Theranos’ recent troubles on their blood testing (Walgreens halting expansion, FDA halting nanotainers as ‘uncleared medical devices’ and last week chain grocery/drugstore Safeway dropping their $350 million deal for 800 locations) have been well covered in media both here and elsewhere. But what if their Unique Selling Proposition–that people should have the ‘basic human right’ to order up their own inexpensive blood tests and then be responsible for their own interpretation–is counter-productive for many patients? After all, it’s what Theranos has been organized and raised $400 million+ on. Dr Robert Wachter of UCSF, who is no top-down Ezekiel-esque ‘nanny stater’, lends a caution: “There are a lot of companies, including Theranos, that have an interest in making you believe that more data will magically make you healthier. It won’t, at least not in the short-term.” When is ’empowerment’ confusing without recourse to interpretation? Some results are easier to read than others. Does having the data make the average person healthier for real? Personally, this Editor would welcome the ability to walk into her local Walgreens and order up a few to see what’s up–but then again she can do her own research and ask a doctor or nurse to help. Who can (inexpensively) close the interpretation gap? Theranos is wrapped in scandal but goes hard to change laws to its advantage (Mashable)
Theranos/FDA update: nanotainers are ‘uncleared medical devices’
And the battering of their USP continues. On the heels of Walgreens Boots Alliance (which this week proposed a merger with #3 Rite Aid to create the largest by location US drugstore chain) putting a screeching halt on expanding its 41 Theranos testing locations, the FDA has told Theranos that its nanotainers are actually ‘uncleared medical devices’ which further violate because they are being shipped over state lines. The company was also scored on handling complaints poorly, keeping poor records and failing to conduct quality audits including on the manufacture of the nanotainers. These were revealed on redacted FDA Form 483s filed as a result of a month-long inspection ending in mid-September, which were published per a Freedom of Information Act (FOIA) request. According to MedCityNews, the nanotainers were mistakenly classified as Class I and not II. Fortune quotes one of the reports: “The design was not validated under actual or simulated use conditions,” (more…)
Integrating inexpensive lab testing, imaging to EHR–and vice versa
In the Dr Eric Topol patient-driven world, personal lab testing would be walk in, keep retail hours and not even need a doctor’s order. That is the model for Theranos, a well-funded low cost blood testing company operating 43 centers in California, Arizona (no doctor order needed) and one Pennsylvania Walgreens. Their latest alliance is with EHR physician practice giant Practice Fusion, which claims about 112,000 doctors actively using its cloud-based, ad supported platform, claims to be the fastest growing US EHR with at present 100 million patient records. The Theranos reporting app, which also connects patients with doctors who can help interpret the results (MD Connect) integrates with other EHRs (though not listed) and now the results will also show in their Practice Fusion patient record. Practice Fusion is also integrating imaging center RadNet‘s results.
Since the late 2000s, Practice Fusion has historically been the game changer in cost (one of the first in the cloud) and in catering to smaller practices. They are good at managing their hype, but as Neil Versel points out, there’s been a CEO ‘change-lobsters-and-dance’, there are questions about revenue and their awaited IPO seems far away, especially given the recent market upset. Hospital EHRs Cerner, Epic and NextGen now all have lower-cost practice versions that integrate with hospital versions. An American College of Physicians (ACP) 2014 survey identified that Practice Fusion is third (and tied with others) among most used practice EHRs behind Epic and eClinical Works, though strongest in solo practices. On the polar opposite of Mr Versel’s skeptical article is this breathless Forbes piece which confuses partnerships with acquisitions. Perhaps self-made billionaire Theranos CEO Elizabeth Holmes may decide to buy Practice Fusion!
2014: a few quotes
As a coda to yesterday’s review of our predictions for 2014, here are a few quotes that particularly struck this editor as of interest in 2014, sometimes because of what was said and sometimes because of who was saying it – it’s left to the reader to decide which.
Arthur L. Caplan, Director of Medical Ethics at the New York University Langone Medical Center at the end of an interesting piece in the New York Times on the finer points of genetic testing said:
If you want to spend wisely to protect your health and you have a few hundred dollars to spare, buy a scale, stand on it, and act accordingly.
