software and services company headquartered in Boulder, Colorado, has used its atlas3D platform to create similar maps for other healthcare organizations, including Roswell Park Cancer Institute, Oregon Health & Science University and the University of Texas Medical Branch.

Mass General’s campus map is built on top of Google Maps, and users can view it in either map mode or satellite mode. They can also use it to get walking directions from one spot on campus to another.

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The map comes complete with information on parking, transportation, dining facilities, pharmacies and buildings around the Mass General campus. It also includes a drop-down menu with details on banks, hotels, museums, post offices, restaurants and a sporting arena near the campus.

Additionally, users can use the map to send personalized links to others to help them find their way around, according to a press release.

Bob O’Melia, concept3D’s vice president of business development, told MedCity the map can assist in improving patients’ and caregivers’ time at the hospital. “We want to reduce that stress level and enhance the patient experience,” he said in a phone interview. “We want to provide a really good 3D digital map that they can explore.”

Mass General’s interactive map is currently patient- and caregiver-focused. But O’Melia mentioned organizations can choose to utilize concept3D’s technology to improve workflow from the employee side as well. For example, concept3D’s platform can be used to help an organization’s security department or human resources department.

concept3D is also in the early stages of working with organizations (though not Mass General) to amp up its technology. “We’re trying to become a little more clinical,” he said. “We’re talking about embedding our map links into appointment reminders.”

Healthcare isn’t the only realm in which concept3D is working. Its atlas3D technology is being used in everything from universities to retirement communities (like Shell Point Retirement Community in Fort Myers, Florida) to convention centers (like Tucson Convention Center in Arizona). “I think it all boils down to lowering frustration levels and enhancing satisfaction levels,” said O’Melia. “We also want to bring [organizations’] buildings to life. People can have an interactive online experience with the campus or buildings before they arrive. Then when they get there, they feel like they know it.”

Photo: Flickr user Tabsinthe https://www.flickr.com/photos/tabsinthe/

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

The robotic have-not: How J&J plans to woo hospitals, knee surgeons

Johnson & Johnson and Verily Life Sciences (formerly Google Life Sciences) have a joint venture to create the next generation of robotic surgery souped up with digital technologies in the future. (Watch out Intuitive Surgical.)

But when it comes to hip and knee replacement today, J&J Depuy Synthes is a robotic have-not.

Competitors have robots or are close to having something robotic in joint replacement.

On Tuesday, Stryker launched its total knee application on the expensive Mako robot during the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego. That same day at AAOS, Smith & Nephew previewed its hand-held robot-assisted device for total knee replacements in advance of a market release in the second quarter. And Zimmer-Biomet was also proudly displaying its robot on the exhibit floor — the Rosa robot acquired with the purchase of French firm Medtech SA – although the robot won’t be doing total knee replacements until 2018.

There is a general notion that robotics will gain ground in orthopedic surgery though the predictions around adoption pace vary greatly.

One analyst — Brandon Henry from RBC Capital Markets — believes Stryker will be the clear winner with the launch of its total knee on its Mako robotic system and will take market share away from Johnson & Johnson DePuy Synthes and Zimmer-Biomet in the next few years. Another — Richard Newitter from Leerink Partners — believes robotics adoption will be much more gradual and only in complex cases but still having one in the short term is better than not having one.

So in the meantime without a robot, how can J&J DePuy Synthes woo hospitals and knee surgeons, some of whom are part of Medicare’s mandatory 90-day bundled payment program called the Comprehensive Care for Joint Replacement.

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Attune Knee on Bone

Company executives are relying on the wide breadth of J&J’s knee offerings, its services chops and a new company-sponsored whitepaper that touts the economic value of its Attune Knee.

“We as a company are moving from a titanium and steel focus to really looking at how can we bring more value to the surgeon,” said Ciro Römer, company group chairman, DePuy Synthes, in an interview on Wednesday at AAOS. “If you look at the actual [knee] platform, 400,000  have been implanted until now with outstanding outcomes. Not great outcomes only with regards to survivorship but more importantly the economic benefit of the Attune knee.”

So what are those economic benefits?

A whitepaper produced by the company and based on data from company-initiated studies, investigator-initiated studies, and independent studies and national joint registries found the following per a company news release: [ Note: Both the whitepaper authors are financially compensated by DePuy Synthes. Dr. David Fisher, director of the Total Joint Center of Excellence at OrthoIndy Hospital in Indianapolis, is a consultant. Co-author David Parkin, an honorary visiting professor at City University  London, and a senior visiting fellow, Office of Health Economics, London, has no formal consulting contract with DePuy Synthes but was paid to analyze the data and produce the report.]

