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Qualcomm pulls the plug on LifeComm
 It’s been more than four years since Qualcomm first announced its plans to help launch a healthcare-focused mobile phone service, called LifeComm. Qualcomm and its (still) undisclosed partners recently decided that it was time to pull the plug on LifeComm after failing to raise additional third party funding, mobihealthnews has learned from an anonymous source.
“Qualcomm is reviewing its options with LifeComm in light of current capital market conditions that have prevented LifeComm from raising the third-party capital necessary to fully develop its initial launch product,” a Qualcomm spokesperson told mobihealthnews when asked for comment. “Wireless healthcare remains a viable and vibrant space. Qualcomm is committed to this market by supporting its partners to enable wireless healthcare solutions. Qualcomm will continue to work with its partners and industry organizations as we innovate and create technologies for wireless healthcare.”
Financing, bridge loans and competitive woes
Qualcomm has been working to establish LifeComm since 2005 but determining the joint venture’s ownership structure has plagued the start-up since its conception. In 2007 Qualcomm CEO Paul Jacobs said that the company’s launch date had been delayed because Qualcomm did not want to be the main investor in a company that offered wireless services. After all, some of Qualcomm’s most important customers are U.S. wireless carriers like Verizon Wireless and Sprint. Continue >>
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BlackBerry: mHealth needs “belts and braces”
For the record, BlackBerry has conducted clinical trials with smartphones paired with Bluetooth-enabled medical peripheral devices for years. Three of the company’s smartphones are among the five most popular smartphones in North America. At least one executive at BlackBerry-maker Research In Motion is a bit curious about all the hype around Apple’s recent medical foray with the iPhone.
mobihealthnews recently had the chance to discuss wireless healthcare trends with Research In Motion’s Fraser Edward who heads the company’s Healthcare Marketing Group. In this second installment, Edward explains the points above and much, much more, including: which types of BlackBerrys physicians prefer, why wireless health needs to adopt a “belts and braces” approach, how RIM’s latest acquisition — Chalk Media — fits into wireless health, and what the BlackBerry App World’s advent signifies. Edward also shares his favorite App World app.
mobihealthnews: Last time we noted that Manhattan Research found twice as many physicians use iPhone this year than last year, but BlackBerry is still the most popular smartphone among physicians.
Fraser Edward: According to the statistics that just came out, three out of the five most popular smartphones sold in North America at the moment are BlackBerrys: the Storm, the Curve and the Bold. As for the other two devices on that list, I’m sure you can guess which ones they are.
mobihealthnews: Any sense of which are more popular with doctors?
Edward: Well, the challenge there is that we tend to sell to the carriers and the carriers sell to the end users, so we don’t have hard intelligence on that. I would say, however, that the touchscreen does have a significant appeal to doctors. That said, device preference tends to rest on how you work. Those physicians who get pages all day long tend to be pretty visual — and those pages can come through the BlackBerry device, as I said before. Maybe the physician will make a call based on that page or they will look at a medical reference app or medical image after getting the page. For that crowd, the larger touchscreen, which is the Storm, would be the preferred device. Of course, it also depends on which carrier you want to go with too or if you have had your number with AT&T for the past 15 years and you don’t want to change. I do think the touchscreen and the larger screen form factors that the Storm represent are very appealing to a lot of physicians. Continue >>
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| CMS slashes CardioNet reimbursement rate
After months of rumors and analyst speculation, Highmark CMS has, after all, cut the reimbursement rate for wireless cardiac monitoring MCOT services from $1,123.07 to $754. While some analysts have been anticipating a rate drop on the order of about $200 for the past few months, the rate cut was almost double that.
CardioNet, the only pure-play wireless health company that has gone public, is credited with creating the reimbursement codes for MCOT or wireless cardiac monitoring from CMS. In the first quarter of this year, CardioNet received Category I CPT Codes and Reimbursement Rates for the professional and technical components of its system, which has set “the stage for a more simplified and stable, reimbursement environment going forward,” CardioNet CEO Randy Thurman said earlier this year.
Since then the reimbursement environment could hardly be called “stable”.
Two weeks ago CardioNet announced a lowered financial outlook for fiscal year 2009 because some commercial payers had planned to reduce their rates for the company’s services, but the company did not include Highmark CMS in that prediction.
During CardioNet’s last quarterly investor call, SVP and Chief Finanical Officer Marty Galvan noted that the company has always assumed some reduction in reimbursement when predicting its earnings through 2011, but Galvan made a caveat: “Candidly the argument is just as strong that we could justify a higher level of reimbursement as there would be any reduction.” Later in the call CEO Randy Thurman assured investors and analysts that the company does not “anticipate any change on reimbursement whatsoever.”