Three months later, Anne Wojcicki, the founder of 23andme – one of the genetic testing organisations mentioned in the last clip – was quoted in this Medcity News piece as saying: (more…)
Looking back over Telehealth & Telecare Aware’s predictions for 2014
Looking back over our predictions made on 31st December last year, it’s hard to quibble with any, and worth hanging on to those that didn’t come good this year.
Our first was
Security and data privacy issues will become a serious mHealth issue in 2014; developers failing to take great care over security and privacy issues will risk very adverse publicity and worse.
Job done: that certainly proved correct, with many being exposed as either selling or potentially selling private information. Clinicians were not immune from privacy invasion either. Here is a US summary of the issues. Attention was drawn to an EU Article 29 data protection opinion (actually published in 2013) that sought to clarify the legal framework applicable to the processing of personal data in the development, distribution and usage of apps on smart devices, and the obligations to take adequate security measures. Many apps got hacked too, including FDA-approved ones. There were also items, such as this one, demonstrating how complex the law is in this area in the US. In the EU, the arrival of the Data Protection Regulation in 2015 (now some say 2016) will undoubtedly improve data privacy significantly, though the failure to treat data used for health purposes differently from (more…)
Tunstall’s challenging year: results reported
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/07/Big-T-thumb-480×294-55535.gif” thumb_width=”150″ /]Breaking News. The topline of Tunstall Healthcare Group’s 2014 results (through 30 Sept 14) is now (partly) public thanks to the Yorkshire Post, Tunstall’s ‘hometown paper’. (We do note that it was published on 23 Dec, in the ‘dead of night’ rolling up to the Christmas holiday.) Notably, there is no report on the Tunstall website and it is too early to show on standard corporate reporting sites such as DueDil and CompanyCheck. The YP article appears to be written partly in press release-speak, which we do not fault them for on limited news available. In summary:
- In the 2014 FY ended 30 September, revenues were £215 million. FY2013 was £221 million, a decrease of £6 million (2.7 percent).
- A corresponding but greater EBITDA (earnings before interest taxation depreciation and amortization) drop to £43.0 million. FY 2013 was £52.7 million, a decrease of £9.7 million (18.4 percent).
- The good news: revenues up 6.8 percent in the Nordics, Southern Europe, Central Europe, and Australasia; Spain’s Televida as a market leader also a bright spot [TTA 19 Dec].
- No such good news in UK and the US (more…)
A boffo week for telemedicine. Will 2015 be online visits’ Big Year?
(Boffo: extremely good or successful, sensational–Webster)
Adding to Monday’s news of ATA’s telemedicine accreditation program was American Well‘s near-simultaneous announcement of an $81 million Series C funding. This brings total funding for the eight year-old Boston-based company to over $128 million, though it is not yet profitable. According to Modern Healthcare, “The capital injection will be used to serve a number of big projects the firm has underway, company co-CEO Dr. Ido Schoenberg said in an interview. Among those are campaigning to ease regulatory constraints, scaling its provider networks and customer outreach, working with insurers to secure more favorable reimbursement and working on its technology, he said.” The institutional, private equity, and corporate investors alluded to in the company release were not disclosed. Its mobile app, Amwell, claims over 1 million downloads with a year-to-year 1,000 percent increase. Major partners include payers Anthem Health, EmblemHealth, the Blue Cross Blue Shields of Massachusetts and Louisiana, Optum Health as well as corporate clients. American Well press release, BostonInno, SEC filing. (Note to American Well: you’re telemedicine, not telehealth)
If this round of funding represents a substantial bet on American Well’s future, another is the new relationship between Walgreens‘ and rival MDLIVE. (more…)
Soapbox: How healthcare disruption can be sidetracked
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/Thomas.jpg” thumb_width=”170″ /]Ron Hammerle’s comment on Disruptive innovation in healthcare hasn’t begun yet: Christensen (TTA 31 Mar), posted on LinkedIn’s Healthcare Innovation by Design group, made the excellent point that a potentially disruptive and decentralizing healthcare service–retail clinics–has been sidetracked, at least in the US, leaving an open question on their reason for being. This Editor thought it was worthy of a Soapbox. Mr. Hammerle knows of what he speaks because his Tampa, Florida-based company, Health Resources Ltd., works with retail and employer-based clinics to connect them via telemedicine/telehealth systems with medical centers.