  • The published report from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) showed that the ATTUNE Knee’s estimated cumulative percent revision was 1.39% at three years (98.61% survivorship)for 4,463 knees, comparing favorably to the class of Cemented Total Knee Arthroplasty that has an estimated

    cumulative percent revision of 1.50%.

  • A U.S. hospital database analysis showed 39% lower odds of patient discharge to a skilled nursing facility when implanted with an ATTUNE Knee, compared to patients who received total knee replacement with a Triathlon Knee. [The Triathlon is the total knee implant made by Stryker.]

The latter data point is important at a time when hospitals are racing to reduce the post-acute costs of a joint replacement procedure. The rationale is that if you can reduce use of a skilled nursing facility after the joint replacement implant procedure, some dent may be made in the overall cost.

But not everyone is buying the easy correlation between implant quality and reduced skilled nursing facility use.

Dr. Thomas Barber, an orthopedic surgeon with Kaiser Permanente said he doesn’t pay a lot of attention to company-produced reports.

“You have to take them at face value,” Barber said in a media roundtable at AAOS on Wednesday. “I saw something the other day from a particular vendor who shall be nameless that said that using their total knee replacement will actually lead to lower SNF length of stay and lower SNF use, and I was like, “Really?”

Meanwhile, while such data may not sway hospitals and surgeons, the technology that DePuy Synthes possesses in it services suite might pique their interest.

The company has a partnership with IBM Watson Health through which the Big Data crunching supercomputer can comb through patient profiles and help providers understand their risk profile.

“The system is fed data about patient profiles and based on the patient profile — whether you have high BMI, whether you have diabetes — and that can help determine what kind of preparation, procedure and very importantly the kind of rehabilitation you will need to have and the most likely complication,” declared Juan-José Gonzalez, president, DePuy Synthes, U.S. in an interview with Römer. “No other company has those capabilities.”

Photo: jpa1999, Getty Images and Johnson & Johnson DePuy Synthes

Virtual rehab to gain ground in orthopedics as bundled payments take hold

If you believe that digital health and orthopedics seem mutually exclusive, then you are sadly out of step with the times.

At a panel presentation about alternative payment models and bundled care at the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego on Tuesday, speakers clearly signaled that virtual therapy would be used more and more in the future. Especially now when bundled care programs like the CMS-mandated Comprehensive Care of Joint Replacement (CJR) is in place in 67 metropolitan statistical areas in the U.S.

That should be good news for digital health startups in the field who are eager to prove the clinical validity of their products, as well as help hospitals to lower the overall cost of joint replacement procedures.

Dr. Owen O’Neill, an orthopedic surgeon with Twin Cities Orthopedics, explained how the large ortho group practice with 116 providers implemented a commercial bundle in 2013 and lessons learned from that program, now in its fifth year.

“I can tell you that 97 percent of our bundles actually are financially positive,” O’Neill declared. “Three percent lose so overall financially they are very successful.”

Still, there are challenges. Under the fee-for-service model, physical therapy offered by Twin Cities Orthopedics was a profit center. Now as the group implemented the bundle, they looked at post-acute care as the area in which costs can be cut. And five years into the program, what was a profit center is now a cost center.

“Future directions, on the therapy side we are looking at things like virtual therapy,” O’Neill said.

Later, in response to a question from this reporter, Richard Iorio, an orthopedic surgeon with NYU Langone Medical Center, echoed O’Neill.

“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.

Iorio did not mention which companies and online programs NYU uses but mentioned there are several out there.

Here are a few that MedCity has come across:

Reflexion Health
This San Diego-based virtual rehab company uses sensors, Microsoft Kinect, and the Vera avatar to guide joint replacement patients through their physical therapy at home. This daily exercise routine done in front of a TV reduces the need for patients to go to a physical therapist or can keep them moving in between sessions. The patient’s physical therapist is in charge at all times and can choose to bring him or her in at their discretion. The system also provides a technology solution for hospitals eager to lower their costs to treat joint replacement patients.

The Vera system is cleared by the FDA and also is able to facilitate the collection of patient-reported outcomes as is required for reimbursement.

Jintronix
This Montreal, Canada-based company also uses sensors and Kinect similar to Reflexion Health, as well as adopts elements of gaming to provide visual feedback for users to make physical therapy and occupational therapy exercises more interesting for patients. The company’s FDA-cleared platform targets patients recovering from stroke, hip replacement, hip fractures and knee replacement. It also helps track patients with multiple sclerosis and Parkinson’s disease.

Force Therapeutics
New York-based Force Therapeutics is a remote monitoring company whose digital health platform provides physical therapy to joint replacement patients. What’s more, patients have access to surgeon videos and instructions, and physicians can track patient progress in between appointments. The goal of Force Therapeutics, as with the above companies is to reduce readmission rates that can increase the cost of the joint replacement episode of care.