In mid-May, CardioNet announced that Highmark CMS had posted its reimbursement rate for MCOT services as $1,234.07 — the same rate it had always been. At the time Merrill Lynch wrote:
“Yesterday Cardionet announced that Highmark (the insurance carrier that currently sets Medicare pricing for [CardioNet]’s MCOT technology) posted its 2009 reimbursement rate for MCOT last week at $1,123, which represents no change from recent history… Because [CardioNet] has not yet talked directly to Highmark about this posting, the posting does not definitively mean Highmark will not cut reimbursement for MCOT or that CMS will not use a lower rate when it ultimately takes over pricing, but logic would strongly suggest that the probabilities of a near term rate cut are now very low.”
Reimbursement rates are crucial for wireless health companies playing in the clinical space – they directly affect a company’s bottom line because they set the price points that the Centers for Medicare and Medicaid Services are willing to pay clinicians for prescribing the products. Commercial payers use those rates as benchmarks for their own — so the importance of reimbursement can’t be overstated.
No one seems to be beating that drum more loudly than CardioNet founder Jim Sweeney, who is now the CEO of IntelliDOT: ”In the world we’re moving into, more than ever, if you can’t justify the cost benefits, then you will fail,” Sweeney said at a recent conference. “In my view, getting the FDA’s approval is not nearly as hard as getting the CPTs and insurance reimbursement approvals.”
CardioNet’s current stewards might add that approval isn’t nearly as hard as keeping reimbursement levels high.
For more on the CardioNet reimbursement rate kerfuffle, read the company press release.
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| It’s a slow road for glucose meter integration
MYLEstone Health’s Matt Tendler has a worthwhile column today over at Diabetes Health that describes the landscape for diabetes management tools on smartphones — with a special emphasis on the iPhone. MYLEstone created the popular Glucose Buddy iPhone app.
mobihealthnews recently broke the news that Glucose Buddy had inked a deal with Roche to embed some of its diabetes management tools into the app. Read the entire interview here.
Here’s a passage from Tendler’s recent column over at Diabetes Health on the challenging road ahead for meter integration for smartphones:
“Unfortunately, the actual implementation of integrating a meter and the iPhone is a process filled with tribulations-mostly internal factors like budget reviews, business development, marketing, hiring of iPhone developers, legal counsel approval, and so on,” Tendler writes. “Everything moves very slowly at the large corporate level. Plus, external factors such as FDA regulations provide extreme liability for a company at this level.”
Read the entire column here.
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| FDA may regulate some mobiles, accessories
It can come as a bit of a shock to people in the consumer electronics, IT and telecommunications industries that FDA might regulate certain equipment like cell phones that companies are planning to put at the center of connected health services. My goal is to outline the factors that FDA considers when deciding whether to regulate such equipment.
Defining a medical device
The natural place to start is with the definition of a medical device. Since it is so central to the analysis, I’m going to quote the statute verbatim. Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:
“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either]
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or]
intended to affect the structure or any function of the body of man or other animals.”
Components vs. Accessories
In the area of mobile health technology, it’s important to understand that an accessory or a component of a medical device is itself a regulated medical device. Further, the difference between an accessory and a component is who buys it. End-users buy accessories, while manufacturers buy components. Thus the exact same piece of equipment could be either an accessory or a component depending on the target purchaser.
That makes a big difference in terms of applicable regulatory requirements. Components are exempt from most FDA regulatory requirements, with the regulatory burdens being borne by the finished device manufacturer. Accessories, on the other hand, since they go right to the end user, must meet the FDA requirements before they leave the hands of the accessory manufacturer. These differences are summarized in Table A below: Continue >>
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| No deal: CardioNet cancels Biotel acquisition
It’s been a tough couple of months for wireless arrhythmia monitoring company CardioNet: The company has terminated its plans to acquire Minnesota-based Biotel, which has its own cardiac arrhythmia monitoring business, an experienced design and development team plus manufacturing capabilities that were set to support CardioNet’s growing business. The deal was originally pegged at $14 million but, according to a press release from Biotel, CardioNet has pulled the plug.
While Biotel does not mention CardioNet’s latest hiccup in its press release, we wonder if the cancelled deal has anything to do with the recent reimbursement news from Highmark CMS: This past Sunday CardioNet confirmed recent analyst speculation that Highmark CMS plans to cut its reimbursement rate for MCOT services substantially from $1,234.07 to just over $700.
Biotel’s press release states that CardioNet had called the deal off because it said Biotel had failed to comply with the terms of the agreement. Biotel President and CEO Steve Springrose weighed in:
“It is unfortunate that CardioNet took this action. Biotel has developed significant new products in wireless MCT and event recorder applications. These products are of significant value to arrhythmia service organizations, and Biotel believes these products are cost effective and well positioned for the current medical reimbursement climate. Biotel has worked to build its shareholder value by expanding its range of products and services. Biotel will continue to position these new wireless products to maximize growth and opportunities going forward.”