When Clayton Christensen first anticipated that retail clinics would be disruptive to the established healthcare industry, their business model was potentially disruptive. What has subsequently happened, however, is a prime example of how potentially disruptive movements can be sidetracked.
After acquiring MinuteClinic and laying the foundation for taking retail clinics national, CVS Caremark chose to make deals with hospitals, which could easily afford to rent, open and operate such clinics without making money on the front end or facing real disruption. Retail clinics were a loss leader to hospitals in exchange for large, downstream revenues, and slightly-enhanced market share for the retailer’s pharmacy.
After CVS shocked Walgreens with one-two punches involving MinuteClinic and Caremark acquisitions, Walgreens came back with three counter-punches of its own:
1. They doubled the number of their clinics (to 700) in less than two years, thwarted AMA opposition, leapfrogged ahead of CVS in clinic count and totally changed the retail clinic model by setting up politically-invisible, broader service, make-your-profit-up-front, employer-based clinics. (more…)
Powerhouse DC lobbying for telehealth, telemedicine
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/02/gimlet-eye.jpg” thumb_width=”150″ /]The Gimlet Eye observes from a houseboat anchored at a remote Pacific island, with coconuts and occasional internet to Editor Donna.
Telehealth and telemedicine have reached a US milestone of sorts: the formation of a Washington, DC-based ‘advocacy’ (a/k/a lobbying) group constituted as a business non-profit. The Alliance for Connected Care is headed by three former Senators (two of whom were ‘amigos’) from both sides of the aisle and backed by a board including the expected (giants Verizon, WellPoint, CVS Caremark, Walgreens)–and the surprising (much smaller remote consult provider Teladoc and HealthSpot, the developer of the HealthSpot Station kiosk–hmmm, must be a fair chunk of their marketing budgets there) flanked by six well known ‘associate members’ including Cardinal Health and Care Innovations (another hmmm). There’s also a hefty ‘advisory board‘ including the American Heart Association and the NAHC (home care). The leadership team members are all members of major Washington law/lobbying firms. Tom Daschle is recognized as one of the most influential former Senators in town via DLA Piper, though himself not a registered lobbyist (OpenSecrets.org). Trent Lott and John Breaux hung out their own shingle and were recently bought by mega-lobbyist Patton Boggs. To put a fine point on it, more high-powered one does not get. The Eye sees that the time is prime for the Big Influence and…
What the Eye sees is Big Financial Stakes: Private insurers are required to cover telehealth in 20 states, as does Medicaid in most. The VA is a major user. But the great big trough of Medicare is new territory; covering 16 percent of the population, the use of telemedicine and telehealth is limited to certain geographic areas. (MedCityNews) This marks the infamous tipping point: the clarion call to ‘build significant and high-level support for Connected Care among leaders in Congress and the Administration’, ‘enable more telehealth to support new models of care’ and ‘establish a non-binding, standardized definition of Connected Care through federal level multi stakeholder-input process’ (whew!) Big companies want in, insurers want reimbursement, and they want it from somewhere as well. Toto, we’re not in the Kansas of Small anymore with ‘connected health’–we are now in the Oz of Big Money and Power Players. Alliance release (Oddly the website looks preliminary despite the big announcement and backing.)
More on this strategy: It’s called ‘soft lobbying’ and it is the latest thing in the Influence Wars. The Alliance for Connected Care is a 501(c)6 non-profit, similar to a business league like the Chamber of Commerce, and this has become a popular tactic. It’s also a less regulated, less transparent way to shape coverage, public opinion and exert influence on legislators. See this well-timed examination from the Washington Post on the corn syrup versus table sugar wars. ‘Soft lobbying’ war between sugar, corn syrup shows new tactics in Washington influence
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