CardioNet originally said it was particularly interested in Biotel’s Agility Centralized Research Services, which is based in Chicago, and provides ECG monitoring services to the medical device and pharma industries as well as to contract research and academic research organizations.
CardioNet’s last big acquisition was PDSHeart in 2007. The financial terms of that deal were not disclosed but the Biotel acquisition is tiny in comparison.
For more on the terminated acquisition, read Biotel’s statement after the jump. Continue >>
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| DexCom taps Topol for board seat
Continuous blood glucose monitoring company DexCom has appointed Dr. Eric Topol to its board of directors.
Topol also serves as Director of the Scripps Translational Science Institute, Founding Member and Chief Medical Officer of the West Wireless Health Institute, Board Member of Triage Wireless and was on CardioNet’s Scientific Advisory Board previously. DexCom looks to be the first wireless health company focused on diabetes that Topol has taken under his wing. It’s worth noting that the West Wireless Health Institute recently announced its first clinical trial would be with Corventis, a wireless remote monitoring company for heart issues.
During an interview with mobihealthnews a few months ago, Topol explained his take on whether chronic disease management should be automated or whether it should rely on the patient to enter the data: ”I think you want both, but you don’t want to rely on patients to enter their own data,” Topol said. “It doesn’t work too well. As a cardiologist, I have patients that enter their blood pressure data and just fax or email it to me, but they don’t want to do that. If I do get it, it’s often an incomplete record. So, I’d like to see this information automated.”
“On the other hand, we want to get that information available to the patient so that they can see it and so that it helps to empower them,” Topol continued. “We don’t want to rely on individuals to manually enter anything, because it just doesn’t get done efficiently. This is especially true if you are doing continuous or near-continuous monitoring. In that case it’s just impossible.”
DexCom’s approach seems to strike the kind of balance between patient empowerment and automation that Topol described.
DexCom’s star product right now looks to be the Seven Plus Sensor, which includes a CBGM sensor that is FDA-approved for seven days of wearing. The monitoring software also includes hypo-alerts, hypo safety alarms and various types of beeps for customization. The device is wireless and water-resistant, too. For more information on the device, check out this write-up from the popular diabetes-centric blog, SixUntilMe, penned earlier this year.
For more on Topol’s appointment to DexCom’s board, read the company press release after the jump. Continue >>
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| Modavox buys new mHealth marketing co.
In late April Augme Mobile, a consumer mobile marketing company, announced a joint venture with Brandofino Communications to form Augme Mobile Health, a specialist in mobile marketing technology for the pharmaceutical industry. This week online broadcasting company Modavox completed its acquisition of Augme Mobile and with it, Augme Mobile Health.
“I see so many possibilities for mobile technology for physicians and patients, and am thrilled to be working with Augme,” Jeannette Brandofino publisher of Brandofino said in April. ”Augme Mobile Health technology will now be encrypted to fulfill HIPAA requirements and will be fully PhRMA-compliant.”
Brandofino publishes Doctor’s Digest, which is available in print and e-subscriptions, vodcasts, podcasts and through an iPhone app.
Augme Mobile Health makes use of text messaging, 2D coding, Shazam visual scanning and audio voice recognition among its mobile marketing technology offerings. Augme says that its ”proprietary technology allows pharma brands to deliver relevant information and offers, to all kinds of mobile devices from any platform or carrier instantaneously.”
For more on the acquisition, read the company press release after the jump: Continue >>
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| Report: $4.9B WiFi healthcare device market
The revenue from worldwide sales of WiFi-enabled healthcare products will reach nearly $5 billion in 2014, according to a recent report from ABI Research. The figure represents an increase of almost 70 percent over today’s market.
“It’s a pretty big business,” ABI Research vice president Stan Schatt said in a statement. “The strong uptake of WiFi in the health industry is underpinned by its need for improved asset management, staff mobility, transfer of digitized records, and standardized administration of medications. In addition, government security requirements including HIPAA often mean replacing older wireless equipment with modern versions.”
“No one vendor has all the necessary pieces to make a complete system for a major medical institution,” says Schatt. “It is truly a Tower of Babel.”
ABI’s market prediction comes on the heels of ON World’s recent prediction of a $6 billion wireless smart home market by 2012.
For more, check out the ABI press release.
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| Shorts: Bayer, Nintendo, Kaiser Permanente
iPhone as hearing aid sounds dubious: TechCrunch points out that the industry may still have a long way to go before we see commercial launches for blood glucose monitors and blood pressure pumps that connected to the iPhone, some health and disability-related apps are available. That includes soundAMP, a hearing aid application that’s available in the AppStore for $9.99. More
Kaiser Permanente’s Annual Report: While it doesn’t seem to mention the nationwide text message reminder service yet, Kaiser Permanente’s 2008 Annual Report came out recently with a number of impressive metrics: 3 million members actively use My Health Manager and they send KP about 600,000 e-mails each month. The users have viewed 26 million test results online, and have filled 3.5 million prescriptions online. Members who book appointments online are up to 50 percent more likely to keep them, KP reported. More
From dedicated devices to mobile health apps: VentureBeat reports on Monrovia, Calif.-based StayHealthy, which recently introduced two health monitoring devices into the market after extended use by researchers. The devices are a body composition machine ($99.95) and a calorie tracker ($69.95). StayHealthy is also developing phone-based apps to help users monitor calorie burn rate that should hit app stores later this year. More
Meter integration for portable video game systems: Bayer teamed up with Paul Wessel, parent to a child with Type 1 diabetes, to create “Didget”, a blood glucose meter which plugs into the handheld (and WiFi-enabled) Nintendo DS. If the child (or adult) consistently checks their glucose levels, they are rewarded with points in a game that can be used to buy items or unlock levels. More
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Parks Associates Webcast: Wireless Technology and Personal Health Applications
July 23
What are the new innovations in wireless technology and its applications for healthcare?
This webcast addresses:
- Market and growth opportunities in the global mobile healthcare market
- Personal health applications and services benefiting from mobility & connectivity
- Mobile personal health platform developments from healthcare service providers, mobile carriers, and start-ups?
Register here ($295)
The World Health Care Congress Leadership Summit on Wireless Health
July 27-28, Boston
This two-day Summit convenes policy-makers, payers, providers and medical group practices from across the nation to discuss business and clinical opportunities for integrating mHealth, Remote Monitoring and Telehealth solutions into existing care systems. Real-life, case studies and the results to-date from pilots at several leading provider organizations will be shared.
Save $300! Enter promo code JXS955 at registration!
Register here
The 5th Annual Smart Services Leadership Summit
July 27-29, San Diego
The premier, invitation only gathering for business leaders and technology experts to explore the growth of M2M and Smart Services across industries, shaping entirely new services and business models.
Register here
The Inaugural Medical Device Connectivity Conference & Exhibition
September 10-11, Boston
This innovative conference and exhibition focuses on the integration of medical devices and information systems. The conference will feature in-depth coverage of strategy and implementation as well as legal/regulatory issues. Keynote speakers include: Tim Gee, Medical Connectivity Consulting and Julian Goldman, MD, Partners HealthCare Biomedical Engineering.
Register here
ATA Mid-Year Meeting
Sept. 24-25, Palm Springs
The Third Annual ATA Mid-Year meeting is one great meeting combining two great tracks & showcasing the latest in products and services:
Track I:
Cutting Edge and Off-The-Shelf Technology: Making the Right Decisions
Track II:
4th Annual Pediatric Telehealth Colloquium
Register here
MobiHealthNews PRESENTS:
Everywhere Healthcare
October 8, San Diego
With today’s wireless networks, the doctor is always in. While connecting patients to caregivers has never been easier, the search for the right business models for wireless health devices and services has just begun.
Don’t miss your appointment at the MobiHealthNews Presents: Everywhere Healthcare event during International CTIA WIRELESS I.T. & Entertainment 2009!
OPEN TO ALL REGISTERED ATTENDEES! There is NO separate registration fee for this event and it is included in ALL registration packages. Please see registration form for details.
Register here
CTIA WIRELESS I.T. & Entertainment 2009
October 6-9, San Diego
No matter what your business is – healthcare, entertainment, fleet management or financial planning – wireless can transform how you do business. International CTIA WIRELESS I.T. & Entertainment brings this possibility to life. With a focus on applications, network architecture and technologies such as LBS, machine-to-machine and WiMAX (just to name a few), this international event brings a community of users, carriers, developers and manufacturers together to generate dialogue, share ideas and debate the economics of MOBILE BUSINESS.
Register here
Health 2.0
October 6-7, San Francisco
With nearly a hundred speakers and plenty of new healthcare demos and technologies on display on stage and in the exhibit hall, you’ll get a sweeping overview of the ways that information technology and the web are changing healthcare. We’ll be looking at the “traditional” Health 2.0 areas like vertical search, online social networks and tools for consumers. But the conference will also be focusing on how new technologies are connecting patients and clinicians, and examining the impact of Health 2.0 technologies on patients lives.
Register here
TEDMED 2009
October 27-30,
San Diego
The fifth in a series created by Marc Hodosh and Richard Saul Wurman, TEDMED celebrates conversations that demonstrate the intersection and connections between all things medical and healthcare related: from personal health to public health, devices to design and Hollywood to the hospital. Together, this encompasses more than twenty percent of our GNP in America while touching everyone’s life around the globe.
Register here
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